BC-5300 Auto Hematology Analyzer
Operator ’s Manual
© 2008-2015 Shenzhen Mindray Bio-medical Electronics C Co., o., Ltd.
All rights Reserved.
For this Operator ’s Manual, the issued Date is 2015-07.
Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
,
,
other countries.
ar are e th the e tr trad adem emar arks ks,, re regi gist ster ered ed or othe otherw rwis ise, e, of Mind Mindra ray y in Chin China a and and All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice.
All information contained in this manual is is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, onl only y if:
all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable applicable national and local requirements; and
the product is used in accordance with the instructions for use.
I
It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or injury of human health.
Be sure to operate the analyzer under the situation specified in this manual; otherwise, the analyzer will not work normally and the analysis results will be unreliable, which would damage the analyzer components and cause personal injury.
This equipment must be operated by skilled/trained clinical professionals.
II
Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.
Malfunction of the instrument or or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
III
Company Contact Manufacturer: E-mail Address:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Ltd.
[email protected]
Tel:
+86 755 26582479 26582888
Fax:
+86 755 26582934 26582500
EC-Representative: Address:
Shanghai International Holding Corp. GmbH(Europe) GmbH(Europe)
Eiffestraβe 80, Hamburg 20537, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
IV
Table of Contents 1
Using This Manual .......................................................................... ..................................................................................... ...........1-1 1-1 1.1
2
4
5
6
1.2 1.3
Who Should Read This Manual Ma nual ............................................................. ............................................................. 1-2 How to Find Information Inform ation ......................................................................... ......................................................................... 1-3
1.4
Conventions Used in This Manual ......................................................... 1-4
1.5
Safety Information .................................................................................. .................................................................................. 1-5
1.6
Symbols ................................................................................................. ................................................................................................. 1-7
Understanding Your Analyzer ....................................... ................................................................... ............................2-1 2-1 2.1
Introduction ............................................................................................ ............................................................................................ 2-1
2.2
Intended Use ............................................................................ .......................................................................................... .............. 2-2
2.3
Main Structure ........................................................................................ ........................................................................................ 2-4
2.4
User Interface ....................................................................................... ....................................................................................... 2-10
3
Introduction ............................................................................................ ............................................................................................ 1-1
2.5 2.6
Shortcut Button/Menu Item .................................................................. .................................................................. 2-13 Software Operation .............................................................................. .............................................................................. 2-14
2.7
Help Information ............ .................................................................................. ........................................................................ 2-25
2.8
Reagents, Controls Contro ls and an d Calibrators ..................................................... 2-28
Understanding the System Principles ............................................... ..................................................... ......3-1 3-1 3.1
Introduction ............................................................................................ ............................................................................................ 3-1
3.2
Aspiration ...................................................................... ............................................................................................... ......................... 3-2
3.3
Dilution ................................................................................................... 3-3
3.4
WBC Measurement ................................................................................ ................................................................................ 3-5
3.5
HGB Measurement M easurement ................................................................................ 3-9
3.6
RBC/PLT RBC/PL T Measurement ....................................................................... 3-10
3.7
Wash .................................................................................................... 3-13
Installing Your Analyzer ............................................................................ ............................................................................4-1 4-1 4.1
Introduction ............................................................................................ ............................................................................................ 4-1
4.2
Installation Requirements ................................................................... ...................................................................... ... 4-2
4.3
Connecting the Analyzer System S ystem ........................................................... 4-4
Customizing the Analyzer Software......................................................... .........................................................5-1 5-1 5.1
Introduction ............................................................................................ ............................................................................................ 5-1
5.2
Common User ........................................................................................ ........................................................................................ 5-2
5.3
Administrator .............................................................. ........................................................................................ .......................... 5-13
Operating Your Analyzer ........................................ ........................................................................... ...................................6-1 6-1 1
Table of Contents
7
6.1
Introduction ............................................................................................ ............................................................................................ 6-1
6.2
Initial Checks ............................................................................ .......................................................................................... .............. 6-2
6.3
Startup and Login ..................................................................... ................................................................................... .............. 6-4
6.4
Daily Quality Control .............................................................................. 6-7
6.5
Sample Collection and a nd Handling H andling ............................................................ 6-8
6.6
Sample Analysis ................................................................................... ................................................................................... 6-12
6.7 6.8
Worklist................................................................................................. Worklist................................................................................................. 6-24 Auto-Sleep ........................................................................................... ........................................................................................... 6-30
6.9
Shutdown ............................................................................................. 6-31
Reviewing Sample Results ....................................................................... .......................................................................7-1 7-1 7.1
Introduction ............................................................................................ ............................................................................................ 7-1
7.2
Graph Review Rev iew ........................................................................................ 7-2
7.3
Table Review ........................................................................................ ........................................................................................ 7-13
7.4
Data Backup............................................................... ......................................................................................... .......................... 7-30
7.5
Data Export ......................................................................................... ........................................................................................... 7-32
7.6
Auto-backup ............................................................... ......................................................................................... .......................... 7-34
7.7 7.8
Auto-restore ......................................................................................... ......................................................................................... 7-35 Compare ......................................................... .............................................................................................. ..................................... 7-36
7.9
Statistics ............................................................................................... ............................................................................................... 7-42
7.10 History .................................................................................................. .................................................................................................. 7-46
8
9
10
Using the QC Programs .......................................................... ............................................................................ ..................8-1 8-1 8.1
Introduction ............................................................................................ ............................................................................................ 8-1
8.2
L-J Quality Control ................................................................................. 8-2
8.3
X mean QC Program............................................................................ 8-53
8.4
X mean m ean R QC Program Pr ogram ........................................................................ ........................................................................ 8-96
8.5
X-B QC Program Pr ogram ........... ................................................................................ ..................................................................... 8-127
Using the Calibration Programs............................................................... ...............................................................9-1 9-1 9.1
Introduction ............................................................................................ ............................................................................................ 9-1
9.2
When to Calibrate ............................................................................... .................................................................................. ... 9-2
9.3
How to Calibrate..................................................................................... ..................................................................................... 9-3
Maintaining Your Analyzer ......................................................................1 ......................................................................10-1 0-1 10.1 Introduction .......................................................................................... .......................................................................................... 10-1 10.2 Maintenance ......................................................................................... ......................................................................................... 10-2 10.3 System Status .................................................................................... .................................................................................... 10-36 10.4 Version and Config. Information......................................................... Information......................................................... 10-43 10.5 Self-test .............................................................................................. 10-45 10.6 Counter ........................................................... .............................................................................................. ................................... 10-51 2
Table of Contents 10.7 Log ..................................................................... ..................................................................................................... ................................ 10-54
11
Troubleshooting Trouble shooting Your Analyzer .............................................................. .............................................................. 1 11-1 1-1 11.1 Introduction .......................................................................................... .......................................................................................... 11-1 11.2 Errors indicated by error messages ..................................................... 1 11-2 1-2
12
Customizing the Print Template .................................................... .............................................................12-1 .........12-1 12.1 Introduction .......................................................................................... .......................................................................................... 12-1 12.2 Entering the Print Template Screen ..................................................... 12-2 12.3 Editing the Template.............................................................. ............................................................................. ............... 12-4 12.4 Managing the Templates ...................................................................... ...................................................................... 12-7 12.5 Other Functions .......................................................... .................................................................................. ........................ 12-10
13
Appendices.............................................................. ................................................................................................ .................................. A-1 A
Index ...................................................................................................... ...................................................................................................... A-1
B
Specifications ............................................................. ......................................................................................... ............................ B-1
C
Communication ...................................................................................... ...................................................................................... C-1
3
1
Using This Manual
1.1 Introduction This chapter explains how to use your BC-5300 operator ’s manual, which is shipped with your BC-5300 AUTO HEMATOLOGY ANALYZER and contains reference information about the BC-5300 and procedures for operating, troubleshooting and maintaining the analyzer. Read this manual carefully before operating your analyzer and operate your analyzer strictly as instructed in this manual.
1-1
Using This Manual
1.2 Who Should Read This Manual This manual contains information written for clinical laboratory professionals to:
learn about the BC-5300 hardware and software.
customize system settings.
perform daily operating tasks.
perform system maintenance and troubleshooting.
1-2
Using This Manual
1.3 How to Find Information This operator ’s manual comprises 12 chapters and 3 appendices. Refer to the table below to find the information you need.
If you want to …
See …
learn about the intended use and parameters of the BC-5300
Chapter
2
Understanding
Your Analyzer learn about the hardware, interface and software of the
Chapter
2
Understanding
BC-5300
Your Analyzer
learn about how the BC-5300 works
Chapter 3 Understanding the System Principles
learn about the installation requirements of the BC-5300
Chapter
4
Installing
Your
Analyzer learn about how to define/adjust system settings
Chapter 5 Customizing the Analyzer Software
learn about the process of sample collection and analysis
Chapter 6 Operating Your Analyzer
learn about how to use the BC-5300 to perform your daily
Chapter 6 Operating Your
operating tasks
Analyzer
review sample results
Chapter 7 Reviewing Sample Results
learn about how to use the quality control programs
Chapter
8
Using
the
QC
Programs learn about how to calibrate the BC-5300
Chapter
9
Using
the
Calibration Programs learn about how to maintain/service the BC-5300
Chapter 10 Maintaining Your Analyzer
learn about how to solve the problems of the BC-5300
Chapter 11 Troubleshooting Your Analyzer
learn about how to customize the print template of BC-5300
Chapter 12 Customizing the Print Template
learn about the technical specifications of the BC-5300
Appendix B Specifications
learn about the conmmunication protocol of the BC-5300
Appendix C Communication
1-3
Using This Manual
1.4 Conventions Used in This Manual This manual uses certain typographical conventions to clarify meaning in the text:
all capital letters enclosed in [ ] indicate a key name on the external keyboard, such as [ENTER].
bold letters included in “ “ indicate text you can find on the screen, such as “ Clean”.
bold letters indicate chapter titles, such as Chapter 1 Using This Manual. Manual.
All illustrations in this manual are provided as examples only. only. They may not necessarily reflect your analyzer setup or data displayed.
1-4
Using This Manual
1.5 Safety Information The following symbols are used to indicate danger and alert information in this manual.
When you see…
Then… read the statement below the symbol . The statement is alerting you to a potentially biohazardous condition. read the statement below the symbol. The statement is alerting you to an operating hazard that can cause personnel injury. read the statement below the symbol. The statement is alerting you to a possibility of analyzer damage or unreliable analysis results. read the statement below the symbol. The statement is alerting you to information that requires your attention.
All the samples, controls, calibrators, reagents, waste and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If leaking happens to the analyzer, the leak is potentially biohazardous.
Please check the firmness of all the doors, covers and boards before running the analyzer.
Make sure all the safety measurements are adopted. Do not disable any safety device or sensor. senso r.
Please take action to any alarm and error message immediately.
Do not touch the moving parts.
Contact Mindray or Mindray-authorized distributors immediately if any damaged part is found.
Be careful when opening/closing and removing/installing the doors, covers and boards of the analyzer.
Discard the analyzer according to government regulations.
Please operate your analyzer strictly as instructed in this manual.
Make sure only Mindray-authorized software is installed on the computer.
Please install the original edition software to prevent the computer from being infected by virus.
Please adopt proper measurements to prevent the reagents from being 1-5
Using This Manual polluted.
It is recommended that the anti-virus software should be installed on the computer and run regularly.
1-6
Using This Manual
1.6 Symbols You will find the following symbols in this manual:
When you see…
Then… read the statement below the symbol . The statement is alerting you to a potentially biohazardous condition. read the statement below the symbol. The statement is alerting you to an operating hazard that can cause personnel injury. read the statement below the symbol. The statement is alerting you to a possibility of analyzer damage or unreliable analysis results. read the statement below the symbol. The statement is alerting you to information that requires your attention.
You may find the following f ollowing symbols of the analyzer system:
When you see…
It means… CAUTION,
CONSULT
ACCOMPANYING
DOCUMENTS. BIOLOGICAL RISK
HIGH VOLTAGE
WARNING, LASER BEAM
WARNING, HOT SURFACE
PROTECTIVE EARTH (GROUND)
1-7
Using This Manual EARTH (GROUND)
ALTERNATING AL TERNATING CURRENT CURRENT
FOR IN VITRO DIAGNOSTIC USE
BATCH CODE
USE BY
SERIAL NUMBER CATALOG CA TALOG NUMBER (FOR CONTROLS)
USE BY (YYYY-MM-DD) (FOR CONTROLS)
DATE DA TE OF MANUFACTURE
MANUFACTURER
TEMPERATURE LIMITATION
CONSULT CONSUL T INSTRUCTIONS FOR USE
IRRITATING SUBSTANCE
THE FOLLOWING DEFINITION OF THE WEEE LABEL APPLIES TO EU MEMBER STATES ONLY: THE USE OF THIS SYMBOL INDICATES INDICA TES THAT THIS PRODUCT PR ODUCT SHOULD NOT 1-8
BE
TREATED
AS
HOUSEHOLD
Using This Manual WASTE.
BY
ENSURING
THAT
THIS
PRODUCT IS DISPOSED OF CORRECTLY, YOU WILL HELP PREVENT BRINGING POTENTIAL NEGATIVE CONSEQUENCES TO THE ENVIRONMENT AND HUMAN HEALTH.
FOR
MORE
DETAILED
INFORMATION WITH REGARD TO RETURNING AND RECYCLING THIS PRODUCT,
PLEASE
DISTRIBUTOR
CONSULT
FROM
WHOM
THE YOU
PURCHASED THE PRODUCT PRODUCT.. THE DEVICE IS FULLY CONFORMANCE WITH
THE
CONCERNING
COUNCIL IN
VITRO
DIRECTIVE DIAGNOSTIC
MEDICAL DEVICES 98/79/EC. AUTHORISED REPRESENTA REPRESENTATIVE TIVE IN THE EUROPEAN COMMUNITY
1-9
Using This Manual
Figure 1-1 Front of the analyzer
(1) The sample probe is sharp and potentially biohazardous, please be careful when operating.
1-10
Using This Manual
Figure 1-2 Back of the Analyzer
(1)
Connect only to a properly earth grounded outlet.
To avoid electric shock, disconnect disconnect power cord prior to removing or replacing fuse.
Replace fuse only with the type and rating specified.
1-11
Using This Manual
Figure 1-3 Front of the analyzer (Front Cover Open)
(1) To avoid injury, do not put your hands around the guide channel of the syringe board.
1-12
Using This Manual
Figure 1-4 Left Side of the Analyzer
(1) To avoid injury, do not put your hands around the guide channel of the syringe board.
1-13
Using This Manual
Figure 1-5 Right Side of the Analyzer
(1) Laser radiation when opening, avoid direct eye exposure.
1-14
2
Understanding Your Analyzer
2.1 Introduction The BC-5300 AUTO HEMATOLOGY ANALYZER is a quantitative, automated hematology analyzer and 5-part differential counter for in Vitro Diagnostic Use in clinical laboratories.
2-1
Understanding Your Analyzer
2.2 Intended Use
The purpose of this analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.
The BC-5300 is a quantitative, automated hematology analyzer and 5-part differential counter used in clinical laboratories. It provides the following 23 basic parameters, 4 parameters for research use, 3 histograms and 1 scattergram of blood samples. It supports 2 measurement modes: CBC and CBC+DIFF. CBC+DIFF.
Parameter Name Name
Abbr. Abbr.
CBC
CBC + DIFF
White Blood Cell count
WBC
*
*
Neutrophils percentage
Neu%
/
*
Lymphocytes percentage
Lym%
/
*
Monocytes percentage Eosinophils percentage
Mon% Eos%
/ /
* *
Basophils percentage
Bas%
/
*
Neutrophils number
Neu#
/
*
Lymphocytes number
Lym#
/
*
Monocytes number
Mon#
/
*
Eosinophils number
Eos#
/
*
Basophils number
Bas#
/
*
Abnormal Lymphocytes percentage
ALY% (RUO)
/
*
Large Immature Cells percentage
LIC% (RUO)
/
*
Abnormal Lymphocytes number
ALY# (RUO)
/
*
Large Immature Cells number
LIC# (RUO)
/
*
RBC
RBC
*
*
Hemoglobin Concentration
HGB
*
*
Mean Corpuscular Volume
MCV
*
*
Mean Corpuscular Hemoglobin
MCH
*
*
Mean Corpuscular Hemoglobin
MCHC
*
*
RDW-CV
*
*
RDW-SD
*
*
Concentration Red Blood Cell Distribution Width Coefficient of Variation Red Blood Cell Distribution Width Standard Deviation
2-2
Understanding Your Analyzer Hematocrit
HCT
*
*
Platelet count
PL PLT T
*
*
Mean Platelet Volume
MPV
*
*
Platelet Distribution Width
PDW
*
*
Plateletcrit
PCT
*
*
White Blood Cell/Basophils Histogram
WBC/BASO
/
*
Histogram White Blood Cell Histogram
WBC Histogram
*
/
Red Blood Cell Histogram
RBC Histogram
*
*
Platelet Histogram
PL PLT T Histogram
*
*
Differential Scattergram
Diff Scattergram
/
*
“*” means the parameter is provided in the mode. “/” means the parameter is not provided.
ALY%, LIC%, ALY# and LIC# are parameters for research use only, not for diagnostic use. For more details about the RUOs, please see 5.3.1 General (Settings) Research use only parameter (RUO parameter).
2-3
Understanding Your Analyzer
2.3 Main Structure The BC-5300 AUTO HEMATOLOGY ANALYZER consists of the m main ain unit (analyzer) and accessories.
Please check the firmness of all the doors, covers and boards before running the analyzer.
The analyzer is heavy, to move it by one person may cause injury. It is advisable for two people move it together when transport is needed, and make sure you follow the instructions and use the proper tools.
Installing other software on the analysis system computer, using mobile storage devices or using the computer for other purposes (e.g. playing games, logging on the internet, etc.) may lead to virus infection, system damage and/or data error. Therefore, please make sure s ure the computer is used for analysis system only.
Figure 2-1 Front of the Analyzer
2-4
Understanding Your Analyzer 1 ---- Power/Status indicator
2 ---- Sample probe
3 ---- Aspirate key
2-5
Understanding Your Analyzer
Figure 2-2 Back of the Analyzer 1 --- Network interface
2 --- M-53D diluent inlet
3 --- M-53LH Lyse inlet
4 --- M-53LEO(Ⅱ)Lyse inlet
5 --- M-53LEO(Ⅰ)Lyse inlet
6 --- AC input
7 --- Waste outlet
2-6
Understanding Your Analyzer
Figure 2-3 Right Side of the Analyzer (Right Door Open) 1 --- Optical system
2 --- Sampling module
3 --- Vacuum chamber
4 --- Reagent heating chamber
5 --- Fluidic valves 7 --- Counting bath
6 --- Vacuum pump/waste pump 8 --- DIFF bath
2-7
Understanding Your Analyzer
Figure 2-4 Left Side of the Analyzer (Left Door Open) 1 --- Fluidic valves
2 --- Syringes
3 --- Air pumps
4 --- Liquid level detection unit
5 --- Pressure chamber
6 --- Fluidic valves
7 --- Power switch
8 --- Circuit boards
2.3.1 Main Unit (Analyzer) The main unit (analyzer) is the principal part of the product. It performs the sample analysis and the data process.
2.3.2 Power/Status Indicator The Power/Status indicator is located in the middle of the right side of the analyzer (front side). It tells you about the status of the analyzer including ready, running, error, sleep and on/off, etc.
2.3.3 Power Switch A power switch is is on the left side of the analyzer. It starts up or closes down the analyzer analyzer..
2-8
Understanding Your Analyzer
To avoid damage, do not turn on/off the power of the analyzer continually in a short time.
2.3.4 Aspirate Key The aspirate key is located behind the sample probe. You can press the key to start the selected analysis cycle, dispense diluent and wake up the analyzer from sleep.
2.3.5 Network Interface A network interface is located on the back of the analyzer. analyzer. It connects the external computer. com puter.
2-9
Understanding Your Analyzer
2.4 User Interface After the starting procedure, you will enter the user interface.
Figure 2-5 User interface The interface can be divided into several areas as follows according to their functions:
1.
Screen title area
The screen title area on the top left corner displays the title of the current screen. The figure
shown above indicates the current screen is “ Standby screen”. 2.
Analysis status area
It indicates the current analysis status and displays in the same way as the Power/Status indicator of the analyzer. Green icon: it means you can proceed to analyze the sample. Flickering green icon: it means the analyzer is not ready for analyze yet. Red icon: it means you can not proceed to analyze the sample, but no error happened. (e.g. the analyzer is in the sleeping mode) Flickering red icon: it means you can not proceed to analyze the sample and it is due to an error(s) happened.
3.
Information area of the next sample 2-10
Understanding Your Analyzer It displays the information about the sample ID, analysis mode (whole blood/prediluted blood) and measurement mode (CBC/CBC+DIFF) of the next sample.
4.
Status area
The area is on the top right of the screen. There are three items from left to right, namely:
LIS/HIS status: Gray icon: disconnected Colorful icon: connected Flickering arrow above the icon: uploading Flickering arrow below the icon: downloading The two arrows flickering at the same time: uploading and downloading at the same time.
Connection status between the analyzer and the computer: Gray icon: The computer is not connected to the analyzer yet. Colorful icon: The computer is connected to t o the analyzer.
Print status: Gray icon: The printer is not connected to the analyzer yet. Colorful icon: The printer is connected to the analyzer. Flickering icon: The printer is printing.
5.
Minimize button
You can click the button to minimize the interface to the taskbar of the operation system.
You can click the interface icon displayed on the taskbar to re-display re-displa y the interface after minimizing it.
6.
Function screen area
It displays the selected screen and the corresponding function buttons.
7.
System time
It displays the time of the operation system. When you move the mouse to this area, the tips will pop up to display the current system time. See Chapter 5 Customizing the Analyzer for ways to modify the time format. Software for Software
8.
Input mode button
It displays the current input mode and you can change the input mode through it. Click the 2-11
Understanding Your Analyzer input mode button to open the input languages menu, and then you can switch to the desired input language by clicking on the menu.
9.
Error message area
When error(s) is reported, the error message area will pop up a help information message box and displays error messages one by b y one. The severity levels are discriminated from high to low by 4 background colors: red, orange, blue, and green. See Chapter 12 Troubleshooting Your Analyzer for for details.
10. Operation/status information area The area displays the information about the current operation of the analyzer/computer, or the current status of the analyzer/computer.
11. Information area of the user logged on This area displays the name and access level of the current user.
12. Menu button
You can click the “ Menu” button on the left bottom corner to open the system menu. Click a menu option, a relevant screen or message box will appear if the option is not followed by the
sy symbol mbol “ ”; where whereas as a submen submenuu will will appear appear ifif the option option is is follow followed ed by the the symbol symbol “ ”. Click Click the submenu, a relevant screen or message box will appear.
13. Shortcut button area The left side of the screen is the shortcut button area. When clicking a certain button, you can enter the relevant screen or a message box will pop up.
2-12
Understanding Your Analyzer
2.5 Shortcut Button/Menu Item Shortcut button/Menu item
Shortcut key
Function
“Menu” button
Alt + M
Open the menu
“Diluent” button
Alt + A
Open the “Diluent” message box
“Worklist” button
Alt + W
Enter the “Worklist” screen
“Graph” button
Alt + G
Enter the “Graph” screen
“Table” button
Alt + L
Enter the “Table” screen
“QC” button
Alt + Q
Enter the “L-J” graph screen
“Logout Logout"" button
Alt + O
Open the “Logout ” message box
“Shutdown” button
Alt + D
Open the “Shutdown ” message box
“Exit” button
Alt + X
Open the “Exit” message box
“Menu””Help””Help”
F1
Open the “Help” message box Open the “Troubleshooting” message box
Click the “Error Message Area” Alt + F1
2-13
Understanding Your Analyzer
2.6 Software Operation Please make sure you fully understand the meaning of the following operations and screens before you start operating the software of the analyzer.
2.6.1 Move the Pointer You can operate the mouse to move the pointer displayed on the screen.
2.6.2 Click Move the pointer to the desired content; left click the mouse then release.
Repeat the operation if you failed to select the content and check the connection of the mouse if necessary. If the problem still exists, please contact Mindray customer service department or your local distributor immediately.
2.6.3 Double Click Move the pointer to the desired content, left click the mouse twice rapidly then release.
Repeat the operation if you failed to select the content and check the connection of the mouse if necessary. If the problem still exists, please contact Mindray customer service department or your local distributor immediately.
2.6.4 Right Click Move the pointer to the desired content; right click the mouse then release.
Repeat the operation if you failed to select the content and check the connection of the mouse if necessary. If the problem still exists, please contact Mindray customer service department or your local distributor immediately.
2.6.5 Scroll Bar In some screens, the information can not be fully displayed in one sight, then a scroll bar (horizontal/vertical) will appear. You You can drag the scroll bar in the following ways to check the rest information. A scroll bar is shown below:
2-14
Understanding Your Analyzer
Click the “ Arrow button” on the scroll bar.
Move the pointer to the slide bar, left click the mouse and hold, then drag the bar at will. will.
Click the blank area on the scroll bar.
2.6.6 Prompt Information The software provides the prompt information for the content displayed (e.g. buttons, titles, etc.)It will display automatically when the pointer moved onto the certain area.
2.6.7 Tab Tab displays one page of the multipage information. E.g. you can enter the “ Settings” tab of
the “L-J” screen to view and set up the information. The “ Settings” tab is shown below.
2-15
Understanding Your Analyzer
2.6.8 Buttons Common buttons The system will perform the function after you clicking the certain button. E.g. the system will
print after you clicking the “ Print” button as shown below.
Arrow button of the combo box Click the button to display the pull-down pull -down list as shown below. The options will be displayed in the pull-down list.
Hide it by clicking the arrow button again:
When a combo list is open, you can select the desired item in the list by using the [↑] and 2-16
Understanding Your Analyzer
[↓] keys on the keyboard.
When a combo list is open, you can hide it by pressing the [Enter] key on the keyboard or selecting a certain option. Then, the original content in the combo box will be replaced by the current selected one.
When a combo list is open, you you can hide it by pressing the [Esc] key on the keyboard without changing the original content.
The scroll bar will appear if the content of the list can not be fully displayed in one screen. You can drag the scroll bar or use the [PgUp] and [PgDn] keys on the keyboard to view the content fully.
Arrow button of the date control The date control is shown below:
After clicking the arrow button on the date control, a date selection box will pop up.
Select the year: click click the displayed year, year, then the arrow buttons will appear on its right right side, and then click the arrow button to select the desired year.
Select the month:
Method 1: click the arrow buttons on the both sides of the date box to switch to the desired month. Method 2: click the current displayed month, then click the desired month from the list appeared as shown below.
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Understanding Your Analyzer
Select the day: click the desired day, day, then the date box box will hide. The selected date (including year, month and day) will replace the original date.
When the date selection box popping up, you can hide it by pressing the [Esc] on the keyboard without changing the date.
Radio button Click the radio button in the circle to select the option. E.g. the following figure shows that the
“Auto Increace” is selected whereas the “Manual Entry” is not selected.
Only one radio button can be selected for a setting option.
2.6.9 Check Box Click the check box in the frame, a mark “√” will appears to indicate the option is selected. e.g. chick the “Switch between different information fields by [Enter] key ” option, it is selected as shown below:
Click the “Switch between different information fields by [Enter] key ” again, the “√” disappeared, it means the option is not selected as shown below:
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Understanding Your Analyzer
More than one check box can be selected at the same time for one setting option.
2.6.10 Edit Box Click the edit box to start editing e diting when the cursor ap appears. pears. Y You ou can enter the characters ch aracters at the location of the cursor and the cursor moves to the right accordingly. Enter the first name into the edit boxes as shown below:
You can also proceed to the following operations in th the e edit box:
Move the cursor to the left or right by using the [←] and [→] key on the keyboard.
Move the cursor to the left of the initial character or the right or the end character by pressing the [Home] and [End] key on the keyboard.
Delete the character on the right of the cursor by using the [Delete] key on the keyboard.
Delete the character on the left of the cursor by using the [Backspace] key on the keyboard.
Switch to a another nother edit edit box by using the [T [Tab] ab] key on the keyboard. keyboard.
Edit boxes of different use require different entered characters.
You don ’t have to enter the separators in the date edit box and the IP edit box.
The scroll bar (horizontal/vertical) will appear if the content of the edit box can not be displayed in one screen. You can drag the scroll bar or use the [PgUp] and [PgDn] keys on the keyboard to view the content fully.
2.6.11 Information Box The content in the information box can only be browsed:
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Understanding Your Analyzer
The scroll bar (horizontal/vertical) will appear if the content of the edit box can not be displayed in one screen. You can drag the scroll bar or use the [PgUp] and [PgDn] keys on the keyboard to view the content fully.
2.6.12 Combo Box The combo box consists of an edit box and an arrow button, which is shown below:
See Arrow button of the combo box section box section for details to complete selecting. See Edit Box Box section for details to complete editing if the combo box is editable.
2.6.13 Form The form contains several cells and check box (sometimes). Click the certain cell to select it:
Then, you can proceed to the following operations:
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Understanding Your Analyzer
Select the cell by using the [↑] and [↓] and [←] and [→] keys on the keyboard.
Select the initial or end cell of the current row by using the [Home] and [End] keys on the keyboard.
Select the next cell of the current line by using the [Enter] key on the keyboard.
Select the next cell of the current row by using the [Tab] [Tab] key on the keyboard (can not
switch to a new row). Move the mouse to the boundary line between rows rows or lines, and then left click the mouse and hold, drawing the boundary line to change the height/width of the row/list, but the height/width of the whole form remains.
For an editable cell, a cursor will appear in the cell if it is double clicked. You can enter the characters from the location of the cursor and the cursor moves to the right at the time. An edited form is shown below:
You can proceed to the t he following operations in the cell:
Move the cursor to the left or right in the cell by using the [←] and [→] keys on the keyboard.
Move the cursor to the left of the initial character or the right or the end character by pressing the [Home] and [End] key on the keyboard.
Delete the character on the right of the cursor by using the [Delete] key on the keyboard.
Delete the character on the left of the cursor by using the [Backspace] key on the keyboard.
Hide the cursor and quit editing by using the [Enter] key on the keyboard. keyboard.
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Understanding Your Analyzer
If a check box exists in the form, see the previous “check box” section for details to operate. The selected check boxes in the forms will not be cleared when you switching among the screens unless you exit the software.
If a check box exists in the form, then when you click the check box, it will be ticked and the record will also be highlighted.
If you wish to select several continuous records in a form, click the initial
record and a “√” mark appears, then click the desired ending record while pressing and holding the [Shift] key on the keyboard, then a set of records are selected conveniently.
If you wish to select several consecutive records, click the first record and then hold and drag the mouse to the last one, and then release the mouse to select them all.
The scroll bar (horizontal/vertical) will appear if the content of the edit box can not be displayed in one screen. You can drag the scroll bar or use the [PgUp] and [PgDn] keys on the keyboard to view the content fully.
2.6.14 System Menu Click the “Menu” button, the system menu with all the first-level options will pop up. If a menu m enu option is followe llowedd by a“ a“ ”mark; itit means means there there is a submenu of the option. option.
Enter the screen or message box of a first-level menu option: option:
Method 1: click the menu option directly. Method 2: move to the desired option by using the [↑] and [↓] keys on the keyboard and then press the [Enter] key to enter the screen.
Enter the screen or message box of a submenu option:
Method 1: click the first-level menu option to open its submenu, and then click the desired option on the submenu. Method 2: first, move to the submenu option on the first- level menu by using the [↑] and [↓]
keys on the keyboard and open the submenu by pressing tthe he [→]or [Enter] key ke y, then move to the desired option by the [↑] and [↓] keys, at last press the [Ent er] key to open the screen. 2-22
Understanding Your Analyzer
Close the menu:
Method 1: click the “ Menu” button to close the system menu. Method 2: press the [←] or [Esc] key on the keyboard to close different levels of menus one by one.
2.6.15 Directory Tree The directory tree can display the content of all the menus of different levels.
A “+”mark indicates the followed menu option has a submenu. Click the menu option, its submenu will fully display and the “ +” mark changes to “-”mark; click the menu option again, its subm enu will hide and “ -” changes to “+” again as shown below:
The menu option without “ +” or “-” mark has no submenu. Click the menu option, the information will display directly.
Use the [↑] and [↓] keys on the keyboard to move the highlig ht bar to the desired menu option.
Use the [Home] and [End] keys on the keyboard to move the highlight bar to the initial or ending option.
Use the [Enter] key on the keyboard to display display the submenu of a menu option. If the menu option has no submenu, the relative information will display directly.
If the submenu of a menu option has displayed, you can hide it by using the [Enter] key on 2-23
Understanding Your Analyzer the keyboard.
The scroll bar (horizontal/vertical) will appear if the content of the edit box can not be displayed in one screen. You can drag the scroll bar or use the [PgUp] and [PgDn] keys on the keyboard to view the content fully.
2.6.16 Message Box According to their different function buttons, the message boxes can be divide into “ Ok”, “Ok/Cancel”, “ Yes/No Yes/No”,” Yes/No/Cancel” and special message boxes. A message box consists of the title area, information area and function buttons. Take Take the
following “Ok/Cancel” message box for example:
After selecting the data you want to delete, click the “OK” button to close the message box and complete the deletion; click the “ Cancel” button to close the message box without deleting the data.
Click the
button on the right side of the title area to close the message box without
deleting the data.
2.6.17 Record Switch Column The current record and the total number of the records are shown in the form “current number/ total number” in the record switch column. It is shown below:
The “2/79” in the above figure indicates the total numb er of the records is 79, and the current record is the second one.
If you wish to switch to the previous or the next record, click
or
If you wish to switch to the first or the last record, click
Click the edit box of the record switch column, enter the desired number of the record,
or
button. button.
and then switch to the relative screen by using the [Enter] key on the keyboard.
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Understanding Your Analyzer
2.7 Help Information The software provides the help information for operation.
2.7.1 Browse the Help Information If you wish to browse the help information, chose “ Menu””Help””Help” option, the following message box will pop up.
The message box displays the help information of the current screen and the corresponding menu (highlighted). If you wish to browse other help information, click the desired menu option then the help information will display on the right. Click the
button on the top right corner to close the message box.
2.7.2 Search the help information If you wish to search the help information by key words, click “Menu””Help””Help” to display the help information of the current screen and the corresponding menu item (the highlighted one).
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Understanding Your Analyzer
Then, click the “Search” tab to enter the key words into the search information box.
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Understanding Your Analyzer
After entering the key words, click the “List Topics” button or press the [Enter] key on the keyboard to start searching.
You can stop searching by clicking the “Stop” button. Then, the obtained result displays.
When the search is finished, all the related menu items will be displayed in the left corner and the corresponding help information will be displayed at the right side screen. You can click the menu m enu item to check the corresponding help information.
2.7.3 Print You can click the “ Print” button to print the current displayed help information.
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Understanding Your Analyzer
2.8 Reagents, Controls and Calibrators Because the analyzer, reagents (diluent, rinse, lyses and probe cleanser), controls, and calibrators are components of a system, performance of the system depends on the combined integrity of all components. You should only use the Mindray-specified reagents (see Appendix B Specifications), Specifications), which are formulated specifically for the fluidic system of your analyzer in order to provide optimal system performance. Do not use the analyzer with reagents from multiple suppliers. In such use, the analyzer may not meet the performance specified in this manual and may provide unreliable results. All references related to reagents in this manual refer to the reagents specifically formulated for this analyzer. Each reagent package must be examined before use. Inspect the package for signs of leakage or moisture. Product integrity may be compromised in packages that have been damaged. If there is evidence of leakage or improper handling, do not use the reagent.
Store and use the reagents as instructed by instructions for use of the reagents.
When you have changed the diluent or lyses, run a background to see if the results meet the requirement.
Pay attention to the expiration dates and open-container stability days of all the reagents. Be sure not to use expired reagents.
After installing a new container of reagent, keep it still for a while before use.
2.8.1 Reagents M-53D Diluent It provides a stable environment for counting and sizing blood cells.
M-53LEO (I) Lyse It breaks down red blood cell walls and cooperates with the M-53LEO (II) lyse to 4-differentiate WBCs.
M-53LEO (II) Lyse It cooperates with the M-53LEO (I) lyse to 4-differentiate WBCs, and dyes Eosinophils.
M-53LH Lyse It breaks down red blood cell walls and converts hemoglobin to a hemoglobin complex to determine the HGB. It 2-differentiates WBCs to Basophils and other WBCs, and determines WBC amount.
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Understanding Your Analyzer M-53P Probe Cleanser It is used to clean the analyzer regularly.
2.8.2 Controls and Calibrators The controls and calibrators are used to verify accurate operation of and calibrate the analyzer. The controls are commercially prepared whole-blood products used to verify that the analyzer is functioning properly. They are available in low, l ow, normal, and high levels. Daily use of all levels verifies the operation of the analyzer and ensures reliable results are obtained. The calibrators are commercially prepared whole-blood products used to calibrate the analyzer. Read and follow the instructions for use to use the controls and calibrators.
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3
Understanding the System Principles
3.1 Introduction The measurement methods used in this analyzer are: the Electrical Impedance method for determining the WBC/BAS, RBC and PLT data; the colorimetric method for determining the HGB; flow cytometry by laser for determining the WBC data. During each analysis cycle, the sample is aspirated, diluted and mixed before the determination for each parameter is performed.
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Understanding the System Principles
3.2 Aspiration The analyzer supports two types of blood samples – whole blood samples and prediluted blood samples. If you are to analyze a whole blood sample, the analyzer will aspirate 20μL (CBC+DIFF mode) or 15μL (CBC mode) of the sample. If you are to analyze a capillary blood sample, you should first manually dilute the sample (20μL of capillary sample needs to be diluted by 180μL o f diluent) and then present the pre-diluted sample to the analyzer, which will aspirate 80μL(CBC+DIFF) or 40μL(CBC ) of the sample.
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Understanding the System Principles
3.3 Dilution Then, the sample will be divided into 2 portions and be diluted and processed by different reagents. After this, they are ready for analysis. This analyzer can process two types of blood samples – whole blood samples and prediluted blood samples.
3.3.1 Whole Blood Mode
WBC counting/HGB, RBC/PLT dilution flow chart
6μL of Whole blood sample
2.5 mL diluent 52.08μL About 1:417.6 dilution
0.5 mL M-53LH lyse
2.448mL diluent
About 1:500 dilution for
About 1:20000 dilution for
WBC/HGB analysis
RBC/PLT RBC/PL T anal ysis
WBC differential dilution flow chart
9 μL whole blood sample
1.1 mL M-53LEO(I) lyse
0.14mL M-53LEO(II) lyse
About 1:139 dilution for WBC analysis
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Understanding the System Principles
3.3.2 Predilute Mode
WBC counting/HGB, RBC/PLT dilution flow chart
20 μL capillary blood
180 μL diluent
About 1:10 dilution
40μL 2.46 mL diluent 60μL About 1:625 dilution
0.5 mL M-53LH lyse
About 1:26000 dilution for
About 1:750 dilution for
RBC/PLT RBC/PL T analysis
WBC/HGB analysis
2.44 mL diluent
WBC differential dilution flow chart
20 μL capillary blood 180 μL diluent
About 1:10 dilution
40μL 1.1 mL M-53LEO(I) lyse
0.14 mL M-53LEO(II) lyse
About 1:320 dilution for WBC analysis 3-4
Understanding the System Principles
3.4 WBC Measurement 3.4.1 Flow Cytometry by Laser
Figure 3-1 WBC Measurement After a predetermined volume of blood is aspirated and diluted by a certain amount of reagent, it is injected into the flow cell. Surrounded with sheath fluid (diluent), the blood cells pass through the center of the flow cell in a single column at a faster speed. When the blood cells suspended in the diluent pass through the flow cell, they are exposed to a laser beam. The intensity of scatter light reflects the blood cell size and intracellular density. The low-angle scattered light reflects cell size, and the high-angle scattered light reflects intracellular density (nucleus size and density). The optical detector receives this scatter light and converts it into electrical pulses. Pulse data collected can be used to draw a 2-dimensional distribution (scattergram). As shown in Figure in Figure 3-2 , X-axis represents the intracellular density and Y-axis the blood cell size. Various types of analysis data can then be obtained from the scattergrams.
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Understanding the System Principles Figure 3-2 DIFF channel scattergram By analyzing the DIFF channel scattergram, the analyzer presents the Lym%, Mon%, Eos% and Neu%.
3.4.2 Electrical Impedance Method WBCs/BASs are counted and sized by the Electrical Impedance method. This method is based on the measurement of changes in electrical resistance produced by a particle, which in this case is a blood cell, suspended in a conductive diluent as it passes through an aperture apertur e of known dimensions. An electrode is submerged in the liquid on both sides of the aperture to create an electrical pathway. As each particle passes through the aperture, a transitory change in the resistance between the electrodes is produced. This change produces a measurable electrical pulse. The number of pulses generated signals the number of particles that passed through the aperture. The amplitude of each pulse is proportional to the volume of each particle. particle.
Figure 3-3 Electrical Impedance method Each pulse is amplified and compared to the internal reference voltage channel, which only accepts the pulses of a certain amplitude. If the pulse generated is above the WBC/BAS lower threshold, it is counted as a WBC/BAS. The analyzer presents the WBC/BAS histogram, whose x-coordinate represents the cell volume(fL) and y-coordinate represents the number of the cells.
3.4.3 Derivation of WBC-Related Parameters Based on the analysis of the DIFF channel scattergram and the Lym region, Neu region, Mon region and Eos region, the analyzer calculates the Lym%, Mon%, Eos% and Neu%. Having 3-6
Understanding the System Principles achieved the WBC, the analyzer proceeds to calculate Lym#, Neu#, Mon# and Eos# per the following equations while Bas# is obtained directly by the Electrical Impedance method and 9
express them in 10 /L.
White Blood Cell count
WBC is the number of leukocytes measured directly by counting the leukocytes passing through the aperture.
Basophils number
Bas# is the number of Basophils measured directly directly by counting the Basophils passing through the aperture.
Basophils percentage
Bas# Bas% 100% WBC WB C
Lymphocytes percentage
Lym%
Particles in Lym region of Diff channel
Sum of all all p partic article less in Diff channel except those in Ghost region
Neutrophils percentage
Neu%
Sum of all all p partic article less in Diff channel except those in Ghost region
Particles in M on region of Diff channel
Sum of all all p partic article less in Diff channel except those in Ghost region
Particles in Eos region of Diff channel
Sum of all all partic p article less in Diff channel exce excep p t those in Ghost region
Lymphocytes number
Lym# W BC Lym%
100％
100％
Eosinophils percentage
Eos%
Particles in Neu region of Diff channel
Monocytes percentage
M on%
100％
Neutrophils number
BC Ne Neu Ne u# W Neu u% 3-7
100％
Understanding the System Principles
Monocytes number
BC Mon% Mon# W
Eosinophils number
Eos# W BC Eos%
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Understanding the System Principles
3.5 HGB Measurement 3.5.1 Colorimetric Method HGB is determined by the colorimetric method. The WBC/HGB dilution is delivered to the HGB bath where it is bubble mixed with a certain amount of lyse, which converts hemoglobin to a hemoglobin complex that is measurable at 525 nm. An LED is mounted m ounted on one side of the bath and emits a beam of monochromatic light, whose central wavelength is 525nm. The light passes through the sample and is then measured by an optical sensor that is mounted on the opposite side. The signal is then amplified and the voltage is measured and compared to the blank reference reading (readings taken when there is only diluent in the bath), an and d the HGB is measured and calculated in the analyzer automatically.
3.5.2 HGB The HGB is calculated per the following equation and expressed in g/L.
HGB(g/L) Constant Ln Blank Photocurrent Sample Photocurr ent
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Understanding the System Principles
3.6 RBC/PLT RBC/PLT Measurement 3.6.1 Electrical Impedance Method RBCs/PLTs are counted and sized by the Electrical Impedance method. This method is based on the measurement of changes in electrical resistance produced by a particle, which in this case is a blood cell, suspended in a conductive diluent as it passes through an aperture of known dimensions. An electrode is submerged in the liquid on both sides of the aperture to create an electrical pathway. As each particle passes through the aperture, a transitory transitor y change in the resistance between the electrodes is produced. This change produces a measurable electrical pulse. The number of pulses generated signals the number of particles that passed through the aperture. The amplitude of each pulse is proportional to the volume of each particle.
Figure 3-4 Electrical Impedance method Each pulse is amplified and compared to the internal reference voltage channel, which only accepts the pulses of a certain amplitude. If the pulse generated is above the RBC/PLT lower threshold, it is counted as a RBC/PLT. The analyzer presents the RBC/PLT histogram, whose x-coordinate represents the cell volume(fL)and y-coordinate represents the number of the cells.
3.6.2 RBC
RBC 12
RBC (10 /L) is the number of erythrocytes measured directly by counting the erythrocytes passing through the aperture. 3-10
Understanding the System Principles
Mean Corpuscular Volume
Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and expresses the result in fL.
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows, where the RBC is 12
expressed in 10 /L, MCV in fL and HGB in g/L.
HCT
M CH
RBC M CV 10 HGB RBC
HGB MCHC 100 HCT
Red Blood Cell Distribution Width Coefficient of Variation
Based on the RBC histogram, this analyzer calculates the CV (Coefficient of Variation, %) of the erythrocyte distribution width.
Red Blood Cell Distribution Width Standard Deviation
RDW-SD (RBC Distribution Width – Standard Deviation, fL) is obtained by calculating the standard deviation of the red blood cell size distribution.
3.6.3 PLT
Platelet count 9
PLT (10 /L) is measured directly by counting the platelets passing through the aperture.
Mean Platelet Volume
Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL).
Platelet Distribution Width
Platelet distribution width (PDW) is the geometric standard deviation (GSD) of the platelet size distribution. Each PDW result is derived from the platelet histogram data and is reported as 10(GSD).
PCT This analyzer calculates the PCT as follows and express it in ％, where the PLT is expressed 3-11
Understanding the System Principles 9
in 10 /L and the MPV in fL.
PCT
PLT MPV 10000
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Understanding the System Principles
3.7 Wash After each analysis cycle, each element of the analyzer is washed.
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4
Installing Your Analyzer
4.1 Introduction
Installation by personnel not authorized or trained by Mindray may cause injury or damage your analyzer. Do not install your analyzer without the presence of Mindray-authorized personnel.
Your analyzer is tested before it is shipped from the factory. International symbols and special handling instructions tell the carrier how to treat this electronic instrument. When you receive your analyzer, carefully inspect the carton. If you see any signs of mishandling or damage, contact Mindray customer service department departm ent or your local distributor imm immediately ediately..
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Installing Your Analyzer
4.2 Installation Requirements
Do not install the software and database in the system disk.
4.2.1 Installation Requirements Check the site for proper space allocation. In addition to the space required for the analyzer itself, arrange for
at least 100 cm on each side, which is the preferred access to perform service procedures.
at least 50 cm behind the back side side for cabling and ventilation.
enough room on and below the countertop to accommodate the diluent and waste containers. The supporting table where the analyzer anal yzer is placed shall be able to withstand at least 60kg of weight.
4.2.2 Power Requirements
Make sure the analyzer is properly grounded.
Before turning on the analyzer, make sure the input voltage meets the requirements.
Using plug-board may bring the electrical interference and the analysis results may be unreliable. Please place the analyzer an alyzer near the electrical outlet to avoid using the plug-board.
Please use the original electrical wire shipped with the analyzer. Using other electrical wire may damage the analyzer or cause unreliable analysis results.
Analyzer
Voltage
Input power
Frequency
A.C. 100V-240V
≤300 VA
50/60 Hz
NOTE
Main supply voltage fluctuations up to ±10% of the nominal voltage.
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Installing Your Analyzer
4.2.3 General Environment
Optimal operating temperature: 15 ℃ - 30 ℃
Optimal operating humidity: 30 % - 85 %
Operating atmospheric pressure: 70 kPa - 106 kPa.
The environment environment should be as free as possible from dust, mechanical vibrations, loud noises, pollution and electrical interference.
It is is advisable to evaluate the electromagnetic environment prior to operation of this analyzer.
Do not use this analyzer analyzer in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as these may interfere with the proper operation.
Do not not place the analyzer near brush-type motors, flickering fluorescent lights, and electrical contacts that regularly open and close.
Do not place the analyzer in direct sunlight or in front of a source of heat or drafts.
The environment should be good ventilation.
Do not place the analyzer on a slope.
4.2.4 Transport and Installation
Transport or installation by personnel not authorized or trained by Mindray may cause injury or damage your analyzer. Do not install your analyzer without the presence of Mindray-authorized personnel.
To avoid damage during the transportation, the sampling assembly of the analyzer is fixed with a plastic cable tie and a clamp. Do remove them before using the analyzer.
The transport and installation shall be conducted by Mindray-authorized personnel. Do not transport or install the analyzer without contacting Mindray customer service department or your local distributor.
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Installing Your Analyzer
4.3 Connecting the Analyzer System
Please make sure the length of the diluent pipe and the waste pipe is not longer than 1500mm; the length of the lyse pipe is not longer than 850mm.
Connect the electrical lines and fluidic lines as follows:
Figure 4-1 Connecting the Electrical Lines
Figure 4-2 Connecting the Fluidic Lines
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5 5.1
Customizing the Analyzer Software Introduction
The BC-5300 is a flexible laboratory instrument that can be tailed to your work environment.
You can use the “Setup” program to customize th e software options as introduced in this chapter. The analyzer divides the operators into two levels, common user and administrator. Note that an administrator can access all the functions open to a common user. This chanter introduces how to customize your analyzer respectively as a common user level and as an administrator.
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Customizing the Analyzer Software
5.2 Common User 5.2.1 General Setup When you log in as a common com mon user, click the “Menu” button, and then select the “Setup”, and then select any setting from the displayed menu to enter the “ General Setup” screen.
Date format Date format can be set at this screen. Note that when the date format setting is changed, all the displayed and printed date format will be affected, including the draw date, delivery date, run date, entry date of the work list, reagent expiration date, quality control date, calibration date, and etc.
Entering the “Date format” screen
At the “General Setup” screen, click the “Date Format” button to enter the setup screen.
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Customizing the Analyzer Software
Selecting date format
YYYY-MM-DD”, “ YYYY/MM/DD YYYY/MM/DD ”, “MM-DD-YYYY”, Six date formats are available: “ YYYY-MM-DD
“MM/DD/YYYY ”, “DD-MM-YYYY” and “DD/MM/YYYY ”. To To select the desired d esired format, click the corresponding radio button.
Apply
Click the “ Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save all the settings and close the setup screen
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But th the e new changes will only be saved after you click the “Apply” or “Ok” button.
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Customizing the Analyzer Software
Reagents
Be sure to set the reagent expiration date before the first use of the analyzer or after a new container of reagent is installed.
You can set the expiration exp iration date of the diluent, LEO (I) lyse, LEO (II) llyse yse and LH lyse at the
“Reagent” screen.
Entering the “Reagent” screen
At the “General Setup” screen, click the “Reagent” button to enter the reagent setup screen.
Selecting whether to set the expiration date
If you wish to set the expiration date for the reagents, you can click the check box “Exp. Date” to select it. This option is selected as default.
If the “Exp. Date” check box is not selected, then the “Reagent Expired” will not be alarmed.
5-4
Customizing the Analyzer Software
Setting the expiration date
After selecting the check box of “Exp. Date”, you can click the arrow button of the edit box to set the expiration date of each reagent by using the date control.
The range of the expiration date is from the current system date to
2099-12-31. You can not edit the open-container expiration date for it is calculated automatically by the software and displayed in the form of text.
If the current system date exceeds the displayed expiration date or the open-container expiration date whichever is earlier , then the “Reagent Expired” will be alarmed.
When the reagent is expired, you can check the expiration date and the open-container expiration date here to determine which one led to the expiration alarm.
When the reagent is expired, you can not run any samples.
If an external barcode scanner is connected, you can click the “Use barcode scanner ” check box to enable it. Scan the barcode b arcode with the external barcode scanner. If the scan is successful, the expiration date of the reagent will be displayed in the corresponding box.
If “Use barcode scanner” is selected, then the date control will be
unavailable for you to enter the expiration date manually.
Apply
Click the “ Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But the new changes will only be saved after you click the “Apply” or “Ok” button.
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Auxiliary
Entering the “ Auxiliary” screen
At the “General Setup” screen, click the “Auxiliary” button to enter the the auxiliary screen.
Selecting reminder of the predilute mode
If you have activated the reminder and selected the predilute mode, a message m essage box will pop up to ask for confirmation every time you try to analyze a sample in the predilute mode.
To activate the reminder, click the “Ask for confirmation” radio button (default). To To deactivate the reminder, click the “Do not ask for confirmation ” radio button.
Setting the sample ID
Select “ Auto Increase” (default) so that the sample ID can increase automatically; select 5-6
Customizing the Analyzer Software
“Manual entry (by keyboard or bar scanner)” if you want to enter the sample ID manually m anually..
Even in the “Auto incre ase” mode, you can still change the sample ID by re-entering the desired number through keyboard or the bar-code scanner.
Enter the prefix of the sample ID in the edit box of “Prefix”.
The new setting of the prefix will only be applied to the later sample IDs. It will not affect the IDs run previously and those already entered in the worklist.
If the prefix is entered, and the sample ID entry method is set as “Auto Increase”, then a revisable prefix will be displayed automatically in the sample ID box every time when you entering/editing the information.
If the sample ID entry method is set as “Manual entry (by barcode scanner or keyboard)”, then no matter the prefix is set or not, the default sample ID of a new record in the worklist will be empty.
Other settings
If you want to add a new record automatically after the previous one is entered and saved in
the worklist, you can select “ Save and jump to next record ”. If you wish to jump to the next record once the current one is validated, you can select the
check box “Validate and jump to next record”. This option is selected as default. If you wish to switch between different information fields by [Enter] key, you can select the
check box “Switch between different information fields by [Enter] key”. The default setting of this option is selected and also support switch by [Tab] key. Click the “ Information fields” button next to the option and the following message box will pop up.
There is a check box in front of each information field; the default setting is all selected. It 5-7
Customizing the Analyzer Software means information entry of all demographics is requested. You can click a check box or some boxes to cancel the selected mark “√”. It means you can jump over the unselected demographics by pressing [Enter] or [Tab] key, leaving them in blank. However, you can also re-locate the cursor in the information field by the mouse to re-enter the information.
Click “Ok” to save the entered information and close the message box, then back to the “Auxiliary” screen. If you wish to delete the completed record from the worklist after each run, you can click the
check box “ Automatically delete completed records from the worklist. ” selecting it by a “√”in the box. The default setting of this th is option is not selected. If you wish to apply the current system date to the “ Draw Time” and “Delivery Time” for new added sample records, you can select the check box “Automatically generate the draw date and delivery date”. The default setting of this option is not selected.
Any change made to the option “Automatically generate draw the date and delivery date” will only be applied to later added sample records. Records entered previously in the worklist will not be affected.
Apply
Click the “ Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But th the e new changes will only be saved after you click the “Apply” or “Ok” button.
5.2.2 User/Lab Management
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User and Password When you log in as a common user, click the “ Menu” button, and then select the “ Setup”, then select “User and Password” from the pop up menu to enter the information list of all the administrators and common users.
Change password
The current login user can change his/her password: 1.
Highlight the current login user in the list, and then click the “ Change password” button, the following message box will pop up.
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2.
Enter the current login password in the edit box “ Old password”, and then enter the new password in the “New password” and “Confirm password” box.
3.
Finish entering; click “Ok”, then a message box will pop up.
4.
Click “OK” to close the message box and back to the previous screen.
The new password could be empty.
Exiting the “User and Password” screen
Click the “Close” button to exit the “User and Password” screen.
Lab Information When you log in as a user of common level, click the “Menu” button, and then select the
“Setup”, and then select “Lab Info.” from the pop-up menu, and then the lab information box will pop up. You can only browse the information.
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Exit
Click the “Cancel” button to exit the “Lab Info.” box.
5.2.3 Shortcut Code When you log in as a user of common level, click the “ Menu” button, and then select the “Shortcut Code”, and then the shortcut code message box will pop up.
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You can click the “Department”, “Deliverer ”, ”, “Diagnosis” and “Gender ” button to check the corresponding shortcut code.
Exit
Click the “Close” button to exit the message box.
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5.3 Administrator 5.3.1 General Setup When you log in as a user of administrator level, click the “Menu” button, and then select the “Setup”, and then select any setting from the displayed menu to enter the “ General Setup” screen. Besides the authorities of common level, a user of administrator level is enabled the following authorities.
Auxiliary
Entering the “ Auxiliary” screen
At the “General Setup” screen, click the “Auxiliary” button to enter the the auxiliary screen.
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Authority setup
To allow common users to edit the ID of the sample run already in the review screen, you can
select the check box “ Edit ID of sample run already”. The default setting of this option is not selected. If you wish to enable users of common level the authority authorit y of editing/restoring the sample result,
you can select the check box “ Edit sample result”. This option is not selected as default. If you wish to enable the users of common level the authority of validating the sample result,
you can click the check box “ Validate sample”. This option is not selected as default.
Apply
Click the “ Apply” button to save all the changes without c losing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
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Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But th the e new changes will only be saved after you click the “Apply” or “Ok” button.
Para. Units Some references/parameters used by the analyzer could in several different units; you can select the desired unit.
Entering the “Para. Units” screen
At the “General Setup” screen, click the “Para. Units” button to enter the the screen.
Parameters of the same group are displayed together, with the first parameter in black and the
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Customizing the Analyzer Software rest in gray gr ay..
Unit standard
Click the check box “ Select unit system” to select the desired unit standard form the following seven ones: Customized, China, International (default), USA, Canada, Netherlands and Britain.
When selecting different unit standards, the corresponding unit list and unit option will display accordingly accord ingly..
If “Customized” is selected, then you can modify the unit of each parameter. If other option is selected except the “Customized”, then the unit of each
parameter can only be browsed.
Para. units Setup
When “Customized” is selected, click the desired parameter, and then click the unit options provided on the right to select a new unit for the parameter.
For parameters in a same group, if the unit of any parameter changes, the units of the rest parameters change accordingly.
The unit of MCH changes according to MCHC and HGB, the operator can not modify it.
If the parameters units change, the format of the data displayed in the list will change accordingly.
Default
When “Customized” is selected, click the “Default” button to have the default units (International) of all parameters displayed in the corresponding cell.
Print
Click the “Print “Print”” button to print all the parameters’ units in the current screen. If you haven’t saved the settings when clicking the “Print” button, a message box will pop up.
Click “ Yes Yes” to save the new settings and print them; click “ No” to print the content of the original settings without saving.
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Apply
Click the “ Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But th the e new changes will only be saved after you click the “Apply” or “Ok” button.
Ref. Range The “Ref. Range” screen is where you view and set the upper and lower limits for your patients. The analyzer flags any parameter value above (H) or below (L) these limits. This analyzer divides patients into 5 demographic groups: General, Man, Woman, Child and
Neonate. You You can also customize another 5 groups. The default setting is “ General”. The recommended limits are provided for f or your reference only. T To o avoid misleading parameter pa rameter flags, be sure to set the patient limits according to the characteristics of your local population.
Entering the “Ref. Range” screen At the “General Setup” screen, click the “Ref. Range” button to enter the the screen.
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Set ref. group
Click the “Set ref. group” button, a message box will pop up.
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You can not modify the names and corresponding information of the five fixed reference groups in the list.
You can modify the names, age range (including age value and unit) and gender of the five customized reference groups.
Double click the “ Ref. Group” cell of the five customized reference group to modify the name of the group.
The reference group name can not be empty.
The names of the five customized groups can not use General, Man, Woman, Child and Neonate. No repetition of the group name allowed.
Double click the age cell of the customized reference group to modify the age; double click the age unit cell to open a combo com bo box with different age units for you to choose from from:: Year, Year, Month, Day, and Hour.
Double click the “ Gender ” cell of the customized reference group to open a combo box with different options for you to choose from: fr om: Not defined, Male, Female, Em Empty pty.. Click the check box of “Automatically match the customized ref. group according to age and gender ” to select it. The option is not selected as default.
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If “Automatically match the customized ref. group according to age and gender ” is not selected, then the five fixed ref. groups will be used to match according to patient’s age and gender automatically.
If “Automatically match the customized ref. group according to age and gender ” is selected but the customized ref. groups have not been edited, then the five fixed ref. groups will be used to match according to patient ’s age and gender automatically.
If “Automatically match the customized ref. group according to age and gender ” is selected and the customized ref. groups have been edited, then the customized ref. groups will be used to match firstly. If matching is failed, and then the five fixed ref. group will be used to match according to patient’s age and gender automatically.
When the customized ref. groups are used to match, the matching will be performed from top down according to the customized ref. groups displayed in the screen.
Click one of the reference groups to highlight it, and then click the “ Set to be default ref. group” button to set this group as the default group when entering the worklist. Click one of the reference groups to highlight it, and then click the “ Default” button to display the default information including group title, age limit, age unit and gender in the corresponding cell.
Click the “Print” button to print out the settings in accordance with the age and gende r of the reference group. If the previous settings are not saved when you click the “ Print” button, a message box will pop up.
Click “ Yes Yes” to save the new settings and print them; click “ No” to print the content of the original settings without saving.
Click the “Ok” button to save and refresh the settings and close the “ Set ref. group” message box.
Set the Ref. range
1.
Click the “Ref. Group” combo box, then select the desired group from the options: General, Man, Woman, Child, Neonate and Customized 1-5.
2.
Drag scroll bar; then click the “ Upper limit” or “Lower limit” cell of the parameter you want to setup.
3.
Enter the desired numbers.
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10 groups of reference range are defined according to 10 reference groups.
When a reference group is selected, the upper and lower limit of the target will change accordingly.
The default reference ranges of the five customized groups are the same as
The change of the reference range will not affect the previous flagging setup, but only affect the following analysis.
the “General” group.
Default
Click the “Default” button to display the default reference range of the current reference group in the corresponding form.
Print
Click the “Print” button to print the reference ranges of all reference groups. If the previous settings are not saved when you click the “Print” button, a message box will pop up.
Click “ Yes Yes” to save the new settings and print them; click “ No” to print the content of the original settings without saving.
Apply
Click the “Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
Click another setup button to switch to the corresponding screen.
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You will not lose tthe he new changes by switching to another screen. But th the e new changes will only be saved after you click the “Apply” or “Ok” button.
Print
Entering the “Print” screen
the screen. At the “General Setup” screen, click the “Print” button to enter the
Setting the print title
Enter the print title in the “Title” box. The default title is “ Hematology Analysis Report”.
Selecting paper type
Click the “Paper type” box to select the desired paper type from f rom the five types: A5 (default), A4, continuous paper, B6 and B5.
Setting number of copies
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Customizing the Analyzer Software If you want multiple copies of the same patient report to be printed, you can enter the desired number (1 - 100) into the “Copies” field. The default number is 1.
Setting print format
Click the “Format” combo box to display the report format options for y ou to select from. The report format in the combo box differs according to the selected paper type. The default formats for different papery types are shown in the following list:
Paper type
Format
Note
Whole page, all para., with graph Half page, all para., without graph Half page, compact A4 Half page, no diff para., with graph microscopic exam results report Common Microscopic Exam. Para. All para., with graph
A5, continuous
All para., without graph
paper, B5 No diff para., with graph
The same as “Half page, compact” of A4 The same as “Half page, all para., without graph” of A4 The same as “Half page, no diff para., with graph” of A4
Common Microscopic Exam. Para. All para., with graph
B6
All para., without graph
No diff para., with graph
The same as “Half page, compact” of A4 The same as “Half page, all para., without graph” of A4 The same as “Half page, no diff para., with graph” of A4
Print Preview
Click the “Print Preview” button to preview the print report.
After editing the print setup, you should preview the report before printing to make sure the setup is correct.
Customizing report format
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You can click the “ Customize” button to enter the “PrintTemplate” screen, and then customize the print template. See Chapter 12 Customizing the Print Template Template for details of how to customize.
Autoprint
The analyzer can auto-print the report in the set format once the analysis result is obtained. Click “On” to enable the autoprint function; click “ Off ” to disable the autoprint function. The
default setting is “ Off ””..
Autoprint after validation
If “Autoprint” is “On”, then the “ Autoprint after validation” check box will be activated. Select the “Autoprint after validation” to autoprint the report only after the sample is validated; otherwise, the report will be printed once the running is finished.
Print Flag
If the flag information is needed in the printed report, you should select the “ Print Flag” check box .The default setting of this option is not selected.
If the default report template that you selected displays the flag information, then the “Print Flag” check box here will be available for you to select.
If the default report template that you selected doesn ’t display the flag information, or the selected templa te is a customized one, then the “Print Flag” check box here will be unavailable for you to select.
Print suspect flags “?”
If the suspect flags “?” are needed in the printed report, you should select the “Print suspect flags “?” “?””” check box. This option is selected as default.
Print ref. range
If the reference range is needed in the printed report, you should select the “ Print ref. range” check box. This option is selected as default.
Print ref. range flags
If the ref. range flags (“H” or “L”) are needed in the printed report, you should select the “ Print ref. range flags” check box. This option is selected as default.
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If “Print ref. range” is selected, then the “Print ref. range flags” option will also be enabled and unavailable for you to edit. The ref. range and the ref. range flags (“H” or “L”) will be printed in the report together.
If you want to de- select the “Print ref. range flags” option when “Print ref.
range” is selected (print the ref. range in the report only), please contact Mindray customer service department or your local distributor.
If “Print ref. range” is not selected, then you can select whether to print the ref. range flags (“H” or “L”) in the report at will.
Print result edited flags
If the result edited flags (“E” or “e”) are needed in the printed report, you should select the
“Print result edited flags” check box. This option is selected as default. For details of how to edit result, please see Edit Result section Result section in 7.2.3 7.2.3 or or 7.3.3 Function of the Buttons Buttons
Print ambient temp. abnormal flags
If the ambient temp. abnormal flags ( “T”) are needed in the printed report, you should select
the “Print ambient temp. abnormal flags ” check box. This option is selected as default.
Print QC graph time
If the test date of each QC point needs to be printed out when printing QC graphs, you can select the “Print QC graph time” check box.
Setting default printer
Click the “Default printer ” check box to display the printers available to the current system, and then you can select one type from them as the default printer to perform perf orm all the print tasks.
If you change the default printer here, then the default printer of the current operation system will also change.
If you change the default printer in the operation system, then the printer name in this check box will also change.
Apply
Click the “ Apply” button, save all the settings without closing the setting window.
Ok
Click the “Ok” button, save all the settings and close the setting window.
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Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But the new changes will only be saved after you click the “Apply” or “Ok” button.
Communication
Entering the “Communication ” screen
At the “General Setup” screen, click the “Communication” button to enter the “Communication” screen.
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The settings here are applied to the communication between the analyzer and the external (i.e. LIS), but not between the analyzer and the terminal software.
Setting IP address
Enter the IP address into the empty (default) “IP address” box.
Setting Port
Enter the port number into the empty (default) “Port” box.
Auto-communication
The function is used for automatically transmitting the sample result to the external data management software or LIS/HIS system.
Click “On” to enable the auto-communication; click “Off ” to disable the auto-communication. The default setting is “ Off ””..
Bidirectional LIS/HIS communication
The function is used for automatically obtaining the sample/patient information from the LIS/HIS system after the sample ID is entered or scanned, and automatically transmitting the sample result to the LIS/HIS system.
Click “On” to enable the bidirectional LIS/HIS communication; click “ Off ” to disable it. The default setting is “ Off ””..
Histogram transmission method
The function is used to select the histogram transmission method. Click “Not Transmit” to disable the transmi ssion of the 3 histograms while transmitting sample records. Click “Bitmap” (default), then the 3 histograms will be transmitted in the form of
graphs to the LIS/HIS system. Click “Data”, then the 3 histograms will be transmitted in the form of data to the LIS/HIS system.
Scattergram transmission method
The function is used to select the scattergram transmission method.
Click “Not transmit” to disable the transmi ssion of the scattergram while transmitting sample records. Click “Bitmap” (default), then the scattergram will be transmitted in the form of graph to the LIS/HIS system.
Communication Acknowledgement
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Customizing the Analyzer Software Select “On”: when IPU software is communicating with LIS/HIS, the HL7 protocol must be strictly followed. After receiving the ACK acknowledgement from LIS/HIS, the communication can be deemed successful; otherwise the communication fails, a communication failure notice will pop up. Select “Off ”: when IPU software is communicating comm unicating with LIS/HIS, even if no ACK acknowledgement from LIS/HIS is received, the communication can be deemed successful; no failure notice will pop up. Communication Comm unication flag “T” is recorded in the communication column in Table Review scr screen. een.
Automatically Transmit Error Info. Automatically transmit the error information to LIS/HIS. Select “On” to enable the automatical transmission of error information; or select “Off ” to disable.
Version The version of the communication protocol, where 2 versions are available for selection (1.0 and 1.1), and the default version is 1.0. Version 1.1 provides the transmission of flag messages including “WBC Abn.”, “DIFF Channel Abnormal”, “RBC System Abnormal”, “ Aspiration Aspiration Abnormal”, “System Abnormal” and “RBC clump?”.
Apply
Click the “ Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save all the settings and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But th the e new changes will only be saved after you click the “Apply” or “Ok” button.
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Research use only parameter (RUO parameter) The RUOs include ALY%, ALY%, LIC%, ALY# and LIC#.
The RUO parameters are for research use only, not for diagnostic use.
Entering the setup screen
At the “General Setup” screen, click the “RUO” button to enter the “RUO” screen.
Setting display
If you wish to display the RUO parameters, param eters, select the “ Display RUO parameters” check box. This option is selected as default.
If “Display RUO parameters” is selected and you also wish to display the “*” mark, you can select the “Display “*” mark” mark” check box. This option is selected as default. If “Display RUO parameters” and “Display “*” mark” mark” are selected and you also wish to display declaration (“*” means “research use only, not for diagnostic use”), you can select the
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“Display declaration” check box. This option is selected as default.
Setting print
If you wish to print the RUO parameters, you can select the “ Print RUO parameters” check box. This option is selected as default.
If “Print RUO parameters” is selected and you also wish to print the “*” mark, you can select the “Print “Print “*” mark” mark” check box. This option is selected as default. If “Print RUO parameters” and “Print “Print “*” mark” are selected and you also wish to print declaration (“*” means “research use only, not for diagnostic use”), you can select the “Print declaration” check box. This option is selected as default.
Any change made to the settings of displaying or printing the RUO parameters, the “*” mark and the declaration will be applied to all the RUO parameters (before and after the change is made).
Apply
Click the “ Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save all the settings and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But the new changes will only be saved after you click the “Apply” or “Ok” button.
Gain You can adjust each digital d igital pot at the “ Gain” screen. It is not recommended to adjust gains frequently.
Entering the “Gain” screen
At the “General Setup” screen, click the “Gain” button to enter the “Gain” screen.
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You can not modify the gains of FS, SS and SF. SF.
Setting the WBC gain
The WBC gain here is under the Whole Blood Mode. Click the current value of the “ WBC” and then enter the new value.
Setting the RBC gain
Click the current value of the “RBC” and then enter the new value.
Setting the WBC(P) gain
The WBC gain here is under the Predilute Mode.
Click the current value of the “WBC (P)” and then enter the new value.
Setting the HGB gain
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Customizing the Analyzer Software You can adjust the HGB blank voltage by adjusting the HGB gain. You can enter the value directly in the edit box or click the adjusting button to adjust the HGB gain.
Apply
Click the “ Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But th the e new changes will only be saved after you click the “Apply” or “Ok” button.
Auto Maintenance
Entering the “ Auto Maintenance” screen
At the “General Setup” screen, click the “Auto Maintenance” button to enter the the screen
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Setting the “ Auto-sleep”
You can set here when to start the auto-maintain auto- maintain procedure after the rrelevant elevant fluidic operation stops. Enter the desired time ranging from 15 to 120 minutes into the “Wait” box.
Setting “Time-based maintenance”
You can enter the desired time in the “ Preset time” or click the adjusting button to set the preset time for time-based maintenance ranging from [0:00(default) – 23:59].
Apply
Click the “ Apply” button to save all the changes without closing the setup screen.
Ok
Click the “Ok” button to save the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
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Customizing the Analyzer Software Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But th the e new changes will only be saved after you click the “Apply” or “Ok” button.
Microscopic Para. You can set the microscopic parameters for the display of the " Microscopic Exam. And Others"" tab at the "Review Others "Review"" screen and the printout template for reports.
Entering the setup screen
At the “General Setup” screen, click the “Microscopic Para.” button to enter the “Microscopic Para.” screen.
The parameters are displayed in the "Para. " Para. List". List".
Creating a microscopic parameter
Do as follows to create a microscopic parameter:
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Click the “New” button, a message box will pop up.
2.
Enter the name name of the new microscopic parameter in in the edit box.
3.
Click “Ok” to save the information of the new parameter, refresh the para. list without closing the message box, and the parameter name entered in the message box will be cleared, and then you can continue to add another new microscopic parameter.
New parameter names can be neither empty nor same as existing ones.
Editing the name of a microscopic parameter
Do as follows to edit the name of a microscopic parameter: 1.
Click the desired parameter, and then click the “Edit” button. A message box will pop up.
2.
You can enter enter a new name for the microscopic parameter in the edit edit box.
3.
Click “Ok” button to save the modified parameter name and close the message box, and then the edited parameter will be highlighted in the list.
Modified parameter names can be neither empty nor same as existing ones.
Deleting a microscopic parameter
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Customizing the Analyzer Software Do as follows to delete a microscopic parameter: 1.
Click the desired cell, and then click the “Delete” button. A message box will pop up.
2.
Click “Ok” to delete the microscopic parameter and close the message box, and then the parameter will be deleted from the list.
1.
Adjust the order of microscopic parameters
Click the “ Adjust Order ” button and a message box will pop up, displaying the current order of the microscopic parameters in the para. list.
2.
The buttons ("Top", "Up", "Down" and "Bottom") to the right of the list are used to adjust the order of the microscopic parameters.
Click on a microscopic parameter to highlight highlight it. Adjust the position of this parameter using the buttons on the right.
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Click the "Top Top"" button to move the highlighted microscopic parameter to the top of the list.
Click the "Up Up"" button to move the highlighted microscopic parameter upward by one position.
Click the "Down Down"" button to move the highlighted microscopic parameter downward by one position.
Click the "Bottom Bottom"" button to move the highlighted microscopic parameter to the bottom of the list.
3.
Click the “Ok” button to save the adjusted order, close the message box and go back to the setup screen. Then the order of parameters will be refreshed.
Ok
Click the “Ok” button to save all the changes and close the setup screen.
Cancel
Click the “Cancel” button to close the setup screen without saving the changes.
Exiting the setup screen
Click another setup button to switch to the corresponding screen.
You will not lose tthe he new changes by switching to another screen. But tthe he new changes will only be saved after you click the “Apply” or “Ok” button.
Flag The administrator can edit a list of flagging rules at the “Flag Rules” scr een een
Entering the “Flag Rules” screen At the “General Setup” screen, click the “Flag Rules”button to enter the “ Flag Rules”screen.
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Customizing the Analyzer Software
Edit/restore a flagging rule (taking leucocytosis as an example) 1. 2.
Click to select “Leucocytosis” from the flag rules table to display the name and rule. Click the “Edit” button to the right of the rule table, and a dialog box below will pop up.
3.
Enter the desired value in the text box and click click “Ok”, and then click the “ Apply Apply” button to save the change, or just click “Ok” to save the change and exit the “Flag Rules” screen.
5-38
Customizing the Analyzer Software
The flag rule entered should be within the display range; otherwise, a dialog box will prompt “Invalid entry. entry.” Two digits are allowed after the decimal point for the entered value.
4.
Click click the “Default button thechange, right of or thejust ruleclick table“Ok to”restore rules, then “ Apply Apply”” to savetothe to savethe thedefault change and and exit the setting.
5.3.2 User/Lab management User and Password When you log in as an administrator, click the “Menu” button, and then select the “ Setup”, then
select “User and Password” from the pop up menu to enter the information list of all the administrators and common users.
Creating a new user
You can take the following f ollowing steps to create a new user:
1. Click the “New” button, a message box will pop up.
5-39
Customizing the Analyzer Software
2. Enter the information in each edit box, and then click the authority combo box to select the
new user as “Common User ” or “ Administrator ””.. 3. Click “Ok” to save the information of the new user, refresh the user list without closing the message box, and all the information fields in the message box will be cleared, and then you can continue to add another new user.
New user names can be neither empty nor same as existing ones.
Editing information of users
You can take the following f ollowing steps to edit the information inform ation of the users:
1. Click the desired cell, then click the “Edit” button, then a message box will pop up.
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Customizing the Analyzer Software
2. You can change the content of each item in the edit box or change the users ’ level by clicking the authority combo box.
3. Click the “Ok” button to save the modified users’ information and close the message box, then the edited record will be highlighted in the users list.
Modified user names can be neither empty nor same as existing ones.
If the current login administrator changes the user level into “common user”, the settings take effect only after logout and then re -login.
Deleting a user
You can take the following f ollowing steps to delete a user: 1.
Click the desired cell, and then click the “ Delete” button; a message box will pop up.
2.
Click “Ok” to delete the user and close the message box, then the user will be deleted from the users list.
You can not delete the current login user.
Reset password
5-41
Customizing the Analyzer Software You can reset a new password for users who forgot the password: 1. Click the desired cell, and then click the “Reset password” button, a message box will pop up.
2. Enter the new password in the “ New password” and “Confirm password” box. 3. Click “Ok” button to save the new password and close the message box.
You can not reset the password for the current login user.
Change password
The current login user can change the password: 1.
Highlight the current login user in the list, and then click the “ Change password” button, the following message box will pop up.
2.
Enter the current login password in the edit box “ Old password”, and then enter the new
5-42
Customizing the Analyzer Software
password in the “New password” and “Confirm password” box. 3.
Finish entering; click “ Ok”, a message box will pop up.
4.
Click “OK” to close the message box and back to the previous screen.
The new password could be empty.
Exiting “User and Password” screen
Click the “Close” button to exit the message box of “ User and Password”.
Lab Information When you login as a user of administrator level, click the “Menu” button, and then select “Setup”, and then select “Lab Info.” from the pop-up menu, and then the lab information box will pop up. All the information fields in the box are activated for you to enter/edit.
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Customizing the Analyzer Software
Entering hospital name
Enter the hospital name into the “Hospital name” box.
Entering lab name
Enter the lab name into the “ Lab name” box.
Entering “Responsible by”
Enter the name into the “Responsible by” box.
Entering contact information
Enter the contact information (telephone number or E- mail) into the “ Contact information” box.
Entering postalcode
Enter the postalcode into the “ Postalcode” box.
Entering analyzer model
Enter the analyzer model into the “ Analyzer model” box.
Entering analyzer name
Enter the analyzer name into the “ Analyzer name” box.
Entering installation date
Enter the installation date into the “Installation date” box. The installation date must be entered and it can not be later than the current system date.
Entering contact in service department
Enter the name into the “Contact in service department ” box.
Entering contact information of service department
Enter the contact information of service department (telephone number or E--mail) into the
“Contact information of service department” box.
Entering remark
Enter the remark into the “ Remark” box.
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Customizing the Analyzer Software
Ok
Click the “Ok” button to save the entered/edited information and close the lab information box.
Cancel
Click the “Cancel” button to close the box without saving the changes.
5.3.3 Shortcut Code You can set the shortcut code for the following items: “ Department”, “Deliverer ”, ”, “Gender ” and “Diagnosis”. The shortcut code is used to t o facilitate the entry entr y of the foregoing items. You can enter the shortcut code and press the [Enter] key instead of entering the whole item.
The shortcut code of different items can be the same.
Department When you log in as a user of administrator level, click the “Menu” button, and then select the
“Shortcut Code” to enter the shortcut code screen.
Adding department
Do as follows to add a new department:
5-45
Customizing the Analyzer Software 1.
Click the “New” button, and then a message box will pop up.
2.
Enter the information into each field.
3.
Click “Ok” to save the information of the new department and refresh the department list without closing the message box. All the information fields in the message box will be cleared, and then you can continue to add other new department.
New added department name must be entered and it can not be the same as existing ones.
The shortcut code of department is not necessary to be entered, but once you set them, each of the code must be unique.
Editing department
Do as followings to edit the department information: 1.
Click the desired form cell and click the “Edit” button, and then the box shown below will pop up.
2.
Enter the information into each field.
3.
Click “Ok” to save the information and close the message box, and then the edited record will be highlighted in the list of department.
New added department name must be entered and it can not be the same as existing ones.
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Customizing the Analyzer Software
The shortcut code of department is not necessary to be entered, but once you set them, each of the code must be unique.
Deleting department
Do as follows to delete department:
1. Click the desired cell of the department, then click the “ Delete” button, and then a message box will pop up.
Yes” to delete the department and close the message box, and then it will also be 2. Click “ Yes deleted from the list of department.
Exiting
Click the “Close” button to exit the “Shortcut Code” message box.
Deliverer At the “Shortcut Code” message box, click the “Deliverer ” button to enter its shortcut code settings.
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Customizing the Analyzer Software
Add, edit and delete the deliverer as instructed in the Department Department section. section.
Diagnosis At the “Shortcut Code” message box, click the “Diagnosis” button to enter its shortcut code settings.
Add, edit and delete the clinical diagnosis as instructed in the Department Department section. section.
Gender At the “Shortcut Code” message box, click the “Gender ” button to enter its shortcut code settings.
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Customizing the Analyzer Software
Add, edit and delete the Gender as instructed in the Department Department section. section.
The existed shortcut code settings for gender can not be modifired.
5-49
6
Operating Your Analyzer
6.1 Introduction This chapter provides step--by--step procedures for operating your analyzer on a daily basis. A flow chart indicating the common daily operating process is presented below. below.
6-1
Operating Your Analyzer
6.2 Initial Checks Perform the following checks before turning on the analyzer.
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spi ll into your eyes, wash them off with plenty of water and immediately go see a doctor.
Keep your clothes, hair and hands away from the moving parts to avoid injury.
You should only use the Mindray-specified reagents. Store and use the reagents as instructed by instructions for use of the reagents.
Check if the reagents are connected correctly before using the analyzer.
After installing a new container of reagent, keep it still for a while before use.
Checking the waste container Check and make sure the waste container is empty.
Checking tubing and power connections
Check and make sure the reagents and waste tubing are properly connected and not bent. Check and make sure the power cord of the analyzer is properly plugged into the power outlet.
Checking the printer (optional)
Check and make sure enough printer paper is installed. Check and make sure the power cord of the printer is properly plugged into power outlet. Check and make sure the printer is properl y connected to the external computer. com puter.
6-2
Operating Your Analyzer
Checking keyboard, mouse and external computer
Check and make sure the network cable of the external computer is connected to the analyzer properly. Check and make sure the keyboard and the mouse are well connected to the external computer.
6-3
Operating Your Analyzer
6.3 Startup and Login Starting the analyzer: 1.
Place the power switch at the left side of the analyzer in the ON position (I). The power indicator light will be on.
2. Make sure the indicator light of the analyzer is on. Starting the external computer and run the system software. 1.
Start the external computer.
2.
Turn on the display. display.
3.
After entering the operation system, double click the “ BC-5300 Auto Hematology Analyzer ” icon to run the software.
4.
After starting the software, the message box will pop up.
5.
Enter the correct user name and password in the “ Login” message box.
6.
Click the “Ok” button to initialize the system.
7.
Before running the software, make sure the network cable of the external computer is connected to the analyzer properly. The analyzer starts initializing only when the connection is detected.
If you failed to run the software continuously, please contact Mindray customer service department or your local distributor immediately.
After startup, please make sure the date/time of the computer is correct.
Up to 12 digits can be entered for user name and password. No Chinese entry is allowed.
During the Initialization, Initialization, the startup information will be displayed displayed in the operation/status information area at the bottom of the screen.
8.
The whole process lasts 4 to 12 minutes. Time needed needed for initializing initializing the system depends
6-4
Operating Your Analyzer on how the analyzer was previously shut down. 9.
After the initialization process, you can enter the “Graph” screen to check the background result.
10. After initialization, if the unhidden sample records in the Worklist are detected, a message box will pop up.
Click “ Yes Yes” to set the first unhidden record in the worklist as the next sample to be run. Click “No” to hide all the records in the worklist.
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Operating Your Analyzer
The background test is to detect the particle interference and electrical interference.
If the background results exceed the Ref. Range for the first time during fluidics initialization, then the analyzer will run the background test one more time.
The sample ID for background test is “0”.
No ref. range or suspect flag is available for background test.
If error happens during initialization (e.g. the background results exceed the Ref. Range), the analyzer will alarm. See Chapter 11 Troubleshooting Your Analyzer for solutions.
For the background Ref. Range of each parameter, please see Appendix B Specifications.
The system opens different functions for the users according to their
authority levels. The user’s authority level depends on the user name and the password when the user logs in the system.
You can click “Logout” button to switch to another user. Enter the new user name and password in the Login message box, and then click “Ok” to re-login as a new user.
Running a test when there is an “Abnormal background”, you would get an unreliable testing result.
During the startup procedure, to start the analyzer first or to run the software first are both acceptable.
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Operating Your Analyzer
6.4 Daily Quality Control Before running any samples, run the controls. See Chapter 8 Using the QC Programs for Programs for details.
6-7
Operating Your Analyzer
6.5 Sample Collection and Handling
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
Do not contact the patients’ sample blood directly.
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
Be sure to use clean K2EDTA anticoagulant collection tubes, fused silica glass/plastic test tubes, centrifugal tubes and borosilicate glass capillary tubes.
Be sure to use the Mindray-specified disposable products including vacuum collection tubes, anticoagulant collection tubes and capillary tubes etc.
6.5.1 Whole blood samples 1.
Use clean K2EDTA(1.5 - 2.2mg/mL) anticoagulant collection tubes to collect co llect venous blood samples.
2.
Mix the sample according to your laboratory’s protocol.
When using the Ф12X75 (without the cap) evacuated collection tube, be sure the volume of the whole blood sample is not less than 0.5mL.
For the whole blood samples to be used for WBC differential or PLT count, you should store them at room temperature and run them within 8 hours after collection.
If you do not need the PLT, MCV and WBC differential results, you can store the samples in a refrigerator (2 ℃ - 8 ℃) for 24 hours. You need to warm the refrigerated samples at room temperature for at least 30 minutes before
6-8
Operating Your Analyzer running them.
Be sure to mix any sample that has been prepared for a while before running it.
6.5.2 Prediluted samples 1.
At the shortcut button area, click the “Diluent” button, then a message box will pop up.
2.
After the preparation is done, the following following message box will pop up.
3.
Present a clean centrifugal tube to the sample probe and make sure the probe reaches the bottom of the tube and the keep the tube vertical, as the figure shows, to avoid spills, hangings and bubbles.
6-9
Operating Your Analyzer
4.
Press the aspirate key to start dispensing the diluent. During During the procedure, a progress bar will display.
5.
The buzzer buzzer sounds when the dispensing is finished, then you can remove the centrifugal tube. Then, the following message box will display. display.
6.
Add 20μL of capillary capillar y blood to the diluent, close the tube t ube cap and shake shak e the tube to mix the sample.
7.
After the prediluted sample is prepared, click the “Cancel” button to exit dispensing the diluent.
6-10
Operating Your Analyzer
8.
After exiting, the above message box will close automatically. automatically.
9.
If more portions portions of diluent are needed, repeat the procedure 3-5.
You can also dispense 180μL of diluent by pipette into the tube.
The prepared diluent is only enough for 20 tubes. Therefore, after 20 tubes, the system needs to run the preparation process again.
Be sure to keep dust from the prepared diluent. After mixing the capillary sample with the diluent, be sure to wait 3 minutes before running the sample.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running it.
Be sure to evaluate predilute stability based on your laboratory’s sample population and sample collection techniques or methods.
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Operating Your Analyzer
6.6 Sample Analysis 6.6.1 Entering Work List Information You can enter the work list information for the next sample before running it.
If the analyzer is shut down abnormally, you will lose the worklist information of the samples that have not been saved yet.
If you want to complete the worklist information after the analysis, see Chapter 7 Reviewing Sample Results for details.
Click the “Worklist” button on the shortcut area or click “Menu”, then select “ Worklist” to enter the “Worklist” screen.
Click the “New” button, then a new record will be added at the bottom of the worklist and this blank record is highlighted. All the fields in the information inform ation entry area are displayed in defaults and are activated.
The Run Status of a new record is “To Be Run”. You can switch between options in the Sample Info./Patients Info area by the
[Tab] key. key. You can also use the [Enter] key to switch after setting, see detai ls 6-12
Operating Your Analyzer in General Setup section of Chapter 5 Customizing the Analyzer Software.
You can skip the options without entering when switching by [Tab] or [Enter], see the setup details in General Setup of Chapter 5 Customizing the Analyzer Software.
Entering the sample ID
Enter the sample ID in the “Sample ID” box.
The sample ID could be letters, numbers and all the keyboard-supported characters (including special characters).
The sample ID must be entered and its acceptable length is [1, 20].
Sample ID being all “0” will be considered invalid.
If the Sample ID ends with a non-numeric letter, the sample ID will not increase automatically.
Selecting analysis mode
Select the blood mode (“WB” or “PD”) and select the measurement mode (“ CBC” or “CBC+DIFF”) from the two pull-down lists respectively. respectively.
In the “CBC” measurement mode, the analyzer only counts the blood cells without further differentiating the white blood cells. 13 parameters and histograms of WBC, RBC and PLT are provided in this mode. In the
“CBC+DIFF” mode, the analyzer counts the blood cells and further differentiates the white blood cells into 5 sub-populations. 23 basic parameters, 4 RUO parameters, scattergrams and histograms of WBC/BASO, RBC and PLT are provided in this mode.
Selecting ref. group
Select the reference group for the sample from the “ Ref. Group” pull-down list. The analyzer will judge the test results according to the reference range of the Ref. group. When the results exceed the reference range, the analyzer will flag.
If you have entered the gender and age of the patient, then the system will provide a matching Ref. Group automatically.
If the auto-matching Ref. Group is different from the one that you selected before (excluding the 5 customized Ref. Groups), then the system will adopt the auto-matching Ref. Group.
Entering the draw time 6-13
Operating Your Analyzer Select the draw date from the date control; enter the draw time into the time edit box.
Entering the delivery time Select the delivery date from the date control and then enter the delivery time into the time edit box.
The delivery date/time can not be earlier than the draw date/time.
The draw and delivery date/time can not be later than the current system date/time.
Entering the patient ID
Enter the patient ID into the “ Patient ID” box.
In the Uni-directional LIS/HIS mode, after you entering the patient ID and pressing the [Enter] key, the matched patient information (including “ Last Name”, “First Name”, “Gender”, “Age”, “Birthday”, “Department” and “Bed No.”) will be displayed in the screen automatically if there is any. You can also proceed to edit the information.
In the Bi-directional LIS/HIS mode, the patient information will adopt those downloaded from the LIS/HIS as default.
Entering the patient name
Enter the patient name into the “Last Name” and “First Name” boxes.
Entering the patient gender
Enter the gender of the patient into the “ Gender ” box or select it from the “ Gender ” pull-down list.
Entering the patient age
The analyzer provides four ways for you to enter the patient age – in years, in months, in days and in hours. The first way is designed for the adult or pediatric patients older than one year; the second for the infant patients one month to one year; the third for the neonatal patients no older than one month and a nd the fourth for the neonatal no older than 24 hours. You You can choose only one of the four ways to enter the patient age.
The “Age” pull-down list provides four ways for you to enter the patient age – in years, in months, in days and in hours, and you can enter the patient age into the box followed by the age unit.
6-14
Operating Your Analyzer
Entering the birthday
Select the patient birthday from the date control.
After entering the birthday, the age field will calculate automatically according to the difference between the current system date and the
“Birthday”, and then a new result of age and its unit will be displayed in the age edit box and the unit combo box respectively. Then, the age box will be unavailable to edit unless the “Birthday” is cleared.
If the entered birthday is later than the current system, it is considered invalid.
Entering the name of the department
Enter the name of the department, from which the sample came, into the “ Department” box or select it from the “Department” pull-down list.
Entering the Bed No.
Enter the bed No. of the patient into the “ Bed No.” box.
Entering the name of the deliverer
Enter the name of the deliverer into the “ Deliverer ” box or select it from the “ Deliverer ” pull-down list (if there are previously saved deliverers’ names in t he list).
Entering the content of diagnosis
Enter the suspicions information of diagnosis into the “ Diagnosis” box.
Entering the remarks
Enter the remarks into the “ Remark” box.
Saving
When finish entering the work list information, you can click the “Save” button or the shortcut key [F2] to save all the information.
The “Sample ID + Mode” of the current record can not be the same as the unhidden records of the following status: “To Be Run”, “Running” and “Error”.
6-15
Operating Your Analyzer
6.6.2 Quick Entering of Next Sample Information If you want to quickly enter the information of next sample and set the analyzer to test it immediately,, please do as follows: immediately 1.
Click the shortcur button “Run”, and then the “Run” dialog box will pop up.
2.
Select the measurement mode and fill in sample ID in the dialog box.
3.
Press [Enter] from keyboard or click “Ok” from the dialog box to close the dialog box and start to count.
You can also select “Run as per the worklist” in the “Run” dialog box to perform counting per the sample information entered in the worklist.
6.6.3 Running the samples
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.
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Operating Your Analyzer
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
The sample probe should be kept away from the tube bottom when the probe is aspirating sample. Otherwise, the aspirated volume may be imprecise.
The probe tip should not contact the sample tube. Otherwise, the blood may spill.
Proper reference range shall be selected at the “Setup” screen before analysis. Otherwise, the results may be flagged erroneously.
Whole Blood , If the sample mode is switched from the Predilute to the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen.
If the previously finished sample was run in whole blood mode, but the next sample will be run in predilute mode, then the message box “Next sample
will be run in Predilute Mode” will pop up on the screen. After you confirm, the analyzer will perform the cleaning procedure once automatically.
When running as per the worklist, then the next sample ID will always be the first unhide (or error) sample to be run in the worklist till there is no unhide sample left or the worklist is empty. If you set the method of entry for the
sample ID as “Auto Increase”, the ID of the latter sample will increase by 1 automatically. If the Sample ID ends with a non-numeric letter letter,, the sample ID will not increase automatically. aut omatically.
If you directly run the sample with an empty worklist, the default analysis mode is the same as the previous sample. The default initial analysis mode is “WB-CBC+DIFF”.
If the Bi-directional LIS/HIS mode is selected, then after the sample ID is entered/scanned and saved, all the corresponding information will be obtained from the LIS/HIS, and then the analyzer starts running per the obtained information. Once the running is finished, the result, graph and sample/patient information will be uploaded to the LIS/HIS.
Running whole blood samples 1.
At the main screen, be sure that the sample mode “WB” is displayed in the “Next Sample” information area.
2.
Shake the whole blood sample as as shown shown below to well well mix it.
6-17
Operating Your Analyzer
3.
When it is ready to run a sample (i.e. the analysis status icon and analyzer indicator is green), present the whole blood sample to the sample probe.
4.
Press the aspirate key to start the analysis.
5.
The sample probe will automatically aspirate the sample. When you hear the beep, remove the sample tube. The analyzer will automatically run the sample and the analysis
status icon and analyzer indicator is flickering in green; the information area of the “Ne xt sample” will be refreshed. 6.
When the analysis is finished, the analysis status icon and analyzer indicator return to long-last green.
7.
Run the rest samples as instructed above.
Running prediluted samples 1.
At the main screen, be sure that the sample mode “ PD” is displayed in the “Next Sample” information area.
2. 3.
Shake the capped prediluted sample to well mix it. When it is ready to run a sample (i.e. the analysis status icon and analyzer indicator is green), carefully open the tube cap and present the prediluted sample to the sample probe.
4.
Press the aspirate key; a message box will pop up.
6-18
Operating Your Analyzer 5.
Press the aspirate key to close the message box and start running.
6.
You can disable the message box before the predilute run. See General Setup section in chapter 5 Customizing the Analyzer Software for details.
The sample probe will automatically aspirate the sample. When you hear the beep, remove the sample tube. The analyzer will automatically run the sample and the analysis
status icon and analyzer indicator is flickering in green; the information area of the “ Next Sample” will be refreshed. 7.
When the analysis is finished, the analysis status icon and analyzer indicator return to lasting green.
8.
Run the rest samples as instructed above.
When the analyzer is running, you can perform any operation (including
new, edit and cancel, etc.) to other “To be run” or “Error” samples in the work list.
When the analyzer is running, you can switch to Graph/Table review screen to perform operations including data browsing, validating, sample information editing and printing, etc., and you can also switch to other screens.
When the analyzer is running, all the functions related to the fluidics sequence are not available.
If you switch to the Graph review screen from other screens, the latest record information together with its result and graph will be refreshed and then displayed.
6.6.4 Dealing with the analysis results Automatic saving of analysis results This analyzer automatically saves sample results. When the maximum number has been reached, the latest result will overwrite the oldest (already backed up). The maximum number of automatic saving results is 40,000.
Parameter flags
If the parameter follows an “H” or “L”, it means the analysis result has exceeded the upper or lower limit of the reference range but still within the display range.
If parameter follows a “?”, it means the analysis result is suspect.
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Operating Your Analyzer
If you see *** as *** as opposed to the result, it means the result is either invalid or out of the display range.
For the background test, the flags of parameter or flags of abnormal blood cell differential or morphology are not available.
Flags of Abnormal Blood Cell Differential or Morphology The analyzer will flag abnormal or suspect WBC, RBC and PLT according to the scattergrams and histograms. The flag information is defined in the following table:
Flag Ty Type pe
Flag information WBC/BASO channel abnormal DIFF channel abnormal Aspiration Abnormal System Abnormal WBC Scattergram Abn. WBC Histogram Abn. WBC abnormal Leucocytosis
Abnormal Leucopenia Neutrophilia Neutropenia
WBC
Lymphocytosis Lymphopenia Monocytosis Eosinophilia Basophilia Left Shift? Immature Granulocyte (IG)? Suspect Abnormal/Atypical Lymphocyte? RBC Lyse Resist? RBC/HGB
Abnormal
RBC System Abnormal Erythrocytosis
6-20
Operating Your Analyzer RBC Histogram Abn. Anisocytosis Macrocytosis Microcytosis Dimorphologic Anemia Hypochromia HGB Abn/Interfere? Suspect
RBC clump? Iron Deficiency? PLT Histogram Abn.
Abnormal
Thrombocytosis
PLT Thrombopenia Suspect
PLT Clump?
The analyzer will flag abnormal or suspect WBC, RBC and P PL LT according to the scattergrams and histograms. The following table shows how the flags affect parameter results:
Type
Whole Blood Flag CBC
WBC
WBC/BASO channel abnormal
DIFF channel abnormal
Aspiration Abnormal
System Abnormal WBC abnormal?
RBC Lyse Resist?
Abnormal WBC scattergram
Abnormal WBC histogram
CBC+ 5DIFF
Predilute
CBC
CBC+ 5DIFF
√
√
√
√
×
√
×
√
√
√
√
√
√
√
√
√
×
√
×
×
×
√
×
×
×
√
√
√
×
√
√
√
6-21
Operating Your Analyzer
RBC/HGB
Left Shift?
×
√
×
×
Immature Granulocyte (IG)?
×
√
×
×
Abnormal/Atypical Lymphocyte? ×
√
×
×
Leucocytosis
√
√
√
√
Leucopenia
√
√
√
√
Neutrophilia
×
√
×
×
Neutropenia
×
√
×
×
Lymphocytosis
×
√
×
×
Lymphopenia
×
√
×
×
Monocytosis
×
√
×
×
Eosinophilia
×
√
×
×
Basophilia
×
√
×
×
RBC System Abnormal
√
√
√
√
HGB Abn/Interfere?
√
√
×
×
RBC clump?
√
√
√
√
Dimorphologic
√
√
×
×
RBC Histogram Abn.
√
√
×
×
Iron Deficiency?
√
√
×
×
Anisocytosis
√
√
×
×
Macrocytosis
√ √
√ √
√ √
√ √
Erythrocytosis
√
√
√
√
Anemia
√
√
√
√
Hypochromia
√
√
√
√
PLT Clump?
√
√
×
×
Thrombocytosis
√
√
√
√
Thrombopenia
√
√
√
√
PL PLT T Histogram Abn.
√
√
×
×
Microcytosis
PLT
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Operating Your Analyzer
When the PLT value is less than 100 microscope is recommended.
109 / L, a manual count by the
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Operating Your Analyzer
6.7 Worklist Click the “Worklist” button on the shortcut area or click the “ Menu” button, then select “Worklist” to enter the “ Worklist” screen.
The upside of the screen is the worklist; the downside is information entry area including Sample Info. and Patient Info. The bottom of the screen is the function button area.
The worklist can save a maximum of 2000 records. All the information fields in the worklist are entered through the information entry area except the “No.”, “Run Status” and “Entry Time”.
If the worklist is empty, all the information fields in the information entry area are blank and displayed in gray.
If a record in the worklist is highlighted, the corresponding information of the record will display in the information entry area.
In the “Worklist” screen, you can perform the following operations to the worklist.
Adjusting the position of each column
Click and hold the title of the column then drag the column to the desired position to adjust the display order.
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Operating Your Analyzer
Adjusting the width of each column
Click and hold the boundary line between the two columns, then drag the line to adjust the width of each column.
Adjusting the position of record
1.
Right click the highlighted record; then the following following shortcut menu will will pop up:
2.
Click “Top” to set the highlighted record as the first record in the worklist.
3.
Click “Up” to move the highlighted record upward by one position.
4.
Click “Down” to move the highlighted record downward by one position.
5.
Click “Bottom” to set the highlighted record as the last record in the worklist.
If you click a record in the worklist to highlight it, the corresponding information of the record will display in the information entry area. You can edit each inform information ation field in the information entry area.
For r ecords ecords whose “Run Status” are “Running”, you can not edit their “Sample ID” and “Mode”.
The information entry area of the records whose “Run Status” are “Finished” will be displayed in gray and unavailable to edit and modify. You can switch to the Graph review or Table review screen to edit and modify the corresponding information.
When the mouse is moved just on the function buttons, the name of the button and the corresponding shortcut key will be displayed. For example, when moving the mouse on the
“Save” button, the tips will pop up:
The function buttons at the bottom of the “ Worklist” screen and their shortcut keys are shown in the table.
Function button
Shortcut key
Save
[F2]
New
[F3]
Insert
[F4]
Delete
[Alt + Delete] 6-25
Operating Your Analyzer
Search
[F5]
Copy
[F6]
Hide
[F7]
Print
[F8]
New
You can click the “ New” button to add a new sample record, see Entering Work List Information section Information section of this chapter for details
Insert
1.
Click one row of the record to highlight it.
2.
Click the “Insert” button to insert a new record before the highlighted record and then the new added blank row will be highlighted. All the fields in the information entry area are displayed in defaults and are activated.
3.
You can enter the sample/patient information in the information entry area, see Entering Work List Information section Information section of this chapter for details.
Save
After performing the “New” or “Insert” operation, you can click the “ Save” button to save all the information.
The “Sample ID + Mode” of the current record can not be the same as the unhidden records of the following status: “To Be Run”, “Running” and “Error”.
If Bi-directional LIS/HIS is enabled, the terminal software will obtain the information from LIS/HIS after you clicking the “Save” button , and then display them in the corresponding field.
Delete
1.
Click the” Delete” button, then the “Delete” message box will pop up.
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Operating Your Analyzer
2.
Click the radio button “Selected Samples”, “All finished records” or “ All records” to select the records you want to delete.” Selected Samples” are those selected with “√” marks in the worklist.
3.
Click the “Ok” button, and then the message box will pop up.
4.
Click the “OK” button to delete the record and refresh the worklist.
The records whose “Run Status” are “Running” can not be deleted.
Search
1.
Click the” Search” button, then the “ Search” message box will pop up.
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Operating Your Analyzer
2.
Click one or more check boxes to define the desired search condition(s). condition(s).
3.
Enter the search content content in the edit box of the desired desired search condition.
4.
If you wish to perform the precise search, you can click the “ Whole Words Only” check box to select it; if you wish to perform the fuzzy search (means to search the related records which contain the content that you entered), you should leave the check box in blank.
5.
Click the “Previous”/”Next” button to start searching upwards/downwards from the highlighted record. The matching record found will be highlighted. Then you can click the
“Previous”/”Next” button to continue searching.
6.
If the first/last record is reached, then the searching cycle will start again from the last/first record upwards/downwards.
A searching cycle will will be completed completed when backing to the initial initial record. If there is no
matching record found, the prompt message box” No record found!” will pop up at the screen; otherwise, the prompt message box” Search finished!” will pop up. Click the “Ok” button to close the message box. 7.
You can repeat procedure 2 to 6 to search for other content; or click the “ Close” button to finish searching and close the message box.
Copy
1.
Click the desired record in the worklist to highlight it.
2.
Click the Copy button to add a new record in worklist and highlight it. The sample ID of this new added record is empty or will automatically increase by 1 based on the last 6-28
Operating Your Analyzer sample ID in the worklist; the other information remains the same as the record be copied from.
If the Sample ID ends with a non-numeric letter, the sample ID will not increase automatically.
Hide
1.
Select the check box of the desired record in the worklist.
2.
Click the “Hide” button to hide the selected record and display it in gray. gray.
If the selected records include both hidden and unhidden records, when you
click the “Hide” button, all of them will be hidden. The records whose “Run Status” are “Running” or “Finished” can not be hidden. You can edit and delete the hidden record.
Cancel
1.
Select the check box of the hidden record in the worklist.
2.
Click the “Cancel” button to cancel the hide and gray display status of the record.
If the selected records are all hidden records, the “Hide” button will be replaced by the “Cancel” button.
Print
1.
Select the check box of the desired record in the worklist.
2.
Click the “Print” button, and then a message box will pop up.
3.
Click “OK” to start printing.
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Operating Your Analyzer
6.8 Auto-Sleep When the time for which the analyzer is free from fluidic operations reaches the value you have set at the "Auto " Auto Maintenance" Maintenance" screen, a dialog box will pop up, prompting “Preparing to sleep, please wait...”. After the preparation, the dialog box closes automatically and the analyzer is in the auto-sleep status. In this mode, you can still perform any other operations which do not involve fluidic operations.
NOTE
To change the time when to start the auto-sleep, see 5.3.1 General Setup for details.
If it is time for auto-sleep, current operations will pause. When the analyzer is in the auto-sleep status, you can continue the operations.
To cancel the auto-sleep, press the aspirate key and a dialog box of “Canceling the sleeping
mode. Please wait...” will pop up. After the auto-sleep is canceled, the dialog box will close automatically.
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Operating Your Analyzer
6.9 Shutdown
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
To ensure stable analyzer performance and accurate analysis results, be
sure to perform thecontinuously “Shutdown”for procedure to shut down the analyzer after it has been running 24 hours.
Be sure to shut down the analyzer strictly as instructed below.
The shutdown procedure includes closing the analyzer and exiting the soft software. ware. The following content will introduce the two procedures respectively. Turning off the analyzer 1.
Click the shortcut button “Shutdown”, or select “Menu”“Shutdown ”“Shutdown” option, the following message box will pop up.
2.
Click the “Ok” button to shut down the analyzer.
3.
During the shutdown procedure, the shutdown information will be displayed in the information indicating area at the bottom of the screen.
4.
After the shutdown is finished, a message box will will pop up.
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Operating Your Analyzer
5.
Place the power switch switch at the left side of the analyzer in the OFF position (O). The message box will be closed automatically.
6.
Empty the waste container and dispose of the waste properly.
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
If the analyzer disconnects with the computer, you can not perform the shutdown procedure.
When the analyzer is running or performing other fluidics sequence, do not shutdown the analyzer forcibly.
If error happens during shutdown procedure, the analyzer will return to the status before the shutdown procedure is performed, and then alarm. See Chapter 11 Troubleshooting Your Analyzer Analyzer for details to remove rem ove the error. er ror.
You can click the “Restart” button to restart the analyzer and perform the startup initialization.
You will not exit the software after the shutdown of the analyzer, an and d you can still perform operations that are available without the cooperation of the analyzer.
Exiting the system software 1.
Click the shortcut button “Exit”, or select “Menu”“Exit”“Exit” option, the following message box will pop up.
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Operating Your Analyzer
2.
Click the “Ok” button to exit the system software.
You must shut down the analyzer before exiting the software.
Closing the external computer 1.
Close the external computer according to the shutdown procedures of the operation system.
2.
Turn off the display. display.
You should exit the terminal software first and then turn off the external computer according to standard procedures. Otherwise, the database of the terminal software might be lost!
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7
Reviewing Sample Results
7.1 Introduction The analyzer automatically saves
analysis results. Totally 40,000 results can be saved,
including sample information, parameters, flags, scattergrams and histograms. You can browse sample sam ple results either in the table or graph mode.
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Reviewing Sample Results
7.2 Graph Review Click the shortcut button “ Graph” or click the “Menu” button, and then select the “ Review”, and then select “Graph” to enter the “Graph” screen:
The “Graph” screen consists of three parts. The upside displays the Sample/Patient Info. The downside displays the Results, Scattergrams, Histograms, Flags, DIFF Graphs, Microscopic Exam Results and Blood Type/ESR results in accordance with the Sample/Patient Info. in the form of tabs including “ Data/Graph”, “DIFF”, “Microscopic Exam. and Others ” and
“Research”. The bottom displays the functional buttons available in the current screen.
7.2.1 Sample/patient information You can use the record switch column in the down do wn right of the screen to browse the sample sam ple records one by one. You can see the Sample/Patient S ample/Patient Info. in the upside of the screen. You can edit all the patient
information except the “Operator ” and the “Validater ”. ”. For details of editing information, see Editing work list information in information in Chapter 6 Operating Operatin g Your Analyzer .
You can can enable users of common level to edit the sample sample ID by setting in the
“Setup” screen, see chapter 5 Customizing the Analyzer Software for details. 7-2
Reviewing Sample Results
You can edit all the information of the sample except the Mode and Run Time.
7.2.2 Tabs
After selecting a sample record, you can click the tab in the downside of the screen to see the corresponding information.
Data/Graph Click the “Data/Graph” tab to see the data/graph information of the record.
You can select whether to display the four RUOs, the “*” mark and the corresponding declarations (“*” means “research use only, not for diagnostic use”) in “Setup” screen, see Chapter 5 Customizing the Analyzer Software for details.
When the results of Bas% and Bas# are expressed in “*”, the second histogram discriminator will not be displayed.
For details of how to edit and restore the result, please see the following Edit Result and Result and Restore Result section Result section of this chapter. When moving the mouse to any graph of the histogram, histogram , an icon of magnifier will appear. Click the icon, a box of enlarged graph will pop up and you can drag the box at will.
7-3
Reviewing Sample Results
When finish browsing, you can click “╳”on the top right of the box to close it.
DIFF You can click the “ DIFF” tab to check the WBC differential information of the record.
The DIFF tab is unavailable in CBC mode. You can select whether to display the four RUOs, the “*” mark and the corresponding declarations (“*” means “research use only, not for diagnostic use”) in “Setup” screen, see Chapter 5 Customizing the Analyzer Software for details.
For details of how to edit and restore the result, please see the following function introduction of the Edit Result and Restore Result section of this chapter. When moving the mouse to any graph of the histogram, histogram , an icon of magnifier will appear. Click
the icon, a box of enlarged graph will pop up and you can drag the box at will.
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Reviewing Sample Results
When finish browsing, you can click “╳”on the top right of the box to close it.
Microscopic Exam. and Others Click the “Microscopic Exam. and Others ” tab, you can browse and enter the microscopic exam and blood type/ESR information of the record.
Entering the Microscopic Exam. information 1.
Selecting the Sample Type
Click the “Sample Type” combo box; select the sample type as “ Venous blood” (default) or “Capillary”.
2.
Entering the date and time of the microscopic exam.
Click the “Microscopic exam. time” edit box, and then enter the date and time of microscopic
exam.
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Reviewing Sample Results
The Microscopic exam. time can not exceed the current system time.
3. Entering the Microscopic Description You can enter the morphology m orphology information for W WBC, BC, RBC and PLT respectively into the multi-line edit box.
4.
Entering the Cell Differential
You can enter the percentage or other form f orm of differential result of each cell differential into the edit box next to the cell differential names respectively.
You can enter a value within the range [0.0-100.0] and the unit is “%”.
Entering the Blood Type information
You can select the blood type of the patient in the “ Blood Type/ESR” column. Click the first combo box next to the blood type, you can select from “ Blank”, “A”, “B”, “O” and “ AB”; click the second combo box, you can select from “ Blank”, “RH+” and “RH-”.
Entering the Blood ESR information
You can enter the blood ESR value into the t he edit box follows the “ ESR”. If the value exceeds the Ref. Range, the flags “H”or “L” will appear to indicate the value exceeds the upper limit or lower limit. You can modify the reference ref erence range of Blood ESR by the following steps: 1.
Click the “Set Reference Range” button, and then a message box will pop up. Enter the upper limit and lower limit of the blood ESR i nto the edit box “Lower limit” and “Upper limit” respectively.
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Reviewing Sample Results
2.
Click the “Ok” button to save all the settings and refresh the information.
You can enter the value up to 3 numeric characters within the range [0,999].
The upper limit can not be smaller than the lower limit.
The entered reference range of the Blood ESR is only applied to the current record, and the default range is [0, 20].
Research Click “Research” tab on the screen, the specific value of each parameter will be displayed.
The specific values of the parameter results that are out of the display range or without data collected cannot be provided.
Edit of the results in the “Data/Graph” tab will not affect the display of parameters in the “Research” tab.
The content of this tab can only be viewed and used for research; it cannot be edited or printed.
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Reviewing Sample Results
7.2.3 Function of the Buttons When the mouse is moved just on the function buttons, the name of the button and the corresponding shortcut key will be displayed. For example, when moving the mouse on the
“Save” button, the tips will pop up:
The shortcut keys of the function buttons butto ns in the graph review screen are shown in the following table
Function button button
Shortcut key key
Save
F2
Validate
F3
Print
F4
Edit Result
F5
Restore Result
F6
Delete
Alt + Delete
Auto-refresh At the graph review screen, when when browsing the results, you can select to activate or deactivate the auto-refresh function to display the latest results. Click the
button at the lower right of the graph review screen to make it raised. Later
on, the graph review screen will refresh automatically autom atically to display the latest results and graphs if any.
When the
button is raised, all the information fields and buttons at the graph review
screen will be unavailable (displayed in gray) except the records switching column.
Click the
button at the lower right of the graph review screen to make it sunk. Later on,
the graph review screen will not refresh even the new results are obtained, but still display the current sample information, results and graphs that you are now browsing. At the mean time, the graph will be displayed in normal size as shown below.
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Reviewing Sample Results
When the
button is sunk, all the operations are available to the current displayed
records.
The default status of the
button at the graph review screen is sunk.
The status of the button keeps still when you return to the graph review screen after exiting.
When you browsing records at the graph review screen by using the switching column, the status of the into suck.
button automatically changes
Save Click the “Save” button to save the modified information on all ta bs of the current result.
Print Click the “Print” button to print the information, results, histograms and scattergrams of the
current sample.
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Reviewing Sample Results
You can set the amount of copies for the printed report in the “Setup” screen.
At the “Setup” screen, you can select whether to print the Flag information
in the report.
Delete 1.
Click the “Delete” button, and then a message box will pop up.
2.
Click “OK” to delete the current displayed sample record in the “ Graph” screen.
The “Delete” button and the corresponding deleting operation are not
available to users of common-level.
Validate Click the “Validate ” button to perform the validating operation.
You can enable the users of common level to validate by setting in the “Setup” screen. Otherwise, the user name and the password of administrator level are required. After validating, you can not edit the Sample/Patient Info. and result. You can not validate the background record.
Cancel (validate) Click the “Cancel” button to cancel the validating operation.
If the current sample result is validated, the “Validate” button will be
replaced by the “Cancel” button. The users of common level is enabled the authority of “Cancel” together 7-10
Reviewing Sample Results
with “Validate” when you setting in the “Setup” screen. Otherwise, the user name and the password of administrator level are required.
After canceling, you can edit the Sample/Patient Info. and result.
Edit Result 1.
Click the “Edit Result” button, then the result of each parameter and and WBC DIFF results will be displayed in an edit box for you to edit.
2. After editing, click the “Save” button to save the change and the edit box disappears.
You can enable the users of common level to edit result by setting in the “Setup” screen. Otherwise, the user name and the password of administrator level are required.
If the result of one parameter is modified, then the result of other related parameter(s) will be changed accordingly and the high or low/suspect flags will also be refreshed.
Only the result of the measurement parameters (WBC, RBC, HGB, HCT and PLT) and WBC DIFF results can be modified.
After editing and then saving WBC DIFF results, the absolute value of each DIFF result will be re-calculated and then refreshed.
If the sum of the DIFF results does not equal to 100.00% after being edited, then the message box “The sum of the DIFF results is not 100.00%!” 1 00.00%!” will pop up when you clicking the “Save” button.
No matter the sample result is validated or not, as long as it is edited, the result of the parameter that you modified manually will be flagged with an “E”. If any parameter result is then changed due to the one that you
modified manually, it will be flagged with an “e”. (“E” or “e” will be displayed between the parameter result and its unit.)
You can not edit the results of the background.
Restore Result 1.
Click the “Restore Result” button, and then the following message box will pop up.
2.
Click “OK” to restore the result to the original measurement value and remove the result edited flags (“E” or “e”).
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Reviewing Sample Results
The users of common level is enabled the authority of “Restore Result” together with “Edit Result” when you setting in the “Setup” screen. Otherwise, the user name and the pass word of administrator level are required.
Up to 1000 latest measurement results of original value can be saved by the analyzer. You can not restore the results of the background.
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Reviewing Sample Results
7.3 Table Review Click the shortcut button “ Table” or Click the “Menu” button, and then select the “ Review” “Table” to enter the following table review screen.
The “Table” screen consists of three parts. The upside of the screen displays the sample records in the form of tables. The downside of the screen displays the Result, Sample/Patient Info., Microscopic Exam Result and Blood Type/ESR Result of the current sample record in the form of tabs. The top and bottom of the screen displays the functional buttons available in the current screen.
7.3.1 Sample Records You can browse each sample sam ple record and its Sample/Patient Sam ple/Patient information in the “ Table” screen.
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Reviewing Sample Results
For the error sample record, the content of each information field is displayed in red.
For the printed sample, its cell in the “Print” column displays “P”. For the unprinted sample, its cell in the “Print” column is blank.
For the validated sample, its its cell cellisinblank. the “Validate” column displays “V”. For the sample not validated, For the transmitted sample, its cell in the “Transmit” column displays “T”. For the sample not transmitted, its cell is blank.
In the sample records table area, you can perform the following operation: Selecting the sample table
Click the “Sample List” combo box, then you can select “Samples within today” (default), “All Samples” and ”Samples found”. The Review List will display different records according to the different options:
Record option
Records displayed
Samples within today
Display only the sample records within today
All Samples
Display all the saved sample records.
Samples found
Display all the sample records met the search requirements.
Adjusting the position of each column Click and hold the title of the column then drag the column to the desired position to adjust the display order.
Ranking the records 1.
Right click the “Run Date” title, and then a shortcut menu will pop up:
2.
Click “Ascending” to rank the records in ascending order of “Run Date + Time” (i.e. the latest tested sample ranks the last in the list).
3.
Click “Descending” to rank the records in descending order of “Run Date + Time” (i.e. the latest tested sample ranks the first in the list).
The records in the graph screen will be ranked the same way as the table screen, in ascending/descending order of “Run Date + Time”. 7-14
Reviewing Sample Results Switching Double click a record in the list; the t he screen will switch to the graph review screen of the record automatically.
7.3.2 Tabs After selecting a sample record, you can click the tab in the downside of the screen to see the corresponding information.
Result You can click the “ Result” tab to see all the results of the highlighted record.
You can select whether to display the four RUOs, the “*” mark and the corresponding declarations (“*” means “research use only, not for diagnostic use”) in “Setup” screen, see Chapter 5 Customizing the Analyzer Software for details.
For details of how to edit and restore the result, please see the following Edit Result and Result and Restore Result section Result section of this chapter.
Sample/patient information You can click the “ Sample/Patient Info.” tab to see the sample information and patient 7-15
Reviewing Sample Results information of the highlighted record in the list.
For details to edit information, see Editing work list information section information section in Chapter 6 Operating Your Analyzer .
Microscopic Exam. and Others Click the “Microscopic Exam. and Others ” tab, you can browse and enter the microscopic exam and blood type/ESR information of the record.
Entering the Microscopic Exam. Information
1.
Selecting the Sample Type 7-16
Reviewing Sample Results
Click the “Sample Type” combo box, and then select the sample type as “ Venous blood” (default) or “Capillary”.
2.
Entering the date and time of the microscopic exam.
Click the “Microscopic exam. time” edit box, enter the date and time of microscopic exam.
3.
The Microscopic Exam. Time can not exceed the current system time.
Entering the Microscopic Description
You can enter the morphology m orphology information for W WBC, BC, RBC and PLT respectively into the multi-line edit box.
4.
Entering the cell differential
You can enter the percentage or other form f orm of differential result of each cell differential into the edit box next to the cell differential names respectively.
You can enter a value within the range [0.0-100.0] and the unit is “%”.
Entering the Blood Type information
You can select the blood type of the patient in the “ Blood Type/ESR” column. Click the first combo box next to the blood type, you can select from “ Blank”, “A”, “B”, “O” and “ AB”; click the second combo box, you can select from “ Blank”, “RH+” and “RH-”.
Entering the Blood ESR information
Enter the blood ESR value in the edit box follows the “ ESR”. If the value exceeds the Ref. Range, the flags “H”or ”L” will appear to indicate the value exceeds the upper limit or the lower limit. You can modify the reference ref erence range of Blood ESR by the following steps: 1.
Click “Set Reference Range” button, and then a message box will pop up. Enter the upper limit and lower limit of the blood ESR into the edit box “ Lower limit” and “Upper limit” respectively.
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Reviewing Sample Results
2.
Click the “Ok” button to save all the settings and refresh the information.
You can enter the value up to 3 numeric characters within the range [0,999].
The upper limit can not be smaller than the lower limit.
The entered reference range of the Blood ESR is only applied to the current record, and the default range is [0, 20].
Research Click “Research” tab on the screen, the specific value of each parameter will be displayed.
The specific values of the parameter results that are out of the display range or without data collected cannot be provided.
Edit of the results in the “Data/Graph” tab will not affect the display of parameters in the “Research” tab.
The content of this tab can only be viewed and used for research; it cannot be edited or printed.
7.3.3 Function of the Buttons When the mouse is moved just on the function buttons, the name of the button and the 7-18
Reviewing Sample Results corresponding shortcut key will be displayed. For example, when moving the mouse on the
“Save” button, the tips will pop up:
The shortcut keys of the function buttons in the table review screen are shown in the following table:
Function button button
Shortcut key key
Save
F2
Validate
F3
Print
F4
Edit Result
F5
Restore Result
F6
Batch Validate
F7
Search
F8
Communication
F9
Delete
Alt + Delete
Deselect
F10
Trend Graph
F11
CV
F12
Save Click the “Save” button to save the modified information on all tabs of the current result.
Search You can search for the specified sample record from all records in the current list as default. 1.
Click the “Search” button, and then a “Search” message box will pop up.
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Reviewing Sample Results
2.
You can define the desired searching conditions.
Entering the sample ID
Select the check box of “Sample ID”, and then enter the desired sample ID into the “ Sample ID” edit box.
Entering the patient name
Select the check boxes of “Last Name” and “First Name”, and then enter the desired patient name into the boxes.
Selecting the “Run Date”
Select the check box of “Run Date”, and then select the limits of the run date.
Selecting the patient gender
Select the check box of “ Gender ”, ”, and then click the radio button “ Male”, “Female” or “Empty” to select the patient gender.
Entering the patient ID
Select the check box of “Patient No.”, and then enter the desired patient No. into the “ Patient No.” edit box. 7-20
Reviewing Sample Results
Entering the department name
Select the check box of “ Department”, and then enter the desired department name in the
“Department” edit box.
Entering the Bed No.
Select the check box of “Bed No.”, and then enter the desired bed No. into the “ Bed No.” edit box.
Entering the Deliverer
Select the check box of “ Deliverer ”, ”, and then enter the desired deliverer into the “ Deliverer ” edit box.
Selecting the Validate Validate Status
Select the check box of the “Validate Status”, and then click the radio button “ Validated” or “Not Validated” to select the validate status.
Selecting the print status
Select the check box of “Print Status”, and then click the radio button “ Printed” or “Not Printed” to select the print status.
Selecting the Communicate Status
Select the check box of the “Communication Status”, and then click the radio button “Transmitted” or “Not Transmitted” to select the communication status.
Selecting the matching type
Select the check box of “Whole Words Only”, and then the precise search will be performed; otherwise, the fuzzy search (means to search the related records which contain the content that you entered) will be preformed.
Selecting the case sensitive
Select the check box of “Case Sensitive”, and then the capital letters and small letters in the edit box will be distinguished when searching; otherwise, the search will be insensitive to the form the letters (i.e. the capital letters and small letters will not be distinguished). 3.
Click “Ok” to perform the search and switch to the “ Samples found” list of the “ Table” screen, and the searching results will display.
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The desired record is searched from all the sample records as default.
Validate Click the “Validate ” button to validate the current highlighted record in the list.
You can enable the users of common level to validate by setting in the
“Setup” screen. Otherwise, the user name and the password of administrator level are required.
After validating, you can not edit the sample/patient information and the result You can not validate the background record.
Batch Validate 1.
Click the “Batch Validate” button, and then the following message box will pop up.
2.
Click the radio button “Selected Samples” or “Specified Samples” to select the records you want to validate.” Selected Samples” are those selected with “√” marks in the review list.
3.
Click the “Specified Samples” radio button to specify the starting and finishing time tim e of the Run Date for the record to be validated.
4.
Click “Ok” to start validating.
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The users of common level is enabled the authority of “Batch Validate”
together with “Validate” when setting in the “Setup” screen. Otherwise, the user name and the password of administrator level are required.
For the validated record, you can not edit the sample/patient information and the result.
The validated record can also be selected in bath validation.
You can select whether automatically de-select validated records or o r not.
Cancel (validate) Click the “Cancel” button to cancel the validating operation.
If the current highlighted record is validated, the “Validate” button will be replaced by the “Cancel” button. The “Cancel” button is only available to the highlighted record in the list.
The users of common level is enabled the authority of “Cancel” together with “Validate” when setting in the “Setup” screen. Otherwise, the user name and the password of administrator level are required.
After canceling, you can edit the sample/patient Information and the result. You can not validate the background record.
Print 1.
Click the “Print” button, and then a message box will pop up.
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2.
Click the radio button “ Selected Samples” or “ Specified Samples” to select the record you want to export.” Selected Samples” are those selected with “√ “ √” marks in the review list.
3.
Click the “Specified Samples” radio button to set the starting and finishing run date of the records to be printed.
4.
Click the “Report” or “List” radio button to select the print format.
5.
When “List” is selected, you can continue to select one of the four print templates, the default template selected is the “ All All Para.” template.
6.
Click “Ok” to start printing.
You can set the amount of copies of the printed report in the “Setup” screen. At the “Setup” screen, you can choose whether to print the Flag prompts in
the report or not.
You can select whether automatically de-select printed records or not. not .
Communication You can do as follows f ollows to transmit the sample record r ecord to the LIS/HIS s ystem. 7-24
Reviewing Sample Results 1.
Click “Transmit ” button, the following message box will pop up.
2.
Click the radio button “ Selected Samples” or “Specified Samples” to select the record you want to transmit.” Selected Samples” are those selected with “√” marks in the review list.
3.
inishing time of the Click the “Specified Samples” radio button to specify the starting and f inishing Run Date for the record to be transmitted.
4.
Click “Start” to start transmitting.
Once the transmission starts, if you click the “Transmit” button again, then the foregoing message box will also pop up but the “Start” button will be r e eplaced placed by the “Stop” button. You can click the “Stop” button to stop transmitting once the transmission of the current sample record is done.
You can select whether to automatically de-select the transmitted records. re cords.
You can select whether to automatically delete the transmitted records. reco rds.
CV You can check the reproducibility r eproducibility of the selected sample records. 1.
Select the sample record used for calculating the reproducibility. reproducibility.
2.
Click the “CV” button to start calculating the reproducibility, and then the result message box will pop up:
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3.
Click the “Calculate deviation” button, and then a message box will pop up. You can check the absolute deviation of the 5 WBC related parameters of percent-style.
4.
When finish browsing, you can click the “Close” button to exit. 7-26
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At least 3 records should be selected to calculate the reproducibility.
Up to all records in the review list can be selected to calculate the reproducibility.
There is no restriction to the sample records being selected to calculate the reproducibility as long as they are in the review list.
Trend Graph You can check the trend graph of all the parameters of the selected sample record. Do as follows: 1.
Select the desired sample record.
2.
Click the “Trend Graph” button, and then a message box with the trend graph of all parameters of the selected record will pop up.
At least 3 records or at most all records in the review list can be selected.
There is no restriction when selecting the sample records as long as they are in the review list.
Checking data
Method 1: click the certain data group to move the green line to the place, and then you can check the data of this group. Method 2: click the arrow buttons on the “Pos./Total” “Pos./Total” control to move the green line and check the data of each group.
Method 3: when the green line is located, you can press the [←] and [→] key on the keyboard to move the green line and check the data of each group. Method 4: when the green line is located, you can press the [Home] or [End] key on the 7-27
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Modifying the range
Method 1: click the arrow buttons next to the range to adjust it. The trend graph will refresh immediately once the range is changed. Method 2: click the edit box of the range and enter the value into it. After entering, press the [Enter] key or switch to other focus to refresh the trend graph.
Delete
The “Delete” button and the corres ponding deleting operation are not available for users of common-level.
1.
Select the sample record you want to delete.
2.
Click the “Delete” button, and then a message box will pop up.
3.
Click “OK” to delete the selected records.
Edit Result 1.
Click the “Edit Result” button, and then in the “ Result” tab, you can edit the result of each parameter and WBC DIFF results in the activated edit box.
2.
After editing, click the “Save” button to save the changes.
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You can enable the users of common level to edit result by setting in the
“Setup” screen. Otherwise, the user name and the password of administrator level are required.
If the result of one parameter is modified, then the result of other related parameter(s) will be changed accordingly and the high or low/suspect flags will also be refreshed.
Only the result of the measurement parameters (WBC, RBC, HGB, HCT and PLT) and WBC DIFF results can be modified.
After editing and then saving WBC DIFF results, the absolute value of each DIFF result will be re-calculated and then refreshed.
If the sum of the DIFF results does not equal to 100.00% after being edited, then the message box “The sum of the DIFF results is not 100.00%!” 1 00.00%!” will pop up when you clicking the “Save” button.
No matter the sample result is validated or not, as long as it is edited, the result of the parameter that you modified manually will be flagged with an “E”. If any parameter result is then changed due to the one that you
modified manually, it will be flagged with an “e”. (“E” or “e” will be displayed between the parameter result and its unit.)
The scattergram of the sample will not be changed even when the differential result of the WBC is modified. You can not edit the results of the background.
Restore Result 1.
Click the “Restore Result” button, and then the following message box will pop up.
2.
Click “OK” to restore the result to the original measurement value and remove the result edited flags (“E” or “e”).
The users of common level are enabled the authority of “Restore Result”
together with “Edit Result” when setting in the “Setup” screen. Otherwise, the user name and the password of administrator level are required.
Up to 1000 latest measurement results of original value can be saved by the analyzer. You can not restore the results of the background.
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7.4 Data Backup You can back up the data of the sample base in the external computer. Do as follows: 1.
At the table review screen, click the “Menu” button, then select “Review” “Data Backup” on the pop-up menu, and then a message box will pop up.
2.
Click the radio button “ Selected Samples” or “ Specified Samples” to select the record you want to backup.” Selected Samples” are those selected with “√ “ √” marks in the review list.
3.
Click the “Specified Samples” radio button to specify the starting and finishing time tim e of the Run Date for the record to be backed up.
4.
Click “Ok” button, the following dialog box will pop up.
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Select the directory and enter the file name.
6.
Click the “Save” button, and then a progress bar will pop up.
7.
When the backup is finished, click “Ok” to exit.
You can not choose the file format when backing up. The backup sample record can not be edited and can only be reviewed in “History”.
Theselected histograms and scattergram will be backed up in the folder of “Bmp” at the location.
You can select whether to automatically clear the "√” mark before the backed up record.
You can select whether to automatically delete the backed up records. reco rds.
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7.5 Data Export You can export the data d ata from the sample base to an external computer and a nd then proceed to edit or save the data: 1.
At the “Table” screen, click the “Menu” button, then select “Review” “Data Export” in the pop-up menu, and then a “Export” message box will pop up.
2.
Click the radio button “Selected Samples” or “Specified Samples” to select the records you want to export.” Selected Samples” are those selected with “√ “ √” marks in the review list.
3.
Click the “Specified Samples” radio button to set the starting and finishing run date of the record to be printed.
4.
Click “Ok” button, and then a message box will pop up.
5.
Select the directory and format and enter name for the exported file. 7-32
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Click “Save”, and then a progress bar will pop up.
7.
After the export is finished, click “ Ok” to exit.
The default format of the exported files is “.csv” and you can also choose the “.txt” format.
The exported sample record will keep the same order as displayed in the table review screen (run time ascending/descending).
You can not review the exported files in “History”, but you can perform the operations including editing and deleting, etc. to the exported files on an external computer.
The histograms and scattergram will be exported in the folder of “Bmp” at the selected location.
You can select whether automatically de-select exported records or o r not.
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7.6 Auto-backup When the terminal software connects the analyzer for 4 hours, the backup will be performed automatically.. A progress bar will pop up. automatically
The progress bar will close once the backup is finished.
You can not perform any operation during the process of backup. The record in the sample base will also be backed up automatically when you exiting the application software.
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7.7 Auto-restore If the data is damaged in the sample base, but the corresponding auto-backed up data is fine, then a message box will pop up.
Click “ Yes Yes” to close the box and display the auto-backed up data into the sample list.
If you choose not to restore the auto-backed up data and running no new samples, then the foregoing message box will still pop up when you run the program again. A progress bar will be displayed on the screen during auto-restoring.
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7.8 Compare Click the “Menu” button, and then select “Review” “Compare” from the pop-up menu to enter the following “Compare” screen.
The “Compare” screen consists of three parts. The top of the screen displays the search conditions: “Patient ID”, “Last Name”, “First Name” and “Run Date”. The middle of the screen displays the tab of the patient’s test results and the trend graphs. The available function buttons are also displayed in the screen.
7.8.1 Tabs Comparison Summary Click the “Comparison Summary” tab in the screen to check the test results of the patient.
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If “Display RUO parameters” is not selected in the “Setup” screen, then the ALY%, LIC%, ALY# and LIC# will not be displayed in the list.
A blank cell of “Result” means no measurement result.
The red flags (“?”, “H” or “L”) indicate the result is either out of limit or suspect.
The yellow background indicates an edited result.
Result Trend Click the “Result Trend” tab in the screen to check the trend graphs of the patient.
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You can click the “ Select Parameter ” combo box at top-left of the screen to select the desired the trend graph.
If “Display RUO parameters” is not selected in the “Setup” screen, then the ALY%, LIC%, ALY# ALY%, ALY# and LIC# LI C# will not be displayed displa yed in the pull-down pull -down list of tthe he combo box.
The x-axis of the “Parameter Trend” shows the No. of the test and the y -axis shows the result of each test. Up to 30 data points can be displayed in the trend graph. If the matched data are more than 30 groups, then only the latest 30 ones will be displayed. The data points in the trend graph are displayed from left to right in the ascending order of Run Date /Time. Thus, the latest data point places the last.
The scale on the x-axis of the trend graph changes according to the number of the result.
The scale on the y-axis of the trend graph changes according to the value of the result.
The down side of the tab displays the result of the single parameter in the form of list. The
corresponding No., run date/time and result are displayed in the list.
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The data in the list corresponds with the data point in the trend graph one by one.
The red flags (“?”, “H” or “L”) indicate the result is either out of limit or suspect.
The yellow background indicates an edited result.
7.8.2 Function of the buttons Search You can search for the certain result of the patient b by y entering the search condition in the top of the screen. 1.
You can define the desired search conditions.
Entering the patient ID
Enter the patient ID into the “ Patient ID” box.
Entering the patient name
Enter the patient name into the “ Last Name” and “First Name” boxes.
Selecting the “Run Date”
Use the date control to specify the range for the run date.
2.
The “Patient ID” must be entered. You can leave the “Patient Name” in blank. An empty entry of run date indicates the whole w hole database will be searched for the certain result and there is no restriction to the run date.
Click the “Search” button to start searching the specified record and the result will be displayed in the two tabs. You can switch between the two tabs to check the result.
Re-fill You can click the “ Re-fill” button to clear all the entered search conditions and then re -fill.
Adjust Parameter Order You can use the “ Adjust Parameter Order ” function to adjust the following parameter order. The display order of the parameter in the “ Comparison Summary” tab and the parameter 7-39
Reviewing Sample Results order when printing The display order of the parameter in the c ombo list of the “Result Trend” tab
Do as follows to adjust parameter order: 1.
Click the “ Adjust Parameter Order ” button, then the following box with the list of the parameter order will pop up
2.
The right of the parameter list displays the order-adjusting buttons, namely, “Top”, “Up”, “Down” and “Bottom”.
Click one parameter in the list to highlight it.
Click the “Top” “Top” button to move the parameter to the top of the list. Click the “Up” button to move the parameter upward by one position. Click the “Down” button to move the parameter downward by one position.
Click the “Bottom” button to move the parameter to the bottom of the list
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Click “Ok” to save the changes and close the box.
Print When the current tab is “Comparison Summary”, you can click the “Print” button to print all the contents of the summary summ ary.. When the current tab is “Result Trend”, you can click the “Print” button to print the displayed result trend and the result list.
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7.9 Statistics You can select or enter the “ Statistical Condition” to realize the statistics of the workload.
7.9.1 Calculate Workload Click the “Menu” button, and then select “Statistics” “Calculate Workload” from the pop-up menu to enter the following “ Workload Summary” screen.
The top of the screen displays the “Statistical Item”, namely, “Department”, “Deliverer ””,, “Operator ” and “Run Date”. Below the “Statistical Item”, it displays the corresponding “Statistical Condition”. The corresponding records are displayed in the workload summary together with the workload statistics. The available function func tion buttons are also displayed in the th e screen.
Workload summary All the records that match the statistical conditions will be displayed in the Workload Summary and be included to calculate the total workload. The records of the same category (i.e. those with the same field in the first fir st column) will be taken to calculate the subtotal workload. The
default information fields in the workload summary are “ Department”, “Deliverer ”, ”, “Operator ””,, “Run Date” and “Sample Load”.
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The cell of the un- selected “Statistical Item” displays blank.
For several results of the same item, they will be displayed in ascending order by run date. Be aware that not all the statistics results in the summary are displayed in ascending order by run date. In the workload summary, the subtotal workload will be displayed below the records recor ds of the same category, category, and the total tot al workload will be displayed in the last.
Function of the buttons
Statistics You can select the desired statistical item and enter the statistical cond condition ition to check the statistics of the workload of the matched record. 1.
You can select the desired statistical statistical item by clicking the check box.
2.
After selecting the statistical statistical item, the corresponding statistical condition w will ill be activated for you to enter.
Entering the Department
Enter the department name into the “ Department” box or select it from the “ Department” pull-down list.
Entering the Deliverer
Enter the name of the deliverer into the “Deliverer ” box or select it from the “ Deliverer ” pull-down list.
Entering the Operator
Enter the name of the operator into the “ Operator ” box or select it from the “ Operator ” pull-down list.
Selecting the Run Date
Use the date control to specify the range for the run date.
The shortcut code entry is supported.
When selecting “All”, it means all the available options of this field will be 7-43
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3.
Click the “Statistics” button to start calculating the workload for the matched records, and then displays the result in the workload summary.
Re-fill
You can click the “ Re-fill” button to clear all the entered statistical conditions and then re -fill. Adjust column order
You can use the “ Adjust order ” function to adjust the column order (including “ Department ”, “Deliverer ”, ”, “Operator ” and “Run Date”) in the workload summary summ ary.. Do as follows: 1.
Click the “ Adjust Order ” button, then the following box with the list of the column (field) order will pop up.
2.
The right of the list displays the order-adjusting buttons, namely, “Top”, “Up”, “Down” and “Bottom”.
Click one field in the list to highlight it.
Click the “Top” button to move the field to the top of the list. Click the “Up” button to move the field upward by one position. Click the “Down” button to move m ove the field downward by one position. 7-44
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Click the “Bottom” button to move the field to the bottom of the list
3.
Click “Ok” to save the changes, close the box and back to the “ Calculate Workload” screen. Then, the column order in the workload summary refreshes.
The statistical result will also be refreshed together with the column order.
Print 1.
Click the “Print” button, and then a message box will pop up.
2.
Click the “Print Summary” or the “Print statistics only” radio button to select the content you want to print.
“Print Summary” means to print out all the records and statistical results in the workload summary.
“Print statistics only” means to print out the statistical results only (including subtotal and total).
3.
Click “Ok” to start printing.
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7.10 History You can review the backed back ed up sample data in “ History”. Do as follows: 1.
At the Table r eview eview screen, click the “ Menu” button, and then select “Review” “History”, and then a dialog box will pop up.
2.
"Sample Select the desired directory and the file name, and then click “ Open” to go to the "Sample Data History" History" screen shown as follows.
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If you select another backed up file, then the history data displayed in the list will be refreshed.
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8
Using the QC Programs
8.1 Introduction Quality Control (QC) consists of strategies and procedures that measure the precision and stability of the analyzer. The results imply the reliability of the sample results. QC involves measuring materials with known, stable characteristics at frequent intervals. Analysis of the results with statistical methods allows the inference that sample results are reliable. Mindray recommends you run the QC program daily with low, normal and high level controls. A new lot of controls should be analyzed in parallel with the current lot prior to their expiration dates. This may be accomplished by running the new lot of controls twice a day for five days using any empty QC file. The QC files calculate the mean, standard deviation and coefficient of variation for each selected parameter. The instrument-calculated means of these ten runs should be within the expected ranges published by the manufacturer. The analyzer provides 4 QC programs: L-J QC, X mean QC, X mean R QC and X-B QC.
You should only use the Mindray-specified controls and reagents. Store Stor e and use the controls and reagents as instructed by instructions for use of the controls and reagents.
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Using the QC Programs
8.2 L-J Quality Control 8.2.1 Editing L-J settings
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
Only users of administrator-level can edit the L-J settings.
For the QC files with saved QC results, if any change is made to the ta target rget or the limits, the changed data will be highlighted h ighlighted in yellow, and the change will be recorded into the system log.
Before analyzing the new lot of controls, you should set a QC file for each lot of controls and you can edit the QC settings in the QC file by one of the following ways: Reading the information provided by the manufacturer
Manual entry
Reading the saved preset values
Reading the information provided by the manufacturer 1.
You can enter the the graph screen in one of the the following ways: ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen; then select “ QC””L-J” on the pop-up menu.
Enter the “L-J” graph screen. 8-2
Using the QC Programs
2.
Click the “Settings” tab to enter the L-J settings screen.
For details to edit the name of the login user, see chapter 5 Customizing the Analyzer Software.
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Using the QC Programs
3.
Select a QC File No. with empty QC information.
4.
Select the QC mode.
5.
You can select the file No. within the range [1, 60].
Different QC files can not have the same lot No. and QC mode.
Set QC ID: if you like to run control in the interval of running blood samples, you can set a specific ID for the control. If such ID is recognized when the analyzer is running blood samples, it will identify the sample as control con trol automatically. When the running ends, the result will be stored in the QC file of the corresponding ID.
Letters, numbers and all characters that can be entered through the keyboard (including special characters) are allowed for the QC ID, but the 8-4
Using the QC Programs number must end with a nonzero number. Chinese and other languages (such as Japanese, Korean, etc) are not supported.
6.
Click the “Read File” button, a message box will pop up for you to select the directory.
7.
Click the “Browse” button to select the directory of the QC information.
8.
Click the “Ok” button to close the message box shown above, and the following message box will pop up.
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9.
The QC files for selection are displayed in the form of "Lot No. (Level)".
Click the “Ok” button to close the message box and go back to the "Read " Read File" File" box. The selected directory is displayed in the " Read From:" From:" edit box.
10. In the "Read File" File" message box, select the "Read "Read Target/Limits" Target/Limits" check box, and click
“Ok” to read the selected QC information to the current QC file.
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If the “Read Target/Limits” is not selected, you have to enter the target and limits manually.
11. Click the “Save” button to save the QC information.
The expiration date can not be earlier than the current system date.
Different QC files can not have the same lot No. and QC mode.
Manual entry 1.
You can enter the the graph screen by one of the following ways: ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””L-J” on the pop-up menu.
Enter the “L-J” graph screen.
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Using the QC Programs
2.
Click the “Settings” tab to enter the L -J setup screen.
For details to edit the name of the login user, see chapter 5 Customizing the Analyzer Software.
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3.
Select a QC File No. with empty QC information.
4.
You can select the file No. within the range [1, 60].
You can enter the lot No. of the control by one of the following ways:
Manual entry Entering by external barcode scanner
The lot No. can not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but no Chinese characters are allowed.
Different QC files can not have the same lot No. and QC mode.
5.
Enter the batch expiration date of the controls.
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6.
You must enter the expiration date, and the entry range is [current system date, 2099-12-31].
Select the QC mode.
Different QC files can not have the same lot No. and QC mode.
7.
Select the control level.
8.
Set QC ID: if you like to run control in the interval of running blood samples, you can set a specific ID for the control. If such ID is recognized when the analyzer is running blood samples, it will identify the sample as control automatically. When the running ends, the result will be stored in the QC file of the corresponding ID.
9.
Letters, numbers and all characters that can be entered through the keyboard (including special characters) are allowed for the QC ID, but the number must end with a nonzero number. Chinese and other languages (such as Japanese, Korean, etc) are not supported.
According to the target list of the corresponding lot No., No., enter the target and limits into the edit boxes of the parameters to be included in the QC run.
10. Click the “Save” button to save all the settings of the QC.
Reading the saved preset values
If there are saved preset values (Target and Limits) for the current level, you can read the preset values into the current QC file. For details of calculating and saving the preset values, see Section 8.2.3 Reviewing QC Results.
1.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””L-J” on the pop-up menu. 8-10
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Enter the “L-J” graph screen.
2.
Click the “Settings” tab to enter the L -J setup screen.
For details of editing the name of the login user, see chapter 5 Customizing
the Analyzer Software.
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3.
Select a QC File No. with empty QC information.
4.
You can select the file No. within the range [1, 60].
You can enter the lot No. of the controls by one of the following ways:
Manual entry Entering by external barcode scanner
The lot No. can not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but no Chinese characters allowed.
Different QC files can not have the same lot No. and QC mode.
5.
Enter the batch expiration date of the controls.
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6.
You must enter the expiration date, and the entry range is [current system date, 2099-12-31].
Select the QC mode.
Different QC files can not have the same lot No. and QC mode.
7.
Select the control level.
8.
Set QC ID: if you like to run control in the interval of running blood samples, you you can set a specific ID for the control. If such ID is recognized when the analyzer is running blood samples, it will identify the sample as control automatically. When the running ends, the result will be stored in the QC file of the corresponding ID.
9.
Letters, numbers and all characters that can be entered through the keyboard (including special characters) are allowed for the QC ID, but the number must end with a nonzero number. Chinese and other languages (such as Japanese, Korean, etc) are not supported.
Click the “Have Preset Values” button to read the saved preset target and limits (correspond to the current level) into the current QC file.
If some parameters to be included in the QC run have no preset values, you
should enter the target and limits for them manually; if you don’t want some parameters with preset values to be included in the QC run, you can cancel the target and limits of them manually after reading the preset values.
10. Click the “Save” button to save all the settings of the QC.
Setting Limits You can take the following f ollowing steps to adjust the display form format at of the limits and the calculation
method of the preset limits. 1.
Click the “Set Limits” button, and then the following message box will pop up.
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2.
Click “By SD” to display the limits in the form of absolute value; click “ By CV” to display the limits in the form of percentage.
3.
If “ By SD” is selected, click the “ 2SD” or “3SD” to select either double or triple standard deviation to be the limits; if “ By CV” is selected, click the “ 2CV” or “3CV” to select either double or triple coefficient of variation to be the limits.
4.
Click the “Ok” button to save all the settings for the limits.
Print Click the “Print” button to print the setting information of the current QC file.
8.2.2 Running controls You can choose from below two methods to run controls: Run controls under QC “Run” screen Run controls in the interval of running blood samples under sample count screen
Run Controls under QC “Run” Screen After editing the QC information, you can start one of the following QC analyses according to the selected QC mode. Whole Blood Predilute
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Using the QC Programs Running controls (whole blood)
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
The sample probe is sharp and potentially biohazardous, Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the unclosed collection tubes and cause biohazard. Exercise caution to the unclosed collection tubes.
Collection tubes broken may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
Keep your clothes, hair and hands away from the moving parts to avoid
1.
injury. The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
Be sure to use the Mindray-specified disposable products including vacuum collection tubes, anticoagulant collection tubes and capillary tubes etc.
Whole Blood , If the sample mode is switched from the Predilute to the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””L-J” on the pop-up menu.
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Using the QC Programs
Enter the “L-J” graph screen.
2.
Click the “Run” tab to enter the L-J run screen.
For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
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Using the QC Programs
3.
Select the QC file No. to be run; the screen displays displays the corresponding file information.
4.
Be sure that the level of the control to be run corresponds with the current QC file.
5.
Be sure that the control to be run is not expired.
6.
Prepare the control as instructed by instructions of the controls.
7.
Run the controls:
1) Make sure the QC mode is “whole blood” and the analysis status icon and analyzer indicator is green.
2) Shake the prepared control as shown below to well mix it.
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Using the QC Programs
3) Click the “Start” button.
4) Present the control to the sample probe. 5) Press the aspirate key to start QC run. 6) When you hear the beep, remove the control. 8.
When finish running, the QC results will be displayed in the current screen and be saved in the QC file automatically. automatically.
9.
Up to 300 QC results can be saved for each QC file.
Do the above procedures to continue running the controls if necessary necessary..
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Using the QC Programs Running controls (Predilute)
1.
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
The sample probe is sharp and potentially biohazardous, Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the unclosed collection tubes and cause biohazard. Exercise caution to the unclosed collection tubes.
Collection tubes broken may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
Keep your clothes, hair and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
Be sure to use the Mindray-specified disposable products including vacuum collection tubes, anticoagulant collection tubes and capillary tubes etc.
You can enter the graph screen in in one one of the following ways: ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””L-J” on the pop-up menu.
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Using the QC Programs
Enter the “L-J” graph screen.
2.
Click the “Run” tab to enter the L-J run screen.
For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
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Using the QC Programs
3.
Select the QC file No. to be run; the screen displays displays the corresponding file information.
4.
Be sure that the level of the control to be run corresponds with the current QC file.
5.
Be sure that the control to be run is not expired.
6.
Prepare the control control as instructed by instructions instructions for use of the controls.
7.
Run the controls:
1) Make sure the QC mode is “ Predilute” and the analysis status icon and analyzer indicator is green.
2) Click the shortcut button “Diluent”, and then a message box will pop up.
3) After the preparation is done, the following message box will pop up.
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Using the QC Programs
4) Present a clean centrifugal tube to the sample probe and make sure the probe reaches the bottom of the tube and keep the tube vertical, as the figure shows, to avoid spills, hangings and bubbles.
5) Press the aspirate key to start dispensing the diluent.
6) The buzzer sounds when diluent is finished, then you can remove the centrifugal tube. 7
shake the tube to mix the sample.
) Add 20μL of control to the diluent, close the tube cap and
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Using the QC Programs
8) Click the “Cancel” button to exit the “Diluent” message box.
9) After the cleaning is finished, close the prompt. 10) Click the “Start” button.
11) Present the prepared control to the sample probe. 12) Press the aspirate key to start QC run. 13) When you hear the beep, remove the control. 8.
When finish running, the QC results will be displayed in the current screen and be saved in the QC file automatically. automatically.
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Using the QC Programs
You can also dispense 180μL of diluent by pipette into the tube.
Be sure to keep dust from the prepared diluent.
After mixing the control with the diluent, be sure to wait 3 minutes before running.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running it.
Be sure to evaluate predilute QC stability based on your laboratory’s sample population and sample collection techniques or methods.
9.
Up to 300 QC results can be saved for each QC file.
Do the above procedures to continue running the controls if necessary necessary..
Browsing the QC result You can click the arrow button in the bottom of the screen to browse the QC result saved in th the e current QC file. You can click the
button or
button to switch to the previous or the next QC result.
You can click the
button or
button to switch to the earliest or the latest QC result
saved in the QC file.
The running result of the expired control will begin with an “O” mark.
The flags “H” or “L” will appear in front of the result that out of the limits.
The enlarging function is available to the scattergrams and histograms of the screen. See details for operation in Chapter 7 Reviewing Sample
Results. For the QC files with saved QC results, if any change is made to the ta target rget or the limits, the changed data will be highlighted in yellow.
Print
Click the “Print” button to print the results of the current QC Run scree n.
Run controls in the interval of running blood samples under sample count screen After setting special “QC ID” for controls under the “Settings” screen, you can run controls in
the intervals of running blood samples under sample count screen. Before running blood samples, when you are editing worklist or entering information for the next sample, be sure to enter the special “QC ID” as “sample ID”. (Refer to 6.6.1 6.6.1 Entering Entering 8-24
Using the QC Programs Work List Information Information and 6.6.2 Quick Quick Entering of Next Sample Information Information for the way to enter sample IDs)
You can start one of the following QC analyses according to the selected QC mode. Whole Blood Predilute
Running controls (whole Blood)
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the unclosed collection tubes and cause biohazard. Exercise caution to the unclosed collection tubes.
Collection tubes broken may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
Keep your clothes, hair and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
Be sure to use the Mindray-specified disposable products including vacuum collection tubes, anticoagulant collection tubes and capillary tubes etc.
If the sample mode is switched from the “Predilute” to “Whole Blood”, the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen. 8-25
Using the QC Programs
1.
Prepare the control control as instructed by instructions instructions for use of the controls.
2.
Confirm under under the main screen that the next sample ID displayed displayed in the “Next Sample” information area is the set QC ID and the sample mode is whole blood.
3.
Shake the control as shown below to well mix it.
4.
When it is ready to run a sample (i.e. the analysis status icon and analyzer indicator is green), present the control to the sample probe.
5.
Press the aspirate key to start the analysis.
6.
When you hear the buzzer beeps, remove the control.
7.
After the analysis analysis completes, the QC results will be automatically saved in the corresponding QC file of the QC ID.
8.
Up to 300 QC results can be saved for each QC file.
Do the above procedures to continue running the controls if necessary necessary..
Running control (predilute)
All the samples, controls, calibrators, reagents, wastes and areas contacted
with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
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Using the QC Programs
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the unclosed collection tubes and cause biohazard. Exercise caution to the unclosed collection tubes.
Collection tubes broken may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
Keep your clothes, hair and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
Be sure to use the Mindray-specified disposable products including vacuum collection tubes, anticoagulant collection tubes and capillary tubes etc.
If the sample mode is switched from the “Predilute” to “Whole Blood”, the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen.
1. 2.
Prepare the control control as instructed by instructions for use of the controls. Confirm under the mian screen that the next sample ID displayed in the “Next Sample” information area is the set control ID and the sample mode is predilute.
3.
Click the shortcut button “Diluent”, a message box will pop up.
4.
The message box will pop up after preparation is done. 8-27
Using the QC Programs
5.
Present a clean centrifugal tube to the sample probe and make sure the probe reaches the bottom of the tube and keep the tube vertical, as the figure shows, to avoid spills, hangings and bubbles.
6.
Press the aspirate key to start dispensing the diluent.
7.
The buzzer buzzer sounds when diluent is is finished, then you can remove the centrifugal tube.
8.
Add 20μL of control to the diluent, close the tube cap a nd shake the tube to mix the
sample.
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Using the QC Programs
9.
Click the “Cancel” button to exit the “Diluent” message box.
10. After the cleaning is finished, close the message box. 11. Present the prepared control to the sample probe. 12. Press the aspirate key to start QC run. 13. When you hear the beep, remove the control. 14. After the running is finished, the QC results will be saved in the QC file of the corresponding QC ID.
You can also dispense 180μL of diluent by pipette into the tube.
Be sure to keep dust from the prepared diluent.
After mixing the control with the diluent, be sure to wait 3 minutes before running.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running it.
Be sure to evaluate predilute QC stability based on your laboratory’s sample population and sample collection techniques or methods.
Up to 300 QC results can be saved for each QC file.
15. Do the above procedures to continue running the controls if necessary necessary..
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Using the QC Programs Browsing the QC result You can switch to the “L-J QC Run” screen and click the arrow button in the bottom of the screen to browse the QC results saved in the corresponding QC file. You can click the
button or
button to switch to the previous or the next QC result.
You can click the
button or
button to switch to the earliest or the latest QC result
saved in the QC file.
The running result of the expired control will begin with an “O” mark.
The flags “H” or “L” will appear in front of the X mean that out of the limits.
The enlarging function is available to the scattergrams and histograms of the screen. See details for operation in Chapter 7 Reviewing Sample Results.
For the QC files with saved QC results, if any change is made to the ta target rget or the limits, the changed data will be highlighted in yellow.
Print
Click the “Print” button to print the results of the current QC Run screen.
8.2.3 Reviewing QC Results After running the controls, you can review the QC results in the following two ways: Graph Table
Graph Review
1.
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””L-J” on the pop-up menu.
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Using the QC Programs
Enter the “L-J” graph screen.
2.
Select the QC file No. you want want to review, review, and then the screen will display the corresponding information and the graph.
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Using the QC Programs
3.
You can drag the scroll bar on the right of the graph vertically to browse the desired graph of the parameter. You can drag the scroll bar down to the graph horizontally to browse all the QC results.
Introduction to the “Graph” screen
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Using the QC Programs
1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points located on the green line. 3- The operator who run the QC analysis and obtained the QC points located on the green line. 4- The QC results of the parameters that correspond to the QC points located on the green line. 5- The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. The QC points are connected by a line to illustrate the distribution trend. 6- The QC point corresponds to each QC result. Only the selected QC point displays its value under the parameter. The black QC point indicates the value is within the limit; the red QC point indicates the value is out of the limit. 7- When you clicking a QC point in the graph, the QC points of other parameters that saved together with this one will be marked by a green line. 8- The relative position of the QC point located on the green line and the total QC points saved currently.
The outliers are excluded from the calculation of Mean, SD and CV%. For the QC files with saved QC results, if any change is made to the ta target rget or the limits, the changed data will be highlighted in yellow.
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Using the QC Programs Browsing the QC result You can click the arrow button in the bottom of the screen to browse the QC result saved in the current QC file. You can click the
button or
QC point; you can click the
button to move the green line to the previous or the next button or
button to move the green line to the first or the
last QC point in the graph. When the location of the green line is selected, you can check the QC results of the QC points located on the green line under each parameter.
New Vial If the reviewed QC results are obtained by analyzing a new vial of control within the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old. 1.
Move the green line to the first QC point of the new vial.
2.
Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3.
After another new vial of control (within (within the same batch) is run and its QC results are saved, you can continue to mark the current QC point of the new vial according to step 1 and 2.
4.
If the current QC point is marked with with the blue line, the “New Vial” button will turn into
“Cancel”; you can click the button to remove the blue line, and then the “Cancel” button will turn back to “New Vial”.
Data Compare If you wish to compare the graphs of the certain parameter obtained by running controls of different lot No., do as follows: 1.
Click the “Data Compare” button to start selecting the desired graph.
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Using the QC Programs
2.
Select the desired QC file No. into the “ File No.” box (3 files can be selected at most). Then, the graph of the selected QC file will be displayed below together with its lot No., QC mode and level.
3.
Select the desired parameter into the “ Parameter ” box.
Browse the graph here the same way as instructed in the “Graph” s creen. Be aware that, for controls of different level, their graphs will be distinguished by the color of orange, black and blue.
4.
Click the “Print” button to print the current comparison if necessary.
5.
Click the “Close” button to exit.
Display Order You can take the following f ollowing steps to adjust the display order of different graphs. 1.
Click the “Display Order ” button to check the current display order of the graphs.
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Using the QC Programs
2.
Click the parameter that you want to adjust.
3.
You can click the can click the
button or button or
button to move parameter upward or downward; you button to move the parameter to the first or the last
position. 4.
Click the “Ok” button to refresh the display order of the graphs.
Saving Preset Values If there are 3 or more than 3 QC results within the limits obtained for the parameters, you can take the following steps to calculate and save the preset value for each parameter: 1.
Click the “Calculate Preset Values” button, and then the screen displays two lines for you to select the range for calculating the preset values.
2.
Click and and drag the two lines respectively to locate them as the beginning and the ending of the range for calculating the preset values.
3.
The Mean, SD and CV% CV% (on the right of the graph) will change into the new results calculated within the selected range.
4.
If you wish to save the new results, you can click the “ Save Preset Values” button to save
the current Mean, SD and CV% as the preset values for the corresponding level (high/normal/low). Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results.
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Using the QC Programs
The calculation and display of the preset values are only available to the parameter (within the calculation range) which has 3 or more than 3 results within the limit. Otherwise, the display of the preset values will be empty.
According to the high, normal and low level of the controls, three set of preset values can be saved respectively.
Entering the reasons for the outliers You can take the following f ollowing steps to enter the reasons ffor or the outliers: 1.
After moving the green line to the desired QC point, you can click the “ Outliers” button to display the QC results, targets and limits of all the parameters located on the green line (the QC results exceed the limit will be displayed in red) and enter the reasons for the outliers.
2.
You can select the reason form the given ones or enter the reasons (up to 200 characters) into the edit box manually after selecting “Others”.
3.
Click the “Ok” button to save the reasons for the outliers and exit.
If you enter the reason for the group of QC points whose results are actually within the limits, then their corresponding QC data both in the QC Graph and QC Table will be displayed in the color of red. And the data will return to
black if you cancel the reason and then save the changes.
Delete The administrator can delete the QC results by the following steps: 8-37
Using the QC Programs 1.
If you wish to delete a single QC result, move the green line to the desired QC result; if you wish to delete all the data, perform step 2 directly.
2.
Click the “Delete” button to select “Current Data” or “ All Data”.
3.
Click the data you want to delete.
4.
Click the “Ok” button and then confirm to delete the selected data.
The deleting operation will be recorded in the log.
Print
Click the “Print” button to print all the file information and graphs of the parameters of the current QC file.
The green line and the corresponding values of the QC points will not be printed.
Table Review
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
1.
You can enter the Table screen by one of the following ways: 8-38
Using the QC Programs
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””L-J” on the pop-up menu.
Enter the “L-J” graph screen.
2.
Click the “Table” tab to enter the L-J table screen.
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Using the QC Programs
3.
Select the QC file No. you want want to review, review, and then the screen will display the corresponding information and the table.
4.
You can drag the scroll bar bar on the right of the table vertically to browse the desired table of the parameter. You You can drag the th e scroll bar down to the table horizontally to browse all the QC results.
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Using the QC Programs
Introduction to the “Table” screen
1- The No. of the QC result saved in the QC file (arranged from left to right in the order that from the earliest to the latest) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag “H” or “L” will be used to prompt the result that out of th e limits 5- The relative position of the highlighted h ighlighted QC point and the total QC points saved currently.
For the QC files with saved QC results, if any change is made to the ta target rget or the limits, the changed data will be highlighted in yellow.
Browsing the QC result You can click the arrow button in the bottom of the screen to browse the QC result saved in th the e current QC file.
You can click the
button or
you can click the
button or
button to highlight the previous or the next QC result; button to highlight the first or the last QC result in the
table.
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Using the QC Programs Delete The administrator can delete the QC results by the following steps: 1.
If you wish to delete a single QC result, click the column contains the desired QC result; if you wish to delete all the data, perform step 2 directly.
2.
Click the “Delete” button to select “Current Data” or “ All Data”.
3.
Click the data you want to delete.
4.
Click the “Ok” button and then confirm to delete the selected data.
The deleting operation will be recorded in the log.
Print You can take tak e the following steps to print the Table: 1.
Click the “Print” button, and then you can select “ All Data” or “Specified Data” to be printed.
2.
Click the “All Data” button and then click the “ Ok” button to print all the file information and tables of the parameters of the current QC file; after clicking the “ Specified Data” 8-42
Using the QC Programs button, you can select the starting and finishing date (the saved date of the QC results) res ults) for
printing, then click the “Ok” button to print the specified data.
Communication If you wish to transmit the QC data to the external data management software or LIS/HIS, do as follows: 1.
Click the “Communication ” button, and then you can select “ All Data” or “Specified Data” to be transmitted.
2.
Click the “All Data” button and then click the “Start” button to transmit the information of the current QC file and QC data . After clicking the “Specified Data” button, you can specify a date range (the date when the QC result was saved), then click the “ Ok” button
to transmit the specified data. The “LIS/HIS connected” icon on the status bar of the screen will flicker during transmission. 3.
While transmitting, the “Start” button in the pop-up message box will be replaced by
“Stop”. You can click the “Stop”button to stop transmitting.
If auto-communication is enabled and a sample is ran during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result starts.
The QC data saved in the process of transmission will not be transmitted.
Data Backup
If you wish to backup the information and the result of the current QC file, do as follows:
1.
Click the “Data Backup” button, a message box will pop up.
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Using the QC Programs
2.
Select the backup directory (the default directory is the folder of “QC Data” under the installation location of the terminal software).
3.
Enter the name for the backup data (the default name is [L-J_QC_date saved_time saved]).
4.
Click the “Save” button to start backing up.
5.
When the backup is finished, a message box will pop up, and then click “ Ok” to exit.
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Using the QC Programs
The backup data can not be modified. You can review the data in “History” screen.
You can click the “Cancel” button to cancel backup when it is in process. Be sure to backup data regularly.
Data Export If you wish to export the information inform ation and the result of the curr current ent QC file, do as follows: 1.
Click the “Data Data Export” button, and then a message box will pop up.
2.
Select the export directory (the default directory is the folder of “QC Data” under the
3.
Enter the name for the export data (the default name is [L-J_QC_date saved_time
installation location of the terminal software).
saved]). 4.
Select the format for the export file.(default format: “. CSV”)
5.
Click the “Save” button to start exporting.
6.
When the export is finished, a message box will pop up, and then click “ Ok” to exit. 8-45
Using the QC Programs
You can modify the exported data but can not review the data in the “History” screen.
You can click the “Cancel” button to cancel export when it is in process.
History
If you wish to review the backed up data, do as follows: 1.
Click the “History” button, and then a message box will pop up.
2.
Locate and then select the desired backup data.
3.
Click the “Open” button to display the data in “History” screen.
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4.
The display format and the function button are the same as the QC table screen. Browse, print, transmit and export the data as instructed in the section of QC Table Review. Review.
5.
After reviewing, click the “Close” button to exit.
Single Parameter QC Graph Single parameter QC graph is the QC graph of one parameter under the L-J QC mode. Click “Menu” “QC” ”L-J QC”, and then click the “Single Para. QC Graph” tab to enter the following screen.
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Using the QC Programs
Single para. QC graph screen The single para. QC graph screen consists of the file information area, QC graph area and the comments area.
File information area
You can select among all valid QC file No. from the “File No.” pull-down list. The default file No. is the L-J QC file used by the current operator, and the file No. cannot be null. The lot No, level, exp. date, QC mode, editor and QC sample ID will be displayed automatically after you select the QC file No..
QC graph area
You can select the parameter param eter to plot QC graph gra ph from the “Parameter ” pull-down list, and select the plotting mode from the “Plotting” pull down list: “By QC Date”, “1/Day”, “All”. The default values of the “Mean” and “SD” boxes are calculated from all the valid QC points on the graph of the selected parameter in the curr current ent QC file by the default plotting mode. You can edit the values manually.
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Using the QC Programs
If there are less than 3 valid QC points of the current parameter, the mean and SD will be null.
If you select “By QC Date” or “1/Day” plotting mode, and there are more than 1 QC point in one day, the points will all be displayed in the graph, but only the latest one will be the connecting point of the plot.
Drag the scroll bar after setting up all the information, and the QC graph will be plotted automatically and the analysis results and operator information will be displayed under the graph.
Comments area
This area displays the conclusion drawn based on the preset rule of outliers, which can be edited by operators.
Browsing the QC result Click the arrow buttons under the screen to browse all the QC points. You can click the can click the
button or button or
button to highlight the previous or the next QC point; you button to highlight the first or the last QC point in the graph.
New Vial If the reviewed QC results are obtained by analyzing a new vial of control within the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old. 1.
Move the green line to the first QC point of the new vial.
2.
Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3.
After another new vial of control (within the same batch) is run and its QC results are saved, you can continue to mark the current QC point of the new vial according to step 1 and 2.
4.
If the current QC point is marked with with the blue line, line, the “New Vial” button will turn into
“Cancel”; you can click the button to remove the blue line, and then the “Cancel” button will turn back to “New Vial”.
Calculate Target Click the “Calculate” button, the following screen will pop up.
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After selecting the date range, the mean, SD and an d CV will be calculated and displayed in to the corresponding boxes automatically automatically.. Click “Apply” to enter the calculated target into the single para. QC graph screen, and then click “OK” to save the target and close the dialog box. Click “Cancel” to exit the “Calculate” screen without saving the calculated target.
If there are no data in the selected date range, a prompt will be displayed: “Not enough data! Reselect a date range and make sure there are more than 5 groups of valid data.”
Save Click “Save” to save the mean and SD (including the manually edited values and the values obtained by calculating target) and display them on the bottom left of the QC graph.
Print Click “Print” to print the QC graph and data on the screen.
Monthly QC Graph Monthly QC graph is the QC graph of one parameter of the high, normal and low levels within one month. Click “Menu” “QC” ”L-J QC”, and then click the “Monthly QC Graph” tab to enter the following screen.
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Monthly QC graph screen The monthly QC graph screen consists of the file information area and QC graph area.
File information area
You can select the parameter param eter to plot QC graph from f rom the “Parameter ” pull-down list; select the level(s) of the control you want to check from the “Level” pull down list; select the plotting mode from the “Plotting” pull down list: “1/Day”, “ All”; and select the date range of all QC data in the QC graph from the “Date Range” pull-down list.
After you set the above conditions, the matching QC files will be acquired and the Lot No., exp. Date, X mean and SD will be displayed in the boxes of the corresponding QC levels. If no data is acquired, the boxes will be null. If the “X Mean” and “SD” boxes are both null, their values cannot be edited, otherwise you can edit the values of X mean and SD, then click “Save” to save the change.
Two QC files of each QC level can be displayed in one month; if there are more than two QC files, the latest two will be displayed.
QC graph area 8-51
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Browsing the QC result Click the arrow button under the screen to browse all the QC points. You can click the can click the
button or button or
button to highlight the previous or the next QC point; you button to highlight the first or the last QC point in the graph.
Print Click “Print” to print the QC graph and data on the screen.
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8.3 X mean QC Program 8.3.1 Editing X mean settings
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
Only administrators can edit the X mean settings.
For the QC files with saved QC results, if any change is made to the ta target rget or the limits, the changed data will be highlighted h ighlighted in yellow, and the change will be recorded into the system log.
Before analyzing a new batch of controls, you should set a QC file for each lot of controls and edit the QC settings in the QC file by one of the following ways: Reading the information provided by the manufacturer Manual entry Reading the saved preset values
Reading the information provided by the manufacturer 1.
You can enter the the graph screen in one of the the following ways: ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen; then select “ QC””X mean” on the pop-up menu.
Enter the "X "X mean" mean" graph screen. 8-53
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2.
Click the “Settings” tab to enter the X mean settings screen.
For details to edit the name of the login user, see chapter 5 Customizing the Analyzer Software.
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3.
Select a QC File No. with empty QC information.
4.
Select the QC mode.
5.
You can select the file No. within the range [1, 60].
Different QC files can not have the same lot No. and QC mode.
Click the “Read File” button, a message box will pop up for you to select the directory.
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6.
7.
Click the “Browse” button to select the directory of the QC information.
Click the “Ok” button to close the message box shown above, and the following message box will pop up.
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8.
The QC files for selection are displayed in the form of "Lot No. (Level)".
Click the “Ok” button to close the message box and go back to the "Read " Read File" File" box. The selected directory is displayed in the " Read From:" From:" edit box.
9.
In the "Read File" File" message box, select the "Read "Read Target/Limits" Target/Limits" check box, and click
“Ok” to read the selected QC information to the current QC file.
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If the “Read Target/Limits” is not selected, you have to enter the target and limits manually.
10. Click the “Save” button to save the QC information.
The expiration date can not be earlier than the current system date.
Different QC files can not have the same lot No. and QC mode.
Manual entry 1.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””X mean” on the pop-up menu.
Enter the “X mean” graph screen.
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2.
Click the “Settings” tab to enter the X mean setup screen.
For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
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3.
Select a QC File No. with empty QC information.
4.
You can select the file No. within the range [1, 60].
You can enter the lot No. of the controls by one of the following ways:
Manual entry Entering by external barcode scanner
The lot No. can not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but no Chinese characters allowed.
Different QC files can not have the same lot No. and QC mode.
5.
Enter the batch expiration date of the controls.
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6.
You must enter the expiration date, and the entry range is [current system date, 2099-12-31].
Select the QC mode.
Different QC files can not have the same lot No. and QC mode.
7.
Select the control level.
8.
Enter the target and limits into the edit boxes of the parameters to be includ included ed in the QC run according to the target list of the corresponding lot No.
9.
Click the “Save” button to save all the settings of the QC.
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Reading the saved preset values
1.
If there are the saved preset values (Target and Limits) for the current level, you can read the preset values into the current QC file. For details of calculating and saving the preset values, see Section 8.3.3 Reviewing QC results.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC”” X mean” on the pop-up menu.
Enter the “X mean” graph screen.
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2.
Click the “Settings” tab to enter the X mean setup screen.
For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
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3.
Select a QC File No. with empty QC information.
4.
You can select the file No. within the range [1, 60].
You can enter the lot No. of the controls by one of the following ways:
Manual entry Entering by external barcode scanner
The lot No. can not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but no Chinese characters allowed.
5.
Different QC files can not have the same lot No. and QC mode.
Enter the batch expiration date of the controls.
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6.
You must enter the expiration date, and the entry range is [current system date, 2099-12-31].
Select the QC mode.
Different QC files can not have the same lot No. and QC mode.
7.
Select the control level.
8.
Click the “Have Preset Values” button to read-in the saved preset target and limits (correspond to the current level) into the current QC file.
If some parameters to be included in the QC run have no preset values, you
should enter the target and limits for them manually; if you don’t want some parameters with preset values to be included in the QC run, you can cancel the target and limits of those parameters manually after read-in the preset values.
9.
Click the “Save” button to save all the settings of the QC.
Setting Limits You can take the following f ollowing steps to adjust the display form format at of the limits and the calculation method of the preset limits. 1.
Click the “Set Limits” button, and then the following message box will pop up.
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2.
Click “By SD” to display the limits in the form of absolute value; click “ By CV” to display the limits in the form of percentage.
3.
If “ By SD” is selected, click the “ 2SD” or “3SD” to select either double or triple standard deviation to be the limits; if “ By CV” is selected, click the “ 2CV” or “3CV” to select either double or triple coefficient of variation to be the limits.
4.
Click the “Ok” button to save all the settings for the limits.
Print Click the “Print” button to print the setting information of the current QC file.
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8.3.2 Running controls After editing the QC information, you can start one of the following QC analyses according to the selected QC mode. Whole Blood Predilute
Running controls (whole blood)
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the unclosed collection tubes and cause biohazard. Exercise caution to the unclosed collection tubes.
Collection tubes broken may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
Keep your clothes, hair and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory. If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
Be sure to use the Mindray-specified disposable products including vacuum collection tubes, anticoagulant collection tubes and capillary tubes etc.
Whole Blood , If the sample mode is switched from the Predilute to the analyzer will perform the switching sequence automatically and a 8-67
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1.
You can enter the graph screen by one of the following ways:
Click the shortcut button “QC”.
Click the “Menu” button on the screen, and then select “ QC”” X mean” on the pop-up menu.
Enter the “X mean” graph screen.
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2.
Click the “Run” tab to enter the X mean run screen.
For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
3.
Select the QC file No. to be run; the screen displays displays the corresponding file information.
4.
Be sure that the level of the control to be run is the same with the current QC file.
5.
Be sure that the control to be run is not expired.
6.
Prepare the control control as instructed by instructions instructions for use of the controls.
7.
Run the controls:
1) Make sure the QC mode is “whole blood” and the analysis status icon and analyzer
indicator is green. 2) Shake the prepared control as shown below to well mix it.
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3) Click the “Start” button.
4) Present the control to the sample probe. 5) Press the aspirate key to start QC run. 6) When you hear the beep, remove the control. 7) After the analyzing is finished, the QC result of the first run will be displayed on the screen.
8) Mix the control well again, to run the control for the second time according to the prompt.
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You can click the “Cancel” button in the message box to cancel the second run and the results obtained in the first run will not be saved as well.
9) When you hear the beep, remove the control. 8.
When finish running, the QC results (values of the two QC runs and the X mean) will be displayed in the current screen and be saved in the QC file automatically. automatically.
9.
When the QC result of the second QC run is obtained, the screen will refresh the displayed histograms and scattergrams according to the second QC run.
Up to 300 QC results (X mean) can be save for each QC file.
Do the above procedures to continue running the controls if necessary necessary..
Running controls (Predilute)
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the unclosed collection tubes and cause biohazard. Exercise caution to the unclosed collection tubes.
Collection tubes broken may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
Keep your clothes, hair and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
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1.
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
Be sure to use the Mindray-specified disposable products including vacuum collection tubes, anticoagulant collection tubes and capillary tubes etc.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC”” X mean” on the pop-up menu.
Enter the “X mean” graph screen.
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2.
Click the “Run” tab to enter the X mean run screen.
For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
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3.
Select the QC file No. to be run; the screen displays displays the corresponding file information.
4.
Be sure that the level of the control to be run is the same with the current QC file.
5.
Be sure that the control to be run is not expired.
6.
Prepare the control control as instructed by instructions instructions for use of the controls.
7.
Run the controls:
1) Make sure the QC mode is “ Predilute” and the analysis status icon and analyzer indicator is green.
2) Click the shortcut button “Diluent”, and then a message box will pop up.
3) After the preparation is done, the following message box will pop up.
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4) Present a clean centrifugal tube to the sample probe and make sure the probe reaches the bottom of the tube and keep the tube vertical, as the figure shows, to avoid spills, hangings and bubbles.
5) Press the aspirate key to start dispensing the diluent.
6) The buzzer sounds when diluent is finished, then you can remove the centrifugal tube. 7) Add 20μL of control to the diluent, close the tube cap and shake the tube to mix the sample.
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8) Click the “Cancel” button to exit the “Diluent” message box.
9) After the cleaning is finished, close the prompt. 10) Click the “Start” button.
11) Present the prepared control to the sample probe. 12) Press the aspirate key to start QC run. 13) When you hear the beep, remove the control. 14) After the running is finished, the QC result of the first run will be displayed on the screen.
14) After the running is finished, the QC result of the first run will be displayed on the screen.
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15) Mix the control in the centrifugal tube well again, to run the control for the second time according to the prompt.
You can click the “Cancel” button in the message messag e boxto cancel the second run and the results obtained in the first run will not be saved as well.
16) When you hear the beep, remove the control. 8.
When finish running, the QC results (values of the two QC runs and the X mean) will be displayed in the current screen and be saved in the QC file automatically. automatically.
You can also dispense 180μL of diluent by pipette into the tube.
Be sure to keep dust from the prepared diluent.
After mixing the control with the diluent, be sure to wait 3 minutes before running.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running it.
Be sure to evaluate predilute QC stability based on your laboratory’s sample population and sample collection techniques or methods.
9.
Up to 300 QC results can be saved for each QC file.
When the QC result of the second QC run is obtained, the screen will refresh the displayed histograms and scattergrams according to the second QC run.
Up to 300 QC results (X mean) can be save for each QC file.
Do the above procedures to continue running the controls if necessary necessary..
Browsing the QC result You can click the arrow button butt on in the bottom of the screen to browse the QC result saved in the current QC file. You can click the
button or
button to switch to the previous or the next QC result.
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You can click the
button or
button to switch to the earliest or the latest QC result
saved in the QC file.
The running result of the expired control will begin with an “O” mark. The flags “H” or “L” will appear in front of the X mean that out of the limits.
The enlarging function is available to the scattergrams and histograms of the screen. See details for operation in Chapter 7 Reviewing Sample Results.
For the QC files with saved QC results, if any change is made to the ta target rget or the limits, the changed data will be highlighted in yellow.
Print Click the “Print” button to print the results of the current QC Run screen.
8.3.3 Reviewing QC Results After running controls, you can review the QC results in the following two ways: Graph Table
Graph Review
1.
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”.
Click the “Menu” button on the screen, and then select “ QC”” X mean” on the pop-up menu.
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Enter the “X mean” graph screen.
2.
Select the QC file No. you want want to review, review, and then the screen will display the corresponding information and the graph.
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3.
You can drag the scroll bar on the right of the graph to browse the desired graph of the parameter. You You can drag the scroll s croll bar down to the graph horizontally to browse all the QC results.
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Introduction to the “Graph” screen
1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points located on the green line. 3- The operator who run the QC analysis and obtained the QC points located on the green line. 4- The QC results of the parameters that correspond to the QC points located on the green line. 5- The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. The QC points are connected by a line to illustrate the distribution trend. 6- The QC point corresponds to each QC result. Only the selected QC point displays its value under the parameter. The black QC point indicates the value is within the limit; the red QC point indicates the value is out of the limit. 7- When you clicking a QC point in the graph, the QC points of other parameters that saved together with this one will be marked by a green line. 8- The relative position of the QC point located on the green line and the total QC points saved currently.
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The value of the QC point is the X mean of each group of QC results.
The outliers are excluded from the calculation of Mean, SD and CV%.
For the QC files with saved QC results, if any change is made to the ta target rget or the limits, the changed data will be highlighted in yellow.
Browsing the QC result You can click the arrow button in the bottom of the screen to browse the QC result saved in the current QC file. You can click the
button or
QC point; you can click the
button to move the green line to the previous or the next button or
button to move the green line to the first or the
last QC point in the graph. When the location of the green line is selected, you can check the QC results of the QC points located on the green line under each parameter.
New Vial If the reviewed QC results are obtained by analyzing a new vial of control within the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old. 1.
Move the green line to the first QC point of the new vial.
2.
Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3.
After another new vial of control (within (within the same batch) is run and its QC results are saved, you can continue to mark the current QC point of the new vial according to step 1 and 2.
4.
If the current QC point is marked with with the blue line, the “New Vial” button will turn into
“Cancel”; you can click the button to remove the blue line, and then the “Cancel” button will turn back to “New Vial”.
Data Compare If you wish to compare the graphs of the certain parameter obtained by running controls of different lot No., do as follows: 1.
Click the “Data Compare” button to start selecting the desired graph.
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2.
Select the desired QC file No. into the “ File No.” box (3 files can be selected at most). Then, the graph of the selected QC file will be displayed below together with its lot No., QC mode and level.
3.
Select the desired parameter into the “ Parameter ” box.
Browse the graph here the same way as instructed in t he “Graph” screen. Be aware that, for controls of different level, their graphs will be distinguished by the color of orange, black and blue.
4.
Click the “Print” button to print the current comparison if necessary.
5.
Click the “Close” button to exit.
Display Order You can take the following f ollowing steps to adjust the display order of different graphs. 1.
Click the “Display Order ” button to check the current display order of the graphs.
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2.
Click the parameter that you want to adjust.
3.
You can click the can click the
button or button or
button to move parameter upward or downward; you button to move the parameter to the first or the last
position. 4.
Click the “Ok” button to refresh the display order of the graphs.
Saving Preset Values If there are 3 or more than 3 QC results within the limits obtained for the parameters, you can take the following steps to calculate and save the preset value for each parameter: 1.
Click the “Calculate Preset Values” button, and then the screen displays two lines for you to select the range for calculating the preset values.
2.
Click and drag the two lines respectively respectively to locate them at the beginning and the ending of the range for calculating the preset values.
3.
The Mean, SD and CV% (on the right of the graph) will change into the new results that
obtained by calculating within the selected range. 4.
If you wish to save the new results, you can click the “ Save Preset Values” button to save the current Mean, SD and CV% as the preset values for the corresponding level (high/normal/low). Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results.
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The calculation and display of the preset values are only available to the parameter (within the calculation range) which has 3 or more than 3 results within the limit. Otherwise, the display of the preset values will be empty. According to can the high, normal and low level of the controls, three sets of preset values be saved respectively.
Entering the reasons for the outliers You can take the following f ollowing steps to enter the reasons for the outliers: 1.
After moving the green line to the desired QC point, you can click the “ Outliers” button to display the QC results, targets and limits of all the parameters located on the green line (the QC results exceed the limit will be displayed in red) and enter the reasons for the outliers.
2.
You can select the reason form the given ones or enter the reasons (up to 200 characters)
into the edit box manually after selecting “Others”. 3.
Click the “Ok” button to save the reasons for the outliers and exit.
If you enter the reason for the group of QC points whose results are actually
within the limits, then their corresponding QC data both in the QC Graph and QC Table will be displayed in the color of red. And the data will return in the color of black if you cancel the reason and then save the changes.
Delete The administrator can delete the QC results by the following steps:
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If you wish to delete a single QC result, move the green line line to the desired QC result; if you wish to delete all the data, perform step 2 dir directly ectly..
2.
Click the “Delete” button to select “Current Data” or “ All Data”.
3.
Click the data you want to delete.
4.
Click the “Ok” button and then confirm to delete the selected data.
The operation of deletion will be recorded in the log.
Print
Click the “Print” button to print all the file information and graphs of the parameters of the current QC file.
The green line and the corresponding values of the QC points will not be printed.
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Table Review
1.
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
You can enter the Table screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC”” X mean” on the pop-up menu.
Enter the “X mean” graph screen.
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2.
Click the “Table” tab to enter the X mean table screen.
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Select the QC file No. you want want to review, review, and then the screen will display the corresponding information and the table.
4.
You can drag the scroll bar on the right of the table vertically to browse the desired table of the parameter. You You can drag the th e scroll bar down to the table horizontally to browse all the QC results.
Introduction to the “Table” screen
1- The No. of the QC result saved in the QC file (arranged from left to right in the order that from the earliest to the latest) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag “H” or “L” will be used to prompt the result (X mean) that out of the limits 5- The relative position of the t he highlighted QC point and the total QC points saved currently.
The value of the QC result is the X mean of each group of QC results.
For the QC files with saved QC results, if any change is made to the ta target rget or the limits, the changed data will be highlighted in yellow.
Browsing the QC result You can click the arrow button in the bottom of the screen to browse the QC result saved in th the e 8-89
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button or
you can click the
button or
button to highlight the previous or the next QC result; button to highlight the first or the last QC result in the
table. Delete The administrator can delete the QC results by the following steps: 1.
If you wish to delete a single QC result, click the column contains the desired QC result; if you wish to delete all the data, perform step 2 directly.
2.
Click the “Delete” button to select “Current Data” or “ All Data”.
3.
Click the data you want to delete.
4.
Click the “Ok” button and then confirm to delete the selected data.
The operation of deletion will be recorded in the log.
Print You can take tak e the following steps to print the Table: 1.
Click the “Print” button, and then you can select “ All Data” or “Specified Data” to be printed.
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2.
Click the “All Data” button and then click the “ Ok” button to print all the file information and tables of the parameters of the current QC file; after clicking the “ Specified Data” button, you can select the starting and finishing date (the saved date of the QC results) res ults) for
printing, then click the “Ok” button to print the specified data.
Communication If you wish to transmit the QC data to the external data management software or LIS/HIS, do as follows: 1.
Click the “Communication ” button, and then you can select “ All Data” or “Specified Data” to be transmitted.
2.
Click the “All Data” button and then click the “Start” button to transmit the information of the current QC file and QC data . After clicking the “Specified Data” button, you can specify a date range (the date when the QC result was saved), then click the “ Ok” button
to transmit the specified data. The LIS/HIS connected icon on the status bar of the screen will flicker during transmission. 3.
While transmitting, the “Start” button in the pop-up message box will be replaced by
“Stop”. You can click the “Stop”button to stop transmitting.
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If auto-communication is enabled and a sample is ran during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result starts.
The QC data saved in the process of transmission will not be transmitted.
Data Backup
If you wish to backup the information and the result of the current QC file, do as follows: 1.
Click the “Data Backup” button, a message box will pop up.
2.
Select the backup directory (the default directory is the folder of “ QC Data” under the installation location of the terminal software).
3.
Enter the name for the backup backup data (the default name is [X_QC_date saved_time sav saved]). ed]).
4.
Click the “Save” button to start backing up.
5.
When the backup is finished, a message box will pop up, and then click “ Ok” to exit.
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The backup data can not be modified. You can review the data in “History” screen.
You can click the “Cancel” button to cancel backup when it is in process. Be sure to backup data regularly.
Data Export If you wish to export the information inform ation and the result of the curr current ent QC file, do as follows: 1.
Click the “Data Export” button, and then a message box will pop up.
2.
Select the export directory (the default directory is the folder of “ QC Data” under the installation location of the terminal software).
3.
Enter the name for the export data (the default name is [X_QC_date saved_time saved]).
4.
Select the format for the export file.(default format: “. CSV”) 8-93
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Click the “Save” button to start exporting.
6.
When the export is finished, a message box will pop up, and then click “ Ok” to exit.
You can modify the exported data but can not review the data in the “History” screen.
You can click the “Cancel” button to cancel export when it is in process.
History
If you wish to review the backed up data, do as follows: 1.
Click the “History” button, and then a message box will pop up.
2.
Locate and then select the desired backup data. 8-94
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Click the “Open” button to display the data in “History” screen.
4.
The display display format and the function button are the same as the QC table screen. Browse, print, transmit and export the data as instructed in the section of QC Table Review. Review.
5.
After reviewing, click the “Close” button to exit.
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8.4 X mean R QC Program 8.4.1 Editing the X mean R Settings
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
Only administrators can edit the X mean R settings.
Before analyzing the new lot of controls, you should set a QC file for each lot of controls and you can edit the QC settings in the QC file by one of the following ways: Manual entry
Manual entry 1.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””X mean R” on the pop-up menu.
Enter the “X mean R” graph screen. 8-96
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2.
Click the “Settings” tab to enter the X mean R setup screen.
For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
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3.
Select a QC File No. with empty QC information.
4.
You can select the file No. within the range [1, 60].
You can enter the lot No. of the controls by one of the following ways:
Manual entry Entering by external barcode scanner
The lot No. can not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but no Chinese characters allowed.
5.
Different QC files can not have the same lot No. and QC mode.
Enter the batch expiration date of the controls.
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6.
You must enter the expiration date, and the entry range is [current system date, 2099-12-31].
Select the QC mode.
Different QC files can not have the same lot No. and QC mode.
7.
Select the control level.
8.
Click the “Save” button to save all the settings of the QC.
Print Click the “Print” button to print the setting information of the current QC file.
8.4.2 Running controls After editing the QC information, you can start one of the following QC analyses according to the selected QC mode. Whole Blood Predilute
Running controls (whole blood)
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
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The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the unclosed collection tubes and cause
1.
biohazard. Exercise caution to the unclosed collection tubes. Collection tubes broken may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
Keep your clothes, hair and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
Be sure to use the Mindray-specified disposable products including vacuum collection tubes, anticoagulant collection tubes and capillary tubes etc.
If the sample mode is switched from the Predilute to Whole Blood , the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen.
You can enter the graph screen by one of the following ways:
Click the shortcut button “QC”.
Click the “Menu” button on the screen, and then select “QC”” X mean R” on the pop -up menu.
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Enter the “X mean R” graph screen.
2.
Click the “Run” tab to enter the X mean R run screen.
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For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
3.
Select the QC file No. to be run; the screen displays displays the corresponding file information.
4.
Be sure that the level of the control to be run is the same with the current QC file.
5.
Be sure that the control to be run is not expired.
6.
Prepare the control control as instructed by instructions instructions for use of the controls.
7.
Run the controls:
1) Make sure the QC mode is “whole blood” and the analysis status icon and analyzer indicator is green. 2) Shake the prepared control as shown below to well mix it.
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3) Click the “Start” button.
4) Present the control to the sample probe. 5) Press the aspirate key to start QC run. 6) When you hear the beep, remove the control. 7) After the analyzing is finished, the QC result of the first analysis will be displayed on the screen.
8) Mix the control well again, to run the control for the second time according to the prompt.
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You can click the “Cancel” “Cancel ” button in the message box to cancel the second run and the results obtained in the first run will not be saved as well.
9) When you hear the beep, remove the control. 8.
When finish running, the QC results (values of the two QC runs, X mean and range R) will be displayed in the current screen s creen and be saved in the QC file automatically.
9.
When the QC result of the second QC run is obtained, the screen will refresh the displayed histograms and scattergrams according to the second QC run.
Up to 300 QC results (X mean and range R) can be saved for each QC file.
Do the above procedures to continue running the controls if necessary necessary..
Running controls (Predilute)
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the unclosed collection tubes and cause biohazard. Exercise caution to the unclosed collection tubes.
Collection tubes broken may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
Keep your clothes, hair and hands away from the moving parts to avoid
injury. The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
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1.
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
Be sure to use the Mindray-specified disposable products including vacuum collection tubes, anticoagulant collection tubes and capillary tubes etc.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””X mean R” on the pop-up menu.
Enter the “X mean R” graph screen.
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2.
Click the “Run” tab to enter the X mean R run screen.
For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
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3.
Select the QC file No. to be run; the screen displays displays the corresponding file information.
4.
Be sure that the level of the control to be run is the same with the current QC file.
5.
Be sure that the control to be run is not expired.
6.
Prepare the control control as instructed by instructions instructions for use of the controls.
7.
Run the controls:
1) Make sure the QC mode is “ Predilute” and the analysis status icon and analyzer indicator is green.
2) Click the shortcut button “Diluent”, and then a message box will pop up.
3) After the preparation is done, the following message box will pop up.
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4) Present a clean centrifugal tube to the sample probe and make sure the probe reaches the bottom of the tube and the keep the tube vertical, as the figure shows, to avoid spills, hangings and bubbles.
5) Press the aspirate key to start dispensing the diluent.
6) The buzzer sounds when diluent is finished, then you can remove the centrifugal tube. 7) Add 20μL of control to the diluent, close the tube cap and shake the tube to mix the sample.
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8) Click the “Cancel” button to exit the “Diluent” messag e box.
9) After the cleaning is finished, close the prompt. 10) Click the “Start” button.
11) Present the prepared control to the sample probe. 12) Press the aspirate key to start QC run.
13) When you hear the beep, remove the control. 14) After the running is finished, the QC result of the first run will be displayed on the screen.
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15) Mix the control in the centrifugal tube well again, to run the control for the second time according to the prompt.
You can click the “Cancel” button in the message messag e boxto cancel the second run and the results obtained in the first run will not be saved as well.
16) When you hear the beep, remove the control. 8.
When finish running, the QC results (values of the two QC runs, X mean and range R) will be displayed in the current screen s creen and be saved in the QC file automatically.
You can also dispense 180μL of diluent by pipette into the tube.
Be sure to keep dust from the prepared diluent.
After mixing the control with the diluent, be sure to wait 3 minutes before
running. Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running it.
Be sure to evaluate predilute QC stability based on your laboratory’s sample population and sample collection techniques or methods.
Up to 300 QC results can be saved for each QC file.
When the QC result of the second QC run is obtained, the screen will refresh the displayed histograms and scattergrams according to the second QC run.
9.
Up to 300 QC results (X mean and range R) can be saved for each QC file.
Do the above procedures to continue running the controls if necessary necessary..
Browsing the QC result You can click the arrow button in the bottom of the screen to browse the QC result saved in th the e 8-110
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button or
button to switch to the previous or the next QC result.
You can click the
button or
button to switch to the earliest or the latest QC result
saved in the QC file.
The running result of the expired control will begin with an “O” mark. If 10 batches of QC results (20 times of QC runs) are obtained, the flags “H” or “L” will appear in front of the X and R that are out of the limits.
The enlarging function is available to the scattergrams and histograms of the screen. See details for operation in Chapter 7 Reviewing Sample Results.
Print Click the “Print” button to print the results of the current QC Run screen.
8.4.3 Reviewing QC Results After running controls, you can review the QC results in the following two ways: Graph Table
Graph Review
1.
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous.Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “QC”” X mean R” on the pop -up menu.
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Enter the “X mean R” graph screen.
2.
Select the QC file No. you want want to review, review, and then the screen will display the corresponding information and the graph.
3.
You can drag the scroll bar on the right of the graph to browse the desired graph of the parameter. You You can drag the scroll bar down to the graph gra ph horizontally to browse all the QC results.
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Introduction to the “Graph” screen
1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points located on the green line. 3- The operator who run the QC analysis and obtained the QC points located on the green line 4- The QC results of the parameters that correspond to the QC points located on the green line. 5- The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. The QC points are connected by a line to illustrate the distribution trend. 6- The QC point corresponds to each QC result. Only the selected QC point displays its value under the parameter. The black QC point indicates the value is within the limit; the red QC point indicates the value is out of the limit. 7- When you clicking a QC point in the graph, the QC points of other parameters that saved together with this one will be marked by a green line.
8- The relative position of the QC point located on the green line and the total QC points saved currently.
The graphs for parameters will be provided only after 10 batches of QC results (20 times of QC runs) are obtained.
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The outliers are excluded from the calculation of Mean, SD and CV%.
Browsing the QC result You can click the arrow button in the bottom of the screen to browse the QC result saved in th the e current QC file. You can click the
button or
QC point; you can click the
button to move the green line to the previous or the next button or
button to move the green line to the first or the
last QC point in the graph. When the location of the green line is selected, you can check the QC results of the QC points located on the green line under each parameter.
New Vial If the reviewed QC results are obtained by analyzing a new vial of control within the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old. 1.
Move the green line to the first QC point of the new vial.
2.
Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3.
After another new vial of control (within (within the same batch) is run and its QC results are saved, you can continue to mark the current QC points of the new vial according to step 1 and 2.
4.
If the current QC point is marked with with the blue line, the “New Vial” button will turn into
“Cancel”; you can click the button to remove the blue line, and then the “Cancel” button will turn back to “New Vial”.
Data Compare If you wish to compare the graphs of the certain parameter obtained by running controls of different lot No., do as follows: 1.
Click the “Data Compare” button to start selecting the desired graph.
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2.
Select the desired QC file No. into the “ File No.” box (3 files can be selected at most). Then, the graph of the selected QC file will be displayed below together with its lot No., QC mode and level.
3.
Select the desired parameter into the “ Parameter ” box.
Browse the graph here the same way as instructed in the “Graph” screen. Be aware that, for controls of different level, their graphs will be distinguished by the color of orange, black and blue.
4.
Click the “Print” button to print the current comparison if necessary.
5.
Click the “Close” button to exit.
Display Order You can take the following f ollowing steps to adjust the display order of different graphs.
1.
Click the “Display Order ” button to check the current display order of the graphs.
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2.
Click the parameter that you want to adjust.
3.
You can click the can click the
button or button or
button to move parameter upward or downward; you button to move the parameter to the first or the last
position. 4.
Click the “Ok” button to refresh the display order of the graphs.
Entering the reasons for the outliers You can take the following f ollowing steps to enter the reasons ffor or the outliers: 1.
After moving the green line to the desired QC point, you can click the “ Outliers” button to display the QC results, total mean and average range of all the parameters located on the green line (the QC results exceed the limit will be displayed in red) and enter the reasons for the outliers.
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2.
You can select the reason form the given ones or enter the reasons (up to 200 characters) into the edit box manually after selecting “ Others”.
3.
Click the “Ok” button to save the reasons for the outliers and exit.
If you enter the reason for the group of QC points whose results are actually within the limits, then their corresponding QC data both in the QC Graph and QC Table will be displayed in the color of red. And the data will return in the color of black if you cancel the reason and then save the changes.
Delete The administrator can delete the QC results by the following steps: 1.
If you wish to delete a single QC result, move the green line line to the desired QC result; if you wish to delete all the data, perform step 2 directly.
2.
Click the “Delete” button to select “Current Data” or “ All Data”.
3.
Click the data you want to delete. 8-117
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Click the “Ok” button and then confirm to delete the selected data.
The operation of deletion will be recorded in the log.
Print
Click the “Print” button to print all the file information and graphs of the parameters of the current QC file.
The green line and the corresponding values of the QC points will not be printed.
Table Review
1.
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
You can enter the Table screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “QC”” X mean R” on the pop -up menu.
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Enter the “X mean R” graph screen.
2.
Click the “Table” tab to enter the X mean R table screen.
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Select the QC file No. you want want to review, review, and then the screen will display the corresponding information and the table.
4.
You can drag the scroll bar on the right of the table vertically to browse the desired table of the parameter. You You can drag the th e scroll bar down to the table horizontally to browse all the QC results.
Introduction to the “Table” screen
1- The No. of the QC result saved in the QC file (arranged from left to right in the order that from the earliest to the latest) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: If 10 batches of QC results (20 times of QC runs) are obtained, t he flag “H” or “L”
will be used to prompt the result (X mean) that out of the limits 5- The relative position of the t he highlighted QC point and the total QC points saved currently.
The total mean, average range and flag for the parameters will be provided only after 10 batches of QC results (20 times of QC runs) are obtained.
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Browsing the QC result You can click the arrow button in the bottom of the screen to browse the QC result saved in th the e current QC file. You can click the
button or
you can click the
button or
button to highlight the previous or the next QC result; button to highlight the first or the last QC result in the
table.
Delete The administrator can delete the QC results by the following steps: 1.
If you wish to delete a single QC result, click the column contains the desired QC result; if you wish to delete all the data, perform step 2 directly.
2.
Click the “Delete” button to select “Current Data” or “ All Data”.
3.
Click the data you want to delete.
4.
Click the “Ok” button and then confirm to delete the selected data.
The operation of deletion will be recorded in the log.
Print You can take tak e the following steps to print the Table: 1.
Click the “Print” button, and then you can select “ All Data” or “Specified Data” to be printed. 8-121
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2.
Click the “All Data” button and then click the “ Ok” button to print all the file information and tables of the parameters of the current QC file; after clicking the “ Specified Data” button, you can select the starting and finishing date (the saved date of the QC results) res ults) for
printing, then click the “Ok” button to print the specified data.
Communication If you wish to transmit the QC data to the external data management software or LIS/HIS, do as follows: 1.
Click the “Communication ” button, and then you can select “ All Data” or “Specified Data” to be transmitted.
2.
Click the “All Data” button and then click the “Start” button to transmit the information of the current QC file and QC data . After clicking the “Specified Data” button, you can
specify a date range (the date when the QC result was saved), then click the Ok button
to transmit the specified data. The “LIS/HIS connected” icon on the status bar of the screen will flicker during transmission. 3.
While transmitting, the “Start” button in the pop-up message box will be replaced by “Stop”. You can click the “Stop”button to stop transmitting.
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If auto-communication is enabled and a sample is ran during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result starts.
The QC data saved in the process of transmission will not be transmitted.
Data Backup
If you wish to backup the information and the result of the current QC file, do as follows: 1.
Click the “Data Backup” button, a message box will pop up.
2.
Select the backup directory (the default directory is the folder of “ QC Data” under the installation location of the terminal software).
3.
Enter the name for the backup data (the default name is [X-R_QC_date saved_time saved]).
4.
Click the “Save” button to start backing up.
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When the backup is finished, a message box will pop up, and then click “ Ok” to exit.
The backup data can not be modified. You can review the data in “History” screen.
You can click the “Cancel” button to cancel backup when it is in process. Be sure to backup data regularly.
Data Export If you wish to export the information inform ation and the result of the curr current ent QC file, do as follows: 1.
Click the “Data Export” button, and then a message box will pop up.
2.
Select the export directory (the default directory is the folder of “QC Data” under the installation location of the terminal software).
3.
Enter the name for the export data (the default name is [X-R_QC_date saved_time 8-124
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Select the format for the export file.(default format: “. CSV”)
5.
Click the “Save” button to start exporting.
6.
When the export is finished, a message box will pop up, and then click “ Ok” to exit.
You can modify the exported data but can not review the data in the “History” screen.
You can click the “Cancel” button to cancel export when it is in process.
History
If you wish to review the backed up data, do as follows: 1.
Click the “History” button, and then a message box will pop up.
2.
Locate and then select the desired backup data.
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Click the “Open” button to display the data in “History” screen.
4.
The display format and the function button are the same as the QC table screen. Browse, print, transmit and export the data as instructed in the section of QC Table Review. Review.
5.
After reviewing, click the “Close” button to exit.
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8.5 X-B QC Program 8.5.1 X-B X- B QC Principles The X-B analysis is a weighted moving average analysis that uses values obtained from patient samples. It uses the 3 red cell indices, MCV, MCH and MCHC to indicate the hematology instrument performance. Effective use of Xsamples and a normal cross section of patients to prevent skewing of indices.
It is recommended the X-B analysis be activated when the sample volume of your laboratory is greater then 100 samples per day. The analyzer can save maximum 500 X-B QC results. When the saved QC results have ha ve reached the maximum number, the newest result will overwrite the oldest.
8.5.2 Editing X-B Settings
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
Only administrators can edit the X-B settings.
At the X-B QC setting screen, you can edit the QC information and configure the sample validity setup.
Editing the QC information Before the X-B analysis, you should finish editing the QC information by one of the following ways:
Manual entry
Reading the saved preset values.
Manual entry 1.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””X-B” on the pop-up menu. 8-127
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Enter the “X-B” graph screen.
2.
Click the “Settings” tab to enter the X-B setup screen.
For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
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3.
In the “Samples/Batch” edit box, you can enter the amount of samples [within the range 20(recommended) to 200] to be included in calculating for an X-B QC point.
4.
Click the “Open” button of “X-B” to open the X-B QC, and from the time on, all the valid samples results will be included to calculate the X-B.
5.
Enter the target and Limits for the QC parameters.
All the targets and limits for the QC parameters shall be entered without empty.
When first use, the default setting will provide the Initial values for the targets and limits of the three QC parameters.
If the QC data have existed in the QC file, you are not allowed to edit the target and limits.
6.
Click the “Save” button to save all the settings of the QC.
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Reading the saved preset values
1.
If there are the saved preset values (Target and Limits) for the X-B QC, you can read-in the preset values into the X-B QC file. For details of calculating and saving the preset values, see Section 8.5.3 Reviewing QC results.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen then select “QC””X-B” on the pop-up menu.
Enter the “X-B” graph screen.
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2.
Click the “Settings” tab to enter the X-B setup screen.
For details of editing the name of the login user, see chapter 5 Customizing the Analyzer Software.
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3.
In the “Samples/Batch” edit box, you can enter the amount of samples [within the range 20(recommended) to 200] to be included in calculating for an X-B QC point.
4.
Click the “Open” button of “ X-B” to open the X -B QC, and from the time on, all the samples results will be included to calculate the X-B.
5.
Click the “Have Preset Values” button to read-in the saved preset target and limits into the X-B QC file.
All the targets and limits for the QC parameters shall be entered without empty.
If some QC parameters have no preset values, you should enter the target and limits for them manually.
If the QC data have existed in the QC file, you are not allowed to have the
preset values.
6.
Click the “Save” button to save all the settings of the QC.
Setting Limits You can take the following f ollowing steps to adjust the display form format at of the limits and the calculation method of the preset limits. 8-132
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Click the “Set Limits” button, and then the following message box will pop up.
2.
Click “By SD” to display the limits in the form of absolute value; click “ By CV” to display the limits in the form of percentage.
3.
If “ By SD” is selected, click the “ 2SD” or “3SD” to select either double or triple standard deviation to be the limits; if “ By CV” is selected, click the “ 2CV” or “3CV” to select either double or triple coefficient of variation to be the limits.
4.
Click the “Ok” button to save all the settings for the limits.
Restoring defaults When editing the QC settings, if you wish to restore the target and limits to the defaults, you
can click the “Restore Default” button to read-in the defaults to the X-B QC file. The default target for each parameter: MCV: 89.5fL MCH: 30.5pg MCHC: 340g/L
The default limits for each parameter: MCV: 2.7 fL MCH: 0.9 pg
MCHC: 10 g/L
If the QC data have existed in the QC file, you are not allowed to restore defaults.
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Setting Sample Validity In X-B QC, sample results conforming to any of the following conditions will be considered as invalid and can not be used in the QC calculation. 1.
Sample results exceeding the linearity range;
2.
Background results;
3.
Sample results not conforming to the "Sample Validity Setup"; Setup";
4.
QC data for other QC programs (L-J QC, X mean QC or X mean R QC);
5.
Calibration data;
6.
Results generated while there are errors which could affect affect the accuracy of the results (insufficient aspiration volume or clogging for example).
"Sample Validity Setup" Setup" is to set up the ranges of valid RBC, MCV, MCH and MCHC results. Only when the results of all these four parameters are within the specified ranges, the sample results can be used for X-B QC calculation. Do as follows to set the sample validity: 1.
Enter the graph screen using one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen; then select “QC””X-B” on the pop-up menu.
Enter the “X-B” graph screen.
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2.
Click the “Settings” tab to enter the X -B setup screen.
For details to edit the name of the login user, see chapter 5 Customizing the Analyzer Software.
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3.
Set the upper and lower limits of the four parameters in the " Sample Validity Setup" Setup" area.
4.
Click "Save Save"" to save the sample validity settings.
5.
If any value you entered is out of range or any upper limit entered is less than the corresponding lower limit, the following message box will pop up when you click the "Save Save"" button.
6.
Click "Ok Ok"" to go to the QC setting screen and modify the invalid values.
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The default validity ranges for the four parameters are: 12
12
1.0×10 /L≤RBC≤8.0×10 /L
50fL≤MCV≤150fL 20pg≤MCH≤40pg 240g/L≤MCHC≤440g/L
The validity entry range for RBC is its linearity range, and the validity entry ranges for other three parameters are those of their display ranges.
All the entries should be numbers with only one decimal point, and the entries should be restricted to the length of the edit boxes.
Once the validity range is changed, the previous results will not be used in the QC calculation as valid results, for example, if 20 valid samples are needed for the X-B QC calculation, when you change the validity range after 10 groups of valid sample results have been acquired, these 10 groups of results will be discarded, and only valid sample results generated afterwards will be used in the QC calculation.
Print Click the “Print” button to print the setting information of the current QC file.
8.5.3 Running controls
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g.them gloves, etc.) and follow safe laboratory procedures when handling andlab thecoat, contacted areas in the laboratory.
After editing the X-B settings, the system will start the X-B run automatically au tomatically.. After every 20-200 results (determined by the setting) are obtained, the system wil willl perform the X-B calculation once automatically. You You can review the result in X-B graph or X-B table.
8.5.4 Reviewing QC Results After the X-B analysis, you can review the QC results in the following two ways:
Graph
Table
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Graph Review
1.
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
You can enter the graph screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””X-B” on the pop-up menu.
Enter the “X-B” graph screen.
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2.
You can drag the scroll bar down to the graph horizontally to browse all the QC results.
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Introduction to the “Graph” screen
1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points located on the green line 3- The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. The QC points are connected by a line to illustrate the distribution trend. 4- The QC results of the parameters that correspond to the QC points located on the green line. 5- When you clicking a QC point in the graph, the QC points of other parameters that saved together with this one will be marked by a green line. 6- The QC point corresponds to each QC result. Only the selected QC point displays its value under the parameter. The black QC point indicates the value is within the limit; the red QC point indicates the value is out of the limit.
7- The relative position of the QC point located on the green line and the total QC points saved currently.
The value of the outlier is the X-B result of each batch of samples.
The outliers are excluded from the calculation of Mean, SD and CV%.
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Using the QC Programs Browsing the QC result You can click the arrow button in the bottom of the screen to browse the QC result saved in the current QC file. You can click the
button or
QC point; you can click the
button to move the green line to the previous or the next button or
button to move the green line to the first or the
last QC point in the graph. When the location of the green line is selected, you can check the QC results of the QC points located on the green line under each parameter.
Saving Preset Values If there are 3 or more than 3 QC results within the limits obtained for the parameters, you can take the following steps to calculate and save the preset value for each parameter: 1.
Click the “Calculate Preset Values” button, and then the screen displays two lines for you to select the range for calculating the preset values.
2.
Click and drag the two lines respectively respectively to locate them at the beginning and the ending of the range for calculating the preset values.
3.
The Mean, SD and CV% (on the right of the graph) will change into the new results that obtained by calculating within the selected range.
4.
If you wish to save the new results, you can click the “ Save Preset Values” button to save the current Mean, SD and CV% as the preset values for the corresponding level (high/normal/low). Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results.
The calculation and display of the preset values are only available to the parameter (within the calculation range) which has 3 or more than 3 results within the limit. Otherwise, the display of the preset values will be empty.
Delete The administrator can delete the QC results by the following steps:
1.
If you wish to delete a single QC result, move the green line line to the desired QC result; if you wish to delete all the data, perform step 2 dir directly ectly..
2.
Click the “Delete” button to select “Current Data” or “ All Data”.
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3.
Click the data you want to delete.
4.
Click the “Ok” button and then confirm to delete the selected data.
The operation of deletion will be recorded in the log.
Print
Click the “Print” button to print all the file information and graphs of the parameters of the current QC file.
The green line and the corresponding values of the QC points will not be printed.
Table Review
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
1.
You can enter the Table screen by one of the following ways:
Click the shortcut button “ QC”. Click the “Menu” button on the screen, and then select “ QC””X-B” on the pop-up menu.
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Enter the “X-B” graph screen.
2.
Click the Table tab to enter the X-B table screen.
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3.
You can drag the scroll bar down to the table horizontally to browse all the QC results.
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Introduction to the “Table” screen
1- QC Result 2- The No. of the QC result saved in the QC file (arranged from left to right in the order that from the earliest to the latest) 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag “H” or “L” will be used to prompt the result that out of the limits 5- The relative position of the highlighted h ighlighted QC point and the total QC points saved currently.
The value of the QC result is the X-B result of each batch of samples.
Browsing the QC result
You can click the arrow button in the bottom of the screen to browse the QC result saved in th the e current QC file. You can click the
button or
you can click the
button or
button to highlight the previous or the next QC result; button to highlight the first or the last QC result in the
table.
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Using the QC Programs Delete The administrator can delete the QC results by the following steps: 1.
If you wish to delete a single QC result, click the column contains the desired QC result; if you wish to delete all the data, perform step 2 dir directly ectly..
2.
Click the “Delete” button to select “Current Data” or “ All Data”.
3.
Click the data you want to delete.
4.
Click the “Ok” button and then confirm to delete the selected data.
The operation of deletion will be recorded in the log.
Print You can take tak e the following steps to print the Table: 1. Click the “Print” button, and then you can select “ All Data” or “Specified Data” to be printed.
2.
Click the “All Data” button and then click the “ Ok” button to print all the file information and tables of the parameters of the current QC file; after clicking the “ Specified Data” 8-146
Using the QC Programs button, you can select the starting and finishing date (the saved date of the QC results) res ults) for
printing, then click the “Ok” button to print the specified data.
Communication If you wish to transmit the QC data to the external data management software or LIS/HIS, do as follows: 1.
Click the “Communication ” button, and then you can select “ All Data” or “Specified Data” to be transm itted.
2.
Click the “All Data” button and then click the “Start” button to transmit the information of the current QC file and QC data . After clicking the “Specified Data” button, you can specify a date range (the date when the QC result was saved), then cl ick the “Ok” button
to transmit the specified data. The “LIS/HIS connected” icon on the status bar of the screen will flicker during transmission. 3.
While transmitting, the “Start” button in the pop-up message box will be replaced by
“Stop”. You can click the “Stop”button to stop transmitting.
If auto-communication is enabled and a sample is ran during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result starts.
The QC data saved in the process of transmission will not be transmitted.
Data Backup
If you wish to backup the information and the result of the current QC file, do as follows: 1.
Click the “Data Backup” button, a message box will pop up.
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2.
Select the backup directory (the default directory is the folder of “QC Data” under the installation location of the terminal software).
3.
Enter the name for the backup data (the default name is [X-B_QC_date saved_time saved]).
4.
Click the “Save” button to start backing up.
5.
When the backup is finished, a message box will pop up, and then click “ Ok” to exit.
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The backup data can not be modified. You can review the data in “History” screen.
You can click the “Cancel” button to cancel backup when it is in process. Be sure to backup data regularly.
Data Export If you wish to export the information inform ation and the result of the curr current ent QC file, do as follows: 1.
Click the “Data Export” button, and then a message box will pop up.
2.
Select the export directory (the default directory is the folder of “QC Data” under the installation location of the terminal software).
3.
Enter the name for the export data (the default name is is [X-B_QC_date saved_time saved]).
4.
Select the format for the ex port file. (Default format: “. CSV”)
5.
Click the “Save” button to start exporting.
6.
When the export is finished, a message box will pop up, and then click “ Ok” to exit. 8-149
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You can modify the exported data but can not review the data in the
“History” screen. You can click the “Cancel” button to cancel export when it is in process.
History
If you wish to review the backed up data, do as follows: 1.
Click the “History” button, and then a message box will pop up.
2.
Locate and then select the desired backup data.
3.
Click the “Open” button to display the data in “History” screen.
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4.
The display format and the function button are the same as the QC table screen. Browse, print, transmit and export the data as instructed in the section of QC Table Review. Review.
5.
After reviewing, click the “Close” button to exit.
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9
Using the Calibration Programs
9.1 Introduction Calibration is a procedure to standardize the analyzer by determining its deviation, if any, from calibration references and to apply any necessary correction factors. There are three calibration programs available on this analyzer: manual calibration, auto calibration using calibrator and auto calibration using fresh blood samples. All the parameters or part of the parameters of WBC, RBC, HGB, MCV and PLT can be calibrated by the calibration procedure.
Calibration procedures administrator-level.
can
only
be
performed
by
users
of
the
You should only use the Mindray-specified calibrators and reagents. Store and use the calibrators and reagents as instructed by instructions for use of the calibrators and reagents.
The analyzer identifies a sample as a calibration sample only if the analysis is started from the “Calibration” screen.
The calculation of reproducibility is included in the calibration procedure.
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Using the Calibration Programs
9.2 When to Calibrate This analyzer is calibrated at the factory just before shipment. It is electronically stable and does not require frequent recalibration if you operate and maintain it as instructed by this manual. You only need to recalibrate this analyzer if:
it iis s the first time this analyzer analyzer has been used (usually done by a Mindray-authorized representative when installing the analyzer).
an analytical component has been changed.
you are going to re-use the analyzer after a long-term storage.
the quality control results indicate there may be a problem.
All of the measured parameters must be calibrated before readings of this analyzer can be used as valid analysis results.
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Using the Calibration Programs
9.3 How to Calibrate 9.3.1 Preparing your analyzer Do the following pre-calibration procedures before calibration. If problems are detected during these checks, do not attempt to calibrate the analyzer. If necessary, necessary, call Mindray M indray customer service department or your local distributor for assistance. 1.
Check and and make sure enough reagents have been prepared for the calibration. You You need to start over the calibration if the reagents run out during the process.
2.
Do the background check. If the analyzer alarms for abnormal background results, see Chapter 12 Troubleshooting Your Analyzer for for solutions.
Run a vial of normal control in the WB-CBC+DIFF mode for 11 consecutive times. Enter the
“Table” screen to check the reproducibility of the second to eleventh runs and make sure they meet the following requirements.
Parameter
Condition
Whole Blood
Predilute
Reproducibility
Reproducibility
(CV%)
(CV%)
WBC
(4.0-15.0)× (4.0-15 .0)×10 10 /L
≤ 2.0%
≤ 4.0%
RBC RB C
(3.5 (3.500-6.0 6.00) 0)×1 ×10 0 /L
≤ 1.5%
≤3.0%
HGB
(110-180)g/L
≤ 1.5%
≤3.0%
MCV
(70-120)fL
≤ 1.0%
≤2.0%
PL PLT T
(150-5 (150-500)×10 00)×10 /L
≤ 4.0%
≤8.0%
3.
Run a vial of high control control three consecutive times and then immediately run the diluent three consecutive times. Calculate the carryover per the following equation.
Carryover (%)
First low - level sample result－Third low - level sample result
Third high - level sample result－Third low - level sample result
The calculated carryovers shall meet the requirements in the following table.
100％
4.
Parameter
Carryover
WBC
≤0.5％
RBC
≤0.5％
HGB
≤0.6％
HCT
≤0.5％
PLT
≤1.0％
It is recommended that you you create a log table for your analyzer. analyzer. This log table should
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Using the Calibration Programs contain all necessary information that is pertinent to your analyzer. Suggested items that you may want to include in the log table are: calibration date, supplier of calibrator, lot number, expected results and limits, and result of background check.
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
Keep your clothes, hair and hands away from the moving parts to avoid injury.
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
You should only use the Mindray-specified controls and reagents. Store and use the controls and reagents as instructed by instructions for use of the controls and reagents.
Be sure to use the Mindray-specified disposable products including vacuum collection tubes, anticoagulant collection tubes and capillary tubes etc.
9.3.2 Manual calibration Do as follows to calibrate the analyzer: 1.
Click “Menu”; select “Calibration” to enter “Calibration Factors” screen. The calibration factors of whole blood mode and predilute mode are displayed at the “ Calibration Factors” screen.
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Using the Calibration Programs
2.
The login users of common-level can not perform the calibration procedures but only browse the calibration factors at the current screen. To perform the calibration, please logout and then re-login as users of administrator-level.
Enter the “Calibration Factors” screen to check the calibration factors and calculate the new factors per the following equation.
New calibratio n factor ＝
Current calibratio n factor Reference value Mean
For example: Supposed the WBC reference value of a calibrator is 8.4, and the current calibration factor of the whole blood mode is 98.9％ Run the calibrator in the whole blood mode m ode for 11 consecutive times and take the WBC results nd
th
of the 2 to 11 runs (n 10) to calculate: 8.1, 8.0, 8.1, 8.1, 8.3, 8.3, 8.2, 8.0, 8.1, 8.3. The obtained CV is 1.5% and Mean is 8.16, which meet the requirements. The new calibration factor is obtained:
New calibratio n factor ＝
98.90 % 8.4 8.16
＝101.81%
The calculated calibration factors shall be between 75％ - 125％.In case of an invalid calibration factor, try to find out the reason (e.g. calibration material not thoroughly thoroughl y mixed, misoperation, etc.).Then recalibrate the analyzer and recalculate the calibration factors.
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3.
The entered calibration factors shall be between 75.0 ％ - 125.0％ (calculate to two decimal places).
Enter the new calibration factors into the factor cell of the parameter that requires calibration.
4.
After the entry, entry, click the “ Save” button at the bottom of the screen. If the new calibration factors are valid and different from the originals, a message box shown below will pop u up. p.
Click “ Yes Yes” to save the news calibration factors and the calibration date of the corresponding parameter changes to the current system date. Then, close the message box and return to the
“Calibration Factors” screen without any cell being highlighted. If the new calibration factors are invalid, the message box will pop up.
Click “OK” to close the message box and the cell of the first invalid calibration factors is highlighted with the data displayed. 5.
After the calibration factors are modified, a prompt will show if you switch to another
screen without clicking the “ Save” button.
If the entered calibration factors are valid, the message box will pop up when you exiting the screen.
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Using the Calibration Programs
Click “ Yes Yes” to save the news calibration factors and the calibration date of the corresponding parameter changes to the current system date and be recorded in the history; then, close the message box and switch to another screen. If the entered calibration factors are invalid, the message box will pop up when you switching to another the screen.
Click “ Yes Yes” to close the message box and switch to another screen without saving; keep the original calibration factors and date.
Other operations Restore
Click the “Restore” button to restore the calibration factors to the values displayed when you entering the “Calibration Factors” screen.
Print If the calibration factors have not been changed, click the” Print” button to print the current calibration factors. If the changed calibration factors are invalid, then a message box will pop up when you clicking
the “Print” button.
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Using the Calibration Programs
Click “OK”, then the cell of the first invalid calibration factors will be highlighted and the data in the cell will not be cleared. If the changed calibration factors are valid but have not been saved, then a message box will pop up when you clicking the “Print” button.
Click “ Yes Yes” to close the message box and save the new calibration factors and date, and then print the new calibration factors; click “No” to close the message box without saving the calibration factors and date, and then print the saved calibration factors before editing.
9.3.3 Auto calibration using calibrators Do as follows to calibrate the analyzer anal yzer with calibrators. 1.
Click the “Menu” button, and then select “ Calibration” to enter the “Calibration Factors” screen.
2.
At the “Calibration Factors” screen, click the “Calibrator ” tab to enter the “ Calibrator ” screen.
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Using the Calibration Programs
Only in the whole blood mode can the calibration using calibrators be performed.
The default “Exp. Date” is the curr ent ent system date.
3.
Enter the lot No. of the calibrator into the “Lot No.” box.
4.
Enter the expiration date. The default “Exp. Date” is the current system date. You can click the “Exp. Date” box, and then edit the date.
5.
Select the parameter to be calibrated calibrated from the check box on the first line of the list.
6.
Enter the target into the “Target” cells.
All the samples, controls, calibrators, reagents, wastes and areas contacted with them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
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Using the Calibration Programs
Only Mindray-specified calibrators shall be used. Mindray will not be responsible for any error result caused by using other calibrators. See the target. instructions for use of the calibrators for the lot No., expiration date and the
The lot No. must be entered.
The expiration date can not be earlier than the current system date.
The entered expiration date should be either the expiration date printed on the labeling or the open-container expiration date, whichever is earlier. The open-container expiration date is calculated as follows: the date that container is opened + the open-container stability days.
7.
Prepare the the calibrator calibrator as instructed by instructions for use of the the calibrators.
8.
Click the “Start” button, and then a message box will pop up.
Press the aspirate key to start the calibration and the message box will close automatically, and then a progress bar will pop up.
Once you click the “Start” button and press the aspirate key to start the first run, the “Start” button will be displayed d isplayed in gray. Then, you can directly pres s the aspirate key to continue the calibration.
9.
After every calibration run, the progress bar will will cl close ose automatically and the analyzer wi willll have different responses according to different analysis results.
9-10
Using the Calibration Programs When the current running is done, if there is a parameter whose calibration data is out of its linear range but still within the display range, then the calibration data will be displayed in the list and a message box will also pop up.
Click “OK” to close the message box and delete the data from the table without saving. When the running is done, if there is a parameter whose calibration data is out of the display rage, then the non-numeric parameter values “***” will be displayed in the list and a message box will pop up.
Click “OK” to close the message box and delete the data from the table without saving. The valid results within the linear range will be displayed directly.
When the valid result is obtained, it will be selected to be included in the calculation for the calibration factors.
10. If the calibration factors have not been calculated but y you ou switch to another screen, then a message box will pop up.
Click “ Yes Yes” to switch to another screen while aborting the calibration data and closing the message box. The original calibration factors remain.
9-11
Using the Calibration Programs 11. When the amount of the valid calibrtion reaches N (N ≥6), the analyzer will automatically calculate the mean, CV% and new calibration factors with all the selected data ( the first data is excluded). You can also select the desired data(5 at least) to calculate the calibration factors. Ever Every y time when you select or de-select a data by clicking the check box, the calibration factors will be refreshed immediately.
The out-of-range CV% does not influence the display of the calibration factors.
When the amount of the valid calibration data in the list reaches 11, a
message box of “Calibrator calibration done!” will pop up. Then, if you press the aspirate key again, the analyzer will beep and does not response.
12. There may be two cases when you you switching to another screen: If the calculated calibration factor of any parameter is out of the range [75%-125%] or the CV% of any parameter exceeds the reproducibility standard, then the calculated calibration factors of all parameters will not be saved and a message box will also pop up.
Click “ Yes Yes” to close the message box and switch to another screen without changing the original calibration factors and the calibration date. If the calculated calibration factors of all parameter are within the range [75%-125%] and the CV% of all parameter are also within the reproducibility standard, then a m message essage box will pop
up.
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Using the Calibration Programs
Click “ Yes Yes” to save the new calibration factors while closing the message box and switching to another screen.
Other operations Print If the calibration factors are invalid, then a message box will pop up when you clicking the
“Print” button.
Click “OK”, then the cell of the first invalid calibration factor will be highlighted and the data in the cell will not be cleared.
If the calibration factors are valid, then a message box will pop up when you clicking click ing the “Print” button.
Yes” to close the message box and save the calibration results and the calibration date, Click “ Yes and then print the contents of the current calibration screen ; click “No” to close the message box without saving.
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Using the Calibration Programs
9.3.4 Auto calibration using fresh blood samples Do as follows to calibrate the analyzer anal yzer with fresh blood samples. 1.
Click “Menu”, select “Calibration” to enter “Calibration Factors” screen.
2.
At the “Calibration Factors” screen, click the “ Fresh Blood” tab to enter the “Fresh Blood” screen.
3.
Prepare 3 to 5 normal fresh blood samples as instructed in Chapter 6 Operating Your Analyzer .
4.
Run each of the prepared samples on the reference instrument (or by the reference method) three times at least. Average the results for your reference values
5.
Click the radio button “Whole Blood” or “Predilute” on the screen to select the desired calibration mode.
If you run the sample in the “Predilute” mode and then switch to the “Whole Blood” mode, the analyzer will switch the sequence automatically and a progress bar will appear on the screen.
6.
Select the sample ID of the current sample from the “ Current sample ID” pull-down list.
7.
Select the parameter to be calibrated from the check box on the first line of the list. 9-14
Using the Calibration Programs 8.
Enter the target into the “Target” cells.
9.
Prepare the whole blood or predilute fresh blood blood sample ready for calibration.
10. Click the “Start” button; a message box will pop up.
Press the aspirate key to start the calibration and the message box will close automatically, then a progress bar will pop up.
After you“Start” click the “Start” pressThen, the aspirate to start the first run, the button willbutton displayand in gray. you cankey press the aspirate key to continue the calibration.
11. After the analysis, the calibration process indication will close automatically and the analyzer will have different responses to different analysis results. If the results are out of the linear range but still within the display range, the message box
will pop up at the same time the results are displayed in the table.
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Using the Calibration Programs
Click “OK” to close the message box and delete the results from the table without saving. If the results are out of the display rage, the non-numeric parameter values “ ***” are obtained and the message box will pop up.
Click “OK” to close the message box and delete the results from the table without saving. The valid results within the linear range ran ge will be displayed directly.
When the valid result is obtained, it is selected to be included in the calculation for the calibration factors.
12. When the amount of the valid calibration reaches N (N ≥6), the analyzer will calculate the
Mean, CV% and Calibration Factors of the data selected with “√ “ √” automatically (the first data is excluded). You can select several data to calculate the calibration factors, but only after 5 groups of the data are selected at least can you get the calibration factors. Every time when you select or cancel a data by selecting its check box, the calibration factors will be refreshed and displayed immediately. immediately.
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Using the Calibration Programs
The out-of-range CV% does not influence the display of the calibration factors. When of the calibration valid calibration theup; table reaches 11,the a promptthe of amount “Fresh blood done!”data will inpop if you press aspirate key again, the analyzer will beep and does not response.
13. Select other calibration samples from the “Current sample ID” pull-down list, run the samples as instructed in steps 8 to 12 to obtain the calibration factors of each sample.
If some parameters have been selected to be calibrated, the column of the parameters will still display in gray when you switch to another blood sample.
14. There may be several cases when switching to another blood sample: If the calibration factors of the blood sample are invalid or the CV% of any parameter exceeds the reproducibility standard, a message box will pop up when you switching to another blood sample.
Click “Yes” to empty the entered target of the current sample, all t he calibration data obtained and each calculated value including calibration factors, then close the message
box and switch to another blood sample. If the calibration factors have not been calculated, the message box will pop up.
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Using the Calibration Programs
Click “Yes” to empty the entered target of the current sample and all the calibration data obtained, then close the message box and switch to another blood sample. If the calibration factors of the sample are valid and the CV% of all the parameters do not exceed the reproducibility standard, you can switch to another blood sam sample ple directly. directly. 15. After calibration factors of at least 3 fresh blood samples are obtained, click the
“Calculate” button to enter the screen of calibration calculation.
Select or cancel the calibration factors of a blood sample to calculate for the Mean calibration factors by selecting the relevant check box. When the selected calibration factors reaches 3 or more than 3, the CV% will be calculated
over again according to the selected calibration factors.
The exceeded CV% does not influence the display of the calibration factors.
When the selected calibration factors reaches 3 or more than 3, the mean calibration factors will be calculated over again according to the selected calibration factors. If the deviation of the 9-18
Using the Calibration Programs calibration factor involved in the mean calibration factor calculation from the previous calibration factor equals to or is greater than 5%, this calibration factor will be considered as invalid, and the following message box will pop up when you try to exit the fresh blood calibration screen.
Click " Yes" Yes" to close the message box, clear current calibration data, and switch to the corresponding screen. Click "No "No"" to go back to the current screen. The invalid calibration factor(s) will be marked with "?" and highlighted in red.
When the calculated mean calibration factor is invalid, you can perform manual calibration at the calibration factor screen.
16. If the mean calibration factors have not been calculated, when you switch to the fresh blood screen or switch to another calibration mode, a message box will pop up.
Click “ Yes Yes” to abort the calibration data and close the message box, switching to the corresponding screen or other calibration mode. The original calibration factors and date remain the same. 17. If the calculated mean calibration factors are valid, when you sw switch itch to the fresh blood screen or switch to another calibration mode, a message box will pop up. 9-19
Using the Calibration Programs
Click “ Yes Yes” to save the current mean calibration factors and refresh the calibration factors and date in the table at the “Calibration Factors” screen. Then, you can switch to another screen or calibration mode. Click “No” to close the message box and switch to another screen or calibration mode without saving the mean calibration factors and all the calibration data.
Other operations Print If the mean calibration factors are invalid, then a message box will pop up when you clicking the “Print” button.
Click “OK”, then the cell of the first invalid calibration factor will be highlighted and the data in the cell will not be cleared. If the mean calibration factors are valid, click the “Print” button to print the following data in the
form of list, namely, the calibration factors of the sample in the “Calculated Result” table, the results included in calculating the calibration factors and the mean calibration factors.
9.3.5 Verify Verifying ing calibration factors It is recommended that you take the following steps to verify the calibration factors: 1. Run the calibrator at least three times and check whether the means of the obtained results
are within the expected ranges. 2. Run the low, normal and high level controls each for three times at least, and check whether the means of the obtained results are within the expected ranges. 3. Run at least three fresh blood samples with known reference values, each for six times at least, and check whether the means of the obtained results are within the expected ranges.
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Using the Calibration Programs
9.3.6 Calibration History Click the “History” tab to enter the calibration history screen.
Calibration history list The history list displays the calibration information for the latest 80 calibrations; you can view the contents in the list, but you are not allowed to modify or delete any content. Detailed calibration data 1. If the calibration mode of the selected record is “Adjust Manually”, the new calibration factor and the original calibration factor are displayed in grey edit box.
If the calibration factors of some parameters are not modified, the corresponding edit boxes are empty.
2. If the calibration mode of the selected record is “Calibrator ”, the new calibration factor, the original calibration factor and all medium data are displayed in grey edit box.
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Using the Calibration Programs
The calibration data marked with “√” are used for calculation of calibration factors.
3. If the calibration mode of the selected record is “Fresh Blood”, the calibration factor, mean calibration factor and original calibration factor of each sample are displayed in grey edit box.
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Using the Calibration Programs
The calibration factors marked with “√” are used for calculation of mean calibration factor.
If the calibration factor of a sample is displayed, you can click the “Detail…” button to display all medium data.
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Using the Calibration Programs
Click “Close” to close the dialog box and return to the “History” screen.
The calibration data marked with “√” are used for calculation of sample calibration factors.
Print Click the “Print” button down to the screen to print all calibration history records in table format.
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10 Maintaining Your Analyzer 10.1 Introduction Preventive and corrective maintenance procedures are required to keep the analyzer in a good operating condition. This analyzer provides multiple maintenance functions for this purpose. This chapter introduces how to use the provided functions to maintain and troubleshoot your analyzer.
All the protective analyzer components surfaces are potentially infectious, take proper measures forand operation or maintenance.
Performing unauthorized maintenance procedures can damage your analyzer. Do not perform any maintenance procedures that are not described in this chapter.
In case of problems not specified in this manual, contact Mindray customer service department or your local distributor for assistance.
Only Mindray-supplied parts can be used for maintenance. For any questions, contact Mindray customer service department or your local distributor.
Exercise caution to avoid contact with the sharp sample probe when performing maintenance.
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Maintaining Your Analyzer
10.2 Maintenance 10.2.1 Manual Sleep You can start the sleep s leep function if stop using the analyzer a nalyzer for a long l ong time.
At the “Motor” and “Valve” tabs of the “Self -test” screen and the “Status” screen, the analyzer can not sleep.
If any influential error happens, the analyzer can not sleep.
Click the “Menu” button on the screen, then select “Shutdown ””Sleep” on the pop-up menu.
The following message box will pop up.
Click the “OK” button to get ready to sleep.
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After the preparation of sleep is complete, the progress bar closes automatically and the analyzer enters the sleep status.
When the analyzer is sleeping, the analysis status icon at the screen displays in red. The indicator on the analyzer displays in red at the time.
You can not run any sample when the analyzer is sleeping.
You can perform the operations without the cooperation of the analyzer when it is sleeping, namely, communication and print etc.
If any error happens during the process of entering the sleep status, the analyzer will not sleep but alarm for the error. See Chapter 11 Troubleshooting Your Your Analyzer for solutions. solution s.
10.2.2 Exiting sleep mode
Different maintenances will be performed by the analyzer automatically when exiting the sleep mode, and the exiting time depends on how long the analyzer was in the sleep mode.
The following two ways are available to exit sleep mode.
The “Cancel” button
Click the Menu button on the screen, then select Shutdown menu.
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The following message box will pop up.
Click the “OK” button to exit the sleep mode.
Cancel on the pop up
After the exiting is complete, the progress bar closes automatically and the analyzer exits the sleep mode.
Aspirate Key Press the aspirate key on the analyzer to exit the sleep mode
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After the exiting is complete, the progress bar closes automatically and the analyzer exits the sleep mode.
If any error happens during the process of exiting the sleep mode, see Chapter 11 Troubleshooting Troubleshooting Your Analyzer for details to remove the error.
After exiting the sleep mode successfully, the analyzer will return to the certain status before sleeping. The analysis status icon at the screen displays in green. The indicator on the analyzer displays in green at the same time.
10.2.3 Replacing Reagent
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally accid entally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
After installing a new container of reagent, keep it still for a while before use.
When you have changed the diluent or lyses, run a background to see if the results meet the requirement.
You should change the reagents when:
a new container of reagent is installed.
the reagent is contaminated
WBC/RBC bubbles are reported.
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Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the pop-up menu.
Click the “Replace Reagent” tab to enter the “Replace Reagent” screen
You can replace any of the following reagents: Diluent
LEO(I) lyse
LEO(II) lyse 10-6
Maintaining Your Analyzer
LH lyse
Keep the diluent container from any strong vibration or collision with other objects. Otherwise unreliable error messages may be reported.
While replacing the diluent container, be sure to follow the following steps: 1) install the supporting board as shown below; 2) insert the cap assembly (shown in the figure below) into the diluent container vertically, and then secure the cap. Otherwise unreliable error messages may be reported.
Do as follows to replace the reagents: 1.
Double click click the icon of the desired reagent, and then enter the lot No. and expiration date of the new reagent.
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Maintaining Your Analyzer
The check box “Change New Vial” should be selected if you wish to change a container of reagent. Then, the edit box of “Lot No.” and “Exp. Date” will be activated for you to enter the new lot No. and expiration date. When finishing the replacement, the analyzer will save the new lot No. and expiration date and then automatically modify the open-container expiration date. The “Change New Vial” check box is selected as default.
The check box “Change New Vial” should not be selected if you only replace the reagent in the container. Then, the edit box “Lot No.” and “Exp. Date” will be unavailable. When finishing the replacement, the analyzer will not modify the open-container expiration date.
The expiration date can not be empty.
1 to 16 digits can be entered into the box of “Lot No.” and an empty entry is allowed.
2.
After the “Use barcode scanner” is selected, you can enter the expiration date of the reagents by the barcode scanner.
Click the “Replace” button to save the entered expiration date and lot No. and start replacing.
3.
After the replacing is complete, the following prompt will pop up.
4.
Click the “OK” button to close the message box.
5.
Do the above procedures to replace other reagents if necessary necessary.. 10-8
Maintaining Your Analyzer
10.2.4 Cleaning You should clean the corresponding components under the following circumstances:
When the background of WBC and (or) HGB relative parameters exceeds the Ref. Range, Range, you should clean the WBC bath.
When the background of RBC and (or) PLT relative parameters exceeds the Ref. Range, Range, you should clean the RBC bath.
When the the background of the scattergram has abnormal excessive cells, you should cl clean ean the DIFF Bath.
When the background of of the scattergram has abnormal excessive cells, or bad differential of WBC, you should clean the flow cell.
When the the sample probe probe is dirty, dirty, you you should clean clean the sample sample probe. probe.
Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the pop-up menu.
Then, click the “Clean” tab to enter the “Clean” screen.
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You can clean any of the following components: WBC bath RBC bath DIFF bath Flow cell Sample probe
Do as follows to clean: 1.
Double click the icon of the desired component to start cleaning.
2.
After the cleaning is completed, a message box will pop up.
3.
Click the “Ok” button to close the message box. 10-10
Maintaining Your Analyzer 4.
Do the above procedures to clean other components if necessary necessary..
10.2.5 Unclogging When clogging happens, you should perform the unclogging procedure.
Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the pop-up menu.
Then, click the “Maintain ” tab to enter the “ Maintain” screen.
10-11
Maintaining Your Analyzer Take the following steps to unclog: 1.
Double click the “ Unclog” icon to start unclogging.
2.
After the unclogging is complete, a message box will pop up.
3.
Click the “Ok” button to close the message box.
4.
Do the above procedures to continue unclogging if necessary necessary..
10.2.6 Zapping Apertures You should perform this procedure to unclog the aperture. apertu re.
Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the pop-up menu.
Then, click the “Maintain ” tab to enter the “ Maintain” screen.
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Do as follows to zap apertures: 1.
Double click the “Zap Apertures” icon to start zapping.
2.
After the zapping is complete, a message box will pop up.
3.
Click the “Ok” button to close the message box.
4.
Do the above procedures to continue zapping apertures ifif necessary necessary..
10.2.7 Flushing Apertures You should perform this procedure to flash apertures.
Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the 10-13
Maintaining Your Analyzer pop-up menu.
Then, click the “Maintain ” tab to enter the “ Maintain” screen.
Do as follows to flash apertures: 1.
Double click the “ Flush Apertures” icon to start flashing.
2.
After the flashing is complete, a message box will pop up.
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Maintaining Your Analyzer
3.
Click the “Ok” button to close the message box.
4.
Do the above procedures to continue flashing apertures if necessary. necessary.
10.2.8 Probe Cleanser Soaking You should perform the probe cleanser soaking under the following circumstances: When the problems including the background results exceeds the Ref. Range, bad differential of scattergram and clogging still exist after other maintenances have been adopted. If your analyzer is to run few samples, you should perform this procedure every two weeks.
Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the pop-up menu.
Then, click the “Maintain ” tab to enter the “ Maintain” screen.
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Take the following steps to perform the probe cleanser soak: 1.
Double click the icon of “ Probe Cleanser Soak”, and then a message box will pop up.
2.
Click “ Yes Yes”, and then the following progress bar will pop up and the analyzer is preparing to soak.
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Maintaining Your Analyzer
3.
After the preparation is done, the message box will pop up.
4.
Perform the first aspiration of the cleanser as instructed. Then, the first-time priming process starts automatically after the aspiration.
5.
When the first-time priming is done, the progress bar closes automatically and the following message box will pop up.
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Maintaining Your Analyzer 6.
Aspirate the cleanser for the second second time as instructed. Then, the second-time priming process starts automatically when the aspiration is done.
7.
When the priming is completed, the progress bar closes and a count-down box will pop up. The soaking process starts.
8.
The soaking process will last about 20 minutes. You may click the “ Stop Soaking” button in the message box to stop it. If you stop soaking in less than 5 minutes, the following message box will pop up.
9.
The cleaning process starts after the soaking progress is done.
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10. After the cleaning is completed, a message box will will pop up.
11. Click the “Ok” button to close the message box. 12. Do the above procedures to perform the probe cleanser soak if necessary necessary..
10.2.9 Probe Cleanser Soaking for Single Channel Probe cleanser soaking for DIFF bath, WBC bath and RBC bath, when the aperture clogs or the abnormal scattergram occurs, can be used to remove the errors.
Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the pop-up menu.
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Maintaining Your Analyzer
Then, click the “Maintain ” tab to enter the “Maintain” screen.
Take the following steps to perform the probe cleanser soak (DIFF bath):
1. Double click the “ DIFF Bath Soaking” icon, and then a message box will pop up.
2. Click “ Yes Yes”, and then the progress bar shown below will pop up and the analyzer is preparing.
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3. When the preparation is done, a message box will pop up.
4. After aspirating the probe cleanser as instructed, the following progress bar will pop up and the analyzer starts priming pr iming automatically.
5. When the priming is complete, the progress bar closes and a count-down box will pop up. The soaking process starts.
6. The soaking process will last about 20 minutes. m inutes. Y You ou may click the “ Stop Soaking” button in the dialog box to stop it. If you stop soaking in less than 5 minutes, the following message box will pop up. 10-21
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7. The cleaning process starts after the soaking progress is done.
8. After the cleaning is complete, a message box will pop up.
9. Click “Ok” to close the dialog box.
Do the above procedures to perform the probe cleanser soaking for WBC W BC bath and RBC bath if
necessary.
10.2.10 Flow Cell Unclogging When the “Flow cell clog” error is reported, you should perform the flow cell unclogging procedure.
Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the pop-up menu.
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Then, click the “Maintain ” tab to enter the “ Maintain” screen.
Take the following steps to unclog: 1. Double click the “Unclog” icon to start unclogging. 2. After the unclogging is complete, a message box will pop up.
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3. Click the “Ok” button to close the message box.
10.2.11 Fluidics initialization After maintaining the fluidic system or replacing a main part of the analyzer, you should perform this procedure to initialize the fluidic system.
Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the pop-up menu.
Then, click the “Maintain the whole device” tab to enter the screen.
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Maintaining Your Analyzer
Do as follows to perform the fluidics initialization: 1.
Double click the icon of “ Fluidics initialization”, and then a message box will pop up.
2.
Click the “ Yes Yes” button to start initialization and “Fluidics initializing… initializing…”” will be displayed in the information area down to the screen.
3.
After the initialization is completed, a message box will display. display.
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Maintaining Your Analyzer
4.
Click the “Ok” button to close the message box.
5.
Do the above procedures to continue initializing the fluidics system ifif necessary necessary..
10.2.12 Clean Fluidics When the background of all parameters exceeds the ref. range, you should perform the procedure.
Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the pop-up menu.
Then, click the “Maintain the whole device” tab to enter the screen.
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Do as follows to clean fluidics: 1.
Double click the icon of “ Clean Fluidics”, and then a message box will pop up.
2.
Click the “ Yes Yes” button to start cleaning and “Fluidics cleaning…” cleaning…” will be displayed in the information area down to the screen.
3.
After the cleaning is complete, a message box will display. display.
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4.
Click the “Ok” button to close the message box.
5.
Do the above procedures to continue cleaning fluidics ifif necessary necessary..
10.2.13 Prepare to Ship If the analyzer is not to be used for over one week or needs a long distance transport (transporting time>2h), you should perform this procedure.
Click the “Menu” button on the screen, and then select “ Service””Maintenance” on the pop-up menu.
Then, click the “Maintain the whole device” tab to enter the screen.
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Do as follows to perform the prepare-to-ship procedure: 1.
Double click the icon of “ Prepare to Ship”, and then a message box will pop up.
2.
Click the “ Yes Yes” button to perform the procedure and a message box shown below will display.
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Maintaining Your Analyzer
3.
Remove all reagent pickup tube assemblies according to the prompt, and then click the
“Ok” button to start emptying the fluidic system. 4.
After the emptying is complete, a message box will pop up.
5.
Place all reagent pickup tube assemblies into the distilled water, and then click the “ Ok” button to start priming.
6.
After the cleaning is done, a message box will display. display.
7.
Remove all reagent pickup tube assemblies from the distilled water water according to the
prompt, and then click “Ok” to start emptying the fluidic system. 8.
After the emptying is complete, a message box will display. You should turn off the power switch according to the prompt displayed on the screen.
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After the prepared to ship procedure is done, you can still use the software.
10.2.14 Auto-cleaning When the sample count times reach or over 100, the analyzer will perform the cleaning procedure automatically once, and a prompt will be displayed on the screen.
If it is the time to perform the auto-cleaning but the analyzer is running or error happens; only after the running is completed or the error is removed will the auto-cleaning starts.
After the auto-cleaning or probe cleanser soaking is complete, or after the analyzer is shut down, the sample count times will reset to zero automatically.
10.2.15 Time-Based Probe Cleanser Soak When it is time for probe cleanser soak (defined by auto maintenance setup), the analyzer will ask you for confirmation to perform the probe cleanser soak.
Click “ Yes Yes”, and then the progress bar shown below will pop up and the analyzer is preparing. 10-31
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When the preparation is done, a message box will pop up.
After aspirating the probe cleanser for the first time as instructed, the following progress bar will pop up and the analyzer starts the first-time priming automatically automatically..
After the first-time priming is done, the progress bar closes and a message box will pop up.
After aspirating the probe cleanser for the second time as instructed, the following progress bar will pop up and the analyzer starts the second-time second-tim e priming automatically.
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When the second-time priming is complete, the progress bar closes and a count-down box will pop up. The soaking process starts.
The soaking process will last about 20 minutes. You may click the “ Stop Soaking” button in the dialog box to stop it after five minutes. The cleaning process starts after the soaking progress is done.
After the cleaning is complete, a dialog box will pop up.
Then, click the “Ok” button to close the box. 10-33
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At the “Self -test” or “Status” screen, the analyzer does not ask for confirmation to perform the probe cleanser soak.
If the procedure of probe cleanser soaking is not started when it is auto-prompted, the confirmation prompt will pop up again after 10 minutes.
10.2.16 Auto-sleeping When the fluidics system stop working for 60 minutes (default), then the analyzer will enter sleeping status automatically autom atically..
When the analyzer is in sleeping status, a prompt will display on the screen.
You can set the waiting time for auto-sleeping, see chapter 5 Customizing the Analyzer Software for details.
At the “Self -test” or “Status” screen, the analyzer can not sle ep.
If it is the time to auto-sleep but the analyzer is error status, then only after the error is removed will the auto-sleeping starts accordingly.
You can perform the operations without the cooperation of the analyzer when it is sleeping, namely, communication and print etc.
10.2.17 Sterilization The user shall perform daily cleaning and sterilization to the cover of the analyzer. Use the specified materials to sterilize the equipment only on ly.. For damage or accident caused by using other materials, Mindray will not provide any guarantee. Mindray bears no responsibility of the validity of the listed chemicals as the infection control solution. For the methods to control infection, please consult the Infection Prevention Department of the hospital or the epidemic experts. The sterilization may damage the analyzer to some extent. It is recommended to perform
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Maintaining Your Analyzer sterilization only necessary in your hospital service plan. Clean the equipment before sterilizing. Recommended disinfectant: 70% ethanol, 70％ isopropyl alcohol and Cidex 2% Glutaral + Activator. Prohibited disinfectant: 3% hydrogen peroxide, Aerodesin 2000, Cidex OPA.
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10.3 System Status
If the results of the status testing exceed the normal range, they will be highlighted by the red background.
10.3.1 Temperature Temperature and Pressure Click the “Menu” button on the screen, and then select “ Service””Status” on the pop-up menu.
Then, click the “Temperature&Pressure” tab and a message box will pop up.
When the sequence is complete, the message box closes automatically and you will enter the
following screen.
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You can check the information about the temperature and pressure, and also export expor t or print the information. Export 1.
Click the “Export” button at the bottom of the screen and then select the desired information from the pop-up message box.
2.
Click the “Browse” button, and then a message box will pop up.
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3.
Select the directory and format for the exported file and enter the file file name.
4.
Click the “Save” button to save the selected information to the specified location.
5.
When the exporting succeeded, click the “Ok” button to exit.
If the exporting failed, you should click the t he “Ok” button and then try again or change another exporting directory; if it does not help, please contact Mindray customer service department or your local distributor.
The default format of the exported information is “.txt” and you can also choose the “.csv” format.
Print 1.
Click the “Print” button at the bottom of the screen and then select the desired information from the pop-up message box.
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Maintaining Your Analyzer 2.
Click the “Ok” button to print the selected information.
The “user not see option in the Printof ” common message level box. can If you wishthe to “Analyzer print the Information” analyzer information, please log out and then log in as user of administrator level.
10.3.2 Voltage Voltage and Current Click the “Menu” button on the screen, and then select “ Service””Status” on the pop-up menu.
Then, click the “Voltage&Current” tab to enter the following screen.
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You can check the information inform ation about the voltage and current, and also export or p print rint the information.
Export 1.
Click the “Export” button at the bottom of the screen and then select the desired information from the pop-up message box.
2.
Click the “Browse” button, and then a message box will pop up.
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3.
Select the directory and format for the exported file and enter the file file name.
4.
Click the “Save” button to save the selected information to the specified location.
5.
When the exporting succeeded, click the “Ok” button to exit.
If the exporting failed, you should click the t he “Ok” button and then try again or change another exporting directory; if it does not help, please contact Mindray customer service department or your local distributor.
The default format of the exported information is “.txt”, and you can also choose the “.csv” format.
Print 1.
Click the “Print” button at the bottom of the screen and then select the desired information from the pop-up message box.
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2.
Click the “Ok” button to print the selected information.
The user of common level can not see the “Analyzer Information” option in the “Print” message box. If you wish to print the analyzer information, please log out and then log in as user of administrator level.
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10.4 Version and Config. Information Click the “Menu” button, select “ Service” “Version and Config. Information” on the menu.
Then you will enter the following screen.
You can check the information about the version and configuration, and export or print them. Export 1.
Click the “Export” button, and then the following message box will pop up
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2.
Select the directory and format for the exported file and enter the file name.
3.
Click the “Save” button to save the selected information to the specified location.
4.
When the exporting succeeded, click the “Ok” button to exit.
If the exporting failed, you should click the t he “Ok” button and then try again or change another exporting directory; if it does not help, please contact Mindray customer service department or your local distributor.
The default format of the exported information is “.txt” and you can also choose the “.cvs” format.
Print
Click the “Print” button at the bottom of the screen to print the information.
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10.5 Self-test
10.5.1 Syringe and Sampling Mechanism
Click the “Menu” button on the screen, and then select “ Service””Self-test” on the pop-up menu.
Then, click the “Sampling Mechanism Assembly Self-test” tab to enter the following screen.
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You can check the status of all items and print the results.
Self-test Double click the desired icon to start self-testing.
When the self-testing is finished, a message box will pop up to inform you the normal testing
results. Then, click the “ Ok” button to close the message box.
If the testing result is abnormal, you should click the “Ok” button and try
again for several times; if it does not help, please contact Mindray customer service department or your local distributor.
Do the above procedures to test other items if necessary. necessary.
Print
Click the “Print” button at the bottom of the screen to print the latest testing results (normal/ abnormal) of all items.
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10.5.2 Valve Click the “Menu” button on the screen, and then select “Service””Self-test” on the pop-up menu.
Then, click the “Valve” tab to enter the following screen.
You can check the status of a single valve or all valves. Single valve
Click the desired Valve No. (e.g. “1”), then identify whether it works work s well by judging its sound 10-47
Maintaining Your Analyzer when opening and closing.
All valves
After clicking the “ All Valves” button, all valves will be tested according to their No. one by one. A progress bar will pop up at the same time.
Whether the valve works well or not is identified by judging its sound when opening and closing
The current status (open/close) of all valves is displayed in the “Status” box of the screen. When testing the valves, they open first and then close.
You can can click the “Cancel” button on the progress bar to stop the testing for all valves.
10.5.3 Others Click the “Menu” button on the screen, and then select “ Service””Self-test” on the pop-up menu.
Then, click the “Others” tab to enter the following screen. 10-48
Maintaining Your Analyzer
You can check the status of all above items and print the results.
Self-test Double click one desired icon to start self-testing.
When the self-testing is finished, a message box will pop up to inform you the testing result.
Then, you can click the “Ok” button to close the message box.
10-49
Maintaining Your Analyzer
If the testing result is abnormal, you should click the “Ok” button and try again for several times; if it does not help, please contact Mindray customer service department or your local distributor.
Do the above procedures to test other items if necessary.
Print
Click the “Print” button at the button of the screen to print the latest testing results (normal/ abnormal) of the items.
10-50
Maintaining Your Analyzer
10.6 Counter Click the “Menu” button on the screen, and then select “ Service””Counter ” on the pop-up menu.
Then you will enter the following screen.
You can check the statistic information inform ation of all the above item items s and the detail statistic information of some items.
10-51
Maintaining Your Analyzer Checking the detail information You can check the detail information for the sample count times, QC times and calibration times.
You can click the “Detail… “ Detail…”” button next to the “ Sample Count Times” to display the detail statistic information about the sample count times.
You can click the “Detail… “ Detail…”” button next to the “QC Times” to display the detail statistic information about the QC times.
You can click the “Detail… “ Detail…”” button next to the “ Calibration Times” to display the detail statistic 10-52
Maintaining Your Analyzer information about the calibration times.
Print
Click the “Print” button at the bottom of the screen to print all the statistic information of the current screen.
10-53
Maintaining Your Analyzer
10.7 Log
If you add a new record when the log is full, the newest record will overwrite the oldest automatically.
Up to records of one year can be saved in the log.
Up to 100 characters can be entered for remarks.
10.7.1 Set Parameters Click the “Menu” button on the screen, and then th en select “ Service””Log” on the pop-up menu.
Then, click the “Set Paras” tab to enter the following screen.
10-54
Maintaining Your Analyzer
You can check the log information, enter remark information and also export and pr print int the information.
Remark 1.
Enter the remark information in the “ Remark” box of the desired log record.
2.
Click the “Save” button at the bottom of the screen to save the remarks.
Print Click the “Print” button at the bottom of the screen. You can select “ Date Range” or “No.
Range” to determine the print range.
10-55
Maintaining Your Analyzer
Print by date range 1) Enter the starting date and finishing date of the records you want to print.
2) Click “Ok” button to print the selected log. Print by No. range 1) Enter the starting date and finishing No. of the log you want to print.
2) Click the “Ok” button to print the selected log.
Detail Click the “Detail…” button to check the details of the highlighted record.
10.7.2 Other Logs
Click the “Menu” button on the screen, and then th en select “ Service””Log” on the pop-up menu.
10-56
Maintaining Your Analyzer
Then, click the “Other Logs” tab to enter the following screen.
You can check the log information, enter remark information and also export and pr print int the information.
Remark 1.
Enter the remark information in the “ Remark” box of the desired log record.
2.
Click the “Save” button at the bottom of the screen to save the remark. 10-57
Maintaining Your Analyzer
Print Click the “Print” button at the bottom of the screen. You can select “ Date Range” or “No. Range” to determine the print range.
Print by date range 1) Enter the starting date and finishing date of the records you want to print.
2) Click the “Ok” button to print the selected log. Print by No. range 1) Enter the starting date and finishing No. of the log you want to print.
2) Click “Ok” button to print the selected log.
Detail Click the “Detail…” button to check the details of the highlighted record.
10.7.3 Error Messages
10-58
Maintaining Your Analyzer
The error message is only available to the users of administrators-level (or higher levels).
Click the “Menu” button on the screen, and then th en select “ Service””Log” on the pop-up menu.
Then, click the “Error Info.” tab to enter the following screen.
You can check the log information, enter remark information and also export and pr print int the 10-59
Maintaining Your Analyzer information.
Remark 1.
Enter the remark information in the “ Remark” box of the desired log record.
2.
Click the “Save” button at the bottom of the screen to save the remark.
Print Click the “Print” button at the bottom of the screen. You can select “ Date Range” or “No. Range” to determine the print range.
Print by date range 1) Enter the starting date and finishing date of the records you want to print.
2) Click the “Ok” button to print the selected log. Print by No. range
1) Enter the starting date and finishing No. of the log you want to print.
2) Click “Ok” button to print the selected log.
Detail Click the “Detail…” button to check the details of the highlighted record.
10.7.4 All Logs
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Maintaining Your Analyzer
The “All Logs” ta b displays all the available log information for the current user.
Click the “Menu” button on the screen, and then th en select “ Service””Log” on the pop-up menu.
Then, click the “All Logs” tab to enter the following screen.
You can check the log information, enter remark information and also export and pr print int the 10-61
Maintaining Your Analyzer information.
Remark 1.
Enter the remark information in the “ Remark” box of the desired log record.
2.
Click the “Save” button at the bottom of the screen to save the remark.
Print Click the “Print” button at the bottom of the screen. You can select “ Date Range” or “No. Range” to determine the print range.
Print by date range
1) Enter the starting date and finishing date of the records you want to print.
2) Click the “Ok” button to print the selected log. Print by No. range 1) Enter the starting date and finishing No. of the log you want to print.
2) Click the “Ok” button to pr int int the selected log.
Detail Click the “Detail…” button to check the details of the highlighted record.
10-62
11 Troublesh roubleshooting ooting Your Analyzer 11.1 Introduction This chapter contains information that is helpful in locating and correcting problems that may occur during operation of your analyzer.
This chapter is not a complete service manual and is limited to problems that are readily diagnosed and/or corrected by the user of the analyzer. If the recommended solution fails to solve the problem, contact Mindray Mind ray customer service department or your local distributor.
11-1
Troubleshooting Your Analyzer
11.2 Errors indicated by error messages During the operation, if error(s) is detected, the analyzer will beep and display the corresponding error message in the pop-up message box. In the error message area, the severity levels are discriminated from high to low by background colors in the order of red, orange, blue, and green.
The red error message means that the analyzer will terminate the current action immediately and you can not perform any operation.
The orange error message means that the analyzer will terminate the current action immediately.
The blue error message means that the analyzer can still proceed with the current action, but other operations related to the error(s) of this kind will be restricted.
The green error message means that the analyzer analyzer can still proceed with the current action
and other operations will not be restricted. The following error message box will pop up.
Figure 11-1 Error messages box You can see the error name(s) and the corresponding troubleshooting information in the pop-up message box. The error names are displayed in order. You can click the error name in the message box to select (highlight) it and check the
corresponding troubleshooting information in the “Troubleshooting” list under the message box. The troubleshooting information of the first error will display (default). Follow the instructions in the message box to remove the error(s) 11-2
Troubleshooting Your Analyzer The following functions are provided in the current message box.
Remove Error
Click the “Remove error ” button, then the system will remove the error automatically if possible. If the error(s) still exists, you should follow the instructions of the trou troubleshooting bleshooting to remove the error(s).
Silent
Click the “Silent” button to disable the alarm.
Close the “Error” message box
Click the “Close” button to close the “Error” message box, but the corresponding error
message will display in the error message area. If you click the error message again, the “Error” message box will be re-opened.
The possible error(s) and the corresponding troubleshooting information are listed below:
Error Name
Troubleshooting Information
Voltage error
1. Please turn off the analyzer power directly and restart the analyzer later. 2. If the error still exists, contact our customer service department.
Laser diode current abnormal
1. Please turn turn off off the the analyzer power directly and and restart the analyzer later. 2. If the error still exists, contact our customer service department.
Drive board communication
1. Click the “Remove error” button to remove this error.
error
2. If the error still exists, contact our customer service
department. Sheath fluid channel clog
1. Click the “Remove error” button to remove this error. 2. If the error still exists, contact our customer service department.
Syringe action error
1. Click the “Remove error” button to remove this error. 2. If the error still exists, contact our customer service department.
Sample probe action error
1. Click the “Remove error” button to remove this error. 2. If the error still exists, contact our customer service department.
Pressure abnormal
1. Click the “Remove error” button to remove this error.
11-3
Troubleshooting Your Analyzer 2. If the error still exists, contact our customer service department. Vacuum abnormal
1. Click the “Remove error” button to remove this error. 2. If the error still exists, contact our customer service department.
DIFF reaction bath temp.
1. Click the “Remove error” button to remove this error.
error
2. If the error still exists, contact our customer service department.
Temperature out of working
1. Make sure the ambient temperature is within the normal
range
range [15, 30]. 2. Analysis results may be incorrect if the ambient temperature is out of the normal range. 3. If the ambient temperature is within the normal range, the error will be removed automatically. 4. If the error still exists, contact our customer service department.
Temperature out of operating
1. The ambient temperature is out of the analysis anal ysis allowable
range
range [10, 40]. 2. Analysis results may be incorrect if the ambient temperature is out of the normal range. 3. If the ambient temperature is within the normal range, the error will be removed automatically. automatically. 4. If the error still exists, contact our customer service department.
Optical System temp. error
1. Click the “Remove error” button to remove this error. 2. If the error still exists, contact our customer service department.
LEO(I) Lyse expired
1. Check if the LEO (I) Lyse is expired. If so, change a new container of lyse.
2. Click the “Remove error” button, and then the “Reagent” settings screen will pop up. Set the reagent expiration date as instructed in Chapter 5 Customizing the Analyzer Software, and then click “Ok”.
3. Click the “Remove error” button again; the error will be removed automatically autom atically.. 4. If the error still exists after a new container of reagent is installed, contact our customer service department. LEO(II) Lyse expired
1. Check if the LEO (II) Lyse is expired. If so, change a new container of lyse.
2. Click the “Remove error” button, and then the “Reagent” 11-4
Troubleshooting Your Analyzer settings screen will pop up. Set the reagent expiration date as instructed in Chapter 5 Customizing the Analyzer Software, and then click “Ok”. 3. Click the “Remove error” button again; the error will be removed automatically autom atically.. 4. If the error still exists after a new container of reagent is installed, contact our customer service department. Diluent expired
1. Check if the diluent is expired. If so, change a new container of diluent.
2. Click the “Remove error” button, and then the “Reagent” settings screen will pop up. Set the reagent expiration date as instructed in Chapter 5 Customizing the Analyzer Software, and then click “Ok”. 3. Click the “Remove error” button again; the error will be removed automatically autom atically.. 4. If the error still exists after a new container of reagent is installed, contact our customer service department. LH Lyse expired
1. Check if the LH Lyse is expired. If so, change a new container of lyse.
2. Click the “Remove error” button, and then the “Reagent” settings screen will pop up. Set the reagent expiration date as instructed in Chapter 5 Customizing the Analyzer Software, and then click “Ok”. 3. Click the “Remove error” button again; the error will be removed automatically autom atically.. 4. If the error still exists after a new container of reagent is installed, contact our customer service department. No Diluent
1. Check whether the diluent container is empty. empty. 2. If there is no diluent, install a new container of diluent.
Then click the “Remove error” button to prime the analyzer with the diluent.
3. Enter “Reagent” settings to modify the reagent expiration date as instructed in Chapter 5 Customizing the Analyzer Software. Software. 4. If there is still plenty of diluent, or if the error still exists after a new container of diluent is installed, contact our customer service department. No LH lyse
1. Check whether the LH lyse container is empty. empty. 2. If there is no LH lyse, change a new container of LH
lyse. Then click the “Remove error” button to prime the 11-5
Troubleshooting Your Analyzer analyzer with the lyse.
3. Enter “Reagent” settings to modify the reagent expiration date as instructed in Chapter 5 Customizing the Analyzer Software. Software. 4. If there is still plenty of reagent, or if the error still exists after a new container of reagent is installed, contact our customer service department. No LEO(I) lyse
1. Check whether the LEO (I) lyse container is empty. empty. 2. If there is no LEO (I) lyse, change a new container of LEO(I) lyse. Then click the “Remove error” button to prime the analyzer with the lyse.
3. Enter “Reagent” settings to modify the reagent expiration date as instructed in Chapter 5 Customizing the Analyzer Software. Software. 4. If there is still plenty of reagent, or if the error still exists after a new container of reagent is installed, contact our customer service department. No LEO(II) lyse
1. Check whether the LEO (II) lyse container is empty. empty. 2. If there is no LEO(II) lyse, change a new container of LEO(II) lyse. Then click the “Remove error” button to prime the analyzer with the lyse.
3. Enter “Reagent” settings to modify the reagent expiration date as instructed in Chapter 5 Customizing the Analyzer Software. Software. 4. If there is still plenty of reagent, or if the error still exists after a new container of reagent is installed, contact our customer service department. Waste is full
1. Empty the waste container or install a new waste container.
2. If the error still exists, contact our customer service department. Right side door open
1. Close the right side door. 2. Click the “Remove error” button to remove this error. 3. If the error still exists, contact our customer service department.
Laser assembly cover open
1. Close the laser assembly cover. 2. If the error still exists, contact our customer service department.
Background abnormal
1. Check whether the diluent is contaminated. 2. If it is not contaminated, click the “Remove error” button 11-6
Troubleshooting Your Analyzer to remove the error. 3. If the error still exists, contact our customer service department. WBC clog
1. Click the “Remove error” button to remove this error. 2. If the error reports frequently, see Chapter 10 Maintenance to Maintenance to soak the WBC channel with the probe cleanser. 3. If the error still exists, contact our customer service department.
WBC bubbles
1. Check whether the pickup tube connection looses. 2. If the connection does not loose, click the “Remove err or. error” button to remove the error. 3. If the error still exists, contact our customer service department.
RBC clog
1. Click the “Remove error” button to remove this error. 2. If the error reports frequently, see Chapter 10 Maintenance to Maintenance to soak the RBC channel with the probe cleanser. 3. If the error still exists, contact our customer service department.
RBC bubbles
1. Check whether the pickup tube connection looses. 2. If the connection does not loose, click the “Remove
error” button to remove the error. err or. 3. If the error still exists, contact our customer service
HGB detecting abnormal
department. 1. Adjust the HGB gain by entering the dialog box box to set the voltage within 4.3 - 4.7V 4 .7V,, preferably 4.5V as instructed in Chapter 5 Customizing the Analyzer Software. Software . 2. If the error still exists, contact our customer service
department. Network communication error
1. Check if the communication cable is well connected. 2. If it is well connected, check whether the communication cable is damaged. 3. If the cable is not damaged, click the “Remove error” button to remove the error. 4. If the error still exists, contact our customer service department.
11-7
12
Customizing the Print Template
12.1 Introduction You can modify the print template based on the default one provided b by y the software in order to customize the format of the report. After customizing and saving a template, you can select the newly customized one in the print setup. And then, the report will be printed in the customized template.
Users of common level have no authority to customize report.
12-1
Customizing the Print Template Template
12.2 Entering the t he Print Template Template Screen Log in as an administrator, and then click "Menu " Menu"" " "Setup Setup"" "Print "Print"" to go to the print setup screen.
1. Click the “Customize” button to enter the “ PrintTemplate” screen, and the following message box will pop up.
2. Enter the correct user name and password in the message box, and go to the print template screen shown as follows. 12-2
Customizing the Print Template Template
1 --- Main screen
2 --- Menu bar
3 --- Toolbar
4 --- Working area
5 --- Toolbar
6 --- Status bar
7 --- Property tab
8 --- Report tab
12-3
Customizing the Print Template Template
12.3 Editing the T Template emplate 12.3.1 Opening a Template You can open a template by one of the following ways:
Click on the "Report " ProjectProperty"" area to display all existing templates in Report"" tab in the "ProjectProperty the current template library. Click one of the template names and the corresponding template will be displayed in the working area.
Click "File File""
"Open Open""
on the menu bar or the
button on the toolbar, and then
specify the directory and select the template file. Click "Open" to open the template.
12.3.2 Editing the Template Property After you open a template, the properties of this template will be displayed under the "Property Property"" tab on the left of the screen. Click the cell to the right of the property name box to edit the property. If the cell is an edit box, modify the property directly; if the cell is a pull-down list, choose the desired value in the list.
12.3.3 Inserting Controls or Businesses Inserting a Control Click "Insert "Insert"" on the menu bar and choose the control you want to insert; or select a control in the tool bar on the bottom left, and drag it to the desired place in the working area.
You can click the working area.
button (line control) to draw a straight line or an oblique line in the
You can click the
button (title control) to add a title in the working area.
You can click the
button (label control) to add the fixed text information in the working
area.
You can click the
button (edit control) to add details associated with the print template
and the changeable information in the working area.
You can click the
button (picture control) to arrange the location and size of the graph
in the working area.
You can click the
button (table control) to add a table in the working area.
Inserting a Business A business is a set of controls which can be inserted in the template to facilitate the editing 12-4
Customizing the Print Template Template process. Do as follows to insert a business: 1. Click "Insert "Insert"" on the menu bar and choose "Head "Head", ", "Body "Body"" or "Tail "Tail". ". The following message box will pop up.
2. Select the desired business name in the pull-down list. Click the "Ok " Ok"" button to close the message box and insert the selected business.
12.3.4 Editing the Control(s) You should select the control(s) contr ol(s) you want to edit before start editing. Click on the control to select it. You can select multiple controls by one of the following ways:
Press and hold the "Ctrl" key on the keyboard, and at the same time, click on the controls you want to select.
Click on the template in the working area and drag the mouse to enclose the controls you want to select in the rectangular box displayed.
Moving the Control(s) You can move the control(s) co ntrol(s) by one of the ffollowing ollowing ways:
Select the control(s) you want to move. Left click and hold hold the mouse, and then move the control to the destination and release.
Select the control(s) you want to move. Press and hold the "Ctrl" key, key, and move the control using the arrow keys on the keyboard.
Aligning the Control(s) Select the control(s), and select the desired alignment options in the "Format " Format"" menu or the corresponding button on the toolbar on the bottom left.
12-5
Customizing the Print Template Template
Modifying the Size of a Control Select the control you want to edit, and then drag the borders to modify the size.
Editing the Property of the Control(s) Select the control(s) you want to edit, and the properties will be displayed under the "Property Property"" tab on the left of the screen. Click the cell to the right of the property name box to edit the property.. If the cell is an edit box, modify the property property proper ty directly; if the cell is a pull-down list, choose the desired value in the list.
12-6
Customizing the Print Template Template
12.4 Managing the Templates Templates 12.4.1 Importing a Template When you enter the main screen, you can see all the imported templates under the "Report " Report"" tab in the "ProjectProperty "ProjectProperty"" area. Do as follows to import a new template to the current template library: 1. On the menu bar, click "File " File"" " "Import Import", ", and the following message box will pop up.
2. Choose the import type and click "Ok "Ok". ". Then the following message box will pop up.
3. Select the template file you want to import and click "Open " Open"" to import the template into the current library. The name of the imported template will be displayed u under nder the "Report " Report"" tab, shown as follows.
12-7
Customizing the Print Template Template
12.4.2 Exporting a Template Template 1. Click on the "Report " Report"" tab in the "ProjectProperty "ProjectProperty"" area to display all the templates in the current template library. 2. Double click the template you want to export to open it in the working area. 3. On the menu bar, click "File " File"" " "Export Export", ", and the following message box will pop up.
12-8
Customizing the Print Template Template
4. Specify the directory you want to save the template and enter the file name. Click "Save " Save"" to save the template.
12.4.3 Previewing a Template Click "File "File"" " "Preview Preview"" on the menu bar or the current template.
button on the toolbar to preview the
12.4.4 Printing a Template Click "File "File""
"Print Print"" "
on the menu bar or the
button on the toolbar to print the current
template.
12.4.5 Deleting a Template Click "File "File""
" "Delete Delete""
on the menu bar or the
button on the toolbar to delete the
current template.
12-9
Customizing the Print Template Template
12.5 Other Functions 12.5.1 Creating a New Business 1. Click "Business "Business"" " "New New"" on the menu bar to open a blank template. 2. Insert the desired controls and modify their properties. 3. Click "Business "Business"" " "Save Save"" on the menu bar, and the following message box will pop up. Enter the information of the business in corresponding boxes and click "Ok " Ok"" to save the business.
12.5.2 Loading the Template Library 1. Click "Setting "Setting"" " "LoadTemplateLib LoadTemplateLib"" on the menu bar, and the following message m essage box will pop up.
