ADVIA Centaur XP Reference Manual

ADVIA Centaur® XP Immunoassay System

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ADVIA Centaur XP Operator’s Guide:

© 2007 Siemens Medical Solutions Diagnostics. All rights reserved. No part of this operator’s guide or the products it describes may be reproduced by any means or in any form without prior consent in writing from Siemens Medical Solutions Diagnostics. ADVIA Centaur, ReadyPack, BR (CA 15-3), CA 125 II, CA 15-3, CA 19-9, and TnI-Ultra are trademarks of Siemens Medical Solutions Diagnostics. RealTime Solutions is a servicemark of Siemens Medical Solutions Diagnostics. Corvac and Monoject are trademarks of Sherwood Medical Company. Lexmark is a trademark of Lexmark International, Inc. Microsoft Excel is a trademark of Microsoft Corporation. Microtainer and Vacutainer are trademarks of Becton, Dickinson and Company. Monovette is a trademark of Walter Sarstedt Kunststoff-Spritzgusswerk. Origin: Ireland

The information in this operator’s guide was correct at the time of printing. However, Siemens Medical Solutions Diagnostics continues to improve products and reserves the right to change specifications, equipment, and maintenance procedures at any time without notice. If the system is used in a manner differently than specified by Siemens Medical Solutions Diagnostics, the protection provided by the equipment may be impaired. See warning and hazard statements.

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ADVIA Centaur XP Operator’s Guide: Contents

Contents 1

System Overview

2

Operating the ADVIA Centaur XP System

3

Calibration

4

Quality Control

5

Performing Maintenance

6

Identifying System Problems

7

Managing Data

8

Configuring the System

Appendix A: Safety Instructions Appendix B: Service, Ordering, and Warranty Appendix C: Reagents and System Fluids Appendix D: Supplies Appendix E: Specifications Appendix F: System Symbols Appendix G: Installation and Relocation Appendix H: Glossary

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Index

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Using This Guide This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. The ADVIA Centaur® XP Operator’s Guide provides information for the following clinical laboratory professionals who use the ADVIA Centaur XP system: •

system operators who perform daily operating tasks such as preparing the system, processing samples, reviewing results, and performing maintenance

•

system key operators who perform daily and other tasks such as reviewing control data, managing data files, and modifying system parameters

Organization The following table describes how this operator’s guide is organized. If you want to . . .

Then refer to . . .

learn about system features such as no-pause reloading and onboard refrigeration, learn about user interface components, how to use online information, and view software maps, review the hardware and the operating sequence, review principles of chemiluminescence and assay reaction formats,

Section 1: System Features Hardware Overview, Software Overview, Technology.

process samples, monitor status, or manage sample results,

Section 2: Operating the System.

review Master Curve and 2-point calibration principles, define Master Curves and calibrators, process calibrators,

Section 3: Calibration.

learn about accessing ADVIA QC, define quality control materials,

Section 4: Quality Control.

perform scheduled maintenance activities, record maintenance activities,

Section 5: Maintenance.

investigate and correct system problems,

Section 6: Troubleshooting.

learn about saving results data files to an archive, learn about backing up your system configuration files,

Section 7: Data Management.

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ADVIA Centaur XP Operator’s Guide: Using This Guide

If you want to . . .

Then refer to . . .

modify test definition parameters, modify system parameters, set up LIS and LAS parameters,

Section 8: System Configuration.

review biohazard precautions, review laser precautions,

Appendix A: Safety.

view warranty, legal, and support information, view contact information,

Appendix B: Warranty and Support Information.

view information about primary reagents, ancillary reagents, and system fluids,

Appendix C: Reagents and System Fluids.

view information about ordering supplies,

Appendix D: Supplies.

view system specifications,

Appendix E: Specifications.

view system symbols,

Appendix F: Symbols.

view the glossary,

Appendix G: Glossary.

Conventions The ADVIA Centaur XP Operator’s Guide uses the following text and symbol conventions: Convention

NOTE:

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Description

BIOHAZARD

Biohazard statements alert you to potentially biohazardous conditions.

LASER WARNING:

Laser Warning statements alert you to the risk of exposure to lasers.

WARNING:

Warning statements alert you to conditions that may cause personal injury.

CAUTION:

Caution statements alert you to conditions that may cause product damage or loss of data. On the system, this symbol indicates that you should refer to the operator’s guide for more information. Note statements alert you to important information that requires your attention.

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Convention

Description

Bold

Bold type indicates commands on the user interface, keys, or the exact text that an operator needs to type. For example, if the word save appears as Save, it refers to the selecting the Save button on the user interface. Another example is typing a specific entry into a text box. If the word welcome appears as welcome, it means that you should type that word into the specified field.

Italic

Italic type refers to the title of a document or a section title in this operator’s guide. For example, Operating the ADVIA Centaur XP System refers to Section 2 of this operator’s guide.

Terminology The following table explains some of the special terminology used in this operator’s guide and the specific actions that you need to take when you see the terminology: Term

Description

Select

To select an item, use your finger to touch the item on the touch-screen monitor or select the item with the system pointing device. The background of the item changes color or displays a black frame to indicate that you selected the item.

Enter

Type the specified information using the keyboard and then press the Enter key.

Scan

Move the hand-held barcode scanner over the specified barcode to enter the information.

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ADVIA Centaur XP Operator’s Guide: System Overview

1 System Overview Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 ADVIA Centaur XP System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Visible Status Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Sample Loading Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Reagent Loading Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Test Sequence Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 Supplies and Wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Computer Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

Software Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17 Workspace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17 Workspace Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17 Status Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18 Task Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18 Function Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19

Software Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21 Opening and Closing Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22 Moving Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22 Window Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22

Online Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22 Accessing Online Help Functions: . . . . . . . . . . . . . . . . . . . . . . . . . .1-23 Accessing Online Documentation . . . . . . . . . . . . . . . . . . . . . . . . . .1-23 Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-23 Window Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-23 Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24 Event Code Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

Software Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25 Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-26 Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27 Quality Control, System View . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-28 Quality Control, Applications View . . . . . . . . . . . . . . . . . . . . . . . . . .1-28 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-29 Setup, System View – Summary . . . . . . . . . . . . . . . . . . . . . . . . . . .1-29 Setup – Test Definition Summary . . . . . . . . . . . . . . . . . . . . . . . . . .1-30 Setup, System View – Profile Summary and Data Administration. .1-31 Setup, Applications View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-31 Functions, System View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-32

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Functions, Applications View – RealTime Solutions and IFUs . . . . 1-32 Functions, Application View – Print . . . . . . . . . . . . . . . . . . . . . . . . 1-32

Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 Direct Chemiluminescence. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 Antibody Binding Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-34 Paramagnetic Particles and Magnetic Separation . . . . . . . . . . . . . 1-34

Assay Reaction Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35 Sandwich Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competitive Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AE-labeled Antigen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AE-labeled Antibody . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antibody-capture Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1-36 1-38 1-39 1-42 1-44

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49

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System Features The ADVIA Centaur XP system is an automated, immunoassay analyzer that offers optimal productivity and efficiency. Comprehensive assay groups provide for cost-effective workstation consolidation. The assay groups include fertility, thyroid function, oncology, cardiovascular, anemia, therapeutic drug monitoring, infectious disease, allergy, adrenal function, and metabolic. All the assays use direct chemiluminescent technology. Tests performed using the ADVIA Centaur XP system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis is not based on the results of a single test. Only a physician can make a diagnosis after evaluating all clinical and laboratory findings.

Intended Use This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. The ADVIA Centaur XP has many features for enhancing laboratory operations: Feature

Description

No-pause Reloading

You can load samples, reagents, and supplies at any time, even while the system processes samples.

Optimal Productivity

The throughput is up to 240 tests per hour and the walkaway time is up to 840 tests.

Automatic Reflex Testing

The system automatically schedules reflex tests based on parameters that you define.

Onboard Refrigeration

Reagents remain in the refrigerated reagent areas, so you can process samples without time-consuming system preparation.

True Stat Capabilities

The system efficiently processes Stat requests via a dedicated Stat port without disrupting sample processing.

Clot Detection and Management

The system ensures sample integrity by detecting complete obstructions in the sample probe, notifying you of the condition, and then performing management and recovery tasks.

Bubble Detection

The system ensures the integrity of the reagent aspiration and dispense in the reagent and the ancillary probes.

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ADVIA Centaur XP Operator’s Guide: System Features

Feature

Description

Automated Cleaning

The system automatically performs the daily cleaning.

Autoschedule Daily Cleaning

You can set up the system to automatically schedule and log the daily cleaning procedure in the Maintenance Log.

User Interface

The intuitive graphical user interface is via a touch-screen monitor making it possible for you to perform your daily tasks directly on the screen without using the keyboard. Context-sensitive help is available for any window or field.

LIS Interface

Bidirectional laboratory information system (LIS) interface allows you to send to and receive information from your LIS. The system supports the ASTM interface protocol.

Laboratory Automation

The ADVIA Centaur XP STS sample transport system is an optional feature that enables you to use the ADVIA Centaur XP system with any laboratory automation system.

RealTime Solutions service

The ADVIA Centaur XP system has integrated, pro-active service features that assist in problem detection and remotely initiated diagnosis of problems, having the effect of faster support resolution. The system supports remotely initiated activities like software updates and on-line documentation updates.

Visible Status Light

The ADVIA Centaur XP system has a status light that is visible from most positions in the room. The status lights correspond to events that occur on the ADVIA Centaur XP system.

Hardware Overview The Hardware Overview section introduces the operating sequence of the system and describes the location and function of the major subsystems and components. This information helps you to perform the following tasks: •

operate the ADVIA Centaur XP system for maximum efficiency

•

perform the maintenance tasks

•

understand the basic test processing sequence, which is essential for effective troubleshooting

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ADVIA Centaur XP System The areas of the system that you can access while the system processes samples are shown in Figure 1-1.

1 2 3 4 5 6

Water bottle Waste bottle Primary reagent compartment Sample tip loader Visible status light Cuvette loader

Figure 1-1

7 8 9 10 11

Sample exit queue Stat entry Sample entry queue Cleaning solution System fluids

ADVIA Centaur XP System

Refer to Software Overview‚ page 1-17.

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ADVIA Centaur XP Operator’s Guide: System Features

The ADVIA Centaur XP system uses several areas of the system while processing samples, as shown in Figure 1-2.

1 2 3 4 5 6 7 8 9 10 11

Primary reagent compartment Primary reagent probes Incubation ring Luminometer Base probe Waste probe Cuvette loading bin Aspirate probes Magnets Wash block Acid probe

Figure 1-2

12 13 14 15 16 17 18 19 20 21

Ancillary probe Sample probe Ancillary reagent queue Sample tip tray Inprocess queue Sample entry queue Sample rack Stat entry Sample exit queue User Interface workstation

ADVIA Centaur XP System – top view

Visible Status Light The status light on the system, visible from most positions in the room, displays colors that correspond to events that occur on the ADVIA Centaur XP system. Off

No error or warning conditions exist and the ADVIA Centaur XP user interface screen saver and status buttons are neutral. • The system is turned off. • The light is disabled. NOTE: If the status light is off for an extended period of time, check the user interface error conditions.

Yellow

At least 1 warning condition exists.

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Red Blinking Yellow or Blinking Red

Blinking Green

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At least 1 critical condition exists that may cause the system to stop aspirating or processing samples. • A new event has occurred. • When you open the status window to view the new condition, the status light maintains the current color and stops blinking. • When you correct all warning or critical conditions, the status light turns off. • When you correct all critical conditions and warning conditions remain, the status light changes to steady yellow. A remote update is in progress. If an error occurs during a remote update, the status light changes to blinking red.

Refer to Enabling the Visible Status Light‚ page 8-44.

Sample Loading Area The sample loading area consists of 3 areas as displayed in Figure 1-3: •

the sample entry queue where you load samples

•

the inprocess queue where the samples reside during processing

•

the sample exit queue where you remove samples

Figure 1-3

Sample Loading Area – top view

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ADVIA Centaur XP Operator’s Guide: System Features

Samples are placed in the sample racks, which hold 5 primary sample tubes or sample cups.

1 2

Tube-type selector Sample rack

Figure 1-4

ADVIA Centaur XP Sample Rack

You load the racks in the sample entry queue and remove them from the sample exit queue. You can enter stat samples into the stat queue.

1 2 3

Sample entry queue Sample exit queue Stat entry

Figure 1-5

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Sample Queues

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Racks enter the inprocess queue where the sample barcode scanner reads the barcode labels on the rack and on each sample cup or tube. When the sample rack is in the inprocess queue, the sample probe aspirates the sample.

1 2 3

Sample tip tray Rack Inprocess queue

Figure 1-6

Inprocess Queue

After each sample in the rack is aspirated, the rack moves from the inprocess queue to the sample exit queue.

Reagent Loading Area You can load ReadyPack® primary reagent packs and ancillary reagent packs into their compartments, Figure 1-7, while the system processes samples.

Figure 1-7

Primary and Ancillary Reagent Compartments – top view

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ADVIA Centaur XP Operator’s Guide: System Features

Refer to Loading Reagents‚ page 2-20.

1 2

Primary reagent shelf Primary reagent door

Figure 1-8

3 4

Reagent holders LEDs

Primary Reagent Compartment

Light-emitting diodes (LEDs) on the primary reagent door indicate the status of the primary packs: •

Green indicates that the reagent pack is loaded and available for use.

•

Blinking green indicates that the system detected that a reagent pack is present but cannot read the barcode.

•

Neutral indicates that no reagent pack is loaded in that position or that the pack is depleted, expired, inactivated, or has no barcode.

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You load ancillary reagent packs in the ancillary reagent entry. The system delivers the packs to the ancillary reagent queue. The ancillary reagent queue stores the packs at a temperature of 4° to 8°C (39° to 46°F). You remove ancillary packs at the ancillary reagent entry.

1 2 3

Ancillary queue indicator lights Ancillary reagent entry Ancillary pack

Figure 1-9

Ancillary Queue

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ADVIA Centaur XP Operator’s Guide: System Features

Test Sequence Hardware The test sequence starts at the inprocess queue and the sample probe where sample is dispensed into a cuvette. The inprocess queue moves the sample tip tray to the sample probe and the sample probe picks up a sample tip.

1 2

Sample tip tray Inprocess queue

Figure 1-10

Inprocess Queue

The sample probe aspirates sample from a container in the inprocess queue and then dispenses sample into a cuvette in the incubation ring.

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The incubation ring is a circular, insulated track that advances the cuvette at 15-second intervals and incubates the cuvette at 37°C (98.6°F).

1 2

Magnets Incubation ring

Figure 1-11

Incubation Ring – top view

The incubation ring moves the cuvette from the sample probe to the ancillary probe and to the reagent probes. The ancillary probe aspirates the ancillary reagents from the packs in the ancillary reagent queue and dispenses the reagents into the cuvette in the incubation ring.

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ADVIA Centaur XP Operator’s Guide: System Features

The rinse station rinses the probe with reagent water before each ancillary reagent aspiration.

1 2

Ancillary probe Rinse station

Figure 1-12

Ancillary Probe and Rinse Station

The incubation ring moves the cuvette to the reagent probes. The 3 reagent probes move independently of each other to aspirate primary reagents from the primary packs and to dispense the reagents into the cuvette in the incubation ring.

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Between samples, the rinse stations rinse the probes with reagent water.

1 2

Reagent probe Rinse station

Figure 1-13

Reagent Probe and Rinse Station

The incubation ring moves the cuvette to the wash station. After the magnetic particles are pulled to the side of the cuvette by magnets positioned along the incubation ring, the aspirate probes draw fluid out of the cuvette. The wash station dispenses wash fluid into the cuvette to wash the magnetic particles.

1 2

Aspirate Probe 1 Aspirate Probe Clip

Figure 1-14

Wash Block

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ADVIA Centaur XP Operator’s Guide: System Features

The incubation ring moves the cuvette to the acid probe, which dispenses acid reagent into the cuvette. The incubation ring moves the cuvette to the elevator, which lifts the cuvette from the incubation ring into the luminometer. The luminometer has 3 parts: a photomultiplier tube (PMT) with photon-counting electronics, a base probe, and a waste probe. When base reagent is dispensed into the cuvette, the chemiluminescent reaction occurs. The luminometer measures the light emitted as relative light units (RLUs). The central processing unit (CPU) processes the data from the PMT and converts the RLUs into results. The system sends the results to an LIS or a printer. The waste probe aspirates the waste fluid from the cuvette and the cuvette drops into the cuvette waste bin. As cuvettes exit the incubation ring, the system continuously adds new cuvettes to the incubation ring. You load cuvettes in the cuvette loading bin, then the system moves the cuvettes to the orientation chute. The orientation chute correctly positions the cuvettes before they enter the vertical cuvette chute. The vertical cuvette chute connects to the preheater, which warms the cuvettes to a temperature of 37°C (98.6°F) before the cuvettes enter the incubation ring.

1 2 3

Cuvette loading bin Orientation chute Vertical cuvette chute

Figure 1-15

4 5

Preheater Incubation ring

Cuvette Cycle

Supplies and Wastes You can load supplies and empty wastes anytime the system is processing samples. Refer to Replenishing Supplies‚ page 2-24.

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Computer Hardware The ADVIA Centaur XP computers control system functions and processes data. The applications module is equipped with a CD-RW drive for software updates and for data storage. The computer has several serial ports, as well as an Ethernet port that expands the communication link between Siemens and your laboratory, allowing for enhanced remotely initiated diagnostics and proactive service. The monitor, keyboard, mouse, and barcode scanner are all connected to the computer.

Keyboard The keyboard offers special icon keys.

1 2 3 4

Symbol keys for the status or task areas Sign In key Print key Help key

Figure 1-16

ADVIA Centaur XP Keyboard

You can use the keyboard to make selections, open windows, and enter information. If you want to . . .

Then . . .

open a window from the workspace,

Press the symbol key for the status or the task area. Press the key of the underlined character of the window title.

close a window,

press the Close Win key.

close all windows,

press the Close All key.

go to the previous window,

press the Prev Win key.

go to the next window,

press the Shift key and the Prev Win key.

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ADVIA Centaur XP Operator’s Guide: System Features

If you want to . . .

Then . . .

print information,

Press the Print key. Use the down arrow to select the Report Options button and then press the Enter key.

print the workspace,

Press the Print key. Use the down arrow to select the Print Workspace button and then press the Enter key.

access the Applications view,

Press the QC icon key on the keyboard.

sign in,

Press the Sign In key. Use the Tab key to move to the New Operator field and then enter your initials. Use the Tab key to move to the Password field and then enter the password. Use the Tab key to move to the Sign In button and then press the Enter key.

access help,

Move to the field on which you want help and then press the help key.

Barcode Scanner LASER WARNING

Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. Use the hand-held barcode scanner to enter barcoded information, such as the information on Master Curve cards or Calibrator Assigned Value cards. Place the scanner on the top barcode of the Master Curve card or Calibrator Assigned Value card. Slowly move the scanner down the card over the barcodes. The scanner beeps after successfully reading a barcode. You can also use the hand-held barcode scanner to enter the Sample ID for patient samples. Refer to Scheduling Patient Samples Using a Hand-Held Barcode Reader‚ page 2-52.

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Monitor NOTE: The touch screen may not respond correctly if it is wet or if your finger or gloves are wet.

The graphical user interface is via a touch-screen monitor, making it possible for you to perform your daily tasks directly on the screen without using the keyboard. The monitor is located on a flexible arm so you can adjust the position of the monitor. The area of software called the workspace is always visible on the monitor.

Software Overview Use the ADVIA Centaur XP user interface workstation to control the operation of the system. The user interface workstation consists of hardware and software that you use to interact with the system.

Workspace The workspace provides access to all system functions and information that an operator requires to operate the system. The workspace is similar to a benchtop. At a benchtop, you can pull several reports (windows) from different files (workspace buttons), and spread them out to review or to enter information. Although you can work on only 1 document at a time (active window), the others are ready for you. You can return the report to the file (close the window) or you can leave the report on the benchtop (leave the window open). The workspace has 2 views: •

system view, offering access to system functions Unless otherwise specified, when the procedure says “At the workspace,...” it refers to the system view workspace.

•

applications view, offering access to a set of applications including the ADVIA QC analyzer, the RealTime Solutions service, and the online documentation browser

To change from the 1 view to the other view, press the QC symbol key on the system keyboard.

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ADVIA Centaur XP Operator’s Guide: System Features

Workspace Toolbar The toolbar buttons are grouped into 3 areas at the top of the workspace: status buttons, task buttons, and function buttons. These buttons open windows that contain related information and tasks.

1 2 3

Status buttons Task buttons Function buttons

Figure 1-17

Workspace Buttons

Status Buttons The status buttons open windows that provide information on the condition of the entire system, specific system areas, supplies, and reagents. The status buttons are only available in the system view.

1 2 3 4 5

System status Date and time field Supplies status Sample status Exception button

Figure 1-18

6 7 8 9

Current system state field Reagent status button Maintenance status Event log status

Workspace Toolbar Status Buttons

•

The System Status button provides access to diagnostic tools and the system information

•

The Supplies Status button opens a window that displays information about the cuvette supply, the sample tip supply, system fluid levels, and waste levels.

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•

The Sample Status button opens a window that displays information about the status of samples that are in process.

•

The Exception Status button directs you to the applications view and the ADVIA QC application.

•

The Reagent Status button opens windows that display information about the onboard primary and ancillary reagents.

•

The Maintenance Status button opens a window that accesses the maintenance schedule, the maintenance log, the maintenance definitions, and the maintenance procedures.

•

The Event Log Status button opens a window that displays the events that occurred on the system and provides access to troubleshooting procedures.

Refer to Monitoring Status in Section 2.

Task Buttons The task buttons provide access to windows associated with specific tasks. When selected, each button displays a list of the windows that are available.

1 2 3 4

Worklist button. Quality Control button Calibration button Setup button.

Figure 1-19

Workspace Toolbar Task Buttons

Button

System View

Applications View

Worklist

accesses tasks associated with analyzing samples: scheduling samples, performing dilutions, reviewing results

inactive

Quality Control

accesses control definition windows

accesses the ADVIA QC application

Calibration

accesses calibration tasks: defining Master Curves, defining calibrators, reviewing calibration results

inactive

Setup

accesses setup tasks: defining dilutions, profiles, tube types, and LIS communications

accesses setup tasks: data management, enabling the visible status light

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Function Buttons The function buttons provide additional capabilities related to the workspace, such as signing in, closing all windows, and requesting printed reports.

1 2 3 4 5

Close All Sign In RealTime Solutions - available in the Applications View Instructions for Use - available in the Applications View Print

Figure 1-20

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Software Windows The windows are designed with a common organization. because the purpose of each window is unique, the organization of each window may vary to best achieve the objective of each window.

1 2 3 4 5

Title bar with Help button View, Sort, and Search fields Information display area Bottom buttons Side buttons

Figure 1-21

Diagram of an ADVIA Centaur XP window

•

The title bar indicates the task area and the name of the specific window. The title bar also contains buttons that access window help, move the window behind other windows, or close the window.

•

The View, Sort, and Search fields control the amount or type of information that is displayed, control the order of information displayed, and locate specific items.

•

The information display area displays the information that you selected in View, Sort, and Search fields.

•

The buttons on the bottom of the window perform actions on all information in the information display area or in open related windows.

•

The buttons on the side of the window perform actions or open windows that provide more information about an item you selected in the information display area.

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Opening and Closing Windows You can open and close windows as needed to perform system functions and access information. •

To close a window, select the Close button.

•

To open a window that provides more information about an item in the list, select a side button with an ellipsis (...).

•

To open a window that provides related information, select a bottom button.

Moving Windows When you open multiple windows, you can move the windows to more easily review information or perform tasks To move a window to a new position in the workspace: •

Using the touch screen, hold your finger on the window title bar and drag the window to a new position.

•

Using the system mouse, position the pointer on the title bar and hold down the left mouse button while dragging the window to a new position.

Window Elements Window elements enable you to make selections and interact with the windows. To move a window behind other open windows, select the Move Back button. •

Tables allow you to review information and to select items.

•

Dropdown lists display options.

•

Data fields allow you to enter or display information.

•

Scroll bar arrows scroll the view to display items that are not visible in the list.

•

You can usually select as many options as required in a table. A check mark displays next to the selected options.

•

You can enable 1 item from the group of options using a diamond option button.

•

You can turn an option on or off by selecting or deselecting the option.

Online Information The ADVIA Centaur XP system provides online help and procedures to answer your questions about operating the system, maintaining the system, and correcting system problems. The system also provides online documentation that you can view and print as necessary.

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Accessing Online Help Functions: When you access online help, you can move the window or change its size to make it easier to view your workspace window while you read the help. The online help topic sometimes offers additional information: •

To access additional information, select the hypertext link. A hypertext link, when selected, opens another help window containing more information on the current topic. In the online help windows, hypertext is blue and underlined.

•

To print a help topic or a procedure, select File and then select Print.

•

To move the help window, select the title bar and drag the window to a new position.

•

To resize the window, select the corner of the help window and drag the corner to resize the window.

Accessing Online Documentation The online document windows available in the browser are in the following list: •

Operator’s Guide

•

Customer Bulletins

•

Assays

•

Library

For more information about using the online browser, perform the following steps: 1. At the system view workspace, press the QC icon key on the keyboard. 2. At the applications view workspace, select the Instructions for Use button. The workspace displays the browser with instructions for using the browser displayed on the page.

Help To access help for a window element, place the pointer on field or button and press the right mouse button. You can also move the cursor to a window element and press the ? key on the keyboard.

Window Help Window help provides information about options available at each window and brief instructions for using the window. To access window help, touch the ? button in the title bar or select the ? using the mouse.

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Maintenance Procedures To access maintenance procedures, select a maintenance activity at the Status – Maintenance window, and then select Procedure. Refer to Performing Maintenance‚ page 5-1.

Event Code Procedures Event code procedures provide brief descriptions and procedures for identifying and solving system events. Use the following steps to access event codes: 1. At the workspace window, select the Event Log button. 2. At the System – Event Log window, select Procedure. 3. At the online information window, select Search. 4. Enter an event code. 5. Select Find. 6. Select the event code from the list. Refer to Using the Event Log‚ page 6-1.

Software Maps Workspace buttons open windows that contain related information and tasks.

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System

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Status

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Worklist

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Quality Control, System View

Quality Control, Applications View

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Calibration

Setup, System View – Summary

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Setup – Test Definition Summary

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Setup, System View – Profile Summary and Data Administration

Setup, Applications View

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Functions, System View

Functions, Applications View – RealTime Solutions Service and IFUs

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Functions, Application View – Print

Technology Chemiluminescence is a chemical reaction that emits energy in the form of light.1–5 When used in combination with immunoassay technology, the light produced by the reaction indicates the amount of analyte in a sample. Direct chemiluminescent reactions directly measure the light energy without the use of added steps or amplifying molecules.6 The ADVIA Centaur XP assays use acridinium ester (AE) as the chemiluminescent label, because AE does not require the addition of a catalyst or substrate.6

Direct Chemiluminescence It is easy to automate direct chemiluminescence using AE and provides many benefits, such as long reagent shelf life, fast reaction time, and assay sensitivity. The ADVIA Centaur XP assays use the dimethyl form of AE because its stability allows long reagent shelf life.6,8

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In ADVIA Centaur XP assays, hydrogen peroxide oxidizes AE and maximizes the light emission by changing the environment from acidic to basic. Oxidation of AE occurs rapidly, with peak light emission occurring within 1 second. The rapid reaction time and very low background make direct chemiluminescence with AE faster than RIA or EIA methods.6,8

1 2 3 4

Light intensity Seconds Acridinium ester Other methods

Figure 1-22

Direct Chemiluminescence Comparison

The AE molecule is much smaller than the alkaline phosphatase molecule used in EIA assays. This smaller size decreases blockage of binding sites, increases diffusion rates, and increases the assay sensitivity.8

1 2

Alkaline phosphatase (MW 68,000) AE (MW 481)

Figure 1-23

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Antibody Binding Principles Antibodies are proteins that are produced by the immune system in response to an antigen. Antibodies are ideal for use in immunoassays because they can be produced to bind to specific antigens. In immunoassays, the antigen is the analyte that is being measured.

1 2 3

Antigen Binding site Antibody

Figure 1-24

Antibody Binding

AE can be covalently bound to an antibody without altering the ability of the antibody to bind to an antigen. To measure an antigen, many ADVIA Centaur XP assays use antibodies that are covalently bound to AE.

Paramagnetic Particles and Magnetic Separation Paramagnetic particles (PMP) are iron oxide crystals that are attracted to a magnetic field.7 In the ADVIA Centaur XP assays, PMP coated with antibody or antigen are called Solid Phase.7 Coated PMP provide approximately 50 times the reactive surface area of coated tubes or beads.6

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During incubation, coated PMP in the cuvette bind to the target antigen or antibody. When the system exposes the cuvette to a magnetic field, the magnets draw the PMP bound to antigen or antibody toward them. While the magnets hold the PMP in place, the system washes away sample and reagent not bound to the coated PMP.

1 2

PMP Antibody

Figure 1-25

Free PMPs

Assay Reaction Formats The ADVIA Centaur XP system directly measures the amount of light that the chemiluminescent reaction emits. ADVIA Centaur XP assays use AE as the label in Lite Reagent and PMP as the Solid Phase. The system uses a variety of formats to detect antigens as well as antibodies. Refer to the ADVIA Centaur Assay Manual. The ADVIA Centaur XP system applies the immunoassay binding principles of antibodies using several formats: •

sandwich format

•

competitive format

•

antibody-capture format

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Sandwich Format Sandwich formats use AE-labeled antibody in the Lite Reagent. 1. The system adds Lite Reagent, containing AE-labeled antibody, to the sample. The AE-labeled antibody binds specifically to the analyte-specific antigen in the sample.

1 2

Acridinium ester Antibody

Figure 1-26

3 4

Analyte-specific antigen in the sample Other antigens

Sandwich Format

2. The system adds Solid Phase containing PMP that are coated with antibody specific for the antigen in the sample. The system incubates the cuvette at 37°C (98.6°F). PMP bind to the antigens that are bound to AE-labeled antibody.

1

PMP-Antibody-Antigen-Antibody-AE complex

Figure 1-27

Sandwich Format with Solid Phase

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3. The cuvette is exposed to a magnetic field, which draws PMP toward the magnets. While the magnets hold PMP in place, sample and reagent not bound to PMP are washed away. The cuvette now contains AE bound to antigen, which is bound to PMP by antibody.

1 2 3

Magnets PMP-Antibody-Antigen-Antibody-AE complex Cuvette

Figure 1-28

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Sandwich Format Assay in Cuvette

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4. The System adds acid and base to initiate the chemiluminescent reaction. The system measures the emission of light in relative light units (RLUs). When the system quantitates the light produced from the oxidation of AE, the system calculates the concentration of antigen. In a sandwich format, the analyte-specific antigen concentration in the sample and the light emission in RLUs have a direct relationship. If more analyte-specific antigen molecules are present in the sample, then more AE is present, and therefore light emission is greater.

1 2

Light emissions (RLUs) Analyte concentration

Figure 1-29

Sandwich Format Result Analysis

Competitive Format Competitive formats include: •

AE-labeled antigen in the Lite Reagent

•

AE-labeled antibody in the Lite Reagent

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AE-labeled Antigen 1. The system adds Lite Reagent, containing AE-labeled antigen, and Solid Phase, containing antibody-labeled PMP, to the sample. The system incubates the cuvette at 37°C (98.6°F). The AE-labeled antigen competes with analyte-specific antigen in the sample for limited binding sites on the antibody, which is bound to PMP. If more analyte-specific antigen is present in the sample, then less AE-labeled antigen is bound. Alternatively, if less analyte-specific antigen in the sample is present, then more AE-labeled antigen is bound.

1 2

Antibody PMP

Figure 1-30

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Analyte-specific antigen in the sample AE-labeled antigen

AE-labeled Antigen

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2. The system exposes the cuvette to a magnetic field, which draws PMP toward the magnets. While the magnets hold PMP in place, the system washes away sample and reagent not bound to PMP. The cuvette now contains analyte-specific antigen from the sample and AE-labeled antigen bound to PMP by antibody.

1 2

PMP-Antibody-Antigen complex PMP-Antibody-Antigen-AE complex

Figure 1-31

AE-labeled Antigen in The Cuvette

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3. The system adds Acid and base to initiate the chemiluminescent reaction. The system measures the emission of light in RLUs. When the system quantiates the light produced from the oxidation of AE, the system calculates the concentration of the analyte. If the sample has a low concentration of analyte-specific antigen, most binding sites on the antibody are bound to AE-labeled antigen. This causes an elevated reading of RLUs from the oxidation of AE. If the sample has a high concentration of analyte-specific antigen, most binding sites on the antibody are bound to antigen from the sample, and few sites are bound to AE-labeled antigen. This causes a lower reading of RLUs from the oxidation of the AE. In a competitive assay with AE-labeled antigen, the concentration of antigen in the sample and the light emission in RLUs have an inverse relationship.

1 2

Light emissions (RLUs) Analyte concentration

Figure 1-32

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AE-labeled Format Result Analysis

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AE-labeled Antibody 1. The system adds Lite Reagent, containing AE-labeled antibody, and Solid Phase, containing antigen-labeled PMP, to the sample. The system incubates the cuvette at 37°C (98.6°F). Antigen bound to PMP competes with analyte-specific antigen in the sample for limited binding sites on AE-labeled antibody. If the sample has more analyte-specific antigen, then it binds less PMP-labeled antigen. Alternatively, if the sample has less analyte-specific antigen, then it binds more PMP-labeled antigen.

1 2 3

AE-labeled antibody PMP-labeled antigen Analyte-specific antigen in the sample

Figure 1-33

AE-labeled Antibody

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2. The system exposes the cuvette to a magnetic field, which draws PMP toward the magnets. While the magnets hold PMP in place, the system washes away sample containing analyte-specific antigen and reagent not bound to PMP. The cuvette now contains PMP-antigen bound to AE by antibody.

1

PMP-Antigen-Antibody-AE complex

Figure 1-34

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PMP-antigent-antibody-AE Complex in the Cuvette

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3. The system adds acid and base to initiate the chemiluminescent reaction. The system measures the emission of light in RLUs. When the system quantitates the light produced from the oxidation of AE, the system calculates the concentration of analyte. If the sample has a low concentration of analyte-specific antigen, the PMP-labeled antigen binds to most binding sites on the antibody. This causes an elevated reading of RLUs from the oxidation of AE. If the sample has a high concentration of analyte-specific antigen, the antigen from the sample binds to most binding sites on the antibody, and few sites are bound to PMP-labeled antigen. This causes a lower reading of RLUs from the oxidation of AE. In a competitive assay with AE-labeled antibody, the concentration of analyte in the sample and the light emission in RLUs have an inverse relationship.

1 2

Light emissions (RLUs) Analyte concentration

Figure 1-35

AE-labeled Antibody Result Analysis

Antibody-capture Format When the substance being measured in the sample is an antibody, the system uses the antibody-capture format. The assay uses a reagent containing an additional antibody that is specifically directed against the antibody in the sample. Antibody-capture formats are usually characterized by 2 cycles of incubation and wash. The purpose of the first incubation and wash is to remove excess interfering substances in the sample. The purpose of the second incubation and wash is to measure the antibody in the sample.

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Antibody-capture assays detect specific IgG antibody or IgM antibody in patient samples. The following example is an antibody-capture assay that detects human IgM antibody in a patient sample. 1. The system adds Solid Phase, containing anti-human IgM antibody bound to PMP, to the sample. The system incubates the cuvette at 37°C (98.6°F). The IgM antibody in the sample binds to anti-human IgM antibody bound to PMP.

1 2

Anti-human IgM Antibody bound to PMP Human IgM Antibody in sample

Figure 1-36

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2. The system exposes the cuvette to a magnetic field, which draws PMP toward the magnets. While the magnets hold PMP in place, the system washes away sample and reagent not bound to PMP. The cuvette now contains IgM antibody from the sample captured by specific anti-human IgM antibody, which is bound to PMP.

1

PMP-Anti-lgM Antibody-IgM complex

Figure 1-37

Antibody-capture Format in the Cuvette

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3. The system adds Lite Reagent, containing AE-labeled antigen, to the cuvette and incubates it at 37°C (98.6°F). The AE-labeled antigen binds to the sample IgM antibody in the sample.

1

AE-labeled antigen

Figure 1-38

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4. The system exposes the cuvette to a magnetic field, which draws PMP toward the magnets. While the magnets hold PMP in place, the system washes away the reagent not bound to PMP. The cuvette now contains AE-labeled antigen bound to sample IgM antibody, which is bound to anti-human IgM antibody, bound to PMP.

1

PMP-Anti-lgM Antibody-IgM-AE-labeled antigen complex

Figure 1-39

Antibody-capture Format in the Cuvette

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5. The system adds acid and base to initiate the chemiluminescent reaction. The system measures the emission of light in RLUs. When the system quantitates light produced from the oxidation of the AE, the system calculates the concentration of the analyte. In this example of an antibody-capture assay, the sample concentration and the light emission have a direct relationship. If more sample IgM antibody is present, then more AE is present, and therefore the light emission is higher.

1 2

Light emissions (RLUs) Analyte concentration

Figure 1-40

Antibody-capture Format Result Analysis

References 1. Whitehead TP, Kricka J, Carter JN, Thorpe G. Analytical luminescence: its potential in the clinical laboratory. Clin Chem 1979; 25/9: 1531–1546. 2. Woodhead JS, Campbell AK, McCapra F, Beheshti I, Weeks I. Acridinium esters as high specific-activity labels in immunoassays. Clin Chem 1983; 29/ 8: 1474–79. 3. Weeks I, Woodhead JS. Chemiluminescence immunoassays. J. Clin Immunoassay 1984; 7/1: 82–89. 4. Patel A, Morton MS, Woodhead JS, Ryall MET, McCapra F, Campbell AK. A new chemiluminescent label for use in immunoassay. Biochem Soc Trans 1982; 10: 224–5. 5. Tietz NW. Fundamentals of clinical chemistry, 3rd ed. Philadelphia: W.B. Saunders Company, 1987; 1010. 6. Kricka LJ. Chemiluminescence immunoassay. The immunoassay handbook, 1st ed. New York: Stockton Press, 1994; 341–343. 7. Dudley R. The immunoassay handbook, 1st ed. New York: Stockton Press, 1994; 161–164.

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8. Dudley R. Chemiluminescence immunoassay: an alternative to RIA. Lab Med 1990; 21/4; 216–221.

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2 Operating the ADVIA Centaur XP System Signing into or out of the System . . . . . . . . . . . . . . . . . . 1-1 Managing Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Using Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Loading Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 ADVIA Centaur Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Loading Samples Using Laboratory Automation Systems . . . . . 1-6 Verifying Barcode Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 Locating Specific Sample Information . . . . . . . . . . . . . . . . . . . . . . . .1-7

Removing Sample Racks from the Inprocess Queue. . . . . . . . . 1-8 Locating Sample Racks in the Sample Exit Queue . . . . . . . . . . 1-8

Monitoring Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 Workspace Status Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 System Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 Supplies Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 Sample Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13 Exception Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14 Reagent Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14 Primary Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15 Ancillary Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18

Maintenance Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18 Event Log Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

Replenishing Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19 Loading Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20 Printing the Reagent Loading Report . . . . . . . . . . . . . . . . . . . . . . .1-21 Relocating Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-21

Managing Primary Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21 Loading Primary Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22 Removing Primary Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22

Managing Ancillary Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23 Loading Ancillary Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . .1-23 Removing Ancillary Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . .1-24

Replenishing Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25 Filling the Water Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25 Emptying the Waste Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27 Attaching the Waste Bottle Stopper . . . . . . . . . . . . . . . . . . . . . . . . .1-30

Replacing the Cleaning Solution. . . . . . . . . . . . . . . . . . . . . . . . 1-31 Adding Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32 Adding Sample Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 Emptying the Sample Tip Waste Bin . . . . . . . . . . . . . . . . . . . . 1-33

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Emptying the Sample Tip Tray Waste . . . . . . . . . . . . . . . . . . . 1-35 Emptying the Cuvette Waste Bin . . . . . . . . . . . . . . . . . . . . . . . 1-35 Replacing System Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36

Managing the Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39 Viewing the Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39 Opening the Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39 Understanding Worklist Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41

Displaying Calibrator Results at the Worklist . . . . . . . . . . . . . . 1-42 Suspending Update of the Worklist . . . . . . . . . . . . . . . . . . . . . 1-43 Rescheduling Samples for Control-bracketed Tests. . . . . . . . . 1-43 Reasons for Discarded Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43 Rescheduling Samples with Discarded Results . . . . . . . . . . . . . . . 1-44

Locating Specific Samples in the Sample Exit Queue . . . . . . . 1-44 Moving Final Results to the Historical Worklist. . . . . . . . . . . . . 1-45

Scheduling Samples Using an LIS . . . . . . . . . . . . . . . . . 1-45 Automatically Scheduling Samples Using an LIS. . . . . . . . . . . 1-46 Loading Samples in Host Query Mode. . . . . . . . . . . . . . . . . . . 1-46 Manually Requesting a Worklist from an LIS . . . . . . . . . . . . . . 1-47 Entering First Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-47 Suspending LIS Communications . . . . . . . . . . . . . . . . . . . . . . 1-47 Configuring the LIS to Accept Results beyond the Dose Response Curve Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-48

Scheduling Samples Using an LAS . . . . . . . . . . . . . . . . 1-48 Manually Scheduling Samples . . . . . . . . . . . . . . . . . . . . 1-48 Scheduling Patient Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-49 Scheduling by Rack ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-50 Scheduling Non-barcoded Samples by Rack ID. . . . . . . . . . . . . . . . . . . 1-50 Scheduling Barcoded Samples by Rack ID . . . . . . . . . . . . . . . . . . . . . . 1-51

Handling SID Mismatches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-52 Scheduling Patient Samples Using a Hand-Held Barcode Reader 1-52

Entering Patient Demographics . . . . . . . . . . . . . . . . . . . . . . . . 1-53 Entering Comments for a Patient Sample . . . . . . . . . . . . . . . . 1-54 Scheduling Stat Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54 Scheduling Batches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-55 Scheduling Calibrators and QC Samples . . . . . . . . . . . . . . . . . 1-56 Entering Dilution Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-56 Entering Reagent Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-57 Changing the Number of Replicates. . . . . . . . . . . . . . . . . . . . . 1-58 Using Control-bracketed Tests . . . . . . . . . . . . . . . . . . . . . . . . . 1-58 Scheduling Control Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Loading Control Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scheduling Start-of-bracket and End-of-bracket Tests . . . . . . . . . . Scheduling Calibrators for a Control-bracketed test . . . . . . . . . . . .

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Modifying the Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59 Selecting Multiple Samples or Tests . . . . . . . . . . . . . . . . . . . . . 1-60 Editing Requests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-61 Modifying a Test for a Request Scheduled by Rack ID . . . . . . . . . .1-61

Deleting Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-61

Evaluating the Results . . . . . . . . . . . . . . . . . . . . . . . . . . 1-62 Result Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-63 Repeating a Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-68 Locating Samples that Require Further Attention. . . . . . . . . . . 1-69 Editing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-69 Releasing Results That Are On Hold . . . . . . . . . . . . . . . . . . . . 1-70 Releasing Results on Hold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-70

Sending Results to an LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-71 Sending All Results Except Results On Hold to an LIS . . . . . . . . . .1-71 Sending Selected Results to an LIS . . . . . . . . . . . . . . . . . . . . . . . .1-71

Deleting Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-72

Printing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-73 Printing Results by Sample. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-73 Printing Results by Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-74 Resetting the Page Numbers for Runtime Reports . . . . . . . . . 1-75 Printing Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-75

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Operating the ADVIA Centaur XP System The ADVIA Centaur XP system accommodates many laboratory environments and workflow styles. Because of this flexibility, operating the ADVIA Centaur XP system can be as easy as loading samples, removing samples, and reviewing system and supply status. The online help for the ADVIA Centaur XP system also contains the most commonly used instructions and procedures.

Signing into or out of the System You must sign in if you need to enter comments or to access areas of the system that are a different level of security, such as selecting system options or editing test results. Use this procedure to sign into the system. 1. At the workspace, select Sign In. 2. Use the Tab key to move to the New Operator field and then enter your initials. 3. Use the Tab key to move to the Password field and then enter the password, if necessary. 4. Select Sign In. The operator ID and security level display on the Sign In button at the workspace. Use this procedure to sign out of the system. 1. At the workspace, select Sign In. 2. At the Sign In window, select Sign Out. The system signs out the current operator and closes the Sign In window.

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Managing Sample Racks CAUTION

Do not interfere with the normal loading movement of sample racks into the inprocess queue. Interfering with the normal loading movement of the sample racks can cause sample queue movement errors and sample queue barcode read errors. You can load samples on to the system at any time, even while the system processes samples. The inprocess queue holds up to 16 racks. Before loading samples ensure that you have met the following conditions: •

You are using defined tube types Refer to Specifications‚ page E-1.

•

You configured the sample racks for the tube types you are loading. Refer to Specifying Sample Tube Types‚ page 8-5.

•

Requests are available for the samples you load. Refer to Managing the Worklist‚ page 2-39.

•

You have sufficient sample volume. Refer to Appendix C, Sample Volume Requirements‚ page C-12.

Using Sample Racks The ADVIA Centaur XP system has sample racks that can handle multiple tube types. The system can also use racks from the ADVIA Centaur system. Refer to ADVIA Centaur Sample Racks‚ page 2-5. •

When you move the Tube-Type Selector to position A—the Auto position— you may use multiple tube types in the rack. NOTE: You can either remove the tube-type selector or move the tube-type selector to position A to make the rack available for multiple tube types.

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When the Tube-Type Selector is in position 2, 3, or 4, you can use only the tube type that corresponds with the tube type you selected in the Setup – Tube-Type & Barcode window.

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ADVIA Centaur XP racks have labels for tube-type selector positions: A, 2, 3, and 4.

1 2 3 4

Tube-type selector in position A Sample tube barcode label Rack barcode Tube-type positions (A, 2, 3, and 4)

Figure 2-1

ADVIA Centaur XP Sample Rack

Refer to the ADVIA Centaur Assay Manual.

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Loading Samples BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. If you use sample cups, label them with the appropriate barcode labels and dispense the sample into the labeled sample cups.

1

Barcode label

Figure 2-2

Sample tube

2. Position the barcode label vertically on the sample cup approximately 2 cm (0.8 in) from the top. 3. Move the tube-type selector to the position for the tube type you are loading in the rack or for multiple tube types. 4. Place the sample tubes or cups in the rack. 5. Ensure that the barcode labels are clearly visible above or between the slots in the rack. 6. Ensure that the tube-type selector is positioned correctly for a single tube type or multiple tube types. CAUTION

Do not manually push a rack into the inprocess queue and do not manually place sample racks near the entrance to the inprocess queue without using the raised area of the sample entry queue as a positioning guide. Failure to follow this instruction can lead to a misread of the sample tube positions in the rack.

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7. Load the rack in the sample entry queue. Ensure that the notch in the rack rests on the raised area of the sample entry queue.

1 2

Sample entry queue Sample start button

Figure 2-3

Sample Entry Queue

CAUTION

Do not press the sample start button until you close the primary reagent door and ensure that all reagent barcodes were read correctly. Starting the system before all reagent barcodes are read correctly can cause erroneous results. Closing the primary reagent door allows the system barcode scanner to rescan the reagent barcodes and acknowledge any changes. 8. If the LED above the Sample Start button is not lit, press the button. The system moves the rack to the inprocess queue. Refer to Verifying Barcode Scanning‚ page 2-6.

ADVIA Centaur Sample Racks When you uses an ADVIA Centaur rack, you can only use only 1 tube type in the rack. ADVIA Centaur racks display tube-type selector positions 1, 2, 3, and 4. The position of the Tube-Type Selector corresponds to the tube type selected in the Setup – Tube Type & Barcode window, indicating the tube type that is currently in the rack.

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NOTE: If you remove the Tube-Type Selector, it is the same as moving the Tube-Type Selector to position 1.

1 2 3 4

Tube-type selector in position 1 Sample tube barcode label Rack barcode Tube-type positions (1, 2, 3, and 4)

Figure 2-4

ADVIA Centaur Sample Rack

Loading Samples Using Laboratory Automation Systems When you load samples using your laboratory automation system, the ADVIA Centaur XP system detects samples moving past the back of the system on a conveyor. The sample probe moves out of the back of the system to aspirate the samples. When you enable the laboratory automation system, the system can also process calibrator, QC, and patient samples that you load into the sample entry queue and the Stat entry. Refer to Defining LAS Communication Options‚ page 8-47.

Verifying Barcode Scanning Use the Status – Samples window to verify that the system read the sample barcode of the samples that you load on to the system. 1. At the workspace, select the Sample Status button to open the Status – Samples window. 2. To locate a specific sample or sample rack, select SID or Rack in the drop-down list.

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NOTE: If the system cannot read a rack barcode, the system does not test the samples, the rack field at the Status – Samples window is empty, and the system ejects the rack.

3. Enter a specific search criterion in Search for. •

If the system did not read the barcode, the No Barcode message displays in the Status column and the system does not test the sample.

•

If the SID for the tube with the No Barcode status is available (for example, from a sample loading list) manually enter the tube barcode.

4. To manually enter the SID, select the sample and then select Enter SID.

Locating Specific Sample Information You can locate specific information by using the appropriate View and Sort combination: 1. At the workspace, select the Sample Status button. 2. To locate a specific sample or sample rack, select SID or Rack in the drop-down list. a. Select a View to determine the samples that the system displays. For example, if you select Inprocess Queue, the system displays the samples in the inprocess queue. The Lab Automation Queue view is only available when lab automation is enabled. Refer to Defining LAS Communication Options‚ page 8-47. b. Select a Sort to determine the order in which the system displays the samples. For example, if you select SID, the system sorts and displays the samples in ascending SID order. The following table describes the View and Sort combinations you can use to perform some routine tasks: Task

View

Sort

Display samples that have error messages

Inprocess Queue

Errors

Display samples in chronological order of when the system scanned the barcode

Inprocess Queue

Scanned

Display samples in ascending alphanumeric order by sample identifier

Inprocess Queue

SID

Display samples in ascending order by rack identifier

Inprocess Queue

Rack

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Removing Sample Racks from the Inprocess Queue You can schedule removal of a sample rack without completing sample aspiration for the scheduled tests, or after sample aspiration for the scheduled tests is completed. 1. At the Status – Samples window, select the sample. 2. Select Remove Rack. 3. When prompted, select Complete or Now. If you want the system . . .

Then select . . .

to finish sample aspiration for the tests in the rack, and then remove the rack

Complete

to cancel sample aspiration for the tests in the rack and remove the rack as soon as possible

Now

NOTE: If you select Now, the system may not eject the sample rack

immediately. The system schedules the rack for ejection and ejects the rack during the next available cycle. This may cause a slight delay before the system ejects the sample rack into the sample exit queue. If sampling stopped due to a problem with the sample tip loader, sample probe, or a fluid sensor, remove the sample racks from the inprocess queue using diagnostic tools. Refer to Using Diagnostic Tools.

Locating Sample Racks in the Sample Exit Queue You can locate specific sample racks in the exit queue. You can access the Status – Exit Queue window from the Status – Samples window or the Worklist – Summary window: 1. At the workspace, select 1 of the following options: •

Select the Sample Status button to open the Status – Samples window.

•

Select Worklist and then select Summary to open the Worklist – Summary window.

2. Select Exit Queue to open the Status – Exit Queue window. Use the Status – Exit Queue window to locate and determine the status of samples in the sample exit queue. •

View the rack position indicators to determine the approximate location in the exit queue of the 24 most recently ejected sample racks.

•

View the exit queue table to determine status of the 48 most recently ejected sample racks.

3. If a flag is associated with the sample and the sample matches a worklist request, select the sample and then select Result Details for more information.

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NOTE: If you select the Exit Queue button at the Worklist – Summary window with a specific sample or test selected in the worklist table, the Status – Exit Queue window opens and displays the sample rack position. NOTE: If you select the Exit Queue button at the Worklist – Summary

window with no sample or test selected in the worklist table, the Status – Exit Queue window opens with no sample rack position selected.

Monitoring Status The system tracks the status of supplies, samples, QC exceptions, reagents, maintenance, and events and alerts you if a system area needs attention. Using the status buttons on the workspace, you can monitor the status of the different system areas.

Workspace Status Area The Workspace Status buttons are only available in the System View. Refer to Status Buttons‚ page 1-18. The system provides 2 visible status indicators—the status buttons and the visible status light—to alert you when the system needs attention. The status buttons and the visible status light change color from neutral to yellow or red to indicate that the system requires attention. •

Yellow indicates that a warning condition exists, such as a low supply.

•

Red indicates that a critical condition exists, such as an empty supply. A critical condition can cause the system to stop aspirating or processing samples.

The status buttons blink to indicate that a new condition has occurred since the last time you reviewed that status window. You can also select an audible alarm to complement the visual indicators. Refer to Defining Alarms‚ page 8-38. The status area also displays the current date, time, and state of the system. The status area can display the following system states: System State

Description

Ready

The system is ready to process samples.

Inprocess

The system is processing samples.

Cleaning

The system is performing the daily or monthly cleaning or priming.

Warming Up

The system is restarted. The thermals are equilibrating to the correct temperature.

Diagnostics

You opened the System – Diagnostic Tools window.

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System State

Description

Mechanics Off

You selected Turn System Mechanics Off in the System Status menu. Power is removed from the robotics.

Check Status

The system is not able to process samples because of a critical condition such as depleted supplies or a system error.

Cleaning Failed

The daily or monthly cleaning is incomplete. You must restart the cleaning procedure at the Status – Maintenance window.

System Status Use System Status to monitor the condition of the system and determine which area of the system needs attention. To open the System Status window, at the workspace select the System Status button and then select System Status in the menu. Do not allow the system to remain in the Inprocess state or the Check Status state for longer than 2 hours without processing samples. Refer to Managing Nonsampling System Status‚ page 6-8. •

Areas change color to indicate they require your attention. Select the area to obtain more detailed information. Select the area to obtain more detailed information. For example, if the cleaning solution is low, the color of the Supplies Status button and the cleaning solution area changes to yellow. If an error occurs in the cuvette loading area that causes the system to stop, the Event Log button and the cuvette loading area change to red.

•

When you position the pointer over an area, the system displays the name of the area.

•

You can select a button to obtain more detailed information on the status of supplies, reagents, samples, maintenance, and the various subsystems.

Supplies Status Use Supplies Status to monitor the level of system supplies. At the workspace, the Supplies Status button changes color to indicate the status of system supplies: •

Yellow indicates that the system is using the reserve. The main supply is removed, the supply is depleted, or the waste is more than 80% full or using the reserve.

•

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Red indicates that a supply and its reserve are depleted, the waste and its reserve are full, or an error condition occurs.

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Select the Supplies Status button to open the Status – Supplies window and determine which supply needs attention. The system does not start if a supply status is yellow. The system stops processing samples if a supply status is red. The system displays status messages in the field below the supply name. For a description of the status messages for each supply and the procedure for replenishing the supply, move the pointer to the supply field and select the help (?) button. The system displays these messages on the Status – Supplies window: Supply Area

Message

Color

Description

Cuvettes

OK

Neutral

At least 1 cuvette is available.

No Cuvette Detected

Red

The cuvette supply is depleted or an error in cuvette loading occurred and the system stopped sampling.

OK

Neutral

At least 120 sample tips are available.

80% Full

Yellow

The bin is more than 80% full.

Not Present

Yellow

The bin was removed. The system is using the reserve.

Sampling Stopped

Red

The system stopped sampling because the cuvette bin is full.

Full

Red

The bin is full.

OK

Neutral

The bin is less than 80% full.

>80% Full

Yellow

The bin is more than 80% full.

Not Present

Yellow

The bin was removed. The system is using the reserve.

Sampling Stopped

Red

The system stopped sampling because the tip bin is full.

Full

Red

The bin is full.

OK

Neutral

The waste area is less than 80% full.

>80% Full

Yellow

The waste area is more than 80% full.

Sampling Stopped

Red

The system stopped sampling because the waste area is full and the current tip tray is empty.

OK

Neutral

The bottle is present and has enough space to continue testing.

Tips

Cuvette Waste

Tip Waste

Tip Tray Waste

Liquid Waste

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Supply Area

Water

Acid, Base

Wash 1 and Wash 3

Cleaning Solution

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Message

Color

Description

Not Present, Using Reserve

Yellow

The bottle was removed. The system is using the reserve.

Full, Using Reserve

Yellow

The bottle is full. The system is using the reserve.

Sampling Stopped

Red

The system stopped sampling because the reserve is almost full.

OK

Neutral

The bottle is present and contains enough fluid to continue testing.

Not Present, Using Reserve

Yellow

The bottle was removed. The system is using the reserve.

Sampling Stopped

Red

The system stopped sampling because the reserve is almost empty.

OK

Neutral

The bottle is present and contains enough fluid to continue testing.

Not Present, Using Reserve

Yellow

The bottle was removed. The system is using the reserve.

Present, Using Reserve

Yellow

The bottle is empty. The system is using the reserve.

Sampling Stopped

Red

The system stopped sampling because the reserve is almost empty.

Reserve Depleted

Red

The system stopped sampling because the bottle and the reserve are empty.

OK

Neutral

The bottle is present and contains enough fluid to continue testing.

Not Present, Using Reserve

Yellow

The bottle was removed. The system is using the reserve.

Present, Using Reserve

Yellow

The bottle is empty. The system is using the reserve.

Sampling Stopped

Red

The system stopped sampling any test that uses this solution because the reserve is almost empty.

Reserve Depleted

Red

The bottle and the reserve are empty. The system stopped sampling any test that uses this solution.

OK

Neutral

The bottle is present and contains enough fluid to clean the system.

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Message

Color

Description

Low

Yellow

The bottle does not contain enough fluid to clean the system.

Not Present

Yellow

The bottle was removed. The system cannot perform the cleaning procedure.

Sample Status Use Sample Status to monitor the samples that are loaded on the system. At the workspace, the Sample Status button changes color to indicate the status of samples that are in the inprocess queue and the lab automation queue: •

Yellow indicates that testing for a sample is not complete because of a problem with a sample.

•

Red indicates that testing for all samples in a sample rack is not complete because of a problem with the sample rack barcode label.

Select the Sample Status button to open the Status – Samples window and review the status of the samples in the inprocess queue and the lab automation queue. NOTE: The Lab Automation Queue view is only available when lab automation is enabled. Refer to Defining LAS Communication Options‚ page 8-47.

The following messages indicate the status of a sample: Message

Color

Description

Aspirated

Neutral

All tests for this sample are aspirated.

Clot Detected

Yellow

The system detected a clot in the.sample probe. Check the sample for clots.

Incomplete Cal Set

Yellow

One of the calibrator levels is not loaded on the system. Ensure that both the high calibrator and the low calibrator are loaded.

Incomplete Set

Yellow

The complete set of controls for this control-bracketed test is not loaded on the system in the same rack. This message can apply to start-of-bracket or end-of-bracket controls. Ensure that all of the controls specified at the Test – Definition window are loaded on the system in 1 rack.

Insufficient

Yellow

Not enough sample volume exists for the requested tests.

Integrity Error

Yellow

The system detected an irregular sample aspiration. Check the sample for bubbles or foam, or check the sample probe tubing and tip-probe connection for leaks. When you perform multiple tests on a patient sample, if the sample produces an integrity error, all tests for that sample are flagged with the integrity error flag.

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Message

Color

Description

LIS Query Pending

Yellow

A request to the LIS from the system for a worklist entry is pending.

No Barcode

Yellow

The system did not read the sample barcode. Select the sample and then select Enter SID to manually enter the SID.

No Bracket

Yellow

This message applies to control-bracketed tests only. The system cannot process this sample at this time because the start-of-bracket controls were not processed or at least 1 of the control results is unacceptable. The system processes the sample after the start-of-bracket controls are processed and produce acceptable results.

No Request

Yellow

The system does not have any test requests for the sample. Schedule tests at your LIS or at the Worklist – Schedule window. If you use a non-Siemens barcode label for kit controls in a control-bracketed test, the system does not recognize the control samples and displays the No Request flag.

Removal Pending

Neutral

You requested this sample rack or tube to be removed from the system. The system removes the rack or tube when sample aspiration is complete. NOTE: If you are at the Lab Automation Queue view, Removal Pending refers to removing a sample tube instead of a rack.

SID Mismatch

Yellow

This message displays only when the system identifies samples by Rack and the system detects an inconsistency in the SID of the sample tube barcode label. For example, the SID Mismatch message displays if you schedule a patient sample with an SID at a specific rack and rack position, the system aspirates that sample, and then you schedule another sample with a different SID at the same rack and rack position. Verify that the sample tube is in the correct position in the rack.

Refer to Verifying Barcode Scanning‚ page 2-6.

Exception Status Selecting this button displays a message directing you to the applications view and ADVIA QC.

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Reagent Status Use Reagent Status to monitor the status of primary and ancillary reagents on the system. The Reagent Status button changes to yellow to indicate that a reagent pack cannot be used. Select the Reagent Status button to open the status window of the reagent that requires attention or to open the Worklist – Reagent Inventory window. If . . .

Then . . .

a primary reagent needs attention or if no reagent needs attention,

the system displays the Status – Primary Reagent window.

an ancillary reagent needs attention

the system displays the Status – Ancillary Reagent window

a reagent pack is not onboard or is below the defined reagent warning counts for tests requested in the current worklist

the system displays the Worklist – Reagent Inventory window

a primary reagent and an ancillary reagent need attention

the system displays the Status – Primary Reagent window and the Status – Ancillary Reagent window

a primary reagent needs attention and a reagent pack is not onboard or is below the defined reagent warning counts for tests requested in the current worklist

the system displays the Status – Primary Reagent window and the Worklist – Reagent Inventory window

an ancillary reagent needs attention and a reagent pack is not onboard or is below the defined reagent warning counts for tests requested in the current worklist

the system displays the Status – Ancillary Reagent window and the Worklist – Reagent Inventory window

a primary reagent and an ancillary reagent need attention, and a reagent pack is not onboard or is below the defined reagent warning counts for tests requested in the current worklist

the system displays the Status – Primary Reagent window, the Status – Ancillary Reagent window, and the Worklist – Reagent Inventory window

Primary Reagents If a primary reagent requires attention or if no reagent requires attention when you select the Reagent Status button, the system displays the Status – Primary reagent window. •

Pack indicators change color to indicate if a pack is available for use. The numbers on the pack indicators and the table correspond to the spaces in the primary reagent compartment.

•

The system displays Status messages for each reagent pack that requires attention.

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An ellipsis (. . .) after a status message indicates that more than 1 status message exists. Select Details to display information about the pack. The following messages indicate the status of a reagent: Message

Color

Description

Cal Due

Neutral

The calibration interval for the test expires within 24 hours or within 25% of the calibration interval, whichever is shorter. Schedule a calibration at the Worklist – Schedule window. You can waive a calibration with a Due status at the Calibration – Summary window if Waive Cal is selected at the Test – Calibration window.

Cal Expired

Yellow

The calibration for the reagent lot expired. Schedule a calibration at the Worklist – Schedule window. You can waive an expired calibration at the Calibration – Summary or Calibration – Data windows if Waive Cal is selected at the Test – Calibration window.

Cal Required

Yellow

No valid calibration exists for the reagent lot. Schedule a calibration at the Worklist – Schedule window.

Check Lot Numbers

Yellow

The test requires a specific primary reagent, ancillary reagent, and calibrator lot combination. Ensure that you use primary reagent, ancillary reagent, and calibrators from kits with the same lot number.

Check Universal Cal

Yellow

No valid calibration exists for the lot of sIgE universal reagent associated with the specific IgE tests. Schedule a calibration for the reference allergen.

Depleted

Yellow

The reagent pack is empty.

Lot Expired

Yellow

The reagent lot expired. Load a new lot of reagent. If necessary, define a Master Curve for the new reagent lot at the Calibration – Master Curve Definition window.

Low Reagent

Yellow

The total number of tests (primary reagent, vial) or milliliters (ancillary reagent) for all onboard packs is equal to or less than the Reagent Warning Counts you entered at the Setup – Additional Options window. This message only displays at the Worklist – Reagent Inventory window.

No Ancillary

Yellow

The test requires an ancillary reagent. Load the appropriate ancillary reagent.

No Barcode

Yellow

The system cannot read the barcode for the reagent pack. The system opens the Status – Enter Primary Barcodes window at which you can enter the barcode.

No Carrier Definition

Yellow

No valid information exists for the vials in the carrier. Use the barcode scanner to enter the information for the vials and carrier at the Status – Scan Carrier window.

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Message

Color

Description

No Master Curve

Yellow

No Master Curve exists for the reagent lot. Define a Master Curve at the Calibration – Master Curve Definition window and then schedule a calibration at the Worklist – Schedule window.

No Optional Diluent

Neutral

An optional diluent for this test is present. If you want to perform dilutions, load the appropriate diluent.

No Required Diluent

Yellow

This test requires a diluent. Load the appropriate diluent.

No sIgE Universal

Yellow

No sIgE universal reagent is present onboard or the pack that is on the system is empty. Load an sIgE universal reagent pack.

No Test Definition

Yellow

No test definition exists for the test.

Not Onboard

Yellow

Samples are scheduled for this test and no reagent packs are loaded. This message only displays at the Worklist – Reagent Inventory window.

Pack Inactive

Neutral

The pack is inactivated. At the Status – Primary Reagent window, you can activate the pack by selecting the pack and then selecting Activate Pack. If you want to specify that the system use an inactive pack for a particular calibrator, control, or patient sample, you can select an inactive pack at the Worklist – Reagent Options window.

Removable

Neutral

You selected Remove Pack at the Status – Primary Reagent window or Remove Carrier at the Status – Primary Reagent window. You can remove the pack or carrier now.

Removal Pending

Neutral

You requested to remove this pack or carrier. After the system completes the tests that use this pack or carrier, the system notifies you that you can remove this pack or carrier.

Reposition

Neutral

The reagent pack or carrier is not positioned for optimal result throughput. You can improve result throughput by moving the pack or carrier to the location in the primary reagent compartment indicated by the arrow and the color on the reagent pack or carrier.

Stability Expired

Yellow

The reagent pack or vial exceeded the stability date. Replace the reagent pack or vial.

Test Inactive

Neutral

The test is inactivated. At the Status – Primary Reagent window, you can activate the test by selecting a pack for the test and then selecting Activate Test. All packs loaded for this test display this status message. At the Status – Carrier Details window, you can activate a specific IgE test when the system is not inprocess by deselecting the Inactivate Test button for that test vial.

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Message

Color

Description

Verify Stability

Neutral

The reagent pack or 1 or more vials in the carrier exceeded the stability date. The system uses the reagent for testing because you selected Use Beyond for this test at the Test – Definition window. NOTE: The manufacturer has set some prove wash reagents to Use Beyond in the test definition and you cannot change it. If you do not want to run these reagents beyond their stability, remove and discard them when the system displays the Verify Stability status.

Vial Inactive

Neutral

One or more vials in the carrier are inactivated. At the Status – Carrier Details window, you can activate the vial by deselecting the Inactivate Vial button for that vial.

Ancillary Reagents If an ancillary reagent requires attention and you select the Reagent Status button, the Status – Ancillary Reagent window is displayed. The following messages indicate the status of a reagent: Message

Color

Description

Depleted

Yellow

The reagent pack is empty.

Lot Expired

Yellow

The reagent lot expired. Load a new lot of reagent.

No Test Definition

Yellow

No test definition exists for the test.

Removal Pending

Neutral

You requested to remove this pack. After the system completes the tests scheduled for this pack, the system ejects the pack.

Stability Expired

Yellow

The reagent pack exceeded the stability date.

Verify Stability

Neutral

The reagent pack exceeded the stability date. The system uses the reagent for testing because you selected Use Beyond for this test at the Test – Definition window.

Maintenance Status Use Maintenance Status to monitor maintenance activities and automated procedures. At the workspace, the Maintenance Status button changes color to indicate the status of maintenance: •

Yellow indicates that a maintenance activity is due or overdue.

•

Red indicates that an automated maintenance procedure did not complete.

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Select the Maintenance Status button to display the Status – Maintenance window and display the procedures that require attention. •

In the Schedule view, the date column displays the date the activity is due.

•

In the Log view, the date column displays the date the activity was completed.

The ADVIA Centaur XP system monitors maintenance activities and notifies you when a scheduled activity is due. The system provides a maintenance schedule for you to record the completion of scheduled maintenance activities. The system then uses this information to automatically update the maintenance schedule with the next time the activity is due. Refer to Defining Maintenance Activities‚ page 5-3.

Event Log Status Use Event Log Status to monitor the events that occur on the system. At the workspace, the Event Log button changes color to notify you of a system warning or critical condition: •

Yellow indicates that a system warning condition occurred. The system continues to operate but requires your attention.

•

Red indicates that a system critical condition occurred. The system stops and requires your attention.

Select the Event Log Status button to open the Status – Event Log window to review system events and resolve system problems. Find events you want to review by selecting a view and then sorting the event log using selected criteria, such as date or severity. •

Select Details to display additional information about the selected event.

•

Select Comments to display or add comments.

•

Select Procedures to access online procedures for troubleshooting events.

The ADVIA Centaur XP system monitors system events and notifies you when an error condition occurs. Refer to Using the Event Log‚ page 6-1.

Replenishing Reagents You manually mix the primary packs and load them on the reagent holders in the primary reagent compartment, which stores the reagents at 4 to 8°C (39 to 46°F). The primary reagent shelf mixes the packs to keep the reagents in suspension. The arrow indicator and color on each pack indicate where you can load the packs to optimize sample throughput. Refer to Appendix C, Handling Reagents, in the ADVIA Centaur Assay Manual.

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Each ancillary pack contains 1 ancillary reagent. The system tracks the volume in the pack. Refer to the ADVIA Centaur Assay Manual. Some ancillary packs are customer-fillable packs.

Loading Reagents You can monitor the volumes of primary and ancillary reagents using the Worklist – Reagent Inventory window. To open the Worklist – Reagent Inventory window from the workspace, perform the following steps: 1. Select Worklist. 2. Select Reagent Inventory. The Worklist – Reagent Inventory window fields display reagent information: •

The Available column displays the total amount of shared reagent that is onboard and available.

•

The Shortage column displays the amount of reagent needed to complete the scheduled tests.

•

The Status column displays the primary reagent status and the ancillary reagent status.

Inventory for primary reagents is expressed in number of tests. Inventory for ancillary reagents, diluents, and ancillary wash solutions is expressed in milliliters. NOTE: Do not add reagent to reagent packs. Each reagent pack contains enough

reagent to process a predetermined number of tests. Each time the system accesses a reagent pack, reagent volume inventory tracks the amount of reagent used. The system does not recognize additional fluid placed in a reagent pack. If you have multiple systems in your laboratory, record the following information before you move a reagent pack from 1 system to another: •

the number of tests remaining in a primary reagent pack

•

the stability information that displays at the Status – Primary Pack Details window

•

the volume remaining in an ancillary reagent pack

•

the stability information that displays at the Status – Ancillary Pack Details window

Enter this information in the appropriate fields at the Status – Primary Pack Details window and the Status – Ancillary Pack Details window when you load the reagents on a different system.

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Printing the Reagent Loading Report The reagent loading report lists the types and quantities of reagents required to perform testing for an existing worklist and is designed to help the operator load and unload reagents to support the worklist. 1. At the workspace, select Print. 2. Select Report Options. 3. At the Print – Report Options window, select Reagent Loading Report. 4. Select Print Report.

Relocating Reagent Packs If you have multiple systems in your laboratory, record the following information before you move a reagent pack from 1 system to another: •

the number of tests remaining in a primary reagent pack

•

the stability information that displays at the Status – Primary Pack Details window

•

the volume remaining in an ancillary reagent pack

•

the stability information that displays at the Status – Ancillary Pack Details window

Enter this information in the appropriate fields at the Status – Primary Pack Details window and the Status – Ancillary Pack Details window when you load the reagents on a different system.

Managing Primary Reagents At the workspace, select the Reagent Status button to open the Status – Primary Reagent window. The pack indicators at the top of the Status – Primary Reagent window correlate to the LEDs on the primary reagent door. The LEDs and the pack indicators turn green or blink to indicate if a pack is available or if the system read the barcode: •

Green indicates that the pack should not be removed when the system is inprocess because the system may be using that pack.

•

Blinking green indicates that the system detected that a pack is present but cannot read the pack barcode. The system automatically opens the Status – Enter Primary Barcodes window.

If . . .

Then . . .

the displayed pack barcode information is correct,

select Save.

no pack barcode information is displayed or the information is not correct,

enter the correct pack barcode and select Save.

•

Neutral indicates that the pack can be removed because the system is not using that pack or that no pack is loaded in that position.

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You can select a pack indicator to display information about the reagent pack in that position. The colors underneath the pack indicator denote the type of pack loaded in that pack position. The number in the Status column indicates the number of tests available in the pack.

Loading Primary Reagent Packs 1. Manually mix the primary packs and load them on the reagent holders in the primary reagent compartment. •

The primary reagent compartment stores the reagents at 4° to 8°C (39° to 46°F).

•

The primary reagent shelf mixes the packs to keep the reagents in suspension.

•

The arrow indicator and color on each pack indicate where you can load the packs to optimize sample throughput.

2. Close the primary reagent door. CAUTION

Do not press the sample start button until you close the primary reagent door and ensure that all reagent barcodes were read correctly. Starting the system before all reagent barcodes are read correctly can cause erroneous results. Closing the primary reagent door allows the system barcode scanner to rescan the reagent barcodes and acknowledge any changes. 3. Press the sample start button for the system barcode scanner to rescan the reagent barcodes and acknowledge any reagent changes. Refer to Appendix C, Handling Reagents, in the ADVIA Centaur XP Assay Manual.

Removing Primary Packs NOTE: Before disposing of a reagent, refer to the ADVIA Centaur Assay Manual to identify any warnings or special instructions that may apply.

1. At the Status – Primary Reagent window, select the reagent pack. 2. Select Remove Pack. 3. When prompted, select Complete or select Now. If you want the system . . .

Then . . .

to complete tests scheduled for the pack,

Select Complete.

to discontinue using the pack without completing the tests,

Select Now.

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CAUTION

Do not remove a primary pack when the system is inprocess if the LED on the primary reagent door is green. Removing a primary pack when the system is inprocess and the LED is green can cause erroneous results and mechanical damage to the system. Wait until the LED is neutral before you remove the primary pack. When the status changes to Removable and the LED changes to neutral, remove the reagent pack.

Managing Ancillary Reagents Each ancillary pack contains 1 cancillary reagent. The system tracks the volume in the pack. For information about ancillary reagent stability, refer to the ADVIA Centaur Assay Manual. Some ancillary packs are customer-fillable packs.

Loading Ancillary Reagent Packs Load the ancillary pack in the ancillary reagent entry with the barcoded side facing outward. An LED next to the ancillary reagent entry turns green to indicate that the pack is loading. The front edge of the pack fits in the notch on the ancillary entry pusher. The system moves the pack into the ancillary reagent compartment.

1 2 3

LEDs Ancillary reagent entry Ancillary pack displaying barcode

Figure 2-5

Ancillary Reagent Entry Queue

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Removing Ancillary Reagent Packs NOTE: Before disposing of a reagent, refer to the ADVIA Centaur Assay Manual to identify any warnings or special instructions that may apply.

1. At the Status – Ancillary Reagent window, select an ancillary pack. 2. Select Remove Pack. 3. When prompted, select Complete or select Now. If you want the system . . .

Then . . .

to complete tests scheduled for the pack,

Select Complete

to eject the pack without completing the tests,

Select Now

The system ejects the pack into the ancillary reagent entry. An LED next to the ancillary reagent entry turns orange to indicate that the pack is exiting the system. 4. Remove the pack from the ancillary reagent entry. If the system is not processing samples, you can remove ancillary reagent packs from the ancillary queue using diagnostic tools. Refer Emptying the Ancillary Queue‚ page 6-69.

Replenishing Supplies You can select the Supplies Status button at the workspace to open the Status – Supplies window and review the status of supplies. Refer to Supplies Status‚ page 2-10. You can also move the pointer to the supply field and press the help (?) button on the pointing device for a description of the status messages for each supply and the procedure for replenishing each supply. The system has the following capacity for supplies: Supply

Capacity

Cuvettes

1000 cuvettes

Tips

840 tips

Cuvette Waste

700 cuvettes

Tip Tray Waste

8 trays

Tip Waste

1000 tips

Liquid Waste

7.5 L

Water

10.0 L

Acid

1500 mL

Base

1500 mL

Wash 1

2500 mL

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Supply

Capacity

Wash 3

2500 mL

Cleaning Solution

2100 mL

2-25

Filling the Water Bottle You can fill the water bottle any time, even while the system processes samples. You do not need to use this procedure if your system is directly plumbed to a water source. 1. Remove the water bottle: a. Pull out the waste and water drawer. b. Open the water bottle lid.

1 2 3 4 5

Waste and water drawer Water tubing Water bottle lid Cap Water bottle

Figure 2-6

Waste and Water Assembly

CAUTION

Do not grasp the tubing when disconnecting the tubing from the top of the water bottle or reservoir. Pulling the tubing can cause crimps. Grasp the fittings, not the tubing.

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c. Disconnect the water tubing from the water bottle and then set the tubing on lint-free tissues or gauze to absorb drips. d. Lift the water bottle up and out. 2. Remove the cap. 3. Fill the spare, clean water bottle with fresh reagent water and install the cap. Refer to Reagent Water Quality‚ page C-4. 4. Install the spare, full water bottle: a. Place the water bottle in the waste and water drawer. b. Connect the water bottle tubing to the bottle. A blue spiral wrap designates this tubing. c. Lower the water bottle lid. d. Push in the waste and water drawer.

Emptying the Waste Bottle You can empty the waste bottle anytime, even while the system processes samples. You do not need to use this procedure if your system is directly plumbed to a drain. 1. Remove the waste bottle: a. Pull out the waste and water drawer. Lift the waste bottle lid. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. b. Disconnect the tubing from the top of the waste bottle and then set the tubing on lint-free tissues or gauze. c. Move the clamp on the sensor aside, remove the sensor from the waste bottle.

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d. Wipe the sensor using lint-free tissues or gauze.

1

Sensor tip

Figure 2-7

Water and Waste Bottles

e. Set the sensor on lint-free tissues or gauze.

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2. Insert the Waste Bottle Stopper into the sensor and tubing openings.

1 2 3 4 5

Waste bottle Sensor clamp Sensor opening Waste bottle stopper Tubing opening

Figure 2-8

Waste Bottle Stopper

3. Remove the waste bottle from the waste and water drawer. 4. Empty the waste bottle: a. At the location in your laboratory designated for waste disposal, loosen the waste bottle cap.

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b. Turn the waste bottle valve counterclockwise to open it.

1

Waste bottle valve

Figure 2-9

Waste Bottle

c. Close the waste bottle valve, ensuring that the waste bottle valve is closed completely. d. Tighten the waste bottle cap. 5. Replace the waste bottle: a. Install the waste bottle in the drawer. b. Remove the waste bottle stopper. c. Clean the stopper using lint-free tissues or gauze and cleaning solution. d. Replace the stopper under the waste bottle handle. Refer to Attaching the Waste Bottle Stopper‚ page 2-30. e. Install the sensor and move the clamp to cover the sensor. f.

Connect the tubing to the waste bottle. An orange spiral wrap designates this tubing.

g. Lower the waste bottle lid. 6. Push in the waste and water drawer. 7. When prompted, verify the waste bottle tubing is reconnected. 8. Select Continue. 9. Close the waste and water drawer.

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Attaching the Waste Bottle Stopper NOTE: This procedure is only applicable when installing or replacing a waste

stopper. 1. Open the waste and water drawer. 2. Lift the waste bottle lid to expose the waste bottle handle.

1 2 3 4

Waste bottle handle Waste bottle stopper Waste bottle lid Cable tie

Figure 2-10

Waste Bottle Stopper Cable Tie

3. Thread the cable tie through the hole on the Waste Bottle stopper. 4. Wrap the cable tie around the handle of the waste bottle. 5. Insert the tip of the tie into the cable tie lock. Adjust the tie as necessary. Do not secure the cable tie too tight. The stopper needs to move freely around the handle and be able to reach the tubing and sensor openings. NOTE: The cable tie cannot be adjusted after you lock it.

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Replacing the Cleaning Solution You can replace cleaning solution at any time, except when the system is performing the daily cleaning procedure or an aspirate or reagent probe cleaning procedure. Cleaning solution is stable for 7 days after preparation. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 1. Open the sample tip waste area door. 2. Remove the cleaning solution bottle: a. Pull out the drawer and the cleaning solution bottle. b. Lift the lid.

1 2 3 4

Lid Sample tip waste area door Cleaning solution bottle Drawer

Figure 2-11

Cleaning Solution Cabinet

c. Remove the bottle. 3. Empty any cleaning solution from the bottle. NOTE: Use ADVIA Centaur XP Cleaning Solution to achieve optimum assay and system performance. Do not use other cleaning solutions.

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4. Prepare the cleaning solution: a. Carefully pour a container of ADVIA Centaur XP Cleaning Solution concentrate into the cleaning solution bottle. b. Fill the bottle with reagent water up to the bottom rim of the opening. 5. Install the bottle on the system. 6. Lower the lid onto the bottle, ensuring that the tubing is in the bottle. 7. Push in the drawer. 8. Close the sample tip waste area door. 9. If you did not empty the sample tip waste bin, select No at the prompt.

Adding Cuvettes You can fill the cuvette loading bin any time, even while the system processes samples. 1. Open the supplies access cover.

1 2

Supplies access cover Cuvette loading bin

Figure 2-12

ADVIA Centaur XP Cuvette Loading Bin

CAUTION

Do not leave the top cover open when you add cuvettes to the cuvette loading bin. Leaving the top cover open allows cuvettes to fall into another part of the system where it may obstruct normal operation. Close the top cover when adding cuvettes to the cuvette loading bin. 2. Load the cuvettes in the cuvette loading bin.

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3. Close the supplies access cover.

Adding Sample Tips You can load sample tips any time, even while the system processes samples. 1. Open the supplies access cover. 2. Remove the protective cover from the bottom of the sample tip tray bundle.

1 2 3

Supplies access cover Tab Protective cover

Figure 2-13

ADVIA Centaur XP Tip Tray Loading Area

3. Install the sample tip trays, ensuring that the tab is facing you and that the notches in the trays are on the right. 4. Pull the tab to release the strap from the trays and then remove the strap. 5. Close the supplies access cover.

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Emptying the Sample Tip Waste Bin You can empty the bin any time, even while the system processes samples. Sample tips are collected in a reservoir while the bin is removed from the system. The reservoir holds enough tips for approximately 5 minutes of operation. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. Open the sample tip waste area door. 2. Pull the sample tip waste bin toward you. 3. Remove the sample tip waste bin.

1 2

Cleaning solution cabinet door Sample tip waste bin

Figure 2-14

Cleaning Solution Cabinet

4. Dispose of the contents of the liner into a container approved for biohazardous waste. NOTE: The liners for the cuvette waste bin and the sample tip waste bin are

not interchangeable. Ensure that the sample tip waste bin liner is installed in the sample tip waste bin. 5. If the liner is damaged, install a new liner. 6. Install the sample tip waste bin, ensuring that the bin is pushed in completely. 7. Close the sample tip waste area door.

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Emptying the Sample Tip Tray Waste You can empty the sample tip tray waste any time, even while the system processes samples. 1. Open the cuvette waste area door. 2. Remove the sample tip trays.

1

Sample tip tray waste area

Figure 2-15

Cuvette and Sample Tip Tray Waste Area

3. Dispose of the contents into a waste container. 4. Close the cuvette waste area door.

Emptying the Cuvette Waste Bin You can empty the bin any time, even while the system processes samples. Cuvettes are collected in a reservoir while the bin is removed from the system. The reservoir holds enough cuvettes for approximately 5 minutes of operation. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. Open the cuvette waste area door.

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2. Pull the cuvette waste bin toward you. 3. Remove the cuvette waste bin.

1

Cuvette waste bin

Figure 2-16

Cuvette Waste Cabinet

4. Dispose of the contents of the bin into a container approved for biohazardous waste. NOTE: The liners for the cuvette waste bin and the sample tip waste bin are not interchangeable. Ensure that the cuvette waste bin liner is installed in the cuvette waste bin.

5. If the liner is damaged, install a new liner. 6. Install the cuvette waste bin, ensuring that the bin is pushed in completely. 7. Close the cuvette waste area door.

Replacing System Fluids Replace Acid Reagent, Base Reagent, wash 1, and wash 3 when any of the following conditions exist: •

one month on the system

•

after expiration

•

insufficient volume.

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You can replace the system fluids any time, even while the system processes samples. The system fluid reservoirs hold enough fluid to allow the system to complete the contents of the incubation ring. WARNING

Do not allow contact of Acid and Base reagents with skin and eyes. Acid and Base reagents are irritating to the skin. Wear suitable eye, face, and skin protection, which include wearing gloves, protective eye shield, and laboratory coat. In case of contact with the eyes, rinse the eyes immediately with plenty of water and seek medical advice. In case of accident or if you feel unwell, seek medical advice. If possible, show the bottle label and the Material Safety Data Sheet. In case of accidental ingestion of reagent, call a physician immediately. NOTE: Replace Acid and Base reagents at the same time to manage lot numbers and to obtain optimum reagent performance.

1. Pull the system fluid drawer towards you. CAUTION

Do not touch the tubing or sensors. Touching the tubing or sensors can cause contamination. 2. Lift a fluid bottle lid at the front edge. CAUTION

Dispose of Acid and Base reagents in accordance with local, state, and federal regulations. Refer to the Material Safety Data Sheets for each material for additional information.

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3. Remove a bottle and discard the fluid into an approved fluid waste container and discard the bottle into an approved solid waste container.

1 2 3 4 5

Fluid bottle lid Wash 1 and 3 Base Acid System fluid drawer

Figure 2-17

System Fluids

4. Write today’s date in the space provided on the new bottle. NOTE: Each system fluid bottle has a designated position in the system fluid drawer. Ensure that you place each system fluid bottle in its designated position.

5. Place the bottle in the drawer and remove the cap, ensuring that you do not dislodge the tubing on the fluid bottle lid. 6. Lower the lid onto the bottle, ensuring that the tubing is in the bottle and that the lid fits securely. 7. Repeat steps 2 through 6 for each bottle. 8. Push in the system fluid drawer. NOTE: If the system is inprocess when you change the system fluids, you do not need to prime the bottles.

9. Prime the system fluid bottles.

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Managing the Worklist You can use the Worklist – Summary window for the following tasks: •

accessing the list of current requests

•

evaluating sample results.

•

reviewing the time due for pending tests

•

Moving Final Results to the Historical Worklist‚ page 2-45

•

Locating Specific Samples in the Sample Exit Queue‚ page 2-44

Viewing the Worklist The system updates the contents of the Worklist – Summary window every 15 seconds. A system update can temporarily interrupt your view of this window. You should suspend the update if you need to access information immediately. To suspend the update, perform the following steps: 1. At the Worklist – Summary window, select Suspend Updating. The system temporarily stops updating the worklist table and the label on the button changes to Resume Updating. NOTE: The system immediately updates the worklist table regardless of the

setting of this button if you perform 1 of the following actions: •

delete a worklist request

•

edit a result

•

add or change a request at the Worklist – Schedule window

2. When you are finished at the Worklist – Summary window, select Resume Updating to allow the system to continue the update.

Opening the Worklist To open the Worklist – Summary window from the workspace, perform the following steps: 1. Select Worklist 2. Select Summary. The sample information is on the left side of the table. The test information is on the right side of the table. The Results column displays time due or results.

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The following table describes the View and Sort combinations you can use to perform some routine tasks: Task

View

Sort

Results

Display the list of all current requests

Current

SID

Conc or Index

Display batch requests as a batch, before the ending rack is scanned

Pending Batches

Scanned

NA*

Display sample results, not all tests are complete

Current Results

SID

Conc or Index

Display samples that have tests that are scheduled or inprocess, but not complete

Pending Tests

SID

NA*

Display Stat sample results

Stats

SID

Conc or Index

Display sample results, all tests are complete

Historical

SID

Conc or Index

Display calibrator results

Calibrators

SID

Conc or Index

Display samples with tests that have RLU values, but not a calculated concentration

Stored RLUs

SID

RLU

Display a list of patient results that have been moved to the historical worklist.

Historical

PID

Conc or Index

Display the list of all current tests for a patient

Current

PID

Conc or Index

Display a list of samples that need to process an end-of-bracket set of controls before the system reports the results NOTE: This view applies to control-bracketed tests only. The Repeat and Release buttons are unavailable in this view because the results are retained until the end-of-bracket controls are processed and acceptable.

Waiting for Controls

SID

NA*

Display a list of samples with discarded test results For more information on discarded test results, refer to Reasons for Discarded Results‚ page 2-43. NOTE: This view applies to control-bracketed tests only. The Release button is unavailable in this view because the results have already been discarded.

Results Discarded

SID

NA*

NA = Not Applicable

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Understanding Worklist Symbols For information on the other symbols displayed on the system software and hardware, refer to System Symbols‚ page F-1. Symbol

Description The tests are scheduled as Stat. A dilution is scheduled for the test. If this symbol displays on the left side of the worklist, it indicates a manual dilution. If this symbol displays on the right side of the worklist, it indicates an automatic dilution. A comment is entered. The sample is in the inprocess queue. In the Worklist, this symbol means the sample has been ejected from the inprocess queue. At the Status – Exit Queue window, this symbol means the sample was scheduled by rack and it has no SID. The system scheduled a repeat for the test or the result was obtained when the test was repeated. On a button, this symbol means the system opens a window when you select the button. In a table, this symbol means the result has multiple flags. The result is on hold so that it can be reviewed before it is released. The result is excluded or the test is disabled. In Worklist, this symbol means you changed the number of replicates for the test or specified a particular reagent lot or pack for the test. In Maintenance, this symbol indicates a maintenance procedure you defined for your laboratory. The test is due to complete at the time displaying to the left of this symbol. Tests for this sample did not complete. Reschedule the tests and reload the sample. This symbol displays only for control-bracketed tests. It represents a Waiting for Controls test, which is a test that needs an end-of-bracket set of controls to be completed before the system reports the result.

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Symbol

Description This symbol displays only for control-bracketed tests. It represents a Results Discarded test. The test result was discarded for 1 or more of the following reasons: An open bracket is a control-bracketed test that has acceptable start-of-bracket control results but the end-of-bracket controls have not been processed. The system did not process the end-of-bracket controls within the acceptable time interval. At least 1 of the end-of-bracket control results was unacceptable. The system aspirated a calibrator before aspirating the end-of-bracket set of controls for an open bracket. The calibration expired before the system processed the end-of-bracket set of controls for an open bracket. The reagent lot expired before the system processed the end-of-bracket set of controls for an open bracket. A field service provider performed controller diagnostics before the system processed the end-of-bracket set of controls for an open bracket. A field or setting for the control-bracketed test was modified at the Test – Definition window before the system processed the end-of-bracket set of controls for an open bracket. You performed 1 of the following functions at the Setup – Data Administration window before the system processed the end-of-bracket set of controls for an open bracket: Test Definition, Update Test Definition, Restore Reagent Inventory, Restore Calibration Data, Restore Quality Control Data, Restore Worklist, Delete

CAUTION

Use caution when deleting a worklist with unreleased results. When you delete a worklist with unreleased results, the system permanently removes the associated unreleased results from the database. If the unreleased results are from an open bracket, the associated samples do not display in the Results Discarded report generated at the Print – Report Options window or the Results Discarded view at the Worklist – Summary window.

Displaying Calibrator Results at the Worklist For calibrators, instead of a numerical value, 1 of the following 3 messages displays in the results column of the Worklist – Summary window: Message

Description

Valid

The calibration is within the observed or defined ranges.

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Message

Description

Invalid

The calibration exceeds either the defined or the observed range for 1 or more calibration expected values. Schedule another calibration at the Worklist – Schedule window.

Verify

The calibration is outside the observed range but within the defined range and an operator accepted the calibration. Schedule another calibration at the Worklist – Schedule window.

Suspending Update of the Worklist The system updates the contents of the Worklist – Summary window every 15 seconds. A system update can temporarily interrupt your view of this window. You should suspend the update if you need to access information immediately. To suspend the update: 1. At the Worklist – Summary window, select Suspend Updating. The system temporarily stops updating the worklist table and the label on the button changes to Resume Updating. NOTE: The system immediately updates the worklist table regardless of the setting of this button if you perform 1 of the following actions:

•

delete a worklist request

•

edit a result

•

add or change a request at the Worklist – Schedule window

2. When you are finished at the Worklist – Summary window, select Resume Updating to allow the system to continue the update.

Rescheduling Samples for Control-bracketed Tests The system carefully manages the reporting of results of control-bracketed tests.

Reasons for Discarded Results Test results are discarded for 1 or more reasons. Refer to Understanding Worklist Symbols‚ page 2-41, and refer to the Discarded Results symbol. CAUTION

Use caution when deleting a worklist with unreleased results. When you delete a worklist with unreleased results, the system permanently removes the associated unreleased results from the database. If the unreleased results are from an open bracket, the associated samples do not display in the Results Discarded report generated at the Print – Report Options window or the Results Discarded view at the Worklist – Summary window.

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Rescheduling Samples with Discarded Results Use this procedure to reschedule control-bracketed test samples with discarded test results. NOTE: Print a list of samples with discarded results as described in Printing Results‚ page 2-72 before selecting Repeat at the Worklist – Summary window. A printed list of samples can help you find the samples for reloading. When you select Repeat at the Worklist – Summary window, the printed list of samples with discarded results is no longer available.

1. Print a list of samples with discarded results: a. At the workspace, select Print. b. Select Report Options. c. At the Print – Report Options window, select Results Report. d. Enter the Starting Date and Ending Date and select the Sort option. e. At the View drop-down list, select Results Discarded. f.

Select Print Report.

2. At the Worklist – Summary window View drop-down list, select Results Discarded. When you access this view, the system automatically selects all listed samples. 3. If required, deselect any samples you do not want to reschedule. 4. Select Repeat. NOTE: Ensure that you reschedule the start-of-bracket and end-of-bracket sets of controls also. The system does not process the samples that you rescheduled until the bracket is opened with acceptable start-of-bracket control results. The system does not report the sample results until the acceptability of the results of the end-of-bracket controls is established.

Locating Specific Samples in the Sample Exit Queue You can view the Status – Exit Queue window to determine the status of the samples in the 48 most recently ejected sample racks. In addition, you can locate the approximate positions of the 24 most recently ejected sample racks in the exit queue. For more information about locating sample racks, refer to Locating Sample Racks in the Sample Exit Queue‚ page 2-8. 1. At the Worklist – Summary window, select a specific sample or a test for that sample.

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2. Select Exit Queue. The system opens the Status – Exit Queue window. If the specified sample is in 1 of the 48 most recently ejected sample racks, the system selects and displays the sample rack position for that sample. If the system cannot locate the requested sample, the system displays a message box. 3. Locate the ejected sample in the sample exit queue. If you select the Exit Queue button and no sample or test is selected in the worklist table, the Status – Exit Queue window opens with no sample rack position selected.

Moving Final Results to the Historical Worklist To manually move worklist entries with final results to the historical worklist, perform the following steps: 1. At the workspace, select Worklist > Summary. 2. Select Move to Historical. Selecting Move to Historical schedules all completed samples, regardless of the date and time the results were obtained, to move to the historical worklist. The system moves up to 5000 worklist entries at a time, with a worklist entry consisting of all test results, flags, demographic information, and comments associated with 1 SID. Depending on the size of your worklist, it may take several minutes to an hour or more for the system to move all of the worklist entries with completed results. To avoid sample processing delays, wait until the system is in the Ready state before manually moving final results to the historical worklist. At the Setup – Sample Handling Options window, you can define the number of hours after which you want results to automatically move to the historical worklist. For more information about setting up an automatic process for moving results to historical, refer to Moving Final Results to the Historical Worklist in Section 8.

Scheduling Samples Using an LIS NOTE: Calibrator samples must be scheduled manually. Refer to Scheduling Calibrators‚ page 3-18, for more information.

Before scheduling patient or control samples, ensure that you perform the following tasks: •

Enter test definitions and customize them for your laboratory. Refer to Modifying or Viewing Test Options‚ page 8-9.

•

Define Master Curves for each reagent lot.

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Refer to Defining a Master Curve‚ page 3-10. •

Define calibrators. Refer to Defining Calibrator Values‚ page 3-14.

•

Define controls. Refer to Using Quality Control Features‚ page 4-1.

•

Load reagents. Refer to Loading Reagents‚ page 2-20.

Automatically Scheduling Samples Using an LIS The ADVIA Centaur XP system can receive worklist entries from the LIS. You can also allow the system to automatically request worklist entries from the LIS when a sample is added to the inprocess queue. To automatically request worklist entries, perform the following steps: 1. At the workspace, select Setup > Summary. 2. Select LIS Communications. 3. At the Setup – LIS Communications window, select System Automatically Queries Host for Worklist.

Loading Samples in Host Query Mode If you set up your system in the Host Query mode and sample identification is by SID, load the sample in any rack and position. If sample identification is by Rack, load the sample in the appropriate rack and position. 1. Load the sample. Refer to Managing Sample Racks‚ page 2-2. CAUTION

Do not press the sample start button until you close the primary reagent door and ensure that all reagent barcodes were read correctly. Starting the system before all reagent barcodes are read correctly can cause erroneous results. Closing the primary reagent door allows the system barcode scanner to rescan the reagent barcodes and acknowledge any changes. 2. If the LED above the Sample Start button is not lit, press the button. The system moves the rack to the inprocess queue. 3. If you schedule by SID and the sample tube does not have a barcode label, you can enter the SID after the sample is scanned: a. At the workspace, select the Sample Status button. b. At the Status – Samples window, select the sample with a No Barcode status and then select Enter SID. c. At the Status – Enter SID window, enter the SID.

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You can enter the SID only while the sample is in the Inprocess Queue.

Manually Requesting a Worklist from an LIS If your system is not set up in Host Query mode, load the samples using a sample loading list generated by the LIS or manually request a worklist from the LIS and then load the samples. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select LIS Communications. 4. At the Worklist – LIS Communication window, select Receive Requests from LIS.

Entering First Names The LIS protocol does not support the use of 2-word first names. If these are used, the ADVIA Centaur XP system returns the second word of the first name to the LIS as a middle name. Insert a hyphen between the 2 words of the first name to keep the 2 parts together.

Suspending LIS Communications When your LIS is not operational or before LIS communications are automatically discontinued at the end of operation, suspend communications. If you do not suspend communications, the ADVIA Centaur XP system continues to send information to the LIS even though the LIS is unable to accept the information and system errors can result. To access the System – Communication Diagnostics window, perform the following steps: 1. At the workspace select Event Log. 2. At the System – Event Log window, select Communication Diagnostics. 3. At the System – Communication Diagnostics window, select Suspend Communications. Refer to Identifying System Problems‚ page 6-1.

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Configuring the LIS to Accept Results beyond the Dose Response Curve Range If concentration results are beyond the dose response curve range, the ADVIA Centaur XP system transmits the results to the LIS as > [the value representing the high limit of the Master Curve or linearity range]. For example, if the highest value on the Master Curve Card is 204, the system transmits the result as “> 204”, with a space between the > symbol and the concentration value. Ensure that your LIS is configured to accept this format.

Scheduling Samples Using an LAS If your lab uses a Laboratory Automation System (LAS), be mindful of the following procedural information: •

Do not place sample tubes with duplicate SIDs in the LAS queue of the ADVIA Centaur XP system. The system does not allow the processing of sample tubes with duplicate SIDs.

•

The System – Event Log window may include events associated with laboratory automation even if your laboratory does not have this feature enabled. You can ignore these events.

•

The ADVIA Centaur XP system may send a red LIS status to the LAS after a reboot and prevent sample processing. To avoid this problem, whenever the system is shut down and rebooted, process a sample with orders through the Inprocess queue. The system reinitializes the LIS and returns a green status to the LAS.

Manually Scheduling Samples Before scheduling patient, calibrator, or control samples, ensure that you perform the following tasks: •

Enter test definitions and customize them for your laboratory. Refer to Modifying or Viewing Test Options‚ page 8-9.

•

Define Master Curves for each reagent lot. Refer to Defining a Master Curve‚ page 3-10.

•

Define calibrators. Refer to Defining Calibrator Values‚ page 3-14.

•

Define controls. Refer to Using Quality Control Features‚ page 4-1

•

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Refer to Loading Reagents‚ page 2-20.

Scheduling Patient Samples NOTE: Do not use the same SID for different samples within the same processing run. You must move the current SID information to the Historical worklist before it is safe to reuse the SID. If you are scheduling by batch, ensure that the SID is unique to the batch. If you use an SID more than once, the system processes only 1 sample request and rejects the other. NOTE: When you schedule Hepatitis B Surface Antigen (HBs) or Hepatitis Surface Antigen Confirmatory (Conf) tests, ensure that 2 Ancillary Probe Wash 1 packs (APW1) are in the ancillary reagent compartment or the system displays a Low Probe Wash message. The system may not process an HBs or Conf test with only 1 APW1 pack on the system.

1. At the workspace, select Worklist. 2. Select Schedule. 3. At the Worklist – Schedule window, select Patient. CAUTION

For most sample processing, do not schedule by Rack ID. If, however, it is necessary to schedule a sample by rack ID, be aware that the system ejects the sample to the exit queue after aspirating the sample. Reflex or other testing cannot complete once the system ejects the sample to the exit queue. To obtain final results for reflex or other testing, reintroduce the sample rack to the front of the sample entry queue. If you are scheduling samples for a control-bracketed test, you must schedule by SID. The system does not allow you to schedule samples for control-bracketed tests by Rack. 4. Select how you want the system to identify the sample: •

If the sample identifier selected at the Setup – Tube Type & Barcode window is SID, you can select Schedule by SID or Schedule by Rack. Refer to Specifying Sample Identification‚ page 8-4.

•

If the sample identifier selected at the Setup – Tube Type & Barcode window is Rack, you can only select Schedule by Rack. Refer to Scheduling Non-barcoded Samples by Rack ID‚ page 2-50 and Scheduling Barcoded Samples by Rack ID‚ page 2-51.

NOTE: After entering the SID or the Rack ID, you must press Enter on the keyboard. If you do not press Enter after entering the SID or the Rack ID, the test selection table and the functions at the bottom of the window do not become active.

5. Enter the SID or the Rack ID and then press Enter.

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•

You can enter up to 13 alphanumeric characters for the SID. Do not use the % symbol as part of an SID.

•

The Rack ID consists of 4 numbers (0001 – 9999) followed by a letter (A – E). Enter the letter in uppercase.

6. If you want to process the sample before routine samples, select Stat. 7. Select or enter the tests or the profiles for the sample. If you use the keyboard to enter the tests or profiles in the Test field or the Profile field, you must enter the test name or profile exactly as it displays on the schedule window. 8. Select Save. You can select Summary to view the requests in the worklist. NOTE: If you have groups of samples with the same tests, scheduling the tests in batch is the most efficient method of scheduling without using an LIS. Refer to Scheduling Batches‚ page 2-54 for more information.

Scheduling by Rack ID NOTE: Move results to historical before reusing a rack for samples scheduled by Rack ID. Moving results to historical prevents merging new results with current results when scheduling samples by rack ID. Scheduling Non-barcoded Samples by Rack ID

The following table contains information about manually scheduling non-barcoded samples by rack ID: If . . .

Then . . .

The system . . .

the system has not scanned the rack and you want to add or modify tests for a request,

select the rack position at the Worklist – Summary window and then select Schedule.

recalls the existing request for that rack position which you can modify..

the system has scanned the rack, and the rack position is in the current worklist, and you want to add or modify tests for a request,

select the rack position at the Worklist – Summary window and then select Schedule.

recalls the existing request for that rack position which you can modify.

the system has scanned the rack, and the rack position is in the current worklist, and you want to create a new request for a new sample for that rack position,

select Worklist from the workspace and then select Schedule. or do not make any selections at the Worklist – Summary window and then select Schedule.

creates a new worklist request for the rack position.

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If . . .

Then . . .

The system . . .

the rack position is not in the current worklist and you want to create a new request for it,

select Worklist from the workspace and then select Schedule. or do not make any selections at the Worklist – Summary window and then select Schedule.

creates a new worklist request for the rack position.

The system functions similarly when the LIS schedules samples by rack ID. •

If the system has not scanned the rack, the system recalls the existing request for that rack position and merges additional tests to that request.

•

If the system has scanned the rack or the rack is not in the current worklist, the system creates a new worklist request for the rack position.

Scheduling Barcoded Samples by Rack ID

When a sample is scheduled by rack ID, the system does not use the SID to process that sample even if the tube has a barcode label. In some cases, if the system scans a barcode label for that sample tube, the system enters the SID from the barcode label to the worklist request for the rack position. This provides a check to identify a possible conflict between the SID in the worklist and the SID on the sample tube barcode label. When the system identifies a possible conflict, it alerts the operator by displaying the SID Mismatch sample status message. The following table contains information about how the system uses the SID for samples scheduled by rack ID: Did the system previously scan the rack position that is in the current worklist?

Worklist SID

Barcode Label

System Action

no

not present

present

makes the SID part of the rack ID in the worklist request

no

present

present, different from worklist SID

displays the SID Mismatch message; possibly incorrect tube

yes, with no barcode label on the tube

not present

present

displays the SID Mismatch message; possibly incorrect tube

yes, with no barcode label on the tube

present

not present

assumes that the sample is the same tube and performs pending or new tests

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Did the system previously scan the rack position that is in the current worklist?

Worklist SID

Barcode Label

System Action

yes, with a barcode label on the tube

present

not present

displays the SID Mismatch message; possibly incorrect tube

yes, with a different barcode label on the tube

present

present, different from worklist SID

displays the SID Mismatch message; possibly incorrect tube

Handling SID Mismatches To prevent an SID Mismatch, use 1 of the following procedures: •

Move results to historical before using the rack in a new worklist.

•

Use a rack that is not used in the current worklist.

To clear an SID Mismatch sample status message, perform 1 of the following corrective actions: •

Edit the SID in the worklist to match the SID on the sample tube barcode label.

•

Enter the SID on the sample tube barcode label into the worklist request.

•

Enter the SID from the sample tube barcode label at the Status – Enter SID window.

•

Eject the rack and place the correct sample tube in the rack position.

Scheduling Patient Samples Using a Hand-Held Barcode Reader LASER WARNING

Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. You can use the hand-held barcode scanner to enter the Sample ID for patient samples: 1. At the workspace, select Worklist. 2. Select Schedule. 3. At the Worklist – Schedule window, select only Patient and Schedule by SID. These are the default options and are already selected when the window displays.

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4. Select Scan Data. The system displays a Scan Data dialog box. 5. Aim the hand-held barcode scanner at the SID barcode and press the trigger. The system displays the progress of the scan in the Scan Data dialog box. When the barcode scanner completes its scan, the Scan Data dialog box closes. 6. Select Save.

Entering Patient Demographics Entering patient demographic information is optional. You can enter patient demographic information at the following times: •

as you schedule samples in the worklist

•

after you create the worklist

•

while samples are processing

After you enter the SID or the Rack ID and select or enter the tests or profiles, perform the following procedure to enter patient demographics: 1. At the Worklist – Schedule window, select Demographics. 2. At the Worklist – Demographics window, enter the demographic information: Field Name

Description

PID

You can enter up to 11 alphanumeric characters for the patient identifier.

Name

You can enter up to 30 alphanumeric characters for the patient’s name. An LIS expects the patient name to be formatted “Last Name, First Name”.

DOB

Use the DD MMM YYYY format (for example: 11 Aug 1975). Use the following abbreviations for months: Jan, Feb, Mar, Apr, May, Jun, Jul, Aug, Sep, Oct, Nov, Dec.

M or F

You can select M (male) or F (female).

Location

You can enter up to 12 alphanumeric characters for the location of the patient in the facility.

Physician

You can enter up to 12 alphanumeric characters for the physician’s name.

Optional

You can enter up to 12 alphanumeric characters for optional information about the patient or sample.

3. Select Continue. 4. Select Save at the Worklist – Schedule window and continue with additional scheduling activities.

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Entering Comments for a Patient Sample You can enter comments for a patient sample, such as the serum is hemolyzed or the patient is non-fasting. NOTE: If you are not currently signed in, you must sign in to the system to enter

comments. 1. At the Worklist – Summary window, select the sample and then select Schedule. 2. At the Worklist – Schedule window, select Demographics. 3. At the Worklist – Demographics window, select Comments. 4. At the Comments window, enter a comment. You can enter up to 3 comments. Comments can be up to 120 alphanumeric characters. The system enters your initials and the date. 5. Select Save. 6. Select Continue at the Worklist – Demographics window. 7. At the Worklist – Schedule window, select Summary to return to the Worklist – Summary window.

Scheduling Stat Samples When you load a sample scheduled as Stat in the sample entry queue, the system processes the sample before routine samples. You can have the system process an existing worklist request as Stat by performing 1 of the following: •

Load the sample into the Stat entry. When you load any sample into the Stat entry, the system processes the sample before routine samples.

•

Before you load the sample, edit the request at the Worklist – Schedule window to schedule the sample as Stat. Refer to Editing Requests‚ page 2-60.

Scheduling Batches When the LIS is not operational or not connected, the most efficient method of scheduling tests is to schedule them in batch at the Worklist – Schedule window. The system performs the requested tests on all samples loaded in the starting rack, ending rack, and all racks in between. 1. At the workspace, select Worklist. 2. Select Schedule. 3. At the Worklist – Schedule window, select Batch.

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4. Enter the rack number of the starting rack in Starting Rack. Rack numbers contain a 4-digit rack identifier. It is not necessary to enter a letter. 5. Enter the rack number of the ending rack in Ending Rack. 6. Select or enter the tests or profiles. If you use the keyboard to enter the tests or profiles in the Test field or the Profile field, you must enter the test name or profile exactly as it displays on the schedule window. 7. Select Save. 8. Load racks. NOTE: You can load racks in any order between the starting rack and the ending rack. Racks loaded before the starting rack and after the ending rack are not included in the batch even if the Rack ID is numerically between the Rack IDs of the starting rack and the ending rack.

As samples are scanned, individual requests are added to the worklist using the primary sample identifier. Batches display at the Worklist – Summary window in the Pending Batches view. When the system scans the ending rack, the system removes the batch from the Pending Batches view. Sample racks loaded in the Stat entry are not recognized as part of a batch and batch test requests are not added to the Stat test request. If you schedule a sample in a batch and also schedule an individual test request for that same sample, the system processes all tests for that sample. If you select SID for sample identification in Setup, you must use SID barcode labels to identify the samples. If sample identification is by SID and the SID barcode label is not recognized by the system, no request is created for the sample. To create a request for the sample, reload the sample with a readable SID barcode label before the ending rack for the batch is loaded.

Scheduling Calibrators and QC Samples •

Refer to Scheduling Calibrators‚ page 3-18.

•

Refer to Scheduling QC Samples‚ page 4-6.

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Entering Dilution Options The ADVIA Centaur XP system provides both automatic and manual dilution options. •

You define automatic dilution options for a specific test, such as diluting all test results greater than a specified concentration limit, at the Test – Ranges window.

•

You define dilution profiles, which automatically schedule multiple dilutions for a test, at the Test – Profile Summary window. Refer to Defining Automatic Dilutions for Tests‚ page 8-30.

•

You define manual dilution options for a specific sample at the Worklist – Dilutions window.

Use this procedure after you enter the SID or the Rack ID and select or enter the tests or profiles to enter dilution information for a specific sample: 1. At the Worklist – Schedule window, select Dilutions. NOTE: You must dilute all samples with the correct ADVIA Centaur XP diluent specified for each test. Physiological saline or commercial albumin are not acceptable diluents for ADVIA Centaur XP assays. Refer to the ADVIA Centaur Assay Manual. NOTE: If the sample has a test selected for which manual dilutions are not

allowed, the Manual Dilution field is not available. 2. For manual dilutions, enter the dilution factor in the Manual Dilution field at the Worklist – Dilutions window. The results are automatically corrected for the specified dilution factor. 3. To define a system-performed dilution option for a specific sample, select a dilution option for each test performed on the sample: •

If the sample is to be tested as defined in the test definition, select Default.

•

If the sample is not to be diluted, select Undiluted Only.

•

If the sample is to be tested only with the specified dilution factor, select Diluted Only.

•

If the sample is to be tested both undiluted and also with the specified dilution factor, select Undiluted & Diluted.

•

If the sample is to be diluted only if the undiluted value is greater than the dilution point defined at the Test – Ranges window, select Dilute if Over.

NOTE: If a dilution profile is scheduled for the test, Dilution Option displays only Profile, which you cannot change. Dilution profiles are defined at the Test – Dilution Profile Definition window. Refer to Defining Dilution Profiles‚ page 8-31.

4. At Dilution, select a dilution factor .

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5. Select Continue. 6. At the Worklist – Schedule window, select Save.

Entering Reagent Options Use this procedure to specify the lot number and the pack of the primary reagent, the ancillary reagent, the diluent, and the vial for tests for a specific sample. Change the reagent options when you want to confirm the performance of the test with another lot number or pack or when you want to test multiple reagent lot numbers in parallel. 1. At the Worklist – Schedule window, after you enter the SID or the Rack and select or enter the tests or profiles, select Reagent Options. 2. After selecting a primary reagent lot number, at the Worklist – Reagent Options window, select the following options: •

a primary reagent pack

•

an ancillary reagent pack

•

a second ancillary reagent pack

•

a diluent pack

•

an allergen vial

3. Select Continue. 4. At the Worklist – Schedule window, select Save. NOTE: If you are performing control-bracketed tests, the list in the Lot field at the Worklist – Reagent Options window displays a plus sign (+) at the end of any reagent lot number used in an open control-bracketed test. An open control-bracketed test is a control-bracketed test that has acceptable start-of-bracket control results but the end-of-bracket controls are not processed. NOTE: The system allows several control-bracketed tests to be open at the same time, including tests using different lots of the same reagent.

Changing the Number of Replicates Use this procedure to change the number of replicates for tests for a specific sample. This option is not available for calibrator samples. You can specify the number of replicates to routinely perform on each test at the Test – Definition window. Refer to Modifying Sample Replicates‚ page 8-14. 1. At the Worklist – Schedule window, after you enter the SID or the Rack and select or enter the tests or profiles, select Reagent Options. 2. At the Worklist – Reagent Options window, enter the number of replicates for the test. You can specify up to 30 replicates for each test.

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3. Select Continue. 4. At the Worklist – Schedule window, select Save.

Using Control-bracketed Tests Refer to the scheduling and loading procedures described in these topics: •

Scheduling Samples Using an LIS‚ page 2-45

•

Manually Scheduling Samples‚ page 2-48

•

Managing Sample Racks‚ page 2-2

Scheduling Control Sets Schedule a complete set of controls at the beginning of a group of samples to open a bracket and at the end of a group of samples to close a bracket. A control set must contain the number of control levels defined at the Test – Definition window. The system does not allow a value of 0 or a value greater than 5. The system does not process extra controls but indicates their status with an Incomplete Set flag at the Worklist – Summary window. In addition, a control set must contain a numerically ascending sequence of control levels beginning with Level 1. For example, if a test requires 3 controls in a set, the controls must follow this sequence: Level 1, Level 2, and Level 3.

Loading Control Sets Place all of the controls within a set in 1 rack. Load the control rack through the sample entry queue or Stat entry. Use the end-of-bracket controls from 1 group of samples as the start-of-bracket controls for the next group of samples, provided the control results are acceptable and none of the system conditions force the system to cancel the control-bracketed test. Refer to Reasons for Discarded Results‚ page 2-43.

Scheduling Start-of-bracket and End-of-bracket Tests If you schedule the start-of-bracket controls and the end-of-bracket controls at the same time, you must perform the following tasks: •

Schedule the start-of-bracket controls with a specific rack ID for the set and a unique position for each control within the set.

•

Schedule the end-of-bracket controls with a different rack ID for the set and a unique position for each control within the set.

If you schedule the start-of-bracket controls and wait until they are processed and have acceptable results before scheduling the end-of-bracket controls, schedule the controls by SID.

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You do not need to enter the rack ID and position of the controls. You can use the same rack for the start-of-bracket controls and end-of-bracket controls as long as the system processed the previous set of controls with acceptable results and ejected the rack.

Scheduling Calibrators for a Control-bracketed test If you schedule and load calibrators for a control-bracketed test and the system aspirates a calibrator before processing the end-of-bracket controls, the system discards any retained patient test results. Retained patient test results are patient test results that are not reported by the system until an end-of-bracket set of controls is processed with acceptable results. Schedule samples for control-bracketed tests by SID only. The system does not allow you to schedule samples for control-bracketed tests by Rack.

Modifying the Worklist You can change entries on the worklist or delete entries from the worklist.

Selecting Multiple Samples or Tests You can select multiple samples or tests at the Worklist – Summary window. The samples or tests can be adjacent or non-adjacent in the worklist table. Use the multiple select feature to perform the following functions: •

delete multiple tests

•

repeat multiple tests

•

release results for multiple tests from hold

•

send results for multiple samples or tests to the LIS

If you want to . . .

Then . . .

select multiple adjacent samples or tests in the worklist summary table,

1.

Use the pointing device to select the first sample or test.

2. Hold down the Shift key while using the pointing device to select the last sample or test to be included in the selection. The system selects all samples or tests in the worklist summary table between and including the first and the last selected item.

3. When the samples or tests are selected, perform the function. select multiple non-adjacent samples or tests in the worklist summary table,

1.

Hold down the Ctrl key while using the pointing device to select each sample or test.

2. When the samples or tests are selected, perform the function.

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NOTE: If you select samples on the left side of the worklist summary table, all tests for the sample are selected.

If you start selecting on the left side of the worklist summary table, the system assumes that you want to select samples even if your last selection at the time is on the right side of the table. The system selects all tests for the samples in the selected rows. If you select tests on the right side of the worklist summary table, you can select specific tests for a sample. If you start selecting on the right side of the worklist summary table, the system assumes that you want to select tests even if your last selection at the time is on the left side of the table. The system selects only tests in the selected rows. If you need to scroll to continue selecting multiple samples or tests, release the Shift or Ctrl key, scroll to the desired location, and then again hold down the Shift or Ctrl key while selecting the sample or test. When you select multiple tests and then select the Delete button, the following information applies: •

The system cannot delete tests that are part of a ratio test and calibrators. The system only deletes the tests that it can delete.

•

The system can only delete a predetermined number of tests at a time. If tests remain highlighted, select the Delete button again to delete more tests.

Editing Requests Use this procedure to perform the following actions: •

add tests

•

change how the system processes a sample (Stat or routine)

•

change dilutions

•

specify reagent lots or packs

•

change the number of replicates

•

change demographics

To edit worklist requests, perform the following steps: 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select a sample or a test. 4. Select Schedule. 5. At the Worklist – Schedule window, edit the request. 6. Select Save to save the change.

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Modifying a Test for a Request Scheduled by Rack ID To modify a test for a worklist request scheduled by rack ID, perform the appropriate action: To process . . .

Then . . .

And . . .

pending tests,

check the worklist to identify sample racks with pending tests

reload the sample rack.

additional tests for a sample,

select the rack position at the Worklist – Summary window, select Schedule, select the tests, and then select Save or schedule tests for the SID required using an LIS

reload the sample rack.

Deleting Requests Use this procedure to delete selected samples or tests. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select a sample, a test, or a batch. If you want to . . .

Then . . .

delete a sample or a test,

select a sample or a test.

delete a batch,

select Pending Batches in View and then select a batch.

4. Select Delete. 5. Select Yes. NOTE: You cannot delete calibrators that are resulted.

If tests have not started or if tests are complete, the entire request is deleted immediately from the worklist. If tests are inprocess, the tests are stopped, the cuvettes are discarded, and the tests, including any completed results, are deleted from the worklist.

Evaluating the Results You can review results, interpretations, and flags at the Worklist – Summary window. Refer to Managing the Worklist‚ page 2-39.

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The Worklist – Summary window provides pop-up windows that display additional information about the samples and tests. To view these pop-up windows for a specific sample or test, use the following options: If you want to view . . .

Then select . . .

the manual dilution factor that you selected at the Worklist – Dilutions window for a sample,

the dilution symbol in the manual dilution column.

the operator specified dilution option and factor that you selected at the Worklist – Dilutions window for a sample,

the dilution symbol in the system dilution column.

the units, up to 4 defined reference ranges, the defined check range, and the defined linearity range for a patient result, NOTE: If the selected result is outside of a range, the range displays in bold text.

a patient result in the result column.

the units for a control result,

a control result in the result column.

the 3 highest priority result flags for a sample,

the flag in the flag column.

NOTE: If multiple flags are associated with a result, an

ellipsis (...) is appended to the flag.

Pop-up windows do not display in the following circumstances: •

The system processes the dilution using operator-specified parameters defined at the Test – Ranges window.

•

The result is outside of the calculation range.

•

The result is for a calibrator.

At the Worklist – Result Details window, you can review additional information to help you evaluate results: •

replicate and mean results

•

reference ranges

•

units

•

complete list of flags for each result

•

access to reagent lot and pack information for each replicate result

To view results and flags, perform the following steps: 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select a result. 4. Select Result Details.

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The system lists results alphabetically by test and in chronological order.

•

The window displays the final result in bold.

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NOTE: You can view a control-bracketed test result at the Worklist – Result Details window when the system releases the result.

If the system has not released the result, the Worklist – Result Details window displays the Waiting for Controls symbol. If the system discarded the result, the window displays the Results Discarded symbol. Refer to System Symbols‚ page F-1. If the control-bracketed test is waiting for controls or the results are discarded, the Worklist – Result Details window does not display RLUs.

Result Flags Flag

Description

Above Check

The result is above the check range entered in the test definition. The test is repeated if you select Repeat if > for Check Range at the Test – Ranges window.

Autorepeat

The system automatically repeated this test as specified in the test definition.

Below Check

The result is below the check range entered in the test definition. The test is repeated if Repeat if < is selected for Check Range at the Test – Ranges window.

Cal Accepted

The result was obtained using an operator-accepted calibration for this test.

Cal Assigned

The result was obtained after you assigned a valid calibration for this test at the Worklist – Summary window.

Cal Invalid

The calibration is invalid for this test. If an RLU is displayed for the test and you have the appropriate level of security, you can assign the previous valid calibration. At the Worklist – Summary window, select the result and then select Assign Cal.

Cal Required

No valid calibration is available for the reagent lot. Schedule a calibration at the Worklist – Schedule window.

Cancelled

A test was cancelled and unable to complete because of a conflict or resource problem while processing.

Check Variable

A result was not obtained for the ratio test because of an error flag for 1 or more of the ratio variables. Check the variables for the ratio.

Clot Detected

A result was not obtained because a clot was detected in this sample.

> Conc Range

The result is above the high value for the concentration calculation defined at the Calibration – Master Curve Definition window. The test is repeated if you select Repeat if > Conc Range at the Test – Ranges window.

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Flag

Description

< Conc Range

The result is below the low value for the concentration calculation defined at the Calibration – Master Curve Definition window. The test is repeated if you select Repeat if < Conc Range at the Test – Ranges window.

Conf N/A

The system cannot calculate a result for a confirmatory test on this sample.

Control bracketed

The system processed this sample as part of a group of samples for a specific test that began and ended with a set of controls. The system does not process samples until it establishes the acceptability of the results of the beginning set of controls. The system does not report sample results until it establishes the acceptability of the results of the ending set of controls. The system displays this flag at the Worklist – Result Details window and the Worklist – Summary window. If your system transmits results to a laboratory information system (LIS), this flag is transmitted also.

Control bracketed restricted

The system processed this sample with a control-bracketed test in the restricted mode. A control-bracketed test is a test that requires evaluating a set of controls at the beginning and end of a group of patient samples. The system does not process samples until it establishes the acceptability of the results of the beginning set of controls. The system does not report sample results until it establishes the acceptability of the results of the ending set of controls. The restricted mode is a mode of processing in which the system performs the same test on a group of samples loaded between defined starting and ending racks without the interruption of any other test or samples. The system displays the Control bracketed restricted flag at the Worklist – Result Details window and the Worklist – Summary window. If your system transmits results to a laboratory information system (LIS), this flag is transmitted also.

Diluted

The result was obtained on a sample that the system automatically diluted.

> Dilution Pt

The result is above the dilution point defined for this test at the Test – Ranges window.

Edited

You modified the result that was reported by the system.

Entered

You manually entered the test result (usually for an off-system test).

Exception

The quality control result caused a defined quality control rule violation.

Excluded

The quality control result is excluded from statistics or the calibrator replicate is excluded from the calibration.

High

The result is above the reference range (normal range) entered in the test definition.

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Flag

Description

High CV

The CV (coefficient of variation) for replicates of the sample is above the acceptable CV entered in the test definition.

Incomplete Cal Set

One of the calibrator levels is not loaded on the system. Ensure that both the high calibrator and the low calibrator are loaded.

In Check Range

The result is equal to or above the defined low limit and equal to or below the defined high limit of the range. The test is repeated if the appropriate Repeat if criteria is selected for Check Range at the Test – Ranges window.

> Index Range

The result is above the high value for the index calculation defined at the Calibration – Master Curve Definition window. The test is repeated if Repeat if > Index is selected at the Test– Ranges window.

< Index Range

The result is below the low value for the index calculation defined at the Calibration – Master Curve Definition window. The test is repeated if Repeat if < Index is selected at the Test– Ranges window.

Insufficient

Not enough sample volume is available for the requested tests.

Integrity Error

A result was not obtained because the system detected an irregular sample aspiration. Check the sample for bubbles or foam, or check the sample probe tubing and the tip-probe connection for leaks.

Investigational

This test is for investigational use only.

> Linearity

The result is above the linearity you entered at the Test – Ranges window. The test is repeated if Repeat if > is selected for Linearity at the Test – Ranges window.

< Linearity

The result is below the linearity you entered at the Test – Ranges window. The test is repeated if Repeat if < is selected for Linearity at the Test – Ranges window.

Lot Expired

The reagent lot expired. Define a Master Curve for a new reagent lot at the Calibration – Master Curve Definition window.

Low

The result is below the reference range (normal range) entered in the test definition.

Low Acid

Insufficient acid reagent is available on the system to perform the test.

Low Base

Insufficient base reagent is available on the system to perform the test.

Low Tips

Insufficient number of sample tips are available to perform the test.

Low Wash 1

Insufficient wash 1 reagent is available on the system to perform the test.

Low Wash 3

Insufficient wash 3 reagent is available on the system to perform the test.

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Flag

Description

Low Probe Wash

Insufficient probe wash is available on the system to perform the test.

Low Water

Insufficient water is on the system to perform the test.

Manual Dilution

A manual dilution was specified for this test result. The result is automatically corrected for the specified dilution factor.

No Ancillary

The test requires an ancillary reagent. Load the appropriate ancillary reagent.

No Bracket

The system cannot process this sample at this time because the start-of-bracket controls were not processed or at least 1 of the control results is unacceptable. The system will process the sample after the start-of-bracket controls are processed and produce acceptable results.

No Calculation

A result was not obtained because a calculation error occurred. For example, the RLUs for the sample are off the curve. For more information, call for technical assistance.

No Cal Lot Match

The test requires a specific primary reagent and calibrator lot combination. Ensure that you use the primary reagent and the calibrators from the same kit.

No Dil Allowed

The system cannot calculate this result because a dilution is not allowed for this test.

No Diluent

An automatic dilution is scheduled and no diluent is loaded for this test.

No Lot Match

The test requires a specific primary reagent and ancillary reagent lot combination. Ensure that you use the primary reagent and the ancillary reagent from the same kit.

No Primary

No primary reagent is loaded for this test. If you are processing control-bracketed test and you get a No Primary flag when you are not out of primary reagent, the system is indicating that patient samples were not processed because insufficient time remained to complete the bracket.

No sIgE Universal

No sIgE universal reagent is onboard or the pack that is on the system is empty.

No Vial Rgt

No allergen reagent is loaded for this test.

Out

The result for this control is above or below the limits entered in the control definition. This flag does not display when quality control rules are defined and enabled for a test.

Overdiluted

A result was not obtained because the diluted sample result is below the overdilution point defined at the Test–Ranges window.

Priming

The system cannot perform the test because the system needs to schedule priming for a probe or a pump.

Redilute

Dilute and repeat the test.

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Flag

Description

repeated

The system automatically repeated the test or you repeated the test by selecting the test and then selecting the Repeat button at the Worklist – Summary window or the Worklist – Result Details window.

restricted

The system processed this sample as part of a group of samples for a specific test loaded between defined starting and ending racks without the interruption of any other test or samples. The system displays this flag only at the Worklist – Result Details window. If your system transmits results to a laboratory information system (LIS), this flag is transmitted also.

Signal Error

A result was not obtained because a signal error occurred. For example, the RLUs for the sample are near zero, because of a low light count to dark count ratio, or of noise. Contact your local technical support provider or distributor.

System Error

The system cannot perform the test because a subsystem is offline.

Test Inactive

The test is inactivated. At the Status – Primary Reagent window, you can activate the test by selecting a pack for the test and then selecting Activate Test. At the Status – Carrier Details window, you can activate a specific IgE test when the system is not inprocess by deselecting the Inactivate Test button for that test vial.

Waste Full

The system cannot perform the test because the cuvette bin, the sample tip bin, the tip tray bin, or the waste bottle is full.

Wrong Pack ID

Primary or ancillary reagent with the specified pack serial number is not loaded for this test.

Wrong Vial ID

Allergen reagent with the specified vial serial number is not loaded for this test.

Waived

The result was obtained using an operator waived calibration for this test.

Repeating a Test Use this procedure to manually schedule a repeat for a completed test. Refer to Defining Automatic Repeats for Sample Error Conditions‚ page 8-27. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select a test on the right side of the worklist.

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4. Select Repeat. If . . .

Then . . .

the sample is in the inprocess queue when the repeat test is scheduled,

the system automatically performs the repeat test on the sample.

the sample has been ejected from the inprocess queue before the repeat test is scheduled,

you must reload the sample.

When the repeat completes, you can review the initial results and the repeated results at the Worklist – Result Details window.

Locating Samples that Require Further Attention You can use the Status – Exit Queue window to locate samples that do not have results, require dilutions, or require other attention due to errors. Refer to Locating Specific Samples in the Sample Exit Queue‚ page 2-44.

Editing Results Use this procedure to change the concentration or index value of a result. You can also use this procedure to enter the result for an off-system test. You must have the appropriate level of security to edit results. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select a sample. 4. Select Result Details. 5. At the Worklist – Result Details window, select a result. 6. Select Edit Result. 7. At the Worklist – Edit Results window, edit the value: •

If the result is a concentration value, change or enter the value in Conc.

•

If the result is an index value, change or enter the value in Index.

•

If the result has both concentration and index values, both fields display at the Worklist – Edit Results window; however, you can only edit the Conc field.

8. Enter comments, as needed, to record why you edited the result: a. Select Comments. b. At the Comments window, enter a comment. You can enter up to 3 comments. Comments can be up to 120 alphanumeric characters. The system enters your initials and the date. If you are not currently signed in, you must sign in to the system. c. Select Save.

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9. At the Worklist – Edit Results window, select Save .

Releasing Results That Are On Hold If the system is holding results for review before sending them to the LIS, use this procedure to remove the hold status. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select test results with the hold status. 4. Open the Worklist – Release Results window by performing 1 of the following actions: If you want to . . .

Then . . .

release the hold status for selected results,

select Release.

review result replicates and flags for a selected result before releasing the hold status,

a.

Select Result Details.

b. Review details for the result. c.

Ensure the result is selected and then select Release.

5. At the Worklist – Release Results window, you can select how you want the system to release the hold status for results. If you want to . . .

Then . . .

release the status for the result selected at the Worklist – Summary window,

select Release Only Selected Results.

release the status for all results for the test selected at the Worklist – Summary window,

select Release All Results on Hold for the Selected Test.

release the status for all results the system is holding for review,

select Release All Results on Hold.

release the status for results within a specific date range,

a.

Select Release Results on Hold within Date Range.

b. Enter the starting date and the ending date.

6. Select Continue. When the system releases the hold status for a result, it automatically sends the result to an LIS if automatic transfer of results is defined for your system. Refer to Defining LIS Communication Options‚ page 8-45.

Releasing Results on Hold At the Worklist – Release Results window, selecting Release All Results on Hold for the Selected Test does not transmit all interim and final results on hold for a selected test to the LIS.

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NOTE: To perform this procedure, at the Setup – LIS Communication window, you must have selected the option System Automatically Sends All Results and Additional Data except Results on Hold.

Use the following procedure to release all results on hold for the selected test: 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary, select the test with the hold status. 4. Select Release. 5. At the Worklist – Release Results window, select Release All Results on Hold for the Selected Test and then select Continue. The system transmits all results on hold to the LIS.

Sending Results to an LIS If automatic transfer of results is not defined for your system, you can manually send results to an LIS. You can send all results except results that you are holding for review or you can select specific test results at the Worklist – Summary window and then release these results to the LIS.

Sending All Results Except Results On Hold to an LIS 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select LIS Communications. 4. At the Worklist – LIS Communications window, select Send All Results Except Results on Hold. 5. You can enter a starting date and an ending date. •

The default for the starting date field is the date and time of the earliest request in the current worklist.

•

The default for the ending date field is the date and time this window was opened.

6. Select Continue. The system sends all results to the LIS that match the criteria you defined.

Sending Selected Results to an LIS 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select the results you want to send to the LIS. Refer to Selecting Multiple Samples or Tests‚ page 2-59, .

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4. Select LIS Communications. 5. At the Worklist – LIS Communications window, select Send All Selected Results. 6. Select Continue. The system sends all selected results, except results on hold, to the LIS.

Deleting Results Use this procedure to delete results. NOTE: Before deleting a worklist, ensure that the system has posted all results

from the worklist. If you delete a worklist while the system is posting results from that worklist, the system may stop processing samples. NOTE: You must have the appropriate level of security to access Data Administration. NOTE: Do not delete results or worklists if the system is in the Cleaning Failed state. Ensure that the system is in the Ready or the Warming Up state and then delete the results or worklists.

1. At the workspace, select Setup. 2. Select Data Administration. 3. At the Setup – Data Administration window, select Worklist. CAUTION

Use care when deleting results. Deleting results permanently removes the results from the database. CAUTION

Use caution when deleting a worklist with unreleased results. When you delete a worklist with unreleased results, the system permanently removes the associated unreleased results from the database. If the unreleased results are from an open bracket, the associated samples do not display in the Results Discarded report generated at the Print – Report Options window or the Results Discarded view at the Worklist – Summary window. NOTE: When you delete a worklist from an open control-bracketed test, the

system does not close the bracket. The system discards any retained patient results. However, it does not delete the controls. 4. Select Delete. 5. At the Setup – Data Administration Options window, you can delete the entire worklist or part of the worklist: •

Select Delete Entire Worklist to request the deletion of the entire worklist. Continue with step 6.

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•

Select Delete Selected Worklist to request deletion of part of the worklist.

•

Select the date ranges and tests that you want to delete from the current or the historical worklist.

If you want to delete . . .

Then . . .

results for all tests in the current worklist,

in result, select Current and in Test, select All.

results for a specific test in the current worklist,

in result, select Current and in Test, select the test for the results you want to delete.

results for all tests in the historical worklist,

in result, select Historical and in Test, select All.

results for a specific test in the historical worklist,

in result, select Historical and in Test select the test for the results you want to delete.

all results for all tests,

in result, select Current & Historical and in Test, select All.

all results for a selected test,

in result, select Current & Historical and in Test, select the test for the results you want to delete.

For the dates, the worklist, and the tests you selected, you can also select the status of the results you want to delete. If you want to delete . . .

Then . . .

pending requests,

Select Pending.

tests that have results,

Select Resulted.

printed results,

Select Printed.

results that were sent to the LIS,

Select Sent.

6. Select Continue to begin the deletion.

Printing Results The system offers 3 printed report types for managing patient results: •

Results Report

•

Test Report

•

Runtime Report

When you select a report, the system displays the options for that report type.

Printing Results by Sample The Results Report is a report of all results for samples in a specific date range according to the specified view and sort options. 1. At the workspace, select Print.

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2. Select Report Options. 3. At the Print – Report Options window, select Results Report. 4. Enter the starting and ending date, view, and sort. Select Save as Default to save the selections as default selections. 5. Select Print Report. View determines the information that is printed. You can select 1 of the following options: •

Results – requests with results

•

Pending Tests – requests that do not have results

•

All – all requests

•

Stats – Stat requests with results

•

Results Discarded – requests with discarded test results for a control-bracketed test The Results Discarded list can help you locate and reload control-bracketed test samples that require repeat testing. Refer to Reasons for Discarded Results‚ page 2-43 NOTE: Ensure that you print the Results Discarded list before selecting

Repeat at the Worklist – Summary window. When you select Repeat at the Worklist – Summary window, the printed Results Discarded list is no longer available. Sort determines the order in which the data is printed. You can select 1 of the following options: •

RLU Measured – in chronological order by the time when the system generated the RLU measurements for the results

•

SID – in ascending alphanumeric order by the sample identifier (SID)

•

Rack – in ascending alphanumeric order by the rack identifier

•

Test – in alphabetical order by test name

Printing Results by Test NOTE: The test report for the HBs Confirmatory assay displays the RLUs for RgtA and RgtB in the wrong columns. The RgtA value is displayed on the RgtB column and the RgtB value is displayed in the RgtA column. The correct RLUs are displayed in the Runtime Result report. The system uses the correct RLUs in the calculation of results.

The Test Report is a report of all results for tests that are defined on the system. 1. At the workspace, select Print. 2. Select Report Options. 3. At the Print – Report Options window, select Test Report.

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4. Enter the starting and ending date, test, and sort. Select Save as Default to save the selections as default selections. 5. Select Print Report. Results are collated by calibration, starting with the earliest calibration. This report can include all results stored by the system. Sort determines the order in which the data is printed. You can select 1 of the following options: •

RLU Measured – in chronological order by the time when the system generated the RLU measurements for the results

•

Interpretation – in alphabetical order by the interpretation of the results

Resetting the Page Numbers for Runtime Reports The Runtime Report prints sample results as they are generated by the system if Automatic Runtime Results Report is selected at the Setup – Print Options window. Refer to Specifying Print Options‚ page 8-41. At the Print – Report Options window, you can restart the page numbers for the runtime report. For example, you can restart the page numbers at the beginning of each day, or at the beginning of each shift in your laboratory. 1. At the workspace, select Print. 2. Select Report Options. 3. At the Print – Report Options window, select Runtime Report. 4. Select Reset Page Numbers.

Printing Notes When you turn off or disconnect the printer at your system, ensure that you deselect the Automatic Runtime Results Report option at the Setup – Print Options window and do not request any other printed report. If the ADVIA Centaur XP system responds to an automatic or manual print request when your printer is turned off or disconnected, a software error can occur. If you request a printed report when no printer is available, use the following procedure to cancel the print request: 1. At the workspace, select Print. 2. Select Cancel Reports. If you want to stop printing reports and you select Cancel Reports, printing does not stop until everything in the printer buffer prints.

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3 Calibration Using a Master Curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 Performing a 2-point Calibration . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 Referencing Serum Calibration for T Uptake . . . . . . . . . . . . . . . 3-4

Understanding Calibration Evaluation Criteria . . . . . . . 3-4 Using Defined Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Using Observed Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 Retained Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 Autoexcluding Calibration Replicates . . . . . . . . . . . . . . . . . . . . 3-10

Defining a Master Curve . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 Using the Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 Using the Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11 Procedural Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14

Deleting A Master Curve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

Defining Calibrator Values . . . . . . . . . . . . . . . . . . . . . . . 3-14 Adding a New Calibrator Definition. . . . . . . . . . . . . . . . . . . . . . 3-14 Using the Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15 Using the Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15

Deleting a Calibrator Definition . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Performing Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . 3-16 Reviewing Calibration Status . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16 Reviewing Calibration History . . . . . . . . . . . . . . . . . . . . . . . . . 3-18 Scheduling Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18 Scheduling Calibrations for Control-bracketed Tests. . . . . . . . . . . .3-19

Managing Calibration Data . . . . . . . . . . . . . . . . . . . . . . . 3-20 Reviewing Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20 Excluding a Calibrator RLU . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23 Waiving a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24 Waiving a Calibration at the Calibration – Summary Window . . . . .3-24 Waiving a Calibration at the Calibration – Data Window . . . . . . . . .3-24

Accepting an Invalid Calibration . . . . . . . . . . . . . . . . . . . . . . . 3-24 Assigning a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25 Managing Calibrations Examples . . . . . . . . . . . . . . . . . . . . . . . 3-25 No Current Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26 Current Valid Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26 Expired Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27

Printing Calibration Data. . . . . . . . . . . . . . . . . . . . . . . . . 3-27

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Calibration The ADVIA Centaur XP system uses a Master Curve and a 2-point, operator-initiated calibration to calibrate qualitative and quantitative assays. The Master Curve and the 2-point calibration method eliminate the need to measure a full standard curve or to include a calibration each time the assay is performed.

Using a Master Curve The Master Curve is part of the manufacturing process for each assay lot number. Measuring the RLU response at multiple concentration levels is the means of performing full standard curves on lot numbers. The standard concentrations and corrected RLUs define the shape of the curve for a particular assay lot number. The manufacturing process uses reagents from a specific lot to generate a Master Curve by performing the assay on standards of varying concentrations on multiple systems over several days. The ensuing standard curve determines the relationship between the defined analyte levels and the RLUs. These concentrations and RLUs become the lot-specific Master Curve and Siemens provides them as barcodes on the Master Curve Card. The Master Curve for a competitive assay has a negative slope, which indicates that the analyte concentration is inversely proportional to the light emission in RLUs.

1 2

Light emissions (RLUs) Analyte concentration

Figure 3-1

Master Curve – Competitive Assay

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The Master Curve for a sandwich assay has a positive slope, which indicates that the analyte concentration is directly proportional to the light emission in RLUs.

1 2

Light emissions (RLUs) Analyte concentration

Figure 3-2

Master Curve – Sandwich Assay

Performing a 2-point Calibration To minimize instrument-to-instrument variability and variability due to environmental factors and reagent age, you must perform a 2-point calibration at regular intervals. The calibration interval is assay specific. Refer to the ADVIA Centaur Assay Manual. To perform a 2-point calibration on the system, you process replicates for 2 calibrators of known value. If the calibrators meet defined validity criteria, the system compares the average RLUs for each calibrator to the Master Curve and determines a system-specific formula. The system then adjusts the observed RLUs to the Master Curve according to this formula: adjusted RLUs = observed RLUs × defined slope + defined intercept

When patient samples or quality control samples are assayed using a quantitative assay, the system matches the adjusted RLU value to its corresponding analyte concentration using the Master Curve. Qualitative assays have a cut-off point that remains constant for each lot number of reagent. The manufacturer establishes this cut-off during product development and bases it on extensive population studies. Manufacturing assigns the analyte concentration associated with the cut-off as, for example, an index value of 1.0. See the method specific product insert for the method cut-off value.

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The RLU relative to the cut-off is the basis for a Master Curve consisting of 6 to 10 standards. The cut-off or index value is represented as a specific level on the Master Curve in Figure 3-3.

1 2 3 4 5

Frequency Nonreactive Reactive Cutoff Index

Figure 3-3

Qualitative Assay Cut-off Point

As with quantitative assays, the assay is calibrated using 2 calibrators of known value in replicate. If the calibrators meet defined validity criteria, then the system compares the calibrator RLUs to the Master Curve and determines an instrument-specific correction formula. When the system assays patient or quality control samples, the RLUs the system reads are adjusted by the formula derived from the 2 known calibrators. The system compares the sample RLUs to the calibration curve, and determines the RLU associated index value. See the method specific insert for the interpretation of results rule for the method. For example, the method may have the following interpretation of results. •

If the index value is greater or equal to 1.0, the system interprets the sample as reactive.

•

If the index value is less than 1.0, the system interprets the sample as nonreactive.

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Referencing Serum Calibration for T Uptake The T Uptake assay on the system provides an indirect measure of the number of unoccupied binding sites on thyroxine-binding proteins in a sample. In this assay, a direct relationship exists between the RLUs the system detects and the number of binding sites available on the thyroxine-binding proteins. This means a higher T Uptake ratio when fewer free binding sites exist and a lower ratio when more free binding sites exist. The T Uptake Master Curve Card provides only lot number and expiration date for the assay reagents. A Master Curve is not necessary for the T Uptake assay because it is a ratio test. The T Uptake assay compares the control and patient sample uptake results with a euthyroid reference serum of known uptake, such as Calibrator A. The T Uptake assay on the system uses Low Calibrator A as follows: T Uptake ratio = (Calibrator A RLUs/Unknown RLUs) * reference serum factor

The reference serum factor is printed on the Calibrator Assigned Value Card provided with Calibrator A. To report results as % T Uptake, the system requires a % T Uptake reference (normal) range. The system multiplies the T Uptake ratio by the midpoint of the % T Uptake reference range to obtain % T Uptake results. For example, if the % T Uptake reference range is defined as 25 to 35% (midpoint of 30) and a sample has a T Uptake ratio of 0.82, the system calculates the % T Uptake as follows: 0.82 × 30 = 24.6%

The system reports 24.6% as the % T Uptake.

Understanding Calibration Evaluation Criteria The ADVIA Centaur XP system evaluates a calibration using values entered from the Master Curve Card when you define a Master Curve for a reagent lot. The Master Curve definition includes the standard concentrations and related RLUs and target values used by the system to evaluate calibration data. The system defines Target values (ranges) for acceptable CV, ratio, slope, and calibrator deviation. The system determines a valid calibration based on whether the calibration data is within these defined ranges and system calculated observed ranges. Use the Calibration – Evaluation Ranges window to review values, review ranges, and review flags for the selected calibration. Refer to the ADVIA Centaur Assay Manual.

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To open the Calibration – Evaluation Ranges window, perform the following steps: 1. At the workspace, select Calibration > Data. 2. Select Evaluation Ranges. The values on the Calibration – Evaluation Ranges window •

Slope is a comparison of high and low calibrator RLUs to the Master Curve. This value describes the relationship of the RLUs expected from the Master Curve data to the measured calibrator RLUs. Slope = (High Cal Expected RLU - Low Cal Expected RLU)/ (High Cal Measured RLU - Low Cal Measured RLU

•

Ratio is a comparison of low and high calibrator RLUs. For sandwich assays, this value is the difference between the mean RLU value of the high calibrator and the mean RLU value of the low calibrator divided by the mean RLU value of the low calibrator. Ratio = (High Cal Mean RLU - Low Cal Mean RLU)/ Low Cal Mean RLU

For competitive assays, this value is the difference between the mean RLU value of the low calibrator and the mean RLU value of the high calibrator divided by the mean RLU value of the high calibrator. Ratio = (Low Cal Mean RLU - High Cal Mean)/High Cal Mean

•

The low and high cal deviations are a measure of how well the high and the low calibrator RLUs fit the Master Curve.

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These values are a relative measure of the deviation of the average RLUs of the low calibrator and the high calibrator from the Master Curve.

1 2 3 4 5

RLUs High cal deviation Master curve Low cal deviation Concentration

Figure 3-4

Master Curve and Low/High Deviations

•

CV is the precision of the calibrator replicates based on RLUs.

•

Acceptable CV is the maximum CV that is acceptable for a valid calibration. The percent coefficient of variation (CV) of the individual calibrator replicates must not exceed a defined acceptable value. This is the first criterion that the system checks after performing a calibration.

•

Critical Precision determines whether an outlier is too far out to automatically exclude it.

Using Defined Ranges The defined ranges are the values for Slope, Ratio, Low Cal Deviation, and High Cal Deviation you enter from the Master Curve Card when you define a Master Curve for a reagent lot. The system always uses these values to evaluate calibrations, even when the system provides observed ranges. Because these ranges are reagent lot specific, the relatively narrow limits of the ranges ensure quality calibration monitoring.

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Using Observed Ranges After performing 4 valid calibrations for a reagent lot and calibrator lot combination, the system calculates observed ranges for Slope, Ratio, Low Cal Deviation, and High Cal Deviation. When you perform subsequent calibrations using the same reagent lot and calibrator lot combination, the system compares results to the defined ranges from the Master Curve definition and also to the observed ranges determined by the system. The system recalculates observed ranges with each valid calibration. Whenever you use a new reagent lot or calibrator lot, observed ranges do not apply until the system performs 4 new valid calibrations for the new reagent lot and calibrator lot combination and establishes new observed ranges. The system must also establish new ranges for the following reasons: •

whenever a calibration expires because the test definition is updated

•

whenever a field service representative resets the system after replacing a major hardware component

Because the observed ranges are specific for your system, they are narrower than the defined ranges and therefore increase the quality of calibration monitoring over the defined ranges. Whenever a calibration is outside of the observed ranges but within the defined ranges, you can accept the calibration. Figure 3-5 shows both defined and observed ranges.

1–4 5 6 7– 8

First 4 valid calibrations Observed ranges begin Valid calibration Invalid calibrations

Figure 3-5

Defined and Observed Ranges

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In Figure 3-5, the first 4 calibrations (1 – 4) of a reagent lot and calibrator lot combination are valid. The system begins calculating observed ranges (5) after the fourth valid calibration. Given this information, you can interpret the following information correctly: •

The point labeled 6 is a valid calibration because it is within the observed range.

•

The point labeled 7 is an invalid calibration because it is outside of the defined range.

•

The point labeled 8 is an invalid calibration because it is outside of the observed range.

Retained Calibration To reduce unnecessary adjustments from calibration to calibration that can cause minor calibration drift or trends, you can use the Retain Cal feature. The Retain Cal feature retains a previously valid calibration to calculate patient and control results. Select the Retain Cal option at the Test – Calibration window. Refer to Defining Calibration Options‚ page 8-16. For the first 4 calibrations of a reagent lot and calibrator lot combination, the system gathers statistical data and uses these calibrations, in turn until expiration, to calculate results. When you select the Retain Cal option, at the fifth and subsequent calibrations the system can use data from a previous valid calibration to calculate results if the new calibration is not statistically different from that previous calibration. When the system uses data from a previous calibration to calculate results, the calibration interval expiration date is based on the date of the new calibration. The system continues to use the same data to calculate results as long as calibrations do not statistically differ from the retained calibration. When a new calibration is not statistically different from a previous valid calibration, it meets the retained calibration limits.

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If a new calibration does not meet the retained calibration limits, the system uses the new calibration to calculate results and set the calibration interval expiration date. The system repeats the process until you use a new reagent lot or calibrator lot. The process starts over with 4 new valid calibrations as in Figure 3-6.

1–4 5– 7

First 4 valid calibrations Valid calibrations in the observed range

Figure 3-6

Defined and Observed Ranges

In Figure 3-6, the first 4 calibrations (1-4) of a reagent lot and calibrator lot combination are valid. The system calculates observed ranges after the fourth valid calibration. When the fifth calibration is a valid calibration that is not statistically different from the fourth calibration, the system retains the fourth calibration and uses it to calculate results. The system bases the calibration interval expiration date on the date of this (fifth) calibration. The sixth calibration is a valid calibration that is statistically different from the fourth calibration. The system uses data from this calibration to calculate results and set the calibration interval expiration date. The seventh calibration is a valid calibration that is not statistically different from the sixth calibration, so the system retains the sixth calibration and uses it to calculate results. The system bases the calibration interval expiration date on the date of this (seventh) calibration. The system bases the calibration interval expiration date on the date of this (seventh) calibration.

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Autoexcluding Calibration Replicates When you select Autoexclude Cal Replicates at the Test – Calibration window, the system evaluates the calibrator results for all replicates and excludes replicates based on Master Curve definition and test definition parameters. To evaluate calibrator replicates, the system performs the following steps: 1. The system checks the CV of the replicates. 2. If the CV of the replicates exceeds the defined Acceptable CV, the system checks for an outlier. 3. If the system finds an outlier (replicate causing the unacceptable CV), it then checks the critical precision. The critical precision is a value in the Master Curve definition used by the system to determine whether an outlier is too far out to exclude it. •

If the deviation of an outlier does not exceed the critical precision limit, the system excludes it and re-evaluates the calibration criteria.

•

If the deviation of an outlier exceeds the critical precision limit, the system cannot exclude the replicate and the calibration is invalid.

The system excludes as many replicates as needed to obtain a valid calibration; however, the system ensures that the minimum number of replicates defined in the test definition are included in the calibration.

Defining a Master Curve Each ADVIA Centaur XP assay kit includes a Master Curve Card that lists the analyte concentration and the RLUs for each Master Curve point. The Master Curve is entered into the system with each new lot number of reagent. You can use the barcode scanner or the keyboard to define the Master Curve.

Using the Barcode Scanner LASER WARNING

Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. 1. At the workspace, select Calibration. 2. Select Master Curve Definition. 3. At the Calibration – Master Curve Definition window, select Scan Data. NOTE: You can delete a Master Curve if no calibrations are run against the Master Curve.

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4. Scan the barcodes on the Master Curve Card from top to bottom.

1

Master curve card barcodes

Figure 3-7

Master Curve Card

5. Select Save.

Using the Keyboard 1. At the workspace, select Calibration. 2. Select Master Curve Definition. 3. At the Calibration – Master Curve Definition window, select Add. 4. Enter the Master Curve values. Master Curve values are displayed on the picture of the Calibration – Master Curve Definition window on the Master Curve Card: a. Select a test.

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b. Enter the lot number and the expiration date. c. Enter the stability data. Manual entry of information into the Stability Data field requires 12 digits. Enter the 3 digit stability data on the Master Curve Card and follow it with 9 zeros (0). d. Enter a concentration value and an RLU value. e. Select Save Value. f.

Repeat steps c. and d. to enter additional values for concentration and RLU.

g. Enter the remaining values.

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Positions of Ratio and Slope on the Master Curve Card are reversed from those positions on the user interface. When manually entering the information, be sure to enter the information into the correct field.

1 2

Calibration – Master Curve Definition window values Calibration – Lot Details window values

Figure 3-8

Master Curve Card

5. Enter the values for lot-specific components, if necessary: a. Select Details. b. At the Calibration – Lot Details window, enter the values from the Master Curve Card. c. Select Continue. 6. At the Calibration – Master Curve Definition window, select Save.

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Procedural Notes •

Manual entry of information into the Stability Data field requires 12 digits. Enter the 3-digit stability data on the Master Curve Card and follow it with 9 zeros (0).

•

Positions of Ratio and Slope on the Master Curve Card are reversed from those positions on the user interface. When manually entering the information, ensure you enter the information into the correct field.

Deleting A Master Curve CAUTION

Do not process samples for a test and reagent lot combination after deleting a Master Curve for that test unless you reboot the system. If you do not reboot the system before running that test, the system may continue processing the samples and never release the results or the system may require a software reload. Use this procedure to delete a Master Curve before calibrations have been performed against it. For example, if you typed incorrect information into 1 of the fields and selected Save before you noticed the error, you can delete the Master Curve and start over. 1. At the workspace, select Calibration. 2. Select Master Curve Definition. 3. At the Calibration – Master Curve Definition window, select the test and lot number. 4. Select Delete. This button is not available if a calibration has been performed for the Master Curve. 5. Select Yes.

Defining Calibrator Values This section contains information about adding or deleting calibrator definitions.

Adding a New Calibrator Definition Use this procedure to add a new calibrator definition or to enter calibrator values for a new lot number of calibrator material. Each Calibrator Kit includes a Calibrator Assigned Value Card that provides the calibrator values for each analyte in the low and high calibrators. You can use the barcode scanner or the keyboard to enter the calibrator values.

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Using the Barcode Scanner LASER WARNING

Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. 1. At the workspace, select Calibration. 2. Select Calibrator Definition. 3. At the Calibration – Calibrator Definition window, select Scan Data. 4. Scan the barcodes on the Calibrator Assigned Value Card. 5. Ensure that the calibrator values are correct. NOTE: After you select Save, you cannot add or delete a test from a calibrator definition.

6. Select Save.

Using the Keyboard 1. At the workspace, select Calibration. 2. Select Calibrator Definition. 3. At the Calibration – Calibrator Definition window, select Add. 4. Enter the calibrator, the lot number, the expiration date, the LIS Code, and the checksum. 5. In the fields below the table, enter the calibrator values from the Calibrator Assigned Value Card. 6. Select a test. a. Select Test. The Test – Selection window displays. b. Select a test. c. Select Continue to close the Test – Selection window 7. At the Calibration – Calibrator Definition window, enter the low concentration value and the high concentration value. 8. Select Save Test. 9. Repeat steps 6 through 8 for each test. 10. Ensure that the calibrator values are correct. NOTE: After you select Save, you cannot add or delete a test from a calibrator definition. If you save an incorrect value, you must delete the calibrator definition and then reenter the test information.

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11. Select Save.

Deleting a Calibrator Definition 1. At the workspace, select Calibration. 2. Select Calibrator Definition. 3. At the Calibration – Calibrator Definition window, select a calibrator name and lot number. CAUTION

Use care when deleting a calibrator definition. Deleting a calibrator definition permanently removes all associated calibration data and sample results from the database. 4. Select Delete. 5. Select Yes.

Performing Calibrations Use the procedures in this section to review the status of calibrations and to schedule a calibration. Calibration intervals are assay specific. Refer to the ADVIA Centaur Assay Manual.

Reviewing Calibration Status You can use the Calibration – Summary window to review the status and due dates of calibrations. To open the Calibration – Summary window from the workspace, select Calibration and then select Summary. The system calculates the next due date by adding the calibration interval to the date of the most recent calibration Calibration Status

Description

Cal Required

No valid calibration exists for the reagent lot. Schedule a calibration at the Worklist – Schedule window.

Current

The calibration is valid. The system uses this calibration to calculate results.

Due

The calibration interval for the test expires within 24 hours or within 25% of the calibration interval whichever is shorter. Schedule a calibration at the Worklist – Schedule window. You can waive a calibration with a Due status at the Calibration – Summary window if you select Waive Cal at the Test – Calibration window.

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Calibration Status

Description

Expired

The calibration for the reagent lot expired. Schedule a calibration at the Worklist – Schedule window. You can waive an expired calibration at the Calibration – Summary or Calibration – Data windows if you select Waive Cal at the Test – Calibration window.

Invalid

The calibration exceeded either the defined or the observed range for 1 or more calibration expected values. Schedule another calibration at the Worklist – Schedule window.

No Master Curve

No Master Curve exists for the reagent lot. Define a Master Curve at the Calibration – Master Curve Definition window, and then schedule a calibration at the Worklist – Schedule window.

Operator Accepted

An operator accepted a calibration that was outside the observed ranges but within the defined ranges.

Waived

A calibration expired and an operator waived the calibration. Schedule a calibration at the Worklist – Schedule window as soon as possible.

You can display specific information by selecting the appropriate View and Sort: •

The View that you select determines the information that the system displays. For example, if you select All Tests, the system displays calibration information for all the tests.

•

The Sort that you select determines the order in which the system displays the calibrations. For example, if you select Status, the system displays the tests in reverse chronological order starting with expired calibrations, calibrations that are due, and then current calibrations.

The following table describes the View and Sort combinations you can use to perform some routine calibration tasks: Task

View

Sort

Display, in order of calibration status, the calibration information for all tests

All Tests

Status

Display, in alphabetical order of test, the calibration information for all tests

All Tests

Test

Display, in order of calibration status, the calibration information for tests using reagents that are currently loaded on the system

Available Reagents

Status

Display, in alphabetical order of test, the calibration information for tests using reagents that are currently loaded on the system

Available Reagents

Test

Display the calibration history for a reagent lot and calibrator lot combination for a specific test

Historical

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Reviewing Calibration History When you select Historical for the View at the Calibration – Summary window, you can display all the calibration information for a reagent lot and calibrator lot combination for a specific test. You can use this information for troubleshooting. Status

Description

Invalid

The calibration exceeds either the defined or the observed range for 1 or more calibration expected values. Schedule another calibration at the Worklist – Schedule window.

Valid

The calibration is within the observed or defined ranges.

Valid, Operator Accepted

An operator accepted a calibration that was outside the observed ranges but within the defined ranges.

Valid, using Date of the Retained Calibration

The status the system displays in the historical view of the Calibration – Summary window for a Valid, Met Retained Cal Limits calibration.

Waived

A calibration expired and an operator waived the calibration. Schedule a calibration at the Worklist – Schedule window as soon as possible.

Waived, using Date of the Retained Calibration

The status the system displays in the historical view of the Calibration – Summary window for a Valid, Met Retained Cal Limits calibration that expired and then was waived.

Scheduling Calibrators Calibrate an assay in the following instances: •

the calibration interval expires

•

a calibration is invalid

•

you use a new lot of assay reagents

•

controls are repeatedly out of range

CAUTION

Do not schedule and load the calibrators before processing the end-of-bracket controls of an open bracket for control-bracketed tests. If you schedule and load calibrators for a control-bracketed test and the system aspirates a calibrator before processing the end-of-bracket controls, the system discards any retained patient test results. For all tests, you must load the reagent lot you want to calibrate before you schedule a calibrator. 1. At the workspace, select Worklist. 2. Select Schedule. 3. At the Worklist – Schedule window, select Calibrator. 4. Select how you want the system to identify the calibrator:

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•

If the sample identifier selected at the Setup – Tube Type & Barcode window is SID, you can select Schedule by SID or Schedule by Rack.

•

If the sample identifier selected at the Setup – Tube Type & Barcode window is Rack, you can only select Schedule by Rack.

Refer to Specifying Sample Identification‚ page 8-4. 5. Select or enter a test for the calibrator. If you use the keyboard to enter the test in the Test field, you must enter the test name exactly as it is displayed on the schedule window. The system automatically displays the calibrators previously defined for the test. You define the calibrator SIDs at the Calibration – Calibrator Definition window. Calibrators do not display in the following situations: •

calibrators are not defined

•

Master Curves are not defined

•

no reagent is onboard

•

the calibration material for defined lots is expired

6. Select a calibrator. •

When scheduling by SID, select the appropriate SID. The system fills in the Rack ID.

•

When scheduling by Rack, you can select specific racks for the calibrators.

7. You can select a reagent lot. 8. If you schedule by rack, enter the Rack ID in Rack. The Rack ID consists of 4 numbers (0001–9999) followed by a letter (A–E). Enter the letter in uppercase. 9. Select Save. 10. Repeat steps 4 through 9 to schedule additional tests for a calibrator. 11. Load low and high calibrators in a rack. 12. Load the rack in the sample entry queue.

Scheduling Calibrations for Control-bracketed Tests When processing control-bracketed tests, ensure that the minimum time interval for calibrations is at least 2 hours over the time entered in the Control Warning field at the Test – Definition window. If you do not, the system does not process the test. If the calibration for a control-bracketed test is invalid, do not schedule controls to start a new bracket until the system processes a valid calibration.

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If you schedule a calibration and schedule a control-bracketed test without waiting for the calibration results, if the calibration is not valid, your controls are also invalid. If a bracket is open, ensure that you schedule and load the end-of-bracket controls that close the bracket before loading any calibrators. If the system aspirates a calibrator before aspirating the end-of-bracket controls of an open bracket, the system discards any retained patient test results.

Managing Calibration Data This section contains information about reviewing calibration data, excluding a calibrator RLU, waiving a calibration, accepting invalid calibrations, and examples of step for managing calibration problems.

Reviewing Calibration Data Use the Calibration – Data window to review the details of a calibration, such as replicate results, status messages, and flags. To open the Calibration – Data window from the workspace, select Calibration and then select Data. Calibration Status

Description

Expired

The calibration for the reagent lot expired. Schedule a calibration at the Worklist – Schedule window. You can waive an expired calibration at the Calibration – Summary or Calibration – Data windows if you select Waive Cal at the Test – Calibration window.

Expired, Retained

The calibration for the reagent lot expired, and then the system retained the calibration. The system uses this calibration to calculate results.

Invalid, Exceeded Defined Ranges

The calibration exceeds the defined range for 1 or more calibration expected values. Ranges display at the Calibration – Evaluation Ranges window. Schedule another calibration at the Worklist – Schedule window.

Invalid, Exceeded Observed Ranges

The calibration exceeds the observed range for 1 or more calibration expected values. Ranges display at the Calibration – Evaluation Ranges window. You can accept the calibration at the Calibration – Data window if you select Accept Cal at the Test – Calibration window.

Valid

The calibration was within the observed or defined ranges.

Valid, Met Retained Cal Limits

This calibration sets the expiration date and points to the retained calibration used to calculate results. The values of this calibration are almost mathematically identical to the values of a previous (retained) calibration.

Valid, Operator Accepted

An operator accepted a calibration that is outside the observed ranges but within the defined ranges.

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Calibration Status

Description

Valid, Operator Accepted, Retained

An operator accepted a calibration, and then the system retained the calibration. The system uses this retained calibration to calculate results.

Valid, Retained

The system uses this calibration to calculate results. The values of this calibration are almost mathematically identical to the most recent calibration.

Waived

A calibration expired and an operator waived the calibration. Schedule a calibration at the Worklist – Schedule window as soon as possible.

The following flags display at the Calibration – Data window: Flag

Description

Bad Replicate

One of the replicates was bad due to signal error. You can manually exclude the replicate at the Calibration – Data window if you have processed more than the minimum number of replicates and Autoexclude Cal Replicates is not selected at the Test – Calibration window. If you cannot manually exclude the replicate, schedule another calibration at the Worklist – Schedule window.

Cal Accepted

An operator accepted a calibration that was outside the observed ranges but within the defined ranges.

Cal Timeout

One of the replicates was processed after the time allowed for an acceptable calibration. Schedule another calibration at the Worklist – Schedule window.

Excluded

An operator excluded a calibrator replicate RLU. You can view or include the replicate RLU at the Calibration – Data window.

Failed Critical Limit

The system could not exclude a calibrator replicate because it exceeded the critical precision limit defined at the Calibration – Master Curve Definition window. You can manually exclude the replicate at the Calibration – Data window if you have processed more than the minimum number of replicates and Autoexclude Cal Replicates is not selected at the Test – Calibration window. If you cannot manually exclude the replicate, schedule another calibration at the Worklist – Schedule window.

Failed Defined High Cal Deviation

The calibration exceeded the high calibrator deviation that is defined at the Calibration – Master Curve Definition window. Schedule another calibration at the Worklist – Schedule window.

Failed Defined Low Cal Deviation

The calibration exceeded the low calibrator deviation that is defined at the Calibration – Master Curve Definition window. Schedule another calibration at the Worklist – Schedule window.

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Flag

Description

Failed Defined Ratio

The calibration is outside the range for the ratio that is defined at the Calibration – Master Curve Definition window. Schedule another calibration at the Worklist – Schedule window.

Failed Defined Slope

The calibration is outside the range for the slope that is defined at the Calibration – Master Curve Definition window. Schedule another calibration at the Worklist – Schedule window.

Failed Observed High Cal Deviation

The calibration exceeded the high calibrator deviation that is calculated by the system. Schedule another calibration at the Worklist – Schedule window.

Failed Observed Low Cal Deviation

The calibration exceeded the low calibrator deviation that is calculated by the system. Schedule another calibration at the Worklist – Schedule window.

Failed Observed Ratio

The calibration is outside the range for the ratio that is calculated by the system. Schedule another calibration at the Worklist – Schedule window.

Failed Observed Slope

The calibration is outside the range for the slope that is calculated by the system. Schedule another calibration at the Worklist – Schedule window.

Failed % Neut

The neutralizing reagent did not reduce the assay signal for the high calibrator to the defined level. Schedule another calibration at the Worklist – Schedule window.

Failed Rgt A Stability

The calibration did not yield the expected results for the Reagent A stability check. Schedule another calibration at the Worklist – Schedule window.

Failed Rgt B Ratio

The calibration did not yield the expected results for the Reagent B ratio check. Schedule another calibration at the Worklist – Schedule window.

High CV

The CV (coefficient of variation) for the replicates of the calibrator is above the acceptable CV entered in the Master Curve definition. You can manually exclude a replicate at the Calibration – Data window if you have processed more than the minimum number of replicates and Autoexclude Cal Replicates is not selected at the Test – Calibration window. If you cannot manually exclude a replicate, schedule another calibration at the Worklist – Schedule window.

Rgt A High Cal CV

The CV (coefficient of variation) for the high calibrator replicate RLU values for Reagent A was too large. Schedule another calibration at the Worklist – Schedule window.

Rgt A Low Cal CV

The CV (coefficient of variation) for the low calibrator replicate RLU values for Reagent A was too large. Schedule another calibration at the Worklist – Schedule window.

Rgt B High Cal CV

The CV (coefficient of variation) for the high calibrator replicate RLU values for Reagent B was too large. Schedule another calibration at the Worklist – Schedule window.

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Flag

Description

Rgt B Low Cal CV

The CV (coefficient of variation) for the low calibrator replicate RLU values for Reagent B was too large. Schedule another calibration at the Worklist – Schedule window.

System Excluded

The system automatically excluded a calibrator replicate RLU. This flag only displays if Autoexclude Cal Replicates is selected at the Test – Calibration window.

Too Few Replicates

The number of acceptable replicate results is less than the number required to calibrate the test. The minimum number of acceptable replicates is defined at the Test – Calibration window. Schedule another calibration at the Worklist – Schedule window.

Excluding a Calibrator RLU You can exclude calibrator RLUs that exceed the defined ranges. The system automatically recalculates the calibration data and rechecks the calibration criteria. RLUs are only excluded if more replicate results exist than the minimum number of replicates defined in the test definition. Further investigation may be appropriate to determine the cause of the outlier. You can have the system autoexclude calibrator RLUs or the operator can manually exclude them. You must have the appropriate level of security to change these settings. Refer to Defining Calibration Options‚ page 8-16. You can manually exclude calibrator RLUs at the Calibration – Data window if you do not select Autoexclude Cal Replicates at the Test – Calibration window. To manually exclude calibrator RLUs use the following procedure: 1. At the workspace, select Calibration. 2. Select Data. 3. At the Calibration – Data window, select the test and the test lot number. 4. Select the calibration date in Calibrated. 5. Review the calibrator RLUs. 6. Select the calibrator RLU from the table. 7. Select Exclude. 8. At the Comments window, enter a comment. You can enter up to 3 comments. Comments can be up to 120 alphanumeric characters. The system enters your initials and the date. If you are not currently signed in, you must sign in to the system. 9. Select Save at the Comments window. The Comments window closes.

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10. Close and reopen the Calibration – Data window to display the symbol indicating that the calibrator RLU is excluded. 11. If required, you can select Include and then select Save to include an excluded calibrator RLU in the calibration.

Waiving a Calibration CAUTION

Do not waive calibrations unnecessarily. Waiving Cals repeatedly may cause misreported results. When the calibration interval for a test expires while samples are in process, you can finish processing samples scheduled for the test by waiving the calibration. Use the Waive Cal option only when tests are Inprocess. The system calculates results for the samples and displays the results for the test as Waived. You must have the appropriate level of security to waive a calibration and you must select Waive Cal at the Test – Calibration window. When you waive a calibration, enter a comment and recalibrate immediately after this. Waiving calibrations repeatedly may cause misreported results. A waived calibration remains waived until the next calibration interval.

Waiving a Calibration at the Calibration – Summary Window 1. At the workspace, select Calibration. 2. Select Summary. 3. In the table at the Calibration – Summary window, select the most recently expired calibration for the test. 4. Select Waive.

Waiving a Calibration at the Calibration – Data Window 1. At the workspace, select Calibration. 2. Select Data. 3. At the Calibration – Data window, select the test and the test lot number. 4. Select the calibration date of the most recently expired calibration in Calibrated. 5. Select Waive.

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Accepting an Invalid Calibration You can accept an invalid calibration that falls outside of the observed range but is within the defined range. The system calculates results for the samples and displays the results for the test as Cal Accepted. You must have the appropriate level of security to accept an invalid calibration and you must enable Accept Cal at the Test – Calibration window. NOTE: If an invalid calibration is accepted, the Verify message displays at the Worklist – Summary window.

1. At the workspace, select Calibration. 2. Select Data. 3. At the Calibration – Data window, select the test and the test lot number. 4. Select the most recent calibration date in Calibrated. 5. Select Accept.

Assigning a Calibration If a calibration is invalid, you can assign a valid calibration to samples that the system processed with that invalid calibration. You can assign the last valid calibration or recalibrate and assign the next valid calibration. The system calculates results for the samples and displays the results for the test as Cal Assigned. You must have the appropriate level of security to assign a calibration to results and you must enable Assign Cal at the Test – Calibration window. 1. At the workspace, select Worklist. 2. Select Summary. 3. At the Worklist – Summary window, select a final result with RLU instead of a concentration value in the result column. 4. Select Assign Cal. 5. At the Worklist – Assign Calibration window, select the results to which you want to assign a calibration. 6. The system displays the sample SID for the result you selected at the Worklist – Summary window. 7. Select Continue. 8. At the Worklist – Summary window, select Save.

Managing Calibrations Examples The following are examples of specific sets of conditions and the available options for those situations.

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No Current Calibration If all of the following conditions apply: •

You have no current valid calibration for the reagent lot that you are using because it is a new lot.

•

You process patient and control samples with calibrators.

•

You perform a calibration and the calibration is invalid because it exceeds the defined ranges.

The system performs the following actions: •

Stops aspirating samples for that test.

•

Continues with inprocess patient and control samples and displays RLUs for results if Assign Cal is selected in the test definition.

You can perform the following actions to report patient results: •

You must repeat the calibration and any patient and control samples that were not processed. The repeated calibration must be valid.

•

You can use the Assign Cal feature to assign the new valid calibration to the patient and control samples with RLU results from the invalid calibration. Control values that are within range indicate that the RLUs of patient samples processed with the invalid calibration are accurate.

Current Valid Calibration If all of the following conditions apply: •

You have a valid calibration that is due to expire for the reagent lot that you are using.

•

You process patient and control samples with calibrators.

•

You perform a calibration and the calibration is invalid because it exceeds the defined ranges.

The system performs the following actions: •

Stops aspirating samples for that test.

•

Continues with inprocess patient and control samples and displays RLUs for results if you selected Assign Cal in the test definition.

You can perform the following actions to report patient results: •

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Control values that are within range indicate that the RLUs of patient samples processed with the invalid calibration are accurate. •

You must repeat any samples that were not aspirated with a rescheduled calibration. The repeated calibration must be valid. The system does not process samples with requests for tests with an invalid calibration.

Expired Calibration If all of the following conditions apply: •

You have an expired calibration.

•

You process patient and control samples with calibrators.

•

You perform a calibration and the calibration is invalid because it exceeds the defined ranges.

The system performs the following actions: •

Stops aspirating samples for that test.

•

Continues with inprocess patient and control samples and displays RLUs for results if Assign Cal is selected in the test definition.

You can perform the following actions to report patient results: •

You can waive the expired calibration and use the Assign Cal feature to assign the waived calibration to the patient and control samples with RLU results from the invalid calibration. Control values that are within range indicate that the RLUs of patient samples processed with the invalid calibration are accurate.

Printing Calibration Data For additional information about operating the printer connected to your system, refer to Printing Notes‚ page 2-74. 1. At the workspace, select Print. 2. Select Report Options. 3. At the Print – Report Options window, select Calibration Data. 4. Select a starting date and an ending date. 5. Press the Enter key. Calibration instances within the selected date range display in the table below the date fields. 6. To print all of the calibration data for the selected date range, select Print All. 7. To print data for 1 or more calibration instances, select the calibrations in the table and then select Print Selection.

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•

To select multiple adjacent calibrations, select the first calibration and then hold down the Shift key while selecting the last calibration. The system selects all calibrations in the table between and including the first and the last selected calibration.

•

To select multiple non-adjacent calibrations, hold down the Ctrl key while selecting each calibration. If it is necessary to scroll to continue selecting multiple calibrations, release the Shift or Ctrl key, scroll to the desired calibration, and then again hold down the Shift or Ctrl key while selecting the calibration.

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4 Quality Control Adding a New Control Definition . . . . . . . . . . . . . . . . . . . 4-1 Entering Expected Values for a New Lot Number . . . . . . . . . . . 4-2 Deleting a Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Lot Number and the Expiration Date . . . . . . . . . . . . . . . . . . . . . 4-3 Pool Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Test Name and Expected Values . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Editing a QC Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Scheduling QC Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Scheduling Controls for Control-bracketed Tests . . . . . . . . . . . . 4-6 Modifying Test Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6 Clearing a No Request Message for End-of-Bracket Controls . . . . .4-6

Exporting Quality Control Data . . . . . . . . . . . . . . . . . . . . 4-7

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Using Quality Control Features The ADVIA Centaur XP system allows you to define each control for use on the system. The system has the following data storage capabilities: •

allows you to define up to 50 tests per control For example, for Ligand Plus 1 you can define up to 50 tests including TSH-3, TSH, T3, T4, FT3, FrT4, and TUp.

•

allows you to define up to 300 controls

•

ability to store results for up to 10 lots of data for each test/control combination For example, for the ADVIA Centaur XP PSA assay you can define 10 different lot numbers of Ligand Plus level 1, Ligand Plus level 2, and Ligand Plus level 3. This helps you manage transitions between lots of quality control material.

Adding a New Control Definition Use this procedure to add a new control definition, including defining the tests for the control and the expected control values for each test. 1. At the workspace, select Quality Control. 2. Select Control Definition. 3. At the Quality Control–Control Definition window, select Add. 4. Enter the name of the control. •

For Routine controls, you can enter up to 11 alphanumeric characters for the control name.

•

For Kit controls, you must enter 11 alphanumeric characters for the control name or the system will not accept it. Ensure that you enter the Kit control name exactly as displayed on the barcode label card.

NOTE: Use only the barcode labels that are manufactured for the kit controls.

Do not create your own barcode labels. If you use a non-Siemens barcode label, the system does not recognize the control as a kit control and does not process it. The name that you enter displays on the quality control windows. NOTE: If you are adding a new control definition for a control-bracketed test, ensure that you select Kit in the Type field. The system allows only the

kit-type format for a control SID in a control-bracketed test. 5. In the Type field, select Routine or Kit.

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•

Routine controls are not provided with the assay reagent kits. Control such as Ligand Plus or Tumor Marker Plus are routine controls.

•

Kit control have specific assay reagent kits.

NOTE: If you are defining a control that does not have a leading K in the barcode, select SID and edit that field to match the barcode of the control. You can select SID only after entering the lot number.

6. Enter the information for the new lot of control, such as type, lot, and expiration date. The lot number and the expiration date are located on the quality control material packaging. You must enter a lot number and an expiration date to save the control definition. You can enter up to 7 characters for the lot number. Enter the date in the format DD MMM YY, for example 26 Oct 99. The system fills in the SID field with the control lot number preceded by K. The SID can be up to 13 characters. If the control is a Routine type and your QC SIDs are different than the lot number, you can edit the SID. 7. Select a Test: a. Select the Test button. The Test–Selection window displays. b. Select a test. c. To close the Test–Selection window, select Continue. 8. Enter the expected values. 9. Select Save Test. 10. Repeat steps 3 through 9 for all tests for the control. 11. Select Save.

Manually Entering Kit Control SID Information If the system cannot read a kit control barcode or if you run out of Siemens barcode labels, use this procedure to manually enter the kit control SID. 1. At the workspace, select the Sample Status button. 2. At the Status – Samples window, select the control with the No Barcode status. 3. Select Enter SID. 4. At the Status – Enter SID window, select Control. 5. Select Kit. 6. Enter the SID. 7. Select Save.

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Entering Expected Values for a New Lot Number NOTE: The system does not allow you to edit the control definition of a kit

control, which is a type of control provided with specific assay reagent kits. 1. Select the name of the control, if required. 2. Select Edit. 3. Enter the information for the new lot of control, such as type, lot, and expiration date. Refer to Lot Number and the Expiration Date‚ page 4-3. 4. Select a Test: a. Select the Test button. The Test–Selection window displays. b. Select a test. c. To close the Test–Selection window, select Continue. 5. Enter the expected values. 6. Select Save Test. 7. Repeat steps 3 through 5 for all tests for the control. 8. Select Save.

Deleting a Control 1. At the workspace, select Quality Control. 2. Select Control Definition. 3. Select the name of the control. 4. Select the information for the lot of control, such as lot and type. CAUTION

Use care when deleting a test from a control definition. Deleting a test from a control definition permanently removes all associated stored data and results from the database. 5. Select Delete. 6. Select Yes. 7. To delete a test from a control definition, select the test, and then select Delete Test.

Lot Number and the Expiration Date Locate the lot number and the expiration date on the quality control material packaging. You must enter a lot number and an expiration date to save the control definition.

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You can enter up to 7 characters for the lot number. Enter the date in the format DD MMM YY, for example 26 Oct 99. The system fills in the SID field with the control lot number preceded by K. The SID can be up to 13 characters. If the control is a Routine type and your QC SIDs are different than the lot number, you can edit the SID.

Pool Number You can enter up to 4 numbers for the pool number. For customers using the QC Online service, the pool number is assigned by the service. If you use your own quality control pools, you can assign a pool number to track results.

Entering the Test Name and Expected Values In the fields below the table, select a test name and enter the QC expected values: If you want to enter . . .

Then . . .

low and high limits,

enter the low and high expected value limits from the expected values charts provided by the quality control manufacturer. The system automatically calculates the mean and 2SD values when you select Save Test.

mean and 2SD,

enter the mean and 2SD values from the expected values charts provided by the quality control material manufacturer. The system automatically calculates the low and high limit values when you select Save Test.

Editing a QC Definition Use this procedure to edit a QC definition: 1. At the workspace, select Quality Control. 2. Select Control Definition. 3. At the Quality Control – Control Definition window, select a control name and a lot number. 4. Select Edit. 5. Edit the QC definition. CAUTION

Use care when deleting a test from a control definition. Deleting a test from a control definition permanently removes all associated stored data and results from the database.

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If you want to . . .

Then . . .

edit the control expected values,

a.

add tests to a defined control,

4-5

Select a test in the table.

b. In the fields below the table, edit the low and high limits, or edit the mean and 2SD values. c.

Select Save Test.

a.

Select Test. The Test – Selection window displays.

b. Select a test. c.

Select Continue to close the Test – Selection window.

d. Enter the low and high limits or enter the mean and 2SD values. e.

Select Save Test.

edit a pool number,

edit the pool number. You can enter up to 4 numbers for the pool number. The pool number is assigned by the QC Online service.

delete tests from a control definition,

a.

Select a test in the table.

b. Select Delete Test. c.

Select Yes.

6. Select Save.

Scheduling QC Samples Use this procedure to schedule controls. As a minimum requirement, you must assay 2 levels of quality control material on each day that samples are analyzed. You must also assay quality control samples when performing a 2-point calibration. Refer to the ADVIA Centaur Assay Manual for assay-specific QC recommendations. 1. At the workspace, select Worklist. 2. Select Schedule. 3. At the Worklist – Schedule window, select Control. NOTE: If you are scheduling controls for a control-bracketed test, you must schedule by SID. The system does not allow you to schedule samples for control-bracketed tests by Rack.

4. Select how you want the system to identify the control: •

If the sample identifier selected at the Setup – Tube Type & Barcode window is SID, you can select Schedule by SID or Schedule by Rack. The control SIDs are defined at the Quality Control – Control Definition window.

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•

If the sample identifier selected at the Setup – Tube Type & Barcode window is Rack, you can only select Schedule by Rack.

Refer to Specifying Sample Identification‚ page 8-4. 5. Select or enter the tests or the profiles for the control. If you use the keyboard to enter the tests or profiles in the Test field or the Profile field, you must enter the test name or profile exactly as it displays on the schedule window. The controls previously defined for the tests are automatically displayed. 6. Select the controls. 7. If you schedule by rack, enter the Rack ID in Rack. The Rack ID consists of 4 numbers (0001–9999) followed by a letter (A–E). Enter the letter in uppercase. 8. Select Save. 9. Repeat steps 4. through 8. to schedule tests or profiles for additional controls. 10. Load sample cups of QC material in a rack. 11. Load the rack in the sample entry queue.

Scheduling Controls for Control-bracketed Tests When scheduling controls for control-bracketed tests, the following requirements apply: •

Each control set must contain a numerically ascending sequence of control levels beginning with Level 1. For example, if a test requires 3 controls in a set, the controls must follow this sequence: Level 1, Level 2, and Level 3.

•

Schedule a complete set of controls at the beginning of a group of samples to open a bracket and at the end of a group of samples to close a bracket. You define the number of levels required in a complete set of controls at the Test – Definition window. Refer to Viewing Control Bracketing Features‚ page 8-18.

•

You can use the end-of-bracket controls from 1 group of samples as the start-of-bracket controls for the next group of samples, if the control results are acceptable and the system is not forced to discard results. Refer to Managing the Worklist‚ page 2-39.

•

If you schedule the start-of-bracket controls and the end-of-bracket controls at the same time, you must perform the following tasks:

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schedule the controls by SID

•

enter a unique rack ID for each set of controls

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Ensure that the start-of-bracket control set and the end-of-bracket control set are in different racks. Ensure that all of the controls within a set are in the same rack. •

If you schedule the start-of-bracket controls and wait until they are processed and have acceptable results before scheduling the end-of-bracket controls, schedule the controls by SID. You do not need to enter the rack ID and position of the controls. You can use the same rack for the start-of-bracket controls and end-of-bracket controls as long as the system processed the previous set of controls with acceptable results and ejected the rack.

•

You must schedule and load the end-of-bracket controls within the acceptable time interval displayed in the Control Warning field at the Test – Definition window. Failure to do so causes the system to discard retained patient results. Refer to Viewing Control Bracketing Features‚ page 8-17.

Modifying Test Ranges When modifying test ranges, ensure that no samples are waiting for an ending bracket. If you modify test ranges for a control-bracketed test that has not completed, the system may not recognize the ending and the control bracket does not complete. The system discards results that are waiting for an ending bracket.

Clearing a No Request Message for End-of-Bracket Controls If you schedule the start-of-bracket controls with a unique rack ID and position for each control, and then schedule the end-of-bracket controls without a rack ID and position for each control, the system displays the No Request message for the end-of-bracket controls at the Status – Samples window. To clear the message and close the bracket, use the following procedure: Refer to Deleting Requests‚ page 2-61, or Scheduling Calibrators and QC Samples‚ page 2-54. 1. Delete the request for the end-of-bracket controls at the Worklist – Summary window. 2. Reschedule the end-of-bracket controls at the Worklist – Schedule window. To avoid receiving the No Request message, if you are scheduling the start-of-bracket and end-of-bracket controls at the same time, use the following guidelines: •

Schedule the start-of-bracket controls with a specific rack ID for the set and a unique position for each control within the set.

•

Schedule the end-of-bracket controls with a different rack ID for the set and a unique position for each control within the set.

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Ensure that the rack ID for the end-of-bracket controls is different from the rack ID of the start-of-bracket controls.

Exporting Quality Control Data Access the ADVIA QC application and refer to online help for the ADVIA QC application Tools window.

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5 Performing Maintenance Reviewing Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Recording Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Accessing Online Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Reviewing the Maintenance Log. . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Printing Maintenance Reports . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Defining Maintenance Activities. . . . . . . . . . . . . . . . . . . . 1-3 Deleting a Maintenance Activity . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Performing Maintenance Procedures . . . . . . . . . . . . . . . 1-4 Performing Daily Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Alternating the Water Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6 Rinsing the System with Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

Performing Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 1-8 Cleaning the Water Bottles and Reservoir. . . . . . . . . . . . . . . . . . . . .1-8 Emptying the Water Trap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14

Performing Monthly Maintenance . . . . . . . . . . . . . . . . . . . . . . . 1-15 Preparing the Cleaning Solution . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16 Cleaning the Exterior of the Reagent Probes. . . . . . . . . . . . . . . . . .1-16 Cleaning the Exterior of the Ancillary Probe . . . . . . . . . . . . . . . . . .1-19 Cleaning the Exterior of the Aspirate Probes. . . . . . . . . . . . . . . . . .1-21 Cleaning the Air Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22

Performing the Monthly Cleaning Procedure . . . . . . . . . . . . . . 1-23 Enhanced Monthly Cleaning Procedure for Systems Using the System Water Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24 First Prompt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Second Prompt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Third Prompt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fourth Prompt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1-24 1-25 1-25 1-26

Monthly Cleaning Procedure for Systems Using Direct Plumbing .1-26 First Prompt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Second Prompt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Third Prompt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fourth Prompt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1-27 1-28 1-28 1-29

As-Needed Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30 Opening the Top Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-31 Cleaning the Probe Rinse Stations . . . . . . . . . . . . . . . . . . . . . . . . .1-32 Cleaning the Reagent Probe Shutter . . . . . . . . . . . . . . . . . . . . . . . .1-35 Cleaning the Primary Reagent Compartment and Reagent Pack Holders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-38 Cleaning the Covers and Pointing Device . . . . . . . . . . . . . . . . . . . .1-40 Cleaning the Cuvette Waste Area . . . . . . . . . . . . . . . . . . . . . . . . . .1-40 Cleaning the Sample Tip Waste Area . . . . . . . . . . . . . . . . . . . . . . .1-46 Wiping the Waste Probe and Cuvette Ejector Rod . . . . . . . . . . . . .1-51

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Maintaining the Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . 1-54 Cleaning the Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54 Labeling Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54 Applying Cal and QC Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-55 Applying Numbered or Customized Labels . . . . . . . . . . . . . . . . . . . . . . 1-56

Checking the Rack Clips on the ADVIA Centaur Racks . . . . . . . . . 1-58

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Performing Maintenance The ADVIA Centaur XP system monitors maintenance activities and notifies you when a scheduled activity is due. In addition, the system notifies you through a color change at the Maintenance Status button and the Status – Maintenance window when routine and extended certification procedures are due. When a certification is due, contact your local technical support provider to schedule the procedure as soon as possible. The system provides a maintenance schedule for you to record the completion of scheduled maintenance activities. The system then uses this information to automatically update the maintenance schedule with the next time the activity is due.

Reviewing Maintenance At the Status – Maintenance window, the background of the maintenance activities changes color to indicate status: •

Yellow indicates that a maintenance activity is due or overdue.

•

Red indicates that an automated maintenance procedure did not finish.

At the workspace, the background of the Maintenance Status button also changes color to indicate status. You can select the Maintenance Status button to open the Status – Maintenance window and display information about maintenance activities. Select the appropriate View and Sort combinations to display specific information at the Status – Maintenance window: •

The View that you select determines the information that the system displays. For example, if you select Schedule, the system displays the scheduled maintenance activities.

•

The Sort that you select determines the order in which the system displays the scheduled activities. For example, if you select Activity, the system sorts and displays the scheduled activities in alphabetical order.

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The following table describes the View and Sort combinations you can use to perform some routine tasks: Task

View

Sort

Determine which maintenance activities are due

Schedule

Time Due

Find a specific maintenance activity

Schedule

Activity

Review the maintenance activities that were performed most recently

Log

Time Completed

Review the history of a specific maintenance activity

Log

Activity

Recording Maintenance After performing a scheduled maintenance activity you can record that activity as complete. You can also enter and review comments. NOTE: If you are not currently signed in, you must sign in to the system.

1. At the workspace, select Maintenance Status. 2. At the Status – Maintenance window, select an activity. 3. Select Completed. The system automatically enters your initials and calculates the date when the activity is due next. 4. You can enter Comments, such as a note that indicates if the maintenance was performed to correct a system problem: a. Select Log in View. b. Select Time Completed in Sort. c. Select an activity. d. Select Comments. e. At the Comments window, enter a comment. You can enter up to 3 comments. Comments can be up to 120 alphanumeric characters. The system enters your initials and the date. f.

Select Save.

Repeat these steps to update the maintenance schedule and enter comments for another activity.

Accessing Online Procedures Online maintenance procedures provide instructions for some of the maintenance activities. 1. At the workspace, select Maintenance Status. 2. At the Status – Maintenance window, select a maintenance activity.

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3. Select Procedure. An online help window opens and displays the maintenance procedure.

Reviewing the Maintenance Log Use the Maintenance Log to review completed activities. You can review the most recent to the oldest activities as well as the history for a specific activity. The historical log is maintained for the last 5000 entries. 1. At the workspace, select Maintenance Status. 2. At the Status – Maintenance window, select Log in View. 3. Select the Sort. If you want to review . . .

Select . . .

the maintenance activities that were performed most recently

Time Completed

the history of a specific maintenance activity

Activity

Printing Maintenance Reports You can print a report of either the scheduled maintenance for the system or the maintenance log. 1. At the workspace, select Print. 2. Select Report Options. 3. In the list of available reports, select Maintenance. 4. Select the View. If you want to print . . .

Select . . .

the scheduled maintenance activities

Schedule.

the completed maintenance activities, including comments and the initials of the person who performed the activities

Log.

5. If you selected Log, enter the Starting Date and Ending Date.

Defining Maintenance Activities You can define maintenance activities that are specific to your laboratory. These activities are part of the regular maintenance schedule. You must have the appropriate level of security to perform these functions. 1. At the workspace, select Maintenance Status.

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2. At the Status – Maintenance window, you can define or edit a maintenance activity. If you want to . . .

Then . . .

define a maintenance activity

a.

edit a maintenance activity

schedule the Daily Cleaning Procedure to occur at a particular time every day

Select Add.

b. Enter the name of the maintenance activity. a.

Select an activity that you defined.

b. Select Definition. c.

At the Status – Maintenance Definition window, select Edit.

a.

Select Perform Daily Cleaning.

b. Select Definition. c.

At the Status – Maintenance Definition window, select Edit.

d. Select Autoschedule. e.

Enter the time that the system should perform the procedure. Specify time in a 4 digit, 24-hour format, for example: 0130 is 1:30 a.m. and 1445 is 2:45 p.m.

3. At the Status – Maintenance Definition window, enter or edit the appropriate information. 4. Select Save. The system displays a symbol next to the maintenance activity you defined at the Status – Maintenance window.

Deleting a Maintenance Activity Use this procedure to delete maintenance activities you defined. 1. At the workspace, select Maintenance Status. 2. At the Status – Maintenance window, select the maintenance activity that you defined. 3. Select Delete.

Performing Maintenance Procedures The online help also contains most maintenance procedures for the ADVIA Centaur XP system.

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Performing Daily Cleaning You can start the daily cleaning procedure when the system is not processing samples. Allow approximately 35 to 60 minutes for the system to complete the cleaning procedure, depending on the setup and status of your system. The cleaning procedure cleans the probes, the rinse stations, wash stations, and associated tubing. Schedule the cleaning procedure after your peak workload to optimize effectiveness of the cleaning procedure and enhance system performance. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. CAUTION

Do not neglect to perform daily cleaning. Choosing to not perform the cleaning procedure can result in bacterial contamination, paramagnetic particle buildup, protein buildup, and crystallization, which can affect patient results. NOTE: You cannot process samples while the cleaning procedure is in progress.

1. If the bottle is more than half full, empty the waste bottle. 2. If necessary, replenish the cleaning solution. Refer to Preparing the Cleaning Solution‚ page 5-17. 3. Ensure that the water bottle is at least 1-quarter full (approximately 2.5 L). NOTE: If the diluter drawer is not closed (up), the daily cleaning procedure

does not prime the wash station diluters correctly.

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4. Ensure that the diluter drawer is closed.

1

Diluter drawer

Figure 5-1

Diluter Drawer

5. At the workspace, select Maintenance Status. 6. Select Perform Daily Cleaning. 7. Select Perform. The system starts the cleaning procedure. NOTE: If the cleaning procedure stops before it completes, the maintenance button turns red and the system prevents you from testing samples until it completes the cleaning procedure or completes a rinse cycle. NOTE: If the cleaning procedure has an error but the rinsing completes

successfully, the maintenance button turns yellow. 8. If an error occurs before the cleaning procedure finishes, perform the following steps: a. At the workspace, select Event Log. b. At the System – Event Log window, look for an event that would indicate the cause of the error. c. Correct the error. d. If you are able to correct the error, reschedule the cleaning procedure to remove the cleaning failed status or select Rinse System With Water. e. If the error persists, call for technical assistance.

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Alternating the Water Bottle Allowing the water bottle to air dry in between uses helps prevent bacterial contamination. 1. Remove the water bottle: a. Pull out the waste and water drawer. b. Open the water bottle lid.

1 2 3 4 5

Waste and water drawer Water tubing Water bottle lid Cap Water bottle

Figure 5-2

Waste and Water Bottles

CAUTION

Do not grasp the tubing when disconnecting the tubing from the top of the water bottle or reservoir. Pulling the tubing can cause crimps. Grasp the fittings, not the tubing. c. Disconnect the water tubing from the water bottle and set aside on lint-free tissues or gauze to absorb drips. d. Lift the water bottle up and out. 2. Remove the cap. 3. Fill the spare, clean water bottle with fresh reagent water and install the cap. Refer to Reagent Water Quality‚ page C-4.

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4. Install the spare, full water bottle: a. Place the water bottle in the waste and water drawer. b. Connect the water bottle tubing to the bottle. c. Lower the water bottle lid. 5. Remove the cap and empty the water bottle you just removed from the system. 6. Rinse the water bottle with reagent water and invert the bottle to dry.

Rinsing the System with Water If the daily cleaning procedure failed, use this procedure to ensure that cleaning solution is completely rinsed from the system tubing. 1. At the workspace, select Maintenance Status. 2. Select Rinse the System with Water. 3. Select Perform. The system rinses the tubing with water.

Performing Weekly Maintenance You need the following materials to perform weekly maintenance procedures: • clean, spare water bottle • ADVIA Centaur XP Cleaning Solution Concentrate • 2 L of prepared cleaning solution • reagent water • maintenance screwdriver • lint-free tissues, gauze, or paper towels • transfer pipettes • clean, spare water reservoir • clean, spare manifold • water reservoir cleaning cover

Cleaning the Water Bottles and Reservoir WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 1. Ensure that the spare water bottle is clean. 2. At the workspace, select System Status. WARNING

Do not clean the primary reagent compartment while the probes are accessing reagent packs. Injury can result.

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3. Select Turn System Mechanics Off. 4. Remove the water reservoir: CAUTION

Use care when handling the glass sensors. Glass sensors are fragile and errors occur on the system when the sensors are damaged. a. Move the clamps that cover the sensors aside, carefully remove the sensors, and let them hang in the drawer. CAUTION

Do not grasp the tubing when disconnecting the tubing from the top of the water bottle or reservoir. Pulling the tubing can cause crimps. Grasp the fittings, not the tubing. b. Disconnect the water tubing fittings and set them aside on paper towels.

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5. Lift the water reservoir out of the system.

1 2 3 4 5 6 7

Reservoir cap Sensor Water tubing fittings Sensor Manifold Water reservoir Water bottle

Figure 5-3

Water and Waste Bottle Assembly

6. Remove the reservoir cap and empty any water from the reservoir. 7. Remove the manifold and install the water reservoir cleaning cover: a. Loosen the 3 knurled captive screws. b. Remove the manifold from the reservoir.

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c. Install the reservoir cleaning cover on the reservoir.

1 2

Reservoir cleaning cover Water reservoir

Figure 5-4

Water Reservoir Assembly

d. Set the reservoir and manifold aside. 8. Install the spare manifold on the spare reservoir: a. Place the manifold onto the spare reservoir and push down into position. b. Tighten the 3 knurled screws. 9. Install the spare water reservoir and clean the sensors: a. Place the spare reservoir in the waste and water drawer. CAUTION

Do not leave cleaning solution residue on the sensors. Residual cleaning solution on the sensors can affect assay results. Clean and rinse the sensors thoroughly. b. Clean the sensors by wiping the sensors with lint-free tissues or gauze saturated with cleaning solution. c. Rinse the sensors by wiping the sensors with lint-free tissues or gauze saturated with reagent water. d. Repeat step c. with fresh lint-free tissues or gauze. e. Install the sensors in the top of the reservoir. f.

Secure the sensors with the clamps.

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g. Connect the 2 water tubing fittings to the top of the reservoir. 10. Remove the water bottle: a. Pull out the waste and water drawer. b. Open the water bottle lid. c. Disconnect the water tubing from the water bottle and set aside on paper towels to absorb drips. d. Lift the water bottle up and out.

1 2 3 4 5

Waste and water drawer Water tubing Water bottle lid Cap Water bottle

Figure 5-5

Waste and Water Bottles

e. Set the water bottle aside. 11. Install the spare water bottle: a. Fill the spare, clean water bottle with fresh reagent water and install the cap. b. Place the spare water bottle in the waste and water drawer. c. Connect the water bottle tubing to the bottle. d. Lower the water bottle lid. e. Push in the waste and water drawer. 12. Select Turn System Mechanics On.

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13. Prime the reservoir: a. At the workspace, select Maintenance Status. b. Select Prime Water from Reservoir to Manifolds. c. Select Perform. d. After the priming is complete, the system is ready for operation. 14. Clean and rinse the water reservoir: a. Pour approximately 1 L of cleaning solution into the reservoir. b. Place the cleaning cover on the reservoir and close tightly. c. Invert the reservoir and swirl the solution a few times. d. Soak the inverted reservoir for 5 minutes. e. Swirl the solution again and then soak the reservoir upright for an additional 5 minutes. f.

Empty the solution from the reservoir.

g. Remove the cleaning cover. CAUTION

Do not leave cleaning solution residue in the water reservoir. Residual cleaning solution in the water reservoir tubing can affect assay performance. Rinse the water reservoir thoroughly with fresh reagent water. h. Thoroughly rinse the inside of the reservoir, and the reservoir cleaning cover at least 3 times to ensure that there is no residual cleaning solution on the components. i.

Fill the reservoir with reagent water.

j.

Install the cleaning cover on the reservoir.

k. Invert the reservoir, swirl the water a few times, and return the reservoir to the upright position. l.

Remove the cleaning cover and empty the water from the reservoir.

m. Invert the reservoir to dry. 15. Clean and rinse the water bottle: a. Remove the cap and empty any water from the water bottle that was removed in step 10.. b. Pour approximately 1 L of cleaning solution into the water bottle. c. Place the cap on the bottle and close tightly. d. Swirl the solution around the inside of the bottle a few times. e. Press some gauze over the holes in the top of the bottle and hold the gauze with your fingers. f.

Invert the bottle, swirl the solution a few times and then return the bottle to the upright position.

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g. Soak the bottle in the upright position for 5 minutes. h. Repeat steps e. and f. i.

Swirl the solution again and then empty the bottle.

CAUTION

Do not leave cleaning solution residue in the water bottle. Residual cleaning solution in the water bottle tubing can affect water filter and assay performance. Rinse the water bottle thoroughly with fresh reagent water. j.

Rinse the inside of the bottle including the tubing at least 5 times with fresh reagent water.

k. Invert the bottle to dry. 16. Clean the manifold: a. Empty the fluid from the tubing using a transfer pipette.

1 2

Manifold tubing Manifold

Figure 5-6

Manifold

b. Fill the tubing with cleaning solution using a transfer pipette. c. Soak the water reservoir manifold in cleaning solution for 5 minutes. d. Empty the fluid from the tubing using a transfer pipette. CAUTION

Do not touch the tubing or sensors. Touching the tubing or sensors can cause contamination.

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e. Rinse each tubing by filling it with reagent water using a clean transfer pipette, removing the fluid and repeating 5 times. CAUTION

Do not leave cleaning solution residue on the manifold. Residual cleaning solution on the manifold can cause corrosion. Rinse the manifold thoroughly with fresh reagent water, including caps, captive screws, and clamps. f.

Thoroughly rinse the manifold and remove excess water from the manifold and tubing.

Emptying the Water Trap Use this procedure to remove condensation that has collected in the water trap. If the water trap fills with condensation, the system can have vacuum problems. CAUTION

Do not remove the water trap when the system is in the Inprocess state or the Cleaning state. Removing the water trap while the system is in one of these states can cause a low vacuum error and cause the system to stop sampling and cancel all of the tests in the ring. 1. Ensure that the system is in 1 of the following states: •

Ready

•

Warming Up

•

Diagnostic

•

Mechanics Off

•

Check Status

BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 2. Pull out the waste and water drawer.

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3. Unscrew and remove the water trap.

1

Water trap

Figure 5-7

Water Trap

4. Remove any liquid from the water trap. The liquid in the water trap is waste condensation. 5. Ensure that the float ball moves freely in the water trap. 6. Ensure that the inner seal of the lid is not missing or damaged. 7. Tightly install the water trap lid and install it in the bracket. Ensure the tubings are still attached. 8. Close the waste and water drawer.

Performing Monthly Maintenance Perform the following tasks every month: • prepare the cleaning solution • clean the exterior of the reagent probes • clean the exterior of the ancillary probe • clean the exterior of the aspirate probe • clean the air filter • perform Monthly Cleaning Procedure

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You need the following materials to perform the Monthly Cleaning Procedure: • approximately 4 L of prepared ADVIA Centaur XP Cleaning Solution for the automated portion of the Monthly Cleaning Procedure • approximately 2 L of prepared ADVIA Centaur XP Cleaning Solution used for soaking and wiping system components • reagent water • large maintenance brush • lint-free tissues, gauze, and paper towels • spare air filter

Preparing the Cleaning Solution Use the cleaning solution for soaking and wiping system components. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. Use this procedure to prepare the cleaning solution for soaking and wiping system components. 1. Carefully pour 1 container of ADVIA Centaur XP Cleaning Solution Concentrate into the container used for soaking system components. You can soak the components in a sink, the cuvette waste bin liner, or another suitable container. 2. Add 2 L of water to the container.

Cleaning the Exterior of the Reagent Probes. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. CAUTION

Do not bend the probe. Bending the probe can cause system errors. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off.

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3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. WARNING

Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. 4. Remove the reagent probes cover by lifting the cover up and then out.

1

Reagent probes cover

Figure 5-8

Reagent Compartment

5. Clean the 3 reagent probes: a. Push the reagent probe assemblies toward the incubation ring by pushing the motors: • Push reagent probe 1 to the right and then toward the incubation ring. • Push reagent probe 2 to the left and then toward the incubation ring.

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•

1 2 3 4 5

5-19

Push reagent probe 3 toward the incubation ring.

Reagent probe 1 Reagent probe 2 Reagent probe 3 Probe – side view. Motor.

Figure 5-9

Diagram – Reagent Probes

b. Use a gentle downward motion to wipe each probe with lint-free tissues or gauze saturated with cleaning solution. c. Check the probes for damage and to ensure that they are not bent. CAUTION

Do not leave cleaning solution residue on the probe. Residual cleaning solution on the probe can damage the probe. Follow the instructions for rinsing the probe. d. Thoroughly rinse the reagent probe, especially the middle of the probe.

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Rinse the probe using a gentle downward motion to wipe each probe with lint-free tissues or gauze saturated with reagent water.

1

Reagent probe

Figure 5-10

Reagent Probe

6. Install the reagent probes cover. 7. Close and secure the top cover. 8. Select Turn System Mechanics On.

Cleaning the Exterior of the Ancillary Probe BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off.

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3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. WARNING

Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. 4. Using cleaning solution, clean the ancillary probe:

Refer to Preparing the Cleaning Solution‚ page 5-17. a. Move the inprocess queue to the right. CAUTION

Do not bend the probe. Bending the probe can cause system errors. b. Pull the probe toward you by holding the top of the probe assembly. c. Check the probe for damage and to ensure that it is not bent. d. Use a gentle downward motion to wipe the probe with lint-free tissues or gauze saturated with cleaning solution. e. Thoroughly rinse the ancillary probe, especially the middle of the probe.

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Rinse the probe using a gentle downward motion to wipe each probe with lint-free tissues or gauze saturated with reagent water.

1 2

Probe assembly Ancillary probe

Figure 5-11

Ancillary Probe

5. Close and secure the top cover. 6. Select Turn System Mechanics On.

Cleaning the Exterior of the Aspirate Probes BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off.

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3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 4. Carefully lift the probe arms up to the highest position. NOTE: It is not necessary to remove the aspirate probes. Clean only the visible portion of the probe.

5. Wipe the visible portion of the probes with lint-free tissues or gauze saturated with cleaning solution. Refer to Preparing the Cleaning Solution‚ page 5-17. 6. Wipe the probes with lint-free tissues or gauze saturated with reagent water.

1 2

Probe clip Aspirate probe

Figure 5-12

Wash Block

CAUTION

Use care that you do not damage probes. To prevent damage to the probe, ensure that each clip is in its locked position. 7. Move the aspirate probes down approximately 1.27 cm (0.5 in) from the highest position. 8. Close and secure the top cover. 9. Select Turn System Mechanics On.

Cleaning the Air Filter 1. Remove the air filter bracket.

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2. Push the air filter up and then out of the bracket.

1

Air filter and bracket

Figure 5-13

ADVIA Centaur XP – back view

CAUTION

Do not install a wet or damp air filter. The moisture can cause system damage. 3. Install the spare, dry air filter in the bracket. 4. Install the bracket and the filter. CAUTION

Do not wash the air filter with cleaning solution. The cleaning solution can damage the filter. 5. Rinse the air filter with water and allow it to dry thoroughly.

Performing the Monthly Cleaning Procedure Allow approximately 30 minutes to complete this procedure. You cannot use the system for testing during this procedure.

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Perform the appropriate monthly cleaning procedure for your system configuration: •

If your system uses the system water bottle, perform the Monthly Cleaning Procedure for Systems Using the System Water Bottle‚ page 5-25.

•

If your system uses direct plumbing for the system water, perform the Monthly Cleaning Procedure for Systems Using Direct Plumbing‚ page 5-28.

Monthly Cleaning Procedure for Systems Using the System Water Bottle BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. CAUTION

Do not put cleaning solution in the water bottle until after you select Perform Monthly Cleaning. If cleaning solution is in the water bottle too soon, it is pumped throughout the system. Follow all instructions as written. 1. At the workspace, select Maintenance Status. 2. At the Status – Maintenance window, select Schedule in View. 3. Select Perform Monthly Cleaning. 4. Select Perform. 5. Select Yes. The system empties the waste reservoir. First Prompt

1. Fill the water bottle with 4 L of cleaning solution: a. When prompted, pull out the waste and water drawer. b. Remove the water bottle. c. Carefully pour 2 containers of ADVIA Centaur XP Cleaning Solution Concentrate into the empty water bottle. d. Add 4 L of water to the water bottle. 2. Load the water bottle on to the system.

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3. Empty the water reservoir and waste bottle: CAUTION

Use care when handling the glass sensors. Glass sensors are fragile and errors occur on the system when the sensors are damaged. a. Disconnect the tubing and remove the sensors and cap from the water reservoir. b. Remove the water reservoir. CAUTION

Do not leave water in the water reservoir during the cleaning procedure. Water in the reservoir dilutes the cleaning solution. Empty the water reservoir completely. c. Empty the water reservoir. d. If the system uses an onboard waste bottle, remove the waste bottle and empty the contents into a container approved for biohazardous waste. 4. Ensure that the water trap is emptied and the bottle lid is tight. 5. Load the empty water reservoir and waste bottle onto the system: a. Install the empty water reservoir on the system. b. Connect the tubing and install the sensors. c. Ensure that the cap on the waste reservoir is tight. d. Install the waste bottle on the system. CAUTION

Do not select Cancel during the First Prompt. If you select Cancel, you must remove the cleaning solution from the system and install the reagent water in a clean water bottle before you select Continue. 6. Select Continue. Second Prompt

1. Rinse the water bottle. Remove and thoroughly rinse the water bottle and cap with reagent water. 2. Add 2 L of reagent water to the water bottle. Do not add more than 2 L of water to the water bottle. Excess water causes the waste bottle to fill before the end of the cleaning procedure, causing the procedure to fail. 3. Place the water bottle on the system. 4. Ensure that the water reservoir contains no more than 1.27 cm (0.5 in) fluid. 5. Select Continue.

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Third Prompt

1. Rinse the water bottle and the water reservoir: a. Disconnect the tubing and remove the sensors from the water reservoir. b. Remove the water bottle and the water reservoir. c. Thoroughly rinse the water bottle and the water reservoir with reagent water to remove residual cleaning solution. 2. Fill the water bottle with 2 L of water and load it onto the system. 3. Load the empty water reservoir onto the system. Ensure that you connect the tubing and install the sensors. 4. Select Continue. Fourth Prompt

1. Remove the water bottle and the water reservoir: a. Disconnect the tubing and remove the sensors from the water reservoir. b. Remove the water bottle and the water reservoir and set them aside. 2. Fill the alternate water bottle with reagent water and install it on the system: a. Install the empty alternate water reservoir on the system. b. Ensure that you connect the tubing and install the sensors. c. Close the waste and water drawer. 3. Select Continue. 4. Observe the water filter. 5. If required, vent air through the air vent filter. When priming is complete, the system returns to the Ready state. 6. Thoroughly rinse the water bottle and the water reservoir that you removed from the system with reagent water, and then invert them to dry.

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Monthly Cleaning Procedure for Systems Using Direct Plumbing BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. CAUTION

Do not put cleaning solution in the water bottle until after you select Perform Monthly Cleaning. If cleaning solution is in the water bottle too soon, it is pumped throughout the system. Follow all instructions as written. 1. At the workspace, select Maintenance Status. 2. At the Status – Maintenance window, in the View drop down, select Schedule. 3. Select Perform Monthly Cleaning. 4. Select Perform. 5. Select Yes. The system empties the waste reservoir. First Prompt

1. Fill the water bottle with 4 L of cleaning solution: a. When prompted, pull out the waste and water drawer and remove the water bottle. b. Carefully pour 2 containers of ADVIA Centaur XP Cleaning Solution Concentrate into the empty water bottle. c. Add 4 L of water to the water bottle. 2. Load the water bottle onto the system.

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3. Empty the water reservoir and waste bottle: CAUTION

Use care when handling the glass sensors. Glass sensors are fragile and errors occur on the system when the sensors are damaged. a. Disconnect the tubing and remove the sensors and float switch from the water reservoir. CAUTION

Do not leave water in the water reservoir during the cleaning procedure. Water in the reservoir dilutes the cleaning solution. Empty the water reservoir completely. b. Remove the water reservoir and then empty it. c. If the system uses an onboard waste bottle, remove the waste bottle and empty the contents into a container approved for biohazardous waste. 4. Ensure that the water trap is emptied and the bottle lid is tight. 5. Install the empty water reservoir and waste bottle onto the system: a. Install the empty water reservoir. b. Ensure that you connect the tubing and install the sensors and float switch. c. Install the waste bottle on the system. d. Ensure that the cap on the waste reservoir is tight.

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6. Move the direct plumbing switch to the off position.

1 2

Direct plumbing switch Off position

Figure 5-14

Direct Plumbing Switch

CAUTION

Do not select Cancel during the First Prompt. If you select Cancel, you must remove the cleaning solution from the system and install the reagent water in a clean water bottle before you select Continue. 7. Select Continue. Second Prompt

1. Rinse the water bottle. Remove and thoroughly rinse the water bottle and cap with reagent water. 2. Add 2 L of reagent water to the water bottle. Do not add more than 2 L of water to the water bottle. Excess water causes the waste bottle to fill before the end of the cleaning procedure, causing the procedure to fail. 3. Place the water bottle on the system. 4. Ensure that the water reservoir contains no more than 1.27 cm (0.5 in) fluid. 5. Select Continue.

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Third Prompt

1. Rinse the water bottle and the water reservoir: a. Disconnect the tubing and remove the sensors from the water reservoir. b. Remove the water bottle and the water reservoir. c. Thoroughly rinse the water bottle and the water reservoir with reagent water to remove residual cleaning solution. 2. Fill the water bottle with 2 L of reagent water and load it onto the system. 3. Load the empty water reservoir onto the system. Ensure that you connect the tubing and install the sensors. 4. Select Continue. Fourth Prompt

1. Remove the water bottle and the water reservoir: a. Disconnect the tubing and remove the sensors and float switch from the water reservoir. b. Remove the water bottle and the water reservoir and set them aside. 2. Install the empty alternate water reservoir and the empty alternate water bottle on the system. Connect the tubing to the water reservoir and the water bottle. 3. Clean the float switch and sensors. Clean the water reservoir float switch and the sensors using gauze soaked with cleaning solution. 4. Rinse the water reservoir float switch and the sensors twice: a. Rinse the water reservoir float switch and the sensors in a container of reagent water. b. Using fresh reagent water, rinse the water reservoir float switch and the sensors again. CAUTION

Do not touch the tubing or sensors. Touching the tubing or sensors can cause contamination. 5. Install the float switch and sensors in the water reservoir. Ensure that the float switch is securely seated in the water reservoir.

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6. Move the direct plumbing switch to the On position. a. Ensure that the dot is visible on the direct plumbing switch, which indicates that direct plumbing is enabled.

1 2

Direct plumbing switch On position

b. Close the waste and water drawer. 7. Select Continue. 8. Observe the water filter. 9. If required, vent air through the air vent filter. When priming is complete, the system returns to the Ready state. 10. Thoroughly rinse the water bottle and the water reservoir that you removed from the system with reagent water, and then invert them to dry.

As-Needed Maintenance For online information about performing maintenance procedures, perform the following steps: 1. At the workspace, select the Status Maintenance button. 2. At the Status – Maintenance window, select the appropriate maintenance task: 3. Select Procedure. 4. Follow the instructions in the online help. NOTE: Most of these procedures are also available in this section of the ADVIA Centaur XP Operator’s Guide.

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Opening the Top Cover WARNING

Do not access the system when it is in the Inprocess state or the Cleaning state. In these states, the system can move a subassembly that could cause injuries. 1. Ensure that the system is in 1 of the following states: •

Ready

•

Warming Up

•

Diagnostic

•

Mechanics Off

•

Check Status

2. Open the cuvette waste area door. 3. Using a Phillips screwdriver, loosen the screw in the top cover.

1

Screw

4. Lift the top cover.

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Cleaning the Probe Rinse Stations Clean the rinse stations for the 3 reagent probes and the ancillary probe when you can see paramagnetic particles on the rinse stations. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. WARNING

Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover.

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4. Remove the reagent probes cover.

1

Reagent probes cover

Figure 5-15

Primary Reagent Compartment

CAUTION

Do not bend the probe. Bending the probe can cause system errors. 5. Push the reagent probe assemblies toward the incubation ring by pushing the motor. •

Push reagent probe 1 to the right and then toward the incubation ring.

•

Push reagent probe 2 to the left and then toward the incubation ring.

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•

1 2 3 4 5

Push reagent probe 3 toward the incubation ring.

Reagent probe 1 Reagent probe 2 Reagent probe 3 Probe Motor

Figure 5-16

Reagent Probes and Incubation Ring

6. Gently push the sample probe and ancillary probe assemblies back toward the incubation ring by pushing the motors. 7. Use a disposable transfer pipette to add 0.5 to 1.0 mL of cleaning solution to each rinse station. Refer to Preparing the Cleaning Solution‚ page 5-17. 8. Clean each rinse station using the small maintenance brush.

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9. Gently insert the brush into the rinse station to a depth of 6.3 cm (2.5 in), and swirl the brush inside the rinse station.

1 2

Small brush Rinse station

Figure 5-17

Rinse Station

10. Remove the brush and then remove the cleaning solution with a transfer pipette. 11. Clean each rinse station: a. Wipe the rinse station with lint-free tissues or gauze saturated with cleaning solution. b. Wipe the rinse station with lint-free tissues or gauze saturated with reagent water. 12. Close and secure the top cover. 13. Select Turn System Mechanics On.

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Cleaning the Reagent Probe Shutter Clean the reagent probe shutter when reagent probe shutter errors occur or splatter is visible on the reagent probe shutter. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 4. Remove the primary reagent packs from the primary reagent compartment and refrigerate them. 5. Remove the reagent probes cover by lifting the cover up and then out.

1

Reagent probes cover

Figure 5-18

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6. Push the reagent probe assemblies toward the incubation ring by pushing the motors. •

Push reagent probe 1 to the right and then toward the incubation ring.

•

Push reagent probe 2 to the left and then toward the incubation ring.

•

Push reagent probe 3 toward the incubation ring.

1 2 3 4 5

Reagent probe 1 Reagent probe 2 Reagent probe 3 Probe Motor

Figure 5-19

Reagent Probes and Incubation Ring

7. Remove the reagent probe shutter: a. Lift the shutter drive arm up and off the shutter drive. b. Slide the shutter to the left until the screw slots are under the screws.

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c. Lift out the shutter.

1 2 3

Shutter drive Shutter drive arm Reagent probe shutter

Figure 5-20

Reagent Probe Shutter Assembly

8. Clean the shutter: Refer to Preparing the Cleaning Solution‚ page 5-17. a. Wipe the shutter with gauze soaked with cleaning solution. b. Rinse the shutter with water. c. Thoroughly dry the shutter. 9. Wipe the surface under the shutter with lint-free tissues or gauze saturated with cleaning solution. 10. Dry the surface under the shutter. 11. Install the shutter by sliding it to the right until the screw slots are under the screws, and then placing the shutter drive arm down on the shutter drive. 12. Install the reagent probes cover. 13. When the system is in the Ready state, return the reagent packs to the primary reagent compartment. 14. Close and secure the top cover. 15. Select Turn System Mechanics On.

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Cleaning the Primary Reagent Compartment and Reagent Pack Holders Clean the primary reagent compartment and reagent pack holders when it becomes difficult to load primary reagent packs. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not clean the primary reagent compartment while the probes are accessing reagent packs. Injury can result. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Open the primary reagent door.

1

Primary reagent door

Figure 5-21

Primary Reagent Compartment

4. Remove the primary reagent packs from the primary reagent compartment and refrigerate them. 5. Wipe excess water from the primary reagent compartment.

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6. Wipe the surfaces of the primary reagent compartment with lint-free tissues or gauze saturated with water.

1 2 3 4

Primary reagent door Primary reagent shelf Reagent holders LEDs

Figure 5-22

Primary Reagent Compartment

7. If reagent has spilled onto the reagent pack holders, wipe the reagent pack holders with lint-free tissues or gauze saturated with water. 8. Dry the primary reagent compartment. 9. Select Turn System Mechanics On. 10. When the system is in the Ready state, return the reagent packs to the primary reagent compartment. NOTE: Reagent mixing does not occur when System Mechanics are off. Some settling of the Solid Phase reagents can occur if the reagents have not been mixed for 2 hours.

11. Ensure that reagents are resuspended before resuming normal operation. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual for information on checking for a Solid Phase pellet and mixing reagent packs by hand. 12. Close the primary reagent door.

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Cleaning the Covers and Pointing Device BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. Refer to Preparing the Cleaning Solution‚ page 5-17. 1. Carefully wipe the following components with lint-free tissues or gauze saturated with cleaning solution: •

sample entry queue

•

exterior covers

•

sample exit queue

•

ancillary entry

•

Stat entry

•

pointing device

•

system fluids tray

•

tray under the system fluids reservoirs

•

tray under the waste and water bottles

2. Rinse the components with lint-free tissues or gauze saturated with water.

Cleaning the Cuvette Waste Area BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. Refer to Preparing the Cleaning Solution‚ page 5-17. 1. Open the cuvette waste area door. 2. Remove any empty sample tip trays and covers from the tip tray bin. 3. With a Phillips screwdriver, remove the screw at the left of the tip tray waste.

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4. Lift the tip tray bin up and then out of the system.

1

Tip tray screw

Figure 5-23

Cuvette Waste Cabinet

5. Remove the cuvette waste bin, empty it, and set it aside.

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6. Remove the cuvette waste chute by releasing it from the magnetic fitting. Slightly rotate the cuvette waste chute, then pull it out and down.

1

Cuvette waste bin

Figure 5-24

Cuvette Waste Cabinet

7. Soak the cuvette waste chute in cleaning solution for 5 minutes. 8. While the cuvette waste chute is soaking, clean the cuvette waste reservoir: a. Open the cuvette waste bin drawer.

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b. Wipe the reservoir with lint-free tissues or gauze saturated with cleaning solution.

1

Cuvette waste reservoir

Figure 5-25

Cuvette Waste Cabinet

c. Rinse the reservoir with lint-free tissues or gauze saturated with reagent water. WARNING

Do not splatter yourself or work area with cleaning solution. The cleanins solution is a biohazardous material and must be used carefully. Scrub the cuvette waste

chute gently to avoid splattering yourself and the work area. 9. Clean the cuvette waste chute: a. Use the large maintenance brush and cleaning solution to gently clean the chute. b. Rinse the chute with water. c. Dry the outside of the chute with paper towels. CAUTION

Do not pinch or trap cables or tubing when installing the chute. Pinching the cables or tubing can cause system errors. 10. Install the cuvette waste chute: a. Place the locator pins at the bottom of the chute in the reservoir.

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b. Push up the top of the chute until it attaches to the magnetic fitting.

1 2 3

Magnet fitting Locator pins Cuvette waste reservoir

Figure 5-26

Cuvette Waste Cabinet

c. Rinse the reservoir with lint-free tissues or gauze saturated with reagent water. WARNING

Do not splatter yourself or work area with cleaning solution. The cleanins solution is a biohazardous material and must be used carefully. Scrub the cuvette waste

chute gently to avoid splattering yourself and the work area. 11. Clean the cuvette waste chute: a. Use the large maintenance brush and cleaning solution to gently clean the chute. b. Rinse the chute with water. c. Dry the inside and the outside of the chute with paper towels. CAUTION

Do not pinch or trap cables or tubing when installing the chute. Pinching the cables or tubing can cause system errors.

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12. Install the cuvette waste chute: a. Place the locator pins at the bottom of the cuvette waste chute in the cuvette waste reservoir. b. Push up the top of the chute until it attaches to the magnetic fitting. Move the top of the cuvette waste chute up until you feel the magnets connect

1 2 3

Cuvette waste reservoir Top of the cuvette waste chute at the magnets Locator pins

Figure 5-27

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13. Ensure that no wires or cables are interfering with the correct positioning of the cuvette waste chute.

1 2

Cuvette waste area wires Cuvette waste chute

Figure 5-28

Cuvette Waste Cabinet

14. Install the sample tip tray bin. 15. Install the cuvette waste bin in the drawer and close the door. 16. If you emptied the cuvette waste bin, select Yes at the prompt. 17. If you emptied the tip tray bin, select Yes at the prompt.

Cleaning the Sample Tip Waste Area The sample tip waste area includes the tip remover, tube, chute, and reservoir. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. Refer to Preparing the Cleaning Solution‚ page 5-17. 1. At the workspace, select System Status.

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2. Select Turn System Mechanics Off. 3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 4. Remove the sample tip remover and sample tip waste tube: a. Gently push the sample probe and ancillary probe back toward the incubation ring. b. Loosen the knurled knob on the sample tip remover. c. Lift the sample tip remover and sample tip waste tube up and out of the system.

1 2 3 4

Sample tip waste tube Sample tip remover Sample probe Knurled knob

Figure 5-29

Sample Tip Waste Assembly

5. Access the sample tip waste chute: a. Open the sample tip waste area door. b. Remove the sample tip waste bin, empty it, and set it aside. c. Pull out the drawer. d. Lift the lid to the cleaning solution bottle and ensure that it remains in the up position. e. Ensure that the checkvalve remains on the end of the tubing. f.

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g. Wipe the cleaning solution tubing with fresh lint-free tissues or gauze to remove excess cleaning solution from the outside and tip of the tubing. WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. 6. Remove the sample tip waste chute by pulling it up and out.

1 2

Sample tip waste chute Sample tip waste reservoir

Figure 5-30

Cleaning Solution Cabinet

WARNING

Do not splatter yourself or work area with cleaning solution. The cleanins solution is a biohazardous material and must be used carefully. Scrub the cuvette waste

chute gently to avoid splattering yourself and the work area. 7. Unscrew the sample tip waste tube from the sample tip remover.

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8. Soak the sample tip remover, sample tip waste tube, and sample tip waste chute in cleaning solution for 5 minutes. 9. Clean the sample tip waste reservoir: a. While the sample tip remover, sample tip waste tube, and sample tip waste chute are soaking, wipe the sample tip waste reservoir with lint-free tissues or gauze saturated with cleaning solution. b. Wipe the sample tip waste reservoir with lint-free tissues or gauze saturated with water. c. Dry the sample tip waste reservoir with lint-free tissues or gauze. 10. Clean the sample tip remover, sample tip waste tube, and sample tip waste chute: a. Use the large maintenance brush to clean the inside of the sample tip waste tube and sample tip waste chute. b. Rinse the sample tip remover, sample tip waste tube, and sample tip waste chute with water. c. Set the sample tip waste tube and sample tip waste chute aside to dry completely. d. Thoroughly dry the sample tip remover. e. Connect the sample tip remover to the spare sample tip waste tube. 11. Install the sample tip remover and sample tip waste tube: a. With the slot on the sample tip remover facing away from you, place the bottom of the sample tip waste tube into the opening below the sample probe. b. Align the 2 locator pins on the right side with the holes on the mounting block. c. Turn the knurled knob until the sample tip remover is secure. 12. Close and secure the top cover. CAUTION

Use care installing the sample tip waste chute. If the sample tip waste chute is not installed correctly on the reservoir or is installed upside down, tip jams can result. Install the chute so that the bottom fits completely in the sample tip waste reservoir. 13. Align the pins on top of the sample tip waste chute with the hooks inside the system, and install the bottom of the chute in the reservoir.

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14. Ensure the wires do not interfere with the sample tip waste chute.

1 2 3 4 5

Reservoir Sample tip waste chute Pin Hook Sample tip waste area wires

Figure 5-31

Sample Tip Waste Assembly

15. Install the cleaning solution bottle: a. Place the bottle in the drawer. b. Close the lid. c. Close the drawer. 16. Install the sample tip waste bin. 17. Close the sample tip waste area door. 18. Select Turn System Mechanics On.

Wiping the Waste Probe and Cuvette Ejector Rod Use this procedure to clean the waste probe and the cuvette ejector rod to prevent waste probe movement errors. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status.

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3. Select Turn System Mechanics Off. 4. Access the luminometer: a. Remove the reagent probes cover.

1

Reagent probes cover

Figure 5-32

Reagent Compartment

WARNING

Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. b. Slide the retaining clip back and remove the waste probe from the luminometer.

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c. Remove the luminometer cover.

1 2 3 4

Nut Luminometer cover Waste probe Cuvette ejector rod

Figure 5-33

Luminometer Assembly

5. Wipe the probe and the cuvette ejector rod with gauze moistened with water. 6. Dry the waste probe and cuvette ejector rod with lint-free tissue or gauze. 7. Install the luminometer cover but do NOT replace the nut. 8. With the cover ajar, reinstall the waste probe so it sits on the white collar in the luminometer. 9. Slide the retaining clip back to lock the probe in position. 10. Ensure that the luminometer cover is securely in place and hand-tighten the nut. 11. Install the reagent probe cover. 12. Close and secure the top cover. 13. Select Turn System Mechanics On. 14. Dry the components thoroughly.

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Maintaining the Sample Racks Clean the sample racks if they look dirty or the system has trouble loading them. Use this procedure to prepare sample racks for use on the ADVIA Centaur XP system. Label the sample racks to match the tube-type positions you specified at the Setup – Tube Type & Barcode window. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials.

Cleaning the Sample Racks WARNING

Do not handle cleaning solution without wearing protective equipment, including gloves, laboratory coat, and safety glasses or protective face shield. Refer to Preparing the Cleaning Solution‚ page 5-17. 1. Wipe the racks with gauze soaked in cleaning solution. NOTE: Soaking the rack could cause the labels to come off.

2. Rinse the racks with water. 3. Allow the racks to dry thoroughly.

Labeling Sample Racks CAUTION

Do not use sample racks with duplicate numbers. Using sample racks with duplicate sample rack identification barcode numbers can result in sample processing errors. When you receive additional sample rack identification barcode labels, ensure that the number range is different from ranges you currently use on your system. 1. If the sample racks are not labeled, position a sample rack identification barcode label on the rack. The A label indicates multiple tube types. The vertical numbers—2, 3, and 4—on the sample rack identification barcode label correspond to the tube-type NOTE: If you are using ADVIA Centaur racks, ensure that you use

ADVIA Centaur labels—1, 2, 3, and 4— for the Tube-Type Selector and use the correct barcode. a. Firmly place the sample rack identification barcode label on the right side of the rack and carefully wrap the label around to the front of the rack.

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b. Ensure that the sample rack identification barcode label does not

cover the indents on the front left side of the rack. c. Ensure that you do not have duplicate sample rack identification numbers.

1 2

Sample rack barcode label Rack identification number

Figure 5-34

ADVIA Centaur XP Sample Rack

Applying Cal and QC Labels

To prepare sample racks to use exclusively for calibrators or QC material, use a Cal or QC label to identify sample racks that contain calibrators or QC material.

1 2

Calibrator label Quality control label

Figure 5-35

ADVIA Centaur XP Sample Rack Labels

The Cal and QC labels remind you where to place the tube-type selector to match the calibrator or QC material tube type in the sample rack. Refer to the Setup – Tube Type & Barcode window to verify the tube-type positions specified for your system.

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On the front of the sample rack identification barcode label, apply a Cal or QC label at the position corresponding to the tube type you use for calibrators or QC material.

1

Sample rack front labels

Figure 5-36

ADVIA Centaur XP Sample Rack – front view

Applying Numbered or Customized Labels

For the remaining racks, you can use the tube-type labels to represent the 4 types of tubes you specified at the Setup – Tube Type & Barcode window. The vertical numbers, 1 to 4, on the sample rack identification barcode label correspond to the 4 tube-type positions specified at the Setup – Tube Type & Barcode window. For example, if you select Large Transfer as Tube Type 1, you can select 1 of the tube type labels to represent large transfer tubes. You can use the blank labels to create your own tube-type labels or color-coded system. Use a permanent marker to write on the blank labels. 1. Apply the tube-type labels to the front of the sample rack identification barcode label, matching each tube-type label to the tube type position you specified at the Setup – Tube Type & Barcode window. For example, if Tube Type 1 is Large Transfer, place the tube-type label you selected to represent large transfer tubes at position 1 on the sample rack identification barcode label. The tube-type labels remind you where the tube-type selector should be located to match the type of tube you place in the sample rack. 2. On the front of the sample rack, align the top and left edge of the first tube-type label with the top and left edge of the sample rack identification barcode label.

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3. Without overlapping the labels, position the next tube-type label directly below the previous tube-type label. Up to 4 tube-type labels can be placed on the sample rack identification barcode label.

1 2

Sample rack label top, left edge Sample rack next label

Figure 5-37

ADVIA Centaur XP Sample Rack

4. Install a tube-type selector on the labeled sample rack: a. Install a tube-type selector on the front of the labeled sample rack. b. Move the tube-type selector to the position corresponding to the type of tube you are using in the sample rack.

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c. Ensure that the tube-type selector does not cover the sample rack identification barcode number.

1 2

Tube type selector Sample rack Identification barcode number

Figure 5-38

ADVIA Centaur XP Sample Rack

Checking the Rack Clips on the ADVIA Centaur Racks 1. Ensure that each position on the rack has a clip. 2. If required, install clips in the rack: a. Push the clip down into the sample rack.

1

Clip

Figure 5-39

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b. Push the clip using a pen to lock it in place.

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6 Identifying System Problems Viewing System Status . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Using the Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Other Event Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Rebooting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 What to Do after Pressing a Fast Stop Button . . . . . . . . . . . . . . 6-5 Recovering from a System Lockup or a Slow User Interface . . . 6-7 Restarting the System After an Error . . . . . . . . . . . . . . . . . . . . . 6-7 Recovering from a Power Disruption . . . . . . . . . . . . . . . . . . . . . . . . .6-7

Managing Nonsampling System Status . . . . . . . . . . . . . . . . . . . 6-8 Clearing Cuvette Obstructions . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9 Checking Cuvette Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9 Verifying the Status of Cuvettes in the Incubation Ring. . . . . . . . . .6-15 Clearing Cuvettes from the Preheater . . . . . . . . . . . . . . . . . . . . . . .6-15 Clearing a Cuvette Jam from the Luminometer or Elevator. . . . . . .6-17

Replacing System Elements . . . . . . . . . . . . . . . . . . . . . . 6-21 Replacing the Preheater Cover . . . . . . . . . . . . . . . . . . . . . . . . 6-21 Replacing Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21 Replacing the Ancillary Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-21 Replacing a Reagent Probe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-23 Replacing an Aspirate Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-26 Replacing the Waste Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-30

Replacing the Waste Bottle Fluid Sensor . . . . . . . . . . . . . . . . . 6-34

Troubleshooting Obstructions and Leaks. . . . . . . . . . . 6-36 Recovering from a Sample Tip Tray Loading Jam . . . . . . . . . . 6-36 Clearing Obstructions from the Sample Exit Queue . . . . . . . . . 6-40 Troubleshooting Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-41

Using Diagnostic Tools . . . . . . . . . . . . . . . . . . . . . . . . . . 6-43 Using the System Diagnostic Tools Window. . . . . . . . . . . . . . . 6-43 Accessing Diagnostic Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-44

Cuvette Handling Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44 Empty Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-44 Empty & Fill Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-45 Prime Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-46

Reagent and Ancillary Probe Tools. . . . . . . . . . . . . . . . . . . . . . 6-47 Dispense Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-47 Home Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-49

Sample Probe Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-50 Home Probe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-50 Load Tip Tray. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-51

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Luminometer Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53 Dark Count with Cuvette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53 Dark Count without Cuvette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54 Home Luminometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-57

Aspirate Probe Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-58 Home Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-58 Dispense Wash Fluid & Aspirate . . . . . . . . . . . . . . . . . . . . . . . . . . 6-59

Performing LIS Communication Diagnostics . . . . . . . . . . . . . . 6-65 Troubleshooting Truncated PIDs in the LIS . . . . . . . . . . . . . . . . . . 6-65

Using System Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-65 Homing the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-65 Homing the Inprocess Queue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Homing the Ancillary Queue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Emptying the Inprocess Queue . . . . . . . . . . . . . . . . . . . . . . . . . . . Emptying the Ancillary Queue . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-66 6-67 6-68 6-69

Resetting the Thermals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70 Performing the Vacuum Test . . . . . . . . . . . . . . . . . . . . . . . . . . 6-70 Performing the Sample Barcode Read Test . . . . . . . . . . . . . . . 6-71 Priming Functions – Prime System . . . . . . . . . . . . . . . . . . . . . 6-72 Priming Functions – Prime Fluid Line. . . . . . . . . . . . . . . . . . . . 6-74 Priming Functions – Prime System Fluid Bottle . . . . . . . . . . . . 6-76 Remote Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-77

Resolving Barcode Problems . . . . . . . . . . . . . . . . . . . . . 6-78 Resolving Hand-held Barcode Scanner Problems . . . . . . . . . . 6-78 Barcode Scanner Reads Sporadically . . . . . . . . . . . . . . . . . . . . . . 6-78 Barcode Scanner Does Not Read . . . . . . . . . . . . . . . . . . . . . . . . . 6-78

Resolving Sample Barcode Scanner Problems . . . . . . . . . . . . 6-79 Barcode Scanner Reads Sporadically . . . . . . . . . . . . . . . . . . . . . . 6-79 Barcodes Do Not Display at Status – Samples Window. . . . . . . . . 6-80

Resolving Reagent Barcode Scanner Problems . . . . . . . . . . . 6-81 Barcodes Do Not Display at Status – Primary Reagent Window . . 6-81

Resolving Ancillary Barcode Scanner Problems . . . . . . . . . . . 6-83 Barcodes Do Not Display at Status – Ancillary Reagent Window . 6-83

Recommended Physical Specifications for Barcodes . . . . . . . 6-83 Barcode Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barcode Color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barcode Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barcode Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barcode Symbology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fixed or Variable Length Barcode . . . . . . . . . . . . . . . . . . . . . . . . . Barcode Scan Check Digit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-84 6-84 6-85 6-87 6-87 6-87 6-88

Barcode Scanning Technique. . . . . . . . . . . . . . . . . . . . . . . . . . 6-89 Barcodes Reserved for ADVIA Centaur XP Systems. . . . . . . . 6-89

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Printing Event Log Reports . . . . . . . . . . . . . . . . . . . . . . 6-89 Printing Event Log Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-90

Investigating Assay Problems . . . . . . . . . . . . . . . . . . . . 6-91 Using Calibration Evaluation Ranges . . . . . . . . . . . . . . . . . . . . 6-91 Evaluating Sandwich Assay Calibrations. . . . . . . . . . . . . . . . . . . . .6-92 Evaluating Competitive Assay Calibrations . . . . . . . . . . . . . . . . . . .6-93

Investigating Discrepant Results. . . . . . . . . . . . . . . . . . . . . . . . 6-95 Discrepant Calibration Results . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-95 Discrepant QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-98 Discrepant Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-101 Problems with a Single Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-103 Problems with Multiple Assays . . . . . . . . . . . . . . . . . . . . . . . . . . .6-104

Assay Specific Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-106 Investigating Failed Proficiency Testing Results. . . . . . . . . . . 6-106

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-107

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Identifying System Problems The ADVIA Centaur XP system provides features to help you identify and correct system problems: •

System Status provides a visual indicator that a component or subsystem has a warning or critical condition.

•

The event log provides information about system errors and accesses information about possible causes and corrective action procedures.

•

Diagnostic tools allow you to test the operation of system components and move system components when you perform corrective action procedures.

•

Remote access enables file accessibility through a modem or through RealTime Solutions service for technical assistance.

Viewing System Status Use System Status to monitor the condition of the system and determine which area of the system needs attention. To determine which area of the system has a warning or critical condition, select the System Status button at the workspace and then select System Status in the drop-down list. The System – Status window opens, and the affected system area and the corresponding button change color to indicate status. For example, when the cleaning solution volume is low, the color of the Supplies button and the cleaning solution area changes to yellow.

Using the Event Log Any warning or critical condition that is captured in the event log causes a change in the background color of the Event Log Status button: •

Yellow indicates that a warning condition exists.

•

Red indicates that a critical condition exists that may cause the system to stop aspirating or processing sample.

Use the System – Event Log window to identify errors and access online information about possible causes and corrective action procedures. The system has 3 types of event codes that can display in the event log: Event Type

Symbol

Definition

Critical

Red triangle

This type of error indicates that the system stopped processing samples.

Warning

Yellow triangle

This type of error indicates that a problem exists with a subassembly or supply. The system continues to process samples.

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Event Type

Symbol

Definition

Information

No symbol

This type of event is not an error condition, but provides a record of when normal operation occurrences happened.

You can display specific information at the System – Event Log window by selecting the appropriate View and Sort combinations: •

The View that you select determines the information that the system displays. For example, if you select Errors, the system displays only the events that are errors.

•

The Sort that you select determines the order in which the system displays the events. For example, if you select Severity, the system displays the events in order of most severe to least severe.

The following table describes the View and Sort combinations you can use to perform some routine tasks: Task

View

Sort

Display the events in reverse chronological in order of when the events occurred

Events

Date

Display the critical and warning events in order of most severe to least severe

Errors

Severity

Display the events by subsystem

Events

Subsystem

1. At the workspace, select Event Log. 2. Select the appropriate view and identify the problem you want to solve. To search for a specific event code in the event log, select Event Code in Search for and then enter the event code. 3. Locate the possible causes and corrective action procedures for the error: a. At the System – Event Log window, select Procedure. b. At the online information window, select Search. c. At the Simple Search window, type the event code exactly as it displays in the event log, including spaces. You can also enter words that describe the event. d. Select Enter. The system displays a list of possible causes and corrective actions. 4. Select a corrective action item to display the procedure on how to perform that corrective action. 5. If you perform a procedure that is a maintenance activity, log the activity at the Status – Maintenance window. 6. Enter a comment, if necessary, to provide additional information about the cause or resolution of an individual event code: a. Select the event.

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b. Select Comments. c. At the Comments window, enter a comment. You can enter up to 3 comments. You can enter comments of up to 120 alphanumeric characters. The system enters your initials and the date. If you are not currently signed in, you must sign into the system. d. Select Save. If the procedure does not correct the problem or if the problem occurs again, call for technical assistance.

Other Event Codes The following event code format indicates a data transfer error: Undefined event code. Call for technical assistance.

If you see this event, write down the event code or print the window and then call for technical assistance.

Rebooting the System 1. At the workspace, select System Status. CAUTION

Do not disconnect the system. Disconnecting the system turns off the thermal components of the primary reagent compartment and ancillary queue. Shut down the system instead. 2. Select Turn System Off. 3. At the prompt, press any key to continue. 4. Wait approximately 2 minutes while the system powers down. This does not remove power from the thermal devices such as reagent refrigeration and probe heaters. 5. Check for obstructions in the following areas before rebooting the system: •

sample entry queue

•

sample exit queue

•

sample tip loader

•

ancillary entry

•

Stat entry

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6. Press the green computer startup button.

1

Computer startup button

Figure 6-1

ADVIA Centaur XP System – back of the system

7. Log in as centaur and then press Enter twice. Use all lower case letters for the login. A password is not required. 8. Wait until the system state is Ready, and then resume normal operation.

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What to Do after Pressing a Fast Stop Button Figure 6-2 displays the 2 fast stop buttons on the system. Use these buttons if there is an obstruction that could cause serious system or physical damage.

1

Fast stop buttons

Figure 6-2

ADVIA Centaur XP – front and back of the system

After pressing a fast stop button, perform the following steps: 1. At the prompt, select Continue. 2. Remove the obstruction. CAUTION

Do not disconnect the system. Disconnecting the system turns off the thermal components of the primary reagent compartment and ancillary queue. Shut down the system instead. 3. Check for obstructions in the following areas before rebooting the system:

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•

rack loader

•

rack exit pusher

•

sample tip loader

•

ancillary entry

4. Press the green computer startup button.

1

Green startup button

Figure 6-3

ADVIA Centaur XP System – back of the system

5. Wait until the system state is Ready. 6. If an error occurs during homing, check the event log and follow the steps prescribed in online troubleshooting. 7. At the workspace, select System Status. 8. Select Diagnostic Tools. 9. At the System – Diagnostic Tools window, select Home System. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 10. Select Perform. 11. At the System – Diagnostic Tools window, select Empty & Fill Ring. WARNING

Ensure that you are clear of subassemblies that can move before closing the System – Diagnostic Tools window. The system returns subassemblies to their home positions and can cause injury.

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12. Close the System – Diagnostic Tools window. 13. When the process completes successfully, resume normal operation.

Recovering from a System Lockup or a Slow User Interface Call for technical assistance if 1 or more of the following conditions exist: •

the software responds very slowly after you make a selection

•

the software locks up

•

the event code 700 01 00 is in the event log

Restarting the System After an Error If the system stops due to an error, ensure that no racks are present in the Stat entry port and no ancillary packs are present at the ancillary entry queue before you restart the system. If a rack or an ancillary pack is present in these positions when you press the Sample Start button, a jam can occur at these positions. You must also note the position of cuvettes after a system error. Refer to Verifying the Status of Cuvettes in the Incubation Ring‚ page 6-15.

Recovering from a Power Disruption Use this procedure to recover from a power outage or power surge. CAUTION

Do not leave the system on if the power is disrupted for an extended period of time. Leaving the power on could cause serious damage to the system when the power is restored.

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If the power disruption is so brief that you do not have the opportunity to turn the main power switch off, reset the system. 1. Turn the main power switch off.

1 2

Main power on/off switch Computer startup button

Figure 6-4

ADVIA Centaur XP – back of the system

Managing Nonsampling System Status Do not allow the system to remain in the Inprocess state or the Check Status state for longer than 2 hours without processing samples. These nonsampling system states can occur even though sample tubes are in the Inprocess queue and tests are pending, or all the sample rack are processed and ejected to the sample exit queue. The system can remain in a nonsampling Inprocess state because of the following conditions: •

sample exit queue is full To correct this, remove sample racks from the exit queue.

•

communication between the system and LIS is lost To correct this, investigate the communication issue with the LIS vendor to determine the root cause.

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Clearing Cuvette Obstructions Cuvette obstructions can occur for various reasons. You can troubleshoot and clear most problems with cuvettes by following the procedures in this section. CAUTION

Do not leave the top cover open when you add cuvettes to the cuvette loading bin. Leaving the top cover open allows cuvettes to fall into another part of the system where it may obstruct normal operation. Close the top cover when adding cuvettes to the cuvette loading bin.

Checking Cuvette Handling Use this procedure to recover from cuvette jams in the cuvette loading bin, orientation chute, or vertical cuvette chute. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off.

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3. Ensure that the cuvette loading bin is not empty.

1 2 3 4

Ring loader Elevator Luminometer Orientation chute

Figure 6-5

5 6 7

Cuvette loading bin Vertical cuvette chute Preheater

Cuvette Loading Assembly

4. Check to see if the cuvettes are stacked in the bin and are preventing loading. You can mix the cuvettes in the bin until they are no longer stacked. 5. Inspect the cuvettes in the bin and remove any damaged or deformed cuvettes. A cuvette can be damaged and contaminated if it was dropped, stepped on, and then loaded into the cuvette loading bin. A deformed cuvette can have a string of plastic coming off of it or be imperfectly molded. 6. Notify your technical representative if you find many deformed cuvettes. 7. Loosen the screw on the left side of the system that secures the top cover and then open the top cover.

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8. Remove and discard all cuvettes from the orientation chute and vertical cuvette chute using a disposable transfer pipette.

1 2

Vertical cuvette chute Orientation chute

Figure 6-6

Cuvette Loading Assembly

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9. Drop a clean cuvette into the vertical cuvette chute.

1 2

Cuvette Bottom window

Figure 6-7

Vertical Cuvette Chute

10. Look for the cuvette at the bottom window of the vertical cuvette chute. 11. If the cuvette does not appear in the bottom window, there is an obstruction in the vertical cuvette chute.

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12. Remove the obstruction: a. Loosen the thumbscrew at the bottom window of the vertical cuvette chute.

1

Thumbscrew

Figure 6-8

Vertical Cuvette Chute

b. Remove the window. c. Pull any jammed cuvettes or other obstruction down and out of the system or use a transfer pipette to dislodge the obstruction. d. Loosen the 2 screws and remove the vertical cuvette chute. e. Check the vertical cuvette chute for obstructions. f.

Replace the vertical cuvette chute.

g. Replace the vertical cuvette chute window and tighten the thumbscrew.

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13. Manually move the conveyor upward and look for binding.

1 2

Conveyor slats. Cuvette Conveyor

Figure 6-9

Cuvette Conveyor

14. Ensure that no cuvettes are jammed in the preheater. 15. Select Turn System Mechanics On. 16. At the Status – Supplies window, select Prime Cuvettes. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 17. Select Perform. 18. Check for air blowing down from the ionizer, which means the conveyor is online even if it does not move. 19. Ensure that cuvettes are loaded onto the cuvette conveyor and orientation chute correctly. 20. Watch the movement of the cuvette conveyor. The conveyor should move freely. 21. Close and secure the top cover. 22. Return to normal operation. 23. If the error persists, call for technical assistance.

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Verifying the Status of Cuvettes in the Incubation Ring The system cannot verify the status of the cuvettes in the incubation ring after you press the fast stop button, or if any of the following events occurs: •

Real Time (RT) processor error

•

User Interface (UI) error If the UI recovers automatically, the status of the cuvettes in the incubation ring does not need to be verified.

•

UI lock-up error

To improve the system recovery time after any of these events, perform the Empty & Fill Ring procedure:

1. At the Workspace window, select System > Diagnostic Tools. 2. At the System – Diagnostic Tools window, select Empty & Fill Ring. Performing the procedure immediately rather than waiting for the system-initiated procedure to empty and fill the incubation ring reduces the system recovery time. 3. Select Load Tip Tray.

Clearing Cuvettes from the Preheater Use this procedure to recover from cuvette jams in the preheater. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 4. Look for a cuvette jammed at the window at the bottom of the vertical cuvette chute. 5. Loosen the thumbscrew on the preheater cover.

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6. Remove the preheater cover.

1 2 3

Ring loader Preheater Screw for the preheater cover

Figure 6-10

4 5 6

Preheater cover Vertical cuvette chute window Preheater assembly

Preheater Assembly

7. Look for any obstructions in the preheater. 8. Remove any jammed cuvettes. 9. Ensure that there are 14 cuvettes in the preheater and that there are no spaces between the cuvettes.

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10. Ensure that the cuvettes do not overlap.

1 2

Cuvette position. Preheater

Figure 6-11

11. Replace the preheater cover and tighten the thumbscrew. 12. Close and secure the top cover. 13. Select Turn System Mechanics On. 14. Return to normal operation. 15. If the error persists, call for technical assistance.

Clearing a Cuvette Jam from the Luminometer or Elevator 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Check the cuvette waste chute: a. Clear any obstructions from the cuvette waste chute. b. Clean the cuvette waste chute. 4. Loosen the screw on the left side of the system that secures the top cover and then open the top cover.

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5. Remove the reagent probes cover.

1

Reagent probes cover

Figure 6-12

Primary Reagent Compartment

CAUTION

Do not turn the knob for the rotor until you move the waste probe up. Turning the knob before moving the waste probe can damage the waste probe. 6. Move the waste probe to the up position.

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7. Turn the knob on the left bottom of the luminometer and listen for cuvettes dropping into the waste bin.

1

Knob

Figure 6-13

Luminometer

8. If the cuvettes do not drop into the waste bin and the luminometer does not turn, check for obstructions in the cuvette waste chute and clean the cuvette waste chute. 9. Remove the black elevator cover by loosening the thumbscrew.

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10. If a cuvette dropped into the elevator as you were rotating the luminometer, remove the cuvette.

1

Thumbscrew

Figure 6-14

Elevator Cover

11. Put your finger into the luminometer through the elevator and check for evidence of fluid in the luminometer. If your glove is wet, call for technical assistance. 12. Install the elevator cover, ensuring that the left side is flush with the edge of the elevator. 13. Verify that the luminometer is operating correctly: a. Select Turn System Mechanics On. b. At the workspace, select System Status. c. Select Diagnostic Tools. d. At the System – Diagnostic Tools window, select Home Luminometer. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. e. Select Perform. f.

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g. Select Perform. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 14. Close the System – Diagnostic Tools window. 15. Install the reagent probes cover. 16. Close and secure the top cover. 17. Return to normal operation. 18. If the error persists, call for technical assistance.

Replacing System Elements This section contains information for replacing basic system elements.

Replacing the Preheater Cover Refer to Clearing Cuvettes from the Preheater‚ page 6-15. At step 10, install the new preheater cover. Continue with the instructions in Clearing Cuvettes from the Preheater.

Replacing Probes This section contains procedures for replacing these probes: •

ancillary probe

•

reagent probes

•

aspirate probe

•

waste probe

Replacing the Ancillary Probe BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. WARNING

Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover.

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2. At the workspace, select System Status. 3. Select Turn System Mechanics Off. NOTE: It is not necessary to remove the tubing from the volume check sensor when disconnecting the tubing from the probe.

4. Disconnect the tubing from the top of the ancillary probe. NOTE: It might be necessary to use pliers to loosen the probe sleeve.

5. Remove the old probe from the sleeve and discard it in a container approved for sharp objects.

1 2 3 4

Top gasket Bottom gasket Sleeve Probe

Figure 6-15

Ancillary Probe

6. Install a new ancillary probe. 7. Tighten the sleeve using the pliers. 8. Connect the tubing. 9. Ensure that the top and bottom gaskets are in place. 10. Select Turn System Mechanics On.

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11. Check for leaks: a. At the workspace, select System Status. b. Select Diagnostic Tools. c. At the System – Diagnostic Tools window, select Dispense Test. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. d. Select Perform. e. Observe the ancillary probe as it moves. If the probe movement is binding, check for interference from tubing or wiring. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 12. Close the System – Diagnostic Tools window. 13. Close and secure the top cover. 14. Return to normal operation. 15. If the error persists, call for technical assistance.

Replacing a Reagent Probe BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Open the top cover.

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4. Remove the reagent probes cover by lifting the cover up and then out.

1

Reagent probes cover

Figure 6-16

Primary Reagent Compartment

WARNING

Use care when working with the reagent probes and ancillary probe. The probe tips are sharp and can cause skin punctures. 5. Push the tubing off of the top of the reagent probe. 6. Loosen the probe sleeve.

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NOTE: It might be necessary to use pliers to loosen the probe sleeve.

1 2 3

Tubing Probe sleeve Probe

Figure 6-17

Reagent Probe

7. Pull the probe down and remove the old reagent probe and sleeve from the holder. 8. Remove the old probe from the sleeve and discard it in a container approved for sharp objects. 9. Install a new reagent probe. 10. Tighten the probe sleeve using the pliers. 11. Connect the tubing. 12. Select Turn System Mechanics On. 13. Verify that the probe is operating correctly: a. At the workspace, select System Status. b. Select Diagnostic Tools. c. At the System – Diagnostic Tools window, select Dispense Test.

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d. Select the probe you replaced. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. e. Select Perform. f.

Ensure that the fluid dispense is steady and straight, with no sputtering.

g. Ensure that there are no leaks at the tubing connection. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 14. Close the System – Diagnostic Tools window. 15. Close and secure the top cover. 16. Install the reagent probes cover. 17. Return to normal operation. 18. If the error persists, call for technical assistance.

Replacing an Aspirate Probe BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Turn System Mechanics Off. WARNING

Use care when working with the aspirate probe. The probe tips are sharp and can cause skin punctures.

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4. Remove and discard the aspirate probe: a. Slide the probe clip away from the probe.

1 2 3

Probe clip Aspirate probe Probe entrance port

Figure 6-18

Wash Block

NOTE: To prevent the aspirate probe from bending, grasp the probe with

the index finger and thumb and carefully disconnect the grounding wire from the aspirate probe.

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b. If you are removing a grounded aspirate probe, disconnect the grounding cable from the aspirate probe.

1 2 3

Tubing to the aspirate probe Grounding cable Aspirate probe

Figure 6-19

Grounded Aspirate Probe

c. Carefully push the tubing off of the probe. d. Carefully lift the probe straight up until it clears the port and then lift the probe towards the front of the system to remove it from the probe holder without bending it. e. Discard the probe in a container approved for sharp objects. NOTE: Ensure that you use the correct type of aspirate probe. The

grounded aspirate probe has connections for a grounding cable and tubing. 5. Install a new aspirate probe: a. Insert the probe tip into the probe entrance port. b. Push the probe into place. c. Connect the tubing to the new aspirate probe. NOTE: To prevent the aspirate probe from bending, grasp the probe with

the index finger and thumb and carefully push the grounding wire onto the new aspirate probe. d. If you are installing a grounded aspirate probe, connect the grounding cable to the aspirate probe. CAUTION

Ensure that you return the probe clip to its locked position to hold the probe firmly in place. Failure to do so can cause mechanical error or poor results.

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e. Slide the probe clip into place, locking the probe.

1 2

Probe clip Aspirate probe

Figure 6-20

Wash Block

6. Close and secure the top cover. 7. Select Turn System Mechanics On. 8. Verify that the probe is operating correctly: a. At the workspace, select System Status. b. Select Diagnostic Tools. c. At the System – Diagnostic Tools window, select Dispense Wash Fluid & Aspirate. d. Select the probe you replaced. e. Select a fluid. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. f.

Select Perform.

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g. If the probe is binding, check the routing of the tubing. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System – Diagnostic Tools window. 10. Return to normal operation. 11. If the error persists, call for technical assistance.

Replacing the Waste Probe BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Turn System Mechanics Off.

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4. To access the luminometer, remove the reagent probes cover.

1

Reagent probes cover

Figure 6-21

Primary Reagent Compartment

5. Remove the waste probe: a. Slide the probe clip away from the probe. b. Push the tubing off of the probe.

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c. Carefully lift the probe up until it clears the waste probe guide and then lift the probe forward to remove it from the probe holder without bending it.

1 2 3

Waste probe Probe clip Waste tubing

Figure 6-22

Luminometer

d. Discard the probe in a container approved for sharp objects.

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e. Remove the luminometer cover.

1 2

Nut Luminometer cover

Figure 6-23

Luminometer Assembly

6. Wipe the top of the waste probe guide with an alcohol prep pad. 7. Place the luminometer cover over the luminometer. Do not secure it at this time. NOTE: Ensure that you use the correct type of probe. The aspirate probes are

cupped at the tip. The waste probe is flat at the tip. 8. Install a new waste probe: a. Attach the waste tubing to the new waste probe. b. Lift up the luminometer cover slightly to insert the probe tip into the waste probe guide. c. Lower the luminometer cover and push the probe into place. CAUTION

Ensure that you return the probe clip to its locked position to hold the probe firmly in place. Failure to do so can cause mechanical error or poor results. d. Slide the probe clip into place, locking the probe. CAUTION

Do not pinch the base pump tubing and wiring under the luminometer cover. Pinching the tubing or wiring can lead to malfunctions.

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9. Install the nut that secures the luminometer cover. 10. Close and secure the top cover. 11. Install the reagent probes cover. 12. Select Turn System Mechanics On. 13. Verify that the waste probe is operating correctly: a. Select Diagnostic Tools. b. At the System – Diagnostic Tools window, select Home Luminometer. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. c. Select Perform. d. If the waste probe is binding, check the routing of the tubing and the position of the probe clip. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 14. Close the System – Diagnostic Tools window. 15. Return to normal operation. 16. If the error persists, call for technical assistance.

Replacing the Waste Bottle Fluid Sensor BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. At the workspace, select System Status. 2. Select Turn System Mechanics Off. 3. Remove the main waste bottle fluid sensor: a. Pull out the waste and water drawer. b. Lift the waste bottle lid. c. Move the clamp on the sensor aside and remove the sensor from the bottle. d. Close the waste bottle lid. e. Twist the sleeve on the connector counterclockwise to remove the old waste bottle fluid sensor.

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f.

Discard the sensor in an approved container for biohazardous material.

1 2

Waste bottle fluid sensor Connector sleeve

Figure 6-24

Waste Bottle Assembly

4. Twist the sleeve on the connector clockwise to tighten the new waste bottle fluid sensor.

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5. Install the fluid sensor in the waste bottle and move the clamp to cover the sensor.

1

Waste bottle fluid sensor

Figure 6-25

Waste and Water Bottles

6. Push in the waste and water drawer. 7. Select Turn System Mechanics On. 8. Verify the installation: a. At the workspace, select the Supplies Status button. b. At the Status – Supplies window, ensure that the Liquid Waste field displays the OK status message. 9. Resume normal operation.

Troubleshooting Obstructions and Leaks Recovering from a Sample Tip Tray Loading Jam If a tip tray jam occurs while the system is processing samples, allow the system to complete processing before clearing the jam. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. Manually move the inprocess queue to the right.

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3. Remove cuvettes and sample tips that may be obstructing the inprocess queue. 4. Manually move the inprocess queue to the right. 5. Remove the used sample tip tray from the tip tray support.

1 2

Sample tip tray Hole in sample tip tray

Figure 6-26

3 4

Pin Inprocess queue

Sample Tip Tray Assembly

6. Lift the sample tip trays out of the sample tip loader. 7. Open the cuvette waste area door.

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8. Remove used sample tip trays and covers. CAUTION

Do not bend the latch while removing the jammed sample trays from the sample tip loader. Bending the latch can cause more sample tip tray jams.

1

Latch

Figure 6-27

Sample Tip Tray Loader

CAUTION

Do not bend pull a jammed tray up through the top of the sample tip loader. Pulling a jammed trays through the top of the sample tip loader can damage the spring clips. Pull jammed trays down through the sample tip tray waste area. 9. If a sample tip tray is stuck in the loader, carefully pull the sample tip tray down through the sample tip tray waste area. NOTE: If you find a deformed sample tip or sample tip tray in the system, notify your technical representative .

10. Load a new sample tip tray into the sample tip loader: a. At the workspace, select System Status. b. Select Diagnostic Tools. c. At the System – Diagnostic Tools window, select Load Tip Tray. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury.

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d. Select Perform. 11. Ensure that the sample tip tray loader and inprocess queue perform the following sequence of events as a new tray is loaded: •

latch snaps over the new sample tip tray cover

•

new sample tip tray drops down smoothly

•

sample tip trays in the loader are not stuck together

•

sample tip tray drops down over the pins on the tip tray support

•

when the inprocess queue moves right, the sample tip tray is locked completely onto the pins

•

as the sample tip tray is pulled out of the loader when the inprocess queue moves right, the cover stays in the loader

•

the cover drops down into the tip tray waste area

•

the empty sample tip tray drops smoothly down into the tip tray waste area

WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 12. Close the System – Diagnostic Tools window. 13. Close and secure the top cover. 14. Return to normal operation. 15. If the error persists, call for technical assistance.

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Clearing Obstructions from the Sample Exit Queue BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. Remove all the sample racks from the sample exit queue.

1

Sample exit queue

Figure 6-28

ADVIA Centaur XP Entry, Stat, and Exit Queues

2. Remove any objects from the sample exit queue. The sensor under the plate of the sample exit queue is magnetic and is able to detect metal objects such as pens and eye glasses at the right end of the sample exit queue. 3. Clean the sample exit queue. 4. If the error persists, call for technical assistance.

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Troubleshooting Leaks Use this procedure if you find substantial amounts of liquid in or around the system. BIOHAZARD

Wear personal protective equipment. Use universal precautions. Refer to Safety Instructions‚ page A-1 for recommended precautions when working with biohazardous materials. 1. Press 1 of the fast stop buttons.

1

Fast stop button

Figure 6-29

ADVIA Centaur XP System – front view and back view

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2. At the workspace, select System Status. CAUTION

Do not disconnect the system. Disconnecting the system turns off the thermal components of the primary reagent compartment and ancillary queue. Shut down the system instead. 3. Select Turn System Off and then select Yes. 4. Access the area of the system where you believe the leak might be originating from. 5. Look for the following problems: •

tubing that is not connected to its fitting

•

leaky valves

•

reservoirs not installed correctly

•

clogs in rinse stations

6. Reconnect the tubing. 7. Check for obstructions in the following areas before rebooting the system: •

sample entry queue

•

sample exit queue

•

sample tip loader

•

ancillary entry

8. Press the green computer startup button.

1

Computer startup button

Figure 6-30

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9. Wait until the system state is Ready. 10. At the workspace, select System Status. 11. Select Diagnostic Tools. 12. At the System – Diagnostic Tools window, select Prime Functions and then select Prime Fluid Line. 13. Select the fluid you want to prime. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 14. Select Perform. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 15. Close the System – Diagnostic Tools window. 16. If the process completes successfully, resume normal operation.

Using Diagnostic Tools WARNING

Do not use diagnostic tools or perform troubleshooting without observing all safety rules. System components move and can cause injury. Only individuals trained by Siemens Medical Solutions Diagnostics should perform troubleshooting. Diagnostic Tools allow you to prime the system, test the operation of system components, and move system components when you perform corrective action procedures.

Using the System Diagnostic Tools Window The System – Diagnostic Tools window puts the system in Diagnostics Mode. Any errors that occur while the system is in Diagnostics Mode appear in the event log. Wait until the system is not processing samples to use diagnostic tools. To open the System – Diagnostic Tools window from the workspace, perform the following steps: 1. At the workspace, select the System Status button. 2. Select Diagnostic Tools.

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3. Select a test and then select Perform. For some tests, the system prompts you to perform certain actions.

Accessing Diagnostic Tools For specific procedures for each diagnostic tool, perform the following steps: 1. At the workspace, select Event Log. 2. Locate the procedure: a. At the System – Event Log window, select Procedure. b. At the online information window, select Find. c. Enter Diagnostic Tools. You can also enter a word or phrase that describes your system problem. d. Select Enter. The system displays a list of Diagnostic Tools. 3. Select a topic to display a diagnostic procedure.

Cuvette Handling Tools Use the following diagnostic tools to test cuvette handling.

Empty Ring Use this test to empty the cuvettes from the incubation ring. During this test, the system performs the following actions: •

checks that the cuvette waste bin can accept another 115 cuvettes

•

homes all subassemblies

•

moves a cuvette into the luminometer and then the incubation ring indexes to advance 1 cuvette The system repeats these steps until all cuvettes are out of the incubation ring.

During this test, the cuvette pusher is not active. You can observe that the system correctly empties cuvettes: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System – Diagnostic Tools window, select Empty Ring. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury.

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5. Select Perform. This process takes approximately 12 minutes to complete. 6. As the system moves all cuvettes out of the incubation ring, watch and listen as the incubation ring, elevator, and luminometer move. 7. If cuvettes are jamming, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System – Diagnostic Tools window.

Empty & Fill Ring Use this test to perform the following actions: •

simultaneously empty the cuvettes from the incubation ring and load the ring with new cuvettes

•

test the operation of the elevator

•

test the operation of the luminometer

•

test the operation of the incubation ring

•

test the operation of the cuvette pusher and cuvette loading bin

•

investigate sensor failures

•

expedite the startup process after performing troubleshooting or installing new software

•

recover from a power outage

During this test, the system performs the following actions: •

checks that the cuvette waste bin can accept another 115 cuvettes

•

homes all subassemblies

•

elevator moves a cuvette into the luminometer, the incubation ring indexes to advance 1 cuvette and then the cuvette loader loads a cuvette into the incubation ring. The system repeats these steps until all cuvettes are out of the incubation ring and replaced with clean cuvettes.

During this test, the cuvette pusher is active.

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You can observe that the system correctly empties cuvettes and fills the ring with cuvettes: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System – Diagnostic Tools window, select Empty & Fill Ring. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. As the system moves all cuvettes out of the incubation ring and loads new cuvettes into the ring, watch and listen as the cuvette pusher, incubation ring, elevator, and luminometer move. This process takes approximately 12 minutes to complete. 7. If cuvettes are jamming, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System – Diagnostic Tools window.

Prime Cuvettes Use this test to perform the following: •

start the cuvette conveyor after the cuvette supply is replenished

•

start the cuvette conveyor after you recover from a cuvette loading jam

During this test, the system performs the following actions: •

cuvette conveyor moves to fill the vertical cuvette chute with cuvettes

During this test, the cuvette pusher is not active. You can observe that the system correctly loads cuvettes: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status.

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3. Select Diagnostic Tools. 4. At the System – Diagnostic Tools window, select Prime Cuvettes. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. Watch and listen as the cuvette conveyor moves. The ionizer is also activated when the cuvette conveyor is operating. You can verify that the ionizer is on by feeling for air blowing down under it as the cuvette conveyor moves. 7. If the cuvettes are jamming, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System – Diagnostic Tools window.

Reagent and Ancillary Probe Tools Use the following diagnostic tools to test the reagent and ancillary probes.

Dispense Test Use this test to perform the following: •

observe the integrity of the stream of water dispensed into the rinse station by ancillary and reagent probes

•

verify correct installation of a new probe

•

investigate vacuum or water errors

During this test, the system performs the following actions: •

homes all subassemblies

•

homes all probes over the rinse stations

•

turns the vacuum and the water pump on

•

activates the rinse station vacuum valve

•

dispenses water into the rinse station

•

repeats the dispense for a selected number of repetitions

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You can observe that the system correctly dispenses water: NOTE: If the diluter drawer is not closed (up), the system does not prime

the wash station diluters correctly. 1. Ensure that the diluter drawer is in the closed, upright position.

. 1

Diluter drawer

Figure 6-31

Diluter Drawer

2. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 3. At the workspace, select System Status. 4. Select Diagnostic Tools. 5. At the System – Diagnostic Tools window, select Dispense Test. 6. Select the probe you want to test. 7. Select the number of times you want the probe to dispense. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 8. Select Perform. The system homes all subassemblies. 9. Look at the stream of fluid as the system dispenses. 10. Ensure that the stream is straight and steady, with no dripping. 11. If the probe is dripping, look for a leaking valve.

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12. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 13. Close the System – Diagnostic Tools window.

Home Probes Use this test to perform the following: •

move the 3 reagent probes, their associated diluters, and the ancillary probe into primary positions

•

identify probe move errors caused by interfering tubing or wiring

•

replace a reagent or ancillary probe

•

verify the installation of a new reagent or ancillary probe

•

clean the reagent probe shutter

•

verify the installation of the reagent probe shutter

•

access the luminometer, preheater, or elevator

During this test, the reagent probe moves to the following positions: •

homes vertically

•

homes horizontally toward the cuvette

•

homes horizontally toward the reagent pack

•

homes horizontally to its rinse station

•

homes the associated diluter

This test does not home the reagent probe shutter or the reagent mixer. During this test, the ancillary probe performs the following actions: •

homes vertically, then homes horizontally in the pack-cuvette direction and then horizontally to its rinse station

•

homes the associated diluters

You can observe that the system correctly homes the primary and ancillary reagent probes: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools.

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4. At the System – Diagnostic Tools window, select Home Probes. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. Watch and listen as the reagent and ancillary probes move. 7. If the probes do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System – Diagnostic Tools window.

Sample Probe Tools Use the following diagnostic tools to test the sample probes.

Home Probe Use this test to perform the following: •

move the sample probe into its primary position

•

investigate sample probe movement errors

During this test, the sample probe moves to the following positions: •

homes vertically

•

homes the probe horizontally in the rack-to-cuvette direction

•

moves the probe horizontally toward the ring

•

moves down as if ejecting a tip

•

moves horizontally to the tip remover

•

moves up and stays above the tip remover

•

sample diluter homes

You can observe that the system correctly homes the sample probe: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status.

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3. Select Diagnostic Tools. 4. At the System – Diagnostic Tools window, select Home Probe. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. Watch and listen as the sample probe and inprocess queue move. 7. If the probe does not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System – Diagnostic Tools window.

Load Tip Tray Use this test to perform the following: •

load a new sample tip tray and reset the counter

•

check the operation of the sample tip loader

During this test, the system performs the following actions: •

homes the sample probe, inprocess queue, rack loader, rack exit pusher, stat pusher, and sample tip loader

•

checks for the presence of a tip tray and the absence of a tip band

•

removes the current tray

•

loads a new tip tray

You can observe that the system correctly loads a tip tray: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. CAUTION

Do not leave tips on the sample tip tray on the inprocess queue when you eject the tray. If tips are are on the tray when you eject the tray, a jam occurs. Ensure that the sample tip tray on the inprocess queue is empty before you select this tool. 2. Remove the sample tip tray from the inprocess queue: a. Manually move the inprocess queue so you can access the sample tip tray.

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b. Move the sample tip tray to the left to disengage the tray from the locking pins.

1 2

Sample tip tray Hole in sample tip tray

Figure 6-32

3 4

Locking pin Inprocess queue

Sample Tip Tray Assembly

c. Lift the sample tip tray off the tray support. 3. At the workspace, select System Status. 4. Select Diagnostic Tools. 5. At the System – Diagnostic Tools window, select Load Tip Tray. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 6. Select Perform. 7. Select Continue. The system resets the counter that determines which tip to pick up next.

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8. Watch and listen as the sample tip loader loads a new sample tip tray. 9. If the sample tip tray does not load correctly, check the event log for related errors and then correct the problem or call for technical assistance. 10. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 11. Close the System – Diagnostic Tools window.

Luminometer Tools Use the following diagnostic tools to test the luminometer.

Dark Count with Cuvette Perform this test in conjunction with the Dark Count without Cuvette test. Use this test to perform the dark count test for a selected number of cuvettes to investigate the following areas: •

PMT errors due to light leaks

•

luminometer errors

During this test, the system performs the following actions: •

homes all subassemblies

•

turns vacuum and water on, but they are not used

•

verifies that there are enough empty, sequential cuvettes to perform the selected number of repetitions

•

loads an empty cuvette in to the luminometer

•

takes a PMT reading when the empty cuvette is moved to the PMT

During this test, the luminometer stays empty after the last cuvette is ejected. New cuvettes are not automatically loaded into the incubation ring, but the system knows the location of the empty slots. You can evaluate the performance of the PMT and luminometer: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System – Diagnostic Tools window, select Dark Count with Cuvette.

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4. In Number of Cuvettes, select the number of cuvettes you want to use for the test. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. The System – Dark Count Data window opens at the completion of the test. • If you select 8 cuvettes, the system displays values for the RLU 1 fields. • If you select 16 cuvettes, the system displays values for the RLU 1 fields and RLU 2 fields. • If you select 24 cuvettes, the system displays values for the RLU 1 fields, RLU 2 fields, and RLU 3 fields. 6. Record the Total Mean. Ensure that the difference between the values for Total Mean obtained in this test and Total Mean obtained in the Dark Count without Cuvettes test is less than 25. RLUs higher than 25 may indicate light leaks. Refer to the procedure Dark Count without Cuvette‚ page 6-54. 7. If the dark count test does not meet specifications, call for technical assistance. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 8. Close the System – Diagnostic Tools window.

Dark Count without Cuvette Use this test to perform the dark count test for a selected number of readings to investigate the following areas: •

PMT errors due to light leaks

•

luminometer errors

During this test, the system performs the following actions: •

homes all subassemblies

•

ejects all cuvettes from the luminometer

•

turns vacuum and water on, but they are not used

•

takes PMT readings at empty slots in the luminometer

During this test, the incubation ring and elevator are not used.

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You can evaluate the performance of the PMT and luminometer: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System – Diagnostic Tools window, select Dark Count without Cuvette. 4. In Number of Cuvettes, select the number of readings you want for the test. When you select the Dark Count without Cuvette test, the system uses the selection from this list as the number of readings it performs at empty slots in the luminometer. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. The System – Dark Count Data window opens at the completion of the test. • If you select 8 cuvettes, the system displays values for the RLU 1 fields. • If you select 16 cuvettes, the system displays values for the RLU 1 fields and RLU 2 fields. • If you select 24 cuvettes, the system displays values for the RLU 1 fields, RLU 2 fields, and RLU 3 fields. 6. Record the Total Mean and Total SD values: a. Ensure that the value for Total Mean is less than 600.

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RLUs higher than 600 may indicate a defective PMT, a wet or dirty luminometer, electronic noise, or light leaks.

1 2

Total SD specification limit Total mean

Figure 6-33

Standard Deviation Specifications

b. Find the Total Mean value that you obtained in the dark count test on the x-axis and determine the corresponding Total SD specification limit from the curve on the chart. c. Verify that the Total SD value that you obtained in the dark count test is at or below the Total SD specification limit. For example, if the Total Mean value of the dark count test is 80, according to the chart, the corresponding Total SD specification limit is 15.00. A Total SD value of 15.00 or less in the dark count test is within specifications. 7. If the dark count test does not meet specifications, call for technical assistance. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 8. Close the System – Diagnostic Tools window.

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Home Luminometer Use this test to perform the following: •

move the luminometer and its associated subsystem components into their primary positions

•

investigate waste probe home sensor errors

•

investigate luminometer home sensor errors

•

recover from a cuvette jam in the luminometer or elevator

During this test, the system performs the following actions: •

checks and homes the elevator down position

•

homes the waste probe

•

moves luminometer to the next load position

•

rotates and pauses luminometer at the remaining 7 positions while the cuvette ejector rod moves down

•

homes luminometer

You can observe that the system correctly homes the luminometer: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools. At the System – Diagnostic Tools window, select Home Luminometer. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 4. 5. Select Perform. 6. Listen as the luminometer moves. 7. If the luminometer does not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System – Diagnostic Tools window.

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Aspirate Probe Tools Use the following diagnostic tools to test the aspirate probes.

Home Probes Use this test to perform the following: •

move the aspirate probes to their primary positions (up) If they are already up, they move down slightly and then back up.

•

identify errors caused by interfering tubing or wiring

•

replace or clean aspirate probes

You can observe that the system correctly homes the aspirate probes: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System – Diagnostic Tools window, select Home Probes. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. Watch and listen as the aspirate probes move. 7. If the aspirate probes do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System – Diagnostic Tools window.

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Dispense Wash Fluid & Aspirate Use this test to perform the following: •

dispense and aspirate wash fluid from selected dispense ports and aspirate probes

•

investigate for pinched tubing

•

investigate for clogged probe

•

verify the installation of a new probe

During this test, the system performs the following actions: •

homes all subassemblies

•

turns vacuum on

•

moves inprocess queue right so you can see the aspirate probes

•

indexes and moves incubation ring

•

opens fluid valves

•

homes diluter

•

dispenses selected fluid into a cuvette through the selected fluid path and dispense port or location

•

selected aspirate probe moves down and aspirates fluid out of the cuvette

•

incubation ring indexes and moves the cuvette to the elevator

•

elevator moves the cuvette into the luminometer

•

incubation ring indexes and moves the cuvette to the selected aspirate probe, if necessary

•

luminometer moves and the system ejects the cuvette

This sequence is repeated for the selected number of repetitions. You can observe that the system correctly dispenses and aspirates wash fluid:

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NOTE: If the diluter drawer is not closed, the system does not prime the wash station diluters correctly.

1. Ensure that the diluter drawer is in the closed, upright position.

1

Diluter drawer

Figure 6-34

Diluter Drawer

2. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 3. At the workspace, select System Status. 4. Select Diagnostic Tools. 5. Select Dispense Wash Fluid & Aspirate. 6. Select the dispense port and aspirate probe pair you want to test. 7. You can select the fluid you want the probe to dispense. 8. Select the number of times you want the selected probe to dispense the selected fluid. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 9. Select Perform. 10. Watch the port dispense the fluid. The stream should be straight and steady. NOTE: Some dispense ports dispense fluid from 2 locations.

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6-61

Dispense port 1 dispenses from the right and left sides of aspirate probe 1.

Dispense port 1 for water Dispense port 1 for wash 1 or wash 3

Figure 6-35

Wash Block

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•

1 2

Dispense port 2 dispenses from the right and left sides of aspirate probe 2.

Dispense port 2 for water Dispense port 2 for wash 1 or wash 3

Figure 6-36

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6-63

Dispense port 3 dispenses from the right and left sides of aspirate probe 3.

Dispense port 3 for wash 1 or wash 3 Dispense port 3 for water

Figure 6-37

Wash Block

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•

1 2 3 4 5

The wash displacement port dispenses from the area between aspirate probe 2 and aspirate probe 3 and the resuspension ports are on the right end of the manifold.

Wash displacement port Resuspension port 2 for water Resuspension port 3 for wash 1 Acid Resuspension port 1 for wash 3

Figure 6-38

Wash Block

11. Watch the aspirate probe aspirate the fluid. All fluid should be aspirated. 12. If the system does not home or if there is a problem with the dispense or aspirate, check the event log for related errors and then correct the problem or call for technical assistance. 13. If the process completes successfully, close and secure the top cover and then resume normal operation. 14. Install the cover behind the sample entry queue. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 15. Close the System – Diagnostic Tools window.

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Performing LIS Communication Diagnostics You can use the Communication Diagnostics window to investigate LIS problems and to suspend communications between the system and the LIS if your LIS is not operational. NOTE: If your LIS is not operational, it is important to suspend communications to avoid system errors. If you do not suspend communications, the ADVIA Centaur XP system continues to send information to the LIS. System errors can occur if the LIS is unable to accept the information.

1. At the workspace, select Event Log. 2. At the System – Event Log window, select Communication Diagnostics. 3. To temporarily stop communications between your system and the LIS, select Suspend Communications and then select Save. The ADVIA Centaur XP system does not send information to the LIS, but can receive information. Information received by the ADVIA Centaur XP system is not scheduled in the worklist until you select Reset LIS Communications. 4. To investigate LIS communication problems, select Perform Diagnostics.

Troubleshooting Truncated PIDs in the LIS The system transmits 0 – 11 characters in the SID field of a result record. If the LIS sends a PID value longer than 11 characters with a worklist, or if a PID manual entry exceeds 11 characters, the PID is truncated when transmitted back with the result.

Using System Tools Use the following diagnostic tools to test the system.

Homing the System Use this test to move all system components to their primary positions. During this test, the system homes the following components: cuvette pusher

cuvette loader

aspirate probes 1, 2, 3, and 4

waste probe

elevator

luminometer

reagent probes 1, 2, and 3

reagent mixer

reagent barcode shutter

reagent probe shutter

reagent barcode scanner

sample probe

rack loader

rack exit pusher

stat pusher

sample tip loader

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inprocess queue ancillary probe

ancillary entry pusher

ancillary door

ancillary queue

During this test, the vacuum and water pump are off. You can observe that the system correctly homes the system: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System – Diagnostic Tools window, select Home System. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 4. Select Perform. 5. If the subassemblies do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 6. If the process completes successfully, resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 7. Close the System – Diagnostic Tools window.

Homing the Inprocess Queue Use this test to move the inprocess queue to its primary position. During this test, the system homes the following components: sample probe

rack loader

rack exit pusher

stat pusher

sample tip loader

inprocess queue

You can observe that the system correctly homes the inprocess queue: NOTE: If the inprocess queue is in the home position, move it out of the home

position before performing this procedure. 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools.

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4. At the System – Diagnostic Tools window, select Home Inprocess Queue. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. Watch and listen as the inprocess queue and sample probe move. a. If the inprocess queue and sample probe do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. b. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 7. Close the System – Diagnostic Tools window.

Homing the Ancillary Queue Use this test to move the ancillary queue to its primary position. During this test, the system homes the following components: ancillary probe

ancillary queue pusher

ancillary door

ancillary queue

You can evaluate if the system correctly homes the ancillary queue: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System – Diagnostic Tools window, select Home Ancillary Queue. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 4. Select Perform. 5. Listen as the ancillary queue moves. a. If the ancillary queue does not move correctly, check the event log for related errors and then correct the problem or call for technical assistance.

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b. If the process completes successfully, resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 6. Close the System – Diagnostic Tools window.

Emptying the Inprocess Queue Use this test to remove all sample racks from the inprocess queue. During this test, the system performs the following actions •

homes the following components: sample probe

inprocess queue

rack loader

rack exit pusher

stat pusher

sample tip loader

•

checks that the exit queue is not full

•

moves the inprocess queue slot to the rack exit position

•

extends and retracts the rack exit pusher

•

stat/sample pusher pushes the rack right

The system repeats these steps until all sample racks are ejected from the inprocess queue or until the sample exit queue is full You can observe that the system correctly empties the inprocess queue: 1. Loosen the screw on the left side of the system that secures the top cover and then open the top cover. 2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System – Diagnostic Tools window, select Empty Inprocess Queue. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. NOTE: The sample exit pusher moves even if there is no rack in that position of

the inprocess queue. 6. Watch and listen as the sample exit pusher pushes the racks out of the inprocess queue.

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7. If the inprocess queue and sample probe do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System – Diagnostic Tools window.

Emptying the Ancillary Queue Use this test to remove all ancillary packs from the ancillary queue. During this test, the system performs the following actions: •

homes the following components: ancillary probe

ancillary queue

ancillary pusher

ancillary door

•

checks that an ancillary pack is not in the ancillary entry

•

moves the next slot in the ancillary queue to the exit position

•

opens the ancillary door

•

extends the ancillary entry pusher

•

moves the ancillary queue counterclockwise

•

retracts the ancillary entry pusher and pack

•

closes the ancillary door

•

waits until the ancillary pack is removed from the ancillary entry

The system repeats these steps for all slots in the ancillary queue. You can observe that the system correctly empties the ancillary queue: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System – Diagnostic Tools window, select Empty Ancillary Queue. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 4. Select Perform. 5. Remove the ancillary pack from the ancillary entry.

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6. Store the ancillary packs in a refrigerator if you need to continue checking this area. 7. If the ancillary queue and ancillary probe do not move correctly, check the event log for related errors and then correct the problem or call for technical assistance. 8. If the process completes successfully, resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 9. Close the System – Diagnostic Tools window.

Resetting the Thermals Use this test to reset system thermal components if there was a thermal error which caused 1 or more components to go offline. During this test, the system performs the following actions: •

sends the restart command to all thermal loops

•

equilibrates thermal components

1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System – Diagnostic Tools window, select Reset Thermals. 4. Select Perform. 5. Close the System – Diagnostic Tools window.

Performing the Vacuum Test Use this test to evaluate the system vacuum pressure. During this test, the system performs the following actions: •

turns the system vacuum on

•

evaluates the system vacuum pressure

1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System – Diagnostic Tools window, select Vacuum Test. 4. Select Perform. Wait until the system displays Vacuum Low, Vacuum Normal, or Vacuum High at the System – Vacuum Test window. 5. Select Cancel Test to stop the system vacuum and conclude the test.

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6. If the system displayed Vacuum Low or Vacuum High, check the event log for related errors and then correct the problem or call for technical assistance. 7. If the Vacuum Test completes successfully, resume normal operation. 8. Close the System – Diagnostic Tools window.

Performing the Sample Barcode Read Test Use this test to evaluate the ability of the sample barcode scanner to read the barcode on a sample rack and the barcodes on the sample tubes in the rack. During this test, the system performs the following actions: •

accepts a sample rack through the sample entry queue or the Stat entry

•

scans the barcode on the sample rack and the barcodes on the sample tubes in the rack

•

evaluates the status of each barcode on the sample tubes in the rack

•

displays the scanned information and barcode status in a table

LASER WARNING

Never look directly at the laser beam or at its reflection from a shiny surface. Looking directly at the laser beam or its reflection could cause damage to the eyes. Only trained field service personnel should perform procedures related to laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers, for more information. 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System – Diagnostic Tools window, select Sample Barcode Read Test. 4. Perform the appropriate action: If you want to...

Then select...

test sample barcode scanning when a rack enters the system through the sample entry queue,

Routine.

test sample barcode scanning when a rack enters the system through the Stat entry,

Stat.

WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. Wait until the System – Sample Barcode Read Test window opens with the test results.

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6. If the test results are unacceptable, check the event log for related errors and then correct the problem or call for technical assistance. 7. If the test results are acceptable, return to normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 8. Close the System – Diagnostic Tools window.

Priming Functions – Prime System Use this test to prime all fluid lines. During this test, the system performs the following actions: •

homes all subassemblies

•

turns vacuum and water pump on

•

dispenses water from reagent and ancillary probes into their rinse stations

•

opens and closes associated valves

•

dispenses fluid into cuvettes for all dispense ports and fluids

•

indexes incubation ring and moves all used cuvettes to the elevator

•

elevator moves the cuvette into the luminometer

•

luminometer moves and the system ejects the cuvette

You can evaluate if the system correctly primes:

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NOTE: If the diluter drawer is not closed (up), the system does not prime the

wash station diluters correctly. 1. Ensure that the diluter drawer is in the closed, upright position.

1

Diluter drawer

Figure 6-39

Diluter Drawer

2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System – Diagnostic Tools window, select Prime Functions, and then select Prime System. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. If the system does not prime correctly, check the event log for related errors and then correct the problem or call for technical assistance. 7. If the process completes successfully, resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 8. Close the System – Diagnostic Tools window.

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Priming Functions – Prime Fluid Line Use this test to prime a selected fluid line with water, wash solution, acid, or base. During this test, the system performs the following actions: •

moves all subassemblies to their home positions

•

turns on vacuum

•

turns on water pump

•

when priming the reagent tubing, the system uses water and dispenses it into the rinse station (fluid primes for approximately 1 second)

•

when priming 1 of the system fluid lines, the system dispenses the selected fluid into a cuvette and then aspirate it

•

dispenses fluid from associated pump or diluter

•

opens and closes associated valves

•

incubation ring moves the cuvettes to the elevator

•

elevator moves the cuvettes to the luminometer

•

luminometer moves and the system ejects the cuvettes

You can observe that the system correctly primes the fluid line: NOTE: If the diluter drawer is not closed (up), the system does not prime the

wash station diluters correctly. 1. Ensure that the diluter drawer is in the closed, upright position.

1

Diluter drawer

Figure 6-40

Diluter Drawer

2. At the workspace, select System Status. 3. Select Diagnostic Tools. 4. At the System – Diagnostic Tools window, select Prime Functions and then select Prime Fluid Line.

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5. Select the fluid line you want to prime. 6. Select the fluid you want to prime. 7. Select the number of times you want to prime the fluid. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 8. Select Perform. 9. You can observe the diluters while the system is performing the test: a. Access the area of the system where you suspect a problem: To test the...

Perform these steps...

sample or ancillary diluters,

loosen the screw on the left side of the system that secures the top cover and then open the top cover.

reagent probe diluters,

loosen the 2 thumbscrews on the left side of the system and then lift the cover up and off.

other system diluters,

open the diluter drawer to observe the diluters move.

1 2

Reagent diluter cover Thumbscrews

Figure 6-41

Primary Reagent Compartment

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b. Ensure that the diluter plunger moves.

1 2 3

From left to right: Reagent Probe 3 Diluter, Reagent Probe 2 Diluter, Reagent Probe 1 Diluter From left to right: Sample Diluter, Ancillary Diluter From left to right: Resuspend Dispense Diluter, Dispense 1 Diluter, Dispense 2 Diluter, Wash Displacement Diluter, Dispense 3 Diluter

Figure 6-42

System Diluter Locations

c. Ensure that the stream is straight and steady. 10. If the test fails or you see leaks, check for disconnected or kinked tubing. 11. If the process completes successfully, close and secure the top cover and then resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 12. Close the System – Diagnostic Tools window.

Priming Functions – Prime System Fluid Bottle Use this test to prime wash solution, cleaning solution, acid, or base from the appropriate system fluid bottle to the reservoir and the associated valve or pump.

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During this test, the system performs the following actions: •

homes all subassemblies

•

turns vacuum and water pump on

•

closes vent valve for the selected system fluid bottle

•

associated pump or diluter primes fluid from system fluid bottle

•

opens and closes associated valves

•

aspirates fluid out of the cuvette

•

incubation ring moves the cuvettes to the elevator

•

elevator moves the cuvettes to the luminometer

•

luminometer moves and the system ejects the cuvettes

You can evaluate if the system correctly primes the system fluid bottle: 1. At the workspace, select System Status. 2. Select Diagnostic Tools. 3. At the System – Diagnostic Tools window, select Prime Functions, and then select Prime System Fluid Bottle. 4. Select the fluid you want to prime. WARNING

Ensure that you are clear of subassemblies that can move before selecting Perform. The system moves subassemblies and can cause injury. 5. Select Perform. 6. If the fluid does not prime correctly, check the event log for related errors and then correct the problem or call for technical assistance. 7. If the process completes successfully, resume normal operation. WARNING

Do not close the System – Diagnostic Tools window until you are clear of subassemblies that can move. The system returns subassemblies to their home positions and can cause injury. 8. Close the System – Diagnostic Tools window.

Remote Access If you are not using the RealTime Solutions service and your system is connected to a modem, select remote access to make your files accessible for technical assistance. This feature allows Siemens Medical Solutions Diagnostics to collect SID and RLU data. Refer to Selecting Remote Access‚ page 8-42.

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Siemens cannot view the workspace by modem. To show a Siemens technical assistance representative information on a window, perform the following steps: 1. At the Workspace, select Print. 2. Select Print Workspace. 3. Fax the printout to the Siemens technical assistance representative.

Resolving Barcode Problems Use this section to identify and resolve barcode problems. This section also contains specifications for creating and using your own SID barcode labels. Check the event log for error messages indicating barcode problems and their possible causes and solutions. If there is a problem with sample barcodes and you are not using Siemens barcode labels, test the system with a Siemens calibrator or control barcode label. If testing the system with a Siemens barcode label or using the suggested solutions does not solve the problem, call for technical assistance. If the barcode scanner is not operating correctly, you can manually enter the information at the appropriate window.

Resolving Hand-held Barcode Scanner Problems LASER WARNING

Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. Use the following procedures to resolve problems with the hand-held barcode scanner.

Barcode Scanner Reads Sporadically 1. Check the scanning technique. Refer to Barcode Scanning Technique‚ page 6-89. 2. Assess the barcode print quality. Refer to Barcode Quality‚ page 6-85. 3. Check and tighten the cable connection between the scanner and the system.

Barcode Scanner Does Not Read 1. Check symbologies and options at the Setup – Tube Type & Barcode window.

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2. For the check digit option, at the Setup – Tube Type & Barcode window, select Disable. 3. Check the barcode scanner, cable, and port. 4. If the problem persists, call for technical assistance.

Resolving Sample Barcode Scanner Problems LASER WARNING

Never look directly at the laser beam or at its reflection from a shiny surface. Looking directly at the laser beam or its reflection could cause damage to the eyes. Only trained field service personnel should perform procedures related to laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers, for more information. Use the following procedures to resolve problems with the sample barcode scanner.

Barcode Scanner Reads Sporadically 1. Assess the barcode print quality. Refer to Barcode Quality‚ page 6-85. If necessary, obtain new barcode labels and place them on the sample tube or sample cup. 2. Ensure that the barcode labels face the opening in the rack when you load sample tubes or cups in the sample rack. 3. Ensure that the sample rack barcode label is not falling off.

Refer to Maintaining the Sample Racks‚ page 5-80. CAUTION

Do not allow racks to get stuck as they are loaded. If the rack hesitates or binds in the input queue, the barcode scanner might not read all the sample barcode labels in the rack or the rack label. If a rack gets stuck as it enters the inprocess queue, remove the rack and then reload it. 4. Ensure that the sample racks load smoothly into the inprocess queue. 5. Ensure that the upright panel behind the sample entry queue is installed. 6. The panel prevents the barcode scanner from reading racks that are already loaded in the inprocess queue. 7. If the problem persists, call for technical assistance.

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Barcodes Do Not Display at Status – Samples Window CAUTION

Do not remove, reposition, or clean the barcode scanner. These actions can damage the scanner or cause additional problems. 1. Ensure that the sample barcodes do not have quality defects such as faded or inconsistent print. Refer to Barcode Quality‚ page 6-85. 2. Ensure that the barcode labels are positioned correctly on the sample rack and the sample tubes or cups. 3. Ensure that the information on the Setup – Tube Type & Barcode window is correct. CAUTION

Do not press the sample start button until you close the primary reagent door and ensure that all reagent barcodes were read correctly. Starting the system before all reagent barcodes are read correctly can cause erroneous results. Closing the primary reagent door allows the system barcode scanner to rescan the reagent barcodes and acknowledge any changes. 4. Press the sample start button and then look for a red light reflection on the rack as the scanner reads the barcode label.

1 2

Red Light Reflection Sample Rack

5. If you cannot determine the cause, you can enter the SID at the Status – Enter SID window. 6. If the problem persists, call for technical assistance.

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Resolving Reagent Barcode Scanner Problems LASER WARNING

Never look directly at the laser beam or at its reflection from a shiny surface. Looking directly at the laser beam or its reflection could cause damage to the eyes. Only trained field service personnel should perform procedures related to laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers, for more information. Use the following procedure to resolve problems with the reagent barcode scanner.

Barcodes Do Not Display at Status – Primary Reagent Window CAUTION

Do not remove, reposition, or clean the barcode scanner. These actions can damage the scanner or cause additional problems. When the system cannot read the primary pack barcode, the system displays the Status – Enter Primary Barcodes window. You can manually enter the barcode in the appropriate field.

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To determine why the system could not read the barcode, use the following tips. If the problem persists, contact your local technical support provider or distributor. •

Ensure that the reagent packs are seated correctly on the reagent shelf in the primary reagent compartment.

•

If only 1 pack is not being read, move it to another position in the primary reagent compartment and then notify your field service representative.

•

Wipe off any condensation from the reagent pack labels and the reagent shelf.

•

If the barcode labels are not correctly placed on the reagent packs, call for technical assistance.

•

Ensure that the reagent barcodes do not have quality defects such as faded or inconsistent print. Refer to Barcode Quality‚ page 6-85.

•

Open and close the primary reagent door and then look for a red light reflection on the back of the primary reagent compartment as the scanner reads the barcode labels.

•

Ensure that the reagent barcode reader moves and that the reagent barcode shutter opens.

1 2 3

Reagent barcode shutter Red light reflection Reagent barcode reader

Figure 6-43

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Primary Reagent Compartment – back view

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If you are unable to resolve the problem, manually enter the barcode at the

Status – Enter Primary Barcode window. Contact your local service provider about the problem.

Resolving Ancillary Barcode Scanner Problems LASER WARNING

Never look directly at the laser beam or at its reflection from a shiny surface. Looking directly at the laser beam or its reflection could cause damage to the eyes. Only trained field service personnel should perform procedures related to laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers, for more information. Use the following procedure to resolve problems with the ancillary barcode scanner.

Barcodes Do Not Display at Status – Ancillary Reagent Window CAUTION

Do not remove, reposition, or clean the barcode scanner. These actions can damage the scanner or cause additional problems. When the system cannot read the ancillary pack barcode, the system displays the Status – Enter Ancillary Barcodes window. You can manually enter the barcode in the appropriate field. To determine why the system could not read the barcode, use the following tips. If the problem persists, contact your local technical support provider or distributor. •

Check the ancillary pack labels for condensation.

•

Ensure that the barcode labels are positioned correctly on ancillary packs.

•

Ensure that the ancillary barcodes do not have quality defects such as faded or inconsistent print. Refer to Barcode Quality‚ page 6-85.

•

Place an ancillary pack in the ancillary entry and then look for a red light reflection as the scanner reads the barcode label.

Recommended Physical Specifications for Barcodes For optimum system performance use Siemens barcode labels for calibrator and control samples. However, if you are making your own labels, the specifications in this section are provided as a guide. The read rates for barcode labels not obtained from Siemens can vary depending upon the print quality of the labels.

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The ability of the ADVIA Centaur XP system to scan a barcode can be affected by the following barcode characteristics: • size • color • quality • positioning • symbology • fixed or variable length • check digit • reserved characters

Barcode Size The required dimensions of the label and the barcode are listed below: Dimension

Size (cm)

Size (in)

maximum label length

8.89

3.50

quiet zone at each end

0.64

0.25

maximum barcode length

7.60

3.00

minimum barcode height

0.64

0.25

minimum narrow bar width

0.02

0.01

The minimum density ratio is 2:1.

Barcode Color Since barcode scanners read at a visible wavelength, the preferred background color is white. The preferred print color of symbols is black. Use of other colors can affect the ability of the system to read the barcode.

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Barcode Quality The ideal barcode label has clean, clear, straight fine lines with high contrast between light and dark areas.

1 2 3 4 5 6

Barcode ink is smeared or smudged Barcode ink is faded Barcode lines are wavy Barcode ink is scratched Barcode ink is slanted Barcode label contains void

Figure 6-44

Problem Barcodes

Problems with the barcode label that may interfere with scanning can include problems with the material or surface on which barcodes are printed, poor quality printing, environmental factors that damage the barcodes during storage or use, and incorrect placement of the barcode label on the sample tube or sample cup.

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The following table contains the quality components and factors causing scanning problems: Quality Components

Factors Causing Scanning Problems

environmental factors during storage and use

abrasion aging chemicals frost fungi and mildew humidity lubricants packaging preservatives protective coatings salt spray solvents and cleaners tape temperature ultraviolet light

label material

conspicuous grain high porosity low opacity

label surface

coating or overlaminate too thick (> 0.076 mm or 0.003 in) high gloss laminates highly textured laminates high matte laminates polarized laminates very coarse surface very smooth surface

placement of label on sample cup

crooked

print quality

faded areas irregularities low scan or symbol contrast no leading or trailing quiet zone scratches smears smudges streaks very dark or very light barcodes very thin or thick lines voids wavy, slanted, or curved lines

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Barcode Positioning Position the barcode vertically on the primary sample tube or sample cup, approximately 2 cm (0.8 in) from the top. If the barcode label is twisted, the barcode scanner might not read the label. Ensure that the labels are placed firmly on the sample cup. It is recommended that you do not place more than 2 labels on a primary sample tube or sample cup.

1

Barcode label position

Figure 6-45

Sample Tube

Barcode Symbology At the Setup – Tube Type and Barcode window, select the appropriate symbologies: • Codabar • Interleaved 2 of 5 • Code 39 • Code 128 Code 128 is the system default symbology and is always active since it is used for all Siemens labels for sample racks, primary reagent packs, ancillary reagent packs, calibrators, and controls.

Fixed or Variable Length Barcode For some barcode symbologies, you can select either a fixed or variable barcode length. The maximum length for an SID is 13 characters. The maximum length of a barcode label in any symbology on ADVIA Centaur XP systems is 20 characters. Use the mapping options for longer barcodes. Use the Setup – Tube Type & Barcode window, to specify your barcode type and enter the barcode length. Use fixed-length values whenever possible. •

If you specify a fixed-length value, the system recognizes only barcode labels with the specified number of characters.

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This reduces the chance of substitution or omission errors. •

If you specify a variable-length value, the system then reads and decodes all labels in the active symbology, regardless of their length.

Barcode Scan Check Digit A check digit is a character included in a barcode symbol that is used with a mathematical algorithm to check the validity of the decoded data. The following table displays the use of check digits and the symbologies available on the system. In this symbology...

A check digit is...

Codabar

a recommended option.

Interleaved 2 of 5

a recommended option.

Code 39

a recommended option.

Code 128

included.

This information does not apply to the master curve, calibrator, and control information that is read by the barcode scanner. 1. At the Workspace, select Setup. 2. Select Summary. 3. Select Tube Type & Barcode. 4. For each active symbology, select the appropriate Check Digit option:

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•

Enable

•

Disable

•

nw7 (Codabar standard check digits)

•

mod16 (Codabar standard check digits)

•

nw7mod16 (Codabar standard check digits)

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Barcode Scanning Technique LASER WARNING

Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers. The barcode scanner is active after selecting Scan at the Calibration – Master Curve Definition window or when the Calibration – Calibrator Definition window is open. Use the following techniques when scanning a barcode: •

Center the barcode scanner over the barcode.

•

Move the barcode scanner from the top of the card to the bottom of the card.

•

Ensure that the system beeps after scanning a barcode before proceeding to the next barcode.

•

Ensure that the tip of the scanner is directly contacting the barcode and that you are not pressing down so hard that you mar the barcode.

Barcodes Reserved for ADVIA Centaur XP Systems Certain characters are reserved by Siemens for all barcode symbologies. You cannot use the reserved characters in an SID code for barcodes of the specified length in the indicated position. The following displays the reserved SID character sequences for barcodes that use a check digit and for barcodes that do not use a check digit. Barcode Length

Character

Position

Reserved

8

K

1

ADVIA Controls

11

Bell Escape Carriage Return K

1 2 3 4

ADVIA Controls

8 or 9

Bell Escape Carriage Return C

1 2 3 4

ADVIA Calibrators

Printing Event Log Reports Use the following procedure to print information from the event log. 1. At the workspace, select Print. 2. Select Report Options.

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3. In the list of available reports, select Event Log. 4. Select the View. If you want to print...

Then select...

all event codes, including informational events as well as errors,

All.

only informational event,

Events.

only warning and critical errors,

Errors.

5. Select the Sort. If you want to print the event codes in the order of...

Then...

most recent first for a specified time period,

Date.

related subsystems,

Subsystem.

lowest event code number to highest event code number,

Events.

most severe to least severe,

Severity.

6. Enter the Starting Date and Ending Date.

Printing Event Log Reports Use the following procedure to print information from the event log. 1. At the workspace, select Print. 2. Select Report Options. 3. In the list of available reports, select Event Log. 4. Select the View. If you want to print . . .

Then select. . .

all event codes, including informational events as well as errors,

All.

only informational event,

Events.

only warning and critical errors,

Errors.

5. Select the Sort. If you want to print the event codes in the order of . . .

Then . . .

most recent first for a specified time period,

Date.

related subsystems,

Subsystem.

lowest event code number to highest event code number,

Events.

most severe to least severe,

Severity.

6. Enter the Starting Date and Ending Date.

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Investigating Assay Problems Use this section when trying to resolve assay problems. First review the following questions, then use the other information in this section to match the symptoms that you find with the problems that can cause them. To help find a pattern or a trend, answer the following questions: •

Does the problem affect only patient samples, controls, or calibrators or does it affect a combination of sample types?

•

Has the problem occurred once or does it appear consistently?

•

Does the problem occur only you use when certain lot numbers of calibrators, controls, or reagents?

•

Have you prepared, handled, and stored reagents, calibrators, controls, and samples?

•

Does the problem affect more than 1 assay?

•

What type of assay (competitive or sandwich) does the problem affect?

•

Is there a common factor affecting performance?

•

Are the RLUs increasing or decreasing in an assay?

To help find a pattern or a trend, collect and print the following data: •

patient sample results

•

quality control results

•

calibration data

•

replicate CVs

Using Calibration Evaluation Ranges You can use calibration evaluation ranges to resolve problems that cause failed calibrations. 1. At the workspace, select Calibration. 2. Select Data. 3. At the Calibration – Data window, review the status and the flags for the calibration data. 4. If the percent coefficient of variation (CV) of the individual calibrator replicates exceeds the defined acceptable value, refer to Discrepant Calibration Results‚ page 6-95. 5. If the calibration is invalid and has failed the defined or observed ranges for slope, ratio, low cal deviation, or high cal deviation, select Evaluation Ranges. 6. At the Calibration – Evaluation Ranges window, compare the Values to the Defined ranges and Observed ranges.

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•

Defined ranges are specified for each lot at the time of reagent manufacture.

•

Observed ranges are established by the system.

7. Determine if the values for slope, ratio, low cal deviation, or high cal deviation are within the defined or observed ranges. If the value is...

Then...

out of the defined range

use the tables that follow to evaluate flagged calibration metrics for sandwich or competitive assays.

out of the observed range but within the defined range

you can accept the calibration. Accepting an invalid calibration due to a failed observed range is acceptable when parts have been replaced on the system, such as probes, tubing, or filters. Refer to Accepting an Invalid Calibration‚ page 3-25.

Refer to Understanding Calibration Evaluation Criteria‚ page 3-4.

Evaluating Sandwich Assay Calibrations Is the value within the defined range? Slope

Ratio

Low Cal Deviation

High Cal Deviation

Possible Causes and Corrective Actions

Yes

Yes

No

Yes

Poor water quality. Ensure that the water quality integrity meets requirements. Refer to Reagent Water Quality‚ page C-4. Calibrator stability has been compromised. Ensure that calibrators (lyophilized, reconstituted, or liquid) are being stored as recommended in the calibrator package insert. Incorrect volume was used to reconstitute lyophilized calibrators. Ensure that the correct volume was used by referring to the calibrator package insert for reconstitution instructions.

No

Yes

No

No

Reagents have exceeded their opened stability. Ensure that reagent packs are stored upright at 2 to 8 °C, and discard any reagents that exceed stability.

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Slope

Ratio

Low Cal Deviation

High Cal Deviation

Possible Causes and Corrective Actions

No

No

No

No

Cleaning solution in the water supply. Ensure that the water bottle is rinsed thoroughly after it is cleaned. Calibrator used was incorrect for the assay. Check the calibrator package insert or the ADVIA Centaur XP Assay Manual to determine the correct calibrator to use with an assay. Ensure that the correct calibrator was poured into the correctly labeled sample tube.

If you cannot resolve the problem, load new reagent packs and calibrators and then schedule another calibration at the Worklist – Schedule window. If the problem persists, call for technical assistance.

Evaluating Competitive Assay Calibrations Is the value within the defined range? Slope

Ratio

Low Cal Deviation

High Cal Deviation

Possible Causes and Corrective Actions

Yes

Yes

No

Yes

Water supply is contaminated. Check the integrity of your reagent water system and ensure that it has been maintained. Refer to Reagent Water Quality‚ page C-4.

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Slope

Ratio

Low Cal Deviation

High Cal Deviation

Possible Causes and Corrective Actions

Yes

Yes

No

No

Cleaning solution in the water supply. Ensure that the water bottle is rinsed thoroughly after it is cleaned. Poor water quality. Ensure that the water quality integrity meets requirements. Refer to Reagent Water Quality‚ page C-4. Water supply is contaminated. Check the integrity of your reagent water system and ensure that it has been maintained. Refer to Reagent Water Quality‚ page C-4. Calibrator stability has been compromised. Ensure that calibrators (lyophilized, reconstituted, or liquid) are being stored as recommended in the calibrator package insert. Incorrect volume was used to reconstitute lyophilized calibrators. Ensure that the correct volume was used by referring to the calibrator package insert for reconstitution instructions.

No

Yes

No

No

Reagents have been frozen. Check reagent storage temperature and ensure that reagents are stored upright at 2° to 8 ° C. Reagents have exceeded their opened stability. Ensure that reagent packs are stored upright at 2° to 8 ° C, and discard any reagents that exceed stability.

No

No

No

No

Cleaning solution in the water supply. Ensure that the water bottle is rinsed thoroughly after it is cleaned. Calibrator used was incorrect for the assay. Check the calibrator package insert or the ADVIA Centaur XP Assay Manual to determine the correct calibrator to use with an assay. Ensure that the correct calibrator was poured into the correctly labeled sample tube.

If you cannot resolve the problem, load new reagent packs and calibrators and then schedule another calibration at the Worklist – Schedule window. If the problem persists, call for technical assistance.

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Investigating Discrepant Results Use this section when you are trying to resolve discrepant calibration, control, and patient results.

Discrepant Calibration Results Possible Cause

Corrective Actions

The calibrators were reconstituted incorrectly: with tap water, with the incorrect volume, with an uncalibrated pipette, or with contaminated reagent water

1.

The calibrators were on the system and then were poured back into the bottle

Incomplete calibrator equilibration after reconstitution

Ensure that the correct volume was used for reconstitution. Refer to the calibrator package insert for reconstitution instructions.

2. Ensure that the pipette is calibrated correctly. 3. Check the integrity of the reagent water. Refer to Reagent Water Quality‚ page C-4.

4. Reconstitute fresh lyophilized calibrators or open fresh liquid calibrators. 5. Recalibrate the assay. 1.

Ensure that calibrators are discarded after being on the system and are not poured back into their respective bottles.1

2. Pour a fresh aliquot of calibrators. 3. If necessary, reconstitute fresh lyophilized calibrators or open fresh liquid calibrators. 4. Recalibrate the assay. 1.

Check the calibrator vial for uniform reconstitution.

2. Check the calibrator package insert for calibrator preparation instructions. 3. If necessary, reconstitute fresh lyophilized calibrators or open fresh liquid calibrators. 4. Recalibrate the assay.

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Possible Cause

Corrective Actions

The calibrators were not stored correctly

1.

Check the calibrator package insert for the storage requirements of lyophilized, reconstituted, and liquid calibrators.

2. If, according to the calibrator package insert, calibrators can be aliquotted and frozen, mix calibrators gently by inversion to ensure a homogeneous solution before aliquotting. 3. If the storage temperature is outside the recommended temperature range, reconstitute fresh lyophilized calibrators or open fresh liquid calibrators that have been stored correctly. 4. Recalibrate the assay. The calibrators were expired

1.

Check the calibrator bottle for the expiration date.

2. Check the calibrator package insert for the stability requirements of lyophilized, reconstituted, and liquid calibrators. 3. Prepare fresh calibrators. Refer to the calibrator package insert.

4. Recalibrate the assay. The incorrect calibrator was used for an assay, or high and low calibrators were poured into mislabeled tubes

1.

To determine the correct calibrator to use with an assay, check the ADVIA Centaur XP Assay Manual.

2. Ensure that the correct calibrator was poured into the correctly labeled sample tube. 3. If the calibrators were poured into mislabeled tubes, discard the mislabeled tubes, and pour a fresh aliquot of calibrators into new correctly labeled tubes. 4. Prepare fresh calibrators. Refer to the calibrator package insert.

5. Recalibrate the assay. The sample tips were bent from storage on their side or damaged by a tray exchange failure

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1.

Store sample tips upright.

2. Do not place the tip tray on the counter, resting on the tips. 3. Do not use trays that have tips that have been damaged by a failure in the tip tray exchange. 4. Recalibrate the assay.

ADVIA Centaur XP Operator’s Guide: Identifying System Problems

Possible Cause

Corrective Actions

Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents

1.

The reagent pack was stored at room temperature for a prolonged period

Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane

Improper resuspension of pierced reagent packs

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Ensure that reagent packs are stored upright at 2 to 8 ° C.

2. Ensure that reagents are not expired or clumped. 3. Ensure that reagents have been thoroughly mixed and that Solid Phase particles are uniformly resuspended. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 4. Discard the old reagent pack and use a fresh reagent pack. 5. Recalibrate the assay. 1.

Ensure that reagent packs are stored upright at 2 to 8 ° C.

2. Discard any reagent that exceeds the opened stability. 3. Obtain a fresh reagent pack. 4. Recalibrate the assay. 1.

Discard the old reagent pack and use a fresh reagent pack.

2. Cover all open primary and ancillary reagent packs following the pierced reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 3. Recalibrate the assay. 1.

Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual, to resuspend pierced reagent packs.

2. Discard the old reagent pack and use a fresh reagent pack. 3. Recalibrate the assay.

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Discrepant QC Results Possible Cause

Corrective Actions

The controls were reconstituted incorrectly: with tap water, with the incorrect volume, with an uncalibrated pipette, or with contaminated reagent water

1.

The controls were on the system and then were poured back into the bottle

Incomplete control equilibration after reconstitution

The controls were not stored correctly

Ensure that the correct volume was used for reconstitution. Refer to the control package insert for reconstitution instructions.

2. Ensure that the pipette is calibrated correctly. 3. Check the integrity of the reagent water. Refer to Reagent Water Quality‚ page C-4.

4. Reconstitute fresh controls. 5. Perform quality control again. 1.

Ensure that controls are discarded after being on the system and not poured back into the respective bottles.1

2. Pour a fresh aliquot of controls. 3. If necessary, reconstitute fresh lyophilized controls or open fresh liquid controls. 4. Perform quality control again. 1.

Check the control vial for uniform reconstitution.

2. Check the control package insert for control preparation instructions. 3. If necessary, reconstitute fresh lyophilized controls or open fresh liquid controls. 4. Perform quality control again. 1.

Check the control package insert for the storage requirements of lyophilized, reconstituted, and liquid controls.

2. If, according to the control package insert, controls can be aliquotted and frozen, then mix controls gently by inversion to ensure a homogeneous solution before aliquotting. 3. If the storage temperature is outside the recommended temperature range, then reconstitute fresh lyophilized controls or open fresh liquid controls that have been stored correctly. 4. Perform quality control again.

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Possible Cause

Corrective Actions

The controls were expired

1.

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Check the control bottle for the expiration date, for the stability

2. Check the control package insert for the stability requirements of lyophilized, reconstituted, and liquid controls. 3. Prepare fresh controls. Refer to the control package insert.

4. Perform quality control again. The incorrect control was used for an assay, or the control was poured into a mislabeled tube

1.

Check the control package insert to be sure that the analyte being tested is present in the control.

2. To determine the correct control to use with an assay, check the ADVIA Centaur XP Assay Manual. 3. Check the control label to ensure that the correct control is being used. 4. Ensure that the correct control was poured into the correctly labeled sample tube. 5. If the controls were poured into mislabeled tubes, discard the mislabeled tubes, and pour a fresh aliquot of controls into new correctly labeled tubes. 6. Prepare fresh controls. Refer to the control package insert.

7. Perform quality control again. Incorrect expected values were entered for the control

1.

Ensure that the expected values are correct. Refer to the control package insert for the correct expected values or enter the QC ranges established for your laboratory.

2. If the values are incorrect, enter the correct values into the Quality Control – Control Definition window. Refer to Defining QC Values‚ page 4-2.

3. Perform quality control again. The sample tips were bent from storage on their side or damaged by a tray exchange failure

1.

Store sample tips upright.

2. Do not place the tip tray on the counter, resting on the tips. 3. Do not use trays that have tips that have been damaged by a failure in the tip tray exchange. 4. Perform quality control again.

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Possible Cause

Corrective Actions

Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents

1.

The reagent pack was stored at room temperature for a prolonged period of time

Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane

Improper resuspension of pierced reagent packs

Ensure that reagent packs are stored upright at 2 to 8 ° C.

2. Ensure that reagents are not expired or clumped. 3. Ensure that reagents have been thoroughly mixed and that Solid Phase particles are uniformly resuspended. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 4. Discard the old reagent pack and use a fresh reagent pack. 5. Perform quality control again. 1.

Ensure that reagent packs are stored upright at 2 to 8 ° C.

2. Discard any reagent that exceeds the opened stability. 3. Obtain a fresh reagent pack. 4. Perform quality control again. 1.

Discard the old reagent pack and use a fresh reagent pack.

2. Cover all open primary and ancillary reagent packs following the pierced reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 3. Perform quality control again. 1.

Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual, to resuspend pierced reagent packs.

2. Discard the old reagent pack and use a fresh reagent pack. 3. Recalibrate the assay. 4. Perform quality control again.

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Discrepant Patient Results Possible Cause

Corrective Actions

Incorrect sample collection, handling, or preparation

1.

The sample was frozen more than once or not mixed thoroughly after thawing

For sample collection and handling information, refer to the ADVIA Centaur XP Assay Manual.

2. Collect a fresh sample from the patient. 3. Perform the assay again. 1.

Thoroughly mix thawed specimens before use.

2. Freeze specimens only once. 3. Collect a fresh sample from the patient. 4. Perform the assay again.

The sample contains heterophilic antibodies

Call for technical assistance to further investigate the probable cause.

Incorrect patient sample, the sample was labeled with the wrong patient ID

1.

The sample was stored at room temperature longer than 8 hours or refrigerated longer than 48 hours The sample and reagent storage areas are outside the recommended storage temperature range

The sample is lipemic or hemolyzed or contains fibrin clots or bubbles

The sample tips were bent from storage on their side or damaged by a tray exchange failure

Collect a fresh sample from the patient.

2. Perform the assay again.

1.

Collect a fresh sample from the patient.

2. Perform the assay again.

1.

Monitor reagent and sample storage areas and correct temperatures, as required.

2. 3. 4. 5. 6.

Collect a fresh sample from the patient. Use a fresh reagent pack. Perform quality control again. Recalibrate the assay if necessary. Perform the assay again.

1.

Rim the sample with applicator sticks and centrifuge the sample.

2. Remove the bubbles. 3. Redraw a fresh sample. 4. Perform the assay again. 1.

Store sample tips upright.

2. Do not place tip tray on counter, resting on tips. 3. Do not use trays that have been damaged by a failure in the tip tray exchange. 4. Perform the assay again.

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Possible Cause

Corrective Actions

Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents

1.

The reagent pack was stored at room temperature for a prolonged period of time

Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane

Incorrect resuspension of pierced reagent packs

Ensure that reagent packs are stored upright at 2 to 8 ° C.

2. Ensure that reagents are not expired or clumped. 3. Ensure that reagents have been thoroughly mixed and that Solid Phase particles are uniformly resuspended. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 4. Discard the old reagent pack and use a fresh reagent pack. 5. Perform quality control again. 6. Recalibrate the assay if necessary. 7. Perform the assay again. 1.

Ensure that reagent packs are stored upright at 2 to 8 ° C.

2. Discard any reagent that exceeds the opened stability. 3. Obtain a fresh reagent pack. 4. Perform quality control again. 5. Recalibrate the assay if necessary. 6. Perform the assay again. 1.

Discard the old reagent pack and use a fresh reagent pack.

2. Cover all open primary and ancillary reagent packs following the pierced reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 3. Perform quality control again. 4. Recalibrate the assay if necessary. 5. Perform the assay again. 1.

Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual, to resuspend pierced reagent packs.

2. Discard the old reagent pack and use a fresh reagent pack. 3. Perform quality control again. 4. Recalibrate the assay if necessary.

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Problems with a Single Assay Possible Cause

Corrective Actions

Incorrect normal range or check range defined for the patient samples

1.

Ensure that test ranges have been entered correctly.

2. Modify test parameters, Refer to Modifying or Viewing Test Options‚ page 8-9.

3. Perform the assay again. The sample tips were bent from storage on their side or damaged by a tray exchange failure

Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, expired or clumped reagents

The reagent pack was stored at room temperature for a prolonged period of time

Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane

1.

Store sample tips upright.

2. Do not place the tip tray on the counter, resting on the tips. 3. Do not use trays that have been damaged by a failure in the tip tray exchange. 4. Perform the assay again. 1.

Ensure that reagent packs are stored upright at 2 to 8 ° C.

2. Ensure that reagents are not expired or clumped. 3. Ensure that reagents have been thoroughly mixed and that Solid Phase particles are uniformly resuspended. Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 4. Discard the old reagent pack and use a fresh reagent pack. 5. Perform quality control again. 6. Recalibrate the assay if necessary. 7. Perform the assay again. 1.

Ensure that reagent packs are stored upright at 2 to 8 ° C.

2. 3. 4. 5. 6.

Discard any reagent that exceeds opened stability. Obtain a fresh reagent pack. Perform quality control again. Recalibrate the assay if necessary. Perform the assay again.

1.

Discard the old reagent pack and use a fresh reagent pack.

2. Cover all open primary and ancillary reagent packs following the pierced reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 3. Perform quality control again. 4. Recalibrate the assay if necessary. 5. Perform the assay again.

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Possible Cause

Corrective Actions

Incorrect resuspension of pierced reagent packs

1.

Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual, to resuspend pierced reagent packs.

2. Discard the old reagent pack and use a fresh reagent pack. 3. Perform quality control again. 4. Recalibrate the assay if necessary.

Problems with Multiple Assays Possible Cause

Corrective Actions

The sample tips were bent from storage on their side, or damaged by a tray exchange failure

1.

Inadequate Solid Phase particle resuspension, storage of reagents on their side or at freezing temperatures, or expired or clumped reagents

The reagent pack was stored at room temperature for a prolonged period

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Store sample tips upright.

2. Do not place the tip tray on the counter, resting on the tips. 3. Do not use trays that have been damaged by a failure in the tip tray exchange. 4. Perform the assay again. 1.

Ensure that reagent packs are stored upright at 2 to 8 ° C.

2. Ensure that reagents are not expired or clumped. 3. Ensure that reagents have been thoroughly mixed and that Solid Phase particles are uniformly resuspended. 4. Discard the old reagent pack and use a fresh reagent pack. 5. Perform quality control again. 6. Recalibrate the assay if necessary. 7. Perform the assay again. 1.

Ensure that reagent packs are stored upright at 2 to 8 ° C.

2. Discard any reagent that exceeds the opened stability. 3. Obtain a fresh reagent pack. 4. Perform the assay again.

ADVIA Centaur XP Operator’s Guide: Identifying System Problems

Possible Cause

Corrective Actions

Reagent evaporation or spill due to loss of the pack membrane or tears in the pack membrane

1.

Incorrect resuspension of pierced reagent packs

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Discard the old reagent pack and use a fresh reagent pack.

2. Cover all open primary and ancillary reagent packs following the pierced reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual. 3. Perform quality control again. 4. Recalibrate the assay if necessary. 5. Perform the assay again. 1.

Refer to Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual, to resuspend pierced reagent packs.

2. Discard the old reagent pack and use a fresh reagent pack. 3. Perform quality control again. 4. Recalibrate the assay if necessary. Reagent mixing was turned off for longer than 2 hours but reagent refrigeration remains on: mechanics off, diagnostic tools window open, database maintenance, severe software errors indicated by event codes starting 700 xx xx Both reagent mixing and reagent refrigeration were turned off for longer than 2 hours: FSE maintenance, power outage

1.

Mix all primary reagent packs following the unpierced or pierced primary reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual.

2. Place the reagent packs back on the system. 3. Verify reagent performance based on acceptable QC results or by criteria established for your laboratory.

1.

Place primary reagent packs in the reagent storage tray at 2 to 8 ° C.

2. Mix all primary reagent packs following the unpierced or pierced primary reagent pack procedures described in Appendix C, Handling Reagents in the ADVIA Centaur XP Assay Manual before placing the reagent packs back on the system. 3. Verify reagent performance based on acceptable QC results or by criteria established for your laboratory.

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Possible Cause

Corrective Actions

The integrity of 1 of the system fluids was compromised

1.

Maintenance procedures were not performed

Ensure that the fluid bottle is positioned correctly.

2. Ensure that the fluid is not expired. 3. Ensure that the fluid onboard stability is not exceeded. 4. Replace the fluid. 1.

Ensure that daily, weekly, and monthly maintenance is performed. Refer to Performing Maintenance Procedures‚ page 5-4.

2. Call for technical assistance. A fluid system lost prime

1.

Check that the fluid bottle and reservoir have sufficient fluid, and if necessary, replace the fluid bottle. Refer to Replacing System Fluids‚ page 2-37.

2. Prime the system fluid line at the System – Diagnostic Tools window and look for fluid flow. 3. Call for technical assistance. Insufficient aspiration of wash solution

1.

Ensure that the aspirate probes clips are slid completely across the probe holder and are firmly against the probe.

2. Perform dispense wash fluid and aspirate at the System – Diagnostic Tools window and look for complete fluid aspiration. 3. Call for technical assistance.

Assay Specific Factors Specific factors can affect the performance of each assay, including storage and handling requirements of the reagents, specimen type and collection requirements, and pretreatment of specimens, if required. In addition, the manufacturer may recommend restrictions on the use of an assay and identify known interferences. Refer to the ADVIA Centaur XP Assay Manual for information specific to each assay.

Investigating Failed Proficiency Testing Results Failed proficiency testing can be caused by the following factors: •

reagents, calibrators, and controls are incorrectly handled

•

routine maintenance of the system is not performed

•

system is not clean

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If you have had prior issues with proficiency testing results or have any questions or concerns, call for technical assistance before you submit your results. To help the product specialist in assisting you, be sure to have the following information available: •

Obtain calibration and control data from the day of testing, including lot number and expiration date.

•

Check all control results and determine if they are within acceptable limits.

•

Ensure that all survey sample preparation procedures have been followed.

•

Note any unusual occurrences such as error flags and non-reproducible results.

•

Check that reagent and instrument reporting categories have been entered correctly.

References 1. Kaplan, Lawrence A. Pesce, Amadeo J. Clinical Chemistry; theory, analysis, and correlation, 2nd edition. St. Louis: C.V. Mosby Company; 1989. 1212 p.

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ADVIA Centaur XP Operator’s Guide: Managing Data

7 Managing Data Maintaining the Database . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Using the Status – Maintenance Window . . . . . . . . . . . . . . . . . . 7-1 Editing Database Maintenance Settings. . . . . . . . . . . . . . . . . . . 7-1 Manually Initiating a Database Maintenance Activity. . . . . . . . . . . . .7-2 Defragmenting the Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2

Performing Data Back Up . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Initiating a Data Backup Manually . . . . . . . . . . . . . . . . . . . . . . . 7-3 Restoring Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Saving Results Data to an Archive. . . . . . . . . . . . . . . . . . 7-4 Archived Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-5

Archiving Result Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 Archive Storage Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7 Autoschedule Archive Result Data . . . . . . . . . . . . . . . . . . . . . . . . . .7-7 Using the As Needed Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8

Manually Creating an Archive. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8 Creating a Date-defined Archive . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9 Using Archive All . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9

Exporting Quality Control Data . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Exporting Test Utilization Data. . . . . . . . . . . . . . . . . . . . 7-10

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Managing Data Data management includes the following functions: •

Database maintenance

•

Performing data backup

•

Creating data archives

•

Exporting data

Maintaining the Database NOTE: You must have the appropriate security level to add or edit system

maintenance activities. The ADVIA Centaur XP system maintains the database automatically by default. You can edit the default settings for the automatic maintenance to make it better fit the schedule of your workload. You can also manually perfom database maintenance, when necessary. When performing the database maintenance, the system deletes worklist entries and associated results based on the parameters set at the Status – Maintenance Definition window. The system creates an archive of results data before deleting them. If you choose not to autoschedule the Archive data maintenance activity, the system does not save the results to an archive before deleting them. Refer to Saving Results Data to an Archive‚ page 7-4

Using the Status – Maintenance Window The Status – Maintenance window displays the status of system database maintenance. If the system is unable to perform database maintenance at the time set in the Status – Maintenance Definition window, the system displays “Overdue” in the Cycle column on the Status – Maintenance window. You have the option to initiate a maintenance procedure manually or to wait for the next autoscheduled maintenance activity. If an error occurs during database maintenance, the maintenance activity ends and the system posts an event in the event log. The system restores the database to its original state and the maintenance activity occurs at the next scheduled time.

Editing Database Maintenance Settings NOTE: The system autoschedules database maintenance by default. The system does not perform the autoscheduled database maintenance while the system is inprocess or during a remote update.

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To edit database maintenance parameters, perform the following steps: 1. At the workspace, select the Status – Maintenance button. 2. At the Status – Maintenance window, select Perform database maintenance. 3. Select Edit. 4. At the Status – Maintenance Definition window, use the Database Threshold dropdown list to select the threshold you want on your system. The default database threshold is 15,000 tests, including replicates. When the database exceeds 15,000, the database maintenance activity trims it down to 15,000. 5. Use the Retain for field drop-down list to select the number of days to keep results not transmitted to the LIS at the time of the database maintenance activity, before the results are deleted. The default value is 4. 6. In the Time field, enter the time of day for the autoscheduled maintenance to occur. The time is a 24-hour format, HHMM. For example, enter 0230 for 2:30 a.m. and enter 1430 for 2:30 p.m. The default value is 0230. 7. Select Save.

Manually Initiating a Database Maintenance Activity When you perform a manual database maintenance activity, the system uses the settings in the database maintenance window. If the current database is not above the database threshold set in the Status – Maintenance Definition window, the system does not delete tests from the database during the database maintenance activity. NOTE: The system does not perform the manual database maintenance if the system is inprocess, performing an autoscheduled database maintenance procedure, or during a remote update.

To manually initiate a database maintenance activity, perform the following steps: 1. At the workspace, select the Status Maintenance button. 2. At the Status – Maintenance window, select Perform database maintenance. 3. Select Perform.

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7-3

Defragmenting the Database As data is added and then deleted from the computer, the data storage becomes fragmented, which can begin to affect system performance. You can perform a data storage defragmentation every 6 months. If your laboratory does not autoschedule database maintenance, the disk defragmentation occurs during the manual database maintenance activity performed at 180 days. After a data storage defragmentation, the system automatically reboots.

Performing Data Back Up Backing up is the process of organizing and storing data on a storage medium. If your system is connected to the RealTime Solutions server, the ADVIA Centaur XP system automatically backs up the following data daily and sends it to the server: • customer-defined test definition • customer-changeable parameters • customer-defined setup options • Event Log • Maintenance Log • system settings • tube types • reagent inventory • quality control data • assay calibration data • instrument calibrations

Initiating a Data Backup Manually If you are not connected to the RealTime Solutions server, you can back up data manually to a storage medium. You should perform the manual backup daily. You must have the appropriate level of security to back up data. 1. At the workspace, select Setup. 2. Select Data Administration. 3. At the Setup – Data Administration window, select All. 4. Insert the storage medium in the appropriate drive on the applications module.

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5. Select Back Up. The status changes to Backup Complete. CAUTION

Do not place the storage medium on the sample entry queue. The magnets under the queue can erase the information on the storage medium. 6. Label the storage medium with the following information: •

date NOTE: You cannot restore data from 1 system on to another system.

•

number of the system, if your laboratory has more than 1 system

Restoring Data CAUTION

Do not perform the Restore function. Performing the Restore function incorrectly can cause corruption of the system software. To avoid potential corruption of the system software, only a trained technical support provider should perform the Restore function at the Setup – Data Administration window. Restore data only when updating the system software. To restore data, the system searches the storage devices for the most current back up in the following order: 1. removable media (CD or DVD) 2. system local drive The system stops the search when at least 1 backup is found. The system restores the latest backup from that location.

Saving Results Data to an Archive NOTE: You must have the appropriate security level to add or edit system

maintenance activities. The ADVIA Centaur XP system can save results data automatically to an archive according to the maintenance settings in the Status – Maintenance Definition window. You can also chose to save the data manually to an archive or chose not to save your results data. You can use your local drive, a CD or a DVD to save files to an archive. Records that you save to an archive are not deleted until the system performs a database maintenance activity. Refer to Maintaining the Database‚ page 7-1 The results data archive is in a format compatible with Microsoft Excel or similar spreadsheet application. Refer to Archived Data‚ page 7-5.

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The system saves results data by worklist. •

If you edit a record that is already saved to an archive, the edited record and all records in that worklist are saved again at a future automatic or manual archive maintenance activity.

•

If you edit an component test of a ratio that is already stored in an archive, the ratio test and its component test are saved to an archive at a future automatic or manual archive maintenance activity.

•

Control-bracketed tests are only eligible for an archive after the system releases them. •

The system does not save control-bracketed tests that are waiting for controls.

•

The system does not save control-bracketed tests with discarded results.

Archived Data This table displays the field name and field format that is displayed in the archive spreadsheet. Explanatory comments are included, where necessary. The field name is the column head of the spreadsheet and the field format is how the data is displayed. Data is sorted in the spreadsheet in ascending order by the SID with a secondary sort on the Result Date and Time. Autoscheduled archive files and archives created by selecting Archive All on the Status–Archive Options window are named using the following format: A_RA__ Field Name

Field Format

Comment

SID

Alphanumeric; maximum of 13 characters

Sample identification for patient, control, or calibrator samples

Rack

Alphanumeric; 5 characters

First 4 digits is the Rack ID Fifth character is the Position Example: 0001A

Result Date and Time

DD MMM YY HH:MM

—

Patient Name

Last Name, First Name; 30 characters maximum

—

PID

Alphanumeric; 11 characters maximum

—

Sex

M, F, or U

—

Test Name

Alphanumeric; 8 characters maximum

—

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Field Name

Field Format

Comment

Dilution Protocol

Neat only Neat and diluted Dilute if over Dilute only Dilution profile

You can select a dilution option at the Worklist– Dilutions window or it can come from the LIS.

Manual Dilution

Alphanumeric; 6 characters maximum

The result is corrected for the dilution factor specified at the Worklist–Dilutions window.

System Dilution

Alphanumeric; 6 characters maximum

Assay dependent; defined in the Test–Ranges window. You can select it in the Worklist–Dilutions window.

Replicate Number

Numeric 2 digits, maximum

—

Result Aspect

Alpha, 4 characters maximum INTR DOSE INDX COFF RLU CLSS (Allergy Class)

—

Data Value

Alphanumeric; 15 characters maximum

Results data

Units

Printable ASCII; 10 characters maximum

For example: µLU/mL There is no value if it is a qualitative result.

F or P

Alpha

The status of the result.

Normal Ranges

Name: Alphanumeric, Low and High Limits: Numeric, 7 characters, a decimal delimiter, and the number of decimal places defined for this system

Example: Name of range: Male Low Limit: 123.4 High Limit: 1234567.8

Result Abnormal Flags

L, H,

—

Result Flag 1, 2, and 3

Alpha, ; 60 characters maximum

The top 3 result flags displayed in the Worklist– Result Details window.

CV

Numeric

This is only for meaned replicate results.

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Field Name

Field Format

Comment

Primary Reagent Lot

Numeric

—

Ancillary Reagent Lot

Numeric

—

Control Lot

Alphanumeric

—

Calibrator Lot

Alphanumeric

—

Control Name

Alphanumeric; 11 characters maximum

From the Control field of the Quality Control–Control Definition window.

Calibrator Name

Alphanumeric

From the Calibrator field of the Calibration–Calibrator Definition window.

Archiving Result Data Use this procedure to save patient, control, and calibrator result data to an archive. You can set up your system to perform an archive event automatically. You can also save to an archive manually, as needed. After saving an archive to a storage medium, you can load the saved data on to another computer and open it in a spreadsheet application. The system autoschedules the Archive result data procedure by default. For information on the stored data format, refer to Archived Data‚ page 7-5.

Archive Storage Media You can store archives on a CD or a DVD. To select the storage medium to use for your backups and archives, perform the following steps: 1. If you are in the System view, press the QC icon (F6) on the keyboard. 2. At the Applications View workspace, select Setup. 3. At the Setup–Applications View window, select the Target Backup/Archive Device. NOTE: If the amount of data to archive is more than the storage device can contain, the system does not perform the archive event. You must select and install a storage device with more capacity before the next scheduled event or manual request.

Autoschedule Archive Result Data When you select Autoschedule for archiving result data, use the 3 settings to determine the frequency, time, and starting day for the archive event to occur. You can use the default settings or enter new information to change the archive schedule.

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NOTE: For autoschedule archives, you must ensure that the selected storage device is in place for the scheduled archive event.

•

Frequency: Enter a number from 1 – 31 to indicate how many days between archive events. The default is 7.

•

Time: Enter a time of day for the archive event to occur. Use a 24-hour format, from 0000 to 2359. The default is 0200.

•

Starting on: Select the day of the week for the start of the archive event. The default is Sunday.

To edit the Autoschedule options, perform the following steps: 1. At the system view Workspace window, select Status – Maintenance. 2. At the Status – Maintenance window, select Archive result data. 3. Select Definition. 4. At the Status – Maintenance Definition window, select Edit. 5. Select Autoschedule. 6. Change 1 or more of the Autoschedule options: Frequency, Time, or Started on. 7. Select Save.

Using the As Needed Option If you do not want your result data archived automatically, you can set the archive options to As needed. To select the As-needed option: 1. At the system view Workspace window, select Status – Maintenance. 2. At the Status – Maintenance window, select Archive result data. 3. Select Definition. 4. At the Status – Maintenance Definition window, select Edit. 5. Deselect Autoschedule. The system deselects the Days option button and selects the As needed option button. The Autoschedule fields are no longer available. 6. Select Save.

Manually Creating an Archive You can create an archive manually at any time, whether or not the archive procedure is set for Autoschedule.

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Use manual archive in the following cases: •

to set the archive procedure to As needed

•

to perform an archive when the system does not perform an automatic archive on schedule

•

to create an archive for investigative work

There are 2 options for manually saving result data to an archive: •

Date-defined Archive This saves a specific date range of available result data to an archive using the date range entered into the Status – Archive Options window.

•

Archive All Archives all result data that was not previously saved to an archive during an autoscheduled archive activity.

Creating a Date-defined Archive A date-defined archive is a set of available result data that falls within a specified date range. You can assign an operator-defined file prefix to each archive file. NOTE: The system archives any records in a single worklist that fall outside the defined archive date and time with the rest of the worklist.

To create a date-defined archive, perform the following steps: 1. At the system view Workspace window, select Status – Maintenance. 2. At the Status – Maintenance window, select Archive result data. 3. Select Perform. 4. At the Status – Archive Options window, enter the starting date and ending date into the appropriate fields. 5. Enter an alphanumeric value into the File Prefix field to identify the date-defined archive. 6. If you want to allow the dated archive to overwrite the current archive storage medium when it is full, select Overwrite Media 7. Select Continue.

Using Archive All When you use Archive All, the resulting archive is the same as the autoscheduled archive. To manually save result data to an archive, perform the following steps: 1. At the Status – Maintenance window, select Archive result data. 2. Select Perform. 3. At the Status – Archive Options window, select Archive All.

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4. Select Continue.

Exporting Quality Control Data For information about exporting Quality Control data, access the ADVIA QC application and refer to online help for the ADVIA QC application Tools window.

Exporting Test Utilization Data CAUTION

Do not place the storage medium on the sample entry queue. The magnets under the queue can erase the information on the storage medium. You can export test utilization data to a CD or DVD. The system exports it in a spreadsheet compatible format. The system exports test utilization data in the following order: • test name assigned by the manufacturer • calibrator product code • number of patient orders • number of calibrators • number of controls • number of total tests used. The first record of the file contains the system serial number and the date and time that you performed the export activity. The system separates each area by tabs and writes the exported data to the file assay.csv. If the data exceeds the size of the CD or DVD, the system notifies you and does not export the data. If this happens, you can reduce the time interval between the starting date and ending date and then export the data again. NOTE: You must have the appropriate level of security to export data.

1. At the system view Workspace window, select Setup. 2. Select Data Administration. 3. Insert the storage medium into the appropriate drive. 4. At the Setup – Data Administration window, select Test Utilization Data. NOTE: Exporting data overwrites any existing storage medium.

5. Select Export. 6. At the Setup – Data Administration Options window, select the starting date and ending date.

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•

The default for the starting date is 30 days before the current date and time.

•

The default for the ending date is the current date and time.

ADVIA Centaur XP Operator’s Guide: Managing Data

•

7-11

The date and time format is DD MMM YY HH:MM. Example: 17 Mar 99 16:30.

7. Select Continue. To view the exported data, set up the following options in the spreadsheet program: •

Delimit each area of information by a tab.

•

Format the column width to display the data and time correctly, if required.

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ADVIA Centaur XP Operator’s Guide: Configuring the System

8 Configuring the System Modifying Sample Options . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Reviewing Sample Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Selecting Sample Throughput Options . . . . . . . . . . . . . . . . . . . . 1-1 Selecting Sample Optimization Options . . . . . . . . . . . . . . . . . . . 1-2 Defining Stat Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Defining the Inprocess Queue Timeout . . . . . . . . . . . . . . . . . . . 1-3 Specifying Sample Identification. . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Specifying Sample Tube Types. . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Specifying Barcode Symbology and Format. . . . . . . . . . . . . . . . 1-6 Defining SID Codes from Barcode Labels . . . . . . . . . . . . . . . . . 1-7 Moving Results to the Historical Database . . . . . . . . . . . . . . . . . 1-8

Modifying or Viewing Test Options . . . . . . . . . . . . . . . . . 1-9 Reviewing Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 Enabling or Disabling a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 Enabling a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10 Disabling a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11

Deleting a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12 Modifying a Test Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13 Modifying the Reagent Stability Option. . . . . . . . . . . . . . . . . . . 1-13 Modifying Sample Replicates . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14 Defining Anonymous Results . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 Defining Units and Decimal Places. . . . . . . . . . . . . . . . . . . . . . 1-15 Defining Calibration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

Using Control Bracketing . . . . . . . . . . . . . . . . . . . . . . . . 1-17 Viewing Control Bracketing Features . . . . . . . . . . . . . . . . . . . . 1-18 Modifying the Control Reminder in Control Bracketing. . . . . . . 1-19

Defining Reference Ranges, Result Interpretations, and Reflex Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20 Defining Reference Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20 Defining Result Interpretations . . . . . . . . . . . . . . . . . . . . . . . . . 1-21 Defining Reflex Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22 Defining Reflex Tests for Reference Ranges. . . . . . . . . . . . . . . . . .1-23 Defining Reflex Tests for Interpretation Ranges . . . . . . . . . . . . . . .1-23

Defining Automatic Sample Repeats . . . . . . . . . . . . . . 1-25 Defining Check Range and Linearity . . . . . . . . . . . . . . . . . . . . 1-25 Defining Repeats for the Concentration and Index Calculation Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27 Defining Automatic Repeats for Sample Error Conditions . . . . 1-28 Defining the Number of Replicates for Automatic Repeats . . . 1-28

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Defining Hold for Repeat Options. . . . . . . . . . . . . . . . . . . . . . . 1-29

Defining Automatic Dilutions . . . . . . . . . . . . . . . . . . . . . 1-31 Defining Automatic Dilutions for Tests . . . . . . . . . . . . . . . . . . . 1-31 Defining Dilution Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32 Deleting Dilution Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33

Defining Calculated Parameters . . . . . . . . . . . . . . . . . . . 1-33 Defining Ratio Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 Defining T Uptake Result Options . . . . . . . . . . . . . . . . . . . . . . 1-35

Defining Off-System Tests. . . . . . . . . . . . . . . . . . . . . . . . 1-35 Defining Test Profile Options . . . . . . . . . . . . . . . . . . . . . 1-36 Defining Test Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36 Deleting Test Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-37

Modifying the Test Display Order . . . . . . . . . . . . . . . . . . 1-37 Modifying System Options . . . . . . . . . . . . . . . . . . . . . . . 1-38 Reviewing System Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38 Viewing the System Serial Number . . . . . . . . . . . . . . . . . . . . . 1-38 Defining the System Name. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38 Specifying Screen Saver Options. . . . . . . . . . . . . . . . . . . . . . . 1-38 Defining Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39 Defining Low Reagent Status . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39 Defining the Control Bracket Reagent Reserve . . . . . . . . . . . . 1-40 Adjusting the Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40 Specifying the Time Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40 Entering a Time Correction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41

Adjusting the Pointing Device. . . . . . . . . . . . . . . . . . . . . . . . . . 1-42 Specifying Print Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42 Selecting Remote Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43 Selecting Remote Software Administration . . . . . . . . . . . . . . . 1-43 Remote Software Administration . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43

Specifying Direct Plumbing or System Bottles . . . . . . . . . . . . . 1-44

Enabling the Visible Status Light . . . . . . . . . . . . . . . . . . 1-45 Defining Backup, Restore, and Archive Options. . . . . . 1-45 Defining LIS Communication Options . . . . . . . . . . . . . . 1-45 Defining LAS Communication Options . . . . . . . . . . . . . 1-48

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Configuring the System The ADVIA Centaur XP setup options allow you to customize sample options, test parameters, and system options for your laboratory. You must have the appropriate level of security to modify test definitions and setup options. At the workspace, you can select Setup to access various setup options. CAUTION

Do not customize options without ensuring that you select the appropriate value for your laboratory and continuing to evaluate the integrity of that value. Failure to do so can cause reporting of unexpected results. For example, if you configure the system to send all results and additional data except results on hold to your LIS, and the LIS is not configured to accept the information, the LIS may identify the additional data inappropriately and fail to distinguish between the final results and the additional data. Your laboratory is responsible for ensuring that all configurations are correct: sample options, test parameters, and system options. This is true regardless of whether your lab personnel set the values, Siemens Medical Solutions Diagnostics personnel set the values to specifications your laboratory provides, or Siemens Medical Solutions Diagnostics personnel set the values to the original default values established at the time of manufacture.

Modifying Sample Options You can modify sample options such as the order that the system performs tests, Stat-handling options, sample tube types, barcode symbology and format, and sample identification by SID or Rack.

Reviewing Sample Setup You can review sample setup options at the Setup – Summary window. To open the Setup – Summary window from the workspace, perform the following steps: 1. At the workspace, select Setup. 2. Select Summary.

Selecting Sample Throughput Options You can specify the order that the system performs tests so that throughput is optimized or tests are performed in the order samples are loaded. 1. At the workspace, select Setup. 2. Select Summary.

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3. At the Setup – Summary window, select Sample Handling. 4. At the Setup – Sample Handling Options window, select the appropriate throughput options: If you want to . . .

Then . . .

automatically perform tests in the most efficient order,

select With Optimized Throughput.

perform every test for each sample in the order you load samples,

select In the Order the Operator Loads Samples. The system does not perform tests in the most efficient order and your system does not have optimal throughput.

5. Select Save.

Selecting Sample Optimization Options You can select the order in which the system aspirates tests when more than 1 test is scheduled for a sample. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Sample Handling. 4. At the Setup – Sample Handling Options window, select the appropriate sample optimization option. If you want to . . .

Then . . .

optimize sample aspiration by processing tests in the order of smallest sample volume required to largest sample volume required,

select To Maximize the Number of Tests Completed.

minimize the unusable volume in the samples by processing tests in the order of the largest sample volume required to the smallest sample volume required,

select To Minimize the Unusable Volume.

5. Select Save.

Defining Stat Options You can select an option to have the system notify you when a Stat is complete and you can select the maximum number of rack positions in the inprocess queue to reserve for Stat racks. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Sample Handling.

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4. At the Setup – Sample Handling Options window, select the appropriate Stat-handling options. If your laboratory...

Then...

does not process Stat samples,

select 0 Stat racks. Selecting 0 maximizes sample throughput because the system can use all of the positions in the inprocess queue for routine samples.

receives an occasional Stat request,

select 1 Stat rack. The system can process 1 Stat rack (containing up to 5 samples) before the routine samples that are loaded in the sample entry queue. This minimizes the impact on sample throughput.

frequently receives several Stat requests at a time,

select 2 Stat racks. The system can process 2 Stat racks (each containing up to 5 samples) before the routine samples that are loaded in the sample entry queue. Selecting 2 Stat racks can affect sample throughput because the system does not use the reserved Stat rack positions for routine samples.

5. Select Save.

Defining the Inprocess Queue Timeout You can define the number of minutes the system holds a rack in the inprocess queue. Do this for racks containing samples that do not have test requests. For example, if you schedule by SID and the system cannot read a sample barcode label, the system holds the sample in the inprocess queue for the number of minutes specified in Inprocess Queue Timeout. During the defined time, you can enter the sample identifier and the system processes the sample without any further operator intervention. If you are unable to enter the sample identifier during the specified time, the system ejects the sample from the inprocess queue after the other samples in the rack are aspirated. You must reload the sample. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Sample Handling. 4. At the Setup – Sample Handling Options window, enter from 4 to 63 minutes in Inprocess Queue Timeout. 5. Select Save.

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Specifying Sample Identification You can specify whether you want the system to identify samples by SID or by Rack. •

SID means the system identifies samples by the sample barcodes that you place on the sample tubes or cups.

•

Rack, which means the system identifies samples by their position in the sample racks.

The Rack ID consists of 4 numbers (0001–9999) followed by a letter (A–E).

1 2

Rack ID Tube positions A, B, C, D, and E

Figure 8-1

ADVIA Centaur XP Sample Rack

CAUTION

Do not identify samples by rack ID unless absolutely necessary. If it is necessary to identify a sample by rack ID, be aware that the system ejects the sample to the exit queue after the sample is aspirated. Reflex or other testing does not occur after the sample moves to the exit queue. To obtain final results for reflex or other testing, you must reintroduce the sample rack to the front of the sample entry queue. Whenever possible, set the system to identify samples by SID. NOTE: If you specify SID, you can override this selection for a sample by selecting Schedule by Rack at the Worklist – Schedule window. If you specify Rack, the system always identifies samples by rack position number and you cannot select Schedule by SID at the Worklist – Schedule window.

1. At the workspace, select Setup. 2. Select Summary.

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3. At the Setup – Summary window, select Tube Type & Barcode. 4. At the Setup – Tube Type & Barcode window, select SID or Rack. 5. Select Save. NOTE: Ensure that you make all of the changes to the Setup – Tube Type &

Barcode window before you reboot the system. If you do not make all of the changes, you must reboot the system more than 1 time. 6. Reboot the system.

Specifying Sample Tube Types NOTE: All tube type and rack information in this section refers to the racks provided with the ADVIA Centaur XP system. If you use racks from the ADVIA Centaur system, refer to ADVIA Centaur Sample Racks‚ page 2-5.

You can specify up to 3 specific types of sample tubes to use on the system or you can use multiple tube types. Refer to Tube Types‚ page E-2. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Tube Type & Barcode. CAUTION

Do not move the tube type selector without verifying the tube type you are using. Ensure that the tube type selector on each sample rack points to the correct tube type as defined at this window. If the tube type selector points to an incorrect tube type, the system can experience problems with sample handling and system errors can result. 4. At the Setup – Tube Type & Barcode window, use Tube Types 2, 3, and 4 to select up to 3 types of sample tubes. The ADVIA Centaur XP system reserves Tube Type 1 for multiple tube types. Regardless of what you enter here, if the tube-type selector is in position A, the rack allows multiple tube types. If you use an ADVIA Centaur rack, you must select a tube type in Tube Type 1. When you load samples, use the tube type selector on the rack to indicate the tube type you are loading. Place the tube-type selector in position A for multiple tube types. Refer to Managing Sample Racks‚ page 2-2. 5. In the LAS Tube Type field, select the tube type you want to use when no tube type is specified in the LAS. The default is Auto, meaning it allows multiple tube types. 6. Select Save.

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NOTE: Ensure that you make all of the changes to the Setup – Tube Type & Barcode window before you reboot the system. If you do not make all of the changes, you must reboot the system more than 1 time.

7. Reboot the system.

Specifying Barcode Symbology and Format You can select up to 4 barcode symbologies: •

Codabar

•

Interleaved 2 of 5

•

Code 39

•

Code 128.

Code 128 is always active. For most symbologies, you can choose the format, the use of check digits, and the use of SID mapping. Refer to Resolving Barcode Problems‚ page 6-78. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Tube Type & Barcode. NOTE: If you are using Code 128, you must exclude the ASCII characters ESC, Bell, and CR (Return) from your barcode labels because the system reserves these for use in the calibrator and control barcode labels.

4. At the Setup – Tube Type & Barcode window, select a barcode symbology. 5. Select Fixed or Variable in Type. If you select Fixed, select the number of characters in your SID barcode label, not including the check digit. 6. Select the number of characters for a barcode of fixed length. NOTE: Select Enable for the check digit for Code 128. Code 128 is the barcode symbology for the Master Curve Card, Calibrator Card, and calibrators.

7. If the barcode uses a check digit, select Enable in Check Digit. 8. Repeat steps 4. through 7. for each symbology. 9. Select Save. NOTE: Ensure that you make all of the changes to the Setup – Tube Type & Barcode window before you reboot the system. If you do not make all of the changes, you must reboot the system more than 1 time.

10. Reboot the system.

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Defining SID Codes from Barcode Labels Use this SID mapping procedure to specify the characters the system reads as the SID code. NOTE: The system requires you to perform this procedure. If you do not, the

system generates an event code when you load a patient sample with a barcode. Without SID mapping information, the system cannot interpret the patient sample barcode or process the sample. The ADVIA Centaur XP system accepts barcodes with a maximum length of 20 characters. However, the system accepts SID codes with a maximum length of 13 characters. If the SID code is embedded in a longer barcode, you can use the SID mapping procedure to specify up to 13 characters of the barcode for use. The SID mapping procedure affects only patient sample barcode labels. This procedure does not affect the barcode labels for calibrators or Siemens QC controls. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Tube Type & Barcode. CAUTION

Use care when entering the SID mapping information. The system uses only the characters specified in this procedure as patient sample SID codes. NOTE: You can select a position of the barcode only once.

4. Enter the barcode positions that you want to use starting with the 1 position field at the bottom of the window. To map the SID, select up to 13 positions of the barcode to display as the 13 characters of the SID in the worklist. You can select the positions to display in any order. For example, if you select the number 6 in the third position, whatever is in the sixth position in the barcode displays in the third position in the SID. For positions you do not want to display, select a number greater than the number of positions in the longest barcode. For example, if you have a 6-character barcode and you want to display the last 3 characters as the SID, select 4, 5, and 6 for the 1, 2, and 3 position fields, and then select a number greater than 6 for the 4 through 13 position fields. If the 6-character barcode is as follows: ABCDEF The system reads the following SID code: DEF

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You can select some symbols to display as characters in the SID, for example +, -, /, *, #. The symbols display in the specified positions for all SIDs. Do not select the % symbol because the system does not accept a % symbol in the SID. 5. Select Save. NOTE: Ensure that you make all of the changes to the Setup – Tube Type &

Barcode window before you reboot the system. If you do not make all of the changes at 1 time, you must reboot the system each time you make changes. 6. Reboot the system.

Moving Results to the Historical Database You can organize the data on your system by moving older results in the current database to the historical database. This option makes it easier for you to review data by limiting what you have to view or sort in the current database. The system retains the older information if you need it. The system only moves worklist entries that contain completed test results. You can manually move all worklist entries and results to the historical database at the Worklist – Summary window. Refer to Moving Final Results to the Historical Worklist‚ page 2-45. You can also specify an automatic option for moving results to the historical database. The system searches every 15 minutes for completed results that meet the specified time interval. For example, if you specify 24 hours for moving the results to historical, every 15 minutes the system searches the current worklist for completed results that are more than 24 hours old. The system moves up to 5,000 worklist entries at a time, with a worklist entry consisting of all of the test results, flags, demographic information, and comments associated with 1 SID. Use this procedure to define the interval, in hours, used by the system to automatically move the worklist entries and results to the historical database. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Sample Handling. NOTE: If you enter a 0 (zero) for the number of hours, the system does not automatically move results from the current database to the historical database. If you enter a 0, manually move results from the current to the historical database to ensure optimum system performance. Refer to Moving Final Results to the Historical Worklist‚ page 2-45.

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4. At the Setup – Sample Handling Options window, enter or edit the number of hours for the interval used by the system to automatically move the results from the current database to the historical database. The number of hours must be a factor of 24 (1, 2, 3, 4, 6, 8, 12, or 24). The time interval starts at midnight. 5. Select Save. The system moves data to the historical database in the approximate time interval that you specify, depending on when testing for the samples is completed.

Modifying or Viewing Test Options You can modify test parameters such as the result units, the number of decimal places for results, and the number of sample replicates. You can also view the parameters for special features such as control bracketing.

Reviewing Tests At the Test – Summary window, you can review the tests defined on your system. Use this window to edit the test definitions, enable or disable tests, and add or delete ratio and off-system tests. 1. At the workspace, select Setup. 2. Select Test Definition Summary. •

Select Definition to modify the opened stability date and number of replicates for each test.

•

Select Ranges to define reference ranges for each test.

•

Select Display Order to define the order in which tests are displayed and printed.

Select the appropriate View and Type to display specific information at the Test – Summary window: •

The View that you select determines the information that the system displays. For example, if you select All, the system displays all tests.

•

The Type that you select determines the order in which the system displays the tests. For example, if you select All, the system displays all tests in alphabetical order.

The following table describes the View and Type combinations you can use to perform some routine tasks: Task

View

Type

display all tests

All

All

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Task

View

Type

display the tests the system is using

Enabled

All

display the tests the system is not using

Disabled

All

display tests of a specific type

All

Standard, Ratio, Off-System, Component, Combination, Allergen, sIgE Universal

display the enabled tests of a specific type

Enabled

Standard, Ratio, Off-System, Component, Combination, Allergen, sIgE Universal

display the disabled tests of a specific type

Disabled

Standard, Ratio, Off-System, Component, Combination, Allergen, sIgE Universal

The following table describes the types of tests: Type

Definition

All

All tests including standard, ratio, off-system, component, combination, allergen, and sIgE universal.

Standard

Typical sandwich and competitive assays, such as TSH.

Ratio

A calculated test, such as RBC folate, in which the system compares the results of 2 assays to each other using a ratio formula.

Off-System

A test, such as hematocrit, that is not performed by the system, but has results reported by the system or that the system uses in a ratio test calculation.

Combination

An assay that consists of more than 1 component assay. The system calculates the result of the combination assay using data from the component assays.

Component

A test that is only ordered as part of a combination assay.

Allergen

An allergen-specific IgE test that measures specific IgE to an antigen that causes an allergic response to a specific substance, such as ragweed. A specific IgE test requires the processing of an allergen reagent and sIgE universal reagents.

sIgE Universal

The Lite Reagent and Solid Phase the system uses in all of the specific IgE tests. The sytem uses the sIgE universal reagents and an allergen reagent to process a specific IgE test.

Enabling or Disabling a Test You can enable or disable any test on your ADVIA Centaur XP system.

Enabling a Test An enabled test is included in the test menu displayed at the ADVIA Centaur XP windows and the system performs the test if it is scheduled.

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When you enable a test, you do not have to perform the following tasks: •

reenter any Master Curves

•

activate an active reagent lot

•

recalibrate a valid calibration

NOTE: If your laboratory wants to enable the HBs or Conf test, ensure that you turn system mechanics off, turn system mechanics on, and then perform a Daily Cleaning Procedure after enabling the test.

1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select the test. 4. Select Enable.

Disabling a Test NOTE: You cannot disable tests that are part of a combination test, ratio test, profile, or sIgE universal test. NOTE: If you schedule the test before disabling it, the disabled test is displayed at the Worklist – Summary window. WARNING

Do not disable a test without updating interference information. If you do not update the interference information, the system may fail to perform the necessary washes and that could potentially cause erroneous results. If you disable a test on your ADVIA Centaur XP system, the interference information for that test changes. The following procedure ensures that the system updates the interference information correctly. If you do not use this procedure, the system requires you to load wash packs to perform unnecessary washes, and may not perform a wash when required. NOTE: To minimize maintenance time, plan to disable tests just before you perform your routine daily cleaning procedure. Refer to Performing Daily Cleaning‚ page 5-5.

1. Ensure you delete all pending orders for the test before disabling it. Refer to Deleting Requests‚ page 2-61. 2. At the workspace, select Setup. 3. Select Test Definition Summary. 4. At the Test – Summary window, select the test. NOTE: Disable HBs if your laboratory does not use it. If you are disabling Conf, also select Reagent A and Reagent B.

5. Select Disable.

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NOTE: Turning system mechanics off and then turning system mechanics on ensures that the HBs test is disabled.

6. At the workspace, select System Status. 7. Select Turn System Mechanics Off. Wait until the system mechanics are off. 8. Select Turn System Mechanics On. NOTE: The daily cleaning procedure (DCP) provides the system with the required probe washes, preventing the need to have the disabled assay-specific wash pack loaded on the system.

9. At the workspace, select Maintenance Status. 10. Select Perform Daily Cleaning. 11. Select Perform. NOTE: If your laboratory wants to enable a test in the future, ensure that you

turn system mechanics off, turn system mechanics on, and then perform the DCP after enabling the test. If you are enabling Conf, enable Reagent A and Reagent B also.

Deleting a Test Deleting a test permanently removes it from the test menu and permanently removes any results associated with the test from the database. You can only delete tests that are defined by your laboratory, such as ratio or off-system tests. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Complete the appropriate tasks. If you want to . . .

Then select . . .

temporarily stop performing the test,

Disable.

add the test to your system test menu,

Enable.

remove the test from your system test menu,

Delete.

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Modifying a Test Name You can modify the test name the system displays and prints on reports. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. 5. At the Test – Definition window, select Edit. CAUTION

Do not select the Reset Defaults button at the Test – Definition window. Selecting this button restores the original options the manufacturer defined and removes any options that your laboratory defined or modified. This global change can have unexpected consequences for your laboratory and, in some instances, creates an unrecoverable error. To change your test definition, refer to Modifying or Viewing Test Options‚ page 8-9. 6. Change the test name information from the default test name, if necessary: a. At Display, enter the test name that you want the system to display. You can enter up to 8 alphanumeric characters for the name the system displays. b. At Print, enter the test name that you want to appear on printed reports. You can enter up to 20 alphanumeric characters for the name the system displays on printed reports. 7. Select Save. If you want to restore the original system values for all options at this window, select Reset Defaults.

Modifying the Reagent Stability Option If Siemens Medical Solutions Diagnostics notifies you of a lot-specific date or obsolete extension, you can modify the reagent stability option if you need to use the reagents beyond the opened or onboard stability date. This option is available only for certain assays. 1. At the workspace, select Setup. 2. Select Test Definition Summary.

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3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. NOTE: If you select the Use Beyond option, refer to the ADVIA Centaur Assay Manual for assay-specific information.

5. At the Test – Definition window, select Edit. If you want to define . . .

Then . . .

use of reagents beyond the opened or onboard stability date,

select Use Beyond at Stability.

use of reagents only within the opened or onboard stability date,

select Do Not Use Beyond at Stability.

6. Select Save.

Modifying Sample Replicates Use this procedure to define the number of patient or quality control replicates that you want the system to routinely perform for a selected test. Refer to Defining the Number of Replicates for Automatic Repeats‚ page 8-28. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. 5. At the Test – Definition window, select Edit. NOTE: If you enter a different number of replicates at the Worklist – Reagent Options window, the system inactivates the number of replicates in the Replicates field for the current worklist.

6. Select the number of replicates in the Replicates field. You can select up to 30 replicates. 7. If the number of replicates is greater than 1, enter the acceptable CV. 8. Select Save.

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Defining Anonymous Results You can define a test so that the system reports results without patient names or identification codes (PID). You can use this option when test results require a high level of confidentiality. NOTE: When you select this option for at least 1 test for a sample, the system saves all test results for that sample without a patient name or PID.

1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. 5. At the Test – Definition window, select Edit. 6. Select Anonymous. 7. Select Save.

Defining Units and Decimal Places You can define the units and the number of decimal places for test results. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. 5. At the Test – Definition window, select Edit. 6. Select Calculate Results. NOTE: You can define how you want the system to report T Uptake results. Refer to Defining T Uptake Result Options‚ page 8-34, for more information on T Uptake reporting.

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7. Select the units for test results. If required, change the conversion factor to convert Master Curve units to the selected units reported by the system. Refer to SI Unit Conversion Factors‚ page C-9. 8. Complete the appropriate task: If you want to define . . .

Then . . .

the number of decimal places for a concentration result,

select the number of decimal places in Conc Decimal.

the number of decimal places for an index result,

select the number of decimal places in Index Decimal.

9. Select Continue. 10. At the Test – Definition window, select Save.

Defining Calibration Options You can review or edit calibration options, such as the calibration interval, for each test. NOTE: Some fields are not available depending on the displayed test. For more information about calibration, refer to Calibration‚ page 3-1.

1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. 5. At the Test – Definition window, select Edit. 6. Select Calculate Results. 7. At the Test – Result Calculation window, select Calibration. 8. At the Test – Calibration window, complete the appropriate tasks. NOTE: The number of calibrator replicates in Minimum and the system

limits for a retained calibration in Retained Cal Limits are established at the time of manufacture. If you want to . . .

Then . . .

define the number of days between required calibrations,

Enter the new values in Cal Interval You can only enter an interval that is less than the default defined by the manufacturer.

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If you want to . . .

Then . . .

define the number of calibrator replicates to perform the first time a calibrator lot is used,

select a number in New Lot. This number must be larger or equal to the number of replicates for Current Lot and Minimum. New Lot ≥ Current Lot ≥ Minimum

define the number of calibrator replicates for the current lot,

select a number in Current Lot. This number must be smaller or equal to the number of replicates for New Lot and larger or equal to the number of replicates for Minimum. New Lot ≥ Current Lot ≥ Minimum

enable the system to allow you to use an expired calibration,

select Waive Cal.

enable the system to allow you to accept a calibration that falls outside the observed range but within the defined range,

select Accept Cal.

enable the system to allow you to assign a valid calibration to results at the Worklist – Summary window,

select Assign Cal.

enable the system to automatically use data from a previous calibration when new calibration values are almost mathematically identical to previous values,

select Retain Cal.

enable the system to automatically exclude a calibrator replicate result when it is outside of the defined ranges for precision,

select Autoexclude Cal Replicates.

9. Select Continue. 10. At the Test – Definition window, select Save.

Using Control Bracketing Control bracketing allows you to begin and end a group of patient samples for a specific test with a set of controls. The system does not process samples until it establishes the acceptability of the results for the start-of-bracket controls. The system does not report sample results until it establishes the acceptability of the results of the end-of-bracket controls.

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This feature allows laboratories to comply with procedural recommendations for certain tests that are regulated very closely. The ADVIA Centaur XP system can perform tests with control bracketing when you enable the feature in the test definition.

Viewing Control Bracketing Features You can view some of the control bracketing features of a test at the Test – Definition window. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. NOTE: Only certain tests allow control bracketing. Your local technical support provider can activate or deactivate the Control Bracket button selection only if Siemens Medical Solutions Diagnostics allows control bracketing for the test.

5. Ensure the Control Bracket button is activated or deactivated for a test, depending on your laboratory requirements. If your laboratory does not require control bracketing for a particular test or if you want to activate control bracketing for a test that has this capability, your local technical support provider can change the selection at the Control Bracket button. NOTE: Only certain tests allow control bracketing. Your local technical support provider can edit the Control Levels field only if Siemens Medical Solutions Diagnostics allows control bracketing for the test.

6. View the Control Levels field for the number of control levels required for each start-of-bracket or end-of-bracket control set when the control-bracketing feature is activated for the test. Your local technical support provider can edit the field for a test that has control bracketing capability, provided the value is between 1 and 5, inclusive.

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7. View the Control Warning field for the maximum allowable time in hours between the start and end-of-bracket controls, as defined by Siemens Medical Solutions Diagnostics. When the system issues the Control Warning, you must process the end-of-bracket controls immediately or any retained patient test results are discarded.

Modifying the Control Reminder in Control Bracketing A control reminder for a control-bracketed test is a system reminder message to schedule and process the end-of-bracket controls. This reminder helps to prevent discarding of retained patient test results. Retained patient test results are patient test results that are not reported by the system until the system processes an end-of-bracket set of controls with acceptable results. If a test has control bracketing enabled and the system is in the Ready state, you can edit the time interval, in hours, from the time that the start-of-bracket control set produces acceptable results to the time that you want to see a control reminder. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. 5. At the Control Reminder field, enter the time interval in hours. The time interval is from the time that the start-of-bracket control set produces acceptable results to the time that you see a reminder to schedule and process the end-of-bracket controls. If you . . .

Then . . .

want the system to remind you to schedule and process the end-of-bracket controls,

enter a value greater than 0 and less than the value in Control Warning.

do not want the system to remind you to schedule and process the end-of-bracket controls,

enter 0.

Refer to Using Control-bracketed Tests‚ page 2-58 or consult the index under Control Bracketing.

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Defining Reference Ranges, Result Interpretations, and Reflex Tests You can define reference ranges for your patient population, result interpretations for results within a certain range, and reflex tests for samples with certain test results.

Defining Reference Ranges Use this procedure to define the ranges for your patient population. Enter the range your laboratory establishes or use the expected values in the ADVIA Centaur Assay Manual. The system displays flags for results outside the defined ranges. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Ranges. 5. At the Test – Ranges window, select Edit. 6. You can enter or edit reference ranges for different patient populations. You can enter up to 7 characters for the name of the reference range. Use the range established in your laboratory or the 1 provided in the ADVIA Centaur Assay Manual. If you want to enter or edit . . .

Then . . .

the name of the reference range, such as Child or Adult,

enter the name in Name of Range.

the low limit or the high limit for the reference range,

enter the low limit or the high limit.

the gender,

select either M for male or F for female.

the age range,

enter the low end of the range on the left and the high end of the range on the right.

NOTE: If you select Reset Defaults, the system resets all options at the Test –

Ranges window in addition to the reference range options. 7. Reset the ranges to the original values, if necessary: a. Select Reset Defaults. b. Select Ranges.

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8. Reset all the parameters and ranges to the original values, if necessary: a. Select Reset Defaults. b. Select All. 9. If required, define reflex tests for test results that are outside the reference ranges. Refer to Defining Reflex Tests for Reference Ranges‚ page 8-23. 10. Select Save.

Defining Result Interpretations A result interpretation is a label that you want the system to use for results within a certain range, for example, reactive or nonreactive. You can define up to 7 custom result interpretations for your laboratory in addition to the result interpretations defined by the manufacturer. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. 5. At the Test – Definition window, select Edit. 6. At the Test Result Calculation window, select Calculate Results. •

Select the button at the lower left of the window if you want to review results before releasing them to an LIS.

•

In the first field at the bottom of the window, the system displays Predefined if the manufacturer defined the information and Operator if you defined the information.

NOTE: You cannot edit the interpretation names and ranges that the manufacturer predefined.

7. At the Test – Result Calculation window, define a result interpretation in the fields below the table using the following procedure: a. Select Add New to activate the interpretation edit field, which is the third field in the row below the table. b. Enter an interpretation in the interpretation edit field. Enter up to 15 alphanumeric characters for the interpretation that you want the system to use for results within a certain range. The remaining fields below the table become active.

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c. Enter the lower and upper limits of the range. Enter up to 6 numeric characters for the lower and upper limits for the interpretation. d. Select Hold at the left field in the row if you want to review results before releasing them to the LIS. e. If required, define a reflex test or profile for test results within a result interpretation range. Refer to Defining Reflex Tests for Interpretation Ranges‚ page 8-23. 8. Select Add Row to add the result interpretation information to the table. 9. Select Continue. 10. At the Test – Definition window, select Save.

Defining Reflex Tests Reflex tests are supplemental tests or profiles the system schedules in response to low or high results for specific tests. You can define a reflex tests for results that are outside a reference range or within an interpretation range. NOTE: You can select a reflex test or profile only if the test definition for the

reflex test or profile is on the system. Refer to Defining Test Profiles‚ page 8-36. NOTE: The system performs a reflex test automatically if the sample is still in the inprocess queue when the system receives the request. If the system ejects the sample before it receives the request, the reflex test remains pending until you reload the sample. NOTE: If both automatic repeat tests and reflex tests are defined for a test, and a

result meets the criteria defined for both, the system does not process the reflex test based on the initial result. The system repeats the test with the defined number of replicates and if any of the repeat replicates meet the reflex criteria, the reflex test is performed. The system does not perform the reflex test if none of the repeat replicates have a result that meets the reflex criteria. For example, the system handles reflex confirmatory tests for a reactive Hepatitis B surface Antigen test (HBsAg) in the manner described below. The recommended protocol for performing the HBsAg test is as follows: 1. Perform the HBsAg test. 2. If the result is reactive, repeat the test in replicates of 2 or more. 3. If 1 or more of the repeat replicates has a reactive result, perform the HBsAg confirmatory test.

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If a reactive test result initiates an automatic repeat, the system schedules an HBsAg confirmatory test only after the system shows the initial reactive result of the HBsAg screen test to be repeatably reactive. If . . .

Then . . .

either repeat replicate is reactive,

the system schedules an HBsAg confirmatory test.

the initial result is reactive and none of the repeat replicates have a reactive result,

the system does not schedule an HBsAg confirmatory test.

Defining Reflex Tests for Reference Ranges You can define a reflex test that the system schedules automatically if a test result is outside a reference range. Refer to Defining Reference Ranges‚ page 8-20. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Ranges. 5. At the Test – Ranges window, select Edit. 6. Select Reflex Tests. 7. At the Test – Reflex Tests window, select the reflex test for the low limit or the high limit of the range. •

Select the test you want the system to schedule if the result is less than the low limit.

•

Select the test you want the system to schedule if the result is greater than the high limit.

8. Select Continue. 9. At the Test – Ranges window, select Save.

Defining Reflex Tests for Interpretation Ranges You can define a reflex test that the system schedules automatically. This is for a test result that is within a range defined for an interpretation label, such as reactive or nonreactive. Refer to Defining Result Interpretations‚ page 8-21. 1. At the workspace, select Setup. 2. Select Test Definition Summary.

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3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. 5. At the Test – Definition window, select Edit. 6. Select Calculate Results. 7. At the Test – Result Calculation window, select the table row that contains the range that requires a reflex test. The system copies the information to the fields below the table. 8. At the Reflex Tests field, select the reflex test or profile that you want the system to perform automatically if a result is within the range. 9. Perform the appropriate action: If you selected . . .

Then . . .

a reflex test.

use the list at the Replicates field to select the appropriate number of replicates.

a reflex profile or ratio,

continue with step 10. You cannot select replicates for a reflex profile or ratio.

10. To add the reflex test information to the table, select Add Row . 11. Select Continue. 12. At the Test – Definition window, select Save.

Defining Automatic Sample Repeats You can define several automatic repeat features that make sample handling easier: •

You can define the result ranges that you want to repeat, such as samples outside the check range or linearity, or samples outside the concentration calculation range or index calculation range on the Master Curve card.

•

You can define the number of replicates for an automatically repeated test.

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•

8-25

You can select whether you want to hold samples in the inprocess queue for repeat tests and the types of samples you want to hold.

If you select . . .

Then . . .

both automatic repeat and hold options,

you do not need to interact with the system to repeat a test. The system holds the racks in the inprocess queue until it completes the results. If the sample requires a repeat test, the system automatically schedules and performs it. If the inprocess queue is full, the system can load an additional sample rack after it ejects a sample rack from the inprocess queue.

automatic repeat options and do not select hold options,

you must reload the sample to repeat a test. The system automatically schedules repeat tests for results outside the defined ranges and the tests remain pending until you reload the sample.

Refer to Manually Scheduling Samples‚ page 2-48.

Defining Check Range and Linearity You can define the check range and linearity range for a test and whether to repeat the test on samples with results that are outside of these ranges. A check range is a range above and below which a result is repeated to verify its accuracy. For example, if you have a test whose reference range is 5 to 12 ng/dL, you may want to repeat all results below 4 and above 15. The low limit of the check range is 4 and the high limit of the check range is 15. Linearity is a range above and below which the test is no longer linear or sensitive. You can find this range in the product insert or you can define your own laboratory-specific linear range. NOTE: If repeats are not allowed for a test, repeat options are not available.

1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Ranges. 5. At the Test – Ranges window, select Edit. NOTE: You do not need to define both a low and a high value for the check

range.

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6. Define the check range. The system flags results that are outside the check range limits. a. Enter or edit the low limit of the check range. b. Enter or edit the high limit of the check range. 7. Define whether to repeat tests on samples with results outside of the check range: If you want to repeat tests with results . . .

Then . . .

less than the low limit of the check range,

select Repeat if < in Check Range.

greater than the high limit of the check range,

select Repeat if > in Check Range.

8. Define the linearity: The system flags results that are outside the linearity limits. a. Enter or edit the low limit of linearity. b. Enter or edit the high limit of linearity. 9. Define if you want to repeat tests on samples with results outside the linearity limits: If you want to repeat tests with results . . .

Then . . .

less than the low limit of linearity,

select Repeat if < in Linearity.

greater than the high limit of linearity,

select Repeat if > in Linearity.

NOTE: If you select Reset Defaults, the system resets all options at the Test – Ranges window in addition to the check range and linearity options.

10. You can reset the ranges at the Test – Ranges window to the original values: a. Select Reset Defaults. b. Select Ranges. 11. You can reset all options and ranges at the Test – Ranges window to the original values: a. Select Reset Defaults. b. Select All. 12. Select Save.

Defining Repeats for the Concentration and Index Calculation Ranges You can define if you want the system to reschedule tests above or below the concentration or index calculation range on the Master Curve card. 1. At the workspace, select Setup. 2. Select Test Definition Summary.

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3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Ranges. 5. At the Test – Ranges window, select Edit. NOTE: If repeats are not allowed for a test, repeat options are not available.

6. Define whether you want the system to repeat tests outside the concentration or index calculation range on the Master Curve card: If you want the system to . . .

Then select . . .

automatically repeat tests with values below the concentration calculation range,

Repeat if < Conc Range.

automatically repeat tests with values above the concentration calculation range,

Repeat if > Conc Range.

automatically repeat tests with values below the index calculation range,

Repeat if < Index.

automatically repeat tests with values above the index calculation range,

Repeat if > Index.

NOTE: If you select Reset Defaults, the system resets all options at the

Test – Ranges window in addition to the concentration and index calculation range options. 7. You can reset the options to the original values: a. Select Reset Defaults. b. Select All. 8. Select Save.

Defining Automatic Repeats for Sample Error Conditions You can create a definition for the system to repeat tests when it detects insufficient sample, a clot, or a sample integrity error, such as sample foam, bubbles, or sample aspiration errors. NOTE: The system uses a new tip each time it aspirates a sample for each test. Therefore, the system discards any clot or other obstruction in the tip before performing a repeat test.

1. At the workspace, select Setup. 2. Select Summary.

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3. At the Setup – Summary window, select Sample Handling. 4. At the Setup – Sample Handling Options window, select the appropriate repeat options. •

Select Repeat if Insufficient Sample is Detected to repeat the sample aspiration when the system detects insufficient sample volume.

•

Select Repeat if Clot is Detected to repeat the sample aspiration when the system detects obstructions in a sample tip.

•

Select Repeat if Sample Integrity Error is Detected to repeat the sample aspiration when the system detects an irregular sample aspiration.

5. Select Save.

Defining the Number of Replicates for Automatic Repeats You can define the number of replicates when a repeat test is performed automatically. If you want the number of repeat replicates to be . . .

Then . . .

different than the number defined for samples in routine tests at the Test – Definition window, or different than the number of repeat replicates defined by Siemens Medical Solutions Diagnostics,

enter a value in the Repeat Replicates field at the Test – Ranges window.

the same as the number defined for samples in routine tests or the same as the number of repeat replicates defined by Siemens Medical Solutions Diagnostics,

leave the Repeat Replicates field blank. The system uses the number of replicates for repeat testing that was used when the test was initially performed. If you enter a different number of replicates at the Worklist – Reagent Options window, the system uses that number for the current sample.

NOTE: If you are manually scheduling a repeat test, the field at the Test – Ranges

window does not apply. To manually schedule a repeat test, change the number of replicates at the Worklist – Reagent Options window, as described in Manually Scheduling Samples‚ page 2-48. Use this procedure to define the number of replicates for samples processed in automatically repeated tests. 1. At the workspace, select Setup. 2. Select Test Definition Summary.

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3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Ranges. 5. At the Test – Ranges window, select Edit. 6. Enter the number of replicates for patient samples processed in automatically repeated tests in the Repeat Replicates field. 7. Select Save.

Defining Hold for Repeat Options If you want the system to automatically retest samples without requiring you to manually reload them, you must define the sample types that you want to hold in the inprocess queue and select the Hold Sample for Repeat option for each test. •

At the Setup – Sample Handling Options window, select the sample types that you want the system to hold. The system holds the selected sample types in the inprocess queue only if you also select the Hold Sample for Repeat option at the Test – Definition window. If you deselect a sample type, the system does not hold that type of sample even if you select the Hold Sample for Repeat option at the Test – Definition window.

•

At the Test – Definition window for each test that requires automatic repeats, select Hold Sample for Repeat. For each test with this option selected, the system holds only the sample types selected at the Setup – Sample Handling Options window. NOTE: The system holds a sample for only 1 repeat test. If you need to repeat

a test on a sample 2 times, you must manually reload the sample for the second repeat test even if you select the hold options. The system automatically ejects samples after repeat tests are aspirated. Define the sample types that you want to hold in the inprocess queue: 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Sample Handling. 4. In Hold Samples for Repeats & Reflex Tests, select each sample type that you want the system to hold in the inprocess queue for additional testing. 5. Select Save.

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Select the Hold Sample for Repeat option for each test: 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Definition. 5. At the Test – Definition window, select Edit. 6. Select Hold Sample for Repeat. This holds samples in the inprocess queue for additional testing based on the repeat criteria you defined at the Test – Ranges window. 7. Select Save.

Defining Automatic Dilutions You can define automatic dilution options for certain tests. These options include diluting test results greater than a specified concentration and scheduling dilution profiles. A dilution profile enables the system to schedule multiple dilutions for a test. You can also define dilution options for specific samples at the Worklist – Dilutions window. Specifying a dilution for a specific sample overrides the automatic dilution option for the test. Refer to Entering Dilution Options‚ page 2-56.

Defining Automatic Dilutions for Tests 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 4. Select Ranges. 5. At the Test – Ranges window, select Edit.

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NOTE: The Dilution Point, Dilution, or Overdilution Point field may not be available depending on the displayed test. NOTE: If you define a Dilution Point, you must also define a Dilution and Overdilution Point. If a you do not define a Dilution, the system does not have enough information to automatically dilute a sample. If you do not define an Overdilution Point, the system does not have enough information to check the diluted result.

6. In Dilution Point, enter the concentration above which you want the system to perform an automatic dilution. If the result is above the concentration limit that you enter in this field, the system flags the test result and automatically schedules a dilution. 7. In Dilution, select the dilution factor. 8. In Overdilution Point, if it is not defined, enter the concentration below which you do not want the system to determine a result for the specific dilution. The Overdilution Point should be equal to the Low Limit of the Linearity range specified at the Test – Ranges window. If no Low Limit is defined, the Overdilution Point should be equal to the sensitivity limit of the assay, as reported in the product instruction in the ADVIA Centaur Assay Manual. The Overdilution Point provides an indication that the system should have diluted the sample at a lower level or not at all. The system compares the uncorrected diluted concentration to the value displayed in Overdilution Point. If the concentration is below the Overdilution Point, the system does not report a result for the sample. For example, if the Overdilution Point for ThCG is 5.0 mIU/mL (IU/L) and the uncorrected result is 4.5 mIU/mL (IU/L) on a sample diluted 1:200, the system does not determine a result for the sample because the concentration is below the specified concentration. The system flags the test result and does not schedule or repeat the test. To obtain a result, you can process the sample undiluted or diluted at a lower level, such as 1:5. NOTE: If you select Reset Defaults, the system resets all options at the Test –

Ranges window in addition to the automatic dilution options. 9. Reset all options to the original values, if necessary: a. Select Reset Defaults. b. Select All. 10. Select Save.

Defining Dilution Profiles You can define a dilution profile that allows you to schedule multiple dilutions for a test. 1. At the workspace, select Setup.

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2. Select Profile Summary. 3. At the Test – Profile Summary window, define or edit a dilution profile. If you want to . . .

Then . . .

define a dilution profile,

select Add Dilution Profile.

edit a dilution profile,

Select a dilution profile. Select Profile Definition. At the Test – Dilution Profile Definition window, select Edit.

NOTE: Siemens Medical Solutions Diagnostics defines the dilution levels

available at the Test – Dilution Profile Definition window. If Siemens Medical Solutions Diagnostics did not define dilution levels for a test, selections for dilution levels are not available. 4. At the Test – Dilution Profile Definition window, enter or edit the appropriate information. a. Select Edit. b. In Profile, edit or add the name of the profile. c. In LIS Code, edit or add the LIS code for the profile. d. In Test, enter the name of the test. e. In Dilution, enter up to 5 dilution factors. 5. Select Save. The system adds the dilution symbol next to the Dilution Profile name on the Test – Profile Summary window.

Deleting Dilution Profiles You can use this procedure to delete a dilution profile. 1. At the workspace, select Setup. 2. Select Profile Summary. 3. At the Test – Profile Summary window, select the profile. 4. Select Delete.

Defining Calculated Parameters You can enter mathematical formulas that the system uses to calculate test results from other test results.

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Defining Ratio Tests You can define the ratio tests for calculated parameters such as free thyroxine index (FTI) and red blood cell folate (RBC folate). The ADVIA Centaur XP system calculates the FTI and RBC folate values using direct measurement, equations, and off-system tests. Refer to the ADVIA Centaur Assay Manual for specific parameters for each test. NOTE: You cannot define a component as part of a Ratio test.

When you request a ratio test, the system automatically schedules all tests defined as part of the ratio. If you request a ratio test and also request a test that is part of the ratio test, the system performs the test twice. One result is used in the calculation of the ratio test and the other result is reported independently. NOTE: When you edit an element of a ratio test, the system automatically recalculates the ratio test result and reports the result with an Edited flag.

1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, define or edit a ratio test: If you want to . . .

Then . . .

define a ratio test,

a.

Select Add Ratio.

b. Enter the test. edit a ratio test,

a.

Select a ratio test.

b. Select Definition. c.

At the Test – Ratio Definition window, select Edit.

4. At the Test – Ratio Definition window, enter the parameters: If you want to . . .

Then . . .

enter the LIS code for a test,

enter the LIS code.

review the result before the system reports the result,

select Hold.

enter the units,

select a unit of measure.

enter the number of decimal places,

select the number of significant digits in Decimal.

enter a reference range,

enter the low limit and the high limit.

NOTE: Use the formula displayed at the Test – Ratio Definition window to

define each ratio test.

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5. Enter the variables for the formula: If you want . . .

Then . . .

the system to use a test result in the calculation,

a.

Select Tests from the list in the first field under the appropriate variable.

b. Select a test from the list in the second field under the variable. to enter a number for the variable,

a.

Select Variable from the list in the first field under the appropriate variable. You can enter a 0 (zero) if you do not want to include Variable a or Variable b in the calculation.

b. Enter a value in the second field under the variable. You can enter a 1 if you do not want to include Variable c or Variable d in the calculation

Examples are as follows: a. RBC Folate = FOLATE × 2100 / HCT Enter the following variables for an RBC Folate: • a = Tests, FOL • b = Variable, 0 • c = Tests, HCT • d = Variable, 2100 b. FTI = T4 × %Uptake / 100 Enter the following variables for FTI: • a = Tests, T4 • b = Variable, 0 • c = Variable, 100 • d = Tests, TUp (%) 6. Select Save.

Defining T Uptake Result Options You can define how you want to report the T Uptake results. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, select TUp. 4. Select Ranges. 5. At the Test – Ranges window, select Edit. 6. Select a percent or a ratio in Result Formula. The following list describes the selections:

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•

Percent 1 – the system calculates percent uptake by multiplying the uptake ratio by the midpoint of the percent uptake reference range defined in the first range field at this window.

•

Percent 2 – the system calculates percent uptake by multiplying the uptake ratio by the midpoint of the reference range defined in the second range field at this window.

•

Percent 3 – the system calculates percent uptake by multiplying the uptake ratio by the midpoint of the reference range defined in the third range field at this window.

•

Percent 4 – the system calculates percent uptake by multiplying the uptake ratio by the midpoint of the reference range defined in the fourth range field at this window.

•

Ratio – the system calculates T Uptake results as a ratio by default.

Refer to the ADVIA Centaur Assay Manual. 7. Select Save.

Defining Off-System Tests An off-system test is a test that the ADVIA Centaur XP system does not perform, but can report or use in a ratio test calculation. For example, you can define hematocrit as an off-system test if you want the system to calculate RBC folate. 1. At the workspace, select Setup. 2. Select Test Definition Summary. 3. At the Test – Summary window, define or edit an off-system test: If you want to . . .

Then . . .

define an off-system test,

a.

Select Add Off-System.

b. Enter the name in Test. edit an off-system test,

a.

Select an off-system test.

b. Select Definition. c.

At the Test – Off-System Definition window, select Edit.

4. At the Test – Off-System Definition window, enter or edit the appropriate information. If you want to . . .

Then . . .

enter the LIS code for a test,

enter the LIS code.

enter the units,

select a unit of measure.

enter the number of decimal places,

select the number of significant digits in Decimal.

enter a reference range,

enter the low limit and the high limit.

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5. Select Save.

Defining Test Profile Options You can define and delete test profiles that allow you to schedule multiple tests for a sample. For example, if you define a thyroid profile, select all of the thyroid assays that you want to include in the profile.

Defining Test Profiles 1. At the workspace, select Setup. 2. Select Profile Summary. 3. At the Test – Profile Summary window, define or edit a test profile: If you want to . . .

Then . . .

define a test profile,

select Add Test Profile.

edit a test profile,

a.

Select a profile.

b. Select Profile Definition. c.

At the Test – Profile Definition window, select Edit.

4. At the Test – Profile Definition window, enter or edit the appropriate information. a. Add or edit the name of the profile. b. Add or edit the LIS code for the profile. c. Select the tests you want in the profile. 5. Select Save.

Deleting Test Profiles 1. At the workspace, select Setup. 2. Select Profile Summary. 3. At the Test – Profile Summary window, select the profile. 4. Select Delete.

Modifying the Test Display Order The default order of tests displayed at the Worklist – Schedule window and on printed reports is the order in which the system activates the tests. The system displays each new test at the end of the list. Use this procedure to change the order in which the system displays the active tests. 1. At the workspace, select Setup. 2. Select Test Definition Summary.

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3. At the Test – Summary window, select Display Order. 4. At the Test – Display Order window, select Edit. 5. Select a test. a. Select Test. The Test–Selection window displays. b. Select a test. c. Select Continue to close the Test–Selection window. 6. Select the target position. 7. Select the appropriate option: If you want to . . .

Then . . .

change the position of the test with the test in the target position,

select Move. The test changes positions with the test in the target position.

insert the test before an existing test in the table,

select Insert. The test is inserted before the target position.

8. Select Save.

Modifying System Options You can modify system options such as the sound of the alarm, the speed and sensitivity of the pointing device, the type of barcode scanner, and the elapsed time required for the screen saver to activate.

Reviewing System Options You can review setup options selected for your system at the Setup – Summary window. To open the Setup – Summary window from the workspace, select Setup and then select Summary. •

Select the Print Options button to specify the printer, the paper size, the automatic runtime results report options, and the report heading.

•

Select the Alarms button to define when you want the alarm to sound, the volume of the alarm, and the type of sound.

•

Select the Additional Options button to define several options, including the system name, time, screen saver options, pointing device options, reagent warning counts, and water and waste options.

Viewing the System Serial Number 1. At the workspace, select Setup. 2. Select Summary.

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3. At the Setup – Summary window, select Additional Options. 4. At the Setup – Additional Options window, view the serial number assigned to your system in the System Serial Number field.

Defining the System Name 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Additional Options. 4. At the Setup – Additional Options window, enter up to 11 alphanumeric characters for the system name. The system displays the name at the workspace. 5. Select Save.

Specifying Screen Saver Options The system has a screen saver that displays the system graphic. You can define the time after which the screen saver activates and define whether or not you want the screen saver to blink for critical conditions. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Additional Options. 4. At the Setup – Additional Options window, in the Screen Saver Timeout field, enter the number of minutes the workspace remains idle before the screen saver displays. The default is 5 minutes. Enter 0 (zero) if you do not want to use the screen saver option. 5. Select Blink for Failures, if you want the background of the screen saver to blink between red and black in critical conditions. 6. Select Save.

Defining Alarms You can define alarms for Message Boxes, and Warning or Failure conditions. Refer to Monitoring Status‚ page 2-9. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Alarms. 4. At the Setup – Alarms window, select Message Box, Warning, or Failure. 5. Select Alarm On or Alarm Off.

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6. Select Continuous Repetitions or Specify Repetitions. 7. If you select Specify Repetitions, enter a number from 1 to 99 in Repetitions to specify the number of times you want the alarm to repeat. 8. Enter a number from 0 to 100 in Volume. A higher number increases the volume of the alarm. 9. Repeat steps 4 through 8 for each condition. 10. Select Save.

Defining Low Reagent Status You can specify warning levels at which the system alerts you that the primary reagent, ancillary reagent, or vial reagent volume is low. A Low Reagent message displays at the Worklist – Reagent Inventory window and the system sends the message to the LIS when the total quantity of reagent loaded for a particular test is equal to or less than the amount specified for the warning level. When a Low Reagent status exists at the Worklist – Reagent Inventory window, the system highlights the test in yellow, the Reagent Status button blinks yellow, and the reagent area of the system graphic displays yellow. 1. At the workspace, select Setup. 2. At the Setup – Summary window, select Additional Options. 3. At the Setup – Additional Options window, in the Reagent Warning Counts Primary field, enter the number of tests at which you want the system to notify you that the primary reagent volume is low. 4. In the Reagent Warning Counts Required Ancillary field, enter the number of milliliters at which you want the system to notify you that the ancillary reagent volume is low. 5. For allergen-specific IgE testing, in the Reagent Warning Counts Vial field, enter the number of tests at which you want the system to notify you that the allergen vial reagent volume is low. 6. Select Save. 7. Close all windows, and then reboot the system.

Defining the Control Bracket Reagent Reserve You can define a Control Bracket Reagent Reserve for control-bracketed tests. This feature ensures that the system has enough reagent for the end-of-bracket controls of a control-bracketed test that is in process. When the reagent reaches the reserved level, the system suspends aspiration of patient samples and reminds you to process the end-of-bracket controls. 1. At the workspace, select Setup. 2. At the Setup – Summary window, select Additional Options.

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3. In the Control Bracket Reagent Reserve field at the Setup – Additional Options window, enter the number of control sets for which the system reserves reagent to process the end-of-bracket controls. You can enter from 1 to 5 sets. For example, if you enter 2 control sets and a test has 3 control levels, the system reserves reagent required to evaluate the following number of quality control samples: 2 × 3 × the number of control replicates defined at the Test – Definition window. 4. Select Save.

Adjusting the Time The system calendar and clock are powered by a long-life battery in order to maintain the correct date and time even if the power is turned off. You can select the time zone appropriate for your laboratory and you can also increase or decrease the time on the system clock.

Specifying the Time Zone 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Additional Options. 4. At the Setup – Additional Options window, select your time zone. 5. Select Save. 6. Reboot the system.

Entering a Time Correction You can increase or decrease the time on the system clock by a maximum of 1440 seconds during 1 setup. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Additional Options. NOTE: The system changes the time on the system clock only if the number of seconds that you enter at the Time Correction field is a new number. If you want to adjust the time by the same number of seconds that had been entered and used by the system earlier, you must enter 0 (zero) in the Time Correction field, save the entry and then enter the actual number for the time adjustment.

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4. At the Setup – Additional Options window, enter the time correction for the system clock: If you are entering a . . .

Then . . .

new time correction that was not used in the previous setting for this window,

enter the number of seconds with a plus sign to increase the time or a minus sign to decrease the time (example: +300 to increase the time 5 minutes or –300 to decrease the time 5 minutes).

time correction that was used in the previous setting for this window (example: you entered a time correction of +300 seconds, the system adjusted the time by this amount, and you want to adjust the time by +300 seconds again),

a.

Enter 0 (zero) in the Time Correction field.

b. Select Save. c.

Enter the number of seconds with a plus sign to increase the time or a minus sign to decrease the time (example: +300 to increase the time 5 minutes or –300 to decrease the time 5 minutes).

5. Select Save. The system gradually adjusts the time on the system clock according to the number of seconds that you entered in the Time Correction field. It can take 3 hours or longer for a correction of 10 minutes. NOTE: Do not reboot after entering a time correction until the system

completes the correction. Rebooting stops the time correction process.

Adjusting the Pointing Device 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Additional Options. 4. At the Setup – Additional Options window, in Acceleration enter a low number to decrease the speed or enter a high number to increase the speed that the pointer moves across the screen. 5. In Sensitivity, enter a low number to make the pointer increase the sensitivity or a high number to decrease the sensitivity when selecting with the pointer device. 6. Select Save.

Specifying Print Options You can specify the printer, the paper size, the automatic runtime results report options, and the laboratory name and heading you want to appear on printed reports. 1. At the workspace, select Setup.

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2. Select Summary. 3. At the Setup – Summary window, select Print Options. 4. At the Setup – Print Options window, select the appropriate printer and paper size. 5. You can print an automatic runtime results report, which is a report of all sample results as the results are being generated: a. Select Automatic Runtime Results Report. b. Enter the interval in hours at which you want page numbering to reset to 1 in Reset Page Numbering. c. Enter the number of full pages of results to print at 1 time in Page Interval. 6. If applicable, you can enter the customer number assigned to you by QC Online. 7. You can enter the laboratory information you want to appear on printed reports •

In Laboratory Name, enter up to 30 characters of text for your laboratory name that you want to print on reports.

•

In Report Header, enter up to 80 characters and up to 6 lines of text that you want to print in the report header.

8. Select Save.

Selecting Remote Access If your laboratory does not have the RealTime Solutions service, you can select remote access to make your files accessible for technical assistance through a modem. The system provides access only to the raw data without patient demographics. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Additional Options. 4. At the Setup – Additional Options window, select Remote Access. 5. Select Save.

Selecting Remote Software Administration If your system is connected to the RealTime Solutions server, some software administration, like the daily backup, occur by default. You do not have to initiate the backup. Remote updates can occur by default, as well, or you can use system settings to determine the actions of your system when a remotely initiated update occurs.

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Remote Software Administration The ADVIA Centaur XP system can perform remote updates when the system is in an appropriate state. At the Setup – Additional Options window Remote Install field, select 1 of the following: •

Prompt If you select Prompt, when a software update is available for download, the system displays the Software Update Available window. In the Software Update Available window, you can respond with 1 of the following actions:

•

Continue If you select Continue, the system proceeds immediately with the software update. Only select this option when the system is not inprocess.

•

Cancel If you select Cancel, the system cancels the update.

•

Later If you enter a date and time—MMM yy hh:mm—and select Later, the system schedules the update for a later time.

•

Proceed If you select Proceed, the system automatically performs the software update as soon as it is remotely initiated. The system only performs an update when it is in an appropriate state. The system enters the attempt into the event log and it makes no further attempts to complete the software update. When you cannot update the software automatically, you can update it using the RealTime Solutions service.

•

Deny You can select Deny to prevent all remote updates. The system logs the availability of new software.

The system can perform a remote update if it is in any of the following states: •

Ready

•

Warming up

•

Mechanics off

•

Check Status

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The system cannot perform a remote update if it is in 1 of the following states: •

Inprocess

•

Restricted

•

Cleaning

•

Failed Cleaning

•

Diagnostics

•

Performing Data Administration

Specifying Direct Plumbing or System Bottles You can specify direct plumbing or system bottles depending on the configuration of your system. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select Additional Options. 4. At the Setup – Additional Options window, select the appropriate option: If you use . . .

Then select . . .

the system bottles for water and waste,

System Bottle under the Water and Waste headings.

direct plumbing for the system water and waste,

Direct Plumbing under the Water and Waste

headings.

5. Select Save.

Enabling the Visible Status Light To enable or disable the visible status light, perform the following steps: 1. At the workspace, press the QC icon on the keyboard. 2. At the applications view workspace, select Setup. 3. Select Setup. 4. At the Setup window, select the check box to enable the visible status light or clear the check box to disable it. 5. Select Save.

Defining Backup, Restore, and Archive Options To select backup and archive options, perform the following steps: 1. At the workspace, press the QC icon on the keyboard. 2. At the applications view workspace, select Setup.

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3. Select Setup. 4. In the Target Backup/Archive Device drop-down list, select the device you want to use for backing up data, restoring data, or storing your archive. 5. If you are using the RealTime Solutions service, select Access to Server. You must select this option to enable the other backup/archive options. 6. Select each option that your laboratory uses: If you want to . . .

Then select . . .

send your results data to the RealTime Solutions server,

Result Data to Server.

send your backup data to the RealTime Solutions server,

Backup Data to Server.

send your logfiles to the RealTime Solutions server,

Logfiles to Server.

7. In Time of Day, enter the time of day for the system to send files to the RealTime Solutions service. Specify time in a 4-digit, 24-hour format HHMM. For example: 0130 is 1:30 a.m. and 1330 is 1:30 p.m. 8. Select Save.

Defining LIS Communication Options You can configure the ADVIA Centaur XP system and LIS to meet your individual laboratory requirements. You can configure the ADVIA Centaur XP system to operate in host query mode and to automatically transfer worklist queries and results to the LIS. To automatically transfer worklist requests and results, your laboratory can use barcoded samples or transfer the information using the rack ID. Your LIS must support the options that you select on the ADVIA Centaur XP system. For more information about LIS communication options, refer the online document ADVIA Centaur XP Interface Specifications. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select LIS Communications. NOTE: The LIS ID is a required field. The system name and the LIS ID must match the name required by the LIS.

4. At the Setup – LIS Communications window, select the appropriate options for the LIS. a. In System Name, enter up to 10 alphanumeric characters. The system name must match the name required by the LIS. b. In LIS ID, enter up to 10 alphanumeric characters. The LIS ID must match the name required by the LIS.

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c. In the upper section of the Setup – LIS Communications window, select options and enter the appropriate parameters for your LIS. 5. Select all of the appropriate options for the ADVIA Centaur XP system. In the lower section of the Setup – LIS Communications window, select options for your ADVIA Centaur XP system. Refer to the documentation for the LIS to determine the appropriate options. If you want to enable the system to . . .

Then select . . .

automatically query the LIS for worklist entries as the system identifies each sample,

System Automatically Queries Host for Worklist.

automatically send all final results to the LIS, except the results on hold,

System Automatically Sends All Results except Results on Hold.

automatically send all interim and final results to the LIS, except the results on hold,

You can define the results that the system holds at the Test – Definition and the Test – Result Calculation windows. System Automatically Sends All Results except Results on Hold and System Automatically Sends All Results & Additional Data except Results on Hold.

Interim and final results include all results except invalid manual dilution results and RLU-only results. The following results are examples of interim results: • replicate results • results of all of the levels in a dilution profile • dilution results that are under range or overdiluted • results that the system cannot calculate because the RLUs are above or below the Master Curve If the LIS does not receive the interim results, contact the LIS administrator to review the result records in the LIS interface. You can define the results that the system holds at the Test – Definition and the Test – Result Calculation windows. automatically send reagent status messages to the LIS,

System Automatically Sends Status to LIS.

send a worklist in response to a query from the LIS,

Respond to LIS Query for Worklist.

send results in response to a query from the LIS,

Respond to LIS Query for Results.

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If you want to enable the system to . . .

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Then select . . .

send Rack IDs with sample results to the LIS,

Send Rack IDs with Results.

remove leading spaces from SIDs when the system receives or sends SIDs,

Remove Leading Spaces from SIDs.

transmit diagnostic messages to the LIS when the system starts up,

Perform Diagnostics at Startup. The LIS acknowledges the messages, indicating successful communications.

6. Select Save. NOTE: If you modified the Setup – LIS Communications window on your

ADVIA Centaur XP system, turn system mechanics off and then turn system mechanics on. This procedure ensures that the LIS option is updated. 7. At the workspace, select System Status. 8. Select Turn System Mechanics Off. NOTE: The Turn System Mechanics On option is not available until the

system mechanics are off. 9. Select Turn System Mechanics On.

Defining LAS Communication Options Laboratory automation is the process by which samples are brought to the analyzers in your laboratory by a sample transport system. When you enhance your ADVIA Centaur XP system with the ADVIA Centaur XP STS sample transport system hardware and select LAS at the Setup – LAS Communications window, you enable your system to access samples from the sample transport system in addition to the sample entry queue and the Stat entry. You can configure the communication options for the ADVIA Centaur XP system and the LAS. 1. At the workspace, select Setup. 2. Select Summary. 3. At the Setup – Summary window, select LAS Communications. 4. At the Setup – LAS Communications window, select the appropriate options: If you want to enable . . .

Then select . . .

the ADVIA Centaur XP system to access samples from the sample transport system,

LAS.

the system to save and log messages from the LAS so you can view the messages at the System – Communication Log window,

Data Capture.

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If you want to enable . . .

Then select . . .

hardware flow control between the system and the LAS,

Handshaking.

5. Select the appropriate baud rate, ensuring that the communication configuration of the LAS agrees with your selection. If your LAS cannot operate at the baud rate selections listed, call for technical assistance. 6. Enter the appropriate timeout information: At . . .

Enter the number of . . .

No Response Timeout,

seconds the system waits for the LAS to reply to a command or response.

No Supplies Timeout,

minutes the system allows a sample tube to remain in the lab automation queue while the operator replenishes low supplies or reagents or empties full waste containers.

No Request Timeout,

minutes the system allows a sample tube to remain in the lab automation queue while the system determines if the sample has any test requests.

Index Queue Timeout,

15-second intervals (cycles) the system allows to wait for a response to the Index Queue command. In an Index Queue command, the system requests the LAS to release the sample tube at the sample access position and then move the next sample into the sample access position.

Tube Travel Timeout,

15-second intervals (cycles) the system allows a sample tube to travel from the first barcode reader to the second barcode reader (the sample access position).

Send SID Timeout,

15-second intervals (cycles) the system allows to wait for a response to the Send SID command. In a Send SID command, the system requests the LAS to send the SID of the sample tube at the sample access position.

7. Select Save.

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Appendix A: Safety Instructions This information summarizes the established guidelines for handling laboratory biohazards. This summary is based on the guidelines developed by the Centers for Disease Control, the Clinical and Laboratory Standards Institute Document M29-A3, Protection of Laboratory Workers from Occupationally Acquired Infections, and the Occupational Safety and Health Administration’s Bloodborne Pathogens Standard.1–3

Protecting Yourself from Biohazards Use this summary for general information only. It is not intended to replace or supplement your laboratory or hospital biohazard control procedures. By definition, a biohazardous condition is a situation involving infectious agents biological in nature, such as the hepatitis B virus, the human immunodeficiency virus, and the tuberculosis bacterium. These infectious agents may be present in human blood and blood products and in other body fluids. The following are the major sources of contamination when handling potentially infectious agents: •

needlesticks

•

hand-to-mouth contact

•

hand-to-eye contact

•

direct contact with superficial cuts, open wounds, and other skin conditions that may permit absorption into subcutaneous skin layers

•

splashes or aerosol contact with skin and eyes

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To prevent accidental contamination in a clinical laboratory, strictly adhere to the following procedures: •

Wear gloves while servicing parts of the instrument that have contact with body fluids such as serum, plasma, urine, or whole blood.

•

Wash your hands before going from a contaminated area to a noncontaminated area, or when you remove or change gloves.

•

Perform procedures carefully to minimize aerosol formation.

•

Wear facial protection when splatter or aerosol formation are possible.

•

Wear personal protective equipment such as safety glasses, gloves, lab coats or aprons when working with possible biohazard contaminants.

•

Keep your hands away from your face.

•

Cover all superficial cuts and wounds before starting any work.

•

Dispose of contaminated materials according to your laboratory’s biohazard control procedures.

•

Keep your work area disinfected.

•

Disinfect tools and other items that have been near any part of the instrument sample path or waste area with 10% v/v bleach.

•

Do not eat, drink, smoke, or apply cosmetics or contact lenses while in the laboratory.

•

Do not mouth pipet any liquid, including water.

•

Do not place tools or any other items in your mouth.

•

Do not use the biohazard sink for personal cleaning such as rinsing coffee cups or washing hands.

To prevent needlestick injuries, needles should not be recapped, purposely bent, cut, broken, removed from disposable syringes, or otherwise manipulated by hand.

References 1. Centers for Disease Control. 1988. Update: Universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus and other bloodborne pathogens in healthcare settings. MMWR, 37:377–382, 387, 388. 2. Clinical and Laboratory Standards Institute (formerly NCCLS). Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - Third Edition. CLSI Document M29-A3.[ISBN 1-56238-567-4]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005). 3. Federal Occupational Safety and Health Administration. Bloodborne Pathogens Standard. 29 CFR 1910. 1030.

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Protecting Yourself from Barcode Scanner Lasers To avoid damage to the eyes, never look directly at the laser beam or at its reflection from a shiny surface. Never point a hand-held barcode scanner at anyone.

Laser Safety Classification of the ADVIA Centaur XP System During normal operation with all of the protective housings in place, the ADVIA Centaur XP system is classified as CDRH Class I and EN 60825-1 Class 1. No direct exposure to laser hazard exists for persons in the immediate area.

laserclass1 . Figure A-1

CDRH Class 1 Label

Some field service procedures require the removal of the protective housings that prevent human access to the laser radiation. The removal of the protective housings may change the classification of the system to CDRH Class 2 and EN60825-1 Class 2. All field service procedures must be followed precisely. Only Siemens-trained field service personnel should perform procedures related to laser assemblies.

Figure A-2

CDRH Class 2 Label

The laser labels are positioned on the instrument as shown below.

Laser Safety Classification of the Barcode Scanners The laser safety classification of the reagent and sample barcode scanners when they are unprotected by the system housings is CDRH Class 2 and EN 60825-1 Class 2. The laser safety classification of the hand-held barcode scanner used with the system is CDRH Class 2 and EN 60825-1 Class 2.

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ADVIA Centaur XP Operator’s Guide: Safety Instructions

Reagent and Sample Barcode Scanners ADVIA Centaur XP Operator’s Guide procedures for testing the reagent or sample barcode scanners contain the following laser warning: LASER WARNING

Never look directly at the laser beam or at its reflection from a shiny surface. Looking directly at the laser beam or its reflection could cause damage to the eyes. Only trained field service personnel should perform procedures related to laser assemblies. Refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers, for more information. The specifications for the laser optical assemblies in the ADVIA Centaur XP ancillary reagent, primary reagent, and sample barcode scanners are summarized in the following table: Characteristic

Specification

Maximum Power Output

1.0 mW

Wavelength

670 nm

Pulse Duration

Continuous Wave (cw)

Units of Beam Divergence

0.7 mr

The locations of the reagent and sample barcode scanners and their associated laser safety labels are shown below. The laser apertures for the sample and ancillary reagent barcode scanners are directed into the system away from the operator. During normal operation, reflections from the sample barcode scanner laser beam may be visible to persons in the immediate area, but no laser safety hazard is associated with this exposure. The laser aperture for the primary reagent barcode scanner is directed toward the barcode labels at the end of the reagent packs inside the primary reagent compartment.

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During normal operation, the barcode scanner does not scan the reagent packs until the primary reagent compartment door is closed. When the primary reagent compartment door is closed, no operator exposure to the laser exists.

1 2 3

Primary Reagent Barcode Scanner Sample Barcode Scanner Ancillary Reagent Barcode Scanner

Figure A-3

Class 1 and Class 2 Laser Hazard Labels

Hand-held Barcode Scanner ADVIA Centaur XP Operator’s Guide procedures that use the hand-held barcode scanner are introduced with the following laser warning: LASER WARNING

Never look directly at the beam of a hand-held barcode scanner or point the scanner at another person. Also, do not look at the reflection of the beam from a shiny surface. Only trained field service personnel should perform procedures related to laser assemblies. For more information about laser safety, refer to Appendix A, Protecting Yourself from Barcode Scanner Lasers.

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This table contains a summary of the specifications for the laser optical assembly in the ADVIA Centaur XP hand-held barcode scanner: Characteristic

Specification

Maximum Power Output

1.0 mW

Wavelength

650 nm

Pulse Duration

7.4 ms

Units of Beam Divergence

2mr

The laser aperture and laser safety label for the hand-held barcode scanner are on the other side of the barcode scanner window:

Hand-Held3

1

Barcode scanner window.

Figure A-4

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1

Handheld Barcode Scanner Laser Warning Label

Appendix B: Service, Ordering, and Warranty This section provides the following information: •

address of the Siemens authorized representative, which is the Siemens contact within the European community

•

addresses for obtaining service and technical information and for ordering supplies

•

system warranty and service delivery policy information

Siemens Authorized Representative Siemens Medical Solutions Diagnostics Chapel Lane, Swords, Co. Dublin, Ireland

Limited Instrument Warranty and Service Delivery Policy Siemens Medical Solutions Diagnostics and its authorized distributors may provide customers who acquire new Siemens instruments with a limited warranty either in a specific agreement or in standard language on their invoices. This limited warranty is designed to protect customers from the cost associated with repairing instruments that exhibit malfunctions due to defects in materials and/or workmanship during the warranty period. Siemens Medical Solutions Diagnostics, at its election, provides warranty service either by providing repair service of the instrument on site, or by exchanging the defective instrument or component, subject to the limitations and exclusions set forth in Replacement of Parts and Warranty and Service Exclusions below. Repairs, replacements or exchanges of instruments or components provided during the warranty or any additional service period, does not extend the warranty or service period beyond the initially agreed upon period. When the customer calls for service, the Siemens representative or authorized distributor informs the customer of the type of service available for the customer’s instrument, and instructs the customer as to how to obtain that service.

Warranty Period The limited warranty period generally commences upon installation of the original instrument at the customer’s location and extends for a period of 1 year thereafter, unless otherwise specifically agreed to by and between Siemens Medical Solutions Diagnostics (or its authorized distributors) and customer in a writing signed by duly authorized representatives of both parties (sales representatives are generally not authorized representatives of Siemens for these purposes).

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Additional Service Period The customers, with some exceptions, may purchase additional service coverage beyond any initial warranty period as part of the original instrument acquisition for second or subsequent years beyond the original installation date. The customer’s original Purchase Invoice or appropriate Agreement Addendum must indicate the term in months for additional service coverage.

Service During Normal Hours The customer may obtain service for instruments during normal business hours by contacting the nearest Siemens Medical Solutions Diagnostics location or authorized distributor. Refer to the list of Siemens locations in this section.

Extent of a Service Call Warranty or service calls generally include onsite repair or exchange of instruments or components, travel to the location of the instrument, and onsite labor during normal business hours. A warranty or service call is initiated by the customer by following the instructions on how to obtain service for the customer’s instrument. The service call is considered complete when any defects in material or workmanship have been corrected by repair or replacement and the instrument conforms to the applicable specifications. When service is complete, the customer receives a copy of the documentation detailing all work performed by the Siemens Medical Solutions Diagnostics representative or authorized distributor.

Service Outside Normal Hours Customers, with some exceptions, may also request service to be delivered or an exchange to be initiated outside normal business hours, including evenings, weekend days, or nationally observed holidays, by contacting the nearest Siemens Medical Solutions Diagnostics location or authorized distributor. Service performed outside normal hours is subject to a surcharge unless the customer has in place a service product option that provides service at the time requested.

Replacement of Parts In performing service, Siemens Medical Solutions Diagnostics or its authorized distributors provide appropriate parts to repair the instrument, or arranges for the exchange of the instrument or affected parts, at no charge with the exception of certain parts or subassemblies that are considered Customer Maintenance Items. Customer Maintenance Items include, but are not limited to, the following items: lamps, electrodes or sensors (which are covered by a separate warranty), reagents, calibrators, controls, paper, and pens. Consult the appropriate system operator’s manuals for a complete list of Customer Maintenance Items for any specific model of instrument.

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Design Changes and Retrofitting of Instruments Siemens Medical Solutions Diagnostics reserves the right to change the design or construction of specific models of instruments at any time without incurring any obligation to make such changes available to individual customers or instruments. If Siemens notifies customers of a change that improves the performance or reliability of their instrument, and requests to retrofit that instrument, the customer must agree to allow Siemens or an authorized distributor, at Siemens’ expense, to retrofit components or make design changes, which does not adversely affect the instrument’s performance characteristics.

Key Operator Designation Each customer designates a key operator who is available to Siemens representatives to describe instrument malfunctions by telephone and/or to perform simple adjustments and corrections as requested. If a key operator is not designated or is unavailable when the customer requests service, the delivery of service may be delayed.

OSHA Requirements (US only) When service is required at a customer location, the customer must provide the Siemens representative with adequate facilities that comply with the regulations of the Secretary of Labor under the Occupational Safety and Health Act (OSHA) of 1970, as amended.

Warranty and Service Exclusions The following exclusions are in addition to any exclusions provided for in any written warranty or service agreement. IF ANY OF THE FOLLOWING EVENTS OCCUR, THE WARRANTY OR SERVICE PROVISIONS DO NOT APPLY: 1. Repairs or modifications have been made to the instrument by someone other than an authorized Siemens Medical Solutions Diagnostics representative. 2. The instrument has been operated using accessories and supplies other than Siemens brand accessories, or consumable supplies and/or reagents not having the same grade, quality, and composition as defined in the system operator’s manuals. 3. Siemens Medical Solutions Diagnostics has notified customers of a change that improves the performance or reliability of their instrument and customer has not agreed to retrofit or make design changes to the instrument. 4. Customer did not purchase the instrument from Siemens Medical Solutions Diagnostics or one of its authorized distributors. 5. The instrument has not been installed within 90 days of shipment to the customer’s facility unless otherwise specified.

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6. The customer has not performed appropriate customer maintenance procedures, as outlined in the system operator’s manuals. 7. The instrument has been misused or used for a purpose for which it was not intended. 8. The instrument has been damaged in transit to the customer or damaged by the customer while moving or relocating it without supervision by a Siemens representative. 9. Damage was caused by floods, earthquakes, tornados, hurricanes, or other natural or man-made disasters. 10. Damage was caused by Acts of War, vandalism, sabotage, arson, or civil commotion. 11. Damage was caused by electrical surges or voltages exceeding the tolerances outlined in the system operator’s manuals. 12. Damage was caused by water from any source external to the instrument. 13. The customer has purchased an alternative agreement whose terms of warranty or service supersede these provisions. Siemens Medical Solutions Diagnostics or its authorized distributors can invoice customers, at current standard labor and parts rates, for instruments repaired to correct damage or malfunctions due to any of the reasons listed above. OTHER THAN AS STATED ABOVE, THERE ARE NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE INSTRUMENT, ITS SALE TO THE CUSTOMER, ITS LEASE TO THE CUSTOMER, OR THE SALE OF THE INSTRUMENT TO THE CUSTOMER AT THE EXPIRATION OR TERMINATION OF THE LEASE AGREEMENT. SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS’ LIABILITY FOR BREACH OF ANY WARRANTY OR SERVICE AGREEMENT SHALL BE LIMITED ONLY TO THE REPAIR OR REPLACEMENT OF DEFECTIVE EQUIPMENT AND SHALL NOT INCLUDE ANY DAMAGES OF ANY KIND, WHETHER DIRECT, INDIRECT, INCIDENTAL, CONTINGENT, OR CONSEQUENTIAL. SIEMENS SHALL NOT BE LIABLE FOR DELAY FROM ANY CAUSE IN PROVIDING REPAIR OR EXCHANGE SERVICE. ANY LIMITATIONS OR OTHER PROVISIONS NOT CONSISTENT WITH APPLICABLE LAW IN PARTICULAR JURISDICTIONS OR A SPECIFIC WRITTEN AGREEMENT DO NOT APPLY TO CUSTOMERS IN THOSE JURISDICTIONS OR SUBJECT TO THOSE AGREEMENTS.

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Information for Technical Assistance Refer to the procedures in this appendix to provide system information that you may need when you call for technical assistance.

Printing the System Serial Number and Versions Use this procedure to print information about the system, such as the serial number and the current version of software used on your ADVIA Centaur XP system. 1. At the workspace, select System Status. 2. Select About the System. 3. At the workspace, select Print. 4. Select Print Workspace. The serial number is displayed on the System Status button. The version information is displayed at the About the System window.

Printing the Event Log Use this procedure to print the list of system events displayed at the System – Event Log window. You can display specific information at the System – Event Log window by selecting the appropriate View and Sort combinations: •

The View that you select determines the information that the system displays. For example, if you select Errors, the system displays only the events that are errors.

•

The Sort that you select determines the order in which the system displays the events. For example, if you select Severity, the system displays the events in order of most severe to least severe.

The following table describes the View and Sort combinations you can use to perform some routine tasks: Task

View

Sort

Display the events in reverse chronological in order of when the events occurred

Events

Date

Display the critical and warning events in order of most severe to least severe

Errors

Severity

Display the events by subsystem

Events

Subsystem

1. At the workspace, select Event Log. 2. Select the appropriate view and identify the problem you want to solve. To search for a specific event code in the event log, select Event Code in Search for and then enter the event code.

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3. Select Print. 4. Select Print Workspace.

Printing Windows on the Workspace Use this procedure to print the workspace, including any windows that are open. Windows that can be helpful in resolving problems include Quality Control – Data, Calibration – Summary, Calibration – Data, and Worklist – Summary. Open the appropriate windows before you print the workspace. 1. At the workspace, select Print. 2. Select Print Workspace.

Printing a Runtime Report Use this procedure to print the report of all results generated (including replicates, ratios, and means) for all samples run. 1. At the workspace, select Print. 2. Select Report Options. 3. At the Print – Report Options window, select Runtime Report. 4. Select Print Report.

Printing Calibration Data You can print detailed information on specific calibration data as described in Section 5, Calibration.

Contacts This section provides the following information: •

the address of the Siemens authorized representative, which is the Siemens contact within the European community

•

the Siemens addresses for obtaining service and technical information and for ordering supplies

Siemens Authorized Representative Siemens Diagnostics Europe Limited Chapel Lane, Swords, Co. Dublin, Ireland

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Addresses For technical assistance contact your local technical support provider. For customer service or additional information contact your local technical support distributor.

Siemens Medical Solutions Diagnostics 511 Benedict Avenue Tarrytown, NY 10591 Siemens Medical Solutions Siemens Medical Solutions Diagnostics Pty Ltd ABN 65 007 436 651 885 Mountain Highway Bayswater Victoria 3153 Australia

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Appendix C: Reagents and System Fluids Handling Reagents This information describes handling requirements for the following ADVIA Centaur XP reagents.

Primary ReadyPackTM Reagent Packs •

Unpierced

•

Pierce

Ancillary ReadyPack Reagent Packs •

Unpierced

•

Pierced

• WARNING

Use care when using diagnostic tools or performing troubleshooting. System

components move and can cause injury. Only Siemens-trained personnel should perform troubleshooting

Primary Reagent Packs During storage the particles in the Solid Phase reagent settle as a pellet at the bottom of the primary reagent pack. These particles must be resuspended homogeneously before use to provide maximum reagent and assay efficiency. Observe the bottom of the primary reagent pack and note the pellet on the bottom of the pack. Mix all primary reagent packs by hand before loading them onto the system. You can hold and mix up to 6 reagent packs at a time. It is important to minimize foaming. Perform the following mixing procedure gently to resuspend the particles. Do not shake the primary reagent pack unless stated to do so in the product instructions.

Unpierced For all other assays, use this procedure if the primary reagent pack is unpierced. 1. With the film side up, hold the reagent pack loosely at the ends with the thumb and index or middle finger of each hand. 2. Carefully raise 1 end of the pack 90× so that the pack is in a vertical position.

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3. Carefully raise the other end of the pack 90× so that the pack is again in a vertical position. Carefully return the pack to a horizontal position. 4. Repeat steps 2 and 3 a minimum of twenty times or until: •

the pellet is broken up and no longer visible on the bottom of the pack

•

no large aggregates are visible floating inside the pack.

5. Adjust the mixing speed to minimize foaming. 6. Mix 5 to 10 times more to ensure complete mixing. 7. Load the unpierced primary reagent pack onto the system. When testing is complete you may remove the reagents from the system or leave them on the system. If you remove the reagents, cover the pierced film area of the primary reagent pack with self-sealing laboratory film and place the pack in the reagent storage tray at 2 to 8×C. Store pierced primary reagent packs upright in the storage tray to minimize spillage. Follow the pierced primary reagent pack procedure before placing the reagent pack back on the system. Reagents left on a system with the power on are automatically mixed by the system and do not require further mixing.

Pierced Use this procedure if the primary reagent pack is pierced. 1. Press gently on the self-sealing laboratory film that covers the pierced film area while mixing. This prevents reagent leakage. 2. With the film side up, hold the reagent pack loosely at the ends with the thumb and middle finger of each hand. 3. From a horizontal position, carefully raise 1 end of the pack 45× and carefully return the pack to a horizontal position. 4. Carefully raise the other end of the pack 45× and carefully return the pack to a horizontal position. 5. Repeat steps 3 and 4 a minimum of twenty times or until 1 of the following actions is true: •

the pellet is broken up and no longer visible on the bottom of the pack.

•

no large aggregates are visible floating inside the pack.

6. Adjust the mixing speed to minimize foaming. 7. Mix 5 to 10 times more to ensure complete mixing. 8. Remove the self-sealing laboratory film and load the pierced reagent pack onto the system.

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When testing is complete you may remove the reagents from the system or leave them on the system. If you remove the reagents, cover the pierced film area of the primary reagent pack with self-sealing laboratory film and place the pack in the reagent storage tray at 2 to 8×C. Store pierced primary reagent packs upright in the storage tray to minimize spillage. Follow the pierced primary reagent pack procedure before placing the reagent pack back on the system. Reagents left on a system with the power on are automatically mixed by the system and do not require further mixing. NOTE: If reagent mixing is turned off for longer than 2 hours but reagent refrigeration remains on, mix all primary reagent packs following the unpierced/ pierced primary reagent pack procedures and place the reagent packs back on the system. Verify reagent performance based on acceptable quality control results or by criteria established for your laboratory.

If both reagent mixing and reagent refrigeration are turned off for longer than 2 hours, put the primary reagent packs in the reagent storage tray at 2 to 8×C. Mix all primary reagent packs following the unpierced/pierced primary reagent pack procedures before placing the reagent packs back on the system. Verify reagent performance based on acceptable quality control results or by criteria established for your laboratory. NOTE: The onboard stability of a primary reagent pack is calculated from the time that the system reads the barcode after the reagent pack is placed on the system for the first time. If a pack is removed from the system, it is recommended that you reload the pack onto the same system. If you load the reagent pack onto a different system, you must track onboard stability and you must adjust reagent test inventory to account for tests previously removed from the pierced reagent pack while on the other system.

Ancillary Reagent Packs Mix all ancillary reagent packs by hand before loading them onto the system.

Unpierced Gently invert ancillary reagent packs several times before loading them into the ancillary queue. It is important to minimize foaming. Do not shake the ancillary reagent pack. When testing is complete you may remove the reagents from the system or leave them on the system. If you remove the reagents, cover the pierced film area of the ancillary reagent pack with self-sealing laboratory film and store the pack at 2 to 8×C. Store pierced ancillary reagent packs upright to minimize spillage. Follow the pierced ancillary reagent pack procedure before placing the reagent pack back on the system.

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Pierced Use this procedure if the ancillary reagent pack is pierced. 1. Press gently on the self-sealing laboratory film that covers the pierced film area while mixing. This prevents reagent leakage. 2. Gently invert the pack several times. 3. Remove the self-sealing laboratory film and load the pierced ancillary reagent pack onto the system. When testing is complete you may remove the reagents from the system or leave them on the system. If you remove the reagents, cover the pierced film area of the ancillary reagent pack with self-sealing laboratory film and store the pack at 2 to 8×C. Store pierced ancillary reagent packs upright to minimize spillage. Follow the pierced ancillary reagent pack procedure before placing the reagent pack back on the system. Do not add reagent to ancillary reagent packs. Each ancillary reagent pack contains enough reagent to process a predetermined number of tests. Each time the system accesses an ancillary reagent pack, reagent volume inventory tracks the amount of reagent used until the pack is empty. The system does not recognize additional fluid placed in an ancillary reagent pack. NOTE: If reagent refrigeration is turned off for longer than 2 hours, store the ancillary reagent packs at 2 to 8×C. Mix all ancillary reagent packs following the unpierced/pierced ancillary reagent pack procedures before placing the reagent packs back on the system. Verify reagent performance based on acceptable quality control results or by criteria established for your laboratory. NOTE: The onboard stability of an ancillary reagent pack is calculated from the time that the pack is first pierced. If a pierced pack is removed from the system, it is recommended that you reload the pack onto the same system. If you load the reagent pack onto a different system, you must track onboard stability and you must adjust reagent volume inventory to account for any reagent previously removed from the pierced reagent pack while on the other system.

Reagent Water Quality Water quality is an important consideration in the laboratory because it can significantly affect the outcome of laboratory procedures and the measurement of patient samples. This document provides an overview of reagent water quality guidelines as specified by the Clinical Laboratory and Standards Institute (CLSI, formerly NCCLS).1 Use these guidelines to evaluate the reagent water quality in your laboratory and to determine the best method for obtaining the water quality you need.

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Good laboratory practices suggest that you establish a protocol that supports the manufacturer’s requirement for the instrument to: •

ensure optimum performance of automated laboratory instruments

•

eliminate water quality as a source of problems when troubleshooting

•

help you to meet requirements for state and federal laboratory certification

What is Reagent Water? Reagent water is laboratory water that meets specifications for clinical laboratory use.2,3 The CLSI has defined 3 grades of reagent water: •

Type I, the highest grade

•

Type II, the intermediate grade

•

Type III, the lowest grade

NOTE: The ADVIA Centaur XP supports the use of Type I and Type II grade reagent water.

The following table lists the CLSI specifications for the 3 types of reagent water. Use this information to determine the water quality in your laboratory. Refer to the CLSI guidelines for common laboratory uses of Type I, Type II, and Type III reagent water. Specification

Type I

Type II

Type III

Maximum bacterial content colony forming units per mL (CFU/mL)*

10 (preferably bacteria free)

1000

not applicable

pH

not applicable

not applicable

5.0–8.0

Minimum resistivity (megohm/centimeter at

10 (inline measurement by sensor or resistor)

1.0

0.1

Maximum silicate (mg/L)‡

0.05

0.1

1.0

Particulate matter (µm)§

smaller than 0.22 µm (water is passed through a 0.22 µm filter)

not applicable

not applicable

Organic compounds**

pretreat with activated carbon or distillation or reverse osmosis

not applicable

not applicable

25 ºC)†

* *

*Bacterial content: The number of colony forming units in water. Bacterial content is a water contaminant you measure to determine water quality. †Resistivity: The ability of water to resist electrical conduction due to the ion content. Resistivity is the standard test measurement for determining water quality. The higher the resistivity, the lower the ion content and the better the water quality.

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* * *

‡Silicates: Compounds you remove to produce Type I reagent water. §Particulate matter: Undissolved (insoluble) substances larger than 0.22 µm are removed by the filter. **Organic compounds: Compounds you remove to produce Type I reagent water.

Purifying Water As with all diagnostic testing procedures, good laboratory practices suggest that you establish a protocol that supports the manufacturer’s requirements for selecting the appropriate type of reagent water. You can then produce reagent water in your laboratory by setting up and maintaining a water purification system which uses the purification methods described in the following table. The following table describes some of the typical laboratory water purification methods. Method

Description

Distillation

Changes water from liquid to vapor and leaves behind impurities such as particulates and bacteria

Deionization

Uses synthetic resins to remove ionized impurities by ion exchange

Reverse Osmosis

Forces water under pressure through a semipermeable membrane to remove dissolved solids and organic impurities

Adsorption

Uses activated carbon, clays, silicates, or metal oxides to remove organic impurities

Filtration

Forces water through a semipermeable membrane to remove insoluble matter, emulsified solids, pyrogens, and microorganisms

The quality of the reagent water you produce depends on the quality of the water you start with (source water), and the performance of your water purification system. To produce the type of water you require, you may need a purification system that uses a combination of methods. For example, if you want to produce Type I water, you need a system that uses adsorption to remove organic impurities, deionization to remove ionized impurities, and filtration to remove particulates.

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Figure C-1 displays a water purification system that combines adsorption, deionization, and filtration to produce Type I water.

1 2 3 4 5 6 7 8 9 10

Pump Source Water Check Valve Flow Controller Resistivity Indicator Valve Filter Type I Water Output Ion Exchange Carbon

Figure C-1

Water Purification System

Maintaining Water Quality You can ensure that the reagent water supply in your laboratory consistently meets CLSI guidelines by: •

storing reagent water properly

•

testing for resistivity and contamination

•

maintaining your water purification system

Establishing procedures for maintaining reagent water quality is also required for laboratory inspection and accreditation by the College of American Pathologists (CAP).4

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ADVIA Centaur XP Operator’s Guide: Reagents and System Fluids

Storing Reagent Water You cannot store Type I reagent water. Use it immediately after you produce it because it degrades quickly and no longer meets Type I reagent water specifications. Additionally, you cannot purchase Type I reagent water because its purity is not reliable. Store Type II and Type III reagent water in glass or polyethylene bottles. Use it as soon as possible after preparation to reduce the risk of contamination by microorganisms.

Testing Reagent Water To monitor water quality and detect problems with your water purification system, test reagent water regularly for resistivity and bacterial contamination. You may also want to send reagent water out of the laboratory periodically for independent evaluation. Record your test results and any corrective action. Refer to the CLSI specifications for information about recommended water testing methods.1

Maintaining the Purification System Efficient operation and regularly scheduled maintenance of your water purification system is the key to optimizing the performance of the system and consistently obtaining reagent quality water. Preventative maintenance reduces the chance of the purification system introducing additional contaminants into source water and ensures that reagent water retains its purity when it is introduced into the laboratory instrument. The following are suggested guidelines for maintaining water purification systems to ensure smooth operation and prevent system problems. For Customized Water Systems: •

Change filters on carbon or membrane filter systems as required.

•

Use a recirculating pump to optimize performance and reduce contamination.

•

Filter the source water before treatment in reverse osmosis systems, and recirculate deionizers in closed loops to extend resin life.

For Distillation Systems: •

Check the water vessels regularly for the presence of a slippery film.

•

Clean and disinfect the vessels as required with an agent that rinses well, such as H2O2.

•

Clean the boiler regularly to remove deposits

•

Test routinely for contamination

For complete information about operation and maintenance requirements for your water purification system, refer to the manufacturer’s specifications.

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Problems Caused by Water Using water that does not meet CLSI guidelines can cause problems with clinical laboratory systems. Some common problems include: •

contamination of system components

•

inaccurate patient and calibration results

•

out-of-range quality control results

•

deterioration of lyophilized quality control material

•

color changes and poor stability and performance of reagents

These problems are caused by failure to use the appropriate type of reagent water, bacterial contamination, and inadequate maintenance of the water purification system. Refer to the troubleshooting section in your system manual for more detailed information about problems caused by water that does not meet reagent water specifications.

References 1. Clinical and Laboratory Standards Institute (formerly NCCLS). Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline- Third Edition. NCCLS document C3-A3 (ISBN 1-56238-336-1). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 1997. 2. Tietz, Norbert W. Fundamentals of clinical chemistry, 3rd ed. Philadelphia: W.B. Saunders Company; 1987. 1010 p. 3. Kaplan, Lawrence A. Pesce, Amadeo J. Clinical Chemistry; theory, analysis, and correlation, 2nd edition. St. Louis: C.V. Mosby Company; 1989. 1212 p. 4. College of American Pathologists, Laboratory General Inspection Checklist Section 1, Quality of water, p. 8. Northfield, IL. 1989.

SI Unit Conversion Factors This appendix provides the SI (system international) unit conversion factors, which convert Mass/IUPAC units to SI units. CAUTION

Do not enter values in SI units when you enter Master Curve data or calibrator assigned values. Using SI units may cause erroneous results. NOTE: Do not enter an SI conversion factor for assays that do not list a factor. The system does not accept an SI conversion factor for these tests.

If you report results in SI units, enter the appropriate units and conversion factor for each test at the Test – Result Calculation window.

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ADVIA Centaur XP Operator’s Guide: Reagents and System Fluids

NOTE: Some assays are not available for some locales. Assay

Common Units

SI Units

Conversion Factor

AFP

ng/mL

IU/mL

0.83

Allergy Screen (ALSCRN)

mIU/mL

mIU/mL

1

BNP

pg/mL

pmol/L

0.289

BR (CA 15-3®)

U/mL

U/mL

1

CA 125 II™

U/mL

U/mL

1

CA 15-3

U/mL

U/mL

1

CA 19-9™

U/mL

U/mL

1

Carbamazepine (CARB)

µg/mL

µmol/L

4.23

CEA

ng/mL

µg/L

1

CKMB

ng/mL

nmol/L

0.0125

Cortisol (COR)

µg/dL

nmol/L

27.59

C-peptide (CpS)

ng/mL

ng/mL

1

Digitoxin (DGTN)

ng/mL

nmol/L

1.307

Digoxin (DIG)

ng/mL

nmol/L

1.28

Estradiol-6 (E2-6)

pg/mL

pmol/L

3.67

Estradiol-6 III (E2-6 III)

pg/mL

pmol/L

3.67

Ferritin (FER)

ng/mL

pmol/L

2.20

Folate (FOL)

ng/mL

nmol/L

2.265

FrT4

ng/dL

pmol/L

12.9

FSH

mIU/mL

IU/L

1

FT3

pg/mL

pmol/L

1.54

Gentamicin (GENT)

µg/mL

µmol/L

2.09

Her-2/neu (H2n)

ng/mL

ng/mL

1

HAV Total (aHAVT)

mIU/mL

mIU/mL

1

HAV IgM (aHAVM)

S/CO

S/CO

1

HBc Total (HBcT)

Index

none

1

HBc IgM (aHBcM)

Index

none

1

Anti-HBs (aHBs)

mIU/mL

mIU/mL

1

HBs AG (HBs)

Index

none

1

HBS AG Confirmatory (Conf)

Index

none

1

HCV

Index

none

1

HCY

µmol/L

µmol/L

1

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Assay

Common Units

SI Units

Conversion Factor

HIV 1/0/2 Enhanced (eHIV)

Index

none

1

Total IgE (tIgE)

IU/mL

IU/mL

1

Intact PTH (iPTH)

pg/mL

pmol/L

0.106

Insulin (IRI)

mU/L

mU/L

1

LH

mIU/mL

IU/L

1

Myoglobin (MYO)

ng/mL

µg/L

1

Phenobarbital (PHNB)

µg/mL

µmol/L

4.31

Phenytoin (PHTN)

µg/mL

µmol/L

3.96

Progesterone (PRGE)

ng/mL

nmol/L

3.18

Prolactin (PRL)

ng/mL

µIU/mL

21.2

PSA

ng/mL

µg/L

1

cPSA

ng/mL

µg/L

1

Rubella G (Rub G)

IU/mL

IU/mL

IU/mL

Rubella M (Rub M)

Index

none

1

Specific IgE (sIgE)

kU/L

kU/L

1

T3

ng/mL

nmol/L

1.54

T4

µg/dL

nmol/L

12.9

anti-TG (aTG)

U/mL

U/mL

1

anti-TPO (aTPO)

U/mL

U/mL

1

Testosterone (TSTO)

ng/dL

nmol/L

0.0347

Theophylline 2 (THEO-2)

µg/mL

µmol/L

5.55

TnI-Ultra™

ng/mL

µg/L

1

Tobramycin (TOBR)

µg/mL

µmol/L

2.14

Total hCG (ThCG)

mIU/mL

IU/L

1

Toxoplasma G (Toxo G)

IU/mL

IU/mL

1

Toxoplasma M (Toxo M)

Index

none

1

TSH

µIU/mL

mIU/L

1

TSH-3

µIU/mL

mIU/L

1

TUp

Index

none

1

Valproic Acid

µg/mL

µmol/L

6.93

Vancomycin

µg/mL

µmol/L

0.69

VB12

pg/mL

pmol/L

0.738

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Sample Volume Requirements For assays processed on the ADVIA Centaur XP system, the minimum required sample volume for a reportable result depends on the following factors: •

sample volume for the assay

•

sample volume needed to prime the sample tip

•

volume of unusable sample for the sample container.

Determining Minimum Sample Volume Use this information to calculate the minimum required volume (MRV) for a reportable result. The sample volume for each assay is specified in the ADVIA Centaur Assay Manual. Refer to Table 1 to determine the tip prime volume and the unusable volume for the specific tube type and sample volume. NOTE: If you selected To Maximize the Number of Tests Completed at the Setup – Sample Handling Options window, use the unusable volume corresponding to the largest sample volume scheduled for that sample. To reduce the unusable volume for samples select To Minimize the Unusable Volume at the Setup – Sample Handling Options window.

•

For a single replicate of 1 test, use the following formula: Sample Volume + Tip Prime Volume + Unusable Volume = MRV

For example, for a TSH-3 scheduled in a small transfer tube, the values are as follows: 200 µL + 20 µL + 100 µL = 320 µL

•

For multiple replicates of 1 test, use the following formula: (Sample Volume + Tip Prime Volume) × No. of Replicates + Unusable Volume = MRV

For example, for 2 replicates of a T4 scheduled in a large transfer tube, the values are as follows: (25 µL + 10 µL) × 2 + 250 µL = 320 µL

•

For multiple tests scheduled for a sample, use the following formula: Sum of (Sample Volume + Tip Prime Volume) for all replicates for all tests + Unusable Volume = MRV

For example, for 2 replicates of a TSH-3 and 3 replicates of a T4 scheduled in an SMSD Sample Cup, the values are as follows: (200 µL + 20 µL) × 2 +(25 µL + 10 µL) × 3 + 150 µL = 695 µL

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Sample Volume Requirements NOTE: It is not necessary to pour off serum from serum gel separator tubes. However, the unusable volume depends on the position of the gel separator layer. Set the probe position so that the lowest probe travel position is above the gel layer. Sample Tube Type*

Sample Volume

Tip Prime Volume

Unusable Volume

Sample Cup SMSD

≤ 50 µL > 50 µL

10 µL 20 µL

50 µL 150 µL

Small Transfer

≤ 50 µL > 50 µL

10 µL 20 µL

100 µL 100 µL

Large Transfer

≤ 50 µL > 50 µL

10 µL 20 µL

250 µL 450 µL

Hitachi

≤ 50 µL > 50 µL to 100 µL > 100 µL

10 µL 15 µL 20 µL

50 µL 50 µL 100 µL

Sarstedt S

≤ 50 µL > 50 µL

10 µL 20 µL

100 µL 125 µL

Sarstedt C

≤ 50 µL > 50 µL

10 µL 20 µL

50 µL 50 µL

Olympus Sample Cup

≤ 50 µL > 50 µL

10 µL 20 µL

150 µL 125 µL

SmithKline Beecham

≤ 50 µL > 50 µL

10 µL 20 µL

200 µL 300 µL

*

Refer to Appendix E, Specifications, for the list of tube types you can use.

System Fluids The fluids described in the table below are for In Vitro Diagnostic Use only. Use the fluids until the expiration date stated on the bottle labels. Use Acid and Base reagents until the expiration date stated on the bottle label or until 28 consecutive days after loading the reagent on the system. Dispose of Acid and Base reagents and cleaning solution using approved disposal techniques for hazardous corrosive liquid wastes. Dispose of Acid and Base reagents in accordance with local, state, and federal regulations. Refer to the Material Safety Data Sheets for each material for additional information.

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Siemens Medical Solutions Diagnostics is not responsible for the performance of the ADVIA Centaur XP system when reagents other than Acid and Base reagents are used. WARNING

Do not allow contact of Acid and Base reagents with skin and eyes. Acid and Base reagents are irritating to the skin. Wear suitable eye, face, and skin protection, which include wearing gloves, protective eye shield, and laboratory coat. In case of contact with the eyes, rinse the eyes immediately with plenty of water and seek medical advice. In case of accident or if you feel unwell, seek medical advice. If possible, show the bottle label and the Material Safety Data Sheet. In case of accidental ingestion of reagent, call a physician immediately. Fluid Name

Volume

Ingredients

Storage

Acid Reagent

1500 mL 5000 tests/bottle

0.5% hydrogen peroxide 0.1 N nitric acid

4–25 ºC

Base Reagent

1500 mL 5000 tests/bottle

< 0.25 N sodium hydroxide and surfactant

4–25 ºC

Wash 1 Reagent

2500 mL

phosphate buffered saline (pH 7.2) with < 0.1% sodium azide and surfactant

4–25 ºC

Wash 3 Reagent

2500 mL

phosphate buffered saline (pH 7.4) with < 0.1% sodium azide and surfactant

4–25 ºC

Cleaning Solution Concentrate

100 mL

~52.5 g/L sodium hypochlorite

2–8 ºC

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Appendix D: Supplies The following is a list of supplies with catalog numbers and REF to assist in the ordering process. The catalog numbers in parentheses are included in the list for reference only. Description

REF

Catalog Number

Barcode Labels, Sample Identification

05296798

(23531)

Brush, Small Maintenance (10)

4934626

(27081)

Cleaning Solution Concentrate

09908593

(112748)

Cuvettes (package of 3000)

08044064

(078-K138-01)

Cuvette Waste Bin

06412376

(572615)

Filter, Air Intake

03918457

(572165)

Filter, Water

02757433

(26970)

range 001 – 100

9391302

(078-0333-01)

range 101 – 200

3828105

(078-0334-01)

range 201 – 300

8579502

(078-0335-01)

range 301 – 400

1160808

(078-0336-01)

range 401 – 500

2115415

(078-0337-01)

Organizer, Master Curve Cards, Barcode Labels, and Calibrator Cards

03364923

(672003)

Pointing Device Convertor

06097004

(115625)

Printer Paper (8.5 x 11” paper, 1-part)

02884702

(20764)

Printer Paper (8.5 x 11” paper, 3-part)

00016339

(751046)

Probe, Ancillary and Reagent

04042237

(571233)

Probe, Ungrounded Aspirate

03040281

(571843)

Probe, Grounded Aspirate

02873484

(125669)

Reagent Storage Tray

06104191

(119147)

Reagents, Acid and Base (5000 tests per bottle)

03852677

(112219)

Sample Cups (bag of 1500)

03832935

(078-K137-01)

Sample Cup Caps (package of 1000)

07286900

(672010)

Sample Racks, unlabeled (box of 60)

7609246

(078-K225-01)

Labels, Sample Rack

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Description

REF

Catalog Number

Sample Rack Handling Kit

8072505

(078-K191-01)

Sample Rack Tray

02339151

(115896)

Sample Rack Tray Holder

7247778

(078-0432-01)

Sample Rack Spring

01734022

(571638C)*

Sample Tip Waste Tube

04213589

(572258B)

Shield, Air Deflector

0177324

(078-0370-01)

Syringe Plunger, 5 mL

08621789

(112247)

Syringe Plunger, 2 mL

07121359

(112248)

Syringe Assembly, 250 µL

01776434

(26134)

Tips, Probe (box of 6480)

07413317

(078-K139-01)

Waste Bin Liner, Tip

00939496

(078-0066-02)

Waste Bin Liner, Cuvette

00942365

(078-0067-02)

Waste Bottle, Main

00528879

(078-K116-01)

Waste Bottle Fluid Sensor Assembly

00367719

(078-B029-01)

Waste Bottle Lid

2894082

(078-0359-01)

Water Bottle, Main

07319604

(078-B046-01)

Water Bottle, Reservoir

03514445

(571101)

Water Reservoir Cleaning Cover (2)

08083183

(112524)

*Only used with ADVIA Centaur racks.

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Appendix E: Specifications This section summarizes the design specifications for the ADVIA Centaur XP system.

Safety Certifications Refer to the DECLARATION OF CONFORMITY shipped with the ADVIA Centaur XP system.

Electromagnetic Compatibility (EMC) Refer to the DECLARATION OF CONFORMITY shipped with the ADVIA Centaur XP system.

Dimensions Depth

104.2 cm (41.0 in)

Height

130.9 cm (51.5 in)

Width

194.3 cm (76.5 in)

Weight

559 kg (1,232 lbs); system has casters

Environmental Specifications Ambient Operating Temperature

18.0 to 30.0 ºC

Relative Humidity

20% to 80%, non-condensing, actively controlled

Storage Temperature

0.0 to 50.0 ºC

Indoor Use Only Altitude

up to 2000 meters

Ventilation

10,000 BTU/hour

IEC 1010-1 Installation Category II IEC 1010-1 Equipment Classification Class I IEC 1010-1 Pollution Degree 2

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ADVIA Centaur XP Operator’s Guide: Specifications

Electrical Requirements Electrical Rating

220 to 240VAC ± 10% ~8A

Power Requirements

50/60Hz

Tube Types This section lists the primary sample tubes, sample transfer cups, transfer tubes, and microsample containers you can use on your system.You can specify up to 3 tube types at the Setup – Tube Type & Barcode window. Refer to Specifying Sample Tube Types‚ page 8-5. The tube type fields at the Setup – Tube Type & Barcode window list the tubes you can use on your system. The + symbol before the tube type indicates that you need to place it into a holder before loading it into the sample rack. Ensure that translucent plastic sample tubes have barcode labels or a printed label facing the barcode reader when you load the tubes onto the system. The system might not detect a translucent tube with no label or a white label with very little printing.

Pre-Set Tube Types The ADVIA Centaur XP system is pre-set to accept the following tube types when you select them at the Setup – Tube Type & Barcode window. Select this tube type...

To use this tube...

Sample Cup SMSD

14 x 100 mm

Siemens

conical

Small Transfer

12 x 75 mm

Various manufacturers

round

Large Transfer

13 x 100 mm

Various manufacturers

round

+Sample Cup Hitachi

13 x 38 mm

Hitachi

conical in 16 x 75 holder

+Microcup Sarstedt S

2.0 mL

Sarstedt

skirted in 13 x 75 holder

+Microcup Sarstedt C

1.5 mL

Sarstedt

conical in 13 x 75 holder

+EzeeNest 13 mm

1.0 mL

Elkay

conical in 13 x 75 holder

Sample Cup Olympus

14 x 100 mm

Olympus

round

Sarstedt 15 x 93

15 x 93 mm

Sarstedt

conical

Starplex Transfer

15.5 x 96.5 mm

Starplex Scientific

conical

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E-3

Instrument Adjustment for Gel Tubes A field service representative can calibrate your system for the following gel tube types. When you calibrate your system for 1 of the following tubes, the selection displays on the Tube Type drop-down lists at the Setup – Tube Type & Barcode window. Select this tube type...

To use this tube...

Large Gel

13 x 75 mm

Becton Dickinson

Vacutainer

13 x 75 mm

Sherwood Medical

Monoject

13 x 100 mm

Becton Dickinson

Vacutainer

13 x 100 mm

Sherwood Medical

Monoject, Corvac

16 x 75 mm

Becton Dickinson

Vacutainer

16 x 75 mm

Sherwood Medical

Monoject

16 x 100 mm

Becton Dickinson

Vacutainer

16 x 100 mm

Sherwood Medical

Monoject, Corvac

16.5 x 92 mm

Sarstedt

Luer Monovette

10.25 x 75 mm

Becton Dickinson

Vacutainer

10.25 x 75 mm

Sherwood Medical

Monoject

1.5 mL

Becton Dickinson

Round bottom, 13x75 holder

Small Gel

+Micro Gel 1.5mL

Additional Tube Types Requiring Instrument Adjustment You can adjust your system for up to 5 additional tube types not listed in the previous tables. Contact technical assistance if you use tube types not listed in the previous tables.

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Multiple Tube Types You can use multiple tube types in the ADVIA Centaur XP sample racks. Move the Tube-Type selector on the rack to position A to use any tube that meets the following parameters: •

maximum height of 102 mm

•

minimum inner tube diameter of 7.69 mm

•

maximum inner tube diameter of 15.5 mm

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Appendix F: System Symbols This section describes the symbols that can display on the exterior of the ADVIA Centaur XP system or on the system packaging. The symbols on the system identify the location of certain components and, where necessary, display warnings for proper operation. The symbols on the system packaging provide you with other important information. For information about symbols that appear in the ADVIA Centaur XP system workspace and windows, refer to Understanding Worklist Symbols‚ page 2-41. Symbol

Description This symbol is used for both Warnings and Cautions. • A Warning indicates the risk of personal injury or loss of life if operating procedures and practices are not correctly followed. • A Caution indicates the possibility of loss of data or damage to or destruction of equipment if operating procedures and practices are not strictly observed. This symbol alerts you to a biohazard. This symbol alerts you to a biohazard.

This symbol alerts you to the risk of exposure to lasers. This symbol alerts you to a potential electrical hazard. This symbol indicates a moving component that can cause injury. This symbol indicates the presence of a part emitting high temperature. This symbol indicates that the input electricity is alternating current. This symbol identifies the location of a protective earth (GND) conductor terminal. This symbol indicates the main power switch.

This symbol indicates that the main power supply is on.

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Symbol

Description This symbol indicates that the main power supply is off. This symbol indicates the fast stop button.

This symbol indicates the computer startup button. This symbol indicates the system hard drive.

This symbol indicates the location of the fan filter. This symbol indicates the location of the cable connections. This symbol indicates the location of a printer port. This symbol indicates the location of the barcode scanner connector. This symbol indicates the location of the laboratory information system (LIS) connector. This symbol indicates the location of the uninterrupted power supply (UPS) connector. This symbol indicates the location of the external modem connector.

CAUTION: Do not connect external devices to the user interface (UI) to real time (RT) connector. Connecting external devices can cause system damage. This symbol indicates the location of the user interface (UI) to real time (RT) connector. This connector is for system connections only.

This symbol indicates the location of the small computer system interface (SCSI) connector. This connector is not used at this time. This symbol indicates the location of the keyboard connector. This symbol indicates the location of the monitor connector. This symbol indicates the location of the sample transport system (STS) connector. This symbol indicates where ancillary reagent packs are loaded or removed. This symbol indicates the sample loading area.

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Symbol

F-3

Description This symbol indicates the Stat entry. This symbol indicates where cuvettes are loaded. This symbol indicates where sample tips are loaded. This symbol identifies the system fluid bottle for Acid reagent. This symbol identifies the system fluid bottle for Base reagent. This symbol identifies the system fluid bottle for wash 1 solution. This symbol identifies the system fluid bottle for wash 3 solution. This symbol identifies the system fluid bottle for cleaning solution.

This symbol identifies the ADVIA Centaur Cleaning Solution concentrate used to prepare the cleaning solution. This symbol identifies the water bottle. This symbol identifies the lid that provides access to the liquid waste bottle. This symbol identifies the door that provides access to the sample tip tray waste. This symbol identifies the door that provides access to the cuvette waste bin. This symbol identifies the door that provides access to the sample tip waste bin. This symbol is used as a guide for placement of the sample rack pusher in the sample entry queue when the system is configured with the ADVIA Centaur XP Universal Rack Option. This symbol indicates that the product has a temperature limitation. In this example, you need to store the product between 2 to 8 ° C. This symbol indicates that a stacking limit is present for this product. In this example, you cannot stack more than 4 products on top of 1 another.

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Symbol

Description This symbol indicates that you should protect the product from strong magnetic fields. This symbol indicates an in vitro diagnostic device or an in vitro diagnostic medical device. This symbol indicates that you should consult instructions for use.

This symbol indicates that the product is fragile and you need to handle it with care. This symbol indicates that you should keep the product dry.

This symbol indicates the number used for ordering a part or product. This symbol indicates the serial number of a part or product. This symbol indicates the revision letter of a part or product. This symbol indicates the name and location of the product manufacturer. This symbol indicates the date of manufacture of the product.

This symbol indicates the manufacturer’s authorized representative within the European community. This symbol indicates that the product or container should be oriented in the direction of the arrows.

This symbol indicates not to use the product if the package is damaged. This symbol is intended to encourage recycling. This symbol indicates that the materials are recycled.

This symbol is intended to facilitate recycling of corrugated materials. The number is licensed in Germany and printed on corrugated shippers. This symbol indicates that the package is printed with soy ink.

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Symbol

F-5

Description This symbol indicates that the product complies with the applicable directives of the European Union. This symbol indicates that the product is CSA approved for safety (Canada). This symbol indicates that the product is UL approved for safety (United States). The WEEE symbol indicates that this equipment is classified as Waste Electrical and Electronic Equipment under the European WEEE Directive. It must be recycled or disposed of in accordance with applicable local requirements.

The following symbols can also display on the exterior of the ADVIA Centaur XP system or 1 of its components. Symbol

Description This symbol indicates that the product is a Class 1 laser product, with no laser exposure during normal operation. This symbol indicates that the product is a Class 2 laser product, with potential exposure to a laser beam.

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Appendix G: Installation and Relocation CAUTION

Do not move or install your ADVIA Centaur XP system. Unauthorized movement or installation can damage your system and void your warranty and/or service contract. Unauthorized movement can also affect your instrument calibrations. A Siemens technical support provider should install or relocate your ADVIA Centaur XP system.

Contact Siemens Medical Solutions Diagnostics when you receive your ADVIA Centaur XP system or if you need to relocate your system within your facility.

Location of the I/O Panels Cables for specific components of the ADVIA Centaur XP system connect to 1 of the 3–input/output (I/O) panels located at the back of the ADVIA Centaur XP system.

1 2 3

I/O Panel at the back of the system I/O Panel on the applications module I/O Panel on the user interface module

Figure G-1

ADVIA Centaur XP System – back view

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Understanding the Input/Output Panels The I/O panels connect to each other and to other system components as in the following illustration:

1 2 3 4 5 6 7

Touch-screen monitor Keyboard Mouse Applications module User interface module Input/Output panel Handheld barcode scanner

Figure G-2

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ADVIA Centaur XP System Input/Output Connectors

ADVIA Centaur XP Operator’s Guide: Installation and Relocation

G-3

Understanding the System Input/Output Panel The System I/O panel is located at the back of the system, as shown in Figure 1-1.

1 2 3 4 5 6 7 8 9

Barcode scanner cable I/O Panel at the back of the system Touch-screen connector in Touch-screen connectors out to the Applications Module and the User Interface Module (as labeled) Video connector in Video connectors out to the applications module and the user interface module (as labeled) Keyboard connector Cable routing channel Lab Automation cable connector

Figure G-3

ADVIA Centaur XP I/O Panel

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Understanding the Applications Module Input/Output Panel The Applications module is the smaller of the two modules located at the side of the ADVIA Centaur XP, as shown in Figure 1-1.

1 2 3 4 5 6 7 8 9 10 11

AC power cord connector Temperature sensor connector Printer connector USB port Printer connector parallel port Status indicator connector Mouse connector Power switch User Interface module connector Video connectors Touch-screen connector Keyboard connector

Figure G-4

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Applications Module Input/Output Panel

ADVIA Centaur XP Operator’s Guide: Installation and Relocation

G-5

Understanding the User Interface Module Input/Output Panel The User Interface module is the larger of the two modules located at the side of the ADVIA Centaur XP, as displayed in Figure 1-1.

1 2 3 4 5 6 7 8 9

Power control connector Touch-screen connector Modem connector AC power cord connector Monitor connector User Interface (UI) to Real Time (RT) connector (This is for system connections only. Do not connect external devices to this connector.) Small Computer System Interface (SCSI) Connector (This connector is not used at this time.) Keyboard connector Printer connector

Figure G-5

User Interface Module Input/Output Panel

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Accessing the I/O Panel at the Back of the Main System The I/O panel at the back of the main system contains connectors for each of the following cables: •

barcode scanner

•

lab automation

•

Video, in and out, for the Applications module and the UI module

•

Touch screen, in and out, for the Applications module and the UI module

•

Keyboard

To access the Input/Output panel, perform the following steps: 1. At the back of the system, lift the I/O panel cover.

1

I/O Panel Cover

Figure G-6 Cover

ADVIA Centaur XP System – Back View I/O Panel Access

2. Locate the appropriate cable connector.

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Accessing the I/O Panels on the Modules The I/O panel on the user interface module and the applications module contain connectors for the necessary cables to and from system components. These connectors and cables are protected by a guard panel attached to the back of the system by 3 screws.

Accessing Both Module’s I/O Panels When you are performing extensive work to both modules, you could remove the cable panel to expose the input/output connectors and cables: 1. At the back of the system, loosen the 3 screws that secure the guard panel to the back of the system.

1

Cable panel with 3 screws

Figure G-7

ADVIA Centaur XP Cable Panel

2. Lift the cable panel away and put it safely to the side to expose the back of the 2 modules.

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Accessing a Single Module’s I/O Panel When you only are moving or checking one or two connectors on a single module, you can slide the affected module toward the front of the system to access its input/output panel. CAUTION

Do not slide the user interface module too far. You can damage the user infterface module if you slide it off the support rails. Be careful with the cables and the user interface module when sliding the user interface module. 1. At the back of the system, locate and loosen the anchor screw or screws for the selected module. The Applcations module has 1 anchor screw and the User Interface module has 2 anchor screws. These are captive screws that remain in place when you unscrew them from the module. NOTE: The figure displays the back of the system without the cable panel. In

most cases, it is not necessary to remove the cable panel.

1 2 3 4 5 6

Applications module Applications module support rail Applications module anchor screw User Interface module User Interface module support rails User Interface module anchor

Figure G-8

ADVIA Centaur XP Modules Rails and Anchor Screws

2. Slide the module toward the front of the system until the I/O panel is accessible.

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Appendix H: Glossary accept

Function used to indicate that a value is valid. For example, you can accept a result or accept an invalid calibration.

acid probe

Mechanical component that dispenses acid reagent into a cuvette to resuspend the magnetic particles and prepare the acridinium ester for light emission.

acid reagent

Solution of 0.5% hydrogen peroxide and 0.1N nitric acid. Acid reagent is added to the magnetic particles in the cuvette after the wash cycle and reacts with the acridinium ester at a low pH. This readies the acridinium ester for light emission.

acridinium ester

Chemical tag responsible for the flash when base reagent is added to the acidified magnetic particle/analyte/AE mixture in the cuvette. Abbreviation: AE.

activate

Function used to enable a test or a pack for full use on the system.

active

Available for full use on the system. An enabled test or a reagent pack can be active or inactive.

active test

Test from the menu that is enabled for use on the system.

analyte

Substance of unknown concentration in a sample.

ancillary entry

Subassembly and area of the system where the operator loads and unloads ancillary packs.

ancillary pack

Container for the additional reagents required for an assay, such as Releasing Agent, DTT, or sample diluent.

ancillary reagent

Additional reagents required for an assay, such as Releasing Agent, DTT, or sample diluent.

ancillary reagent probe

Component that aspirates ancillary reagents from the ancillary queue and dispenses them into cuvettes.

antibody

Protein (immunoglobulin molecule) produced by the body in response to the presence of an antigen. Antibodies are used as part of the body’s resistance to disease. Abbreviation: Ab.

antibody-capture assay

Antibody-antigen reaction in which the antibody of unknown concentration in a sample is captured by an additional antibody specifically directed against it. The additional antibody is bound to Solid Phase. Excess interfering substance is washed from the sample. Antigen labeled with acridinium ester is added and binds with the captured antibody from the sample. The measurable signal produced by the reaction is directly proportional to the concentration of antibody in the sample.

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antigen

Substance that stimulates the production of and combines specifically with corresponding antibodies. Abbreviation: Ag. See also immunogen.

archive

A comprehensive collection of data. A file designed for space-efficient, long-term storage.

aspirate probe

Mechanical device used to draw fluid (water or wash reagent) from the cuvette. The system has 4 aspirate probes: aspirate probe 1, aspirate probe 2, aspirate probe 3, and aspirate probe 4.

assay

Generic term that refers to the chemical analysis for a specific analyte in a sample. Each assay possesses a unique test protocol. Also called test.

assay format

The sequence of events during an assay, including incubation time, wash and aspirate cycles, and addition of reagents.

automatic dilutions

Dilutions performed by the system when a result exceeds the dilution point defined at the Test – Ranges window. Dilutions performed by the system when scheduled by the operator at the Worklist – Dilutions window.

automatic transfer

Option used to automatically send test results from the system to a remote device, or to automatically receive worklist requests from a remote device.

background

Electronic signal of the photomultiplier tube (PMT) in the absence of light.

back up

Process of copying the data files contained on the system hard disk to diskettes.

barcode

Encoded information that is read by an optical scanner.

barcode label

A label containing encoded information that is placed on reagent vials and sample cups. See also barcode.

barcode scanner

Optical device that scans and decodes barcoded information from the label on a reagent pack, a sample cup, or a primary sample tube. ADVIA Centaur barcode scanners include: ancillary barcode scanner, hand-held barcode scanner, sample barcode scanner, and reagent barcode scanner.

base probe

Mechanical component that dispenses base reagent into a cuvette causing the chemiluminescent reaction.

base reagent

Solution of < 0.25N sodium hydroxide. Base reagent is dispensed into the cuvette in the luminometer. The pH shift and accompanying electron excitation cause the chemiluminescent reaction.

batch

Method of order entry that provides the convenience of specifying 1 or more tests on multiple samples.

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baud rate

Speed of data transmission in bits per seconds (bps) between the system and a remote device.

bidirectional interface

Interface configuration allowing information to be transferred to and from another device.

buffer (chemistry)

Solution composed of a weak acid or base and its salt that is used for controlling ionic strength. Buffers maintain the pH of a solution.

buffer (electronic)

Data storage used to compensate for differences in information flow rate or in the time that events occur when data is transmitted between devices.

calibration

The use of 2 samples of known concentrations that you process on your system. The calibration data is then used to normalize your system against a stored master curve. The system calculates results from the normalized curve.

calibration curve

Data that normalizes the system against stored Master Curve data for the tested analyte. The calibration data compensates for current running conditions and instrument variability. The system calculates the required sample dose from the normalized curve.

calibration data

Details of the calibration including the SID, concentration, RLU, CV, and flags for the low and high calibrators.

calibration interval

Number of days or hours between required calibrations.

calibrator

Solution that contains a known concentration or a known reactivity of 1 or more analytes and that provides a reference for converting measured signals into concentrations. Calibrators are analyzed with reagents to obtain calibration data points. See calibration data.

Calibrator Assigned Values card

Card that contains the calibrator information for a specific lot of calibrators. The card contains the lot number and expiration date, and the high and low calibrator values for each analyte contained in the calibrator. This information is on the card in text and barcodes for you to enter in the system.

cancel

Function used to ignore changes made at a window.

catalog number

A unique number associated with each Siemens product. The number is used when ordering the product.

CD-ROM

Compact disc read-only memory. An electronic storage medium on which you can store data but does not allow you to edit or write over the data

CD-RW

Compact disc rewritable. An electronic storage medium that allows you to overwrite the current files on the CD.

central processing unit

Main printed circuit board of a computing system that interprets instructions and directs the system operations. Abbreviation: CPU.

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character parity

Transmission setting used to check for transmission errors between the system and a remote device. This setting must be the same at the system and the remote device to maintain compatibility between the systems.

check digit

Digit at the end of the barcode used to verify that the barcode was correctly scanned.

check range

Value entered in the test definition beyond which the operator can program the system to automatically repeat tests. Also called alert range or action range.

checksum

Variable, 2-digit, hexadecimal number that is part of the data link message frames and supports error detection. Variable hexadecimal number that ensures the Master Curve and the Calibrator definition values entered are valid.

chemiluminescence

Oxidation reaction of an organic chemical compound. The chemiluminescent reaction emits light.

chemiluminescent immunoassay

Assay that uses an antibody-antigen reaction to determine the presence of an analyte. The amount of analyte is quantitated by a chemiluminescent reaction.

chemiluminescent reaction

Light-emitting chemical transformation caused by the oxidation of an organic chemical compound.

coefficient of variation

Percent coefficient of variation among the replicates for a sample.

communication ports

Serial RS-232 ports on the system that can connect the system to an external, remote device, such as an LIS or a data management system.

competitive assay

Antibody-antigen reaction in which the antigen (Ag) of unknown concentration in a sample and a labeled antigen in an assay reagent compete for a limited amount of antibody (Ab) in an assay reagent. The measurable signal produced by the Ab/labeled-Ag reaction is inversely proportional to the unknown concentration of Ag in the sample. Antibody-antigen reaction in which the antibody of unknown concentration in a sample and a labeled antibody in an assay reagent compete for a limited amount of antigen in an assay reagent. The measurable signal produced by the Ag/labeled-Ab reaction is inversely proportional to the unknown concentration of Ab in the sample.

completed assay

Assay for which a valid result was generated or for which all required sample aspirations are complete. Required reagent aspirations may not have completed.

concentration

Amount of analyte measured. Abbreviation: Conc.

confidence interval

A statistical value that describes how likely the statistical results are to be accurate.

configuration

Settings of software and hardware.

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context-sensitive online information

Information that is about the operator’s current task and that is accessible without interrupting the current task.

continuous level sensing

Measurement of a wide range of resolvable fluid levels. For example, sample levels can be measured at any volume.

continuous operation

Operation allowing the system to process samples without interruptions to add or remove samples, empty waste containers, or replenish supplies.

control

Quality control material used to determine if the system is reporting valid results.

control-bracketed test

A test that requires you to begin and end a group of patient samples with a set of controls. The system does not process samples until it establishes the acceptability of the results of the start-of-bracket controls. The system does not report sample results until it establishes the acceptability of the results of the end-of-bracket controls is established.

control bracket reagent reserve

A setting that allows you to ensure that the system has enough reagent to complete the end-of-bracket controls of a control-bracketed test that is in process.

control reminder

A system reminder that you should process end-of-bracket controls soon to prevent the system from discarding retained patient test results. The control reminder applies only to control-bracketed tests. The timing for the control reminder is configurable at the Test – Definition window.

control warning

A system warning that you must process the end-of-bracket controls as soon as possible or the system discards retained patient test results. The control warning applies only to control-bracketed tests. The timing for the control warning is established by the manufacturer.

control value range

Range of acceptable results established by the quality control material manufacturer. The control value range is provided in the assay manual.

corrective action

Activity performed by the operator to solve a problem.

cursor

A bar at the window that indicates where you can enter data.

cut-off point

Medical decision point for a qualitative assay. Results above the cut-off point are reported with a different qualitative interpretation than those below the cut-off point.

cuvette

Plastic, disposable container that holds the reaction mixture on the system. The chemiluminescent reaction occurs inside the cuvette.

cycle count

Each time the sample probe picks up a sample tip, the cycle count increments by 1.

dark count

Electronic background signal of the photomultiplier tube (PMT) in the absence of light.

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data bits

Number of bits transmitted between a system and a remote device.

default value

Value defined and preset by Siemens.

define

Establish a value for a variable or symbol, or to establish what the variable represents.

delete

Function used to remove an object, such as a file, from the database.

demographics

Information about a patient or sample such as name, identification number, date of birth, sex, location, and physician.

diluent

Protein-based solution used to dilute a sample.

dilution point

See dilution setpoint.

dilution setpoint

Value that indicates the concentration beyond which the system dilutes the sample and repeats the test.

disable

Command or condition that does not allow a specific event to proceed. Function used to remove a test from the menu.

diskette drive

Device that writes information to, and reads information from, a 3.5-inch diskette.

DVD-RW

Digital Versatile Disc Rewritable. A rewritable optical storage medium having greater capacity than a CD.

enable

Command or condition that permits a specific event to proceed. Function used to add a test to the menu.

equivocal

Interpretation of a qualitative assay for which a definitive result is not possible. Certain qualitative assays have equivocal zones that are established as a range on either side of the cut-off point. Also called indeterminate. Abbreviation: Equiv.

ethernet

A network connection that allows a computer to connect to other computers on the same network.

event

System activity such as a manual operation or an error recorded by the system in the event log.

event log

List of system occurrences (events) including errors, from the most recent to the oldest. This information includes the date and time of each occurrence.

exit queue

Area on the system where sample racks are moved after leaving the inprocess queue. You can remove the sample racks from the exit queue.

expiration date

The date beyond which the manufacturer does not guarantee correct performance of the reagent or material.

firmware

Software that the system downloads to the Machine Controller boards.

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flag

Remark or message about the status of a result. The flag is next to the result at the window and on printed reports.

flash

Short burst of light produced during the chemiluminescent reaction when acridinium ester is oxidized. Acridinium ester is oxidized when the pH rapidly changes from acidic to basic with the addition of base reagent.

graphical user interface

Tool for communicating information to the operator using graphics on the system monitor. Abbreviation: GUI.

hand-held barcode scanner

System hardware tool that outputs a laser beam across a barcode and decodes the reflected laser light on return to the laser scanner engine.

hard disk drive

Device that stores data and contains all system programming.

hardware

Physical components of the system.

host query

System interface setup that specifies that the system request a remote device such as an LIS to upload requests or information.

ID

Identification. Used in SID (sample identification) and PID (patient identification).

immunoassay

Chemical test that uses an antibody-antigen reaction to determine the presence of a specific analyte or to quantify a specific analyte. The test measures an antibody or an antigen.

immunochemiluminometric assay

Type of sandwich assay in which the measurable signal produced by the reagent-labeled antibody-antigen reaction is proportional to the unknown concentration of antigen or antibody in a sample. See also sandwich assay. Abbreviation: ICMA.

immunogen

Substance of appropriate size and species specificity which, when introduced to the body, stimulates the production of antibodies. An immunogen can be an antigen or a hapten conjugated to a large protein.

inactivate

Function used to limit the use of a test or a pack on the system.

inactive

Not available for full use on the system. You can schedule only calibrators and controls for inactive tests and reagent packs.

inactive test

Test that is not enabled for use on the systems.

include

Function used to add a value for consideration with other values.

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incubation ring

Area where cuvettes are incubated at 37°C to prepare the sample and reagent for the chemiluminescent reaction. The incubation ring also positions the cuvettes for sample and reagent dispenses and magnetic particle washes and resuspensions. Also called ring.

index

Qualitative result that represents the relative concentration of an analyte based on a cutoff.

inprocess

Status of a test when the sample is in the inprocess queue and is detected by the system or the sample is in progress. Status of the system when it is processing samples.

intercept

Factor used with slope to correlate the assay results with another method. You obtain the intercept and the slope from a regression equation based on method comparison studies.

key operator

Designated operator available to Siemens representatives to describe instrument malfunctions by telephone and/or to perform simple adjustments and corrections as requested.

keyboard

System component you use to type information or to respond to a system prompt.

label

Substance coupled to an antigen or antibody that provides the measurement signal for an immunoassay.

laboratory information system

Laboratory computer system that can be interfaced to the system. Abbreviation: LIS.

light count

Measured electronic signal of the photomultiplier tube (PMT) during the chemiluminescent reaction.

light emitting diode

Electronic device made from semiconductor materials that emits light when current flows through it. Abbreviation: LED.

link

Method of directly accessing information or data. A link in the user interface transfers information to a related window based on a selection. Required data must be present for the information to transfer. In the online information system, a link is a quick way to access more information about a topic.

LIS Code

Alphanumeric code that identifies a test, profile, or calibrator to your hospital or laboratory computer.

Lite Reagent

Assay reagent containing antibody or antigen labeled with acridinium ester in buffer.

luminometer

Subassembly and component of the system where the chemiluminescent reaction occurs and is measured.

lyophilized material

A liquid material that is freeze-dried to a powder for long term stability. Reconstitute lyophilized material with water or other liquid before use.

manual dilution

A dilution of the sample made before placing the sample on the system.

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Master Curve

Multi-point curve that is generated for each lot of Solid Phase and Lite Reagent for a particular test. The Master Curve is the reference curve used to convert a measured signal into sample concentration. Calibration data normalizes the system against stored Master Curve data for the tested analyte.

minimum detectable volume

Smallest reagent or sample volume detectable by the system. Also called base volume.

modem

Device that converts the digital signals generated by the computer’s serial port to the modulated analog signals required for transmission over a telephone line and transforms incoming analog signals to their digital equivalent.

monitor

Device that produces an on-screen display.

monoclonal antibody

Antibody produced through the fusion of a myeloma cell and a B lymphocyte. Antibodies produced by a single fusion event have identical structure, affinity, and specificity for a given antigen.

nonreactive

Nonreactive result. A result below the cut-off limit for a reactive result.

normal range

See reference range.

numeric keys

Keys that are labeled with numbers and mathematical symbols and are on the right side of the keyboard.

observed limits

Range calculated by your system for each test after the fourth valid calibration of a reagent and calibrator lot combination. The system uses data from additional valid calibrations of the reagent and calibrator lot combination to continually recalculate this range.

off-system test

Test that is not run on the system but whose results are entered in the result database and printed on a patient report. You can use off-system test results in ratio tests.

optimize placement

Function that indicates where to place reagent packs so that reagent probes can most efficiently operate.

Pack ID

Identification code contained in the barcode on a reagent pack that the system recognizes as unique to that pack.

paramagnetic particles

Magnetic particles used in the Solid Phase reagent. Abbreviation: PMP.

patient identification code

Unique code that identifies the patient from whom a sample is obtained. Abbreviation: PID.

pending samples

Samples for which tests are scheduled or inprocess, but not complete.

pending tests

Tests that are scheduled or inprocess, but not complete.

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photomultiplier tube

Sensitive photodetector that captures individual photons of light. The photodetector consists of a vacuum-filled photo tube with a cathode (usually 9 diodes) and an anode that the system uses to generate a signal (pulse) during the measurement phase. The signal is directly proportional to the amount of illumination produced by the reaction and can be converted into sample concentration. Abbreviation: PMT.

photon

Unit of light; quantum of radiant energy.

PID

Patient identification code.

pointing device

Apparatus, such as a mouse or a trackball used to interact with system software through the user interface.

polyclonal antibody

Antibody produced through injection of antigen into animals.

power supply

Electronic subsystem that converts the AC voltages in the power line to the DC voltages used inside the system.

pretreatment

Process that occurs to prepare a sample for testing. For example, pretreatment can include sample dilution to meet assay requirements or addition of a pretreatment agent to a sample to protect the analyte from releasing agent.

primary pack

Primary reagent pack containing the Solid Phase and Lite Reagent.

primary sample tube

Tube used to collect patient blood samples by venipuncture.

prime

Function that introduces reagents into the fluidic system in preparation for analyzing samples.

profile

Group of related tests or a group of the same test with different dilution specifications.

prompt

Questions, instructions, or commands that help you complete the current task.

QC

Quality control.

quality control

Process of verifying the performance of the system using products containing specific analytes within a predetermined concentration range. Abbreviation: QC.

quality control material

Product containing 1 or more specific analytes with a predetermined concentration range or reactivity used to verify the performance of the system.

quality control sample

Protein-based product containing specific analytes within a predetermined concentration range used to verify the performance of the systems.

query timeout

Maximum number of seconds required for a remote device to respond to a query from the system.

rack

Sample rack. Device used to present sample tubes to the system. The sample rack contains space for up to 5 sample tubes.

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Rack ID

Positional identification code. The unique code that identifies each sample rack and the positional location of the sample in the rack. Called Rack at the windows.

random access

Mode of operation in which the system processes samples for multiple assays in the most efficient order.

ratio definition

Formula the system uses to calculate the results of a ratio test.

ratio test

Test that calculates results from the results of other tests. FTI is an example of a ratio test.

raw data

Total photon count that the system received for a flash. The raw data is not corrected.

reagent probe 1, 2, or 3

Three independent components that aspirate reagents from the primary packs and dispense them into cuvettes.

reagent water

Water that meets specification for clinical laboratory use.

reference range

Range of values for each assay from a defined population. Each laboratory should establish its own reference ranges for the diagnostic evaluation of patient results. The normal range is a reference range for the healthy population and can be defined by sex, age, or other patient attribute. Reference ranges can also exist for various pathological states. For example, there may be reference ranges for hypothyroid, euthyroid, and hyperthyroid states. The assay manual provides the expected values for each assay.

relative light unit

Counts generated when the PMT detects light during the chemiluminescent reaction. A relative light unit is calibrated against a tritium source and is unique to its measurement. Abbreviation: RLU.

replicate

Number of times that a sample is performed for a scheduled test. The system calculates the mean value from the results of the replicates of the calibrator, the control, or the patient sample.

reservoir

A container holding water, waste fluid, waste cuvettes, waste sample tips, or system fluids to allow for continuous operation while the operator empties the waste containers or replenishes the supplies.

results

Dose concentration, ratio cutoff, or qualitative answer (positive, negative, reactive, nonreactive) for an assay performed on a sample.

sample

Specimen used for testing such as a patient sample, control, or calibrator.

sample cup

Disposable container that holds patient, control, or calibrator samples.

sample identification code

Unique code that identifies each sample. Abbreviation: SID.

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ADVIA Centaur XP Operator’s Guide: Glossary

sample probe

Component that picks up a sample tip and then aspirates a sample and dispenses it into a cuvette.

sandwich assay

Antibody-antigen reaction in which the antigen of unknown concentration in a sample is sandwiched between antibody bound to solid phase and antibody labeled with acridinium ester. The measurable signal produced by the reaction is directly proportional to the concentration of antigen in the sample.

save

Function used to add an object to the database or to include updates to an object in the database.

screen

Component of the monitor that displays windows, programs, menus, data, prompts, messages, and other operating information.

search

Function used to locate an item in a list.

sign in

To enter a password or code to access the system or an area of the system.

sign out

To indicate that you are finished working in the system or an area of the system.

SI units

International system for units of measure.

SID

Sample identification.

slope

Factor used along with intercept to correlate the assay results with results from another method. You obtain the slope and the intercept from a regression equation based on method comparison studies.

software

Computer instructions that generate and carry out commands to control system operation.

Solid Phase

An assay reagent consisting of paramagnetic particles covalently bound to antigen or antibody suspended in a buffer.

sort

Function used to change the order of items in a list. For example, you can sort the worklist by patient name or by SID.

stability

Degree of a reagent’s resistance to chemical change or degradation.

startup

The events that occur when the system uses the software to initialize the hardware.

status

Information about the current operating condition of the system.

stop bits

Number of data bits that maintain synchronization between the system and a remote device during data transmission.

subsystem

A hardware functional area of the system, such as incubation ring, luminometer, and reagent probes. Machine controller boards drive subsystems.

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ADVIA Centaur XP Operator’s Guide: Glossary

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subsystem failure

Message classification category meaning subsystem failure; may be operator-recoverable. The message has a red background.

subsystem warning

Message classification category meaning subsystem goes offline if the operator does not interact. The message has a yellow background.

symbology

Set of rules for encoding information in a barcode.

system clock

Twenty-four hour clock that the system uses to monitor various system functions, such as calibration intervals, and to track the time of events.

troubleshooting

Determining the cause of a system or assay performance problem.

2-point calibration

An assay calibration that uses 2 known concentrations to normalize the Master Curve for current operating conditions.

update

Function used to overwrite information with new information. For example, when a new master test definition is issued, you update the master test definition for access to the latest version.

USB

Universal Serial Bus, provides a serial bus standard

for connecting devices, usually to a computer. valid

Acceptable. Refers to calibration results.

view

Function used to limit the items that display in a list. For example, you can display all the samples in the worklist or just samples with requests.

waive

Function that allows you to use an expired calibration.

waste bottle

Container on the system that is the main receptacle for liquid waste.

water bottle

Container on the system that holds the main supply of the reagent water.

window

Screen display area that you can independently move or manipulate. Windows can overlap each other.

worklist

List of scheduled patient samples, controls, and calibrators, including identification and requested tests for each entry.

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ADVIA Centaur XP Operator’s Guide: Glossary

Index Numerics 4676_1511_CPrmRgt 41 4677_1512_CRgtShr 38 4678_1513_CCovers 43 4679_1514_CSplRck 56 4688_1507_CAirFil 23 4693_1527_EmtyWaTrap 15 4694_1528_CWPrbCEjR 53 4695_1529_CExReagPrb 17 4696_1530_CExAncPrb 20 A accepting an invalid calibration 25 acid probe 4, 14 Acid Reagent composition 13 acid reagent dispensing 14 replacing 37 acridinium ester 33, 35 adding control requests 5 ADVIA Centaur system topview figure 4 AE antibody binding 34 air filter cleaning 23 alarms defining 38 ancillary barcode scanner 83 ancillary entry cleaning 43 ancillary pack 12, 20 barcode 9 loading 9 removing 9 storing 9 ancillary probe 4, 12 cleaning 20 ancillary queue troubleshooting 67 ancillary reagent 12 status 18 ancillary reagent entry 9

ancillary reagent pack removing 24 ancillary reagent queue 4, 9, 12 anonymous results defining 15 antibody 34 AElabeled 36 antibodycapture assay 35, 44 antigen 34, 36 aspirate probe exterior cleaning 22 aspirate probes 4, 13 cleaning 22 illustration 14 replacing 26 troubleshooting 58 aspirated message 13 assay antibodycapture 35 competitive 35, 38 reaction time 35 sandwich 35 technology 35 assay problem 103, 104 assay specific factors 106 assigned value card calibrator values 14 assigning calibrations 25, 17 authorized representative 1, 6, 7 autoexclude calibrator replicates 10 automatic dilutions defining 30 automatic runtime results report resetting page numbers 75 specifying 41 automatic sample repeats check range 25 concentration calculation range 26 defining 24 defining number of replicates 28 holding options 29 index calculation range 26 linearity 25 078D0473-03 Rev. A

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ADVIA Centaur XP Operator’s Guide: Index

sample error conditions 27 autoschedule daily cleaning procedure 3 B backing up calibration data 3 quality control data 3 reagent inventory 3 test definition 3 backing up event log 3 backing up maintenance log 3 backing up setup 3 backing up system 3 backing up tube types 3 barcode ancillary pack 9 check digit 88 color 84 error messages 78 length 87 positioning 87 quality 85 reserved 89 sample 6 scanning technique 89 size 84 specifications 83 symbology 87 troubleshooting 78 barcode labels defining custom 7 barcode read test 71 barcode scanner 16 barcode symbology selecting 6 base probe 4, 14 Base Reagent composition 13 base reagent replacing 37 batches loading sample racks 55 scheduling 55 blinking yellow status button 9

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button fast stop 5 buttons function 19 status blinking 18 task 19 workspace 17 C calibration accepting invalid 25, 17 assigning 25, 17 autoexclude calibrator replicates 10 defined ranges 6 discrepant 95 due to expire, managing 26 evaluation criteria 4 examples of managing calibrations 25 expired, managing 27 history 18 invalid, managing 25 master curve 1 observed ranges 7 print report 27 retained 8 retaining 17 software map 28 status 16 T Uptake 4 two-point 1 waiving expired 24, 17 Calibration button 19 calibration data backing up 3 printing 27 replicate results 20 review 20 status messages 20 calibration display sort 17 view 17 calibration evaluation criteria 4 calibration history 18 calibration options

ADVIA Centaur XP Operator’s Guide: Index

defining 16 calibration status 18, 20 cal required 16 current 16 due 16 expired 17, 20 expired, retained 20 historical 17, 18 invalid 17 invalid, exceeded defined ranges 20 invalid, exceeded observed ranges 20 no master curve 17 operator accepted 17 valid 20 valid, met retained cal limits 20 valid, operator accepted 20 valid, operator accepted, retained 21 valid, retained 21 waived 17, 21 calibrator autoexcluding a replicate 17 display at Worklist – Summary window 42, 25 excluding RLU 23 scheduling 56, 18 calibrator values defining 14 capacity cuvette 25 cuvette waste 25 fluid waste 25 inprocess queue 6 reagent water 25 sample exit queue 7 sample rack 6 sample tip tray waste 25 sample tip trays 25 system fluid reservoir 37 tip waste 25 central processing unit 14 check digit 88 check range defining 25 chemiluminescent

3

immunoassay 34 chemiluminescent reaction 14 Cleaning aspirate probe exterior 22 cuvette waste area 43 sample time waste area 49 water bottles and reservoirs 8 cleaning air filter 23 ancillary entry 43 ancillary probe 20 aspirate probes 22 covers 43 cuvette waste chute 43 cuvette waste reservoir 43 drip trays 43 pointing device 43 primary reagent compartment 41 probe rinse stations 34 reagent pack holders 41 reagent probe shutter 38 reagent probes 17 rinse stations 34 sample entry queue 43 sample exit queue 43 sample racks 56 sample tip remover 49 sample tip waste chute 49 sample tip waste reservoir 49 sample tip waste tube 49 Stat entry 43 system fluids tray 43 waste probe and cuvette ejector rod 53 water bottle and reservoir 8 cleaning solution for soaking and wiping system components 17 preparing 32 replacing 31 clearing cuvette jams vertical cuvette chute 9 clearing jams elevator 17 orientation chute 9

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ADVIA Centaur XP Operator’s Guide: Index

clot detected message 13 clot detection repeating samples 27 color on primary pack 8 comments deleting 3 editing 3 entering 69 symbol 41 comments for patient samples entering 54 competitive assay 35, 38 master curve 1 concentration calculation ranges automatic repeats 26 Control Bracket button 18 control bracket reagent reserve defining 39 Control Bracketing 17 archive 5 control reminder 19 control-bracketed tests 58 evaluating results 63 reagent options 57 reasons for discarded results 43 rescheduling samples 43 scheduling controls for 6 scheduling patient samples 49 viewing features 18 Control Levels field 18 Control reminder modifying 19 control requests adding 5 Control Warning field 18 control-bracketed test scheduling and loading samples 58 Control-Bracketing Messages Incomplete Set 13 controls editing 4 scheduling requests 5 covers

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cleaning 43 critical condition 9 current calibration status 16 custom barcode labels defining 7 customer service 6 customer tube types restoring 4 cut-off point qualitative assays 3 cuvette loading 14 cuvette ejector rod cleaning 53 cuvette jams 9 cuvette loading clearing jams 9 cuvette loading bin 4, 14 filling 32 cuvette waste area cleaning 43 cuvette waste bin 14 emptying 35 cuvette waste chute cleaning 43 cuvette waste reservoir cleaning 43 cuvettes loading 46 D Daily Cleaning Procedure autoscheduling 3 daily cleaning procedure 5 Dark Count with Cuvette 53 data collection 77 data files maintaining 1 decimal places defining 15 defaults resetting 20, 26, 27, 31 defined ranges for calibration 6

ADVIA Centaur XP Operator’s Guide: Index

defined validity criteria qualitative assay 3 quantitative assay 2 defining alarms 38 anonymous results 15 automatic dilutions 30, 31 automatic repeats, number of replicates 28 automatic sample repeats 24 calibration options 16 calibrator replicates 17 check range 25, 26 control bracket reagent reserve 39 custom barcodes 7 decimal places 15 dilution factor 31 dilution point 31 dilution profiles 31 inprocess queue timeout 3 LAS communication options 47 linearity 25, 26 LIS communication options 45 low reagent status 39 maintenance activities 3 off-system tests 35 opened stability 14 overdilution concentration 31 print options 41 ratio tests 33 reference ranges 20 reflex tests 22 repeats for the concentration calculation ranges 26 result interpretations 21 screen saver options 38 sensitivity 26 Stat options 2 system name 38 T Uptake result options 34 test profiles 36 units 15 defining calibrator values 14 defining master curve using keyboard 11

5

using scanner 10 defining sample handling maximizing tests 2 minimizing unusable volume 2 optimizing throughput 2 Defining SID Codes from Barcode Labels 7 deleting dilution profiles 32 entire worklist 72 requests 61 selected sample results 72 selected worklist 72 test 10, 11, 12 deleting tests from a QC definition 5 determining supplies status 10 diluters 76 dilution symbol 41 dilution factor defining 31 dilution options entering 56 specifying 57 dilution point defining 30 dilution profiles defining 31 deleting 32 dilutions automatic 30 manual 56 direct plumbing specifying 44 disabled symbol 41 disabling a test 10, 11, 12 discarded results 74 Discarded results reasons for 43 discrepant calibration 95

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ADVIA Centaur XP Operator’s Guide: Index

patient results 101 QC results 98 discrepant results 91, 95 Dispense Test 47 displaying samples by rack identifier 7 by sample identifier 7 error messages 7 in chronological order 7 drip trays cleaning 43 due calibration status 16 due, calibration managing 26 E editing control definition 4 QC expected values 4 requests 61 results 69 elevator 14 clearing jams 17 Empty Ancillary Queue 69 Empty Inprocess Queue 68 Empty Ring 44 emptying cuvette waste bin 35 sample tip tray waste 35 sample tip waste bin 33 enabling a test 10 entering comments for patient samples 54 dilution options 56 patient demographics 53 rack numbers 55 reagent options 57 error codes identifying 1 evaluating results 62 event code not in online help 3

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event log 1 backing up 3 restoring 4 status 19 excluded symbol 41 excluding a calibrator replicate automatically 17 excluding a calibrator RLU 23 exit queue clearing obstructions 40 locating sample racks 8 locating samples 44 expired calibration status 17, 20 expired calibration managing 27 waiving 24 expired, retained calibration status 20 exporting quality control data 8, 3, 10 F failure condition 9 fast stop button 5 field help 23 filter water 30 flags calibration data 23 defining 21 fluid sensor replacing 34 function buttons 19 functions software map 29, 31 H Hand-held barcode scanner Master Curve 16 patient samples 16 scanning patient samples 52 HBsAg reflex confirmatory test 22 help explaining 22

ADVIA Centaur XP Operator’s Guide: Index

field 23 help button 23 help key 23 historical database moving results 8 historical results deleting 73 historical worklist manually moving results 45 holding samples for repeat 29 Home Probes 49 Home System 65 I Incomplete Set message 13 incubation ring 4, 14 magnets 11 temperature 11 index value nonreactive 3 qualitative assays 3 reactive 3 indicators pack 21 information online 22 information display area 20 inprocess queue 4, 5, 6, 7 capacity 6 removing sample racks 8 symbol 41 inprocess queue timeout defining 3 insufficient message 13 insufficient sample volume repeating samples 27 interpretation ranges reflex tests 23 Invalid 42 invalid calibration status 17 invalid calibration accepting 25, 17 assigning 25 managing 25

7

invalid, exceeded defined ranges calibration status 20 invalid, exceeded observed ranges calibration status 20 L label chemiluminescent 33 laboratory automation loading samples 6 LAS communication options 47 light emission 14, 33 lightemitting diode 8 linearity defining 25 LIS communication options 45 querying 47 releasing results on hold 70 requesting a worklist 47 scheduling samples 46 Sending results not on hold 71 sending results to 71 Sending selected results 71 Load Tip Tray 51 loading batches 55 primary pack 8 primary reagent pack 22 sample racks illustration 5 samples 5 illustration 4 laboratory automation 6 samples for control-bracketed tests 58 locating sample racks exit queue 8 sample exit queue 8 locating samples exit queue 44 lot-specific barcodes master curve 1 low reagent warning defining 39

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ADVIA Centaur XP Operator’s Guide: Index

luminometer 4, 14 cleaning 53 troubleshooting 53, 57 M magnetic particles 13 magnets 4, 11, 13 maintaining acid and base reagents 37 cuvette loading bin 32, 33 data files 1 sample tip waste bin 35 waste bottle 27 water bottle 25 maintenance status 18 maintenance log backing up 3 restoring 4 maintenance procedures 23 Maintenance Status button 18, 19 managing the worklist 39 managing calibrations examples 25 manifold cleaning 14 manually adding test requests 47 master curve calibration 1 competitive assay 1 concentrations 10 defining 10 qualitative assays 3 quantitative assays 1, 2 relative light units 10 sandwich assay 2 specific lot 1 standard concentrations 1 standard curve 1 master curve card barcodes 1 master curve definition 10 maximizing number of tests 2

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message Aspirated 13 Clot Detected 13 Incomplete Cal Set 13 Incomplete Set 13 Insufficient 13 Integrity Error 13 LIS Query Pending 14 Low Reagent 39 No Barcode 14 No Bracket 14 No Request 14 Removal Pending 14 SID Mismatch 14 Stat 2 Messages Incomplete Set 13 messages reagent status 18 sample status 13 minimizing unusable volume 2 Mismatch SID 52 modem accessing files 42 modifying control reminder 19 reagent stability option 13 sample replicates 14 sample replicates for automatic repeats 24 system options 37 test options 9 Modifying control reminder 19 monitor 17 monitoring status 9 multiple flags symbol 41 N No Barcode message 14, 16 No Bracket message 14 no calibration calibration status 16 no master curve

ADVIA Centaur XP Operator’s Guide: Index

calibration status 17 No Request message 14 O observed ranges for calibration 7 off-system tests defining 35 onboard plumbing specifying 44 online information explaining 22 operating sequence 2 optimized throughput defining 1 order modifying test display 36 ordering supplies 1 orientation chute 14 clearing cuvette jams 9 overdilution concentration defining 31 P pack indicators 21 Pack ID selecting 57 paramagnetic particles 35 patient demographics 53 entering 53 patient samples scheduling 49 pending requests deleting in worklist 73 photomultiplier tube 14 pointing device 43 adjusting 41 pop-up window view 62 positioning the rack indicator illustration 4 power failure

9

recovering from 7 preheater 14 clearing jams 15 temperature 14 primary pack loading 8 primary pack status 21 primary reagent status 8, 18 primary reagent compartment 3, 4 cleaning 41 temperature 8 primary reagent door 8 primary reagent pack loading 22 removing 22 primary reagent probes 4 primary reagent shelf 8 primary reagent status 8 primary sample tube 6 Prime Cuvettes 46 Prime Fluid Line 74 Prime System 72 Prime System Fluid Bottle 76 principles antibody binding 34 printed results deleting 73 printer specifying 41 printing calibration data 27 reagent loading report 21 sample results 73 test results 74 printing information for technical assistance 5 printing report type reagent loading report 21 results report 73 test report 74 printing system information 5 probe rinse stations cleaning 34 probes

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ADVIA Centaur XP Operator’s Guide: Index

troubleshooting 47 problem multiple assay 104 single assay 103 procedure button 23 procedures 22 event codes 23 maintenance 23 processing batch requests 55 Stat requests 54 proficiency testing investigating failed 106 profiles dilution, defining 31 dilution, deleting 32 test, defining 36 test, deleting 36 Q QC discrepant 98 QC definition editing 4 QC statistics exporting 8, 10 qualitative assay cut-off point 3 index value 3 master curve 3 two-point calibration 3 quality control deleting tests 5 editing control definitions 4 editing expected values 4 software map 27 quality control data backing up 3 exporting to diskette 3 quantitative assay calibration 1 master curve 1 two-point calibration 1 user-initiated calibration 1 quantitative two-point calibration.

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See

two-point calibration. querying an LIS 47 R rack specifying for sample identification 4 rack barcode 6 racks loading illustration 5 range concentration calculation 26 interpretation 21 patient population 20 reference 20 ratio test calculated 4 reference serum 4 T Uptake 4 ratio tests defining 33 reaction chemiluminescent 14 reagent defining opened stability 14 stability option, modifying 13 reagent barcode scanner 81 reagent holder 8 reagent inventory backing up 3 reagent lots and packs specifying 57 reagent options entering 57 reagent pack holders cleaning 41 reagent probe 13 reagent probe shutter cleaning 38 reagent probes cleaning 17 replacing 23 reagent status 15 Reagent Status button 18

ADVIA Centaur XP Operator’s Guide: Index

Reagent status messages 18 Depleted 18 Lot Expired 18 No Test Definition 18 Removal Pending 18 Stability Expired 18 Verify Stability 18 reagent water 3 Reasons for Discarded Results 43 red status button 9 reference ranges defining 20 reflex tests 23 reference serum calibration T Uptake 4 reflex tests defining 22 interpretation ranges 23 reference ranges 23 reflex tests for HBsAg test 22 refrigeration ancillary reagent queue 9 primary reagent compartment 8 remote access 77 selecting 42 Removal Pending message 14 removing sample racks from inprocess queue 8 repeat symbol 41 repeating a test 68 repeating samples check range 25 concentration calculation range 26 holding options 29 index calculation range 26 linearity 25 sample error conditions 27 Replacing cleaning solution 31 replacing acid and base reagents 37 aspirate probe 26

11

cleaning solution 31 reagent probe 23 waste bottle fluid sensor 34 waste probe 30 replicate symbol 41 replicate calibrator results 20 replicates entering 58 modifying 14 specifying 57, 58 reports laboratory name and heading 41 print options 41 printing 73 representative authorized 1, 6, 7 requesting tests manually 47 requests deleting 61 editing 61 rescheduling samples control-bracketed tests 43 Reset Thermals 70 resetting defaults 20, 26, 27, 31 restoring customer tube types 4 restoring event log 4 restoring maintenance log 4 restoring setup 4 restoring system data 4 result flags defining 21 result interpretations defining 21 result on hold releasing 70 symbol 41 results defining flags 21 defining interpretations 21 deleting 73 discarded 74

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ADVIA Centaur XP Operator’s Guide: Index

discrepant assay 103, 104 discrepant calibration 95 discrepant patient 101 discrepant QC 98 editing 69 evaluating 62 printing 73 reporting without patient names or PIDs 15 T Uptake options 34 Results Discarded symbol 42 results in worklist deleting 73 resume update worklist 39, 43 retained calibration 8 retaining a calibration 17 reviewing calibration data 20 calibration status 16 rinse station 12, 13 rinse stations cleaning 34 RLU troubleshooting 53 See also relative light unit. runtime report resetting page numbers 75 specifying 41 S sample identification 4 integrity error, repeating samples 27 loading 5 minimum volume 12 optimization 2 options, modifying 1 status 13 messages 13 throughput options 1 tube types 5, 2 sample barcode 6 sample barcode read test 71 sample barcode scanner 7, 79 sample cup 6

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barcode illustration 4 loading illustration 4 sample entry queue 3, 4, 5, 6 cleaning 43 sample exit queue 3, 4, 5 capacity 7 cleaning 43 clearing obstructions 40 locating sample racks 8 locating samples 44 sample loading area 5 sample position identifying 55 sample probe 4, 7 sample rack 4, 6 capacity 6 clips 60 loading 6 sample racks 2 cleaning 56 sample results printing 73 sample start button 6 Sample Status button 18 sample status messages 13 sample tests repeating 68 sample tip troubleshooting 51 sample tip remover 10 cleaning 49 sample tip tray 4, 7 loading jam 36 sample tip waste emptying 33 sample tip waste area cleaning 49 sample tip waste chute cleaning 49 sample tip waste reservoir cleaning 49 sample tip waste tube

ADVIA Centaur XP Operator’s Guide: Index

cleaning 49 samples deleting selected results 72 sandwich assay 35, 36 master curve 2 scanner sample barcode 7 Scanning patient samples hand-held barcode reader 52 scheduling batches 55 calibrator 18 calibrators 56 control requests 5 patient samples 49 samples for control-bracketed tests 58 Stat samples 54 screen saver options specifying 38 selecting multiple samples in the worklist 60 selecting multiple tests in the worklist 60 sending results manually to an LIS 71 sensitivity defining 26 separation bound from free 37 serial number viewing 37 service 1, 6, 7 under warranty 1 setup backing up 3 restoring 4 Setup button 19 setup summary software map 28 SI unit conversion factors 9 SID Mismatch 52

13

specifying for sample identification 4 SID mismatch preventing 52 signing in 1 signing out 1 software maps 23 Calibration 28 functions 28, 31 Quality Control 27 SetupSummary 28 status 25 system 24 worklist 26 Software Overview 17 sort calibration display 17 View and Sort 7 specific reagent symbol 41 specifications 1 barcode 83 specifying ancillary reagents 57 dilution options 57 reagent lots and packs 57 replicates 57 stability ancillary reagent 20 stability option modifying 13 standard concentrations master curve 1 standard curve master curve 1 Stat defining a message 2 defining the number of racks 2 options, defining 2 symbol 41 Stat entry 3, 4 cleaning 43 Stat samples scheduling 54 stat/sample barcode scanner 79

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ADVIA Centaur XP Operator’s Guide: Index

Status system 18 status ancillary reagent 18 event log 19 maintenance 18, 19, 18 monitoring 9 primary pack 21 primary reagent 8 reagents 18, 15 samples 18, 13 messages 13 software map 25 supplies 18, 10 status button color 9 status buttons blinking 18 status message calibration 18, 20 stop button 5 storing ancillary pack 9 summary window type 9 view 9 supplies ordering 1 status 10 suspend update worklist 39, 43 symbol at Status – Exit Queue window 41 comment 41 dilution 41 ejected from inprocess queue 41 excluded 41 inprocess queue 41 multiple flags 41 repeat 41 replicate 41 reschedule 41 result on hold 41 results discarded 42 specific reagent 41

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stat 41 time due for test completion 41 waiting for controls 41 symbols 1 event log 1 system backing up 3 bottles, specifying 44 clock, changing 40 name, defining 38 options, modifying 37 restoring 4 signing in 1 signing out 1 software map 24 system fluid reservoir capacity 37 system fluids tray cleaning 43 system state description 9 System Status button 18 T T Uptake calculating result 4 defining result options 34 master curve card 4 ratio test 4 reference serum calibration 4 task buttons 19 technical assistance printing information 5 temperature ancillary queue 9 primary reagent compartment 8 troubleshooting 70 test definition backing up 3 test display order modifying 36 test name modifying 13 test options modifying 9

ADVIA Centaur XP Operator’s Guide: Index

test profiles defining 36 deleting 36 test results printing 74 test type all 10 allergen 10 combination 10 component 10 off-system 10 ratio 10 sIgE universal 10 standard 10 tests deleting 10, 11, 12 deleting from a QC definition 5 disabling 10 enabling 10 modifying name 13 reviewing 9 sample repeating 68 threshold reagent warning 39 time entering time correction 40 specifying time zone 40 tip tray loading 51 title bar 20 top cover opening 33 troubleshooting aspirate probe 26 barcode 78 clearing jams from vertical cuvette chute 9 cuvette jams in cuvette loading 9 cuvette jams in preheater 15 tube sizes 6 tube types 5 backing up 3 tube-type selector 6 two-point calibration

15

adjusted signal 2, 3 defined validity criteria 2, 3 instrument specific correction formula 3 qualitative assays 3 quantitative assay 1, 2 user-initiated 1 type summary window 9 test 10 tube 5 U units defining 15 user interface workstation 4 using sample cups 4 V vacuum test 70 Valid 42 valid, met retained cal limits calibration status 20 valid, operator accepted calibration status 20 valid, operator accepted, retained calibration status 21 valid, retained calibration status 21 Verify 42, 25 verifying barcode scanning 6 vertical cuvette chute 14 clearing cuvette jams 9 view calibration display 17 pop-up window 62 summary window 9 view, Calibration – Summary historical 18 Viewing control bracketing features 18 W Waiting for Controls symbol 41 waived calibration status 17, 21

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ADVIA Centaur XP Operator’s Guide: Index

waiving calibrations 24, 17 warning defining low reagent 39 warning condition 9 warranty 1 wash block 4 wash fluid 13 wash station 13 waste bin cuvette emptying 35 sample tip emptying 33 sample tip tray waste emptying 35 waste bottle emptying 27 waste bottle fluid sensor replacing 34 waste fluid from cuvette 14 waste probe 4, 14 aspirating waste fluid 14 cleaning 53 replacing 30 water bottle 7 filling 25 water bottle and reservoir cleaning 8 water bottles and reservoirs cleaning 8 water filter 30 water trap emptying 15 windows closing 21 elements 21 moving 21 opening 21 structure 20 title bar 20 worklist deleting requests 61 editing requests 61

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managing 39 results deleting 73 resume update 39, 43 software map 26 suspend update 39, 43 Worklist – Reagent Options window plus sign 57 Worklist button 19 workspace 17 workspace buttons 17 Y yellow status button 9