Descripción: Elecsys - Host Interface Manual...
Roche Diagnostics GmbH ®
Elecsys Analyzer Host Interface Manual
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Elecsys Analyzer Host Interface Manual ID No. 1804022-001
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Document: RDElec4.2 Final.doc
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Elecsys Host Interface Manual
V 4.2 –Version 01/05
Elecsys® Host Interface Manual
WARRANTY Roche Diagnostics makes no warranties for the RD Host Interface and Elecsys Analyzer Host Interface Manual beyond those set forth in the operations manual for the Elecsys Analyzer. Roche Diagnostics disclaims all other warranties, express or implied, including but not limited to the implied warranties of merchantability and fitness for a particular purpose. In no event shall Roche Diagnostics be liable for the incidental or consequential damages arising from the use of the interface.
TRADEMARKS AND COPYRIGHTS Elecsys is a trademark of a member of the Roche group. Copies of Documents E1381 – 91 and E1394 – 91 have been reproduced with permission, from the Annual Book of ASTM Standards. Copyright American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 194282959, U.S.A
VERSIONS Version
Date
Software
1.0
June 96
released
1.4
May 97
not released
2.0 3.0
Aug. 97 Mar. 98
released not released
4.0
August 00
4.01 4.02 4.2
Nov. 00 Dez. 00 Jan. 05
Modifications corrections by RD as regard contents; re-format update to version 1.4x (mainly chapter 4) – protocol changes Elecsys 2010 – add events/traces from implem. Refer. – add Elecsys 1010 How to ...(chapter 2) review to version 2.x (mainly chapter 4) update to version 2.x (chapter 4.3.6, 4.3.7) – protocol changes Elecsys 2010 – add LSM – Assay Reference Table 5.1 – Auto Dilution Reference Table 5.2 update to version 4.0, changes in CI, add new features of Elecsys 1010 (batch, query mode and MSRs) inclusion of minor corrections Page 157, leding zeros New Alarms in Chapter 5.3 for E2010
© 2000, Roche Diagnostics GmbH. All rights reserved. Lab Diagnostics Global System Support Sandhofer Straße 116 D-68305 Mannheim, Germany No part of the contents of this book may be reproduced or transmitted in any form or by any means without the written permission of Roche Diagnostics GmbH.
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Table of Contents 1
INTRODUCTION ........................................................................................................... 1-9 1.1 How to read this Manual................................................................................................................ 1-9 1.1.1 Intended Audience.................................................................................................................................................. 1-9 1.1.2 Documentation Conventions.............................................................................................................................1-10 1.1.3 Further Help .............................................................................................................................................................1-10
2
1.2
Short Description of Elecsys 2010 .............................................................................................1-11
1.3
Short Description of Elecsys 1010 .............................................................................................1-12
1.4
Features of the Elecsys Host Interface...................................................................................... 1-13
HOW TO ... ...................................................................................................................2-15 2.1 ... use the Interface for Elecsys 2010.........................................................................................2-15 2.1.1 ... connect the Interface for Elecsys 2010.....................................................................................................2-15 2.1.2 ... set up the Interface for Elecsys 2010 ........................................................................................................2-15 2.1.3 ... operate the Interface of Elecsys 2010.......................................................................................................2-18 2.2 ... use the Interface for Elecsys 1010.........................................................................................2-20 2.2.1 ... connect the Interface for Elecsys 1010.....................................................................................................2-20 2.2.2 ... set up the Interface for Elecsys 1010 ........................................................................................................2-20 2.2.3 ... operate the Interface of Elecsys 1010.......................................................................................................2-26 2.3
3
... do Troubleshooting and Maintenance ..................................................................................2-27
THEORY OF OPERATION ..........................................................................................3-29 3.1
Overview of the Interface.............................................................................................................3-29
3.2 Description of Transmission Protocol.......................................................................................3-29 3.2.1 Basics..........................................................................................................................................................................3-29 3.2.1.1 OSI model.............................................................................................................................................................3-29 3.2.1.2 ASTM......................................................................................................................................................................3-31 3.2.1.3 Description of Terms Specific to ASTM...................................................................................................3-33 3.2.2 Application Layer ...................................................................................................................................................3-34 3.2.2.1 Types of Events ..................................................................................................................................................3-34 3.2.2.2 Event Related Data Processing ...................................................................................................................3-38 3.2.2.3 Message Priorities ............................................................................................................................................3-39 3.2.2.4 Events.....................................................................................................................................................................3-39 3.2.2.5 Error Detection and Recovery......................................................................................................................3-41 3.2.3 Presentation Layer.................................................................................................................................................3-45 3.2.3.1 Message Structure: Records ........................................................................................................................3-45 3.2.3.2 Message Structure: Fields.............................................................................................................................3-51 3.2.3.3 Common Field Types: ......................................................................................................................................3-54 3.2.4 Data Link Layer.......................................................................................................................................................3-55 3.2.4.1 General Description .........................................................................................................................................3-55 3.2.4.2 Establishment Phase (Link Connection)..................................................................................................3-56 3.2.4.3 Transfer Phase....................................................................................................................................................3-61 3.2.4.4 Termination Phase (Link Release) .............................................................................................................3-64 3.2.4.5 Frame Format......................................................................................................................................................3-64 3.2.5 Physical Layer..........................................................................................................................................................3-66 3.3 Example ...........................................................................................................................................3-66 3.3.1 Test Selection for New Sample ID ..................................................................................................................3-66 3.3.2 Upload Results after Tests are Performed...................................................................................................3-67
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ENGINEERING REFERENCE ......................................................................................4-69
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4.1 Physical Layer................................................................................................................................ 4-69 4.1.1 Cabling ....................................................................................................................................................................... 4-69 4.1.2 Interface Specifications....................................................................................................................................... 4-71 4.1.3 Critical Timings ....................................................................................................................................................... 4-72 4.2 Data Link Layer.............................................................................................................................. 4-73 4.2.1 State Diagram ......................................................................................................................................................... 4-73 4.2.2 Control Codes.......................................................................................................................................................... 4-74 4.2.3 Critical Timings ....................................................................................................................................................... 4-74 4.2.4 Message Frame / Checksum Calculation.................................................................................................... 4-75 4.2.5 ASCII Table............................................................................................................................................................... 4-77 4.3 Presentation Layer........................................................................................................................ 4-78 4.3.1 Allowed and Disallowed Characters.............................................................................................................. 4-78 4.3.2 Delimiters .................................................................................................................................................................. 4-78 4.3.3 Common Field Types............................................................................................................................................ 4-78 4.3.4 Table of Record Levels ........................................................................................................................................ 4-80 4.3.5 Structure of Messages ........................................................................................................................................ 4-81 4.3.6 ASTM 1394 Standard Records ......................................................................................................................... 4-83 4.3.6.1 Message Header Record (Level 0) (H Record).................................................................................. 4-84 4.3.6.2 Message Terminator Record (Level 0) (L Record)........................................................................... 4-86 4.3.6.3 Patient Information Record (Level 1) (P Record).............................................................................. 4-88 4.3.6.4 Test Order Record (Level 2) (O Record)............................................................................................... 4-90 4.3.6.5 Result Record (Level 3) (R Record)........................................................................................................ 4-98 4.3.6.6 Comment Record (Level 0...3) (C Record) .........................................................................................4-101 4.3.6.7 Request Information Record (Level 1) (Q Record).........................................................................4-102 4.3.7 RD Specific Records and their IDs ...............................................................................................................4-105 4.3.7.1 Action Confirmation Record (Level 1) .................................................................................................4-105 4.3.7.2 Action Request Record (Level 1)...........................................................................................................4-106 4.3.7.3 Calibrator Parameters Record (Level 2)..............................................................................................4-107 4.3.7.4 Calibration Result Record (Level 2)......................................................................................................4-108 4.3.7.5 Diluent Parameters Record (Level 2)...................................................................................................4-110 4.3.7.6 Instrument Configuration Record (Level 1) .....................................................................................4-111 4.3.7.7 Instrument Status Record (Level 1)......................................................................................................4-114 4.3.7.8 Log File Record (Level 1) ..........................................................................................................................4-117 4.3.7.9 Processing Message Record (Level 1)...............................................................................................4-118 4.3.7.10 Control Parameters Record (Level 2) ............................................................................................4-119 4.3.7.11 Result Context Record (Level 1) .......................................................................................................4-120 4.3.7.12 Raw Result Record (Level 4) ..............................................................................................................4-121 4.3.7.13 Service Data Record (Level 1) ...........................................................................................................4-122 4.3.7.14 Sample Status Record (Level 1)........................................................................................................4-124 4.3.7.15 Test Application Record (Level 1) ....................................................................................................4-126 4.3.7.16 Test Conditions Record (Level 1) .....................................................................................................4-127 4.3.7.17 Substance Data Record (Level 1).....................................................................................................4-128 4.3.8 Error States and Error Recovery ....................................................................................................................4-131 4.4 Application Layer ........................................................................................................................ 4-133 4.4.1 Message Priorities...............................................................................................................................................4-133 4.4.2 Types of Messages..............................................................................................................................................4-133 4.4.2.1 Test Order Message ......................................................................................................................................4-133 4.4.2.2 Result Message ...............................................................................................................................................4-135 4.4.2.3 Substance Data Message ...........................................................................................................................4-137 4.4.2.4 Calibrator Parameters Message ...............................................................................................................4-141 4.4.2.5 Control Parameters Message ....................................................................................................................4-142 4.4.2.6 Calibration Data Message...........................................................................................................................4-143 4.4.2.7 Instrument Status Message........................................................................................................................4-144 4.4.2.8 Log File Message............................................................................................................................................4-145 4.4.2.9 Test Conditions Message ............................................................................................................................4-146 4.4.2.10 Test Application Message......................................................................................................................4-147 4.4.2.11 Instrument Configuration Message....................................................................................................4-148
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4.4.2.12 Service Data Message ............................................................................................................................ 4-149 4.4.2.13 Processing Message................................................................................................................................ 4-149 4.4.2.14 Action Request / Action Confirmation Message ......................................................................... 4-150 4.4.3 Trigger events (Overview) ............................................................................................................................... 4-151 4.5 Test Selection via Specific Test Number ................................................................................4-154 4.5.1 Get Test Numbers from Test Condition Message:................................................................................ 4-154
5
TABLES...................................................................................................................... 5-155 5.1
Assay Reference Table Version 1.48.......................................................................................5-155
5.2 Auto Dilution Reference Table..................................................................................................5-159 5.2.1 General Specification: ....................................................................................................................................... 5-159 5.2.2 Detailed Specification ....................................................................................................................................... 5-159
6
5.3
Alarm Flags Elecsys 2010 ..........................................................................................................5-160
5.4
Alarm Flags Elecsys 1010 ..........................................................................................................5-162
EXAMPLES ............................................................................................................... 6-165 6.1 Trace Examples Standard Records ..........................................................................................6-165 6.1.1 Trace: Test Selection Disk Version .............................................................................................................. 6-165 6.1.2 Trace: Test Selection Rack Version (1st sample without bar-code) .............................................. 6-166 6.1.3 Trace: Test Selection Batch Mode (Elecsys 1010)................................................................................. 6-169 6.1.4 Trace: Test Selection Batch Mode (Elecsys 2010)................................................................................. 6-169 6.1.5 Trace: Result Message...................................................................................................................................... 6-170 6.2 Trace Examples Standard Records ..........................................................................................6-173 6.2.1 Trace: Batch Result Upload from Result Screen.................................................................................... 6-173 6.2.2 Trace: Host Cancels Test Selections (Example for Contention) ...................................................... 6-175 6.2.3 Trace: Sample Scan............................................................................................................................................ 6-176 6.3 Trace Examples Manufacturer Specific Records..................................................................6-181 6.3.1 Trace: Reagent Scan.......................................................................................................................................... 6-181 6.3.2 Trace: Substance Data Message.................................................................................................................. 6-186 6.3.3 Trace: Calibrator Parameters Message...................................................................................................... 6-191 6.3.4 Trace: Control Parameters Message........................................................................................................... 6-192 6.3.5 Trace: Calibration Data Message................................................................................................................. 6-193 6.3.6 Trace: Instrument Status Message .............................................................................................................. 6-193 6.3.7 Trace: Test Conditions Message................................................................................................................... 6-194 6.3.8 Trace: Test Application Message ................................................................................................................. 6-195 6.3.9 Trace: Instrument Configuration Message............................................................................................... 6-196 6.3.10 Trace: Service Data Message ........................................................................................................................ 6-197 6.3.11 Trace: Processing Message............................................................................................................................ 6-199
7
ASTM DESIGNATION: E 1381 - 91...................................................................... 7-201 7.1
Scope .............................................................................................................................................7-202
7.2
Referenced Documents..............................................................................................................7-203
7.3
Terminology ..................................................................................................................................7-203
7.4
Significance and Use ..................................................................................................................7-204
7.5 Physical Layer ..............................................................................................................................7-204 7.5.1 Overview Physical Layer................................................................................................................................... 7-204 7.5.2 Electrical Characteristics.................................................................................................................................. 7-205 7.5.3 Mechanical Characteristics ............................................................................................................................ 7-206 7.6 Data Link Layer ............................................................................................................................7-208 7.6.1 Overview Data Link Layer ............................................................................................................................... 7-208 V 4.2 –Version 01/05
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Establishment Phase (Link Connection) ....................................................................................................7-208 Transfer Phase ......................................................................................................................................................7-209 Termination Phase (Link Release)................................................................................................................7-211 Error Recovery.......................................................................................................................................................7-212 Restricted Message Characters.....................................................................................................................7-213 Appendix 1: STATE DIAGRAM.................................................................................................. 7-214
7.8 Appendix 2: Seven-Bit ASCII Code Charts ............................................................................ 7-215 7.8.1 Appendix 2.1: Decimal Character Code .....................................................................................................7-215 7.8.2 Appendix 2.2: Hexadecimal Character Code............................................................................................7-216
8
ASTM DESIGNATION: E 1394 - 91.......................................................................8-217 8.1
Scope............................................................................................................................................. 8-217
8.2
Referenced Documents ............................................................................................................. 8-218
8.3 Terminology ................................................................................................................................. 8-218 8.3.1 Description of Terms Specific to this Standard:......................................................................................8-218 8.4 Significance and Use ................................................................................................................. 8-219 8.4.1 General Information:...........................................................................................................................................8-219 8.5 Information Requirements in Clinical Testing ...................................................................... 8-221 8.5.1 General Approach ...............................................................................................................................................8-221 8.5.2 Logical Structure of the Message Level Protocol ..................................................................................8-223 8.6 Message Content - General Considerations......................................................................... 8-225 8.6.1 Character Codes ..................................................................................................................................................8-225 8.6.2 Maximum Field Lengths ...................................................................................................................................8-226 8.6.3 Maximum Record Length.................................................................................................................................8-226 8.6.4 Delimiters ................................................................................................................................................................8-226 8.6.5 Data Record Usage Overview.........................................................................................................................8-229 8.6.6 Common Field Types..........................................................................................................................................8-230 8.6.7 Examples of Basic Record Types...................................................................................................................8-232 8.7
Message Header Record........................................................................................................... 8-237
8.8
Patient Information Record....................................................................................................... 8-239
8.9 Test Order Record....................................................................................................................... 8-244 8.9.1 Multiple Orders.....................................................................................................................................................8-244 8.9.2 General Applications..........................................................................................................................................8-245 8.10
Result Record .............................................................................................................................. 8-251
8.11
Comment Record ........................................................................................................................ 8-254
8.12
Request Information Record..................................................................................................... 8-255
8.13
Message Terminator Record .................................................................................................... 8-258
8.14
Scientific Record......................................................................................................................... 8-259
8.15
Manufacturer Information Record .......................................................................................... 8-261
8.16 APPENDIX - Non mandatory Information .............................................................................. 8-262 8.16.1 X1. Comparison of Specifications E1238 and E1394.............................................................................8-262
9
HOST INTERFACE SIMULATOR FOR THE ASTM PROTOCOL.........................9-263 9.1
Purpose of the ASTM Interface Test Tool .............................................................................. 9-263
9.2
Main Screen of the Test Tool.................................................................................................... 9-264
9.3
Main Menu System .................................................................................................................... 9-265
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Multifunctional text editor .........................................................................................................9-267
9.5 Technical Details .........................................................................................................................9-268 9.5.1 Record editor rules............................................................................................................................................. 9-268 9.5.2 TCP/IP Communication .................................................................................................................................... 9-269 9.6 Data Flow of ASTM Test program ............................................................................................9-270 9.6.1 ELECSYS 2010...................................................................................................................................................... 9-270 9.6.2 ELECSYS 1010...................................................................................................................................................... 9-273 9.6.3 STA, STA-C, STA-R............................................................................................................................................. 9-275 9.6.4 Cardiac Reader .................................................................................................................................................... 9-276 9.6.5 Modular................................................................................................................................................................... 9-278 9.6.6 VS II........................................................................................................................................................................... 9-279 9.6.7 LSM .......................................................................................................................................................................... 9-280 9.6.8 PSM .......................................................................................................................................................................... 9-281 9.6.9 Amplilink................................................................................................................................................................. 9-282 9.7
10
Software Updates of the ASTM Host Interface Test Tool ...................................................9-283
INDEXES .............................................................................................................. 10-291
10.1
Tables.......................................................................................................................................... 10-291
10.2
Figures ........................................................................................................................................ 10-293
10.3
Record Names........................................................................................................................... 10-294
11
GLOSSARY...............................................................................................................11-1
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Introduction
Introduction This section contains • how to read this manual • short description of Elecsys 2010 and Elecsys 1010 • features of the host interface
1.1
How to read this Manual
1.1.1 Intended Audience This manual is intended to meet the needs of the following groups of readers: • Operators of the Elecsys Analyzers or the Laboratory Systems Manager (not available in US) • Maintenance and service personnel • Software Engineers developing host interfaces for laboratory management software Only part of the information in this manual is needed in common by all groups mentioned above. Major parts of the manual are specific to each of these groups. To facilitate information retrieval the structure and outline of this manual takes account of these specific demands: • Section 1 "Introduction" contains general information about the Elecsys analyzer and its host interface helpful to all groups of readers. • Section 2 "How to" meets the needs of operators as well as maintenance and service personnel. This section contains detailed instructions for procedures and methods. • Section 3 "Theory of operation" provides information to software engineers who intend to develop interface software on host computers. This section contains a detailed introduction to the basic operation of the host interface (for example transmission protocol). • Section 4 "Engineering Reference" is a reference based on the basic information of section 3. Whereas section 3 is a systematic introduction and is to be continuously read like a tutorial, this section provides reference oriented access to information. The software engineer familiar with section 3 will most likely refer to this section. • Section 5 "Tables" is reference oriented. It contains additional information to all sections. • Section 6 "Examples" contains traces recorded with a simulator and/or host test tools.
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1.1.2 Documentation Conventions This manual uses the following special typefaces: Typeface
Meaning
Special font
This font is used for system and screen output, such as prompt signs and screen messages.
Italic and special font
This font is used for user input, such as commands, options to commands and arguments.
Table 1-1: Special Typefaces
1.1.3 Further Help In case of questions or difficulty please contact your local Roche Diagnostics Service Department. Field Sales Representatives (FSRs) may contact the central Service Management of Roche Diagnostics GmbH (Germany): Roche Diagnostics GmbH Lab Diagnostics Global System Support Sandhofer Straße 116 D-68305 Mannheim Germany
Tel:
+49 621 / 759-4204
Fax:
+49 621 / 759-4394
E-Mail:
[email protected] [email protected] [email protected]
US Roche Response Center Customer Technical Support: Tel:
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Introduction
Short Description of Elecsys 2010 Elecsys 2010 is a fully automatic analyzing system with direct, random access for the determination of immunological tests using an electrochemiluminescent (ECL) process. The analyzer can measure serum and plasma samples. The results are output in a quantitative form. The handling of Elecsys 2010 is very easy; manual error sources have been reduced to a minimum. By using ready-to-use reagents and calibrators, the preparation of these materials is no longer required. RD ready-to-use controls are also available dependent on the test. The closed reagent containers (reagent packs) are kept at a constant temperature of 20 °C in the reagent disk, thus ensuring long stability. Because the reagents and calibrators are registered using bar-codes, manual registration is also no longer necessary. By using bar-coded sample containers, the time for measurement preparation is reduced enormously. Top Cover (right)
Top Cover (left)
Incubator User Interface
System Reagents Circuit breaker
Reagent Disk Interface Connector
Distilled Water Bar Code Reader Tips Sample Disk
Cups
Liquid Waste
Floppy Disk Drive & Solid Waste
Operation Switch Figure 1-1: Elecsys 2010 Disk Version
Elecsys 2010 is especially suited for use in medium to large size laboratories. By means of the Laboratory-System-Manager (LSM) designed by Roche Diagnostics, several Elecsys 2010 analyzers can be centrally controlled (not available in US). The analyzer can also be connected to an existing laboratory EDP (Host).
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Figure 1-2: Elecsys 2010 Rack Version
1.3
Short Description of Elecsys 1010 The Elecsys 1010 is a fully automatic analyzer system for determination of immunological tests using an electrochemiluminescent (ECL) process. All components and reagents for the laboratory routine are integrated in or on the analyzer. Incubator
Sipper arm
S/R Probe
Measuring Cell
S/R Arm
ProCell & CleanCell
Liquid Waste Container
Distilled water container
S/R Disk
Control unit Printer
Figure 1-3: Elecsys 1010
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Operation of the analyzer is easy and intuitive. The reagents are stable and can generally be directly loaded on to the analyzer system. The consistent use of bar-coded reagents greatly reduces the need for time consuming manual inputs when performing the daily routine. Additional automation can be achieved by connecting a laboratory EDP system. Serum and plasma samples in primary tubes or secondary cups on tubes can be used. Bar-coded sample tubes are recognized. There are also two STAT positions available for STAT samples. Results are produced either qualitative or quantitative depending on the test. The typical test throughput is 50 results per hour.
1.4
Features of the Elecsys Host Interface • Bi-directional data transfer according to ASTM specifications: The host interface adds the ability of bi-directional data transfer to Elecsys analyzers via a RS232C asynchronous serial interface. The interface protocol relies on ASTM standard specifications 1381-91 (low level protocol) and 1394-91 (high level protocol; reference see page 3-32). • Test selection query mode (auto request): When samples are scanned (registered), the analyzer requests test orders from the host as soon as a sample bar-code is scanned. The host answers directly to the inquiry with appropriate test selections (Elecsys 1010 and Elecsys 2010). • Test selection batch mode: The host can download new or additional test orders to the instrument at any time before samples are scanned (registered). Also it is possible to cancel whole samples by the host (Elecsys 1010 and Elecsys 2010). • Automatic result upload: If set up the analyzer sends test results as soon as all measured data are available for one sample. • Specific result upload: If set up the operator decides whether undocumented results should be sent to the host (single or all). • Communicate additional manufacturer specific information: Beneath the above mentioned standard information (test orders and test results) the host interface updates regularly manufacturer specific information like alarms or instrument status. It communicates additionally inventory data, quality control and calibration data. Combined with the Laboratory Systems Manager (not available in US) you can take full control of those available data in a comfortable way. Since there is no need for interpretation the host ignores this data according to the ASTM specifications.
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How to ...
How to ... This section contains • how to set up the interface • how to operate the interface • how to do troubleshooting and maintenance
2.1
... use the Interface for Elecsys 2010
2.1.1 ... connect the Interface for Elecsys 2010 To connect the Elecsys 2010 analyzer to a laboratory EDP system (host) use a serial connection cable and the bi-directional interface connection on the left side of the instrument. The cable is described in section 4.1.1. Caution: Switch off the instrument before connecting the cable.
2.1.2 ... set up the Interface for Elecsys 2010 After switching on the instrument with the circuit breaker (right back side) it is also necessary to switch on the communication. Synchronize the parameters of the instrument interface with the host before turning on communication. The adjustments stay active when the instrument is powered off at the operation switch.
Buttons relevant for communication setup
Figure 2-1: UTIL Screen
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The DOCUMENTATION SETUP screen offers the operator options for managing results: Print and/or Upload to the Host. This setup influences what should be performed when the DOC key or the “document all” button is touched or when automatic documentation is performed. To set up automatic upload of test results to the host computer • touch the UTIL screen button • touch the DOCUMENTATION SETUP screen • touch the "Print/Upload" or "Upload" button. • touch the "Automatic ON" to receive requests as soon as they are available or the "Automatic OFF" button to manually send results.
Figure 2-2: DOCUMENTATION SETUP screen
To enter or change the setup parameters • touch the UTIL screen button • touch the INTERFACE SETUP screen button • touch the "Communication Off" button if communication is on. • touch the buttons for setting the correct values (color must be cyan) Baud Rate
2400, 4800, 9600, 19200
Data Bits
7,8
Stop Bits
1,2
Parity
none, odd, even and
Sync
on, off
• touch the "Communication On" button to reinitialize communication.
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Figure 2-3: INTERFACE SETUP screen
Note:
Only the buttons that are actually colored cyan (light blue) are active, i.e. can be selected.
Figure 2-4: Screen "Communication Confirmation"
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2.1.3 ... operate the Interface of Elecsys 2010 The need for operator interaction during up- and downloads depends on the mode in which the interface is running. In general all pending information, mostly manufacturer specific information will be sent when the communication is switched on. While the host can download test selections any time as batch or as response to an inquiry, the handling of results depends on the DOCUMENTATION SETUP setting. Both communication partners can send whenever they have data to send. In case that both want to transfer simultaneously the instrument has higher priority so the host must wait until the instrument is ready. The DOCUMENTATION SETUP screen influences what should be performed when the DOC key or the [“document all”] button is touched or when automatic documentation is performed. • Document Options Upload or Print/Upload and Automatic ON: When selected all results will automatically be transmitted by the analyzer in the order of sampling. When the bar code of a sample is scanned the sample will be assigned a sequence and position number (which is carrier number and position in the carrier) automatically. The analyzer requests test orders for each sample from the host using the sample bar code for bar-coded samples or the rack identification and position number for non bar-coded samples for identification. It is necessary to perform the sample programming at the host prior to that procedure. • Document Options Upload or Print/Upload and Automatic OFF: In this mode the operator must decide if the samples should be printed and/or sent to the host automatically or by manual initialization (setup see Figure 2-2). When this option is set to "AUTOMATIC Off" the transfer of results to the host can be triggered manually by using the DOC key or the "Document All“ button in the folder "Results“ (see Figure 2-5). Then there is an additional choice if the results already documented ("DOC"), or the results not yet documented ("Non Doc") or if all results ("All’) will be printed and/or uploaded at once. Pressing the DOC key initializes upload of the actual displayed sample. • Transfer of data due to manual events: If the host initializes the sending of Manufacturer Specific Records events like Reagent Scan, Bar Code Card Scan, Sample Scan or Start will trigger information exchange initiated by the analyzer (substance data, inventory) (see chapter 4.3.7.6). • Transfer of data due to automatic events: If the host initializes the sending of Manufacturer Specific Records events like alarm messages, consumption of inventory, changing instrument configuration or status, as well as calibrations create automatic information flow to the host. This information can be ignored by the host.
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Figure 2-5: Manual trigger to upload results
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How to ...
... use the Interface for Elecsys 1010
2.2.1 ... connect the Interface for Elecsys 1010 To connect the Elecsys 1010 analyzer to a laboratory EDP system (host) use a serial connection cable and the bi-directional interface connection on the left side of the instrument. The cable is described in section 4.1.1. Caution: Switch off the instrument before connecting the cable.
2.2.2 ... set up the Interface for Elecsys 1010 After switching on the instrument it is also necessary to switch on the communication. Synchronize the parameters of the instrument interface with the host before switching on communication. To set up communication parameters use the UTILITIES menu
Interface Setup
Utilities
Figure 2-6: UTILITIES Screen
• Press the UTILITIES key to open the UTILITIES main menu.
The arrow keys can be used to navigate between the input fields.
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Figure 2-7: INTERFACE Setup Screen
• Press the soft key to open the INTERFACE SETUP screen. Use the arrow keys to navigate between the fields. • Select the field HOST PROTOCOL. Press ENTER to open the pop-up window with selectable options. Use the arrow keys to select the appropriate host protocol. Press the ENTER key when complete. Refer to Fig. 2-8.
Figure 2-8: Select Host Protocol
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OFF:
A host is not connected.
HOST:
A host is connected.
LSM:
A host with a Laboratory Systems Manager is connected (not available in the US).
INTERNAL:
Not a customer option. Only for service personnel.
• HOST QUERY: Indicates whether host query mode is on or off. This field is only active if a setting other than OFF is selected for HOST PROTOCOL. The default setting is ON. If the setting is OFF, the host works in batch mode. • Input Instrument Network name: Displays the name of the analyzer as used in a network. The default setting is ELECSYS 1010. This name can be changed. • Select SERIAL INTERFACE HOST and touch the buttons for setting the correct values Baud Rate
1200, 2400, 4800, 9600, 19200
Data Bits
7,8
Stop Bits
1,2
Parity
none, odd, even
COMMENT: The Elecsys 1010 works without handshake. BAUD RATE: Displays the used communication speed in bits per second.
When ENTER is pressed, a pop-up window opens where a communication speed can be selected. DATA BITS: Displays the number of bits per data word that is used for communication.
When ENTER is pressed, a pop-up window opens where the number of data bits can be selected.
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STOP BITS: Displays the number of stop bits per data word that is used for communication.
When ENTER is pressed, a pop-up window opens where the number of stop bits can be selected. PARITY: Displays the parity recognition used for communication.
When ENTER is pressed, a pop-up window opens where the parity can be selected. SENDING ADDITIONAL DATA: Displays the following additional manufacturer specific records: RR: Raw Result RC: Result Context PM: Processing Message
Select YES or NO using the horizontal soft key at the bottom right of the screen. SUBSTANCE DATA TIMEOUT: Specifies the timeout for a manufacturer-specific record. This record contains general substance information (reagents, diluents, pretreatments, system reagents, calibrators, instrument calibrators, control, waste).
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diluent packs. After the upload after the run preparation scan the instrument should not use reagent pack inventory for inventory check or run calculation until a configurable time-out has run down. The respective action should be delayed. The time-out should be different from the time-out for order queries. The instrument should accept a reagent pack data download in every instrument state and use the information for all further actions. If the instrument receives such a download after the time-out has run down, a warning should be generated and added to the message history. HOST QUERY TIMEOUT: Specifies the timeout for the host query mode.
A number between 0 and 99 can be entered. The default setting is 99.
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SAMPLE BAR CODES: This area is used to specify the types of sample bar codes most frequently used on the analyzer. This reduces the read time significantly. DELETE LEADING ZEROS: Displays whether the sample bar code is processed with (YES) or without (NO) a fixed cut leading zero. AUTOMATIC POSITIONING: This mode is used when working with non-bar-coded samples and the host download is without a position number. Select YES or NO using the horizontal soft key at the bottom right of the screen. OPTIMIZED BATCH SEQUENCING: Selects the sequence change for complementary tests. Select YES or NO using the horizontal soft key at the bottom right of the screen.
Figure 2-9: Instrument Setup Screen
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DOCUMENTATION OPTION: Displays the Documentation Options which defines the behavior of result print out and/or upload to the Host.
AUTOMATIC, RESULT ORDER: Results are uploaded automatically in the order in which the results of individual test were measured. AUTOMATIC, SAMPLE ORDER: Results are uploaded automatically when all tests for a sample have been measured. MANUAL When this option is selected, the UPLOAD RESULT key displayed in the TEST REPORT screen. This option allows individual results to be sent to the host. OFF Results are not uploaded. Note:
Results must be either printed out, stored on a floppy disk or sent to the laboratory EDP (host). If one of these functions has been performed, the result is said to be documented and the position number is released for further use.
2.2.3 ... operate the Interface of Elecsys 1010 The Elecsys 1010 interface works in batch mode or in query mode. The need for operator interaction during uploads and downloads depends on the mode in which the interface is running. In general all pending information will be send when the communication is switched on. While the host can download test selections any time as batch or as response to an inquiry, the handling of results depends on the Documentation Options setting. Both communication partners can send whenever they have data to send. In case that both want to transfer simultaneously the instrument has higher priority so the host must wait until the instrument is ready.
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... do Troubleshooting and Maintenance The Elecsys User Interface software does not provide any means to troubleshoot the communication line. There are sophisticated error treatments inherent to the interface protocol. The host system must be able to trace and interpret error related protocol information and may react by outputting adequate screen messages. Following two hints may help you in case of • no communication at all: Check the cabling and the interface setup. • problems with the protocol: A simulator program is available as a software tool for analyzing communication problems as well as for development of host drivers. It can simulate either communication partner (host or analyzer) and writes communication traces to files to be analyzed off-line in a very convenient way supported by extensive help files. If you require this program, please contact your local Roche representative.
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Theory of Operation
Theory of Operation This section contains • an overview of the Interface • a description of Transmission Protocol • an example
3.1
Overview of the Interface As described in section 1.3 the host interface enables the Elecsys analyzer to exchange test results, test requests and all related data with a laboratory host computer system. Physically, the analyzer and host are connected by an RS 232 interface. Logically they use a standard protocol called ASTM (with proprietary extensions). ASTM is an implementation of the OSI model, which tries to classify the diversity of functions needed for such a message exchange using hierarchical layers. Once you are familiar with the OSI model you will easily understand the ASTM protocol layers. Whereas OSI defines seven layers, ASTM summarizes these layers into just four. In the next section after a short introduction to the OSI model and ASTM we will describe every layer of the ASTM protocol in detail.
3.2
Description of Transmission Protocol
3.2.1 Basics
3.2.1.1 OSI model The Elecsys Host Interface Protocol is consistent with the OSI (Open System Integration) model of the ISO (Organization for International Standards). The OSI model describes a system-independent method of transferring messages. Sending and receiving of messages is broken down into functions which are hierarchically classified into seven layers. Each layer restricts communication to the next higher and the next lower layer. It makes its communication services available only to the next higher layer. The layers do not interpret the messages. They just add transportation services like cutting the message in portions, putting envelopes around, calculating checksums, watching for a transmission receipt or converting bits and bytes into electrical current. Although the message has to travel through the different layers to be sent or received, transportation is virtually horizontal. This means a layer communicates with its partner layer on the other end of the communication link at equal hierarchical position without knowing about the functions of the lower layers (they are fully transparent to the higher layers). So protocols are defined between equal layers. Interchange of information between the next higher and the next lower layer is system specific and need not be known to the communication partner. This classification of
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communication functions is a highly efficient method to break down complex communication tasks into small portions that are easy to handle and interchangeable.
Figure 3-1: The OSI model explained by example
For you as a software engineer it is important to know, that you can program a low level layer (e.g. the Data Link Layer) without having to know about the protocol. You need not know what kind of messages the doctor and the laboratory are exchanging or what the phone numbers of the lab are. All you need to know is the protocol for the Data Link Layer and the interface structure to the neighboring layers. In our example you have to know that you will get messages from the Network Layer. The task is to break them down into words. You then have to program a packing algorithm meeting the protocol definitions of your layer. That means putting the words in frames with "$$$" around the words. Then you must add a trailing checksum calculated according to the protocol definitions. The ready to send frames must be transferred to the Physical Layer with a request to send these frames. Please note that this example does not reflect the processes of the Elecsys host interface. It shows a strongly simplified communication process to clarify classification of the diverse communication functions into layers. OSI implementations can
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summarize communication functions into less than seven layers like the ASTM protocol does with its four layers.
3.2.1.2 ASTM The ASTM protocol uses four hierarchical layers for processing communication data: • Application layers virtually exchange messages (e.g. test results) • Presentation layers virtually exchange records. One message consists of multiple records. • Data link layers virtually exchange frames. One record consists of one or more frames. • Physical layers physically exchange 8 bit ASCI codes through standard serial interfaces. One frame consists of max. 240 record letters (bytes) and 7 bytes of delimiter and checksum data.
Frame
Send/Receive
Frame
Send/Receive
Frame
Send/Receive
Frame
Send/Receive
Frame
Send/Receive
Frame
Send/Receive
Frame
Send/Receive
Frame
Send/Receive
Record
Record
Build Message Record Message
Communication Data Analyze Message
Record
Record
Figure 3-2: Correlation between Message Record Frame
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Figure 3-3: Layers of the ASTM-Protocol
The ASTM protocol definition is divided into a low level and a high level protocol. The ASTM low level protocol defines the data communication method by frames and is described in sections 3.2.4 and 3.2.5. The ASTM high level protocol defines the message structure, message resending process, record structure and types of records and their use. It is described in sections 3.2.2 and 3.2.3. Details of the ASTM protocol can be found in the Annual Book of ASTM Standards. Copyright American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, U.S.A
• ASTM E1381-94 Low Level Protocol: Specification for Low Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems. • ASTM E1394-91 High Level Protocol: Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems.
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3.2.1.3 Description of Terms Specific to ASTM To clarify some terms this chapter defines some specific wording according to the ASTM specifications (see also Glossary). • message - a textual body of information. Example: The test results of all orders for a group of patients and the related data. • battery - a group of tests ordered together, for example, an admitting battery. The term battery is used in the document synonymously with the term profile or panel. The test elements within a battery may be characteristic of a single physiologic system, for example, liver function tests, or many different physiologic systems. The battery is simply a convention by which a user can order multiple tests by specifying a single name. • test - a determination of a single analyte or a combination of values from other determinations or observations which constitute a measure of a single system attribute. Example: Determination of TSH in serum. • record - an aggregate of fields describing one aspect of the complete message. Example: The Patient Information Record in a "Measured Data Message" contains information related to the patient whose test results are reported. • field - one specific attribute of a record which may contain aggregates of data elements further referring the basic attribute. Example: The Patient Name Field in the Patient Information Record. • repeat field - a single data element which expresses a duplication of the field definition it is repeating. Used for demographics, requests, orders and the like, where each element of a repeat field is to be treated as having equal priority or standing to associated repeat fields. Example: The Test ID Field of an Order Record may contain the IDs of more than one test. The IDs of the multiple tests are all listed in the Test ID Field separated by the Repeat Delimiter. • component field - a single data element or data elements which express a finer aggregate or extension of data elements which precede it. For example, parts of a field or repeat field entry. As an example, the patient's name is recorded as last name, first name, and middle initial, each of which is separated by a component delimiter. Components cannot contain repeat fields. • upload - data transmitted from a clinical instrument to a computer system. Example: When the analyzer has finished all tests for a certain sample it downloads the results to the host. • download - data transmitted from a computer system to a clinical instrument. Example: The host orders the tests for a group of patients by uploading a test order message to the instrument.
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3.2.2 Application Layer At the Application Layer the Instrument (i.e. the analyzer) and the Host (i.e. LIS / HIS) exchange messages. The high level ASTM protocol defines the structure of these messages but cannot define the trigger events for messages or the reactions to messages. Such specifications are part of the individual implementation of the ASTM protocol, typically they depend on features of the Instrument (and Host). As you will see in section 3.2.2.1 messages are constructed by combining predefined records. The predefined set of records covers the typical messages to be exchanged between Instrument and Host. By use of manufacturer defined records this set can be extended to the needs of special features of the Instrument. More detailed information on the manufacturer specific records is beyond the scope of this section, however will be found in the section Engineering Reference. In the next sections the messages, trigger events, reactions and error handling are discussed.
3.2.2.1 Types of Events Most analyzers operate in a sample oriented manner, which means essential data transmission can be done by ordering tests and sending results. For further types of messages which do not need any intervention by the operator or host please refer to the section Engineering Reference. The standard messages can be divided into 6 types of events: • Inquiry to Host Example: The Instrument has scanned the sample bar-codes and needs the worklist (list of tests) to be performed with these samples (test selection). It informs the Host of this need by use of an request information message to the Host.
Message Header
Request Information
Message Terminator
H Q L
Figure 3-4: Inquiry to Host
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• Response from Host Example: The Host receives the inquiry for test selections. It reacts by sending the data using a test order message from Host.
H P
Message Header
Patient Information
O
Test Order
L
Message Terminator
Figure 3-5: Response from Host
• Inquiry to Instrument Example: The Host needs the results of a specific sample. It informs the Instrument of this need by use of a request information message to Instrument. Comment: Usually with the option "Automatic Upload On" all results for a sample will be sent to the Host as soon as ready. So there is no need to ask for results at the Elecsys 2010.
H Q L
Message Header
Request Information
Message Terminator
Figure 3-6: Inquiry to Instrument
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• Response from Instrument Example: The Instrument receives the inquiry for test results. It reacts by sending the data using a result message from Host.
Message Header
H P
Patient Information
O
Test Order
R
Result
Message Terminator
L
Figure 3-7: Response from Instrument
• Unrequested Upload to Host Example 1 "Query Mode" ("Automatic Upload On"): The Instrument sends all test results directly after completion of all tests for a sample without prior reception of an inquiry from the Host. Example 2 "Batch Mode" ("Auto. Upload Off" and "Auto. Printout Off"): The operator initializes manually to send all test results without prior reception of an inquiry from the Host.
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H
Message Header
P
Patient Information
O
Test Order
R
Result
L
Message Terminator
Figure 3-8: Automatic Upload to Host
• Unrequested Download from Host Example: The Host operator has completed the selection of tests for a set of samples. The Host sends this test selection data by a test order message without prior reception of an inquiry from the Instrument.
H P
Message Header
Patient Information
O
Test Order
L
Message Terminator
Figure 3-9: Batch Download from Host
The first four types of messages occur in a synchronous exchange of messages alternatively requesting and responding (e.g. triggered by a sample bar-code scan or all test for a sample are performed). This procedure is called "Query Mode" or "Auto Request Mode" (Documentation Setup is Automatic Upload ON).
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The last two types of messages occur in an asynchronous transfer of messages. An operator triggers the transmission of an up- or download message and the receiver of the message has to be prepared to interpret, store and react to this message. This procedure is used in "Batch Mode" (Documentation Setup is Automatic Upload OFF and Automatic Printout OFF). Beneath the above mentioned standard messages a couple of manufacturer information is sent automatically from the Elecsys instrument. This extensive information will provide a very comfortable information handling and interchange together with the Laboratory Systems Manager (LSM). Standard Hosts should ignore all manufacturer data like it is defined in the ASTM specification. Most Manufacturer Messages are typically asynchronous messages (one way information), like the Alarm Messages from the Instrument. Others, like the above mentioned Test Selection or Test Result Messages, can be exchanged in the synchronous as well as asynchronous way (answer & response).
3.2.2.2 Event Related Data Processing Instrument requests a message from the Host (instrument is sending): • After the request the instrument waits for the response from the Host for a certain time. • When the certain time has passed and another message has to be sent the instrument starts sending the new message to the Host. • When the instrument fails in sending a request to the Host the instrument stops resending the request. Instrument responds to requests from Host (instrument is sending). • After having received the request the instrument responds to this request at first priority. • When the instrument fails to send the response it stops resending the response. Instrument provides the Host with information (instrument is sending) • When the transfer of an upload message fails the instrument re-sends the upload message. • Resending the upload message is allowed twice. When the resending of the message fails twice the sending of this upload message is stopped. Host requests information from the instrument (instrument is receiving): • After having received a request from the Host the instrument responds to this request at first priority. • When the instrument fails to send the response message it tries again. • When resending the response fails twice, the response to this request is stopped. • When the Host requests canceling the inquiry, the response to this inquiry is also stopped. V 4.2 –Version 01/05
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Instrument requests from the Host • After having received the response from the Host the instrument updates the data base (DB) based on this response. (The update of the DB based on the response depends on the instrument status. When the DB is not updated the instrument reports this status to the Host as an alarm message.) Host provides the instrument with information • After having received the download from the Host the instrument updates the data base (DB) based on this download. (The update of the DB based on the download depends on the instrument status. When the DB is not updated the instrument reports this status to the Host as an alarm message.)
3.2.2.3 Message Priorities As message transmission is triggered by external events, it is possible, that more than one message is waiting to be sent by the instrument. Therefore priority levels are defined for each class of message (see Table 3-1).
Priority
Sending Order
Types of messages
High
1
Response (re-send)
Low
2
Response
3
Report the received message situation (re-send)
4
Report the received message situation
5
Inquiry (re-send)
6
Inquiry
7
Upload (re-send)
8
Upload
Table 3-1: Message Priorities
3.2.2.4 Events Table 3-2 to Table 3-7 summarize the messages used by the Elecsys analyzer with their events. The column "Records" shows the record types mentioned earlier which are used to construct the message. Records are discussed in detail in section 3.2.3.1. Please note that ASTM standard specifications primarily define the exchange of messages between analyzer and host for ordering tests, receiving results and managing patient related data. For system related, manufacturer dependent data as it is exchanged between the instrument and the LSM (Laboratory Systems Manager, not available in US), the ASTM standard specifies a "Manufacturer Information Record".
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This definition guarantees the exchange of "Manufacturer Specific Records" (MSR) by still using a standardized message exchange. As manufacturer defined messages contain highly specific information and can be subject to modifications by Roche Diagnostics without notification they are not listed in the following tables but for completeness in chapter 4.3
Messages
Records
Trigger Events
Inquiry of test selection information
Q
sample disk scanning
Messages
Records
Reception by Instrument
Test selection information
P, O
after inquiry
Table 3-2: Request from instrument to Host
Table 3-3: Response from Host to instrument
When executing the sample disk scanning, the instrument sends a request message for the test selection information to the Host after each sample bar-code scanned. The data is only requested for normal samples and control samples of which test selection information has not yet been registered.
Messages
Records
Reception by Instrument
Inquiry of test selection information
Q
any time
Inquiry of measured data
Q
any time
Table 3-4: Request from Host to instrument
Messages
Records
Trigger Events
Test selection information
P, O
Inquiry from Host
Measured data
P, O, R, C
Inquiry from Host
Table 3-5: Response from instrument to Host
The transmission of upload messages is asynchronous, i.e. it is not requested by an inquiry of the Host but triggered by events: • Measured data: ⇒ When all the measured result data of a normal or control sample are performed the instrument uploads the data under the condition that "Upload Options: Automatic ON" is requested on the DOCUMENTATION SETUP screen. This is configurable on Elecsys 1010 and the data can be sent automatically, in result order, or sample order. ⇒ When pressing the "Print All" button key on the Results screen on Elecsys 2010, the instrument uploads the measured data under the condition that "Upload
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Options" and "Print Options" are set to "Automatic OFF" on the DOCUMENTATION SETUP screen. ⇒ After turning on the power switch, the instrument is in the stand-by status. The instrument uploads all the remaining measured data which have not been uploaded before.
Messages
Records
Trigger Events
Measured data
P, O, R, C,
Completion of Tests, pressing "Print All"-button, power on
Table 3-6: Upload from instrument to Host
Messages
Records
Reception by Instrument
Test selection information
P, O
any time
Request cancel
Q
any time
Table 3-7: Download from Host to instrument
Please note that on Elecsys 2010 according to the ASTM specifications only one request record may be outstanding at a time, the receiver of a request record must terminate the request, when finished, via the message terminator record, or the sender must cancel the request before sending a second logical request. Therefore the "Request Information Record" (Q) can be used by the Host for canceling requests previously transmitted to the instrument. This is done by leaving fields 3 to 12 empty, field 1 is "Q", 2 is "1" and 13 is "A" (see 4.3.6.7). Canceling / deleting of samples in the data base will be done with the "Test Order record" (O) where the Action Code is "C".
3.2.2.5 Error Detection and Recovery Communication errors are detected at all different layers. The layers try to correct these errors at their level. If an error cannot be corrected by the error recovery procedures of a specific layer, it reports that error to the next higher layer. At last the Application Layer has to try a correction of the detected error condition or has to generate an alarm. In general there are six types of errors as following (see also description of errors in the specific sections of the related layer): • Send error: When the sending of a message fails at the Data Link Layer because of time outs or exceeded retransmission counts this error type is detected. Recovery: Resending of the message. • Receive error: When the receiving of a message fails at the Data Link Layer because of time outs or at the Presentation Layer because of detection of invalid Records this error type V 4.2 –Version 01/05
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is detected. Recovery: Sending of the appropriate termination code for "receiving message failed" in the Termination Record of the receipt message (see Table 3-8). • Improper message error: When the Presentation Layer receives an invalid message this error type is detected. A message is invalid because of wrong structure (see 3.2.3.1 Message Structure: Records) or record data not based on the rules (see 3.2.3.2 Message Structure: Fields). Recovery: Sending of the appropriate termination code for "receiving message failed" in the Termination Record of the receipt message (see Table 3-8). • Message acceptance error: As mentioned earlier response and download messages normally result in an update of the instrument's data base. There are certain conditions of the instrument, when an update of the data base is not possible. Such an impossibility of updating the data base results in a "Message acceptance error". Recovery: Sending of the appropriate termination code for "refusing received message" in the Termination Record of the receipt message (see Table 3-8). • Hardware error: When the Physical Layer reports a communication error this error type is detected. Recovery: After re-initialization of the communication circuit and a delay of 40 seconds sending messages are re-sent to the Host. • Application error: When the Data Link Layer detects an unrecoverable error this error type is picked up. Recovery: After re-initialization of the communication circuit and a delay of 40 seconds those messages are re-sent to the Host. The result status after the reception of a message from the Host is reported to the Host by the response message (in case of a received inquiry) or (in case of a received response or download) a Receipt Message containing only the framing "H" and "L" (Header and Termination) records (see 3.2.3.1). In both cases the reception status is reported by using the Termination Code Field in the Termination record ("L"). When receiving "response" and "download" messages normally, the instrument does not report the message receiving situation to the Host.
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Attribute of message
Theory of Operation
Message receiving situation normal
Inquiry abnormal
There is a response data.
F
There is no response data.
I
Not all data in records are in accordance to the rules. (Improper message error)
Q
Receive error Hardware error Application error
E
normal
Response & Download
Invalid attribution
*
abnormal
abnormal
Termination code
no message All data in records are not as ruled. (Improper message error) Message refusal Receive error (*) Hardware error (*) Application error (*)
E
The last record is not the Termination record.
R
Improper message error Receive error Hardware error Application error (*)
E
The instrument reflects the valid record data on the data base. Table 3-8: Termination Codes to different Error States
The occurrence of communication errors which cannot be corrected (e.g. by retransmission) results in an alarm condition of the Instrument. All layers report error states to the Application Layer. There they are reported to the operator. Communication errors detected by the Host are also reported to the Instrument’s Application Layer by the Termination Code in the Message Termination Record which is terminating every message. Table 3-9 summarizes the possible Alarms.
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Alarm Name
Contents
Cause of Alarm
Source Layer
Communication re-sending occurred
When sending a message, re-sending of the message occurred
Re-sending a message succeeded
Application
Communication re-sending failed
Re-sending a message failed
Re-sending a message failed
Application
Communication message acceptance error
Impossible to update the data base using the message.
Picked up the message acceptance error.
Application, Message Acceptance error
Communication message format illegal error
• There was a valid record, but no Termination Record. • There was no valid record. • The first record was not a header record. • There was an undefined record. • There was a record that was not in accordance to the rules.
• The last record was not the Termination record • Picked up the improper message errors.
Presentation, Improper Message Error
Communication application error
Application error happened.
Picked up the application error.
Data Link, Application Error
Communication sending error
Re-sending a message failed at the low level
Picked up sending error
Data Link, Send Error
Communication sending error
Time out happened at the lower level
Picked up sending error
Data Link, Send Error
Communication receiving error
Time out happened at the lower level
Picked up receiving error
Data Link, Receive Error
Communication device error
Hardware error happened.
Picked up the hardware error.
Physical, Hardware Error
Communication sending message aborted
Sending a message has been aborted
Received the Termination code = R
Any, from Host (Presentation)
Communication receiving message aborted
Receiving a message has been aborted
Received the Termination code = T
Any, from Host (Presentation)
Table 3-9: List of Alarm Conditions
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3.2.3 Presentation Layer
3.2.3.1 Message Structure: Records The typical message contains a set of information. E.g. the response message to a test result inquiry contains four levels (0-3) of information: • Data relating to the patients who’s test results are transmitted. • Data relating to the orders (test batteries) the test results belong to. • Data relating to the test results of each test battery for every patient. • Comment data with information belonging to each result. As you can see, there is a hierarchical structure in this set of information. Multiple comments can belong to one test result. Multiple test results can belong to one order (requested test profile). Multiple orders can belong to one patient. Multiple patients can belong to one message transmitted. Instead of repeating the patient data and order data for each test result, the order and patient data can be used like headlines in a hierarchical outline like the one of this document. This reduces transmission of redundant data and reflects the typical relational database model used for storing the message information. Note:
Elecsys 2010 only uses one patient per message and only one order per message can be made (with multiple test selections via repeat fields).
ASTM defines messages to consist of a hierarchy of records of various types (see Figure 3-10). Records at level zero contain information pertaining to the sender identification and completion of transmission. They can be seen as a kind of framing information relating to the message. Records at level one of the hierarchy contain information about individual patients. Records at level two contain information about test order requests and specimens. Records at level three contain information about test results. Comment records may be inserted at any level in the hierarchy. A comment record always relates to the immediately preceding patient, order, result, scientific or manufacturer information record. Therefore, if a comment record were to follow a patient record (level one), then that comment record would be treated as a level two record. A comment record may not follow the message terminator record. Manufacturer information records may be inserted at any level in the hierarchy (with the exception of level 0). This record type always relates to the immediately preceding patient, order result, scientific or comment record. Therefore, if a manufacturer information record were to follow a patient record (level one), then the record would be treated as a level two record. This record may not follow the message terminator record.
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Additional record types are the request-information record and the terminator record. The request-information record provides for the request of demographics or test results to or from the clinical instrument for specified patients, specimens, tests, dates, and so on. The message terminator record must be the very last record of the message.
(Level 0) (Level 1) (Level 1) (Level 2) (Level 2) (Level 3) (Level 3) (Level 3) (Level 4) (Level 4) (Level 4) (Level 4) (Level 4) (Level 3) (Level 2) (Level 3) (Level 3) (Level 3) (Level 3) (Level 3) (Level 3) (Level 2) (Level 3) (Level 3) (Level 3) (Level 3) (Level 3) (Level 4) (Level 1) (Level 1) (Level 1) (Level 1) (Level 0)
HEADER MANUFACTURER INFORMATION 1 PATIENT 1 (general information about patient) | COMMENT 1 Record (relates to previous patient PATIENT 1) | ORDER 1 (information about the first battery requested) | | COMMENT 1 Record (relates to previous order ORDER 1 ) | | RESULT 1 (information about the first result of battery 1) | | RESULT 2 (information about the second result of battery 1) | | | COMMENT 1 Record (Relates to RESULT 2) | | | COMMENT 2 Record (Relates to RESULT 2) | | | | | | | | | | | RESULT n (information about the last result of battery 1) | ORDER 2 (information about battery 2) | | RESULT 1 (information about the first result of battery 2) | | RESULT 2 (information about the second result of battery 2) | | | | | | | | RESULT n (information about the last result of battery 2) | ORDER n (information about the last battery for the first patient) | | RESULT 1 (first result of the last order) | | | | | | | | RESULT n (information about the last result of battery n) | | | COMMENT 1 Record (Relates to RESULT n) PATIENT 2 (all of the structure repeats) PATIENT n MESSAGE TERMINATOR Figure 3-10: Hierarchical Structure of Messages
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ASTM defines a given set of record types (see Table 3-10). One type (manufacturer information, identifier "M") can be used for manufacturer specific extension of this set (see Table 3-11). Most of the record types are related to each other in a definite hierarchy. At level zero is the message header and message terminator. At level one is the patient record, the request-information record and the scientific record. At level two is the test order record. At level three is the result record. The comment records do not have an assigned level. Level
Record Name
Identifier
0
Message Header Record
H
1
Patient Information Record
P
2
Test Order Record
O
3
Result Record
R
0..3
Comment Record
C
0..3
Manufacturer Information Record
M
0
Message Terminator Record
L
1
Request Information Record
Q
1
Scientific Record (This record is not used by the Roche Diagnostics implementation)
S
Table 3-10: Standard Record Types and Levels
The Roche Diagnostics specific records (MSR) follow the levels described below.
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Level
Record Name
Identifier
1
MSR - Action Confirmation (This record is not used by the
M-AC
Roche Diagnostics implementation) 1
MSR - Action Request
M-AR
(This record is not used by the Roche Diagnostics implementation) 1
1
MSR - Calibration Result
M-CR
(This record is not used by the Roche Diagnostics implementation) MSR - Calibration Order (Elecsys 1010 only) (This record is M-CO not used by the Roche Diagnostics implementation)
1
MSR - Calibrator Parameters
M-CP
1
MSR - Calibration Scheme (Elecsys 1010 only) (This record is not used by the Roche Diagnostics implementation)
M-CS
2
MSR - Control Parameters
M-QP
1
MSR - Control Scheme (Elecsys 1010 only) (This record is not used by the Roche Diagnostics implementation)
M-QS
2 1 1 1 1
MSR - Diluent Parameters MSR - Instrument Configuration MSR - Instrument Status MSR - Log File MSR - Processing Message
M-DP M-IC M-IS M-LF M-PM
1
MSR - Change Communication Protocol (Elecsys 1010 only) M-PX (This record is not used by the Roche Diagnostics implementation)
4 4 1
MSR - Raw Result MSR - Result Context MSR - Sample Status
M-RR M-RC M-SS
(This record is not used by the Roche Diagnostics implementation) 1 1 1 1
MSR - Service Data MSR - Substance Data MSR - Test Application MSR - Test Conditions
M-SD M-XT M-TA M-TC
Table 3-11: Manufacturer Defined Records and Levels
• Message Header Record (H) - This record contains information about the sender and the receiver, that is, it identifies the instrument(s) and the computer systems whose records are being exchanged. It also defines the field, repeat field, and component field delimiter characters. • Patient Information Record (P) -This record type contains information about an individual patient. • Test Order Record (O) - When sent from the computer system to the instrument, this record represents a test order and may be followed by one or more result records which would contain information pertinent to the test being ordered. When sent by the instrument to the computer system, it provides information about the specimen/test request, and may be followed by result records (at least one record for each test within the ordered batteries). • Result Record (R) - Each result record contains the results of a single analytic determination.
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• Comment Record (C) - Comment records can apply to any other record except the message trailer record. They may be free standing messages sent to or from the instrument, unrelated to a particular patient or test procedure. • Request Information Record (Q) - This record is used to request information for new tests, for tests previously ordered, and possibly for tests previously reported. A single request information record may request demographic information, or results (only on Elecsys 2010) for an individual test, multiple tests, or all tests for a single date, a series of dates, or a range of dates, or both, and for an individual patient, group of patients, individual specimens, groups of specimens, etc. • Scientific Record (S) - This record is used to exchange results between clinical sites for the purposes of proficiency testing or method development (not used by the Roche Diagnostics implementation). • Manufacturer Information Record (M) - This record, which is similar to the comment record, may be used to send complex structures where use of the existing record types would not be appropriate. The fields within this record type are defined by the manufacturer. • The manufacturer specific records defined by Roche Diagnostics are classified by a sub record ID (see Table 3-11). They were introduced for the communication with the Laboratory Systems Manager. A standard host usually will ignore those messages. A sequence of patient records, order records, or result records at one level is terminated by the appearance of a record type of the same or higher level. Thus, a sequence of results for one battery of tests is terminated by the next test order, patient, manufacturer information, request information, or message terminator record. An order record may never appear without a preceding patient record and a result record may never appear without a preceding order record. When an order is transmitted, it must be preceded by a patient record. All orders that follow apply to the patient in the preceding patient record. When a result is transmitted, it must be preceded by an order record and a patient record to maintain the prescribed hierarchy. In order to determine buffering requirements, both transmitter and receiver must use common rules for storing transmitted data in order to ensure proper error logging and error recovery procedures. Since data content is structured in a hierarchical fashion, any decremental change in the hierarchical level will trigger storage of all data transmitted prior to said level change. This rule may be considered as the minimal implementation. In the following example (Table 3-13), permanent storage of data, by the receiver, should occur at points: E, G, L, M, N, Q. Q is assumed as saved by virtue of the record type function.
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Line #
Record Type
(Level) Increment
A
Header
(Level 0)+0
B
Patient 1
C
(Level 1)+1 Order 1
D
(Level 2)+1 Result 1
E
(Level 3)+1
Order 2
F
(Level 2)-1
Order 3
G
(Level 1)-1 Order 1 Comment 1
(Level 3)+1
J
Result 1
(Level 3)+0
K
Comment Result 2
M
Order 2
N
Patient 3
O
Order 1
P Q
{Save E-F}
(Level 2)+1
I
L
{Save A-D}
(Level 2)+0
Patient 2
H
Action
(Level 4)+1 (Level 3)-1
{Save G-K}
(Level 2)-1
{Save L}
(Level 1)-1
{Save M}
(Level 2)+1 Result 1
Message Terminator
(Level 3)+1 (Level 0)-3
{Save N-P}
Table 3-12: Information Storage Requirements, Transmission Example
Line Failure Occurs At:
Requires Retransmission Of:
A
A
B
A, B
C
A, B, C
D
A, B, C, D
E
A, B, C, D, E
F
A, B, E, F
G
A, B, E, F
H
A, G, H
I
A, G, H, I
J
A, G, H, I, J
K
A, G, H, I, J, K
L
A, G, H, I, J, K, L
M
A, G, H, L, M
N
A, G, M
O
A, N, O
P
A, N, O, P
Q
A, N, O, P, Q
Table 3-13: Error Recovery at Presentation Layer
Transmission line failure, determined at the transmission protocol level, requires a mechanism for restarting the incomplete message. If a transmission failure occurs, transmission shall restart at the last logical record not presumed saved as outlined. In order to fulfill hierarchical record level requirements, all logical records necessary to reach the restart record point must be repeated prior to transmitting the record where
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line failure originally occurred. Using the transmission example as given, the following record recovery examples would be valid. 3.2.3.2 Message Structure: Fields The smallest element of information in any record is the field, containing a single item of information, such as a date, a patient name, or a numeric test result. In the upper layers, ASTM does not define a limit for the length of a message, record or field, so the length of a message is flexible. There are special delimiter characters to indicate the end of record fields (see Table 3-14). ASTM defines specific sets of fields for each record type (see section 4.3.7). All data are represented as eight bit values, within the range (0-255), where 0-127 are defined by the ASCII standard (ANSI X3.4-1986) and values 128-255 are undefined by this standard. Values 0-31 are disallowed with the exception of 7, 9, 11, 12, and 13, where 13 is reserved as a record terminator. Values 32-126 and 128-254 are allowed. Values 127 and 255 are also disallowed. It is the responsibility of the instrument vendor and computer system vendor to understand the representation of any extended or alternate character set being used. As an example, the numeric value 13.5 would be sent as four byte value characters 13.5 or ASCII(49), ASCII(51), ASCII(47), ASCII(53). Allowed Characters:
7, 9, 11, 12, 13, 32-126. 128-254
Disallowed Characters:
0-6, 8, 10, 14-31, 127, 255
Within text data fields, only the ASCII characters 32-126 and the undefined characters 128-254 are permitted as usable characters (excluding those used as delimiter characters in a particular transmission). Furthermore, all characters used as delimiters in a particular transmission are excluded from the permitted range. Delimiter characters are defined for each message in the header record. The sender is responsible for screening all text data fields to ensure that the text does not contain those delimiters. Alphanumeric characters should not be used as delimiters because they are likely to appear within field content. Moreover, some alphabetic characters have special uses as follows:
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record type IDs
.
decimal point (period)
,
comma
S, P, R, C
priority codes
L, H, , N, U, D, B, W
result codes
C, P, F, X, I, O
result status
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The following delimiters are used as standard in the ASTM specifications:
Delimiter
Character
Char.
ASCII decimal
ASCII hex.
Record delimiter
= carriage return
13
0Dh
Field delimiter
= vertical bar
|
124
7Ch
Repeat delimiter
= backslash
\
92
5Ch
Component delimiter
= caret
^
94
5Eh
Escape delimiter
= ampersand
&
37
26h
Table 3-14: Delimiter Characters as used in ASTM Specifications
• Record Delimiter - Carriage return (ASCII 13) is the delimiter for the end of any of the defined record types. • Field Delimiter - A single allowable character excluding ASCII 13 (carriage return), separates adjacent fields. The field delimiter is variable and defined in the message header. The same delimiter must be used in all records following a header and preceding a message terminator record. • Repeat Delimiter - A single allowable character excluding ASCII 13 and the value for the field delimiter. The repeat delimiter must be defined in the message header and is used to separate variable numbers of descriptors for fields containing parts of equal members of the same set. • Component Delimiter - A single allowable character excluding ASCII 13 and the field and repeat delimiter values. The component delimiter is used to separate data elements of fields of a hierarchical or qualifier nature. For example the street, city, state, zip, etc. of an address field would be separated by component delimiters. • Escape Delimiter - A single allowable character excluding ASCII 13 and the field, repeat, and component delimiter values. The escape delimiter is used within text fields to signify special case operations. Applications of the escape delimiter are optional and may be used or ignored at the discretion of either transmitter or receiver. However, all applications are required to accept the escape delimiter and use it to correctly parse fields within the record. Use of Escape Delimiter - The escape delimiter may be used to signal certain special characteristics of portions of a text field (for example, imbedded delimiters, line feed, carriage return, etc.). An escape sequence consists of the escape delimiter character followed by a single escape code ID (listed below), followed by zero or more data characters followed by another (closing) occurrence of the escape delimiter character. No escape sequence may contain a nested escape sequence. The following escape sequences are pre-defined.
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&H&
start highlighting text
&N&
normal text (end highlighting)
&F&
imbedded field delimiter character
&S&
imbedded component field delimiter character
&R&
imbedded repeat field delimiter character
&E&
imbedded escape delimiter character
&Xhhhh&
hexadecimal data Any number of hexadecimal digits (0-9, A-F) may follow (that is, &XA& could equal line feed).
&Zcccc&
Local (manufacturer defined) escape sequence Any number of legal characters may follow.
Fields are identified by their position, obtained by counting field delimiters from the front of the record. This position-sensitive identification procedure requires that when the contents of the field are null, its corresponding field delimiter must be included in the record to ensure that the i'th field can be found by counting (i-1) delimiters. Delimiters are not included for trailing null fields; that is, if the tenth field was the last field containing data, the record could terminate after the tenth field, and therefore would contain only nine delimiters. Transmitted records may include more fields than are required by a receiving system. When processing a message, the receiving system may ignore any field it does not require. Fields must always be transmitted, however, in the positional order specified. A system may transmit a null value for a field because (1) it does not know the value, (2) it knows the value is irrelevant to the receiving system, or (3) the value has not changed since the last transmission, or any combination thereof. To exemplify case (3), a lab within a tightly linked hospital network may never transmit the patient's date of birth, sex, or race in the patient record when transmitting the order and result records to the requesting system, because it knows that the hospital registry system always broadcasts new or changed patient data to the receiving system. Because the sending system can use null values to indicate no change, a null value does not overwrite existing data in the receiving system. In rare circumstances, for example, if a system erroneously sent a patient’s date of birth when the date of birth was actually unknown, the receiving system should replace its existing value for a field with a null value. A field containing only a pair of double quotes (ASCII-34) should be treated as an instruction to the receiver that the existing contents pertaining to that field definition should be deleted.
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3.2.3.3 Common Field Types: • Universal Test ID - This field is defined as a four part field with provisions to further define the test identification via use of component fields. The test ID field is used to identify a test or battery name. The four parts which are defined below are the universal test identifier, the test name, the test identifier type and the manufacturer defined test code. All test ID parts must be separated by a component delimiter and are position dependent. As an example, additional information which may be included in this field type are instrument ID, organism ID (for sensitivity tests), well number, cup number, location number, tray number, bar code number, etc. It is the responsibility of the instrument manufacturer to define the data content of the test ID field. When the test ID is used in the result record, there must be sufficient information within the test ID field to determine the relationship of the test result to the test battery or batteries ordered. • Universal Test ID (Part 1) - This is the first component of the test ID field. This field is currently unused but reserved for the application of a universal test identifier code, should one system become available for use at a future time. • Universal Test ID Name (Part 2) - This would be the test or battery name associated with the universal test ID code described in 5.1. • Universal Test ID Type (Part 3) - In the case where multiple national or international coding schemes exist, this field may be used to determine what coding scheme is employed in the test ID and test ID name fields. • Manufacturer’s or Local Code (Part 4) - This is the code defined by the manufacturer. This code may be a number, characters, or multiple test designator based on manufacturer defined delimiters (that is, AK.23.34-B). Extensions or qualifiers to this code may be followed by subsequent component fields which must be defined and documented by the manufacturer. For example, this code may represent a three part identifier such as - Dilution^Diluent^Description. • Dates and Times - In all cases, dates are recorded in the YYYYMMDD format as required by ANSI X3.30. December 1, 1989 would be represented as 19891201. When times are transmitted, they are represented as HHMMSS, and are linked to dates as specified by ANSI X3.43. Date and time together are specified as up to a fourteen-character string: YYYYMMDDHHMMSS. • Time Zone - The time zone may be optionally appended to the date/time field in the format +HHMM or -HHMM as appropriate. The default time zone is that of the sender. • Telephone Numbers - Phone numbers are recorded as free text, which may contain extensions such as area code, country code, beeper number, hours to mail, etc. • Multiple Phone Numbers - When multiple telephone numbers apply, they may be included in one field and separated from each other by repeat delimiters. The first such entry is considered the primary or the daytime number.
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• Fixed Measurements and Units - When a field contains a specific observation, for example, patient's weight, patient's height, or collection volume, the default units of measurement for that observation are specified in the field definition. When the observation is measured in the default units, the units need not be transmitted. If the measure is recorded in units different from the default, for example, if the weight is measured in pounds rather than kilograms, the measurement units must be transmitted. In this case the units are transmitted in the same field as the measurement. The units follow the measure and are separated from it by a component delimiter, for example, 100^lb. Units should be expressed in ISO standard abbreviations in accordance with ISO 2955. • Addresses - An address occupies a single field in a record. The address may be comprised of five components (street address, city, state, zip or postal code, and country code) separated by component delimiters so that the receiving party can break them into separate fields as needed. An example would be 52 Hilton Street #B42^Chicago^IL^60305^USA. The country need only be transmitted when it cannot be assumed from the context. The components of this field are position dependent. • Provider and User IDs - Physician's and other health staff codes may be transmitted as internal code numbers, as full names, or both, as mutually agreed upon between the sender and the receiver. When both the name and ID number are sent, ID numbers should come first and be separated from the name by a component delimiter. Each component of the name is also separated by a component delimiter. The order of the components of the name are (1) last name, (2) first name, (3) middle initial or name, (4) suffix, for example, Jr., Sr., etc., and (5) title, for example, Dr., Mr., etc. Thus, if Dr. John G. Jones, Jr. had an identifier of 401-0, his number and name would be transmitted as 401-0^JONES^JOHN^G^JR^DR>. When necessary, more than one ID may be sent within one field. Multiple IDs in one field are separated by repeat delimiters. • Record Sequence Number - This is a required field used in record types that may occur multiple times within a single message. The number used defines the i'th occurrence of the associated record type at a particular hierarchical level and is reset to one whenever a record of a greater hierarchical significance (lower number) is transmitted or if the same record is used at a different hierarchical level (for example, comment records).
3.2.4 Data Link Layer 3.2.4.1 General Description As described earlier the Data Link Layer has to perform the following services: • Link and release of connection: Establishes which system sends and which systems receives information.
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• Cut messages in smaller frames of text, delimit frames: Provides for recognition of frames • Synchronize transfer of frames and sequential control: Maintains the sequential order of information across the connection. • Error detection: Senses transmission and format errors. • Error recovery: Attempts to recover from detected errors by re-transmitting defective frames or returning the link to a neutral state from otherwise unrecoverable errors. The ASTM low level protocol is a simplex stop and wait protocol. E.g. information always flows in one direction at a time. Replies occur after information is sent, never at the same time. In contradiction to other communication protocols there is no master slave relation. Both instrument as well as host may initialize the communication. To establish which system sends and which system receives information and to assure the actions of sender and receiver are well coordinated, there are three distinct phases in transferring information: • Establishment Phase (Link Connection) • Transfer Phase • Termination Phase (Link Release)
Establishment Phase
Sender
ENQ
Termination Phase
Transfer Phase
intermediate frame
end frame
EOT
Receiver ACK
ACK
ACK
Figure 3-11: Three Phases at Data Link Layer
3.2.4.2 Establishment Phase (Link Connection) At the Data Link Layer both communication partners can be in one of the three following states: • Idle: Waiting to become a receiver • Sender: Initiates establishment phase, sends record information in frames and ends with termination phase
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• Receiver: Receives frames and sends acknowledgment codes. At the same time only one device can be sender and only one device can be receiver. Both devices can be in idle state at the same time. If the Presentation Layer asks the Data Link Layer to transfer a record, the device must change from idle state to sender state. To ensure that only a single device tries to become sender at one time and the communication partner is listening (i.e. in receiver state) the device intending to become sender has to initiate the Establishment Phase. Therefore it sends the ASCII code 5 [ENQ] and waits for the partner to send code 6 [ACK] to signal that it changed from Idle to receiver state. The reception of [ACK] completes the Establishment Phase and starts the Transfer Phase. In idle state any other character received than [ENQ] will be ignored. Receiving an [ENQ] should be answered with [ACK] and sets the receiver into receiver state. This would be the regular procedure for the Establishment Phase. In case of error there are three more ways the receiver can respond to an [ENQ]: • The receiver sends any character than [ACK]. Typically this would be an ASCII code 21 (15hex) [NAK] when the receiver is busy. The sender waits an amount of time (e.g. Elecsys waits 10 seconds) and then tries establishment with another [ENQ]. This cycle is repeated until a [ACK], [NAK], or any other character is received.
Establishment Phase
retry
retry 10 sec
ENQ
Sender
1 sec
ENQ
ENQ
Transfer Phase
abort 15 sec
EOT
ENQ
Receiver xxx
ENQ
ACK
Figure 3-12: Response is any character
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• The receiver sends an [ENQ]. In ASTM terms this situation is called "Contention" as both devices try to become senders. The instrument system has by definition the higher priority to transmit information when contention occurs. Therefore the host system has to stop sending [ENQ] but has to answer with [ACK] or [NAK] when it detects contention. On the other hand the Elecsys waits at least 1 second and then returns another [ENQ]. This cycle is repeated until a [ACK], [NAK], or any other character is received.
Establishment Phase
retry 10 sec
ENQ
Sender
retry 1 sec
ENQ
ENQ
Transfer Phase
abort 15 sec
EOT
ENQ
Receiver xxx
ENQ
ACK
Figure 3-13: Contention: Response is any [ENQ]
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• The receiver does not respond. The receiver waits 15 seconds, initiates the Termination Phase by sending an [EOT] (ASCII code 4), and displays an error message.
Establishment Phase
retry
retry 10 sec
ENQ
Sender
1 sec
ENQ
Transfer Phase
abort 15 sec
ENQ
EOT
ENQ
Receiver xxx
ACK
ENQ
Figure 3-14: Time out: No response
• The receiver sends an [ACK]. The sender changes to Transfer Phase and initiates the record transfer. Alternatively, if the Elecsys is in Test Mode, it initiates the Termination Phase by sending an [EOT] (ASCII code 4).
Establishment Phase
retry 10 sec
ENQ
Sender
retry 1 sec
ENQ
ENQ
Transfer Phase
abort 15 sec
EOT
ENQ
Receiver xxx
ENQ
ACK
Figure 3-15: Establishment Phase confirmed, continue with Transfer Phase
Figure 3-16 shows the four possible responses to an [ENQ] in a flowchart presentation. Entry point "A" is triggered by the Presentation Layer when requesting
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transmission service from the Data Link Layer. Point "B" is the entry point for retrials in case of errors. Point "C" marks the transition to the Transfer Phase of this layer (Figure 3-17).
A Message to be sent
B Send [ENQ]
Start Timer
Read RS232
No
Yes Message received ?
Yes
No
No
Yes [ACK] ?
[ENQ] ?
Time out (15 s) ? Yes
Device = Analyzer
Yes
No Wait 20 sec
Error: 'No answer from host'
No
Wait 1 sec
Error: Contention on Line
Error: 'Answer different from [ACK]'
No Error: Go on with Transfer Phase
Send [EOT]
B
B
B
C
Figure 3-16: Establishment Phase, Flowchart
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3.2.4.3 Transfer Phase The Presentation Layer builds and interprets records containing the information of the messages. These records are exchanged with the Data Link Layer, which is expected to transmit them during the Transfer Phase. As the records may have an extensive byte length, one task of the Data Link Layer is to cut records into portions not longer than 240 bytes. These portions are packed in frames. Another seven bytes of delimiters, checksum and identifiers are added as frame overhead to the frame message. Thus the frame length may vary between 8 and 247 bytes. There are two types of frames: intermediate frames and end frames. Messages (i.e. records) longer than 240 bytes are cut into one or more portions of 240 byte put into an intermediate frame. The remaining bytes for the last frame are put into the end frame. For example there are two intermediate frames and one end frame for records with a length from 481 up to 720 bytes. Records with a maximum length of 240 bytes result in only one end frame. Two different Records are never put together in a single frame! After each frame sent, the sender stops transmission until a reply is received or a timeout occurs. Normally the receiver sends an [ACK] or [EOT] receipt to signal that the last frame was received successfully and that it is prepared to receive the next frame. [EOT] has the meaning of [ACK] but additionally requests the Sender to stop transmission as soon as possible (Receiver Interrupt). ASTM specifications allow the sender to treat a receiver interrupt like a normal [ACK], i.e. it is able to implement a special receiver interrupt routine. The receiver sends a [NAK] response to signal that the last frame was not successfully received and that it is prepared for a retransmission of the last frame. So there are 3 ways a host can respond to frame transmission of the analyzer: • The host sends an [ACK] or [EOT]. The Elecsys sends the next record. Since the Elecsys has more data to transfer it continues to transmit records (starting with Establishment Phase). • The Host sends any other character but [ACK] or [EOT] (e.g. [NAK]). The Elecsys repeats the transmission of the record. This cycle is repeated until a "Number of On Error Retries" of six is reached. At this point the Elecsys initiates the Termination Phase by sending an [EOT] and displays an error message. • The Host does not respond. The Elecsys waits 15 seconds, initiates the Termination Phase by sending an [EOT] and displays an error message. These are the reactions to different host responses to a frame transmission of the Elecsys. When the Elecsys is in Receiver State and waits to receive a frame from the host, there are three possible scenarios: • The host sends frame characters. If a complete frame is received it is checked for the right frame number and a
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correct checksum. Valid frames are answered with an [ACK] by the Elecsys. Invalid frames result in a [NAK] response and rejection of the invalid frame. • The host does not complete sending a frame. When neither Reception of a frame is completed nor an [EOT] is received 30s after Elecsys responded with the last [ACK] or [NAK], a time-out occurs. Elecsys discards the last incomplete message, changes to Idle State and regards the line to be in the neutral state. • The host sends an [EOT]. This resets the Elecsys to Idle State. Only completely received frames are regarded to be valid. Figure 3-17: Transfer Phase, Flowchart shows the three possible responses to a frame transmission. Entry point "C" is triggered by successful completion of the Establishment Phase. It is also reentry point for subsequent successful frame transmissions. Point "D" is the entry point for retrials in case of answers different from [ACK]. Point "E" marks the transition to the Termination Phase of this Layer (Figure 3-18).
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C Reset Retry Counter
D Send Frame
Start Timer
Read RS232
Message received ?
Yes
No
No
No
Yes [ACK] or [EOT] ?
Time out (15 sec) ? Yes
Send next record
Retry no. +1
No Retry Counter > x ? (X=1 to 9) Yes
Error: 'No answer from host'
Error: 'Answer different from [ACK]'
E
E
No
D
Last record ?
C
Yes
E
Figure 3-17: Transfer Phase, Flowchart
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3.2.4.4 Termination Phase (Link Release) The Termination Phase is the transition of both communication partners to idle state. It can only be initiated by the sender by simply sending an [EOT] code. There is no response of the receiver to that message. Whenever a receiver detects an [EOT] it has to change to idle state, regarding the line to be in the neutral state.
E Send EOT
A Figure 3-18: Termination Phase, Flowchart
3.2.4.5 Frame Format As mentioned earlier there are two kinds of frames: • The intermediate frame [STX]
FN
Text first char. ...... Text last char.
ETB
CH
CL
[CR]
[LF]
ETX
CH
CL
[CR]
[LF]
• The end frame [STX]
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FN
Text first char. ...... Text last char.
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[STX]
is the ASCII code 2, indicating the beginning of a frame transmission.
FN
is a one digit Frame Number (1,2,3,4,5,6,7 or 0). Frames are cyclically numbered to enable the receiver to check for valid frame sequences. The first frame of a message gets number 1, the eighth frame gets number 0, the ninth gets number 1 again and so on.
[ETB]
is the ASCII code 23 (17hex), indicating the end of the text block of an intermediate frame.
[ETX]
is the ASCII code 3, indicating the end of the text block of an end frame.
CH, CL
represent the high nibble (= most significant 4 bit) and the low nibble (=least significant 4 bit) of the 8 bit checksum, respectively. CH and CL are represented as two digits of hex numbers. The checksum is the modulo 8 of the sum of ASCII values of the frame characters starting with and including "FN" and completing with [ETX] respectively [ETB] (Example see Table 4-7).
Text
is the data content of a frame (max. 240 characters). Records are sub divided into intermediate frames with 240 characters maximum indicated by [ETB]. The only or last remaining frame will be indicated by [ETX]. Different records must be sent in different frames! Allowed characters are listed in Table 3-15 and Table 3-16.
Allowed Characters:
7, 9, 11, 12, 13, 32-126, 128-254
Disallowed Characters:
0-6, 8, 10, 14-31, 127, 255
Table 3-15: Allowed and disallowed ASCII codes
The Presentation Layer uses some characters as special delimiter codes. These characters may not be used as normal message text:
Delimiter
Character
Char.
ASCII decimal
ASCII hex.
Record delimiter
= carriage return
13
0Dh
Field delimiter
= vertical bar
|
124
7Ch
Repeat delimiter
= backslash
\
92
5Ch
Component delimiter
= caret
^
94
5Eh
Escape delimiter
= ampersand
&
37
26h
Table 3-16: Delimiter Characters
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3.2.5 Physical Layer Physical connection between the Elecsys analyzer and a host computer system is established by means of standard serial interfaces and a RS232C cable with three cores. For the cable (scheme see 4.1.1) and connectors a special 0-modem type with 9 pin female sub-D connector on host side and 9 pin male sub-D connector on Elecsys side is used. Synchronization (not used in US= is achieved by passive software handshaking (XON/XOFF) but can be switched off completely during the interface setup of the Elecsys analyzer. The Elecsys itself never will send Xon/Xoff. If you switch off synchronization at the Physical Layer, the next higher synchronization will be a software synchronization by frame packages performed by the Data Link Layer. As the maximum length of a frame is 247 bytes, the host interface will then have to buffer or process at least 247 bytes in real time. Baud rate (2400 to 19200), data bits (7 or 8), stop bits (1 or 2) and parity (none, odd, even) are also adjustable during the interface setup of the Elecsys analyzer.
3.3
Example
3.3.1 Test Selection for New Sample ID Communication is switched on. Start Run is requested. After the scanner recognized the sample bar code the analyzer requests the lists of tests to be performed with this sample. The host responds by sending the test selection data. This procedure repeats for each sample in the sample disk:
Instrument requests test selections for sample 000004: Message Header
Requ. Info.: ID# 000004
Message Terminator
H ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK]
ELEC
HOST
[STX]2Q|1|^000004^278^0^19^^SAMPLE^NORMAL||ALL| |||||||O[CR] [ETX]38[CR][LF] [ACK]
ELEC HOST ELEC
[STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Q
L
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Host responds with test selections for, sample 000004 10=TSH, 20=T4, 30=FT4:
H
P
O
L
Message Header
HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&|||ASTM-Host[CR][ETX]59[CR][LF] [ACK]
HOST ELEC
[STX]2P|1||000004[CR][ETX]5B[CR][LF] [ACK]
HOST ELEC
[STX]3O|1|000004|278^0^19|^^^10^0\^^^20^0|R|||||| N||||||||||||||O[CR][ETX]58[CR][LF] [ACK]
HOST ELEC HOST
[STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Patient Info. ID# 000004
Test Order: TSH, T4
Message Terminator
3.3.2 Upload Results after Tests are Performed Communication is switched on. Upload option is "Automatic ON". After the tests of a sample are being performed the instrument sends the results to the host. This procedure repeats for each sample in the sample disk: Message Header
Patient Info. ID# 000004
Test Order: ID# 000004
H ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK]
ELEC HOST
[STX]2P|1||000004[CR][ETX]5B[CR][LF] [ACK]
ELEC
[STX]3O|1|000004|278^0^19^^SAMPLE^NORMAL|ALL| R|19960614142107|||||X||||||||||||||0[CR][ETX]25[CR] [LF] [ACK]
P
O
HOST Result TSH: 2.01 µIU/ml
R ELEC HOST
Result T4: 320.0 nmol/l
R ELEC HOST
Comment: out of range
[STX]5R|2|^^^20^0|320.0|nmol/l|58.80^151.0|L||F||| 19970425120351|19970425122213|[CR][ETX]EC[CR][LF] [ACK]
C ELEC
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[STX]4R|1|^^^10^0|2.01|uIU/ml|1.69^2.43|||F|||1997 0509135452|19970509141314|[CR][ETX]E3[CR][LF] [ACK]
[STX]6C|1|I|49^Above normal(expected)range|I [CR][ETX]58[CR][LF]
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Result HBSAG: negative
HOST
[ACK]
ELEC
[STX]7R|1|^^^400^|-1^0.453|COI|^|||F||| 19970618105515|19970618111337|[CR][ETX]0A[CR][LF] [ACK] [STX]0L|1[CR][ETX]39[CR][LF] [ACK] [EOT]
R
HOST ELEC HOST ELEC
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4
Engineering Reference
Engineering Reference This section contains • Physical layer • Data link Layer • Presentation layer • Trace Examples
4.1
Physical Layer
4.1.1 Cabling There are two different versions of connection plugs for Elecsys instruments. The older instruments have a female socket so cable type b) is needed. The newer instruments have a male socket so cable type a) must be used.
a) Plug to Elecsys
Plug to Host
b)
Plug to Host
Plug to Elecsys
Figure 4-1: Data Cable Wiring Diagram (----- for optional bridges)
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Figure 4-1 illustrates the wiring of the 3 core data cable used to connect the Elecsys analyzer to a DTE - host (e.g. PC) with 9 pin or 25 pin D-sub-connector. Connect the cable to the 9-pin socket at the left hand side of the analyzer. Do not connect pin 1 on both sides of the cable shield. Note: on host side do not use pins 4-6, 7-8 (US only). Caution: Switch off the instrument at the circuit breaker on the right side of the analyzer before connecting the cable. Host Connector
Printer
User Interface
Figure 4-2: Elecsys 2010 connectors (left case side)
Printer
Host Connector
Figure 4-3: Elecsys 1010 connectors (left case side)
Pin No. Signal 1 GND
Explanation Analyzer frame
Direction (only DTE) use for shield
3
Txd
Transmit Data
out
2
Rxd
Receive Data
in
5
SG
Signal Ground
-
Table 4-1: Pin-Out Descriptions
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Table 4-1 gives the pin-out descriptions of the used pins. None of the handshake lines is used. They remain unconnected. The Elecsys analyzer does not need bridges between handshake pins. Since most host systems need bridges, you should use them equally on both sides so that there is no danger of mixing up the two connectors. There is no hardware handshake. Therefore you must shorten pins 8 (CTS) to 7 (RTS) and 4 (DTR) to 6 (DSR) at least for the host connector. If your host interface supports only 25-pin connectors, you will probably have to shorten pins 4 (RTS) to 5 (CTS) and 6 (DSR) to 20 (DTR). The interfaces of the Elecsys analyzers are defined as Data Terminal Equipment (DTE). As the interfaces of most computer systems (e.g. PCs) are defined as DTEs too, both sides will send data on pin 3 (Txd) and receive data on pin 2 (Rxd) (This is only for 9 pin connectors. The sub-D 25 connector has Rxd on pin 3 and Txd on pin 2). To avoid this you will have to cross over lines 2 and 3 as is usually done with 0-modem cables. If your computer system is defined as a Data Communication Equipment (DCE) or you use modems to connect your Elecsys analyzer to a host system, you must not cross over lines 2 and 3. DCEs send data on pin 2 and receive data on line 3 (with sub-D 25 connectors vice versa!). Pin 1 of the Elecsys connector is used as a shielded connection. It is grounded to the analyzer's frame. To avoid ground loops do not connect line 1 on both sides to pin 1 of the connectors. Pin 1 should be left open on one side of the cable. At the other side the cable shield should be connected.
4.1.2 Interface Specifications The data transmission specifications are given below. Item
Specification
Remarks
Interface
RS232C Asynchronous Serial Interface
Max. cable length 15m
Handshaking*
Software, can be switched off
XON/XOFF
Communication Method
Half duplex
Data bits
7 or 8
Stop bits
1 or 2
Parity bit
None, even, odd
Transmission speed
1200, 2400,4800,9600,19200
BPS
Maximum data block size
247 bytes
max. frame size
Character Code
ASCII, shift JIS
Table 4-2: Transmission Specification
(*Not used in US)
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4.1.3 Critical Timings Phase
State
Timer Starts
Timer Stops
Time-out
Reaction
Transmission of [ENQ]
Reply of [ACK],[NAK],[ENQ]
15 s
Sender enters Termination Phase
Contention (Host Timer)
[ENQ] from Analyzer
20 s
Host enters Idle + retransmits [ENQ]
Contention (Analyzer Timer)
After Time-out
1s
Analyzer retransmits [ENQ]
Receiver
after sending of last [ACK]
complete reception of valid frame or [EOT]
30 s
Receiver enters Idle State
Sender
after transmission of last character of frame
any reply of Receiver
15 s
Sender enters Termination Phase
Establishme Sender nt
Transfer
Table 4-3: Critical timings: Summary of Time-outs
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Engineering Reference
Data Link Layer
4.2.1 State Diagram
Figure 4-4: Sender / Receiver State Diagram (according to ASTM E1381-91)
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4.2.2 Control Codes Code
Description
Mnemonic
0A hex
Line Feed
[LF]
0D hex
Carriage Return
[CR]
02 hex
Start of Text
[STX]
03 hex
End of Text
[ETX]
04 hex
End of Transmission
[EOT]
05 hex
Inquiry
[ENQ]
06 hex
Acknowledge
[ACK]
15 hex
Not Acknowledged
[NAK]
17 hex
End of Transmission Block
[ETB]
Table 4-4: Control Codes
Allowed Characters:
7, 9, 11, 12, 13, 32-126, 128-254
Disallowed Characters:
0-6, 8, 10, 14-31, 127, 255
Table 4-5: Allowed and disallowed ASCII codes
4.2.3 Critical Timings Phase
State
Timer Starts
Timer Stops
Time-out
Reaction
Transmission of [ENQ]
Reply of [ACK],[NAK],[ENQ]
15 s
Sender enters Termination Phase
Contention (Host Timer)
[ENQ] from Analyzer
20 s
Host enters Idle + retransmits [ENQ]
Contention (Analyzer Timer)
After Time-out
1s
Analyzer retransmits [ENQ]
Receiver
after sending of last [ACK]
complete reception of valid frame or [EOT]
30 s
Receiver enters Idle State
Sender
after transmission of last character of frame
any reply of Receiver
15 s
Sender enters Termination Phase
Establishme Sender nt
Transfer
Table 4-6: Summary of Time-outs
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4.2.4 Message Frame / Checksum Calculation The intermediate frame [STX]
FN
Text first char. ...... Text last char.
ETB
CH
CL
[CR]
[LF]
Text first char. ...... Text last char.
ETX
CH
CL
[CR]
[LF]
The end frame [STX]
FN
[STX]
is the ASCII code 2, indicating the beginning of a frame transmission.
FN
is the frame number modulo 8. Frames of a single Transmission Phase are consecutively numbered beginning with 1. So FN runs from 1 to 7, continues with 0, 1 and so on. Use ASCII codes for the digits "0" to "7" (4855)!
Text
is the data content of a frame (max. 240 characters). Records are sub divided into intermediate frames with 240 characters maximum indicated by [ETB]. The only or last remaining frame will be indicated by [ETX]. Different records must be sent in different frames! Allowed characters are listed in Table 4-5.
[ETB]
is the ASCII code 23 (17hex), indicating the end of the text block of an intermediate frame.
[ETX]
is the ASCII code 3, indicating the end of the text block of an end frame.
CH, CL
represent the high nibble (= most significant 4 bit) and the low nibble (=least significant 4 bit) of the 8 bit checksum, respectively. CH and CL are represented as two digits of hex numbers. The checksum is the modulo 8 of the sum of ASCII values of the frame characters starting with and including "FN" and completing with [ETX] respectively [ETB] (Example see Table 4-7).
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Symbol
Character
Value (decimal)
Sum
Value (hex)
Sum
[STX]
[STX]
002
0
02h
00h
FN
‘1’
049
49
31h
31h
Text
[ETX]
‘T’
+084
133
+54h
85h
‘e’
+101
234
+65h
EAh
‘s’
+115
349
+73h
15Dh
‘t’
+116
465
+74h
1D1h
[ETX]
+003
468
+03h
468
= 468
MOD 256 212
1D4h = 1D4h
Mod 100h = 212
= D4h
CH
‘D’
068
44h
CL
‘4’
052
34h
[CR]
[CR]
013
0Dh
[LF]
[LF]
010
0Ah
Table 4-7: Calculation of Checksum
Checksum is sum of transmitted character codes including from FN to [ETX] or [ETB] modulo 100 hex. It is an 8 bit value expressed and transmitted as a two digit hex number, most significant digit first.
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4.2.5 ASCII Table
Char Hex
Dec
NUL 00
Char
Char
Char
Char
Char
Hex Dec
Hex Dec
Hex Dec
Hex Dec
Hex Dec
Hex Dec
Hex Dec
DLE 10
1
11
2
12
3
13
04
14
5
15
ENQ 05
06
16
7
17
8
18
9
19
10
1A
BEL
20
1C
13
1D
14
1E
15
1F
33
28
25
29
36
34
37
35
2B
28
2C
29
2D
30
2E
38
36
39
37
31
2F
51
43
40
38
41
39
42
3A
52
44
53
45
54
46
55
47
45
3D
56
48
46
3E
57
49
58
4A
47
3F
68
54
69
55
60
4C
61
4D
62
4E
63
4F
62
83
63
70
56
71
57
72
58
73
59
74
5A
84
64
85
65
86
66
87
67
77
5D
88
68
78
5E
89
69
90
6A
79
5F
100
74
101
75
92
6C
93
6D
94
6E
102
76
103
77
104
78
105
79
106
7A
95
6F
118
w 119
x 120
y 121
z 122
{ 107
7B
108
7C
109
7D
110
7E
111
7F
123
|
m
124
}
n
_
117
v
l
^
116
u
k 6B
115
t
j
91
114
s
i
]
O
73
h
\
N
99
113
r
g
[
M
72
f
Z
5C
98
112
q
e
Y
76
71
d
X
5B
97
c
W
75
70
b
V
L
?
82
p 96
a
U
K 4B
61
T
J
59
81
S
I
>
/
53
H
=
.
67
60
R
G
<
-
52
F
;
3C
66
` 80
Q
E
:
44
51
D
9
3B
65
C
8
43
50
B
7
,
US
42
6
+
27
50
P 64
A
5
* 2A
41
4
)
26
49
3
(
24
RS
SI 0F
27
GS
SO 0E
26
FS
CR 0D
25
ESC
12
35
40
2
'
23
1B
32
&
22
11
34
@ 48
1
%
21
FF 0C
24
SUB
VT
31
$
EM
LF
0B
23
CAN
HT
33
#
19
ETB
BS
0A
22
SYN 6
30
"
18
NAK
ACK
09
21
DC4 4
0
32
!
17
DC3
EOT
08
20
DC2
ETX 03
07
Space
16
DC1
STX 02
Char
0
SOH 01
Char
125
~
o
126
DEL 127
Table 4-8: ASCII Codes
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4.3
Engineering Reference
Presentation Layer
4.3.1 Allowed and Disallowed Characters Allowed Characters:
7, 9, 11, 12, 13, 32-126, 128-254
Disallowed Characters:
0-6, 8, 10, 14-31, 127, 255
Table 4-9: Allowed and disallowed ASCII codes
4.3.2 Delimiters The Presentation Layer uses some characters as special delimiter codes. These characters may not be used as normal message text:
Delimiter
Character
Char.
ASCII decimal
ASCII hex.
Record delimiter
= carriage return
13
0Dh
Field delimiter
= vertical bar
|
124
7Ch
Repeat delimiter
= backslash
\
92
5Ch
Component delimiter
= caret
^
94
5Eh
Escape delimiter
= ampersand
&
37
26h
Table 4-10: Delimiter Characters
4.3.3 Common Field Types
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Field Definitions
ASTM
Universal Test ID Component 1: Component 2: Component 3: Component 4:
6.6.1 6.6.1.1 6.6.1.2 6.6.1.3 6.6.1.4
Universal Test ID (Part 1; reserved for future) ^Universal Test ID Name (Part 2; reserved for future) ^Universal Test ID Type (Part 3; reserved for future) ^Manufacturer’s or Local Code (Part 4)
Dates and Times Format: YYYYMMDDHHMMSS Component 2: ^Time Zone Format: ±HHMM
6.6.2 6.6.2.1
Telephone Numbers free text format Component 2: ^Multiple Phone Numbers
6.6.3
Fixed Measurements and Units Component 2: ^Unit
6.6.4
Addresses Component 1: Component 2: Component 3: Component 4: Component 5:
6.6.5 Street Address ^City ^State ^Zip or Postal Code ^Country Code
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Field Definitions
ASTM
Provider and User IDs Component 1: Last Name Component 2: ^First Name Component 3: ^Middle Initial or Name Component 4: ^Suffix (e.g. Jr., Sr.) Component 5: ^Title (e.g. Dr., Mr.)
6.6.6
Record Sequence Number
6.6.7
Table 4-11: Common Field Types
Data Type
Explanation
char[n]
n character string
d
date in format YYYYMMDD (see E1394-91 - 6.6.2)
d_t
date / time YYYYMMDDHHMMSS (see E1394-91 - 6.6.2 and above)
int
integer number (depends on context could be: byte, int (16 bit), or long (32 bit) see RD application data specs for detailed ranges)
pos_int
positive (16 bit) integer (1..65535)
t
time in format HHMMSS (see E1394-91 - 6.6.2)
text
string with undefined length (exactly defined by the data base model according to limits given by ASTM protocol specification)
unit
units in ISO 2955 abbreviations or actual used unit (also amount of tests)
Table 4-12: Data Type Definition
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4.3.4 Table of Record Levels Level
Record Name
Identifier
0
Message Header Record
H
1
Patient Information Record
P
2
Test Order Record
O
3
Result Record
R
0..3
Comment Record
C
0..3
Manufacturer Information Record
M
0
Message Terminator Record
L
1
Request Information Record
Q
1
S Scientific Record (This record is not used by the Roche Diagnostics implementation)
Table 4-13: Standard Record Types and Levels
The Manufacturer Specific Records are specific for the Roche Diagnostics Elecsys instrument and must be received but should be ignored by the host. In newer software releases these records are switched off by default to reduce the communication traffic.
Level
Record Name
Identifier
1
MSR - Action Confirmation
M-AC
(This record is not used by the Roche Diagnostics implementation) 1
MSR - Action Request
M-AR
(This record is not used by the Roche Diagnostics implementation) 1
MSR - Calibration Result
M-CR
(This record is not used by the Roche Diagnostics implementation) 1
MSR - Calibration Order (Elecsys 1010 only) M-CO (This record is not used by the Roche Diagnostics implementation)
1
MSR - Calibrator Parameters
1
MSR - Calibration Scheme (Elecsys 1010 only) M-CS (This record is not used by the Roche Diagnostics implementation)
M-CP
2
MSR - Control Parameters
1
M-QS MSR - Control Scheme (Elecsys 1010 only) (This record is not used by the Roche Diagnostics implementation)
M-QP
2
MSR - Diluent Parameters
M-DP
1
MSR - Instrument Configuration
M-IC
1
MSR - Instrument Status
M-IS
1
MSR - Log File
M-LF
1
MSR - Processing Message
M-PM
1
MSR - Change Communication Protocol (Elecsys 1010 only) M-PX (This record is not used by the Roche Diagnostics implementation)
4
MSR - Raw Result
M-RR
4
MSR - Result Context
M-RC
1
MSR - Sample Status
M-SS
(This record is not used by the Roche Diagnostics implementation) 1
MSR - Service Data
M-SD
1
MSR - Substance Data
M-XT
1
MSR - Test Application
M-TA
1
MSR - Test Conditions
M-TC
Table 4-14: Manufacturer Defined Records and Levels
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• Level 0: Contains information pertaining to the sender identification and completion of transmission in standard ASTM defined records. • Level 1: Contains information about individual patients in standard ASTM defined records. • Level 2: Contains information about test order requests and samples/specimens in standard ASTM defined records. • Level 3: Contains information about test results in standard ASTM defined records. • Level 0..3: Comment and manufacturer information records. (These records always relate to the immediately preceding patient, order result, scientific or comment record. Therefore, if a comment were to follow a patient record (level one), then the record would be treated as a level two record. This record may not follow the message terminator record.)
4.3.5 Structure of Messages • A sequence of patient records, order records, or result records at one level is terminated by the appearance of a record type of the same or higher level. Thus, a sequence of results for one battery of tests is terminated by the next test order, patient, manufacturer information, request information, or message terminator record (Figure 4-5). • An order record may never appear without a preceding patient record and a result record may never appear without a preceding order record. When an order is transmitted, it must be preceded by a patient record. All orders that follow apply to the patient in the preceding patient record. When a result is transmitted, it must be preceded by an order record and a patient record to maintain the prescribed hierarchy.
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(Level 0) (Level 1) (Level 1) (Level 2) (Level 2) (Level 3) (Level 3) (Level 3) (Level 4) (Level 4) (Level 4) (Level 4) (Level 4) (Level 3) (Level 2) (Level 3) (Level 3) (Level 3) (Level 3) (Level 3) (Level 3) (Level 2) (Level 3) (Level 3) (Level 3) (Level 3) (Level 3) (Level 4) (Level 1) (Level 1) (Level 1) (Level 1) (Level 0)
Engineering Reference
HEADER MANUFACTURER INFORMATION 1 PATIENT 1 (general information about patient) | COMMENT 1 Record (relates to previous patient PATIENT 1) | ORDER 1 (information about the first battery requested) | | COMMENT 1 Record (relates to previous order ORDER 1 ) | | RESULT 1 (information about the first result of battery 1) | | RESULT 2 (information about the second result of battery 1) | | | COMMENT 1 Record (Relates to RESULT 2) | | | COMMENT 2 Record (Relates to RESULT 2) | | | | | | | | | | | RESULT n (information about the last result of battery 1) | ORDER 2 (information about battery 2) | | RESULT 1 (information about the first result of battery 2) | | RESULT 2 (information about the second result of battery 2) | | | | | | | | RESULT n (information about the last result of battery 2) | ORDER n (information about the last battery for the first patient) | | RESULT 1 (first result of the last order) | | | | | | | | RESULT n (information about the last result of battery n) | | | COMMENT 1 Record (Relates to RESULT n) PATIENT 2 (all of the structure repeats) PATIENT n MESSAGE TERMINATOR Figure 4-5: Structure of Messages
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4.3.6 ASTM 1394 Standard Records This chapter gives an overview of the implementation of ASTM standard records in the Roche Diagnostics Elecsys analyzer systems and the Workarea Manager LSM since Version 3.0 (Laboratory Systems Manager). Both Elecsys 2010 and Elecsys 1010 are able to communicate in query mode or batch mode. Query Mode:
The instruments identifies a sample identification or a rack/position identification and asks the host for test selections. Results will be uploaded as soon as available and/or as manually selected from the result data base.
Batch Mode:
The host sends test selections prior to starting the measurement. Results will be uploaded as soon as available and/or as manually selected from the result data base.
Note:
In the following tables the columns 2010 and 1010 represent the implementation for Elecsys 2010 and Elecsys 1010. The column LSM represents the implementation for LSM (not available in US).
: :
Upload from instrument to host (created or stored on the instrument) Download from host to instrument (accepted by instrument when downloaded). Note: Those fields should be sent by the host.
—: Ignored
: Used for upload, processed when downloaded —: Used for upload, ignored when downloaded
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LSM
1010
2010
Data Type
Ref. 7.1.
Field
Data Content
4.3.6.1 Message Header Record (Level 0) (H Record)
Comments
H | 7.1.
Record type ID (H)
1
char[1]
H
This record contains information about the sender and receiver (identification of the instrument and the computer system whose records are being exchanged). It also defines the field, repeat field and component field delimiter characters. Attention: there is no delimiter between the first and the second field in this record
Delimiter definition
2
char[4]
|\^&
field, repeat, component, escape -> default: |\^&; see Table 4-16
Message control ID
3
text
—
—
—
unique number or other ID that uniquely identifies the transmission for use in network systems
Access password
4
text
—
—
—
Sender name or ID
5
text {^...} {\...}
—
—
Sender street address
6
text
—
—
—
Reserved field
7
—
—
—
Sender telephone number
8
text
—
—
—
Characteristics of sender
9
text
—
—
—
any characteristics of sender as: parity, checksums, optional protocols, etc.
Receiver ID
10
text
—
—
—
Elecsys 2010: only in debugging mode (refer to Table 4-17) Elecsys 1010: text (e.g. “E1010”)
Comment or special instructions
11
text
—
—
—
string passed directly to the shell (command interpreter) of the instrument OS when processing ID set to 'D'
Processing ID
12
char[1]
P, D, (T), (Q)
—
—
Elecsys 2010: refer to Table 4-16 (software version >= 3.x)
Version No.
13
int
1
—
—
—
always 1
date and time of message
14
d_t
—
—
—
Current date and time when message was generated Elecsys 1010: only sent in debugging mode
sender name or ID ^BM (manufacturer) ^E2 (instrument type: Elecsys 1010) ^software version Example Elecsys 1010: ^BM^E2^0.910 Elecsys 2010: only in debugging mode manufacturer specific; using repeat and/or component delimiters this field may also reflect the software or firmware revisions, multiple instruments available on this line, etc.
Table 4-15: Message Header Record
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Field Name
ID
Option
delimiter definition 7.1.2
Record delimiter = carriage return
|
Field delimiter = vertical bar [124]
\
Repeat delimiter = backslash [92]
^
Component delimiter = caret[94]
&
Escape delimiter = ampersand
P
Production: Treat message as an active message to be completed according to standard processing.
D
Debugging: Message is initiated for the purpose of a debugging program.
processing ID 7.1.12
[13]
[37]
Table 4-16: Field Options for Message Header Record
The assignment of the "sender ID"/"receiver ID" will be done from the Host/LSM by using the fields and the "processing ID" in the "Message Header" record according to the scenario presented below. This Host assigned ID is different from the user defined instrument name transferred in the Manufacturer Specific Record [M-IC]. In the table the "sender ID"/"receiver ID"/"processing ID" are abbreviated as SID/RID/PID. The Elecsys instruments never send the flag 'D' (debugging mode) as processing ID. But each time Host sends 'D', the instrument has to actualize its Instrument ID. Instrument sends next and following messages with this memorized ID (SID) disregarding whether LSM has sent a different ID (RID).
Instrument
Dir
...
Host
Comment
...
...
SID = || RID = || PID = |P|
prior to the assignment all packages sent from the Host have the "sender ID"/"receiver ID" empty
SID = || RID = || PID = |P|
before the assignment all packages sent from the instrument have the "sender ID"/"receiver ID" empty
...
...
...
SID = |Host #| RID = |Instr. #| PID = |D|
Host sends the Message Header with "processing ID" = D, i.e., in debugging mode Instrument memorizes this RID as it's ID
SID = |Instr. #| RID = |Host #| PID = |P|
instrument sends next and following messages with its "S ID"= "last sent RID in debugging mode" = memorized instrument ID.
...
...
...
SID = |Host #| RID = |Instr. #| PID = |P|
the Host sends next and following messages with "sender ID"/"receiver ID" set correspondingly Instrument does not check whether the RID matches the memorized instrument ID
Table 4-17: Procedure for assignment of Sender ID and Receiver ID
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LSM
record type ID (L) 1
char[1]
L
sequence number
2
pos_int
1
termination code
3
char[1]
Nil, E, F, I, Q
— — — — —
Field
Ref. 13.1
2010
Data content
Data Type
4.3.6.2 Message Terminator Record (Level 0) (L Record)
Comments
L | 13.1.
Last record in each message see Table 4-19 and Table 4-20
Table 4-18: Message Terminator Record
Field Name
ID
Option
termination code 13.1.3
Nil, N
normal termination normal end of message (default when empty)
Remark
E
unknown system error
for message that was aborted automatically due to a communications error; with this record the termination code 'E' is sent back only if the message could be received completely according to the low level specifications (syntactically correct), but could not be handled by the receiver due to the content of the message (semantically). This can only happen if there is a bug in the implementation of the communication protocol module or if the receiver doesn't know the content of fields sent by the sender, e.g. unknown Test Code. For sending this Message a time-out must be defined (e.g. 10 minutes). No automatic repetition of the message should take place.
F
last request for information processed
normal end of message sent in response to a remote query message (final), indicating that all data has been sent
I
no information available from last query
normal end of an empty message (no data found) sent in response to a remote query message
Q
error in last request for information
for the response to an invalid (unprocessable) remote query
Table 4-19: Field Options for Message Terminator Record
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Attribute of message
Engineering Reference
Message receiving situation normal
Inquiry abnormal
There is response data.
F
There is no response data.
I
Not all data in records are in accordance with the rules. (Improper message error)
Q
Receive error Hardware error Application error
E
normal
Response & Download
Invalid attribution
abnormal
abnormal
Termination code
no message All data in records are not as ruled. (Improper message error) Message refusal Receive error (*) Hardware error (*) Application error (*)
E
The last record is not the Termination record.
R
Improper message error Receive error Hardware error Application error (*)
E
* The instrument reflects the valid record data in the data base. Table 4-20: Termination Codes to different Error States
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LSM
Data content
—
—
This identifier is the unique ID assigned and used by the practice to identify the patient and his/her results upon return of the results of testing. May be patient ID or sample id.
This identifier is the unique processing number assigned to the patient by the laboratory. Elecsys: not used as sample identifier (e.g., BC) but received with test order and sent back with results to make the assignments unique
Comments
P | 8.1.
1
char[1]
Sequence Number 2
pos_int
Practice Assigned Patient ID
3
text
Laboratory Assigned Patient ID
4
text
patient ID No.3
5
text
—
patient name
6
text ^text ^text ^text
—
—
mothers maiden name
7
text
—
—
date of birth
8
d
—
—
Date in standard format YYYYMMDD
patient sex
9
char[1]
(M), (F), (U)
—
—
M: F: U:
male, female, unknown
patient race-ethnic 10 origin
text
(W), (B), (O), (NA), (H)
—
—
W: B: O: NA: H:
white black Asian native American Hispanic
patient address
11
text
—
—
reserved field
12
—
—
—
patient telephone number
13
text
—
—
attending physician ID
14
text
—
—
—
special field 1
15
text
—
—
—
special field 2
16
text
—
—
—
patient height (in cm)
17
int {^unit}
—
—
patient weight in (kg)
18
int {^unit}
—
—
patient’s known or 19 suspected diagnosis
text
—
—
patient active medications
20
text
—
—
patient’s diet
21
text
—
—
practice field No.1 22
text
—
—
—
practice field No.2 23
text
—
—
—
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2010
Record Type ID (P)
Ref. 8.1.
Field
Data Type
4.3.6.3 Patient Information Record (Level 1) (P Record)
Can be requested by using ASTM Request Information Record (Q)
— last name ^first name ^middle name or initial ^suffix, title separated by a component delimiter (see E1394 6.6.6.)
ICD-9 code
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Data content
Ref. 8.1.
Field
Data Type
Elecsys Host Interface Manual
—
—
—
—
Comments
P | 8.1.
admission and discharge dates
24
d {\d}
admission status
25
char[2]
location
26
text
—
—
nature of alternative diagnostic code and classifiers
27
text
—
—
alternative diagnostic code and classification
28
text
—
—
patient religion
29
char[1] or text
(P), (C), (M), (J), (L), (H)
—
—
P: Protestant C: catholic M: Mormon J: Jewish L: Lutheran H: Hindu or text for other
marital status
30
char[1]
(M), (S), (D), (W), (A)
—
—
M: S: D: W: A:
isolation status
31
char[3] or text
—
—
see E1394-91 8.1.31 ARP: antibiotic resistance precautions BP: blood and needle precautions ENP: enteric precautions NP: precautions for neutropenic patient PWP: precautions for pregnant women RI: respiratory isolation SE: secretion/excretion precautions SI: strict isolation WSP: wound and skin precautions
language
32
text
—
—
hospital service
33
text
—
—
hospital institution
34
text
—
—
dosage category
35
text
—
—
(OP), (PA), (IP), (ER)
OP: PA: IP: ER:
outpatient preadmit inpatient emergency room
DRG or AVG
A: P1: P2:
married single divorced widowed separated
ADULT PEDlATRlC (1-6 months) PEDIATRIC (6 months - 3 years)
Table 4-21: Patient Information Record
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pos_int
3
text
Bar code content / Sample-Id (max. length = 22) Note: Stop bar code like ‘000’ is not allowed as sample ID! This text field represents a unique identifier for the specimen assigned by the computer system and returned by the instrument.
instrument specimen ID
4
text {^text} {^text} {^text} {^text} {^text}
* —
— — — — — — —
— — — — — — —
Sequence # ^carrier # (carrier is rack or disk) ^Position in carrier ^format ^data carrier type (‘CONTROL’, ‘SAMPLE’) ^container type (‘NORMAL’, ‘REDUCED’) …^container cap type …^initial volume Container type is Normal for 75 mm and 100 mm tubes, for all other tubes it is Reduced. The host might change the container type. In a later software release there will be a switch for the default container type. *Note: Query mode: All 6 components (2010) will be sent by the instrument. In response to a query the host should echo back all components (at least sequence number). Batch mode: For batch download the host can define rack ID and position number (no sequence number). Elecsys1010: Carrier # is always 0
universal test ID
5 text ^text ^text ^text
— — —
— — —
— — —
{^text} \...
—
— —
— —
Field
Ref. 9.4.
2010
Data content
Data Type
4.3.6.4 Test Order Record (Level 2) (O Record)
record type ID (O) 1
char[1]
sequence number
2
specimen ID
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O
Comments
O | 9.4.
Sent from computer system to instrument to order test with required conditions (the conditions can be transferred with the Result Record, which follows this Order Record). Sent from instrument to computer system to provide information about specimen and results. Test Order is requested using ASTM Request Information Record
4 or more part field: universal test ID ^universal test name ^universal test ID type ^manufacturer defined test code; see E1394-91 6.6.1; only the 4th and following components are relevant for Elecsys and LSM: RD-test number (see the Assay Reference Table in chapter 5). ^auto-dilution fact.(Table 4-23 /Table 5-2) ^pre dilution ^instrument identification universal test ID = ‘ALL‘ for order record in a result message
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5
priority
6
LSM
1010
2010
Data content
Ref. 9.4.
Field
Engineering Reference
Data Type
Elecsys Host Interface Manual
Comments
O | 9.4.
Note: For Elecsys it is not allowed to use the same test request multiple times in the same Order Record. The last digit of the three digit application number references the generation of the test. Therefore in case of a generation change the new test generation must be treated as a new test. E.g.: 170 TNTSTAT ^^ test ^ generation For test selections from Host the test generation is ignored by the instrument. That means in case of the Host asks for a test selection (e.g. 170) it might happen that the instrument measures and sends back the application number for a newer test (e.g. 171). If the Host is able to ignore the last digit there is no need to change the test selection with each new generation of a test. char[1]
S, R
In case of a registration update (sample is already in the data base) it is impossible to change the priority (see Table 4-24) If there is no data in this field, the instrument registers receiving date and time to this field.
requested/ordered 7 date and time
d_t
—
—
8 Specimen collection date and time
d_t
—
—
—
collection end time
9
d_t
—
—
—
collection volume(in ml)
10
int {^unit}
—
—
—
collector ID
11
text
—
—
—
action code
12
char[1]
— — — —
— —— —
— —— ——
{\...}
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N, C, Q, X, A
from Host: Elecsys 2010: A: add request to existing sample N: new request C: cancel request for existing sample N\Q: new request for control samples Elecsys 1010: A: add request to existing sample N: new request C: cancel request for existing sample Q: for existing control samples A\Q: for existing control samples N\Q: for new control samples C\Q: for cancel requests of control sample LSM: A,Nil: add request for existing sample N: new request C: cancel request for existing sample
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2010
Data content
Ref. 9.4.
Field
Engineering Reference
Data Type
Elecsys Host Interface Manual
action code (continued...)
12
danger code
13
text
—
—
—
relevant clinical informat.
14
text
—
—
—
date/time 15 specimen received
d_t
—
—
—
specimen 16 descriptor (type & source)
text ^text
—
—
—
text
—
—
—
physician’s 18 telephone number
text
—
—
—
user field No.1
text
—
—
—
user field No.2
20
text
—
—
—
laboratory field No.1
21
text
—
—
—
laboratory field No.2
22
text
—
—
—
date/time results reported or last modified
23
d_t
—
—
—
instr. charge to computer system
24
text
—
—
—
instrument section 25 ID
text
—
—
—
report types
char[1]
— — — —
— — — — — —
— — — — — —
—
—
—
26
O | 9.4.
from Instrument.: Elecsys 2010: X: normal samples and X\Q: for control samples Elecsys 1010: Nil: normal samples and Q: for control samples LSM: Nil: normal samples and Q: for control samples In case of a registration update (sample is already in the data base), it is impossible to change the sample’s type (see Table 4-25)
ordering physician 17
19
Comments
{\...}
O, I, Z, Q, F, Y
reserved field
27
location or ward of specimen collection
28
text
—
—
—
nosocomial infection flag
29
text
—
—
—
specimen service
30
text
—
—
—
specimen institution
31
text
—
—
—
type: blood, urine, serum, ...; source: left arm, right lung, ...
see Table 4-26
Table 4-22: Test Order Record
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Sample Type
Protocol
Diluent Protocol or Pretreatment Protocol
Engineering Reference
Tests
Auto Dilution from Instrument
Auto Dilution from Host
Quantitative Tests
[NONE]
NOT Available (Use Default auto-dilution ratio)
Qualitative Tests
[NONE]
NOT Available (Use Default auto-dilution ratio)
Quantitative Tests
[NONE] or Reference No. in Reference Table is responding to assigned auto-dilution ratio
Available (assigning auto-dilution ratio is possible)
Qualitative Tests
[NONE]
NOT Available (assigning auto-dilution ratio is impossible)
[NONE]
NOT Available (Use Default auto-dilution ratio)
“Sample” Other Protocol (Not Diluent Protocol) (Not Pretreatment Protocol)
“Control”
Table 4-23: Auto Dilution Factor is set corresponding to this table
Field Name
ID
priority 9.4.6
R
routine
S
STAT (short turn around time) Instrument does not overwrite this priority if this specimen has already been assigned priority different.
Registration
Option
already assigned priority “Normal”
Update “STAT”
New
priority (sent from Host)
priority
R
“Normal”
S
IMPOSSIBLE !
[NONE]
“Normal”
R
IMPOSSIBLE !
S
“STAT”
[NONE]
“STAT”
R
“Normal”
S
“STAT”
[NONE]
“Normal”
*** RS System ----- Can not assign “STAT” priority. ( = S ) Table 4-24: Priority for sample registration Elecsys 2010
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Field Name
ID
Option
action code 9.4.12
N
new requests accompanying a new specimen Instrument overwrites existing test order Information to this new test order Information concerned with this specimen. Elecsys 2010: Instrument adds this new test order information to the existing test order information belonging to this specimen.
A
add the requested tests to an already existing sample
C
cancel request for the battery or tests named Instrument deletes this specimen from data base.
Q
treat specimen as a Q/C test specimen. Elecsys 2010: In case of control samples following two characters are added “\Q”
X
specimen or test already in process.
Registration
already assigned sample’s type “Sample“
Update “Control“
New
“Sample” or “Control”
action code (sent from Host)
sample’s type
N or A
“Sample“
N\Q or A\Q
IMPOSSIBLE !
[NONE]
“Sample“
N or A
IMPOSSIBLE !
N\Q or A\Q
“Control“
[NONE]
“Control“
N or A
“Sample“
N\Q or A\Q
IMPOSSIBLE !
[NONE]
“Sample“
Table 4-25: Sample registration and update Elecsys 2010
Field Name
ID
Option
report types 9.4.26
O
order record; user asking that analysis be performed
I
in instrument pending
Z
no record of this patient (in response to query)
Q
response to query (this record is a response to a request-information query)
F
final result
Y
no order for this record Table 4-26: Field Options for Test Report Type
NOTES: 1. Whenever the Host downloads test selections for a new "CONTROL“ sample, the instrument registers this sample as a "Foreign Control“. (A "RD Control“ can be registered only by reading the sample bar code.) 2. In case that the Host answers with a test selection for an outstanding query, it is necessary to set the same Sequence No. and Sample ID as the instrument asked for in the Query Message. If these data (Sequence No. and Sample ID) are not same as
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asked for from the instrument, the instrument ignores this message as the answer to the Query and continues waiting for the correct answer from Host. In case no Sample ID was sent from the instrument ("specimen ID“ field is empty), the Host can set the correct Sample ID in the answering Test Order Message. Also in this case, it is necessary to answer with the same Sequence No. as the instrument queried for. 3. The instrument registers test selections from Host as follows.
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Contents in “specimen ID” field 9.4.3 and “Instrument specimen ID” field 9.4.4 (sent from Host) Patt
Sample Seq No. ID
1
Seq No.
3
4
6
7
5
: [space]:
Search
Disk No./ RackID & Key Position No.
2
Engineering Reference
Registration
Upd. New
Sample ID
Disk No./ Rack ID & Position No.
Seq No.
Seq No.
Seq No.
If the same sample ID is assigned for different samples, the instrument only updates the sample which was found first according to the search algorithm. In case of a new registration, the instrument assigns “@SeqNo” as Sample ID automatically. If the Host does not answer to a query with the same Sample ID, the instrument does not update this sample. However, if “@SeqNo” was assigned as sample ID (sample without bar-code), the instrument overwrites this sample ID with the one which was sent from Host.
Sample ID or Disk No./ Rack ID & Position No.
Comment
If the instrument cannot find a corresponding sample in database by searching with “Sample ID” key, then the instrument searches the sample again by using “Disk No./ Rack ID & Position No.” key. If “@SeqNo” was assigned as sample ID (sample without bar-code), the instrument overwrites this sample ID with the one which was sent from Host. In case of a registration update (button on the screen), the instrument overwrites Disk No./ Rack ID & Position No. to the one that were sent earlier from Host.
Instrument does not overwrite Disk No./ Rack ID & Position No. to the one that were sent from Host.
If the host does not answer to a query with the corresponding Sample ID, the instrument does not update the sample. If “@SeqNo” was assigned as sample ID (sample without bar-code), the instrument overwrites this sample ID with the one which was sent from Host. The instrument does not overwrite Disk No./ Rack ID & Position No. to the one that were sent from Host.
Set or Available, Not Set or NOT Available
4. When the Host queries for test selections of a sample, the instrument searches the test selections of the sample by using “Search Key”. “Search Key” is as follows.
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Contents in “starting range ID number” field 12.1.3 Search (sent from Host) Sample Patt. Seq No. ID 1
Seq No.
Sample ID
3 4
Disk No./ RackID & Key Position No.
2
5 6
7
Comment
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Disk No./ Rack ID & Position No. Seq No.
“Sample ID” is ignored.
Sample ID
“Disk No./Rack ID & Position No.” are ignored.
Seq No.
“Disk No./Rack ID & Position No.” are ignored.
Seq No.
“Sample ID” and “Disk No./Rack ID & Position No.” are ignored.
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record type ID (R) 1
char[1]
sequence number
2
pos_int
universal test ID
3 text ^text ^text ^text
R
LSM
1010
2010
Data content
Ref, 10,1.
Field
Data Type
4.3.6.5 Result Record (Level 3) (R Record)
Comments
R | 10.1.
result transfer record; can be requested using ASTM Request Information Record see Test Order universal test ID, ^universal test name, ^universal test ID type, ^manufacturer defined test code; see E1394-91 6.6.1; only the 4th and following components are relevant for Elecsys: ^RD-test number (see the Assay Reference Table in chapter 5) ^auto-dilution factor (see Table 5-2) ^pre dilution ^instrument identification Further details see Order Record.
— — —
— — —
— — —
^Auto Dil.
—
— —
—
e.g.: 1,97; -1; =1.0 >10.0
In case that a result is above the upper limit (normal range) the following two characters are added in the front of the result: ‘>=’ in future versions this will be changed to ‘>’ In case that a result is below the lower limit (normal range), following a character is added in the front of the result: ‘ 1.35 ‘G’ will be replaced by ‘I’.
Comments
C | 11.1.
Comment records may be inserted anywhere except after the message terminator record. Each comment record shall apply to the first non-comment record preceding it. Processing depends on the related record. Generally for Elecsys1010: comments from Host can be ignored; instrument. uses it for predefined remarks. clinical instrument system
Table 4-31: Comment Record
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Q
2010
LSM
char[1]
1010
record type ID (Q) 1
Data content
Ref. 12.1.
Field
Data Type
4.3.6.7 Request Information Record (Level 1) (Q Record)
Comments
Q | 12.1.
Request information for new/repeat tests, demographic inf.; Data sets: results (not for 1010) for single/multiple test, all tests for a single date, series of dates, range of dates, individual patient, group of patients, individual specimen, group of specimens, etc. Note: LSM only supports a global query for the request of all test selections from host.
sequence number
2
starting range ID number (patient ID/specimen ID/instrument specimen ID)
3
pos_int
Patient component is not relevant for Elecsys 1010 empty component or ALL: requesting all available information; specimen ID and instrument specimen ID are as in Test order record:
text ^text ^text ^text ^text {^text} {^text} {^text}
e.g.: ^1234
— —
— — — — — — — —
— — — — — — — —
patient ID (= empty) ^specimen ID (= sample ID) ^Sequence # ^carrier # ^Position in carrier ^format ^data carrier type (‘CONTROL’, ‘SAMPLE’) ^container type (‘NORMAL’, ‘REDUCED’) Container type is Normal for 75 mm and 100 mm tubes, for all other tubes it is Reduced. The host might change the container type. In a later software release there will be a switch for the default container type. Note: Carrier #: For Elecsys rack version the rack identification is read after the 5 samples (6th position). Therefore as long as the real rack ID is unknown the instruments queries with a default rack ID “@nnn”. The host should ignore this default rack ID. The host should echo back all components (at least the sequence #). For more details please see notes page 4-104. Note for LSM: Query for ALL tests and all samples.
ending range ID number
4
universal test ID
5
text
nature of request time limits
6
char[1]
—
beginning request results date and time
7
d_t
—
ending request results date and time
8
d_t
requesting physician name
9
10 requesting physician telephone number
—
—
—
—
—
query always for ALL tests.
—
S: specimen collect date (not relevant for Elecsys 1010), R: result test date (default if empty)
—
—
For Elecsys 1010: results time = ready time
—
—
—
text
—
—
—
text
—
—
—
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Data content
Ref. 12.1.
Field
Engineering Reference
Data Type
Elecsys Host Interface Manual
Comments
Q | 12.1.
user field No. 1
11
text
—
—
—
user field No. 2
12
text
—
—
Control Lot Number
— — — —
— — — — — — —
— — — — — — —
refer to Table 4-33 (see E1394-91 12.1.13); C, P, S, M, D are not relevant for Elecsys, only O is used by the instrument, the others are needed for Host/LSM A: Abort of request by instrument after time-out. Elecsys 1010: O: Request for orders by the instrument;
request 13 information status codes
char[1]
O, F, N X, I, R, A
Table 4-32: Request Information Record
Field Name
ID
Option
starting range ID number 12.1.3
ALL
all specimen results ordered by the inquiring system (current implementation supports ALL only)
universal test ID 12.1.5
ALL
signifies a request for all results on all tests
request O information status codes 12.1.13
requesting test orders and demographics only (no results)
F
final results
N
requesting new or edited result only
X
results cannot be done, request canceled
A
abort/cancel last request criteria (allows a new request to follow) Table 4-33: Field Options for Request Information Record
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NOTES: 1. Sample/Result Handling - Behavior: The instrument queries for test selections depending on the following conditions: ASTM field 12.1.3 component
^2
^3
^4
^5
Query (disk version)
ID
Seq#
Rack/Disk#
Pos#
Case 1: Bar-coded sample: Case 2: No BC, but SID assigned: Case 3: No BC, no SID assigned: Case 4: empty position:
– –
– – – –
no query
** no query ** **
no query
Query (rack version) Case 1: Bar-coded sample: Case 2: No BC, but SID assigned: Case 3: No BC, no SID assigned: Case 4: empty position: Case 5: No BC, rack Id not read: Case 3: No BC, SID assigned rack Id not readable: : –: **:
query contains this field, means empty field, default Rack ID (sequential number = @nnn, e.g. @1 or @100) Table 4-34: Sample/Result Handling - Behavior
2. If the rack identification bar code (RID) has not been read the (common) default RID is used. 3. When results are uploaded the following components are filled with data: Sample Identification (SID),
ASTM field 9.4.3
Sequence Number (Seq #),
ASTM field 9.4.4 component 1
Rack Identification (RID), and
ASTM field 9.4.4 component 2
Position Number (Pos #).
ASTM field 9.4.4 component 3
4. Timing: a) During the time interval 18.6s and 34.6s of the instrument cycle nothing is sent to host but queries. b) Instrument may send queries at any other time in the cycle though and may also answer to queries at any time. c) Also a certain time interval is reserved for upload, e.g. results upload only at the beginning of the cycle. d) If samples for a rack are being queried but not all queries are answered yet, a time-out is defined when the rack should be skipped (with its remaining samples). This time out is reached as soon as there is the first cycle without sampling. 5. No additional records are needed for the communication protocol concerning rack sampler/rack conveyer. 6. Also no additional fields are needed. 7. Some new contents of the existing fields are necessary. 8. Many new alarm messages are necessary.
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4.3.7 RD Specific Records and their IDs This chapter gives an overview on the implementation of Manufacturer Specific Records (MSRs) in the Roche Diagnostics Elecsys analyzer systems as it is allowed within the rules of the ASTM standard specifications. These records expand the functionality of the Roche Diagnostics’ Laboratory Systems Manager LSM. In order to reduce communication traffic MSRs will not be sent by default. Nevertheless, the host can select or query for additional information in MSRs with the Instrument Configuration Record (see page 4-111). For a general Host system it is recommended to ignore these records if received. If there is a query, the record type sub-ID is extended with the letter “Q”, for example M-XT becomes M-XTQ.
record type ID (M) 1
char[1]
M
sequence number
2
pos_int
record type sub-ID 3 (AC)
char[2] ^text ^text
AC ^BM ^E1
^text
^1
command
4
text
processing status
5
char[1]
additional action result
6
text
1010
2010
Data content
Ref. AC
Field
Data Type
4.3.7.1 Action Confirmation Record (Level 1)
Comments
BM.AC
Confirmation of processing actions. (This record is not used by the Roche Diagnostics implementation)
Roche specific record identifier ^BM ^instrument type abbreviation (E1 for Elecsys 2010) ^version #
STOP, START,
STOP or START
O, A, T
O: A: T:
—
optional field for several action that can deliver a result, e.g., maintenance operation – results of self test
action processed; not allowed in current system state; Could not be processed within timeout
Table 4-35: Action Confirmation Record
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M
1010
2010
Data content
Ref. AR
Field
Data Type
4.3.7.2 Action Request Record (Level 1)
Comments
BM.AR
record type ID 1 (M)
char[1]
Request for instrument action (ordering STOP/START etc.). (This record is not used by the Roche Diagnostics implementation)
sequence number
2
pos_int
record type sub-ID (AR)
3
char[2] ^text ^text ^text
AR ^BM ^E1 ^1
Roche specific record identifier ^BM ^instrument type abbreviation (E1 for Elecsys 2010) ^version #
command
4
text
STOP, START; STOP_ SAMPLING; PAUSE; RESUME; DO_MAINT; DO_SELFTEST; INITIALIZE; SHUT_DOWN; STAND_BY; TESTRUN; SCAN
STOP; START; STOP_SAMPLING; PAUSE; RESUME; DO_MAINT; DO_SELFTEST; INITIALIZE; SHUT_DOWN; STAND_BY; TESTRUN; SCAN
time out
5
int
—
in seconds
additional parameters
6
int {^int…}
—
Table 4-36: Action Request Record
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record type ID (M)
1
char[1]
sequence number
2
pos_int
record type sub-ID 3 (CP)
M
text ^text ^text
CP(Q) ^BM ^E1
^text
^1
test number
4
text
calibrator level
5
char[1]
target value / unit
6
text {^unit}
A, B, C, D, E (P), (N), (R)
Query*
1010
2010
Data content
Ref. CP
Field
Data Type
4.3.7.3 Calibrator Parameters Record (Level 2)
Comments
BM.CP
*
*
Roche specific record identifier ^BM ^instrument type abbreviation (E1 for Elecsys 2010; E2 for Elecsys 1010) ^version #
*
test No. for which the calibrator is valid
— — —
— — —
—
Level 1 to 5 are uploaded as ‘A’ to ‘E’. not relevant for Elecsys 2010 and Elecsys 1010 : P and N for qualitative tests (positive and negative control) R for recalibrator
—
calibrator parameters definition; this record should follow the general substance data for calibrators
reference value ^current unit; empty for qualitative tests. Elecsys 1010: value and unit!
reagent lot number
7
int
—
test reagent lot for which the calibrator is valid
reagent package number
8
int {^int}
—
—
—
e.g. corresponding reagent individual package number
Table 4-37: Calibrator Parameters Record
*For Elecsys 2010 only
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record type ID (M) 1
char[1]
M
sequence number
2
pos_int
record type sub-ID 3 (CR)
char[2] ^text ^text
CR ^BM ^E1
^text
^1
1010
2010
Data content
Ref. CR
Field
Data Type
4.3.7.4 Calibration Result Record (Level 2)
Comments
BM.CR
(This record is not used by the Roche Diagnostics implementation)
Roche specific record identifier ^BM ^instrument type abbreviation (E1 for Elecsys 2010) ^version #
test number
4
text
test No.., blank set No.; not relevant for instrument calibration
test lot numb.
5
int
reagent lot No./ blank set lot No.
Unit
6
unit
actual unit of the test
test container description
7
field components: carrier type, ^carrier ID, ^position in carrier; Elecsys 2010: carrier type = RD (Reagent Disk);
test package number
8
e.g. corresponding reagent; individual reagent pack number (for Elecsys 2010 reagent pack & optional pretreatment)
N: L: M: R: I:
text ^text ^text
calibration method 9
e.g.: RD ^1 ^5
int {^int} char[1] ^char[1]
N^R, L^R, N^M, L^M, I^
quantitative, qualitative, master (LINC), recalibration (renewed), instrument calibration (not relevant for Elecsys 1010)
replication number 10
int
—
as overwriting of the default set by test conditions
date/time calibration completed
11
d_t
date/time when result is ready
result states
12
char[1]
O, Q, F, (X), A
— —
O: OK, Q: questionable, F: failed, X: cannot be measured, A: acceptance of the result (for LSM to be able to release calibration)
result characteristics
13
I, M, S, R, D, L, B, F, T, C
result characteristics component : characteristic ID ^ text1 ^ text2 see Table 4-39 Alarm Level is one of: 0 – “green”, 1 – “yellow”, 2 – “red”, according to the color definition; characteristic text is the string to be displayed at the UI (max. length = 10)
curve parameters
14
list of test number specific (application) curve parameters, e.g., A, B, C, D for Rodbard curve parameter[0]^ curve parameter[1]^ curve parameter[2]^ curve parameter[3]^ curve parameter[4]\ 2point correction parameter[0]^ 2point correction parameter[1]\ 1point correction parameter[0]
char[1] ^char[1] ^text {\...}
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calibrators container description
15
calibrators result
16
text ^text ^text ^text ^text
e.g.: SD ^1 ^7
1010
2010
Data content
Ref. CR
Field
Engineering Reference
Data Type
Elecsys Host Interface Manual
BM.CR
Comments
field components: carrier type ^carrier ID, ^position in carrier ^calibrator lot number ^calibrator bottle number; Elecsys 2010: carrier type = SD (sample disk for reagent calibrators) or R1 (reagent disk for BlankCell); Elecsys 1010: carrier type = SRD; repeat field for more vials/bottles
effective signal (only one value per single measurements, n values for replicates); this field component is repeated for each calibrator level Elecsys 2010: 6 signals
{\...} text {^ ... } {\...}
Table 4-38: Calibration Result Record
[For Quantitative tests] Criteria
characteristic ID
text1
text2
Missing values
I
0 (OK), 1 (Question), 2 (Fail)
ex. AA--CC----
Monotony of curve
M
0 (OK), 1 (Question), 2 (Fail)
ex. A---E
Minimum signal
S
0 (OK), 1 (Question), 2 (Fail)
ex. AA--CC----
Calibration factor
R
Value of Calibration factor [NONE]
Deviation of dupl. Measurement
D
0 (OK), 1 (Question), 2 (Fail)
ex. A---E
[For Qualitative tests] Criteria
characteristic ID
text1
text2
Missing values
I
0 (OK), 1 (Question), 2 (Fail)
ex. AA--
Monotony of curve
M
[NONE]
[NONE]
Minimum signal
S
[NONE]
[NONE]
Calibration factor
R
[NONE]
[NONE]
Deviation of dupl. Measurement
D
0 (OK), 1 (Question), 2 (Fail)
ex. -B
Slope
L
0 (OK), 2 (Fail)
OK or NG
Min/Max signal
B
0 (OK), 1 (Question), 2 (Fail)
ex. >- INTERFACE SETTINGS) See 0060 a. Retry action b. Verify that HOST is online and ready See 0060 a. Switch analyzer off/on b. Check HOST ready c. Check HOST connection cable d. Check interface settings (UTILITIES -> INTERFACE SETTINGS) Cable PC9; cable to Host / a. Switch analyzer LSM; PCB OEM master off/on b. Check HOST ready c. Check HOST connection cable d. Check interface settings (UTILITIES -> INTERFACE SETTINGS) SW error a. Switch analyzer off/on b. Reload operating software c. If error recurs, call Technical Support SW error a. Switch analyzer off/on b. Reload operating software c. If error recurs, call Technical Support Record sent from Host/LSM a. Call Technical is not implemented Support Manufacturer Specific a. Call Technical Record with Query sent from Support Host/LSM is not implemented Record sent from Host/LSM a. Call Technical is implemented, but it’s Support contents is not in accordance with the Host/LSM interface specification.
Result Value N/A
N/A N/A
N/A
N/A
N/A
N/A N/A
N/A
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0080
Message
Description
Host / LSM Interface: OEM master - host Sample / interface control memory full
Tables
Level
E
Possible Causes
No memory available in database for requested sample/control.
a. Transfer all processed sample/control results into sample/control history. No memory available in a. Transfer all database for requested processed sample/control order. sample/control results into sample/control history. Order with sample ID a. Use a position not requests an occupied currently occupied position via Host/LSM. by a pending sample. b. Use same position after operation has been finished Order with sample ID a. Wait until samples at requests an occupied STAT STAT positions are position via Host/LSM. processed Sample ID / STAT ID already a. Wait until Sample ID ordered or results available. / STAT ID is processed
0081
OEM master - host Sample / interface control order memory full
E
0082
OEM master - host Position is interface occupied by pending sample
E
0083
OEM master - host Both STAT interface positions are occupied OEM master - host Priority interface change of already existing sample OEM master - host No interface generation of ordered test is scanned yet
E
0086
OEM master - host Control not interface useable for required test
E
0087
OEM master - host Dilution not interface available for requested test
E
0088
OEM master - host Download interface not possible in current system status OEM master - host Download of interface reagent substance data although timeout is finished OEM master - host Download interface position already used
E
Host/LSM tried to send instrument configuration data during operation
W
E
0084
0085
0089
0090
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E
E
Remedy
A test is ordered by Host/LSM but not any Test Reagent Pack of the ordered test (any generation of that test) has been scanned. A Control was requested for a test, but the Control is not applicable for required test generation, because a. No control scheme is defined for the requested test, or b. No control is existing for the requested test, or c. No control card was scanned. A dilution was requested for a test, but the Dilution Reagent Pack for that test has not already been scanned; The test is not dilutable
Result Value N/A
N/A
N/A
N/A N/A
a. Scan Test Reagent Pack of ordered test. The ordered and scanned test generation may differ a. Define control scheme for the requested test. b. Scan control and control card
N/A
a. if test is dilutable, scan a dilution Reagent Pack for requested test b. if test is not dilutable, call Technical Support for Host/LSM a. Repeat download after operation has been finished
N/A
Download of reagent substance data after run initialization.
a. Call Technical Support
N/A
An order without sample ID requests an occupied position via Host/LSM.
a. Wait until position is processed b. Download another position.
N/A
N/A
N/A
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Examples
Examples 6.1
Trace Examples Standard Records
6.1.1 Trace: Test Selection Disk Version Instrument queries test selections for sample ‘000004’ (Seq# = 40, Disk# = 0, Pos# = 4): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2Q|1|^000004^40^0^4^^SAMPLE^NORMAL||ALL ||||||||O[CR][ETX]C5[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Host sends back test selections for sample ‘000004’ (Container type changed by Host to REDUCED): HOST ELEC HOST ELEC HOST ELEC HOST
ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&||||||||||P[CR][ETX]0D[CR][LF] [ACK] [STX]2P|1[CR][ETX]3F[CR][LF] [ACK] [STX]3O|1|000004|40^0^4^^SAMPLE^REDUCED| ^^^10^0\^^^50^0\^^^20^0\^^^30^0|R|19970425085218||| ||N||||||||||||||Q[CR][ETX]6C[CR][LF] [ACK] [STX]4L|1|F[CR][ETX]FF[CR][LF] [ACK] [EOT]
Instruments queries for test selections for control ‘PC U1’: ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2Q|1|^PC U1^37^0^1^^CONTROL^NORMAL||ALL |||||||190599|O[CR][ETX]7D[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Host sends back test selections: HOST ELEC HOST
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[ENQ] [ACK] [STX]1H|\^&||||||||||P[CR][ETX]0D[CR][LF]
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ELEC HOST ELEC HOST
ELEC HOST ELEC HOST
Examples
[ACK] [STX]2P|1[CR][ETX]3F[CR][LF] [ACK] [STX]3O|1|PC U1|37^0^1^^CONTROL^NORMAL| ^^^10^0\^^^50^0\^^^20^0\^^^30^0|R|19970403110957||| ||N\Q||||||||||||||Q[CR][ETX]58[CR][LF] [ACK] [STX]4L|1|F[CR][ETX]FF[CR][LF] [ACK] [EOT]
6.1.2 Trace: Test Selection Rack Version (1st sample without bar-code) Instrument queries test selections for sample ‘000002’ (For the 1st sample the sample ID could not be read or is not available. Therefore the instrument skips this sample until the rack ID is read. For the 2nd sample the rack ID is not yet known. Therefore the instrument asks with default rack ID @95). ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2Q|1|^000002^424^@95^2^^SAMPLE^NORMAL||ALL| |||||||O[CR][ETX]75[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Host sends back test selections: HOST ELEC HOST ELEC HOST ELEC HOST
ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&|||CAEv 2.0||||||||1|[CR] [ETX]D5[CR][LF] [ACK] [STX]2P|1||000002|||||||||||||||||||||||||||||| |[CR][ETX]5D[CR][LF] [ACK] [STX]3O|1|000002|424|^^^400^0\^^^450^0|R| 19970618110435|||||N||||||||||||||Q|||||[CR][ETX]A8 [CR][LF] [ACK] [STX]4L|1|F[CR][ETX]FF[CR][LF] [ACK] [EOT]
Instrument queries test selections for sample ‘000003’ (For the 3rd sample the rack ID is not yet known. Therefore the instrument asks with default rack ID @95). ELEC HOST ELEC HOST ELEC HOST
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[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2Q|1|^000003^425^@95^3^^SAMPLE^NORMAL|| ALL||||||||O[CR][ETX]78[CR][LF] [ACK]
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Examples
[STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Host sends back test selections: HOST ELEC HOST ELEC HOST ELEC HOST
ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&|||CAEv 2.0||||||||1|[CR][ETX]D5[CR][LF] [ACK] [STX]2P|1||000003|||||||||||||||||||||||||||||| |[CR][ETX]5E[CR][LF] [ACK] [STX]3O|1|000003|425|^^^400^0\^^^450^0|R| 19970618110438|||||N||||||||||||||Q|||||[CR][ETX]AD [CR][LF] [ACK] [STX]4L|1|F[CR][ETX]FF[CR][LF] [ACK] [EOT]
Instrument queries test selections for sample ‘000004’ (For the 4th sample the rack ID is now known. Therefore the instrument asks with the real rack ID 01402). ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2Q|1|^000004^426^01402^4^^SAMPLE^NORMAL|| ALL||||||||O[CR][ETX]C4[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Host sends back test selections: HOST ELEC HOST ELEC HOST ELEC HOST
ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&|||CAEv 2.0||||||||1|[CR][ETX]D5[CR][LF] [ACK] [STX]2P|1||000004|||||||||||||||||||||||||||||| |[CR][ETX]5F[CR][LF] [ACK] [STX]3O|1|000004|426|^^^400^0\^^^450^0|R| 19970618110440|||||N||||||||||||||Q|||||[CR][ETX]A8 [CR][LF] [ACK] [STX]4L|1|F[CR][ETX]FF[CR][LF] [ACK] [EOT]
Instrument queries test selections for sample ‘000005’ (For the 5th sample the rack ID is known. Therefore the instrument asks by the real rack ID 01402). ELEC HOST ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK]
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Examples
[STX]2Q|1|^000005^427^01402^5^^SAMPLE^NORMAL|| ALL||||||||O[CR][ETX]C7[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Host sends back test selections: HOST ELEC HOST ELEC HOST ELEC HOST
ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&|||CAEv 2.0||||||||1|[CR][ETX]D5[CR][LF] [ACK] [STX]2P|1||000005|||||||||||||||||||||||||||||| |[CR][ETX]60[CR][LF] [ACK] [STX]3O|1|000005|427|^^^400^0\^^^450^0|R| 19970618110442|||||N||||||||||||||Q|||||[CR][ETX]AC [CR][LF] [ACK] [STX]4L|1|F[CR][ETX]FF[CR][LF] [ACK] [EOT]
Instrument now queries test selections for the first sample in the rack ‘01402’ (For the 1st sample the sample ID was not read. Therefore the instrument asks by rack ID and position). ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2Q|1|^^423^01402^1^^SAMPLE^NORMAL||ALL| |||||||O[CR][ETX]9A[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Host sends back test selections with sample ID (In that case the sequence number 423 identifies the sample, the host echos back all entries): HOST ELEC HOST ELEC HOST ELEC HOST
ELEC HOST ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&|||CAEv 2.0||||||||1|[CR] [ETX]D5[CR][LF] [ACK] [STX]2P|1||000001|||||||||||||||||||||||||||||| |[CR][ETX]5C[CR][LF] [ACK] [STX]3O|1|000001|423^01402^1^^SAMPLE^NORMAL| ^^^400^0\^^^450^0|R|19970618110433|||||N||||||||||| |||Q|||||[CR][ETX]4D[CR][LF] [ACK] [STX]4L|1|F[CR][ETX]FF[CR][LF] [ACK] [EOT]
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6.1.3 Trace: Test Selection Batch Mode (Elecsys 1010) Host sends test selection (FT3) for sample ‘01’ without carrier ID/position #: HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&|||ELECTEST[CR][ETX]D7[CR][LF] [ACK] [STX]2P|1[CR][ETX]3F[CR][LF] [ACK] [STX]3O|1|01||^^^60^0|R||||||N||||||||||||||O [CR][ETX]3D[CR][LF] [ACK] [STX]4L|1|F[CR][ETX]FF[CR][LF] [ACK] [EOT]
Host sends test selection (FT3) for sample ‘02’ without carrier ID/position #: HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&|||ELECTEST[CR][ETX]D7[CR][LF] [ACK] [STX]2P|1[CR][ETX]3F[CR][LF] [ACK] [STX]3O|1|02||^^^60^0|R||||||N||||||||||||||O [CR][ETX]3E[CR][LF] [ACK] [STX]4L|1|F[CR][ETX]FF[CR][LF] [ACK] [EOT]
6.1.4 Trace: Test Selection Batch Mode (Elecsys 2010) Host sends in one message test selections (FT4, TSH, T4) for samples ’140’ to ‘142’ and control ‘999’ without carrier ID/position #. This example shows different possibilities in field contents: HOST ELEC HOST ELEC HOST ELEC HOST
ELEC HOST
ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&|||HOST|||||||P[CR][ETX]4B[CR][LF] [ACK] [STX]2P|1[CR][ETX]3F[CR][LF] [ACK] [STX]3O|1|140||^^^30\^^^10\^^^20|R| 19970523102030|||||N||||||||||||||O[CR][ETX]93 [CR][LF] [ACK] [STX]3O|1|141|^^^^SAMPLE|^^^30\^^^10\^^^20|R| 19970523102030|||||N||||||||||||||O[CR][ETX]93 [CR][LF] [ACK]
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ELEC HOST
ELEC HOST ELEC HOST
Examples
[STX]5O|2|142|^^^^SAMPLE^REDUCED|^^^10\^^^20|R| 19970523102030|||||N||||||||||||O[CR] [ETX]21[CR][LF] [ACK] [STX]7O|3|999|^^^^CONTROL|^^^020^0\^^^010^0|R| 19970523102030|||||N||||||||||||||O[CR][ETX]B1 [CR][LF] [ACK] [STX]1L|1|[CR][ETX]B6[CR][LF] [ACK]
6.1.5 Trace: Result Message Instrument sends results for control sample ‘000004’ (Seq# = 40, Disk# = 0, Pos# = 4): ELEC HOST ELEC HOST ELEC HOST ELEC
HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2P|1[CR][ETX]3F[CR][LF] [ACK] [STX]3O|1|000004|40^0^4^^SAMPLE^REDUCED|ALL|R| 19970425120322|||||X||||||||||||||O|||||[CR][ETX]6C [CR][LF] [ACK] [STX]4R|1|^^^10^0|0.016|uIU/ml|0.230^3.80|L||F||| 19970425120351|19970425122213|[CR][ETX]79[CR][LF] [ACK] [STX]5C|1|I|48^Below normal(expected)range|I [CR][ETX]57[CR][LF] [ACK] [STX]6R|2|^^^50^0|1.17|ng/ml|0.846^2.02|||F||| 19970425120557|19970425122419|[CR][ETX]DE[CR][LF] [ACK] [STX]7R|3|^^^20^0|4.41|ug/dl|5.13^13.52|L||F||| 19970425120433|19970425122255|[CR][ETX]1C[CR][LF] [ACK] [STX]0C|1|I|48^Below normal(expected)range|I[CR][ETX]52[CR][LF] [ACK] [STX]1R|4|^^^30^0|0.091|ng/dl|1.01^1.79|L||F||| 19970425120515|19970425122337|[CR][ETX]13[CR][LF] [ACK] [STX]3C|1|I|48^Below normal(expected)range|I[CR][ETX]55[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
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Instrument sends results for control ‘PC U1’ (In that example Raw Results are switched on.): ELEC HOST ELEC HOST ELEC HOST ELEC
HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC HOST ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2P|1[CR][ETX]3F[CR][LF] [ACK] [STX]3O|1|PC U1|37^0^1^^CONTROL^NORMAL|ALL|R| 19970425115705|||||X\Q||||||||||||||O|||||[CR][ETX] 66[CR][LF] [ACK] [STX]4R|1|^^^10^0|1.99|uIU/ml|1.69^2.43|||F||| 19970425115733|19970425121555|[CR][ETX]F2[CR][LF] [ACK] [STX]5M|1|RR^BM^E1^1||14242\13924\14154\13391\1 2613\12836\13062\13757\13053\13469\13147\12980\1331 2\13396\13501\13563\13639\13351\13155\12979\12857\1 3264\13391\13492\13343\13791\13345\13346\13752\1282 1\12993\13695\13696\14166\13736\13114\12690\12[ETB] 9C[CR][LF] [ACK] [STX]6517\13395\13264\12968\13375\13029\13117\1 3465\13267\13507\12716\13380\13316\13145\12736\1267 9\12555\13334\13347\13635\13291\13372\13694\13063\1 3278\13166\13523\12749\12977\13293\12872\12550\1281 5\12657\12718\13367\13141\13495\13466\13869\13[ETB] 06[CR][LF] [ACK] [STX]7520\13464\13565\22636\29929\33176\34453\3 4874\34951\34859\34748\34606\34414\34273\34127\3397 1\33799\33657\33534\33408\33303\33197\33114\32970\3 2860\32637\32585\32472\32434\32285\32210\32150\3210 1\31976\31815\31758\31693\31590\31552\31396\31[ETB] 3D[CR][LF] [ACK] [STX]0296\31256\31194\31103\31156\31026\30899\3 0894\30786\30742\30696\30591\30502\30582\30470\3036 3\30369\30350\30191\30183\30096\30065\30026\29933\2 9920\29881\29832\29783\29822\29769\29712\29527\2949 2\29499\29531\29487\29444\29403\29317\29248\29[ETB] 5E[CR][LF] [ACK] [STX]1190\29177\29196\29128\29081\29051\28995\2 9032\29019\29002\29034\28952\28864\28814\28819\2879 1\28825\28762\28709\28655\28563\28528\28514\28488\2 8344\28360\28345\28352\28260\28343\28275\28286\2827 6\28344\28308\28255\28157\28067\28031\28130\28[ETB] AB[CR][LF] [ACK] [STX]2156\28122\28175|28083[CR][ETX]1D[CR][LF] [ACK] [STX]3M|1|RC^BM^E1^1|10|TSH|190524|487|1|190599 ||[CR][ETX]18[CR][LF] [ACK] [STX]4R|2|^^^50^0|1.45|ng/ml|1.11^1.70|||F||| 19970425115939|19970425121801|[CR][ETX]A4[CR][LF] [ACK]
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ELEC .. .. ELEC HOST ELEC HOST ELEC HOST ELEC .. .. ELEC HOST ELEC HOST ELEC HOST ELEC .. .. ELEC HOST ELEC HOST ELEC HOST ELEC
V 4.2 –Version 01/05
Examples
[STX]5M|1|RR^BM^E1^1||13104\13200\13457\13463\1 3195\13161\.....
[STX]2321\35302\35259|196679[CR][ETX]57[CR][LF] [ACK] [STX]3M|1|RC^BM^E1^1|50|T3|192955|240|1|190599| |[CR][ETX]B1[CR][LF] [ACK] [STX]4R|3|^^^20^0|10.49|ug/dl|8.10^12.41|||F||| 19970425115815|19970425121637|[CR][ETX]0A[CR][LF] [ACK] [STX]5M|1|RR^BM^E1^1||14010\14245\13863\13399\1 3671\13047\.....
[STX]2592\38558\38544|457109[CR][ETX]65[CR][LF] [ACK] [STX]3M|1|RC^BM^E1^1|20|T4|190764|257|1|190599| |[CR][ETX]B3[CR][LF] [ACK] [STX]4R|4|^^^30^0|1.52|ng/dl|1.36^1.84|||F||| 19970425115857|19970425121719|[CR][ETX]AC[CR][LF] [ACK] [STX]5M|1|RR^BM^E1^1||13277\13330\13316\13684\1 3247\13300\.....
[STX]2033\28004\28064|28403[CR][ETX]0F[CR][LF] [ACK] [STX]3M|1|RC^BM^E1^1|30|FT4|192882|1228|1|19059 9||[CR][ETX]2C[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
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Examples
Trace Examples Standard Records
6.2.1 Trace: Batch Result Upload from Result Screen Instrument sends results for sample ID# 007 (R): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2P|1||007|||||||||||||||||||||||||||||||[CR][ ETX]D2[CR][LF] [ACK] [STX]3O|1|007|274^0^17^^TUBE|ALL|R|19960614142107| ||||X||||||||||||||0|||||[CR][ETX]45[CR][LF] [ACK] [STX]4R|1|^^^10^0||ulU/ml|0.230^3.80|8||X|||000000 00000000|19960614144523|[CR][ETX]7B[CR][LF] [ACK] [STX]5C|1|I|Assay·reagent·short|G[CR][ETX]90[CR][L F] [ACK] [STX]6R|2|^^^20^0||nmol/l|58.80^151.0|47||X|||0000 0000000000|19960614144523|[CR][ETX]01[CR][LF] [ACK] [STX]7C|1|I||G[CR][ETX]3B[CR][LF] [ACK] [STX]0R|3|^^^30^0||pmol/l|11.80^24.60|47||X|||0000 0000000000|19960614144523|[CR][ETX]F9[CR][LF] [ACK] [STX]1C|1|I||G[CR][ETX]35[CR][LF] [ACK] [STX]2L|1[CR][ETX]3B[CR][LF] [ACK] [EOT]
Instrument sends results for sample ID# 000010 (R): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2P|1||000010|||||||||||||||||||||||||||||||[C R][ETX]5C[CR][LF] [ACK] [STX]3O|1|000010|279^0^20^^TUBE|ALL|R|199606141426 48|||||X||||||||||||||0|||||[CR][ETX]D8[CR][LF] [ACK] [STX]4R|1|^^^10^0||ulU/ml|0.230^3.80|8||X|||000000 00000000|19960614144811|[CR][ETX]7B[CR][LF] [ACK] [STX]5C|1|I|Assay·reagent·short|G[CR][ETX]90[CR][L F] [ACK] [STX]6R|2|^^^20^0||nmol/l|58.80^151.0|47||X|||0000 0000000000|19960614144811|[CR][ETX]01[CR][LF]
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HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
Examples
[ACK] [STX]7C|1|I||G[CR][ETX]3B[CR][LF] [ACK] [STX]0R|3|^^^30^0||pmol/l|11.80^24.60|47||X|||0000 0000000000|19960614144811|[CR][ETX]F9[CR][LF] [ACK] [STX]1C|1|I||G[CR][ETX]35[CR][LF] [ACK] [STX]2L|1[CR][ETX]3B[CR][LF] [ACK] [EOT]
Instrument sends results for sample ID# 0002121 (R): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2P|1||0002121|||||||||||||||||||||||||||||||[ CR][ETX]91[CR][LF] [ACK] [STX]3O|1|0002121|277^0^21^^TUBE|ALL|R|19960614142 650|||||X||||||||||||||0|||||[CR][ETX]05[CR][LF] [ACK] [STX]4R|1|^^^10^0||ulU/ml|0.230^3.80|8||X|||000000 00000000|19960614144935|[CR][ETX]82[CR][LF] [ACK] [STX]5C|1|I|Assay·reagent·short|G[CR][ETX]90[CR][L F] [ACK] [STX]6R|2|^^^20^0||nmol/l|58.80^151.0|47||X|||0000 0000000000|19960614144935|[CR][ETX]08[CR][LF] [ACK] [STX]7C|1|I||G[CR][ETX]3B[CR][LF] [ACK] [STX]0R|3|^^^30^0||pmol/l|11.80^24.60|47||X|||0000 0000000000|19960614144935|[CR][ETX]00[CR][LF] [ACK] [STX]1C|1|I||G[CR][ETX]35[CR][LF] [ACK] [STX]2L|1[CR][ETX]3B[CR][LF] [ACK] [EOT]
Instrument sends results for sample ID# 0002436 (R): ELEC HOST ELEC HOST ELEC HOST ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2P|1||0002436|||||||||||||||||||||||||||||||[ CR][ETX]9A[CR][LF] [ACK] [STX]3O|1|0002436|273^0^15^^TUBE|ALL|R|19960614142 100|||||X||||||||||||||0|||||[CR][ETX]03[CR][LF]
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HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
Examples
[ACK] [STX]4R|1|^^^10^0||ulU/ml|0.230^3.80|8||X|||000000 00000000|19960614150232|[CR][ETX]75[CR][LF] [ACK] [STX]5C|1|I|Assay·reagent·short|G[CR][ETX]90[CR][L F] [ACK] [STX]6R|2|^^^20^0|320.0|nmol/l|58.80^151.0|23||X|| |19960614144410|19960614150232|[CR][ETX]1A[CR][LF] [ACK] [STX]7C|1|I|Concentration·out·of·expected·value·ra nge|G[CR][ETX]DB[CR][LF] [ACK] [STX]0R|3|^^^30^0|34.12|pmol/l|11.80^24.60|46||X|| |19960614144452|19960614150314|[CR][ETX]23[CR][LF] [ACK] [STX]1C|1|I|Low·sample·signal|G[CR][ETX]A7[CR][LF] [ACK] [STX]2L|1[CR][ETX]3B[CR][LF] [ACK] [EOT]
6.2.2 Trace: Host Cancels Test Selections (Example for Contention) Host cancels Test Selections for sample ID# 000010 on the instrument (O): HOST ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC HOST
[ENQ] [ACK] [STX]1H|\^&|||ASTM-Host[CR][ETX]59[CR][LF] [ACK] [STX]2P|1||000010[CR][ETX]58[CR][LF] [ACK] [STX]3O|1|000010|||R||||||C||||||||||||||O[CR][ETX ]E4[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Host cancels Test Selections for sample ID# 000004 on the instrument (O): HOST ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&|||ASTM-Host[CR][ETX]59[CR][LF] [ACK] [STX]2P|1||000004[CR][ETX]5B[CR][LF] [ACK] [STX]3O|1|000004|||R||||||C||||||||||||||O[CR][ETX ]E7[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK]
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Examples
[EOT]
Host tries to cancel Test Selections for sample ID# 000010 a second time (O): HOST ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC HOST
[ENQ] [ACK] [STX]1H|\^&|||ASTM-Host[CR][ETX]59[CR][LF] [ACK] [STX]2P|1||000010[CR][ETX]58[CR][LF] [ACK] [STX]3O|1|000010|||R||||||C||||||||||||||O[CR][ETX ]E4[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Contention because instrument tries to send warning and host continues canceling: HOST ELEC ELEC
[ENQ] [ENQ] [EOT]
Instrument has priority and therefore sends alarm (M-PM): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|PM^BM^E1^1|19960613114441|863^0|Interfac e·acceptance·error·:·44-01-09|W[CR][ETX]F5[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
6.2.3 Trace: Sample Scan Instrument sends Instrument Status: Sample Scan (M-IS): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|IS^BM^E1^1|N|O|||||||1[CR][ETX]CE[CR][LF ] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Instrument sends query for sample ID 0002436 (Q): ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK]
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ELEC HOST ELEC HOST ELEC HOST ELEC
Examples
[STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2Q|1|^0002436^267^0^15^^TUBE||ALL||||||||O[CR ][ETX]B4[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Host responds with test selection for sample ID 0002436 (O): HOST ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC HOST
[ENQ] [ACK] [STX]1H|\^&|||ASTM-Host[CR][ETX]59[CR][LF] [ACK] [STX]2P|1||0002436|||||||||||||||||||||||||||||||[ CR][ETX]9A[CR][LF] [ACK] [STX]3O|1|0002436||^^^10^0\^^^20^0\^^^30^0|R|||||| N||||||||||||||O|||||[CR][ETX]6F[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Instrument sends query for sample ID 007 (Q): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2Q|1|^007^268^0^16^^TUBE||ALL||||||||O[CR][ET X]EE[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Host responds with test selection for sample ID 007 (O): HOST ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&|||ASTM-Host[CR][ETX]59[CR][LF] [ACK] [STX]2P|1||007|||||||||||||||||||||||||||||||[CR][ ETX]D2[CR][LF] [ACK] [STX]3O|1|007||^^^10^0\^^^20^0\^^^30^0|R||||||N||| |||||||||||O|||||[CR][ETX]A7[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
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Instrument sends query for sample ID 000010 (Q): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2Q|1|^000010^270^0^20^^TUBE||ALL||||||||O[CR] [ETX]6C[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Host responds with test selection for sample ID 000010 (O): HOST ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC ELEC HOST
[ENQ] [ACK] [STX]1H|\^&|||ASTM-Host[CR][ETX]59[CR][LF] [ACK] [STX]2P|1||000010|||||||||||||||||||||||||||||||[C R][ETX]5C[CR][LF] [ACK] [STX]3O|1|000010||^^^10^0\^^^20^0\^^^30^0|R||||||N ||||||||||||||O|||||[CR][ETX]31[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Instrument actualizes inventory for 18 Reagent Positions (M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC HOST .. .. ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|||||||||||||||||RD||1|R[CR][E TX]7D[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|TR|10|TSH|||RP|SCE1|200|19137 5|1051|19960604162839|||00000000|184||RD||2|A\C[CR ][ETX]42[CR][LF] [ACK] [STX]4M|3|XT^BM^E1^1|TR|20|T4|||RP|SCE1|200|189920 |344|19960531085131|||00000000|194||RD||3|A[CR][ET X]0C[CR][LF] [ACK] [STX]5M|4|XT^BM^E1^1|TR|30|FT4|||RP|SCE1|200|19087 5|786|19960612095136|||00000000|186||RD||4|A[CR][E TX]68[CR][LF] [ACK] [STX]6M|5|XT^BM^E1^1|||||||||||||||||RD||5|R[CR][E TX]89[CR][LF] [ACK]
[STX]3M|18|XT^BM^E1^1|BS|1|BlankCel|||RP|SCE1|225| 93|121219|19960531085131|||00000000|201||RD||18|A[ CR][ETX]69[CR][LF]
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Examples
[ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Instrument actualizes inventory for Tips and Cups (M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|TP||||||||||||||170||TR|||A[C R][ETX]87[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|VS||||||||||||||66||VR|||A[CR ][ETX]64[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Instrument actualizes inventory for ProCell and CleanCell (M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|AB|ABCC1|||||||||||||36|||||A [CR][ETX]CB[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|CC|ABCC1|||||||||||||32|||||A [CR][ETX]CC[CR][LF] [ACK] [STX]4M|3|XT^BM^E1^1|AB|ABCC2|||||||||||||42|||||A [CR][ETX]CD[CR][LF] [ACK] [STX]5M|4|XT^BM^E1^1|CC|ABCC2|||||||||||||63|||||A [CR][ETX]D5[CR][LF] [ACK] [STX]6L|1[CR][ETX]3F[CR][LF] [ACK] [EOT]
Instrument actualizes inventory for Distilled Water and Liquid Waste (M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|DW||||||||||||||0|||||A[CR][E TX]70[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|LW||||||||||||||0|||||A[CR][E TX]7A[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF]
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[ACK] [EOT]
Instrument sends Instrument Status: Stand By (M-IS): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|IS^BM^E1^1|B|O|||||||1[CR][ETX]C2[CR][LF ] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
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Examples
Trace Examples Manufacturer Specific Records
6.3.1 Trace: Reagent Scan Instrument sends Instrument Status: Reagent Scan (M-IS): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|IS^BM^E1^1|R|O|||||||1[CR][ETX]D2[CR][LF ] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Instrument sends alarm message (M-PM): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|PM^BM^E1^1|19960614141329|790^0|Cell·tem perature·(>30min)·:·36-03-02|W[CR][ETX]98[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Instrument sends inventory for assay buffer ProCell container 1(M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|AB|ABCC1|||||||||||||36|||||A [CR][ETX]CB[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Instrument sends inventory for CleanCell container 1(M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|CC|ABCC1|||||||||||||32|||||A [CR][ETX]CA[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK]
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[EOT]
Instrument sends inventory for assay buffer ProCell container 1(M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|AB|ABCC2|||||||||||||42|||||A [CR][ETX]C9[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Instrument sends inventory for CleanCell container 2(M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|CC|ABCC2|||||||||||||63|||||A [CR][ETX]CF[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Instrument sends inventory for Tips (M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|TP||||||||||||||170||TR|||A[C R][ETX]87[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Instrument sends inventory for cups (M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|VS||||||||||||||66||VR|||A[CR ][ETX]62[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
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Instrument sends inventory for 18 Reagent Positions (M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC
HOST
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|||||||||||||||||RD||1|R[CR][E TX]7D[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|TR|10|TSH|||RP|SCE1|200|19137 5|1051|19960604162839|||00000000|184||RD||2|A\C[CR ][ETX]42[CR][LF] [ACK] [STX]4M|3|XT^BM^E1^1|TR|20|T4|||RP|SCE1|200|189920 |344|19960531085131|||00000000|194||RD||3|A[CR][ET X]0C[CR][LF] [ACK] [STX]5M|4|XT^BM^E1^1|TR|30|FT4|||RP|SCE1|200|19087 5|786|19960612095136|||00000000|186||RD||4|A[CR][E TX]68[CR][LF] [ACK]
Empty positions 5 to 17: ELEC HOST .. .. ELEC
HOST ELEC HOST ELEC
[STX]6M|5|XT^BM^E1^1|||||||||||||||||RD||5|R[CR][E TX]89[CR][LF] [ACK]
[STX]3M|18|XT^BM^E1^1|BS|1|BlankCel|||RP|SCE1|225| 93|121219|19960531085131|||00000000|201||RD||18|A[ CR][ETX]69[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Instrument sends test application information for 18 Reagent Positions (M-TA): ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK]
Empty positions 1: ELEC HOST
[STX]2M|1|TA^BM^E1^1|MBC^[CR][ETX]49[CR][LF] [ACK]
MBC for positions 2 to 4: ELEC
HOST ELEC
V 4.2 –Version 01/05
[STX]3M|2|TA^BM^E1^1|MBC^0004514016752096128364300 04296908900174602025175435786365866398139504296327 52030331313115480247516883730983098553876935784453 82004153507853507660848583220488619479825085536708 4320964973604965125278948118558160581935329323[ETB ]7F[CR][LF] [ACK] [STX]490446089435965546297871967355802095015406094 21525215360044880174602025175435786365866398139504 29632752030331313115480247516883730983098553876935 78445382004153507853507660848583220488619479825085
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HOST .. ..
Examples
5367084320964973604965125278948118558160581935[ETB ]7F[CR][LF] [ACK] [STX]532932390446089435965546297871967355802095015 40609421525215360044881234567890123456789012345678 9012345678901234567890123457257[CR][ETX]D9[CR][LF] [ACK]
Empty positions 5 to 17: ELEC HOST
[STX]4M|5|TA^BM^E1^1|MBC^[CR][ETX]4F[CR][LF] [ACK]
MBC for positions 18: ELEC
HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC
[STX]1M|18|TA^BM^E1^1|MBC^052063164065680310932953 75387381226730105337861473364266429567980574507556 87447608635128839825543277655032335300048205922714 01653753873812267301053378614733642704085397572677 0143134461349120853156210868765336924100821831[ETB ]59[CR][LF] [ACK] [STX]210641844224067890123456789012345678901234567 89012345678901234567890123456789012345678901234567 89012345678901234567890123456789012345678901234567 89012345678901234567890123456789012345678901234567 8901234567890123456789012345678901234567890123[ETB ]6F[CR][LF] [ACK] [STX]345678901234567890123456789012345678901234567 89012345678901234567890123456789012345678901234567 89012345678901234567890123455845[CR][ETX]1E[CR][LF ] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Instrument sends inventory for 18 Reagent Positions (M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC
HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|||||||||||||||||RD||1|R[CR][E TX]7D[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|TR|10|TSH|||RP|SCE1|200|19137 5|1051|19960604162839|||00000000|184||RD||2|A\C[CR ][ETX]42[CR][LF] [ACK] [STX]4M|3|XT^BM^E1^1|TR|20|T4|||RP|SCE1|200|189920 |344|19960531085131|||00000000|194||RD||3|A[CR][ET X]0C[CR][LF] [ACK] [STX]5M|4|XT^BM^E1^1|TR|30|FT4|||RP|SCE1|200|19087 5|786|19960612095136|||00000000|186||RD||4|A[CR][E TX]68[CR][LF] [ACK]
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HOST ELEC HOST ELEC
Examples
[STX]6M|5|XT^BM^E1^1|||||||||||||||||RD||5|R[CR][E TX]89[CR][LF] [ACK] [STX]3M|18|XT^BM^E1^1|BS|1|BlankCel|||RP|SCE1|225| 93|121219|19960531085131|||00000000|201||RD||18|A[ CR][ETX]69[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Instrument sends inventory for Tips and Cups (M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|TP||||||||||||||170||TR|||A[C R][ETX]87[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|VS||||||||||||||66||VR|||A[CR ][ETX]64[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Instrument sends inventory for ProCell and CleanCell (M-XT): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|AB|ABCC1|||||||||||||36|||||A [CR][ETX]CB[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|CC|ABCC1|||||||||||||32|||||A [CR][ETX]CC[CR][LF] [ACK] [STX]4M|3|XT^BM^E1^1|AB|ABCC2|||||||||||||42|||||A [CR][ETX]CD[CR][LF] [ACK] [STX]5M|4|XT^BM^E1^1|CC|ABCC2|||||||||||||63|||||A [CR][ETX]D5[CR][LF] [ACK] [STX]6L|1[CR][ETX]3F[CR][LF] [ACK] [EOT]
Instrument sends inventory for Distilled Water (M-XT): ELEC HOST ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK]
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Examples
[STX]2M|1|XT^BM^E1^1|DW||||||||||||||0|||||A[CR][E TX]70[CR][LF] [ACK]
Instrument sends inventory for Liquid Waste (M-XT): ELEC HOST ELEC HOST ELEC
[STX]3M|2|XT^BM^E1^1|LW||||||||||||||0|||||A[CR][E TX]7A[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
Instrument sends Instrument Status: Stand by (M-IS): ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|IS^BM^E1^1|B|O|||||||1[CR][ETX]C2[CR][LF ] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
6.3.2 Trace: Substance Data Message Host queries for Substance Data at container position 12: HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&||||||||||P||[CR][ETX]05[CR][LF] [ACK] [STX]2M|1|XTQ^BM^E1^1|||||||||||||||||||12|[CR] [ETX]18[CR][LF] [ACK] [STX]3L|1|I[CR][ETX]01[CR][LF] [ACK] [EOT]
Instrument sends back Substance Data for position 12: ELEC HOST ELEC HOST ELEC
HOST ELEC HOST ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|TR|30|FT4|||RP|SCE1|200|19 2882|1228|19970423094333|||19970800|196||RD||12|A[C R][ETX]DB[CR][LF] [ACK] [STX]3L|1|F[CR][ETX]FE[CR][LF] [ACK] [EOT]
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Instruments actualizes Substance Data: ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|CC|ABCC1|||||||||||||107 |||||A[CR][ETX]FD[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT] [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|AB|ABCC2|||||||||||||35 |||||A[CR][ETX]CB[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT] [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|TP||||||||||||||303 ||TR|||A[CR][ETX]85[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT] [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|VS||||||||||||||150 ||VR|||A[CR][ETX]8C[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
Instrument sends update for Substance Data ELEC HOST ELEC HOST ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|||||||||||||||||RD||1|R[ETX]7D[CR][LF] [ACK]
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HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC
V 4.2 –Version 01/05
Examples
[STX]3M|2|XT^BM^E1^1|TR|40|T-UP|||RP|SCE1|200| 190543|17|19970424161410|||19970400|169||RD||2|A[CR ][ETX]8C[CR][LF] [ACK] [STX]4M|3|XT^BM^E1^1|TR|310|AFP|||RP|SCE1|100|1 89872|178|19970424161410|||19970400|96||RD||3|A[CR] [ETX]83[CR][LF] [ACK] [STX]5M|4|XT^BM^E1^1|TR|10|TSH|||RP|SCE1|200|19 0524|487|19970424161411|||19970800|182||RD||4|A[CR] [ETX]92[CR][LF] [ACK] [STX]6M|5|XT^BM^E1^1|||||||||||||||||RD||5|R[ETX]89[CR][LF] [ACK] [STX]7M|6|XT^BM^E1^1|TR|320|PSA|||RP|SCE1|100|1 92831|446|19970424161411|||19970500|89||RD||6|A[CR] [ETX]91[CR][LF] [ACK] [STX]0M|7|XT^BM^E1^1|TR|170|HCGSTAT|||RP|SCE1|1 00|190554|100|19970424161411|||19970500|75||RD||7|A [CR][ETX]A7[CR][LF] [ACK] [STX]1M|8|XT^BM^E1^1|TR|210|CKMBSTAT|||RP|SCE1| 100|190557|75|19970424161411|||19970500|54||RD||8|A [CR][ETX]CB[CR][LF] [ACK] [STX]2M|9|XT^BM^E1^1|TR|60|FT3|||RP|SCE1|200|19 0884|158|19970424161411|||19970400|182||RD||9|A[CR] [ETX]7C[CR][LF] [ACK] [STX]3M|10|XT^BM^E1^1|||||||||||||||||RD||10|R< CR>[ETX]DE[CR][LF] [ACK] [STX]4M|11|XT^BM^E1^1|||||||||||||||||RD||11|R< CR>[ETX]E1[CR][LF] [ACK] [STX]5M|12|XT^BM^E1^1|TR|50|T3|||RP|SCE1|200|19 2955|240|19970424161411|||19970700|184||RD||12|A[CR ][ETX]8A[CR][LF] [ACK] [STX]6M|13|XT^BM^E1^1|TR|20|T4|||RP|SCE1|200|19 0764|257|19970424161411|||19971100|184||RD||13|A[CR ][ETX]8A[CR][LF] [ACK] [STX]7M|14|XT^BM^E1^1|TR|30|FT4|||RP|SCE1|200|1 92882|1228|19970424161411|||19970800|184||RD||14|A[ CR][ETX]0C[CR][LF] [ACK] [STX]0M|15|XT^BM^E1^1|TR|200|TNTSTAT|||RP|SCE1| 100|190560|78|19970424161411|||19970500|18||RD||15| A[CR][ETX]FB[CR][LF] [ACK] [STX]1M|16|XT^BM^E1^1|TR|300|CEA|||RP|SCE1|100| 192838|577|19970424161411|||19970500|96||RD||16|A[C R][ETX]DA[CR][LF] [ACK] [STX]2M|17|XT^BM^E1^1|||||||||||||||||RD||17|R< CR>[ETX]EB[CR][LF]
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HOST ELEC
HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST
V 4.2 –Version 01/05
Examples
[ACK] [STX]3M|18|XT^BM^E1^1|DR|1|DilUni2|||RP|SCE1|40 000|7878787|777|19970424161411|||19991200|40000||RD ||18|A[CR][ETX]6B[CR][LF] [ACK] [STX]4M|1|DP^BM^E1^1|10||[CR][ETX]73[CR][LF] [ACK] [STX]5M|2|DP^BM^E1^1|20||[CR][ETX]76[CR][LF] [ACK] [STX]6M|3|DP^BM^E1^1|30||[CR][ETX]79[CR][LF] [ACK] [STX]7M|4|DP^BM^E1^1|40||[CR][ETX]7C[CR][LF] [ACK] [STX]0M|5|DP^BM^E1^1|50||[CR][ETX]77[CR][LF] [ACK] [STX]1M|6|DP^BM^E1^1|60||[CR][ETX]7A[CR][LF] [ACK] [STX]2M|7|DP^BM^E1^1|100||[CR][ETX]A7[CR][LF] [ACK] [STX]3M|8|DP^BM^E1^1|110||[CR][ETX]AA[CR][LF] [ACK] [STX]4M|9|DP^BM^E1^1|120||[CR][ETX]AD[CR][LF] [ACK] [STX]5M|10|DP^BM^E1^1|130||[CR][ETX]D7[CR][LF] [ACK] [STX]6M|11|DP^BM^E1^1|140||[CR][ETX]DA[CR][LF] [ACK] [STX]7M|12|DP^BM^E1^1|150||[CR][ETX]DD[CR][LF] [ACK] [STX]0M|13|DP^BM^E1^1|160||[CR][ETX]D8[CR][LF] [ACK] [STX]1M|14|DP^BM^E1^1|170||[CR][ETX]DB[CR][LF] [ACK] [STX]2M|15|DP^BM^E1^1|180||[CR][ETX]DE[CR][LF] [ACK] [STX]3M|16|DP^BM^E1^1|200||[CR][ETX]D9[CR][LF] [ACK] [STX]4M|17|DP^BM^E1^1|210||[CR][ETX]DC[CR][LF] [ACK] [STX]5M|18|DP^BM^E1^1|220||[CR][ETX]DF[CR][LF] [ACK] [STX]6M|19|DP^BM^E1^1|230||[CR][ETX]E2[CR][LF] [ACK] [STX]7M|20|DP^BM^E1^1|300||[CR][ETX]D9[CR][LF] [ACK] [STX]0M|21|DP^BM^E1^1|310||[CR][ETX]D4[CR][LF] [ACK] [STX]1M|22|DP^BM^E1^1|320||[CR][ETX]D7[CR][LF] [ACK] [STX]2M|23|DP^BM^E1^1|330||[CR][ETX]DA[CR][LF] [ACK] [STX]3M|24|DP^BM^E1^1|340||[CR][ETX]DD[CR][LF] [ACK]
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ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[STX]4M|25|DP^BM^E1^1|350||[CR][ETX]E0[CR][LF] [ACK] [STX]5M|26|DP^BM^E1^1|360||[CR][ETX]E3[CR][LF] [ACK] [STX]6M|27|DP^BM^E1^1|370||[CR][ETX]E6[CR][LF] [ACK] [STX]7M|28|DP^BM^E1^1|380||[CR][ETX]E9[CR][LF] [ACK] [STX]0M|29|DP^BM^E1^1|390||[CR][ETX]E4[CR][LF] [ACK] [STX]1M|30|DP^BM^E1^1|400||[CR][ETX]D5[CR][LF] [ACK] [STX]2M|31|DP^BM^E1^1|410||[CR][ETX]D8[CR][LF] [ACK] [STX]3M|32|DP^BM^E1^1|420||[CR][ETX]DB[CR][LF] [ACK] [STX]4M|33|DP^BM^E1^1|430||[CR][ETX]DE[CR][LF] [ACK] [STX]5M|34|DP^BM^E1^1|440||[CR][ETX]E1[CR][LF] [ACK] [STX]6M|35|DP^BM^E1^1|450||[CR][ETX]E4[CR][LF] [ACK] [STX]7M|36|DP^BM^E1^1|460||[CR][ETX]E7[CR][LF] [ACK] [STX]0M|37|DP^BM^E1^1|470||[CR][ETX]E2[CR][LF] [ACK] [STX]1M|38|DP^BM^E1^1|480||[CR][ETX]E5[CR][LF] [ACK] [STX]2M|39|DP^BM^E1^1|490||[CR][ETX]E8[CR][LF] [ACK] [STX]3M|40|DP^BM^E1^1|500||[CR][ETX]D9[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
ELEC HOST ELEC HOST ELEC
HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|TP||||||||||||||254||TR||| A[CR][ETX]8A[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|VS||||||||||||||126||VR||| A[CR][ETX]91[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK]
HOST ELEC
V 4.2 –Version 01/05
Examples
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ELEC
HOST ELEC
HOST ELEC HOST ELEC HOST ELEC HOST ELEC ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
Examples
[STX]2M|1|XT^BM^E1^1|AB|ABCC1|||||||||||||110| ||||A [CR][ETX]F4[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|CC|ABCC1|||||||||||||107| ||||A [CR][ETX]FF[CR][LF] [ACK] [STX]4M|3|XT^BM^E1^1|AB|ABCC2|||||||||||||19||| ||A[CR][ETX]D1[CR][LF] [ACK] [STX]5M|4|XT^BM^E1^1|CC|ABCC2|||||||||||||20||| ||A[CR][ETX]CE[CR][LF] [ACK] [STX]6L|1[CR][ETX]3F[CR][LF] [ACK] [EOT] [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|DW||||||||||||||0|||||A[ETX]70[CR][LF] [ACK] [STX]3M|2|XT^BM^E1^1|LW||||||||||||||0|||||A[ETX]7A[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
6.3.3 Trace: Calibrator Parameters Message Instrument read Calibrator Bar code card: ELEC HOST ELEC HOST ELEC
HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|RC||||||||190763|||||19971 100|||||| [CR][ETX]CF[CR][LF] [ACK] [STX]3M|1|CP^BM^E1^1|20|A|47.50|99999999|[CR]71[CR][LF] [ACK] [STX]4M|2|CP^BM^E1^1|20|B|74.70|99999999|[CR]76[CR][LF] [ACK] [STX]5M|3|CP^BM^E1^1|20|C|0.000|99999999|[CR]67[CR][LF] [ACK] [STX]6M|4|CP^BM^E1^1|20|D|0.000|99999999|[CR]6A[CR][LF] [ACK]
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ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
Examples
[STX]7M|5|CP^BM^E1^1|20|E|0.000|99999999|[CR]6D[CR][LF] [ACK] [STX]0M|6|CP^BM^E1^1|20|A|46.80|190619|[CR]E7[CR][LF] [ACK] [STX]1M|7|CP^BM^E1^1|20|B|139.0|190619|[CR]E5[CR][LF] [ACK] [STX]2M|8|CP^BM^E1^1|20|C|0.000|190619|[CR]DB[CR][LF] [ACK] [STX]3M|9|CP^BM^E1^1|20|D|0.000|190619|[CR]DE[CR][LF] [ACK] [STX]4M|10|CP^BM^E1^1|20|E|0.000|190619|[CR]08[CR][LF] [ACK] [STX]5M|11|CP^BM^E1^1|20|A|50.40|190764|[CR]10[CR][LF] [ACK] [STX]6M|12|CP^BM^E1^1|20|B|147.0|190764|[CR]16[CR][LF] [ACK] [STX]7M|13|CP^BM^E1^1|20|C|0.000|190764|[CR]0D[CR][LF] [ACK] [STX]0M|14|CP^BM^E1^1|20|D|0.000|190764|[CR]08[CR][LF] [ACK] [STX]1M|15|CP^BM^E1^1|20|E|0.000|190764|[CR]0B[CR][LF] [ACK] [STX]2L|1[CR][ETX]3B[CR][LF] [ACK] [EOT]
6.3.4 Trace: Control Parameters Message Instrument read Control Bar code card: ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BM^E1^1|CS|6|PCTM1||||||190475||||| 19980500||||||[CR][ETX]8F[CR][LF] [ACK] [STX]3M|1|QP^BM^E1^1|300||5.07|21.00|21.00|[CR] [ETX]D1[CR][LF] [ACK] [STX]4M|2|QP^BM^E1^1|310||0.000|30.00|30.00|[ETX]F8[CR][LF] [ACK] [STX]5M|3|QP^BM^E1^1|320||1.89|21.00|21.00|[CR] [ETX]DD[CR][LF]
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HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
Examples
[ACK] [STX]6M|4|QP^BM^E1^1|330||0.000|21.00|21.00|[ETX]FE[CR][LF] [ACK] [STX]7M|5|QP^BM^E1^1|340||0.000|48.00|48.00|[ETX]13[CR][LF] [ACK] [STX]0M|6|QP^BM^E1^1|350||0.000|36.00|36.00|[ETX]08[CR][LF] [ACK] [STX]1M|7|QP^BM^E1^1|360||0.000|30.00|30.00|[ETX]FF[CR][LF] [ACK] [STX]2M|8|QP^BM^E1^1|370||0.000|36.00|36.00|[ETX]0E[CR][LF] [ACK] [STX]3M|9|QP^BM^E1^1|380||0.000|27.00|27.00|[ETX]11[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
6.3.5 Trace: Calibration Data Message Instrument sends Calibration Data: ELEC HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|CR^BM^E1^1|30|192882|ng/dl|RD^1^12| 1228|N^M||19970423103101|O|I^0^----------\M^0^----\S^0^----------\R^1.00^0.000\D^0^----|252858.000000^4.043450^1.316730^8366.690430^0.0000 00\-376.218567^1.254267\1.000000| SD^1^1^192881^0\SD^1^2^19288[ETB]9D[CR][LF] [ACK] [STX]31^0\SD^1^^^\SD^1^^^\SD^1^^^|48008^49049\ 14824^14835\-0.000^-0.000\-0.000^-0.000\-0.000^0.000[CR][ETX]50[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
6.3.6 Trace: Instrument Status Message Query from the HOST: HOST ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&||||||||||P||[CR][ETX]05[CR][LF]
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ELEC HOST ELEC HOST ELEC HOST
Examples
[ACK] [STX]2M|1|ISQ^BM^E1^1||||||||||[CR][ETX]CD[CR][LF] [ACK] [STX]3L|1|N[CR][ETX]06[CR][LF] [ACK] [EOT]
Answer from the Instrument: ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|IS^BM^E1^1|P|O|||||||1[CR][ETX]D0[CR][LF] [ACK] [STX]3L|1|F[CR][ETX]FE[CR][LF] [ACK] [EOT]
6.3.7 Trace: Test Conditions Message Host queries for Test Conditions: HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&||||||||||P||[CR][ETX]05[CR][LF] [ACK] [STX]2M|1|TCQ^BM^E1^1||||||||||||[CR][ETX]C0[LF] [ACK] [STX]3L|1|N[CR][ETX]06[CR][LF] [ACK] [EOT]
Instrument sends Test Conditions ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|TC^BM^E1^1|10|TSH|uIU/ml||1^1^2||0.23 0^3.80|||||y[CR][ETX]BD[CR][LF] [ACK] [STX]3M|2|TC^BM^E1^1|20|T4|ug/dl|0.078|1^1^2||5 .13^13.52|||||y[CR][ETX]1A[CR][LF] [ACK] [STX]4M|3|TC^BM^E1^1|30|FT4|ng/dl|0.078|1^1^2|| 1.01^1.79|||||y[CR][ETX]2B[CR][LF] [ACK] [STX]5M|4|TC^BM^E1^1|40|T-UP|TBI||1^1^2||0.780^1.36 |||||y[CR][ETX]CA[CR][LF] [ACK]
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ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
Examples
[STX]6M|5|TC^BM^E1^1|50|T3|ng/ml|0.651|1^1^2|| 0.846^2.02|||||y[CR][ETX]23[CR][LF] [ACK] [STX]7M|6|TC^BM^E1^1|60|FT3|pg/ml|0.651|1^1^2|| 2.60^5.08|||||y[CR][ETX]3D[CR][LF] [ACK] [STX]0M|7|TC^BM^E1^1|170|HCGSTAT|mIU/ml||1^1^2| |10.00^10000|||||y[CR][ETX]33[CR][LF] [ACK] [STX]1M|8|TC^BM^E1^1|200|TNTSTAT|ng/ml||1^1^2|| 0.000^0.100|||||y[CR][ETX]1A[CR][LF] [ACK] [STX]2M|9|TC^BM^E1^1|210|CKMBSTAT|ng/ml||1^1^2| |0.000^5.00|||||y[CR][ETX]18[CR][LF] [ACK] [STX]3M|10|TC^BM^E1^1|300|CEA|ng/ml||1^1^2|| 0.000^4.60|||||y[CR][ETX]B6[CR][LF] [ACK] [STX]4M|11|TC^BM^E1^1|310|AFP|ng/ml|1.21|1^1^2| |0.000^7.74|||||y[CR][ETX]91[CR][LF] [ACK] [STX]5M|12|TC^BM^E1^1|320|PSA|ng/ml||1^1^2|| 0.000^4.00|||||y[CR][ETX]D1[CR][LF] [ACK] [STX]6L|1|F[CR][ETX]01[CR][LF] [ACK] [EOT]
6.3.8 Trace: Test Application Message Instrument updates after Reagent Scan (18 positions): ELEC HOST ELEC HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|TA^BM^E1^1|MBC^[CR][ETX]49[CR][LF] [ACK] [STX]3M|2|TA^BM^E1^1|MBC^0000073020541408073423 408272868970401024207088112425726995522278400085632 231777669297608445188410723609433841494584124036199 600867368979427860003939208585621911776331572324922 7720861959956379520410800716598208614910419697[ETB] 6C[CR][LF] [ACK] [STX]428124440275558507399223485853072638514921 257569795532681255201024207088112425726995522278400 085632231777669297608445188410723609433841494584124 036199600867368979427860003939208585621911776331572 3249227720861959956379520410800716598208614910[ETB] 6B[CR][LF] [ACK] [STX]541969728124440275558507399223485853072638 514913878872166048859935212345678901234567890123456 789012345678901234567890123451438[CR][ETX]F6[CR][LF ]
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HOST .. .. HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC
Examples
[ACK]
[ACK] [STX]2M|17|TA^BM^E1^1|MBC^[CR][ETX]80[CR][LF] [ACK] [STX]3M|18|TA^BM^E1^1|MBC^000333744171017800002 641473272859104532526702804814815681164846933488627 236410004464433511996961594968750326892606422004827 675568290953199921385777626576220951942179361466434 4749070091307666161922310535701565974500756030[ETB] 65[CR][LF] [ACK] [STX]469622922688395344823987366966976927052338 677472890613569352722842171719767890123456789012345 678901234567890123456789012345678901234567890123456 789012345678901234567890123456789012345678901234567 8901234567890123456789012345678901234567890123[ETB] B1[CR][LF] [ACK] [STX]545678901234567890123456789012345678901234 567890123456789012345678901234567890123456789012345 6789012345678901234567890123455924[CR][ETX]1E[CR][L F] [ACK] [STX]6L|1[CR][ETX]3F[CR][LF] [ACK] [EOT]
6.3.9 Trace: Instrument Configuration Message Host queries for Instrument Configuration: HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST
[ENQ] [ACK] [STX]1H|\^&||||||||||P||[CR][ETX]05[CR][LF] [ACK] [STX]2M|1|ICQ^BM^E1^1|||||||||||||||[CR][ETX]29 [CR][LF] [ACK] [STX]3L|1|N[CR][ETX]06[CR][LF] [ACK] [EOT]
Instrument sends Instrument Configuration: ELEC HOST ELEC HOST ELEC
HOST ELEC HOST
V 4.2 –Version 01/05
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|IC^BM^E1^1||S|S|B|ELEC1|^All^SD^^|133707 |080640^19970424^02 - 03^4426||^0^0||||| [CR][ETX]75[CR][LF] [ACK] [STX]3L|1|F[CR][ETX]FE[CR][LF] [ACK]
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Examples
ELEC
[EOT]
ELEC HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&||||||||||P||[CR][ETX]05[CR][LF] [ACK] [STX]2M|1|IC^BM^E1^1|||||ELEC1|^All^SD^^|133711 ||||||||[CR][ETX]7A[CR][LF] [ACK] [STX]3L|1|N[CR][ETX]06[CR][LF] [ACK] [EOT]
HOST ELEC HOST ELEC
6.3.10 Trace: Service Data Message Instrument sends Service Data: ELEC HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC HOST ELEC ELEC HOST ELEC HOST ELEC
HOST ELEC
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[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|SD^BM^E1^1||19970409^^10119||Calibrat or\165\30\R1\119^123^142^159^162^158^155^155^156^15 5^150^145^141^139^137^134^131^129^127^126^124^123^1 22^121^120^119^118^118^118^118^118^118^119^119^119^ 119^118^102^88^88^91^90^84^80^79^80^78^77^76^7[ETB] 86[CR][LF] [ACK] [STX]36^75^75^75^75^75^76^76^76^76^77^77^79^79^ 79^80^81^81^82^82^83^83^86^90^92^91^90^90^90^90^90^ 89^89^88^88^87^84^80^77^78^80^80^79^78^78^79^79^78^ 78^78^78^78^78^78^78^78^78^78^78^78^78^78^78^78^78^ 73^68^61^59^59^65^255^255^255^255^255^255^255^[ETB] 35[CR][LF] [ACK] [STX]4255|ClotDetection|[CR][ETX]09[CR][LF] [ACK] [STX]5L|1[CR][ETX]3E[CR][LF] [ACK] [EOT] [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|SD^BM^E1^1||19970409^^10119||Calibrat or\165\30\Sample\62^67^84^96^96^92^93^97^94^73^59^6 0^62^58^51^47^47^47^45^44^43^43^44^44^44^45^46^47^4 8^49^50^52^53^54^55^56^57^59^60^61^62^63^64^65^66^6 7^68^69^70^71^71^72^73^74^74^75^76^76^77^77^78[ETB] 32[CR][LF] [ACK] [STX]3^79^79^79^80^80^81^81^82^82^82^85^88^90^9 0^88^88^88^88^87^87^86^85^84^83^82^81^81^80^79^78^7 7^77^76^75^72^68^65^66^68^67^66^66^66^66^66^66^66^6
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ELEC HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC HOST ELEC
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5^66^65^65^66^65^68^70^72^70^66^65^255^255^255^255^ 255^255^255^255|ClotDetection|[CR][ETX]CA[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|SD^BM^E1^1||19970409^^10136||ABLevelCheck ^13874\13216\13330\13198\13477\13489\13397\13340\12 850\13044\13900\13657\13112\13096\13342\13117\13547 \13373\13052\13283\13361\13452\13642\13846\13536\13 004\13103\13410\12896\13427\13014\12747\13[ETB]90[C R][LF] [ACK] [STX]3077\13132\13810\13370\12833\13306\13462\1 4055\13522\13696\13337\13187\13752\13710\13873\1334 9\13300\12898\13026\12903\13050\13221\12766\13550\1 3289\13350\13104\13380\13230\13710\13455\13220\1345 6\13090\12989\13167\14146\13911\13733\13509\13[ETB] A0[CR][LF] [ACK] [STX]4619\12977\12868\13001\13390\13478\13448\1 3057\13432\14641\16415\17284\17317\17861\17667\1754 6\17782\17874\18048\18406\18186\18509\18104\17859\1 8156\18099\18454\18838\18377\18915\18419\18539\1826 8\18281\17801\18205\18456\18332\18396\18459\18[ETB] 90[CR][LF] [ACK] [STX]5458\18435\18481\18481\18284\18477\18127\1 8303\18382\18477\18298\17933\17959\18205\18087\1810 8\17851\18074\17893\17866\17966\17888\17871\18377\1 7986\18562\18445\18485\18543\18542\18212\18224\1783 4\17829\18090\18158\18004\17924\17873\17944\17[ETB] C7[CR][LF] [ACK] [STX]6418\17616\17704\18022\17713\17793\17757\1 7821\17830\18144\17823\17912\17866\17890\17997\1788 8\17601\17297\17514\18263\17525\17514\17236\17821\1 7896\18001\17691\18097\18398\18421\17848\18088\1824 3\17849\18216\17606\17701\18284\18186\18424\18[ETB] 96[CR][LF] [ACK] [STX]7078\17751\18581\18231\18079\18148\17791\1 8174|ADCRawData|[CR][ETX]F6[CR][LF] [ACK] [STX]0L|1|F[CR][ETX]FB[CR][LF] [ACK] [EOT]
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6.3.11 Trace: Processing Message Instrument sends Alarm Message: ELEC HOST ELEC HOST ELEC
HOST ELEC HOST ELEC
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[ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|PM^BM^E1^1|19970525132822|858^0| Communication Message Format Error : 44-0108|W[CR][ETX]EA[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
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ASTM Designation: E 1381 - 91
ASTM Designation: E 1381 - 91
Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems Reprinted, with permission, from the Annual Book of ASTM Standards. Copyright American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, U.S.A This standard is issued under the fixed designation E 1381; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval. The American Society for Testing and Materials takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility. This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years and if not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM Headquarters. Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards, 1916 Race St., Philadelphia, PA 19103.
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Scope • This specification describes the electronic transmission of digital information between clinical laboratory instruments and computer systems. The clinical laboratory instruments under consideration are those that measure one or more parameters from one or more patient samples. Often there will be automated instruments that measure many parameters from many patient samples. The Computer systems considered here are those that are configured to accept instrument results for further processing, storage, reporting, or manipulation. This instrument output may include patient results, quality control results, and other related information. Typically, the computer system will be a Laboratory Information Management System (LIMS). • The terminology of the Organization for International Standards (ISO) Reference Model for Open Systems Interconnection (OSI) is generally followed in describing the communications protocol and services. The electrical and mechanical connection between instrument and computer is described in the Physical Layer section. The methods for establishing communication, error detection, error recovery, and sending and receiving of messages are described in the Data Link Layer section. The data link layer interacts with higher layers in terms of send and receive "messages", handles data link connection and release requests, and reports the data link status. • Specification E 1394 is concerned with message content in the interface between clinical instruments and computer systems. The major topics are found in the following sections.
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Referenced Documents ASTM Standard:(1) E1394 Specification for Transferring Information Between Clinical Instruments and Computer Systems ANSI Standards:(2) X3.4-1986 American National Standard Code for Information Systems-Coded Character Sets-7-Bit American National Standard Code for Information Interchange (7-Bit ASCII). X3.15-1976 American National Standard for Bit Sequencing of the American National Standard Code for Information Interchange in Serial-by-Bit Data Transmission. X3.16-1976 American National Standard Character Structure and Character Parity Sense for Serial-by-Bit Data Communication in the American National Standard Code for Information Interchange. ISO Standard: International Standard ISO 7498-1984(E), Information Processing Systems-Open Systems Interconnection-Basic Reference Model, International Organization for Standardization. Other Document:(3) EIA-232-D-1986 Interface Between Data Terminal Equipment and Data CircuitTerminating Equipment Employing Serial Binary Data Interchange
(1) Annual Book of ASTM Standards, Vol. 14.01. (2) Available from American National Standards Institute, 1430 Broadway, New York, NY 10018 (3) Available from Electronics Industries Association, 2001 I Street, N. W., Washington, DC 20006
7.3
Terminology Sender The device that has a message to send and initiates the transmission process. Receiver The device that responds to the sender and accepts the message. Parts of a communication The parts of communication between instrument and computer are identified by the following terms. The parts are hierarchical and are listed in order of most encompassing first.
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Session A total unit of communication activity, used in this standard to indicate the events starting with the establishment phase and ending with the termination phase, as described in subsequent sections. Message A collection of related information on a single topic, used here to mean all the identity, tests, and comments sent at one time. Frame A subdivision of a message, used to allow periodic communication housekeeping such as error checks and acknowledgments.
7.4
Significance and Use • Nearly all recent major clinical instruments have provision for connection to a computer system, and in nearly all laboratories that have implemented a LIMS, there is a need to connect the laboratory's high volume automated instruments to the LIMS so that results can be transferred automatically. To accomplish this connection, both the instrument and the computer must have compatible circuits and appropriate software, and there must be a proper cable to connect the two systems. • Without this standard specification, the interface between each different instrument and each different computer system is likely to be a different product. This increases the cost, the chances for compatibility problems, and the difficulty of specifying and designing a proper system. In addition, interfaces for every instrument-computer combination may not be available, forcing expensive and time-consuming custom development projects. • This standard specification defines the electrical parameters, cabling, data codes, transmission protocol, and error recovery for the information that passes between the instrument and the laboratory computer. It is expected that future products from instrument manufacturers and computer system developers, released after the publication of this specification, will conform to this specification, and that will lead to plug-together compatibility of clinical instruments and computer systems.
7.5
Physical Layer
7.5.1 Overview Physical Layer The mechanical and electrical connection for serial binary data bit transmission between instrument and computer system is described in the physical layer. The topology is point-to-point, a direct connection between two devices.
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7.5.2 Electrical Characteristics The voltage and impedance levels for the generator and receiver circuits are as specified in the EIA-232-D-1986 standard. Signal Levels • For the data interchange circuits, a marking condition corresponds to a voltage more negative than minus three volts with respect to signal ground at the interface point. A spacing condition corresponds to a voltage more positive than plus three volts with respect to signal ground at the interface point. • Binary state ONE (1) corresponds to the marking condition; binary state ZERO (0) corresponds to the spacing condition. • The signal levels conform to the EIA-232-D-1986 standard. Character Structure • The method of data transmission is serial-by-bit start/stop. The order of the bits in a character is: (a) One start bit, corresponding to a binary 0, (b) The data bits of the character, least significant bit transmitted first, (c) Parity bit, (d) Stop bit(s), corresponding to a binary 1. • The time between the stop bit of one character and the start bit of the next character may be of any duration. The data interchange circuit is in the marking condition between characters. • Even parity corresponds to a parity bit chosen in such a way that there are an even number of ONE bits in the sequence of data bits and parity bit. Odd parity corresponds to an odd number of ONE bits when formed in the same way. • All devices must be capable of sending and receiving characters consisting of one start bit, eight data bits, no parity bit, and one stop bit. • The default character structure consists of one start bit, eight data bits, no parity bit, and one stop bit. Eight data bit character sets are allowed but not specified by this standard. Other character structures can be used for specialized applications, for example, seven data bits, odd, even, mark or space parity, or two stop bits. • The character bit sequencing, structure, and parity sense definitions conform to ANSI standards X 3.15-1976 and X 3.16-1976. Speed • The data transmission rate for instruments shall be at least one of these baud rates: 1,200, 2,400, 4,800, or 9,600 baud. The preferred rate is 9,600 baud and should be the default setting of the instrument when more than one baud rate is available. The computer system must have the capability for all four baud rates. • Devices may optionally have the capability for other baud rates such as 300, 19,200, and 38,400 baud for use in specialized applications. V 4.2 –Version 01/05
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Interface Connections • The conforming connection specified here defines the point of interconnection between the domain of the instrument and the domain of the computer system (see Table 7-1). Within the domain of either device, any appropriate connection system may be used, preferably with suitable cable locking hardware. • The conforming connection utilizes a 25-position connector. The connector contact assignments are listed in Table 1. Connector contacts not listed are unused. The connector contact assignments conform to the EIA-232-D-1986 standard for the circuits that are used.
TABLE 1:
Connector Contact Assignments
Contact
EIA
Direction
No.
Circuit
1
...
Shield
...
No connection
2
BA
Transmitted Data
Output
Input
3
BB
Received Data
Input
Output
7
AB
Signal Ground
...
...
Description
Instrument
Computer
Table 7-1: Connector Contact Assignments
• Contact 1 is the shield connection, it connects to the instrument's (the DTE) frame. The shield connection is left open at the computer (the DCE) to avoid ground loops. There will be no connections on any other pins. All other pins will be open circuits.
7.5.3 Mechanical Characteristics Connector • The conforming connector associated with the instrument is a commercial type DB-25P (subminiature D male) style connector. The conforming connector associated with the computer is a commercial type DB-25S (subminiature D female) style connector. The connector dimensions must correspond to those given in the EIA-232-D-1986 standard. • When the conforming connector of the instrument is cable mounted, it shall be configured with a locking device such as No. 4-40 or M-3 thread female screw locking hardware. When the conforming connector of the computer is cable mounted, it shall be configured with a locking device such as No. 4-40 or M-3 thread male screw locking hardware. V 4.2 –Version 01/05
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Instrument Domain
Computer Domain
Instrument
Computer (DCE)
(DTE)
Conforming Connection
FIG. 1(a) Connector Strategy for Instrument Computer Connection - Cable Mounted
Figure 7-1: Connector Strategy for Instrument Computer Connection - Cable Mounted
• When the conforming connector of either device is chassis mounted, it shall be configured with devices such as No. 4-40 or M-3 thread female screw locking hardware. The mating cable connector shall use devices such as No. 4-40 or M-3 thread male screw locking hardware.
Instrument Domain
Computer Domain
Instrument
Computer (DCE)
(DTE)
Conforming Connection
Extension Cable
Conforming Connection
FIG. 1(b) Connector Strategy for Instrument Computer Connections - Chassis Mounted
Figure 7-2: Connector Strategy for Instrument Computer Connections - Chassis Mounted
• When the conforming connector of the instrument is cable mounted and the conforming connector of the computer is chassis mounted, then a change in the cable mounted locking hardware is necessary.
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Cable Any extension cables to connect the instrument to the computer require a female connector on one end to mate with the instrument and a male connector on the other end to mate with the computer. Detailed requirements of an interconnecting cable are undefined but good engineering practice should be followed in selecting the cable and connectors. Shielded cable and connectors may be necessary to suppress electromagnetic interface (EMI). Low capacitance cable may be necessary for long cable lengths or the higher data rates. Appropriate connector locking hardware should be used at the conforming connectors.
7.6
Data Link Layer
7.6.1 Overview Data Link Layer The data link layer has procedures for link connection and release, delimiting and synchronism, sequential control, error detection, and error recovery. • Link connection and release establish which system sends and which system receives information. Delimiting and synchronism provide for framing of the data and recognition of frames. Sequence control maintains the sequential order of information across the connection. Error detection senses transmission or format errors. Error recovery attempts to recover from detected errors by retranslating defective frames or returning the link to a neutral state from otherwise unrecoverable errors. • The data link layer uses a character-oriented Protocol to send messages between directly connected systems. (See ANSI X3.4-1986. Also, see 7.8 for the coding of the ASCII characters.) Some restrictions are placed on the characters which can appear in the message content. • The data link mode of operation is one-way transfer of information with alternate supervision. Information flows in one direction at a time. Replies occur after information is sent, never at the same time. It is a simplex stop-and-wait protocol. • At times, the two systems are actively operating to transfer information. For the remainder of the time the data link is in a neutral state. See Figure 7-3. • There are three distinct phases in transferring information between instrument and computer system. In each phase, one system directs the operation and is responsible for continuity of the communication. The three phases assure the actions of sender and receiver are coordinated. The three phases are Establishment (see 7.6.2), Transfer (see 7.6.3) and Termination (see 7.6.4).
7.6.2 Establishment Phase (Link Connection) • The establishment phase determines the direction of information flow and prepares the receiver to accept information.
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• The sender notifies the receiver that information is available. The receiver responds that it is prepared to receive before information is transmitted. • A system which does not have information to send normally monitors the data link to detect the establishment phase. It acts as a receiver, waiting for the other system. • The system with information available initiates the establishment phase. After the sender determines that the data link is in a neutral state, it transmits the transmission control character to the intended receiver. • Upon receiving the , the receiver prepares to receive information. All other characters are ignored. It replies with the transmission control character signifying it is ready. With this sequence of events, the establishment phase ends and the transfer phase begins. • A receiver that cannot immediately receive information, replies with the transmission control character. Upon receiving , the sender must wait at least 10 s before transmitting another . • Systems not having the ability to receive information always reply to an with a . Systems not having the ability to send information never transmit an . Contention Should both systems simultaneously transmit an , the data link is in contention. The instrument system has priority to transmit information when contention occurs. Contention is resolved as follows: (a) Upon receiving a reply of to its transmitted , the computer system must stop trying to transmit; it must prepare to receive. When the next is received, it replies with an or depending on its readiness to receive. (b) Upon receiving a reply of to its transmitted , the instrument must wait at least 1 s before sending another .
7.6.3 Transfer Phase During the transfer phase, the sender transmits messages to the receiver. The transfer phase continues until all messages are sent. Frames Messages are sent in frames, each frame contains a maximum of 247 characters (including frame overhead). Messages longer than 240 characters are divided between two or more frames. • Multiple messages are never combined in a single frame. Every message must begin in a new frame.
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• A frame is one of two types, an intermediate frame or an end frame. Intermediate frames terminate with the characters , checksum, and . End frames terminate with the characters , checksum, and . A message containing 240 characters or less is sent in a single end frame. Longer messages are sent in intermediate frames with the last part of the message sent in an end frame. The frame structure is illustrated as follows: FN text C1 C2 ← intermediate frame FN text C1 C2 ← end frame where:
Start of Text transmission control character
FN
single digit Frame Number 0 to 7
text
Data Content of Message
End of Transmission Block transmission control character
End of Text transmission control character
C1
most significant character of checksum 0 to 9 and A to F
C2
least significant character of checksum 0 to 9 and A to F
Carriage Return ASCII character
Line Feed ASCII character
Frame Number The frame number permits the receiver to distinguish between new and retransmitted frames. It is a single digit sent immediately after the character. • The frame number is an ASCII digit ranging from 0 to 7. The frame number begins at 1 with the first frame of the transfer phase. The frame number is incremented by one for every new frame transmitted. After 7, the frame number rolls over to 0, and continues in this fashion. Checksum The checksum permits the receiver to detect a defective frame. The checksum is encoded as two characters which are sent after the or character. The checksum is computed by adding the binary values of the characters, keeping the least significant eight bits of the result. • The checksum is initialized to zero with the character. The first character used in computing the checksum is the frame number. Each character in the message text is added to the checksum (modulo 256). The computation for the checksum does not include , the checksum characters, or the trailing and . • The checksum is an integer represented by eight bits, it can be considered as two groups of four bits. The groups of four bits are converted to the ASCII characters of the hexadecimal representation. The two ASCII characters are transmitted as the checksum, with the most significant character first.
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• For example, a checksum of 122 can be represented as 01111010 in binary or 7A in hexadecimal. The checksum is transmitted as the ASCII character 7 followed by the character A. Acknowledgments After a frame is sent, the sender stops transmitting until a reply is received. • The receiver replies to each frame. When it is ready to receive the next frame, it transmits one of three replies to acknowledge the last frame. This reply must be transmitted within the time-out period specified in 7.6.5. • A reply of signifies the last frame was received successfully and the receiver is prepared to receive another frame. The sender must increment the frame number and either send a new frame or terminate. • A reply of signifies the last frame was not successfully received and the receiver is prepared to receive the frame again. • A reply of signifies the last frame was received successfully, the receiver is prepared to receive another frame, but is a request to the sender to stop transmitting. (See the following section on receiver interrupts.) Receiver Interrupts The receiver interrupt is a means for the receiver to request the sender to stop transmitting messages as soon as possible. • During the transfer phase, if the receiver responds to a frame with an in place of the usual , the sender must interpret this reply as a receiver interrupt request. The is a positive acknowledgment of the end frame, signifies the receiver is prepared to receive next frame, and is a request to the sender to stop transmitting. • The sender does not have to stop transmitting after receiving the receiver interrupt request. If the sender chooses to ignore the , the receiver must re-request the interrupt for the request to remain valid. • If the sender chooses to honor the receiver interrupt request, it must first enter the termination phase to return the data link to the neutral state. This gives the receiver an opportunity to enter the establishment phase and become the sender. The original sender must not enter the establishment phase for at least 15 s or until the receiver has sent a message and returned the data link to the neutral state.
7.6.4 Termination Phase (Link Release) The termination phase returns the data link to the clear or neutral state. The sender notifies the receiver that all messages have been sent. • The sender transmits the transmission control character and then regards the data link to be in a neutral state. Upon receiving , the receiver also regards the data link to be in the neutral state.
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7.6.5 Error Recovery Methods are described which enable both sender and receiver to recover, in an orderly way, from errors in data transmission. Defective Frames A receiver checks every frame to guarantee it is valid. A reply of is transmitted for invalid frames. Upon receiving the , the sender retransmits the last frame with the same frame number. In this way, transmission errors are detected and automatically corrected. • Any characters occurring before the or after the end of the block character (the or ) are ignored by the receiver when checking the frame. A frame should be rejected because: (a) Any character errors are detected (parity error, framing error, etc.) (b) The frame checksum does not match the checksum computed on the received frame, (c) The frame number is not the same as the last accepted frame or one number higher (modulo 8) • Upon receiving a or any character except an or (a condition), the sender increments a retransmit counter and retransmits the frame. If this counter shows a single frame was sent and not accepted six times, the sender must abort this message by proceeding to the termination phase. An abort should be extremely rare, but it provides a mechanism to escape from a condition where the transfer phase cannot continue. Time-outs The sender and receiver both use timers to detect loss of coordination between them. The timers provide a method for recovery if the communication line or the other device fails to respond. • During the establishment phase, the sender sets a timer when transmitting the . If a reply of an , , or is not received within 15 s, a time-out occurs. After a time-out, the sender enters the termination phase. • During the establishment phase, if the computer (as receiver) detects contention, it sets a timer. If an is not received within 20 s, a time-out occurs. After a time-out, the receiver regards the line to be in the neutral state. • During the transfer phase, the sender sets a timer when transmitting the last character of a frame. If a reply is not received within 15 s, a time-out occurs. After a time-out, the sender aborts the message transfer by proceeding to the termination phase. As with excessive retransmissions of detective frames, the message must be remembered so it can be completely repeated. • During the transfer phase, the receiver sets a timer when first entering the transfer phase or when replying to a frame. If a frame or is not received within 30 s,
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a time-out occurs. After a time-out, the receiver discards the last incomplete message and regards the line to be in the neutral state. • A receiver must reply to a frame within 15 s or the sender will time-out. A receiver can delay its reply for up to 15 s to process the frame or to otherwise go busy. Longer delays cause the sender to abort the message. • Receivers that cannot process messages fast enough to keep up with a sender may cause message buffer overflows in the sender. A sender can normally store at least one complete message. Storage space for more than one outgoing message is desirable but optional.
7.6.6 Restricted Message Characters The data link protocol is designed for sending character based message text. Restrictions are placed on which characters may appear in the message text. The restrictions make it simpler for senders and receivers to recognize replies and frame delimiters. Additional characters are restricted to avoid interfering with software controls for devices such as multiplexes. • A character is not permitted to appear in the message text; it can appear only as the last character of a frame. • None of the ten transmission control characters, the format effector control character, or four device control characters may appear in message text. The restricted characters are: , , , , , , , , , , , , , , and .
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Appendix 1: STATE DIAGRAM Receiving Device Busy Send
Sending Device
Receive
Data to Send Awake
Receive or Time Out Time Out
Waiting
Receive Zero Retry Count
Get Frame
Increment %8 Count
Good New Frame
Frame Received
Bad Frame Send Timer := 30
Next Frame Set up
Retries = 6 Send
Time Out
Frame Ready
New Frame Increment %8 Count
Have Data to Send
Done
Increment %8 Count
Retries < 6 Send Timer := 30
Frame ok
Receive or Contention Timer(Inst) := 1 or (Comp) := 20 or Busy Timer := 10
Waiting
Send
Good Repeat Frame
Contention or Busy Timer Running
Set %8 Count to 1 Send Timer := 15
Send Set %8 Count to 1 Timer := 30
Send Timer := 30
Send
Idle
Send Frame Timer := 15
Repeat Frame
Old Frame Set up
Accept Ignore Zero Retry Count Increment %8 Count
Interrupt Requested
Waiting Receive
Receive Increment Retries (Receiving any character except or )
Figure 7-3: State Diagram
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Note 1
"%8“ represents modulo 8.
Note 2
"=“ represents assignment of a value. "Timer:= 15" resets the timer to 15s as used here.
Note 3
Arrow associated normal text denotes a condition; arrow associated italicized text denotes action taken.
7.8
Appendix 2: Seven-Bit ASCII Code Charts
7.8.1 Appendix 2.1: Decimal Character Code
dec
CHR ASCII Character
Decimal Character Code 000 001 002 003 004 005 006 007 008 009 010 011 012 013 014 015
NUL SOH STX ETX EOT ENQ ACK BEL BS HT LF VT FF CR SO SI
016 017 018 019 020 021 022 023 024 025 026 027 028 029 030 031
DLE DC1 DC2 DC3 DC4 NAK SYN ETB CAN EM SUB ESC FS GS RS US
032 033 034 035 036 037 038 039 040 041 042 043 044 045 046 047
SP ! " # $ % & ' ( ) * + , . /
048 049 050 051 052 053 054 055 056 057 058 059 060 061 062 063
0 1 2 3 4 5 6 7 8 9 : ; < = > ?
064 065 066 067 068 069 070 071 072 073 074 075 076 077 078 079
@ A B C D E F G H I J K L M N O
080 081 082 083 084 085 086 087 088 089 090 091 092 093 094 095
P Q R S T U V W X Y Z [ \ ] ^ _
096 097 098 099 100 101 102 103 104 105 106 107 108 109 110 111
` a b c d e f g h i j k l m n o
112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127
p q r s t u v w x y z { | } ~ DEL
Table 7-2: Decimal Character Code
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7.8.2 Appendix 2.2: Hexadecimal Character Code
hex
CHR ASCII Character
Hexadecimal Character Code 00 01 02 03 04 05 06 07 08 09 0A 0B 0C 0D 0E 0F
NUL SOH STX ETX EOT ENQ ACK BEL BS HT LF VT FF CR SO SI
10 11 12 13 14 15 16 17 18 19 1A 1B 1C 1D 1E 1F
DLE DC1 DC2 DC3 DC4 NAK SYN ETB CAN EM SUB ESC FS GS RS US
20 21 22 23 24 25 26 27 28 29 2A 2B 2C 2D 2E 2F
SP ! " # $ % & ' ( ) * + , . /
30 31 32 33 34 35 36 37 38 39 3A 3B 3C 3D 3E 3F
0 1 2 3 4 5 6 7 8 9 : ; < = > ?
40 41 42 43 44 45 46 47 48 49 4A 4B 4C 4D 4E 4F
@ A B C D E F G H I J K L M N O
50 51 52 53 54 55 56 57 58 59 5A 5B 5C 5D 5E 5F
P Q R S T U V W X Y Z [ \ ] ^ _
60 61 62 63 64 65 66 67 68 69 6A 6B 6C 6D 6E 6F
` a b c d e f g h i j k l m n o
70 71 72 73 74 75 76 77 78 79 7A 7B 7C 7D 7E 7F
p q r s t u v w x y z { | } ~ DEL
Table 7-3: Hexadecimal Character Code
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Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems Reprinted, with permission, from the Annual Book of ASTM Standards. Copyright American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, U.S.A This standard is issued under the fixed designation E1394; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.
8.1
Scope • This standard covers the two-way digital transmission of remote requests and results between clinical instruments and computer systems. It is intended to document the common conventions required for the interchange of clinical results and patient data between clinical instruments and computer systems. This standard specifies the message content for transferring information between a clinical instrument and a computer system. It enables any two such systems to establish a logical link for communicating text to send result, request, or demographic information in a standard and interpretable form. This standard does not necessarily apply to general analytical instruments in an industrial analytical nor research and development setting. • This standard specification is intended to apply to the structure of messages exchanged between clinical instruments and computer systems by means of defined communications protocols. Low-level communications protocols and data transfer requirements are beyond the scope of this standard. A separate specification is available from ASTM detailing a standard for low-level data transfer communications. • This standard specifies the conventions for structuring the content of the message and for representing the data elements contained within those structures. It is applicable to all text oriented clinical instrumentation. It has been specifically created to provide common conventions for interfacing computers and instruments in a clinical setting. It would also be applicable to interfacing instruments in clinical practice settings, such as physicians' offices, clinics, and satellite laboratories.
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Referenced Documents ASTM Standards: E1238 Specification for Transferring Clinical Laboratory Data Messages Between Independent Computer Systems (1) E1239 Guide for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Automated Patient Care Information Systems (2) ANSI Standards:(2) X3.30 ANSI Information System Codes X3.40 ANSI Information System Codes X3.43 ANSI Information Systems Codes X3.50 ANSI Information Systems Codes ISO Standards:(3) ISO 5218 Information Interchange-Representation of Human Sexes ISO/lEC JTC1 ISO 2955-93 Information Processing-Representation of SI and Other Units in Systems with Limited Character Sets.
(1) Annual Book of ASTM Standards, Vol 14.01. (2) Available from American National Standards Institute, 1430 Broadway, New York, NY 10018. (3) Available from International Standards Organization, 1 Rue de Varembe. Case Postale 56, Crt 1221, Geneva 20 Switzerland.
8.3
Terminology
8.3.1 Description of Terms Specific to this Standard: message A textual body of information. battery A group of tests ordered together, for example, an admitting battery. The term battery is used in the document synonymously with the term profile or panel. The test elements within a battery may be characteristic of a single physiologic system, for example, liver function tests, or many different physiologic systems. The battery is simply a convention by which a user can order multiple tests by specifying a single name.
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test A determination of a single analyte or a combination of values from other determinations or observations which constitute a measure of a single system attribute. record An aggregate of fields describing one aspect of the complete message. field One specific attribute of a record which may contain aggregates of data elements further referring the basic attribute. repeat field A single data element which expresses a duplication of the field definition it is repeating. Used for demographics, requests, orders and the like, where each element of a repeat field is to be treated as having equal priority or standing to associated repeat fields. component field A single data element or data elements which express a finer aggregate or extension of data elements which precede it. For example, parts of a field or repeat field entry. As an example, the patient's name is recorded as last name, first name, and middle initial, each of which is separated by a component delimiter. Components cannot contain repeat fields. upload Data transmitted from a clinical instrument to a computer system. download Data transmitted from a computer system to a clinical instrument.
8.4
Significance and Use
8.4.1 General Information: • This specification provides for two-way transmission allowing for data-flow in either direction. It provides for sending demographic and test information to or from clinical instruments. This specification has sufficient flexibility to permit the addition of fields to existing record types or the creation of new record types to accommodate new test and reporting methodologies. • This specification is related to Specification E1238. Both standards use positional convention to define the structure of messages that exchange information about
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clinical test requests and results. The set of conventions specifies a hierarchical set of records in which the records higher in the hierarchy contain information that is common to all records lower in the hierarchy and thus avoids redundancy in linking data together. The positional convention is simple and direct to implement, requiring only a sequence of strings each having variable length delimited fields which are positionally specified. • Specification E1238, in its entirety, is not appropriate for use as a clinical instrument to computer system interface. The conventions of Specification E1238 regarding record types and the organization of data elements within the records have been adhered to as closely as possible to ensure that common data elements defined there and used within instruments are specified as closely as possible. This facilitates the use of this specification consistent with Specification E1238 in a number of settings. There are three compelling reasons for developing a separate standard which deviates from Specification E1238. • The scope of Specification E1238 is specifically targeted to accommodate information transfer between two independent computer systems requiring shared patient demographic and test result data. Specification E1238 contains extensive requirements and limitations, much of which may be of little, if any, use by clinical instrument systems. Further, clinical instruments have test and instrument specific requirements outside the scope of Specification E1238 and, as such, are not available within the existing Specification E1238. • The structure of Specification E1238 provides great flexibility in the ordering and reporting of test results and patient demographics. While this is appropriate for use by advanced computer systems of equivalent rank, Specification E1238 clearly falls beyond the technical limitations of many clinical laboratory instruments. This specification attempts to identify, and simplify, all complex data structures and interface procedures and, where practical, restricts multiple procedural options to single procedures appropriate for the clinical instrument setting. Further, this specification has attempted to assign a master/slave hierarchy where conflicts may occur, assigning appropriate responsibility for data processing or reporting operations to the party (clinical instrument or computer system) better able to process a particular task. For example, in all cases involving the ordering or reporting of tests, the instrument manufacturer is solely responsible for assigning the test and result ID numbers (see 8.6.6). These reductions in flexibility directly result in increased structure and clarity, which is deemed more appropriate for ensuring successful interface implementation within the clinical instrument setting. • Specification E1238 was developed independent of data protocol and transfer considerations. Specification E1238 uses maximum field and record lengths. Combined with its record level checksum and error recovery facilities, Specification E1238 may be implemented without a data protocol layer. By contrast, this message-content specification has been developed in cooperative effort with a correlative ASTM low-level data transfer and protocol specification. V 4.2 –Version 01/05
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While each specification (message-content and low-level protocol) is designed to be independently implemented and maintained, the message-content specification presumes that a protocol layer exists that will handle record blocking/deblocking, error detection and recovery, and other associated data transport tasks. As such, all protocol level operations and limitations existing in Specification E1238 are not applicable, and therefore not included in this document.
8.5
Information Requirements in Clinical Testing
8.5.1 General Approach • Messages may contain one or more requests/results for one or more patients. Tests may be requested as groups of many individual tests. These groups are referred to as batteries. Examples of batteries are tests produced on a multichannel analyzer, such as a CHEM12, physiological groupings of tests (such as liver function tests) and Minimum Inhibitory Concentration tests (MICs) in microbiology testing. The fact that a series of tests is contained in a battery does not imply that they are all performed on the same analytic instrument. • Messages consist of a hierarchy of records of various types. Records at level zero contain information pertaining to the sender identification and completion of transmission. Records at level one of the hierarchy contain information about individual patients. Records at level two contain information about test order requests and specimens. Records at level three contain information about test results. • Comment records may be inserted at any level in the hierarchy. A comment record always relates to the immediately preceding patient, order, result, scientific or manufacturer information record. Therefore, if a comment record were to follow a patient record (level one), then that comment record would be treated as a level two record. A comment record may not follow the message terminator record. • Manufacturer information records may be inserted at any level in the hierarchy. This record type always relates to the immediately preceding patient, order result, scientific or comment record. Therefore, if a manufacturer information record were to follow a patient record (level one), then the record would be treated as a level two record. This record may not follow the message terminator record. • Additional record types are the request-information record and the terminator record. The request-information record provides for the request of demographics or test results to or from the clinical instrument for specified patients, specimens, tests, and dates, and the like. The message terminator record must be the very last record of the message. • The smallest element of information in any record is the field, containing a single item of information, such as a date, a patient name, or a numeric test result.
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• The test order record contains information about ordering a single test, test battery, or a series of tests or batteries, as discussed in 8.6.5 and 8.9. • Most of the record types are related to each other in a definite hierarchy. At level zero is the message header and message terminator. At level one is the patient record, the request-information record and the scientific record. At level two is the test order record. At level three is the result record. The comment and manufacturer information records do not have an assigned level. • A sequence of patient records, order records, or result records at one level is terminated by the appearance of a record type of the same or higher level. Thus, a sequence of results for one battery of tests is terminated by the next test order, patient, manufacturer information, request information, or message terminator record. • An order record may never appear without a preceding patient record and a result record may never appear without a preceding order record. • When an order is transmitted, it must be preceded by a patient record. All orders that follow apply to the patient in the preceding patient record. When a result is transmitted, it must be preceded by an order record and a patient record to maintain the prescribed hierarchy. • Each instrument manufacturer adhering to this standard may decide which fields are applicable for their particular application with the exception of those fields necessary to identify the record type or parse individual fields. Thus the need to send the hierarchy of records need not generate large messages.
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8.5.2 Logical Structure of the Message Level Protocol
Table 8-1: Logical Structure of a Message
• Logical Information Storage Requirements - In order to determine buffering requirements, both transmitter and receiver must use common rules for storing transmitted data in order to ensure proper error logging and error recovery procedures (see paragraph below). Since data content is structured in a hierarchical fashion, any decremental change in the hierarchical level shall trigger storage of all data transmitted prior to said level change. This rule may be considered as the minimal implementation. Data may be saved at more frequent intervals at the receiver's option. See Table 8-2.
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Table 8-2: Logical Information Storage Requirements
• Logical Transmission Error Recovery Requirements - Transmission line failure, determined at the transmission protocol level, requires a mechanism for restarting the incomplete message. If a transmission failure occurs, transmission shall restart at the last logical record not presumed saved as outlined in the upper paragraph. Procedures for determining time before retransmission or maximum number of retransmissions are not within the scope of this document. In order to fulfill hierarchical record level requirements, all logical records necessary to reach the restart record point must be repeated prior to transmitting the record where line failure originally occurred. Using the transmission example as given in the upper paragraph, the following record recovery examples would be valid.
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Line Failure Occurs At:
Requires Retransmission Of:
A
A
B
A, B
C
A, B, C
D
A, B, C, D
E
A, B, C, D, E
F
A, B, E, F
G
A, B, E, F
H
A, G, H
I
A, G, H, I
J
A, G, H, I, J
K
A, G, H, I, J, K
L
A, G, H, I, J, K, L
M
A, G, H, L, M
N
A, G, M
O
A, N, O
P
A, N, O, P
Q
A, N, O, P, Q
Message Content - General Considerations
8.6.1 Character Codes • All data shall be represented as eight bit values, within the range (0-255), where 0-127 are defined by the ASCII standard (ANSl X3.4-1986) and values 128-255 are undefined by this standard. Values 0-31 are disallowed with the exception of 7, 9, 11, 12, and 13, where 13 is reserved as a record terminator. Values 32-126 and 128-254 are allowed. Values 127 and 255 are, also, not allowed. It is the responsibility of the instrument vendor and computer system vendor to understand the representation of any extended or alternate character set being used. As an example, the numeric value 13.5 would be sent as four byte value characters 13.5 or ASCII(49), ASCII(51), ASCII(47), ASCII(53). Allowed Characters:
7, 9, 11, 12, 13, 32-126. 128-254
Disallowed Characters:0-6, 8, 10, 14-31, 127, 255 • Within text data fields, only the ASCII characters 32-126 and the undefined characters 128-254 are permitted as usable characters (excluding those used as delimiter characters in a particular transmission). Furthermore, all characters used as delimiters in a particular transmission are excluded from the permitted range. The sender is responsible for screening all text data fields to ensure that the text does not contain those delimiters. Unless otherwise stated, contents of data fields shall be case sensitive.
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8.6.2 Maximum Field Lengths This specification assumes that all fields are variable in length. No storage is allocated (except for the delimiter) for a null field. When, for example, ten characters of data are entered within a field, only ten characters will be used. This specification does not define a maximum length for any field or record and relies upon the receiver's buffering capabilities, and the logical layer's transport facilities, to parse information into workable lengths for transmission and processing purposes. It is the responsibility of the instrument vendor and computer system vendor to agree on any arbitrary field or record truncation that may need to be imposed. It is recommended that the instrument vendor provide documentation disclosing any field or record limits that will be mandated by the clinical instrument.
8.6.3 Maximum Record Length None imposed.
8.6.4 Delimiters • Alphanumeric characters should not be used as delimiters because they are likely to appear within field content. Moreover, some alphabetic characters have special uses as follows:
H, P, O, R, C, Q, E, L, M
record type IDs
.
decimal point (period)
,
comma
S, P, R, C
priority codes
L, H, , N, U, D, B, W
result codes
C, P, F, X, I, O
result status
For the purpose of providing examples, the following delimiters are used in this specification: Record Delimiter carriage return () Carriage return (ASCII 13) shall be the delimiter for the end of any of the defined record types. Field Delimiter Default: vertical bar (|) A single allowable character as defined in 8.6.1 excluding ASCII 13 (carriage return), shall separate adjacent fields. The field delimiter is variable and defined in the message header. The same delimiter must be used in all records following a header and preceding a message terminator record.
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Repeat Delimiter Default: backslash (\) A single allowable character as defined in 8.6.1 excluding ASCII 13 and the value for the field delimiter defined in 8.6.4. The repeat delimiter must be defined in the message header and is used to separate variable numbers of descriptors for fields containing parts of equal members of the same set. Component Delimiter Default: caret (^) A single allowable character as defined in 8.6.1 excluding ASCII 13 and the field and repeat delimiter values. The component delimiter is used to separate data elements of fields of a hierarchical or qualifier nature. For example the street, city, state, zip, etc. of an address field would be separated by component delimiters. Escape Delimiter Default: ampersand (&) A single allowable character, as defined in 8.6.1 excluding ASCII 13 and the field, repeat, and component delimiter values. The escape delimiter is used within text fields to signify special case operations. Applications of the escape delimiter are optional and may be used or ignored at the discretion of either transmitter or receiver. However, all applications are required to accept the escape delimiter and use it to correctly parse fields within the record. • Use of Escape Delimiter The escape delimiter may be used to signal certain special characteristics of portions of a text field (for example, imbedded delimiters, line feed, carriage return, etc.). An escape sequence consists of the escape delimiter character followed by a single escape code ID (listed below), followed by zero or more data characters followed by another (closing) occurrence of the escape delimiter character. No escape sequence may contain a nested escape sequence. The following escape sequences pre-defined.
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start highlighting text
&N&
normal text (end highlighting)
&F&
imbedded field delimiter character
&S&
imbedded component field delimiter character
&R&
imbedded repeat field delimiter character
&E&
imbedded escape delimiter character
&Xhhhh&
hexadecimal data
&Zcccc&
Local (manufacturer defined) escape sequence
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Any number of hexadecimal digits (0-9, A-F) may follow (that is, &XA& could equal line feed).
Note 2
Any number of legal characters may follow.
Specification of Delimiters The actual delimiters to be employed in a given transmission shall be specified in the header message. It is the responsibility of the sender to avoid the inclusion of any delimiter characters within the field contents. The receiving computer will determine what characters to use by reading the specifications of the header it receives. See 8.6.4 for examples of delimiters used for this document. Delimiters for Null Values Fields shall be identified by their position, obtained by counting field delimiters from the front of the record. This position-sensitive identification procedure requires that when the contents of the field are null, its corresponding field delimiter must be included in the record to ensure that the i'th field can be found by counting (i-1) delimiters. Delimiters are not included for trailing null fields; that is, if the tenth field was the last field containing data, the record could terminate after the tenth field, and therefore would contain only nine delimiters. Fields of No Concern to the Receiving System Transmitted records may include more fields than are required by a receiving system. When processing a message, the receiving system may ignore any field it does not require. Fields must always be transmitted, however, in the positional order specified. Fields with Null Values • A system may transmit a null value for a field because (1) it does not know the value, (2) it knows the value is irrelevant to the receiving system, or (3) the value has not changed since the last transmission, or any combination thereof. To exemplify case (3), a lab within a tightly linked hospital network may never transmit the patient's birthdate, sex, or race in the patient record when transmitting the order and result records to the requesting system, because it knows that the hospital registry system always broadcasts new or changed patient data to the receiving system. • Because the sending system can use null values to indicate no change, a null value does not overwrite existing data in the receiving system. In rare circumstances, for example, if a system erroneously sent a patient’s birthdate when the birthdate was actually unknown, the receiving system should replace its existing value for a field with a null value. • A field containing only a pair of double quotes (ASCII-34) should be treated as an instruction to the receiver that the existing contents pertaining to that field definition should be deleted.
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8.6.5 Data Record Usage Overview Data shall be exchanged in records of different types. Each record is introduced by a field (number one) identifying the record type, and terminated by a carriage return. The following record types are defined. Note 3
The record type ID field shall be case insensitive.
Message Header Record (H) This record shall contain information about the sender and the receiver, that is, it shall identify the instrument(s) and the computer systems whose records are being exchanged. It also defines the field, repeat field, and component field delimiter characters. see also structure of Message Header Record (8.7) Patient Identifying Record (P) This record type contains information about an individual patient. see also structure of Patient Information Record (8.8) Test Order Record (O) When sent from the computer system to the instrument, this record shall represent a test order and may be followed by one or more result records which would contain information pertinent to the test being ordered. When sent by the instrument to the computer system, it shall provide information about the specimen/test request, and may be followed by result records (at least one record for each test within the ordered batteries). see also structure of Test Order Record (8.9) Result Record (R) Each result record shall contain the results of a single analytic determination. see also structure of Result Record (8.10) Comment Record (C) Comment records shall apply to any other record except the message trailer record. They may be free standing messages sent to or from the instrument, unrelated to a particular patient or test procedure. see also structure of Comment Record (8.11) Request Information Record (Q) This record shall be used to request information for new tests, for tests previously ordered, and possibly for tests previously reported. A single request information record may request demographic information, or results for an individual test,
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multiple test, or all tests for a single date, a series of dates, or a range of dates, or both, and for an individual patient, group of patients, individual specimens, groups of specimens, etc. see also structure of Request Information Record (8.12) Scientific Record (S) This record shall be used to exchange results between clinical sites for the purposes of proficiency testing or method development. see also structure of Scientific Record (8.14) Manufacturer Information Record (M) This record, which is similar to the comment record, may be used to send complex structures where use of the existing record types would not be appropriate. The fields within this record type are defined by the manufacturer. see also structure of Manufacturer Information Record (8.15)
8.6.6 Common Field Types Universal Test ID This field is defined as a four part field with provisions to further define the test identification via use of component fields. The test ID field is used to identify a test or battery name. The four parts which are defined below are the universal test identifier, the test name, the test identifier type and the manufacturer defined test code. All test ID parts must be separated by a component delimiter and are position dependent. As an example, additional information which may be included in this field type are instrument ID, organism ID (for sensitivity tests), well number, cup number, location number, tray number, bar code number, etc. It is the responsibility of the instrument manufacturer to define the data content of the test ID field. When the test ID is used in the result record (8.10), there must be sufficient information within the test ID field to determine the relationship of the test result to the test battery or batteries ordered. • Universal Test ID (Part 1) This is the first component of the test ID field. This field is currently unused but reserved for the application of a universal test identifier code, should one system become available for use at a future time. This field may alternatively contain multiple codes separated by repeat delimiters, or the field may contain the text ALL, which signifies a request for all results on all tests or batteries for the patients/specimens/tests defined in 0 and within the dates described in 8.12. • Universal Test ID Name (Part 2) This would be the test or battery name associated with the universal test ID code described in Universal Test ID (Part 1) (see above).
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• Universal Test ID Type (Part 3) In the case where multiple national or international coding schemes exist, this field may be used to determine what coding scheme is employed in the test ID and test ID name fields. • Manufacturer’s or Local Code (Part 4) This is the code defined by the manufacturer. This code may be a number, characters, or multiple test designator based on manufacturer defined delimiters (that is, AK.23.34-B). Extensions or qualifiers to this code may be followed by subsequent component fields which must be defined and documented by the manufacturer. For example, this code may represent a three part identifier such as - Dilution^Diluent^Description. Dates and Times In all cases, dates shall be recorded in the YYYYMMDD format as required by ANSI X3.30. December 1, 1989 would be represented as 19891201. When times are transmitted, they shall be represented as HHMMSS, shall be linked to dates as specified by ANSI X3.43. Date and time together shall be specified as up to a fourteencharacter string: YYYYMMDDHHMMSS. • Time Zone The time zone may be optionally appended to the date/time field in the format +HHMM or -HHMM as appropriate. The default time zone is that of the sender. Telephone Numbers Phone numbers shall be recorded as free text, which may contain extensions such as area code, country code, beeper number, hours to mail, etc. • Multiple Phone Numbers When multiple telephone numbers apply, they may be included in one field and separated from each other by repeat delimiters. The first such entry is considered the primary or the daytime number. Fixed Measurements and Units When a field contains a specific observation, for example, patient's weight, patient's height, or collection volume, the default units of measurement for that observation are specified in the field definition. When the observation is measured in the default units, the units need not be transmitted. If the measure is recorded in units different from the default, for example, if the weight is measured in pounds rather than kilograms, the measurement units must be transmitted. In this case the units are transmitted in the same field as the measurement. The units follow the measure and are separated from it by a component delimiter, for example, 100^lb. Units should be expressed in ISO standard abbreviations in accordance with ISO 2955.
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Addresses An address occupies a single field in a record. The address may be comprised of five components (street address, city, state, zip or postal code, and country code) separated by component delimiters so that the receiving party can break them into separate fields as needed. An example would be 52 Hilton Street #B42^Chicago^IL^60305^USA. The country needs only to be transmitted when it cannot be assumed from the context. The components of this field are position dependent. Provider and User IDs Physician's and other care givers' codes may be transmitted as internal code numbers, as full names, or both, as mutually agreed upon between the sender and the receiver. When both the name and ID number are sent, ID numbers should come first and be separated from the name by a component delimiter. Each component of the name is also separated by a component delimiter. The order of the components of the name shall be (1) last name, (2) first name, (3) middle initial or name, (4) suffix, for example, Jr., Sr., etc., and (5) title, for example, Dr., Mr., etc. Thus, if Dr. John G. Jones, Jr. had an identifier of 401-0, his number and name would be transmitted as 401-0^JONES^JOHN^G^JR^DR>. If necessary, more than one ID may be sent within one field. Multiple IDs in one field are separated by repeat delimiters. Record Sequence Number This is a required field used in record types that may occur multiple times within a th
single message. The number used defines the i occurrence of the associated record type at a particular hierarchical level and is reset to one whenever a record of a greater hierarchical significance (lower number) is transmitted or if the same record is used at a different hierarchical level (for example, comment records). E.g. for the first patient transmitted, 1 shall be entered, for the second, 2, ... until the last as defined.
8.6.7 Examples of Basic Record Types The following examples are given for a set of transmitted results for a given patient. These will show how the employment of the conventions defined lead to a valid message. In these examples the first two fields of each line (record) of the message body contain the record type and the integer record sequence number (excepting the header record). Carriage return is indicated by (CR). To simplify the example, all the V 4.2 –Version 01/05
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components of each record have not been included. Ellipses (...) are used to indicate fields that are left out and comments are enclosed in square brackets. Record hierarchical levels are shown by indentation. Note 4
You may wish to study the record definitions outlined in Section 7 before reviewing the samples shown in Figs. 3, 4, 5, 6, and 7. Trailing fields, unused, may or may not have field delimiters transmitted. Both cases should be handled by the receiving parser.
Minimal Implementation (No Patient ID or Specimen ID) Figure 3: H|\^& P|1 O|1|||^^^A1 R|1||0.356 P|2| O|1|||^^^A2 R|1||1.672 . . P|96 O|1|||^^^H12 R|1||0.402 L|1
Note 1
This sample is not recommended for implementation.
Note 2
Direction: instrument to computer system.
No Patient ID; Specimen ID and Multiple Results Shown Figure 4: H|\^& P|1 O|1|927529||^^^A1\^^^A2 R|1|^^^A1|0.295||||||||19890327132247 R|2|^^^A2|0.312||||||||19890327132248 P|2| O|1|927533||^^^A3\^^^A4 R|1|^^^A3|1.121||||||||19890327132422 R|2|^^^A4|1.097||||||||19890317132422 L|1
Request from Analyzer for Test Selections Figure 5a: on Specimens 032989325 - 032989327 H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314 Q|1|^032989325|^032989327|ALL||||||||O
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Response from Computer System from Previous Request Figure 5b: H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314 P|1|2734|123|306-87-4587|BLAKE^LINDSEY^ANN^MISS O|1|032989325||^^^BUN|R O|2|032989325||^^^ISE|R O|3|032989325||^^^HDL\^^^GLU|R P|2|2462|158|287-17-2791|POHL^ALLEN^M. O|1|032989326||^^^LIVER\^^^GLU|S P|3|1583|250|151-37-6926|SIMPSON^ALBERT^MR O|1|032989327||^^^CHEM12\^^^LIVER|R L|1|F
Results from Given Ordered Test Selections Shown in Various Formats Figure 5c: H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314 P|1|2734|123|306-87-4587|BLAKE^LINDSEY^ANN^MISS C|1|L|Notify IDC if tests positive|G O|1|032989325||^^^BUN|R R|1|^^^BUN|8.71 C|1|I|TGP^Test Growth Positive|P C|2|I|colony count >10,000|P O|2|032989325||^^^ISE|R R|1|^^^ISE^NA|139\mEq/L R|2|^^^ISE^K|4.2\mEq/L R|3|^^^ISE^CL|111\mEq/L O|3|032989325||^^^HDL|R R|1|^^^HDL|70.29 O|4|032989325||^^^GLU|R R|1|^^^GLU|92.98 C|1|I|Reading is Suspect|I P|2|2462|158|287-17-2791|POHL^ALLEN^M. O|1|032989326||^^^LIVER|S R|1|^^^LIVER^AST|29 R|2|^^^LIVER^ALT|50 R|3|^^^LIVER^TBILI|7.9 R|4|^^^LIVER^GGT|29 O|2|032989326||^^^GLU|S R|1|^^^GLU|91.5 P|3|1583|250|151-37-6926|SIMPSON^ALBERT^MR O|1|032989327||^^^LIVER|R R|1|^^^AST|28 (Test ID field Implicitly Relates to LIVER order) R|2|^^^ALT|49 R|3|^^^TBILI|7.3 R|4|^^^GGT|27
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O|2|032989327||^^^CHEM12|R R|1|^^^CHEM12^ALB-G|28 (Test ID field Explicitly Relates to CHEM12 order) R|2|^^^CHEM12^BUN|49 R|3|^^^CHEM12^CA|7.3 R|4|^^^CHEM12^CHOL|27 R|5|^^^CHEM12^CREAT|4.2 R|6|^^^CHEM12^PHOS|12 R|7|^^^CHEM12^GLUHK|9.7 R|8|^^^CHEM12^NA|138.7 R|9|^^^CHEM12^K|111.3 R|10|^^^CHEM12^CL|6.7 R|11|^^^CHEM12^UA|7.3 R|12|^^^CHEM12^TP|9.2 L|1
Request from Computer System to Instrument for Previously Run Results Figure 5d: H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314 Q|1|^032989326|ALL||||||||O L|1
Reply to Result Request Figure 5e: H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314 P|1|2462|158|287-17-2791|POHL^ALLEN^M. O|1|032989326||^^^LIVER|S R|1|^^^AST|29 R|2|^^^ALT|50 R|3|^^^TBILI|7.9 R|4|^^^GGT|29 O|2|032989326||^^^GLU|S R|1|^^^GLU|91.5 L|1
Microbiology Order and Result Download of Demographics and Order Figure 6a: H|\^&||Password1|Micro1|||||LSI1||P|1.20|19890501074500 P|1||52483291||Smith|John|Samuels|19699401|M|W|4526 C Street^Fresno^CA^ 92304||(402)7823424x242|542^Dr.Brown|||72^in.|175^lb.||Penicilin|||| 19890428|IP|Ward1||C|M|WSP||ER|PC^Prompt Care O|1|5762^01||^^^BC^BloodCulture^POSCOMBO|R|198905011530| 198905020700||| 456^Farnsworth|W|||198905021130|BL^Blood| 123^Dr.Wirth|||||||Instrument#1||ER|N R|1|^^^Org#|51^Strep Species||||N
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R|2|^^^Bio|BH+^Beta Hemolytic|||N L|1
Microbiology Order and Result Upload of Finalized Results Figure 6b: H|\^&||Password1|Micro1|||||LSI1||P|1.20|19890501074500 P|1||52483291 O|1|5762^01||^^^BC^^|||||||||||BL||||||||||F R|1|^^^ORG#|103^Group D Entero R|2|^^^AM^MIC|>16 R|3|^^^AM^INTERP1|++ R|4|^^^AM^DOSAGE1|PO 250-500 mg Q6h R|5|^^^AM^DOSAGE1^COSTCODE|$25 R|6|^^^AM^INTERP2|+++ R|7|^^^AM^DOSAGE2|IV 1.0-2.0 gm Q4h R|2|^^^P^MIC| 28 KB) with several text parts is displayed with the Editor option, the Search option automatically loads the next text part when the search text is not found.
NEW
An additional option box on the Delimiter Selection screen makes it possible to select between using the locally defined delimiters or the received delimiters. If the second option is selected the received delimiters in the header record from the other side overwrite then locally defined delimiters.
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Version 1.04 BUG
On the ‘Options > RS232 Parameters’ screen the handshake options Xon/Xoff and RTS/CTS were exchanged.
BUG
If a TA frame with empty application data was received the program was terminated with an error message.
BUG
If a large file with additional scroll bar was displayed in the record editor and a default host or instrument message was selected, the scroll bar did not disappear.
NEW
There are menu options for opening help files that contain the ASTM Specifications 1394 and 1381 in the Help menu.
NEW
There are different device names (host and instrument) stored for each supported instrument.
Version 1.05 BUG
Elimination of trailing delimiters and blanks.
Version 1.06 BUG
If a result message with multiple result records was received by the Host simulator, only the last result was stored in the database.
NEW
On the ‘Mode of Operation’ screen an 18-character operator name can be entered which appears in the head lines of the trace and record files.
NEW
The records of the trace file of the CAEV evaluation system can also be extracted with the trace extract function.
Version 1.07 NEW
If an update of the test program (newer version) is started after installation the ASTM.INI is deleted and newly created with default values.
Version 1.08 BUG
The delimiter definition within the Header record was misinterpreted in the parser window.
NEW
The two ASTM Specification help files have been updated.
NEW
The actually selected instrument is displayed in the title bar of the Host- / Instrument Messages Windows within the record editor.
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Version 1.09 BUG
If STA was selected as instrument, TS default profile was deactivated and there is no worklist for a specific request, the host simulator sent a Header and a Termination Record to the instrument.
BUG
The option not to save the Manufacturer Records in the trace file did not work well. Now all messages that contain a Manufacturer Record as second (!) record after the Header record are not stored in the trace file.
BUG
The TS Request/TS Info handling after Contention was improved.
BUG
The size of the Action Code field in the Test Selection and Test Results tables had to be enlarged to avoid error messages when receiving records with more than 1 character information in this field.
Version 1.10 BUG
If the Editor screen was left via the Close menu option of the Control box, the software crashed.
BUG
A software send buffer allows to create and send a record file (ELECSYS 2010 in INST mode) with multiple requests completely, even if the host interrupts by answering test selections. The max. number of records for the send buffer is limited to 200. If the record file contains more records a corresponding error message is displayed and the last incomplete message in the record file is removed.
NEW
For ELECSYS 2010 the non-barcode mode is supported. Test selections can be requested by barcode or by sequence No. The test selection table has additional fields for sequence, carrier and position No.
NEW
On the Error simulation screen there is an additional option of sending a record without the record delimiter (carriage return before ETX). In the receiving routine the existence of this record delimiter is checked.
NEW
On the ‘Operation Mode’ screen the colors for host and instrument trace messages can be selected.
NEW
Different instrument icons on the main screen.
NEW
There is an additional ‘System Info’ window available on the Info screen.
Version 1.11 NEW
The Elecsys 1010 is implemented. It can be selected on the ‘Operation Mode’ screen. There is a separate database and parser info file.
NEW
If Elecsys 2010 or 1010 is selected, there is an additional menu option in the Help menu of the Trace/Record editor. This menu option ‘ELECSYS Test List’ displays all test codes and names of the Elecsys systems.
NEW
Wherever the BM test No. appears in a field of a record, the test name is displayed in the parser information window behind the code in brackets.
NEW
As additional indication the text color within the trace/record editor changes to blue as soon as a text change takes place. When the text is stored it appears again in black.
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Version 1.2 BUG
In the German version, the Parity options ‘Gerade’ and ‘Ungerade’ have been exchanged.
BUG
The software crashed, if in Host mode DB Access was disabled and requests have been received.
NEW
The instrument icons are integrated in the software. They are no longer included as ICO files.
NEW
The sequence No. is echoed within the test selection message from host to the ELECSYS.
NEW
A new menu option in the ‘Trace’ menu allows to enter a comment line which is inserted into the trace file. This option is also available by clicking the right mouse button on the trace window.
NEW
The actual trace file size is displayed below the trace file name.
Version 1.3 NEW
Not only the sequence No. is echoed within the test selection message from host to the ELECSYS but all components of the instrument specimen ID.
NEW
There are new columns for the Container Type info in the Request, Test Selection and Result database tables for ELECSYS 2010 and 1010. The database files are not compatible with the previous version !!!
Version 1.4 NEW
On the ‘Mode of Operation’ screen there are separate option controls for echoing Sequence No., Carrier No., Position No., Carrier Type, Container Type of the Request Record Q within the Order Record O of the test selection message from Host to analyzer.
Version 1.5 NEW
A different send buffer structure allows to send multiple request (as instrument simulator) where, with the appropriate timing setting, the host may answer each single request. The number of messages to send is displayed above the trace window. The new main menu item ‘Clear Send Buffer’ allows to delete all messages to send and thus abort a running transmission.
NEW
A comment above the trace window indicates an active error simulation.
NEW
On the DB form there is a main menu item ‘Create Report’ displayed, if the results table is displayed. If exactly one sample in the results table is selected, a report with all results of that sample in generated and stored to the text file ‘REPORT.TXT’.
NEW
When installing the software version 1.5, the database files are normally not updated. However, since the version 1.4 the structure of the Elecsys databases has changed. If an old database structure is detected when starting the 1.5 for the first time, the database files for Elecsys are deleted and the operator is asked to install the software again. Then a default database with the new structure is installed.
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Version 1.6 BUG
In Elecsys 2010-Host mode, you may select on the ‘Operation Mode’ screen which data item shall be echoed within the order record of the test selection message (Seq. No., Carrier No., ...). This setting is now also used if the default profile is sent or if the empty test selection (‘Z’ as Report Type) is sent to the Elecsys 2010.
BUG
If the above mentioned empty test selection was sent, there were two field delimiters instead of one between Test ID and Priority (fields 5 and 6 of the Order Record).
BUG
In Elecsys 2010-Host mode, the tool displayed an error message as soon as it received a Request Record with empty ID field.
Version 1.7 BUG
There were invalid time values within the Communication Trace when the tool was activated over midnight.
Version 2.0 BUG
When the tool worked as Elecsys 2010 Host, a field delimiter was missing within the ‘empty’ test selection message. This message is sent if no TS is found in the database and Default Profile is disabled.
BUG
The Parser Information files for the Elecsys 2010 is adapted to Host Manual version 3.x.
NEW
The LSM was added as additional instrument on the ‘Operating Mode’ screen. There is a separate database, message and parser file for the LSM included.
NEW
On the main screen there is a list where the last x messages are entered as ‘realtime monitor’. The max. number of messages to store is set by default to 20 and may be modified within the ASTM.INI file with any text editor. (see section ‘Not in GUI’).
Version 3.0 - Eval 2 BUG
When working as host the simulator sent two L records within the test selection message as answer to a realtime request.
BUG
The trace time is now identical with the system time.
BUG
The cancel request message (Status A) really cancels a previous TS request (=> the TS message is not sent).
NEW
The Modular was added as new instrument.
NEW
The tool was developed with VB 5.0 and therefore needs a 32-bit operating system like Windows 95 or Windows NT.
NEW
TCP/IP was implemented as an alternative to the RS232 interface.
Version 3.0 - Eval 3 - 28th of October 1998 BUG
When receiving a TS request from Modular with leading spaces, the Host test tool did not find the corresponding TS in the database.
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Version 3.0 - Eval 4 - 11th of November 1998 BUG
All BM Test Number fields in all tables of database E20_DATA.MDB (Elecsys 2010) have been enlarged to 4 characters.
BUG
Simulator as Modular Host appends all component delimiters in the third field of the order record.
BUG
Simulator as Modular Host echoes seq, ID, type, rack, pos, specID in the default test selection according to the echo setting on the Mode of Operation screen.
NEW
It is possible to start more than one instance of the program.
NEW
The main screen of the program may be minimized.
Version 3.0 - Eval 5 - 17th of November 1998 BUG
The Operation Mode screen is displayed again.
Version 3.0 - Eval 6 - 28th of November 1998 BUG
When sending TS request as Modular the P record was missing.
BUG
When sending TS request as Modular the ID field is enlarged to 13 characters by leading spaces.
BUG
When sending results as Modular the ID field is enlarged to 13 characters by leading spaces, the operator ID and comment fields are filled with spaces.
Version 3.0 - Eval 7 – 10th of December 1998 NEW
For serial communication COM ports 1 to 10 may be selected (if available via interface board and Windows configuration).
NEW
The selection of the type of handshake was removed from the Interface Setting screen. No handshake is taken as default.
NEW
The TCP/IP functionality was improved.
NEW
If the Modular TS request contains a ************* as ID because of unreadability of the barcode, the TestSelection database is searched for matching rack and position number.
NEW
If the Modular TS request has an empty ID field the TestSelection database is searched for matching sequence number.
NEW
If the result message from the Modular contains Absorbance data, they are written to the database. !!!! Structure of MOD_DATA.MDB was changed !!!!
NEW
When sending Modular results out of the database, there is a question if absorbance data shall be sent, if available in the database table.
Version 3.0 - Eval 8 – December 1998 BUG
The simulator as LSM host stores all results of a multi-order result message.
NEW
The delay between records, delay between messages and reaction to request time may be entered in milliseconds.
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Version 3.12 – March 1999 NEW
When working as Modular host it is possible to activate and define rules for a reflex testing.
NEW
The ‚Trace File / Extract Records‘ function also extract records from Modular communication trace files.
Version 3.2 – March 1999 NEW
Length of port numbers on the TCP/IP setting screen was increased from 4 to 5 digits.
NEW
Address on the About window was changed.
Version 3.3 – March 1999 BUG
Complete software crashed if record editor was opened, then default profile was selected in the Messages menu and the cursor was placed into the Order record.
BUG
Within the record editor the key combination Crtl+V inserted the clipboard text two times.
NEW
Cardiac Reader as instrument option implemented.
NEW
Parser Info has been changed within xxx_CONF.MDB databases. Databases incompatible with former version !!! Full Installation necessary !!!
Version 3.4 – April 1999 NEW
The parser function now allows option lists for single components within a field. Therefore parser info has been changed within xxx_CONF.MDB databases Databases incompatible with former version !!! Full Installation necessary !!!
NEW
The complete test list is displayed for Elecsys 1010,2010 and Modular with menu option ?/Test List within the Record Editor. The test list is displayed sorted by code as well as by test name.
NEW
During installation of the tool, sub-directories for each supported instrument are created and example traces and record files are copied into those sub-directories.
NEW
The line wrap feature within the record editor window was disabled so that each complete record is displayed in one line.
Version 3.5 – April 1999 BUG
After sending two messages out of the database table the main menu options remained disabled.
BUG
Within the parser info window also 2-digit test numbers are provided with the corresponding test name out of the test list.
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Version 3.6 – May 1999 NEW
Received Cardiac Reader messages are stored in the database. Requests are answered.
Version 3.7 – July 1999 NEW
The Aliquoter VS II is supported.
NEW
When opening the file dialogue for display or delete record (*.DAT) or trace (*.TRC) files a preview of the selected file is displayed in a text window beside the file list control.
Version 3.8 – September 1999 BUG
The software does not hang up anymore if a message only consists of [NUL] characters.
NEW
The PSM is supported.
NEW
The Roche ASTM Standard as Instrument was removed.
NEW
Manufacturer records for Elecsys 1010 are implemented.
NEW
Frames around the device icons and the date/time on the main screen.
NEW
Each database got an additional field ‚Received‘ in the 1. Position of each table where the date and time (format: YYYYMMDDHHMMSS) of reception is entered.
NEW
The configuration data tables moved from the xxx_CONF.MDB to the xxx_DATA.MDB database files. The xxx_CONF.MDB files are no longer needed.
NEW
The database tables may be sorted by clicking on the header of the corresponding column.
NEW
When sending results from the database screen, there are options for sending absorbance data or not, sending sample per message or multiple samples per message and sending only the selected entries or all table entries with the same sample ID.
NEW
On the ‚Mode of Operation‘ screen the function ‚Realtime Result Generator‘ may be activated if the tool works as instrument. For each received test selection the tool generates a result message and sends it after a specified time.
NEW
The Amplilink is supported.
Databases incompatible with former version !!! Full Installation necessary !!!
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Indexes
Indexes
10.1 Tables TABLE 1-1: SPECIAL TYPEFACES...........................................................................................................................................................1-10 TABLE 3-1: MESSAGE PRIORITIES.........................................................................................................................................................3-39 TABLE 3-2: REQUEST FROM INSTRUMENT TO HOST ..........................................................................................................................3-40 TABLE 3-3: RESPONSE FROM HOST TO INSTRUMENT .......................................................................................................................3-40 TABLE 3-4: REQUEST FROM HOST TO INSTRUMENT ..........................................................................................................................3-40 TABLE 3-5: RESPONSE FROM INSTRUMENT TO HOST .......................................................................................................................3-40 TABLE 3-6: UPLOAD FROM INSTRUMENT TO HOST ...........................................................................................................................3-41 TABLE 3-7: DOWNLOAD FROM HOST TO INSTRUMENT ....................................................................................................................3-41 TABLE 3-8: TERMINATION CODES TO DIFFERENT ERROR STATES...................................................................................................3-43 TABLE 3-9: LIST OF ALARM CONDITIONS ...........................................................................................................................................3-44 TABLE 3-10: STANDARD RECORD TYPES AND LEVELS ....................................................................................................................3-47 TABLE 3-11: MANUFACTURER DEFINED RECORDS AND LEVELS ...................................................................................................3-48 TABLE 3-12: INFORMATION STORAGE REQUIREMENTS, TRANSMISSION EXAMPLE ....................................................................3-50 TABLE 3-13: ERROR RECOVERY AT PRESENTATION LAYER .............................................................................................................3-50 TABLE 3-14: DELIMITER CHARACTERS AS USED IN ASTM SPECIFICATIONS ...............................................................................3-52 TABLE 3-15: ALLOWED AND DISALLOWED ASCII CODES ...............................................................................................................3-65 TABLE 3-16: DELIMITER CHARACTERS ................................................................................................................................................3-65 TABLE 4-1: PIN-OUT DESCRIPTIONS ...................................................................................................................................................4-70 TABLE 4-2: TRANSMISSION SPECIFICATION........................................................................................................................................4-71 TABLE 4-3: CRITICAL TIMINGS: SUMMARY OF TIME-OUTS .............................................................................................................4-72 TABLE 4-4: CONTROL CODES ...............................................................................................................................................................4-74 TABLE 4-5: ALLOWED AND DISALLOWED ASCII CODES .................................................................................................................4-74 TABLE 4-6: SUMMARY OF TIME-OUTS ................................................................................................................................................4-74 TABLE 4-7: CALCULATION OF CHECKSUM .........................................................................................................................................4-76 TABLE 4-8: ASCII CODES .....................................................................................................................................................................4-77 TABLE 4-9: ALLOWED AND DISALLOWED ASCII CODES .................................................................................................................4-78 TABLE 4-10: DELIMITER CHARACTERS ................................................................................................................................................4-78 TABLE 4-11: COMMON FIELD TYPES...................................................................................................................................................4-79 TABLE 4-12: DATA TYPE DEFINITION ..................................................................................................................................................4-79 TABLE 4-13: STANDARD RECORD TYPES AND LEVELS ....................................................................................................................4-80 TABLE 4-14: MANUFACTURER DEFINED RECORDS AND LEVELS ...................................................................................................4-80 TABLE 4-15: MESSAGE HEADER RECORD ..........................................................................................................................................4-84 TABLE 4-16: FIELD OPTIONS FOR MESSAGE HEADER RECORD ......................................................................................................4-85 TABLE 4-17: PROCEDURE FOR ASSIGNMENT OF SENDER ID AND RECEIVER ID..........................................................................4-85 TABLE 4-18: MESSAGE TERMINATOR RECORD .................................................................................................................................4-86 TABLE 4-19: FIELD OPTIONS FOR MESSAGE TERMINATOR RECORD .............................................................................................4-86 TABLE 4-20: TERMINATION CODES TO DIFFERENT ERROR STATES ................................................................................................4-87 TABLE 4-21: PATIENT INFORMATION RECORD ..................................................................................................................................4-89 TABLE 4-22: TEST ORDER RECORD .....................................................................................................................................................4-92 TABLE 4-23: AUTO DILUTION FACTOR IS SET CORRESPONDING TO THIS TABLE ..........................................................................4-93 TABLE 4-24: PRIORITY FOR SAMPLE REGISTRATION ELECSYS 2010 ..............................................................................................4-93 TABLE 4-25: SAMPLE REGISTRATION AND UPDATE ELECSYS 2010 ...............................................................................................4-94 TABLE 4-26: FIELD OPTIONS FOR TEST REPORT TYPE ......................................................................................................................4-94 TABLE 4-27: RESULT RECORD ..............................................................................................................................................................4-99 TABLE 4-28: REFERENCE RANGES .......................................................................................................................................................4-99 TABLE 4-29: RESULT ABNORMAL FLAGS ............................................................................................................................................4-99 TABLE 4-30: RESULT STATUS ............................................................................................................................................................ 4-100 TABLE 4-31: COMMENT RECORD ..................................................................................................................................................... 4-101 TABLE 4-32: REQUEST INFORMATION RECORD .............................................................................................................................. 4-103 TABLE 4-33: FIELD OPTIONS FOR REQUEST INFORMATION RECORD.......................................................................................... 4-103 TABLE 4-34: SAMPLE/RESULT HANDLING - BEHAVIOR ............................................................................................................... 4-104 TABLE 4-35: ACTION CONFIRMATION RECORD.............................................................................................................................. 4-105 TABLE 4-36: ACTION REQUEST RECORD ......................................................................................................................................... 4-106 TABLE 4-37: CALIBRATOR PARAMETERS RECORD ......................................................................................................................... 4-107 V 4.2 –Version 01/05
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TABLE 4-38: CALIBRATION RESULT RECORD ..................................................................................................................................4-109 TABLE 4-39: CALIBRATION RESULT CHARACTERISTICS .................................................................................................................4-110 TABLE 4-40: CALIBRATION ORDER RECORD ....................................................................FEHLER! TEXTMARKE NICHT DEFINIERT. TABLE 4-41: CALIBRATION SCHEME RECORD ..................................................................FEHLER! TEXTMARKE NICHT DEFINIERT. TABLE 4-42: DILUENT PARAMETERS RECORD.................................................................................................................................4-110 TABLE 4-43: INSTRUMENT CONFIGURATION RECORD ...................................................................................................................4-113 TABLE 4-44: INSTRUMENT STATUS RECORD ...................................................................................................................................4-114 TABLE 4-45: INSTRUMENT STATUS FLAGS .......................................................................................................................................4-115 TABLE 4-46: ALARM LEVEL OF PROCESSING ...................................................................................................................................4-115 TABLE 4-47: LOG FILE RECORD .........................................................................................................................................................4-117 TABLE 4-48: PROCESSING MESSAGE RECORD ................................................................................................................................4-118 TABLE 4-49: ALARM LEVEL ................................................................................................................................................................4-118 TABLE 4-50: CHANGE COMMUNICATION PROTOCOL RECORD .....................................FEHLER! TEXTMARKE NICHT DEFINIERT. TABLE 4-51: CONTROL PARAMETERS RECORD ...............................................................................................................................4-119 TABLE 4-52: CONTROL SCHEME RECORD.........................................................................FEHLER! TEXTMARKE NICHT DEFINIERT. TABLE 4-53: RESULT CONTEXT RECORD ..........................................................................................................................................4-120 TABLE 4-54: RAW RESULT RECORD ..................................................................................................................................................4-121 TABLE 4-55: SERVICE DATA RECORD ...............................................................................................................................................4-123 TABLE 4-56: SAMPLE STATUS RECORD ............................................................................................................................................4-124 TABLE 4-57: SAMPLE STATUS ............................................................................................................................................................4-125 TABLE 4-58: TEST APPLICATION RECORD ........................................................................................................................................4-126 TABLE 4-59: TEST CONDITIONS RECORD .........................................................................................................................................4-127 TABLE 4-60: SUBSTANCE DATA RECORD.........................................................................................................................................4-130 TABLE 4-61: INFORMATION STORAGE REQUIREMENTS, TRANSMISSION EXAMPLE..................................................................4-131 TABLE 4-62: ERROR RECOVERY REQUIREMENTS, TRANSMISSION EXAMPLE ............................................................................4-132 TABLE 4-63: MESSAGE PRIORITIES ....................................................................................................................................................4-133 TABLE 4-64: TERMINATION CODES TO DIFFERENT ERROR STATES ..............................................................................................4-152 TABLE 4-65: ABILITY TO RENEW DATA BASE ..................................................................................................................................4-153 TABLE 4-66: LIST OF ALARM CONDITIONS ......................................................................................................................................4-153 TABLE 4-67: CROSS REFERENCE LIST TEST CODE AND TEST NUMBER .........................................................................................4-154 TABLE 5-1: ASSAY REFERENCE TABLE ..............................................................................................................................................5-158 TABLE 5-2: AUTO DILUTION RATIO REFERENCE TABLE .................................................................................................................5-159 TABLE 5-3: LIST OF ALARM FLAGS FOR ELECSYS 2010 ................................................................................................................5-161 TABLE 7-1: CONNECTOR CONTACT ASSIGNMENTS ......................................................................................................................7-206 TABLE 7-2: DECIMAL CHARACTER CODE .........................................................................................................................................7-215 TABLE 7-3: HEXADECIMAL CHARACTER CODE ...............................................................................................................................7-216 TABLE 8-1: LOGICAL STRUCTURE OF A MESSAGE ..........................................................................................................................8-223 TABLE 8-2: LOGICAL INFORMATION STORAGE REQUIREMENTS ...................................................................................................8-224 TABLE 8-3: REQUIREMENT COMPARISON BETWEEN SPECIFICATIONS E1238 AND E1394 ....................................................8-262 TABLE 9-1: DATA FLOW OPTIONS FOR THE ELECSYS 2010 ANALYZER; INSTRUMENT MODE.............................................9-271 TABLE 9-2: DATA FLOW OPTIONS FOR THE ELECSYS 2010 ANALYZER; HOST MODE ..........................................................9-272 TABLE 9-3: DATA FLOW OPTIONS FOR THE ELECSYS 1010 ANALYZER; INSTRUMENT MODE.............................................9-273 TABLE 9-4: DATA FLOW OPTIONS FOR THE ELECSYS 1010 ANALYZER; HOST MODE ..........................................................9-274 TABLE 9-5: DATA FLOW OPTIONS FOR THE STA ANALYZER; INSTRUMENT MODE ..................................................................9-275 TABLE 9-6: DATA FLOW OPTIONS FOR THE STA ANALYZER; HOST MODE ................................................................................9-275 TABLE 9-7: DATA FLOW OPTIONS FOR THE CARDIAC READER; INSTRUMENT MODE ...............................................................9-276 TABLE 9-8: DATA FLOW OPTIONS FOR THE CARDIAC READER; HOST MODE ............................................................................9-277 TABLE 9-9: DATA FLOW OPTIONS FOR THE MODULAR ANALYZER; INSTRUMENT MODE ........................................................9-278 TABLE 9-10: DATA FLOW OPTIONS FOR THE MODULAR ANALYZER; HOST MODE...................................................................9-278 TABLE 9-11: DATA FLOW OPTIONS FOR THE ALIQUOTER VS II; INSTRUMENT MODE ..............................................................9-279 TABLE 9-12: DATA FLOW OPTIONS FOR THE ALIQUOTER VS II; HOST MODE ...........................................................................9-279 TABLE 9-13: DATA FLOW OPTIONS FOR THE LSM; INSTRUMENT MODE ...................................................................................9-280 TABLE 9-14: DATA FLOW OPTIONS FOR THE LSM; HOST MODE ................................................................................................9-280 TABLE 9-15: DATA FLOW OPTIONS FOR THE PSM; INSTRUMENT MODE ...................................................................................9-281 TABLE 9-16: DATA FLOW OPTIONS FOR THE PSM; HOST MODE ................................................................................................9-281 TABLE 9-17: DATA FLOW OPTIONS FOR THE AMPLILINK; INSTRUMENT MODE .........................................................................9-282 TABLE 9-18: DATA FLOW OPTIONS FOR THE AMPLILINK; HOST MODE ......................................................................................9-282
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10.2 Figures FIGURE 1-1: ELECSYS 2010 DISK VERSION .......................................................................................................................................1-11 FIGURE 1-2: ELECSYS 2010 RACK VERSION ......................................................................................................................................1-12 FIGURE 1-3: ELECSYS 1010...................................................................................................................................................................1-12 FIGURE 2-1: UTIL SCREEN ....................................................................................................................................................................2-15 FIGURE 2-2: DOCUMENTATION SETUP SCREEN .......................................................................................................................2-16 FIGURE 2-3: INTERFACE SETUP SCREEN .......................................................................................................................................2-17 FIGURE 2-4: SCREEN "COMMUNICATION CONFIRMATION" ............................................................................................................2-17 FIGURE 2-5: MANUAL TRIGGER TO UPLOAD RESULTS ......................................................................................................................2-19 FIGURE 2-6: UTILITIES SCREEN ..........................................................................................................................................................2-20 FIGURE 2-7: INTERFACE SETUP SCREEN .........................................................................................................................................2-21 FIGURE 2-8: SELECT HOST PROTOCOL ................................................................................................................................................2-21 FIGURE 2-9: INSTRUMENT SETUP SCREEN ..........................................................................................................................................2-25 FIGURE 3-1: THE OSI MODEL EXPLAINED BY EXAMPLE ...................................................................................................................3-30 FIGURE 3-2: CORRELATION BETWEEN MESSAGE RECORD FRAME............................................................................3-31 FIGURE 3-3: LAYERS OF THE ASTM-PROTOCOL ...............................................................................................................................3-32 FIGURE 3-4: INQUIRY TO HOST .............................................................................................................................................................3-34 FIGURE 3-5: RESPONSE FROM HOST....................................................................................................................................................3-35 FIGURE 3-6: INQUIRY TO INSTRUMENT ................................................................................................................................................3-35 FIGURE 3-7: RESPONSE FROM INSTRUMENT ......................................................................................................................................3-36 FIGURE 3-8: AUTOMATIC UPLOAD TO HOST ......................................................................................................................................3-37 FIGURE 3-9: BATCH DOWNLOAD FROM HOST ...................................................................................................................................3-37 FIGURE 3-10: HIERARCHICAL STRUCTURE OF MESSAGES ...............................................................................................................3-46 FIGURE 3-11: THREE PHASES AT DATA LINK LAYER ........................................................................................................................3-56 FIGURE 3-12: RESPONSE IS ANY CHARACTER ....................................................................................................................................3-57 FIGURE 3-13: CONTENTION: RESPONSE IS ANY [ENQ]...................................................................................................................3-58 FIGURE 3-14: TIME OUT: NO RESPONSE .............................................................................................................................................3-59 FIGURE 3-15: ESTABLISHMENT PHASE CONFIRMED, CONTINUE WITH TRANSFER PHASE ..........................................................3-59 FIGURE 3-16: ESTABLISHMENT PHASE, FLOWCHART .......................................................................................................................3-60 FIGURE 3-17: TRANSFER PHASE, FLOWCHART ..................................................................................................................................3-63 FIGURE 3-18: TERMINATION PHASE, FLOWCHART ............................................................................................................................3-64 FIGURE 4-1: DATA CABLE WIRING DIAGRAM (----- FOR OPTIONAL BRIDGES) ..........................................................................4-69 FIGURE 4-2: ELECSYS 2010 CONNECTORS (LEFT CASE SIDE) .........................................................................................................4-70 FIGURE 4-3: ELECSYS 1010 CONNECTORS (LEFT CASE SIDE) .........................................................................................................4-70 FIGURE 4-4: SENDER / RECEIVER STATE DIAGRAM (ACCORDING TO ASTM E1381-91) ........................................................4-73 FIGURE 4-5: STRUCTURE OF MESSAGES .............................................................................................................................................4-82 FIGURE 7-1: CONNECTOR STRATEGY FOR INSTRUMENT COMPUTER CONNECTION - CABLE MOUNTED ............................ 7-207 FIGURE 7-2: CONNECTOR STRATEGY FOR INSTRUMENT COMPUTER CONNECTIONS - CHASSIS MOUNTED ...................... 7-207 FIGURE 7-3: STATE DIAGRAM ............................................................................................................................................................ 7-214 FIGURE 9-1: MAIN SCREEN OF THE TEST TOOL .............................................................................................................................. 9-264 FIGURE 9-2: MULTIFUNCTIONAL TEXT EDITOR ................................................................................................................................ 9-267
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10.3 Record Names For field definitions see pages printed in bold.
A ACTION CONFIRMATION ....................................................................................................................................................3-46, 4-79, 4-104 ACTION REQUEST ...............................................................................................................................................................3-46, 4-79, 4-105
AUTO DILUTION FACTOR ...................................................................................................................................................................... 4-92
C C................................................................................................................................................................... SEE COMMENT SEE COMMENT
CALIBRATION ORDER ....................................................................................................................................................3-46, 4-79, 4-110 CALIBRATION RESULT ......................................................................................................................................... 3-46, 4-79, 4-107, 4-108 CALIBRATION SCHEME ................................................................................................................................. 3-46, 4-79, 4-111, 4-112 CALIBRATOR PARAMETERS ................................................................................................................................................3-46, 4-79, 4-106 CHANGE COMMUNICATION PROTOCOL .................................................................................................................. 3-46, 4-79, 4-121 COMMENT .................................................................................................................................................................................... 4-78, 4-100 COMMENT ................................................................................................................................................................................................... 3-45 COMMENT .................................................................................................................................................................................................... 3-47 CONTROL PARAMETERS .....................................................................................................................................................3-46, 4-79, 4-122 CONTROL SCHEME ...................................................................................................................................................... 3-46, 4-79, 4-123
D DILUENT PARAMETERS.......................................................................................................................................................3-46, 4-79, 4-112
H H ...................................................................................................................................... SEE MESSAGE HEADER SEE MESSAGE HEADER
I INSTRUMENT CONFIGURATION ............................................................................................................................ 3-46, 4-79, 4-113, 4-115 INSTRUMENT STATUS .........................................................................................................................................................3-46, 4-79, 4-116
L L ..................................................................................................................... SEE MESSAGE TERMINATOR SEE MESSAGE TERMINATOR LOG FILE ............................................................................................................................................................................3-46, 4-79, 4-119
M M ......................................................................................................................................................... SEE MANUFACTURER INFORMATION M-AC............................................................................................................ SEE ACTION CONFIRMATION SEE ACTION CONFIRMATION MANUFACTURER INFORMATION.................................................................................................................................................................... 4-78 MANUFACTURER INFORMATION ......................................................................................................................................................... 3-37, 3-45 M-AR................................................................................................................................... SEE ACTION REQUEST SEE ACTION REQUEST
M-CO ................................................................................................................... SEE CALIBRATION ORDER SEE CALIBRATION ORDER M-CP ................................................................................................ SEE CALIBRATOR PARAMETERS SEE CALIBRATOR PARAMETERS M-CR .................................................................................................................... SEE CALIBRATION RESULT SEE CALIBRATION RESULT M-CS ................................................................................................................................................................. SEE CALIBRATION SCHEME M-DP ................................................................................................................ SEE DILUENT PARAMETERS SEE DILUENT PARAMETERS MESSAGE HEADER .............................................................................................................................................................................4-78, 4-83 MESSAGE HEADER ....................................................................................................................................................................................... 3-45 MESSAGE HEADER ........................................................................................................................................................................................ 3-46 MESSAGE TERMINATOR ................................................................................................................................................................... 4-78, 4-85 MESSAGE TERMINATOR ............................................................................................................................................................................... 3-45 M-IC .......................................................................................SEE INSTRUMENT CONFIGURATION SEE INSTRUMENT CONFIGURATION M-IS........................................................................................................................ SEE INSTRUMENT STATUS SEE INSTRUMENT STATUS M-LF...................................................................................................................................................................SEE LOG FILE SEE LOG FILE M-PM............................................................................................................ SEE PROCESSING MESSAGE SEE PROCESSING MESSAGE M-PX ......... SEE CONTROL SCHEME SEE CHANGE COMMUNICATION PROTOCOL SEE CHANGE COMMUNICATION PROTOCOL V 4.2 –Version 01/05
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M-QP .............................................................................................................SEE CONTROL PARAMETERS SEE CONTROL PARAMETERS
M-QS ........................................................................................................................................................................SEE CONTROL SCHEME M-RC ...................................................................................................................................SEE RESULT CONTEXT SEE RESULT CONTEXT M-RR ........................................................................................................ SEE SUBSTANCE DATA SEE RAW RESULT SEE RAW RESULT M-SD ............................................................................................................................................. SEE SERVICE DATA SEE SERVICE DATA M-SS....................................................................................................................................... SEE SAMPLE STATUS SEE SAMPLE STATUS M-TA ............................................................................................................................... SEE TEST APPLICATION SEE TEST APPLICATION M-TC...................................................................................... SEE TEST CONDITIONS SEE TEST CONDITIONS SEE TEST CONDITIONS M-XT .......................................................................................................................................................................... SEE SUBSTANCE DATA
O O ............................................................................................................................................................ SEE TEST ORDER SEE TEST ORDER
P P ....................................................................................................................... SEE PATIENT INFORMATION SEE PATIENT INFORMATION PATIENT INFORMATION ........................................................................................................................................3-46, 4-78, 4-87, 4-88 PATIENT INFORMATION ......................................................................................................................................................................3-31, 3-45 PATIENT INFORMATION ................................................................................................................................................................................. 3-31 PROCESSING MESSAGE ..................................................................................................................................................... 3-46, 4-79, 4-120
Q Q ................................................................................................................... SEE REQUEST INFORMATION SEE REQUEST INFORMATION
R R ...............................................................................................................................................................................SEE RESULT SEE RESULT RAW RESULT ..................................................................................................................................................................... 3-46, 4-79, 4-125 REQUEST INFORMATION .................................................................................................................................................. 4-78, 4-101, 4-102 REQUEST INFORMATION .....................................................................................................................................................................3-39, 3-45 REQUEST INFORMATION ................................................................................................................................................................................ 3-47 RESULT ................................................................................................................................................................................ 4-78, 4-97, 4-98 RESULT ......................................................................................................................................................................................................... 3-45 RESULT CONTEXT .............................................................................................................................................................. 3-46, 4-79, 4-124 RESULT ......................................................................................................................................................................................................... 3-47
S S ................................................................................................................................................................................................ SEE SCIENTIFIC SAMPLE STATUS................................................................................................................................................................ 3-46, 4-79, 4-128
SCIENTIFIC .................................................................................................................................................................................................4-78 SCIENTIFIC .................................................................................................................................................................................................... 3-45 SCIENTIFIC ..................................................................................................................................................................................................... 3-47 SERVICE DATA................................................................................................................................................... 3-46, 4-79, 4-126, 4-127 SUBSTANCE DATA ............................................................................................................................................... 3-46, 4-79, 4-132, 4-134
T TEST APPLICATION ............................................................................................................................................................ 3-46, 4-79, 4-130 TEST CONDITIONS ............................................................................................................................................................. 3-46, 4-79, 4-131 TEST ORDER ............................................................................................................................................................ 4-78, 4-89, 4-92, 4-93 TEST ORDER ................................................................................................................................................................................................. 3-45 TEST ORDER .................................................................................................................................................................................................. 3-46
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Glossary
Glossary
Definition
ASTMReference
Description
addresses
6.6.05
An address occupies a single field in a record. The address may be comprised of five components (street address, city, state, zip or postal code, and country code) separated by component delimiters so that the receiving party can break them into separate fields as needed. An example would be 52 Hilton Street #B42^Chicago^IL^60305^USA. The country needs only to be transmitted when it cannot be assumed from the context. The components of this field are position dependent.
battery
3.1.02
A group of tests ordered together, for example, an admitting battery. The term battery is used in the document synonymously with the term profile or panel. The test elements within a battery may be characteristic of a single physiologic system, for example, liver function tests, or many different physiologic systems. The battery is simply a convention by which a user can order multiple tests by specifying a single name.
component field
3.1.07
A single data element or data elements which express a finer aggregate or extension of data elements which precede it. For example, parts of a field or repeat field entry. As an example, the patient's name is recorded as last name, first name, and middle initial, each of which is separated by a component delimiter. Components cannot contain repeat fields.
data record usage overview
6.5
Data is exchanged in records of different types. Each record is introduced by field (number one) identifying the record type, and terminated by a carriage return. The following record types are defined. Note: The record type ID field shall be case insensitive.
dates and times
6.6.02
In all cases, dates are recorded in the YYYYMMDD format as required by ANSI X3.30. December 1, 1989 would be represented as 19891201. When times are transmitted, they are represented as HHMMSS, and are linked to dates as specified by ANSI X3.43. Date and time together shall be specified as up to a fourteen-character string: YYYYMMDDHHMMSS.
delimiter, component delimiter
6.4.05
A single allowable character as defined in 6.1.1 excluding ASCII 13 and the field and repeat delimiter values. The component delimiter is used to separate data elements of fields of a hierarchical or qualifier nature. For example the street, city, state, zip, etc. of an address field would be separated by component delimiters.
delimiter, escape delimiter
6.4.06
A single allowable character, as defined in 6.1.1, excluding ASCII 13 and the field, repeat, and component delimiter values. The escape delimiter is used within text fields to signify special case operations. Applications of the escape delimiter are optional and may be used or ignored at the discretion of either transmitter or receiver. However, all applications are required to accept the escape delimiter and use it to correctly parse fields within the record. - Use of Escape Delimiter: The escape delimiter may be used to signal certain special characteristics of portions of a text field (for example, imbedded delimiters, line feed, carriage return, etc.). An escape sequence consists of the escape delimiter character followed by a single escape code ID (listed below), followed by zero or more data characters followed by another (closing) occurrence of the escape delimiter character. No escape sequence may contain a nested escape sequence. The following escape sequences are pre-defined.
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Definition
ASTMReference
Description
delimiter, field delimiter
6.4.03
A single allowable character as defined in 6.1.1 excluding ASCII 13 (carriage return), shall separate adjacent fields. The field delimiter is variable and defined in the message header. The same delimiter must be used in all records following a header and preceding a message terminator record.
delimiter, record delimiter
6.4.02
Carriage return (ASCII 13) is the delimiter for the end of any of the defined record types.
delimiter, repeat delimiter
6.4.04
A single allowable character as defined in 6.1.1 excluding ASCII 13 and the value for the field delimiter defined in 6.4.3. The repeat delimiter must be defined in the message header and is used to separate variable numbers of descriptors for fields containing parts of equal members of the same set.
delimiter, specification of delimiters
6.4.07
The actual delimiters to be employed in a given transmission are specified in the header message. It is the responsibility of the sender to avoid the inclusion of any delimiter characters within the field contents. The receiving computer will determine what characters to use by reading the specifications of the header it receives. See 6.4.1 for examples of delimiters used for this document.
delimiters for null values
6.4.08
Fields are identified by their position, obtained by counting field delimiters from the front of the record. This position-sensitive identification procedure requires that when the contents of the field are null, its corresponding field delimiter must be included in the record to th ensure that the i field can be found by counting (i-1) delimiters. Delimiters are not included for trailing null fields; that is, if the tenth field was the last field containing data, the record could terminate after the tenth field, and therefore would contain only nine delimiters.
download
3.1.09
Data transmitted from a computer system to a clinical instrument.
field
3.1.05
One specific attribute of a record which may contain aggregates of data elements further referring the basic attribute.
fields of no concern to the receiving system
6.4.09
Transmitted records may include more fields than are required by a receiving system. When processing a message, the receiving system may ignore any field it does not require. Fields must always be transmitted, however, in the positional order specified.
fields with null values
6.4.10
A system may transmit a null value for a field because - (1) it does not know the value, - (2) it knows the value is irrelevant to the receiving system, or - (3) the value has not changed since the last transmission, or any combination thereof. To exemplify case (3), a lab within a tightly linked hospital network may never transmit the patient's date of birth, sex, or race in the patient record when transmitting the order and result records to the requesting system, because it knows that the hospital registry system always broadcasts new or changed patient data to the receiving system. - Because the sending system can use null values to indicate no change, a null value does not overwrite existing data in the receiving system. In rare circumstances, for example, if a system erroneously sent a patient’s date of birth when the date of birth was actually unknown, the receiving system should replace its existing value for a field with a null value. - A field containing only a pair of double quotes (ASCII-34) should be treated as an instruction to the receiver that the existing contents pertaining to that field definition should be deleted.
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Definition
ASTMReference
Description
fixed measurements and units
6.6.04
When a field contains a specific observation, for example, patient's weight, patient's height, or collection volume, the default units of measurement for that observation are specified in the field definition. When the observation is measured in the default units, the units need not be transmitted. If the measure is recorded in units different from the default, for example, if the weight is measured in pounds rather than kilograms, the measurement units must be transmitted. In this case the units are transmitted in the same field as the measurement. The units follow the measure and are separated from it by a component delimiter, for example, 100^lb. Units should be expressed in ISO standard abbreviations in accordance with ISO 2955.
manufacturer's or local code (part 4)
6.6.01.4
This is the code defined by the manufacturer. This code may be a number, characters, or multiple test designator based on manufacturer defined delimiters (that is, AK.23.34-B). Extensions or qualifiers to this code may be followed by subsequent component fields which must be defined and documented by the manufacturer. For example, this code may represent a three part identifier such as
message
3.1.01
A textual body of information.
multiple phone numbers
6.6.03.1
When multiple telephone numbers apply, they may be included in one field and separated from each other by repeat delimiters. The first such entry is considered the primary or the daytime number.
provider and user IDs
6.6.06
Physician's and other health staff codes may be transmitted as internal code numbers, as full names, or both, as mutually agreed upon between the sender and the receiver. When both the name and ID number are sent, ID numbers should come first and be separated from the name by a component delimiter. Each component of the name is also separated by a component delimiter. The order of the components of the name shall be (1) last name, (2) first name, (3) middle initial or name, (4) suffix, for example, Jr., Sr., etc., and (5) title, for example, Dr., Mr., etc. Thus, if Dr. John G. Jones, Jr. had an identifier of 401-0, his number and name would be transmitted as 401-0^JONES^JOHN^G^JR^DR>. When necessary, more than one ID may be sent within one field. Multiple IDs in one field are separated by repeat delimiters.
record
3.1.04
An aggregate of fields describing one aspect of the complete message.
record sequence number
6.6.07
This is a required field used in record types that may occur multiple th times within a single message. The number used defines the i occurrence of the associated record type at a particular hierarchical level and is reset to one whenever a record of a greater hierarchical significance (lower number) is transmitted or if the same record is used at a different hierarchical level (for example, comment records).
record, comment (C)
6.5.05
Comment records can apply to any other record except the message trailer record. They may be free standing messages sent to or from the instrument, unrelated to a particular patient or test procedure.
record, manufacturer information (M)
6.5.08
This record, which is similar to the comment record, may be used to send complex structures where use of the existing record types would not be appropriate. The fields within this record type are defined by the manufacturer.
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Definition
ASTMReference
Description
record, message header (H)
6.5.01
This record contains information about the sender and the receiver, that is, it identifies the instrument(s) and the computer systems whose records are being exchanged. It also defines the field, repeat field, and component field delimiter characters.
record, patient identifying (P)
6.5.02
This record type contains information about an individual patient.
record, request information (Q)
6.5.06
This record is used to request information for new tests, for tests previously ordered, and possibly for tests previously reported. A single request information record may request demographic information, or results for an individual test, multiple test, or all tests for a single date, a series of dates, or a range of dates, or both, and for an individual patient, group of patients, individual specimens, groups of specimens, etc.
record, result
6.5.04
Each result contains the results of a single analytic determination.
record, scientific (S)
6.5.07
This record is used to exchange results between clinical sites for the purposes of proficiency testing or method development.
record, test order (O)
6.5.03
When sent from the computer system to the instrument, this record represents a test order and may be followed by one or more result records which would contain information pertinent to the test being ordered. When sent by the instrument to the computer system, it provides information about the specimen/test request, and may be followed by result records (at least one record for each test within the ordered batteries).
repeat field
3.1.06
A single data element which expresses a duplication of the field definition it is repeating. Used for demographics, requests, orders and the like, where each element of a repeat field is to be treated as having equal priority or standing to associated repeat fields.
telephone numbers
6.6.03
Phone numbers are recorded as free text, which may contain extensions such as area code, country code, beeper number, hours to mail, etc.
test
3.1.03
A determination of a single analyte or a combination of values from other determinations or observations which constitute a measure of a single system attribute.
time zone
6.6.02.1
The time zone may be optionally appended to the date/time field in the format +HHMM or -HHMM as appropriate. The default time zone is that of the sender.
universal test ID
6.6.01
This field is defined as a four part field with provisions to further define the test identification via use of component fields. The test ID field is used to identify a test or battery name. The four parts which are defined below are the universal test identifier, the test name, the test identifier type and the manufacturer defined test code. All test ID parts must be separated by a component delimiter and are position dependent. As an example, additional information which may be included in this field type are instrument ID, organism ID (for sensitivity tests), well number, cup number, location number, tray number, bar code number, etc. It is the responsibility of the instrument manufacturer to define the data content of the test ID field. When the test ID is used in the result record, there must be sufficient information within the test ID field to determine the relationship of the test result to the test battery or batteries ordered.
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Glossary
Definition
ASTMReference
Description
universal test ID (part 1)
6.6.01.1
This is the first component of the test ID field. This field is currently unused but reserved for the application of a universal test identifier code, should one system become available for use at a future time.
universal test ID name (part 2)
6.6.01.2
This would be the test or battery name associated with the universal test ID code described in 6.6.1.1.
universal test ID type (part 3)
6.6.01.3
In the case where multiple national or international coding schemes exist, this field may be used to determine what coding scheme is employed in the test ID and test ID name fields.
Upload
3.1.08
Data transmitted from a clinical instrument to a computer system.
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