Host-Manual Elecsys V4!1!1010

Roche Diagnostics GmbH Elecsys Analyzer Host Interface Manual
Elecsys Analyzer Host Interface Manual ID No. 1804022-001
V 4.01 Version 11/00
Document: RDElec4_01 Final.doc
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
1.0 1.4
Date
June 96 May 97
Software
released not released
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
2.0 3.0
Aug. 97 Mar. 98
released not released
4.0
August 00
4.01
Nov. 00
2000, Roche Diagnostics GmbH. All rights reserved. Lab Diagnostics Global System Support Sandhofer Strae 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.
II
Table of Contents
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 1.2 1.3 1.4 Short Description of Elecsys 2010 .............................................................................................1-11 Short Description of Elecsys 1010 .............................................................................................1-12 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 ... 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
ENGINEERING REFERENCE ......................................................................................4-69

1-3
Table of Contents
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
1-4
Table of Contents
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
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 5.3 5.4 Alarm Flags Elecsys 2010 ..........................................................................................................5-160 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
ASTM DESIGNATION: E 1381 - 91...................................................................... 7-201

7.1 7.2 7.3 7.4 Scope .............................................................................................................................................7-202 Referenced Documents..............................................................................................................7-203 Terminology ..................................................................................................................................7-203 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 4.01 Version 11/00 1-5
Table of Contents
7.6.2 7.6.3 7.6.4 7.6.5 7.6.6 7.7
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
ASTM DESIGNATION: E 1394 - 91.......................................................................8-217

8.1 8.2 Scope............................................................................................................................................. 8-217 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 8.8 Message Header Record........................................................................................................... 8-237 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 8.11 8.12 8.13 8.14 8.15 Result Record .............................................................................................................................. 8-251 Comment Record ........................................................................................................................ 8-254 Request Information Record..................................................................................................... 8-255 Message Terminator Record .................................................................................................... 8-258 Scientific Record......................................................................................................................... 8-259 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
HOST INTERFACE SIMULATOR FOR THE ASTM PROTOCOL.........................9-263

9.1 9.2 9.3 Purpose of the ASTM Interface Test Tool .............................................................................. 9-263 Main Screen of the Test Tool.................................................................................................... 9-264 Main Menu System .................................................................................................................... 9-265
1-6
Table of Contents
9.4
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 Software Updates of the ASTM Host Interface Test Tool ...................................................9-283
10
10.1 10.2 10.3
INDEXES .............................................................................................................. 10-291

Tables.......................................................................................................................................... 10-291 Figures ........................................................................................................................................ 10-293 Record Names........................................................................................................................... 10-294
11
GLOSSARY...............................................................................................................11-1
1-7
Table of Contents
1-8
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.
1-9
Introduction
1.1.2 Documentation Conventions

This manual uses the following special typefaces:
Typeface
Special font Italic and special font
Meaning
This font is used for system and screen output, such as prompt signs and screen messages. 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 Strae 116 D-68305 Mannheim Germany
Tel: Fax:
+49 621 / 759-4204 +49 621 / 759-4394
E-Mail: peter.centner@roche.com thomas.meckel@roche.com guenter.knoop@roche.com
US Roche Response Center Customer Technical Support: Tel: 800 428 - 236
1-10
Introduction
1.2
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 (left)
Top Cover (right)
Incubator User Interface System Reagents Circuit breaker Reagent Disk Interface Connector
Distilled Water Bar Code Reader Tips Sample Disk Cups
Liquid Waste
Operation Switch Figure 1-1: Elecsys 2010 Disk Version
Floppy Disk Drive & Solid Waste
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).
1-11
Introduction
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
Distilled water container
Liquid Waste Container
S/R Disk
Control unit Printer
Figure 1-3: Elecsys 1010
1-12
Introduction
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.
1-13
Introduction
1-14
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
2-15
How to ...
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 Data Bits Stop Bits Parity Sync 2400, 4800, 9600, 19200 7,8 1,2 none, odd, even and on, off
touch the "Communication On" button to reinitialize communication.
2-16
How to ...
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"
2-17
How to ...
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.
2-18
How to ...
Figure 2-5: Manual trigger to upload results
2-19
How to ...
2.2
... 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.
2-20
How to ...
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
2-21
How to ...
OFF: HOST: LSM: INTERNAL: HOST QUERY:
A host is not connected. A host is connected. A host with a Laboratory Systems Manager is connected (not available in the US). Not a customer option. Only for service personnel.
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 Data Bits Stop Bits Parity 1200, 2400, 4800, 9600, 19200 7,8 1,2 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.
2-22
How to ...
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).
A number between 0 and 9 can be entered. The default setting is 0. The LSM may download substance data for a reagent pack after an upload for that pack without query from the instrument. No diluent parameter record is added for V 4.01 Version 11/00 2-23
How to ...
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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How to ...
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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How to ...
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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2.3
... 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
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
Record Frame
Send/Receive
Record
Frame
Send/Receive
Build Message Record Communication Data Analyze Message Message
Frame
Send/Receive
Frame
Send/Receive
Record Frame
Send/Receive
Record
Frame
Send/Receive
Frame
Send/Receive
Figure 3-2: Correlation between Message
Record
Frame
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Theory of Operation
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
H Q L
Request Information
Message Terminator Figure 3-4: Inquiry to Host
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Theory of Operation
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 O L
Message Header
Patient Information
Test Order
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 O R L
Patient Information
Test Order
Result
Message Terminator
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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Message Header
H P O R L
Patient Information
Test Order
Result
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 O L
Message Header
Patient Information
Test Order
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 4.01 Version 11/00 3-38
Theory of Operation
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
High
Sending Order
1 2 3 4 5 6 7
Types of messages
Response (re-send) Response Report the received message situation (re-send) Report the received message situation Inquiry (re-send) Inquiry Upload (re-send) Upload
Low
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
Inquiry of test selection information
Table 3-2: Request from instrument to Host
Records
Q
Trigger Events
sample disk scanning
Messages
Test selection information
Records
P, O
Reception by Instrument
after inquiry
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
Inquiry of test selection information Inquiry of measured data
Table 3-4: Request from Host to instrument
Records
Q Q
any time any time
Messages
Test selection information Measured data
Records
P, O P, O, R, C
Trigger Events
Inquiry from Host 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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Theory of Operation
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
Measured data
Records
P, O, R, C,
Trigger Events
Completion of Tests, pressing "Print All"-button, power on
Table 3-6: Upload from instrument to Host
Messages
Test selection information Request cancel
Records
P, O Q
any time 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 4.01 Version 11/00 3-41
Theory of Operation
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
Message receiving situation

normal There is a response data. There is no response data. Not all data in records are in accordance to the rules. (Improper message error) abnormal Receive error Hardware error Application error All data in records are not as ruled. (Improper message error) Message refusal Receive error (*) Hardware error (*) Application error (*) The last record is not the Termination record. Improper message error Receive error Hardware error Application error (*)
Termination code
F I Q E no message
Inquiry
normal
Response & Download
abnormal
Invalid attribution
abnormal
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 Instruments 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
Communication re-sending occurred Communication re-sending failed Communication message acceptance error Communication message format illegal error
Contents
When sending a message, re-sending of the message occurred Re-sending a message failed Impossible to update the data base using the message. 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. Application error happened. Re-sending a message failed at the low level Time out happened at the lower level Time out happened at the lower level Hardware error happened. Sending a message has been aborted Receiving a message has been aborted
Cause of Alarm
Re-sending a message succeeded Re-sending a message failed Picked up the message acceptance error. The last record was not the Termination record Picked up the improper message errors.
Source Layer
Application Application Application, Message Acceptance error Presentation, Improper Message Error
Communication application error Communication sending error Communication sending error Communication receiving error Communication device error Communication sending message aborted Communication receiving message aborted
Picked up the application error. Picked up sending error Picked up sending error Picked up receiving error Picked up the hardware error. Received the Termination code = R Received the Termination code = T
Data Link, Application Error Data Link, Send Error Data Link, Send Error Data Link, Receive Error Physical, Hardware Error Any, from Host (Presentation) 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 whos 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
0 1 2 3 0..3 0..3 0 1 1
Record Name
Message Header Record Patient Information Record Test Order Record Result Record Comment Record Manufacturer Information Record Message Terminator Record Request Information Record Scientific Record (This record is not used by the Roche Diagnostics implementation)
Identifier
H P O R C M L Q 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
1 1
Record Name
MSR - Action Confirmation (This record is not used by the
Identifier
M-AC M-AR
Roche Diagnostics implementation)

MSR - Action Request
(This record is not used by the Roche Diagnostics implementation)

1 MSR - Calibration Result M-CR
1
1
(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)
MSR - Calibrator Parameters M-CP
1
2
MSR - Calibration Scheme (Elecsys 1010 only) (This record is not used by the Roche Diagnostics implementation)
MSR - Control Parameters
M-CS
M-QP
1
2 1 1 1 1
MSR - Control Scheme (Elecsys 1010 only) (This record is not used by the Roche Diagnostics implementation)
MSR - Diluent Parameters MSR - Instrument Configuration MSR - Instrument Status MSR - Log File MSR - Processing Message
M-QS
M-DP M-IC M-IS M-LF M-PM
MSR - Change Communication Protocol (Elecsys 1010 only) M-PX (This record is not used by the Roche Diagnostics implementation)
MSR - Raw Result MSR - Result Context MSR - Sample Status M-RR M-RC M-SS
4 4 1

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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Theory of Operation
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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Theory of Operation
Line #
A B C D E F G H I J K L M N O P Q
Record Type
Header Patient 1 Order 1 Result 1 Order 2 Order 3 Patient 2 Order 1 Comment 1 Result 1 Comment Result 2 Order 2 Patient 3 Order 1 Result 1 Message Terminator
(Level) Increment
(Level 0)+0 (Level 1)+1 (Level 2)+1 (Level 3)+1 (Level 2)-1 (Level 2)+0 (Level 1)-1 (Level 2)+1 (Level 3)+1 (Level 3)+0 (Level 4)+1 (Level 3)-1 (Level 2)-1 (Level 1)-1 (Level 2)+1 (Level 3)+1 (Level 0)-3
Action
{Save A-D} {Save E-F}
{Save G-K} {Save L} {Save M}
{Save N-P}
Table 3-12: Information Storage Requirements, Transmission Example
Line Failure Occurs At:

Table 3-13: Error Recovery at Presentation Layer
Requires Retransmission Of:

A A, B A, B, C A, B, C, D A, B, C, D, E A, B, E, F A, B, E, F A, G, 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, L, M A, G, M A, N, O A, N, O, P A, N, O, P, Q
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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Theory of Operation
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: Disallowed Characters: 7, 9, 11, 12, 13, 32-126. 128-254 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: H, P, O, R, C, Q, E, L, M . , S, P, R, C L, H, <, >, N, U, D, B, W C, P, F, X, I, O record type IDs decimal point (period) comma priority codes result codes result status
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Theory of Operation
The following delimiters are used as standard in the ASTM specifications:
Delimiter
Record delimiter Field delimiter Repeat delimiter Component delimiter Escape delimiter
Character
= carriage return = vertical bar = backslash = caret = ampersand
Char.
<CR> | \ ^ &
ASCII decimal
13 124 92 94 37
ASCII hex.
0Dh 7Ch 5Ch 5Eh 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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Theory of Operation
&H& &N& &F& &S& &R& &E& &Xhhhh&
start highlighting text normal text (end highlighting) imbedded field delimiter character imbedded component field delimiter character imbedded repeat field delimiter character imbedded escape delimiter character 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 patients 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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Theory of Operation
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. Manufacturers 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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Theory of Operation
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^ChicagoÎL^60305ÛSA. 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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Theory of Operation
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
Transfer Phase
Termination Phase
Sender
ENQ
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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Theory of Operation
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
Transfer Phase
retry 10 sec
retry 1 sec 15 sec
abort
Sender
ENQ
ENQ
ENQ
EOT
ENQ
Receiver
xxx ENQ ACK
Figure 3-12: Response is any character
3-57
Theory of Operation
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
Transfer Phase
retry 10 sec
retry 1 sec 15 sec
abort
Sender
ENQ
ENQ
ENQ
EOT
ENQ
Receiver
xxx ENQ ACK
Figure 3-13: Contention: Response is any [ENQ]
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Theory of Operation
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
Transfer Phase
retry 10 sec
retry 1 sec 15 sec
abort
Sender
ENQ
ENQ
ENQ
EOT
ENQ
Receiver
xxx ENQ ACK
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
Transfer Phase
retry 10 sec
retry 1 sec 15 sec
abort
Sender
ENQ
ENQ
ENQ
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
3-59
Theory of Operation
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
Yes Message received ? No [ENQ] ?
No [ACK] ?
Yes
Yes
No
No
Time out (15 s) ? Yes
Device = Analyzer No Wait 20 sec
Yes
Wait 1 sec
Error: 'No answer from host'
Error: Contention on Line
Error: 'Answer different from [ACK]'
No Error: Go on with Transfer Phase
Send [EOT]
Figure 3-16: Establishment Phase, Flowchart
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Theory of Operation
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
3-61
Theory of Operation
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).
3-62
Theory of Operation
C
Reset Retry Counter
D
Send Frame
Start Timer
Read RS232
Message received ? No
Yes
Yes [ACK] or [EOT] ? No Send next record
No
Time out (15 sec) ? Yes
Retry no. +1
No Retry Counter > x ? (X=1 to 9) Yes Error: 'Answer different from [ACK]'
No
Last record ?
Yes
Error: 'No answer from host'
Figure 3-17: Transfer Phase, Flowchart
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Theory of Operation
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]
The end frame

[STX] FN Text first char. ...... Text last char. ETX CH CL [CR] [LF]
3-64
Theory of Operation
[STX] FN
is the ASCII code 2, indicating the beginning of a frame transmission. 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] CH, CL
is the ASCII code 3, indicating the end of the text block of an end frame. 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: Disallowed Characters:
7, 9, 11, 12, 13, 32-126, 128-254 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.
<CR> | \ ^ &
ASCII decimal
13 124 92 94 37
ASCII hex.
0Dh 7Ch 5Ch 5Eh 26h
Table 3-16: Delimiter Characters
3-65
Theory of Operation
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
H
ELEC HOST ELEC HOST [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK]
Requ. Info.: ID# 000004
Q
ELEC [STX]2Q|1|^000004^278^0^19^^SAMPLE^NORMAL||ALL| |||||||O[CR] [ETX]38[CR][LF] [ACK]
HOST
Message Terminator
L
ELEC HOST ELEC [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
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Theory of Operation
Host responds with test selections for, sample 000004 10=TSH, 20=T4, 30=FT4:
Message Header
HOST ELEC HOST ELEC
[ENQ] [ACK] [STX]1H|\^&|||ASTM-Host[CR][ETX]59[CR][LF] [ACK]
Patient Info. ID# 000004
HOST ELEC
[STX]2P|1||000004[CR][ETX]5B[CR][LF] [ACK]
Test Order: TSH, T4
HOST ELEC
[STX]3O|1|000004|278^0^19|^^^10^0\^^^20^0|R|||||| N||||||||||||||O[CR][ETX]58[CR][LF] [ACK]
Message Terminator
HOST ELEC HOST
[STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
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
H
Patient Info. ID# 000004
P
ELEC HOST [STX]2P|1||000004[CR][ETX]5B[CR][LF] [ACK]
Test Order: ID# 000004
O
ELEC [STX]3O|1|000004|278^0^19^^SAMPLE^NORMAL|ALL| R|19960614142107|||||X||||||||||||||0[CR][ETX]25[CR] [LF] [ACK]
HOST
Result TSH: 2.01 IU/ml
R
ELEC HOST [STX]4R|1|^^^10^0|2.01|uIU/ml|1.69^2.43|||F|||1997 0509135452|19970509141314|[CR][ETX]E3[CR][LF] [ACK]
Result T4: 320.0 nmol/l
R
ELEC HOST [STX]5R|2|^^^20^0|320.0|nmol/l|58.80^151.0|L||F||| 19970425120351|19970425122213|[CR][ETX]EC[CR][LF] [ACK]
Comment: out of range
C
ELEC [STX]6C|1|I|49Âbove normal(expected)range|I [CR][ETX]58[CR][LF]
3-67
Theory of Operation
HOST
Result HBSAG: negative
[ACK]
R
ELEC HOST ELEC HOST 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]
3-68
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 Host Plug to Elecsys
b)
Plug to Host
Plug to Elecsys
Figure 4-1: Data Cable Wiring Diagram (----- for optional bridges)
4-69
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 3 2 5 Txd Rxd SG
Explanation Analyzer frame Transmit Data Receive Data Signal Ground
Direction (only DTE) use for shield out in -
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
Interface Handshaking* Communication Method Data bits Stop bits Parity bit Transmission speed Maximum data block size Character Code
Specification
RS232C Asynchronous Serial Interface Software, can be switched off Half duplex 7 or 8 1 or 2 None, even, odd 1200, 2400,4800,9600,19200 247 bytes ASCII, shift JIS
Remarks
Max. cable length 15m XON/XOFF
BPS max. frame size
Table 4-2: Transmission Specification
(*Not used in US)
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4.1.3 Critical Timings

Phase State Timer Starts
Transmission of [ENQ] Contention (Host Timer) Contention (Analyzer Timer) Transfer Receiver Sender after sending of last [ACK] after transmission of last character of frame
Timer Stops
Reply of [ACK],[NAK],[ENQ] [ENQ] from Analyzer After Time-out complete reception of valid frame or [EOT] any reply of Receiver
Time-out
15 s 20 s 1s 30 s 15 s
Reaction
Sender enters Termination Phase Host enters Idle + retransmits [ENQ] Analyzer retransmits [ENQ] Receiver enters Idle State Sender enters Termination Phase
Establishme Sender nt
Table 4-3: Critical timings: Summary of Time-outs
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4.2
Data Link Layer
4.2.1 State Diagram
Figure 4-4: Sender / Receiver State Diagram (according to ASTM E1381-91)
4-73
4.2.2 Control Codes

Code
0A hex 0D hex 02 hex 03 hex 04 hex 05 hex 06 hex 15 hex 17 hex
Description
Line Feed Carriage Return Start of Text End of Text End of Transmission Inquiry Acknowledge Not Acknowledged End of Transmission Block
Mnemonic
[LF] [CR] [STX] [ETX] [EOT] [ENQ] [ACK] [NAK] [ETB]
Table 4-4: Control Codes
Allowed Characters: Disallowed Characters:
7, 9, 11, 12, 13, 32-126, 128-254 0-6, 8, 10, 14-31, 127, 255
4.2.3 Critical Timings

Phase State Timer Starts
Transmission of [ENQ] Contention (Host Timer) Contention (Analyzer Timer) Transfer Receiver Sender after sending of last [ACK] after transmission of last character of frame
Timer Stops
Reply of [ACK],[NAK],[ENQ] [ENQ] from Analyzer After Time-out complete reception of valid frame or [EOT] any reply of Receiver
Time-out
15 s 20 s 1s 30 s 15 s
Reaction
Sender enters Termination Phase Host enters Idle + retransmits [ENQ] Analyzer retransmits [ENQ] Receiver enters Idle State Sender enters Termination Phase
Establishme Sender nt
Table 4-6: Summary of Time-outs
4-74
4.2.4 Message Frame / Checksum Calculation

The intermediate frame
[STX] FN Text first char. ...... Text last char. ETB CH CL [CR] [LF]
The end frame

[STX] FN Text first char. ...... Text last char. ETX CH CL [CR] [LF]
[STX] FN
is the ASCII code 2, indicating the beginning of a frame transmission. 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] CH, CL
is the ASCII code 3, indicating the end of the text block of an end frame. 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).
4-75
Symbol
[STX] FN Text
Character
[STX] 1 T e s t
Value (decimal)
002 049 +084 +101 +115 +116 +003 468 MOD 256 212
Sum
0 49 133 234 349 465 468 = 468
Value (hex)
02h 31h +54h +65h +73h +74h +03h Mod 100h
Sum
00h 31h 85h EAh 15Dh 1D1h 1D4h = 1D4h = D4h
[ETX]
[ETX]
= 212 44h 34h 0Dh 0Ah
CH CL [CR] [LF]
D 4 [CR] [LF]
068 052 013 010
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.
4-76
4.2.5 ASCII Table
Char
Hex Dec
Char
Hex Dec
Char
Hex Dec
Char
Hex Dec
Char
Hex Dec
Char
Hex Dec
Char
Hex Dec
Char
Hex Dec
NUL
00 0
DLE
10 16
Space
20 32 30
0
48 40
@
64 50
P
80 60
`
96 70
p
112
SOH
01 1
DC1
11 17 21
!
33 31
1
49 41
A
65 51
Q
81 61
a
97 71
q
113
STX
02 2
DC2
12 18 22
"
34 32
2
50 42
B
66 52
R
82 62
b
98 72
r
114
ETX
03 3
DC3
13 19 23
#
35 33
3
51 43
C
67 53
S
83 63
c
99 73
s
115
EOT
04 4
DC4
14 20 24
$
36 34
4
52 44
D
68 54
T
84 64
d
100 74
t
116
ENQ
05 5
NAK
15 21 25
%
37 35
5
53 45
E
69 55
U
85 65
e
101 75
u
117
ACK
06 6
SYN
16 22 26
&
38 36
6
54 46
F
70 56
V
86 66
f
102 76
v
118
BEL
07 7
ETB
17 23 27
'
39 37
7
55 47
G
71 57
W
87 67
g
103 77
w
119
BS
08 8
CAN
18 24 28
(
40 38
8
56 48
H
72 58
X
88 68
h
104 78
x
120
HT
09 9 19
EM
25 29
)
41 39
9
57 49
I
73 59
Y
89 69
i
105 79
y
121
LF
0A 10
SUB
1A 26 2A
*
42 3A
:
58 4A
J
74 5A
Z
90 6A
j
106 7A
z
122
VT
0B 11
ESC
1B 27 2B
+
43 3B
;
59 4B
K
75 5B
[
91 6B
k
107 7B
{
123
FF
0C 12 1C
FS
28 2C
,
44 3C
<
60 4C
L
76 5C
\
92 6C
l
108 7C
|
124
CR
0D 13 1D
GS
29 2D
45 3D
=
61 4D
M
77 5D
]
93 6D
m
109 7D
}
125
SO
0E 14 1E
RS
30 2E
.
46 3E
>
62 4E
N
78 5E
^
94 6E
n
110 7E
~
126
SI
0F 15 1F
US
31 2F
/
47 3F
Table 4-8: ASCII Codes
?
63 4F
O
79 5F
_
95 6F
o
111
DEL
7F 127
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4.3
Presentation Layer
4.3.1 Allowed and Disallowed Characters

Allowed Characters: Disallowed Characters: 7, 9, 11, 12, 13, 32-126, 128-254 0-6, 8, 10, 14-31, 127, 255
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.
<CR> | \ ^ &
ASCII decimal
13 124 92 94 37
ASCII hex.
0Dh 7Ch 5Ch 5Eh 26h
Table 4-10: Delimiter Characters
4.3.3 Common Field Types

Field Definitions
Universal Test ID Component 1: Component 2: Component 3: Component 4: Universal Test ID (Part 1; reserved for future) Ûniversal Test ID Name (Part 2; reserved for future) Ûniversal Test ID Type (Part 3; reserved for future) ^Manufacturers or Local Code (Part 4)
ASTM
6.6.1 6.6.1.1 6.6.1.2 6.6.1.3 6.6.1.4 6.6.2 6.6.2.1
Dates and Times Format: YYYYMMDDHHMMSS Component 2: ^Time Zone Format: HHMM Telephone Numbers free text format Component 2: ^Multiple Phone Numbers Fixed Measurements and Units Component 2: Ûnit Addresses Component 1: Component 2: Component 3: Component 4: Component 5: Street Address ^City ^State ^Zip or Postal Code ^Country Code
6.6.3
6.6.4 6.6.5
4-78
Field Definitions
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.) Record Sequence Number
Table 4-11: Common Field Types
ASTM
6.6.6
6.6.7
Data Type
char[n] d d_t int pos_int t text unit
Explanation
n character string date in format YYYYMMDD (see E1394-91 - 6.6.2) date / time YYYYMMDDHHMMSS (see E1394-91 - 6.6.2 and above) integer number (depends on context could be: byte, int (16 bit), or long (32 bit) see RD application data specs for detailed ranges) positive (16 bit) integer (1..65535) time in format HHMMSS (see E1394-91 - 6.6.2) string with undefined length (exactly defined by the data base model according to limits given by ASTM protocol specification) 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
0 1 2 3 0..3 0..3 0 1 1
Record Name
Message Header Record Patient Information Record Test Order Record Result Record Comment Record Manufacturer Information Record Message Terminator Record Request Information Record
Identifier
H P O R C M L Q
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
1 1 1
Record Name
MSR - Action Confirmation
Identifier
M-AC M-AR M-CR

MSR - Action Request

MSR - Calibration Result
(This record is not used by the Roche Diagnostics implementation) 1

1
MSR - Calibration Order (Elecsys 1010 only) M-CO (This record is not used by the Roche Diagnostics implementation)
MSR - Calibrator Parameters M-CP
1
2
MSR - Calibration Scheme (Elecsys 1010 only) M-CS (This record is not used by the Roche Diagnostics implementation)
MSR - Control Parameters M-QP M-QS MSR - Control Scheme (Elecsys 1010 only) (This record is not used by the Roche Diagnostics implementation) 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
2 1 1 1 1
1
4 4 1 1 1 1 1
MSR - Change Communication Protocol (Elecsys 1010 only) M-PX (This record is not used by the Roche Diagnostics implementation)
MSR - Raw Result MSR - Result Context MSR - Sample Status M-RR M-RC M-SS M-SD M-XT M-TA M-TC

MSR - Service Data MSR - Substance Data MSR - Test Application MSR - Test Conditions
Table 4-14: Manufacturer Defined Records and Levels
4-80
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.
4-81
(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 4-5: Structure of Messages
4-82
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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4.3.6.1 Message Header Record (Level 0) (H Record)
Data Content
2010
1010
Data Type
LSM
Ref. 7.1.
Field
Comments
H | 7.1.
Record type ID (H)
char[1]
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 field, repeat, component, escape -> default: |\^&; see Table 4-16 sender name or ID ^BM (manufacturer) Ê2 (instrument type: Elecsys 1010) ^software version Example Elecsys 1010: ^BMÊ2^0.910 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. unique number or other ID that uniquely identifies the transmission for use in network systems
Delimiter definition Message control ID Access password Sender name or ID
2 3 4 5
char[4] text text text {^...} {\...}
|\^&
Sender street address Reserved field Sender telephone number Characteristics of sender Receiver ID
6 7 8 9 10
text
any characteristics of sender as: parity, checksums, optional protocols, etc. Elecsys 2010: only in debugging mode (refer to Table 4-17) Elecsys 1010: text (e.g. E1010) string passed directly to the shell (command interpreter) of the instrument OS when processing ID set to 'D' Elecsys 2010: refer to Table 4-16 (software version >= 3.x)
text text text
Comment or special instructions Processing ID
11
text
12
char[1]
P, D, (T), (Q) 1
Version No. date and time of message
13 14
int d_t
always 1 Current date and time when message was generated Elecsys 1010: only sent in debugging mode
Table 4-15: Message Header Record
4-84
Field Name
delimiter definition 7.1.2
ID
<CR> | \ ^ &
Option
Record delimiter = carriage return Field delimiter = vertical bar [124] Repeat delimiter = backslash [92] Component delimiter = caret[94] Escape delimiter = ampersand [37] Production: Treat message as an active message to be completed according to standard processing. Debugging: Message is initiated for the purpose of a debugging program. [13]
processing ID 7.1.12
P D
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
... SID = || RID = || PID = |P|
Comment
... prior to the assignment all packages sent from the Host have the "sender ID"/"receiver ID" empty before the assignment all packages sent from the instrument have the "sender ID"/"receiver ID" empty
SID = || RID = || PID = |P| ... ... 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 instrument sends next and following messages with its "S ID"= "last sent RID in debugging mode" = memorized instrument ID.
SID = |Instr. #| RID = |Host #| PID = |P| ... ... 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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4.3.6.2 Message Terminator Record (Level 0) (L Record)

Data Type
Data content
2010
1010
LSM
Ref. 13.1
Field
Comments
L | 13.1.
record type ID (L) 1 sequence number termination code 2 3
char[1] pos_int char[1]
L 1 Nil, E, F, I, Q
Last record in each message see Table 4-19 and Table 4-20
Table 4-18: Message Terminator Record
Field Name
termination code 13.1.3
ID
Nil, N E
Option
Remark
normal termination normal end of message (default when empty) 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. normal end of message sent in response to a remote query message (final), indicating that all data has been sent normal end of an empty message (no data found) sent in response to a remote query message for the response to an invalid (unprocessable) remote query
last request for information processed no information available from last query error in last request for information
Table 4-19: Field Options for Message Terminator Record
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normal There is response data. There is no response data. Not all data in records are in accordance with the rules. (Improper message error) abnormal Receive error Hardware error Application error All data in records are not as ruled. (Improper message error) Message refusal Receive error (*) Hardware error (*) Application error (*) The last record is not the Termination record. Improper message error Receive error Hardware error Application error (*)
Termination code
F I Q E no message
Inquiry
normal
Response & Download
abnormal
Invalid attribution
abnormal
* The instrument reflects the valid record data in the data base. Table 4-20: Termination Codes to different Error States
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4.3.6.3 Patient Information Record (Level 1) (P Record)

Data Type
Data content
2010
1010
LSM
Ref. 8.1.
Field
Comments
P | 8.1.
Record Type ID (P) Practice Assigned Patient ID
char[1] pos_int text
Can be requested by using ASTM Request Information Record (Q) 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 last name ^first name ^middle name or initial ^suffix, title separated by a component delimiter (see E1394 6.6.6.)
Sequence Number 2 3
Laboratory Assigned Patient ID
text
patient ID No.3 patient name
5 6
text text ^text ^text ^text
mothers maiden name date of birth patient sex
7 8 9
text d char[1] (M), (F), (U) (W), (B), (O), (NA), (H)
Date in standard format YYYYMMDD M: F: U: W: B: O: NA: H: male, female, unknown white black Asian native American Hispanic
patient race-ethnic 10 origin
text
patient address reserved field patient telephone number attending physician ID special field 1 special field 2 patient height (in cm) patient weight in (kg)
11 12 13 14 15 16 17 18
text text text text text int {ûnit} int {ûnit} text
ICD-9 code
patients known or 19 suspected diagnosis patient active medications patients diet 20 21
text text text text
practice field No.1 22 practice field No.2 23
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Data Type
Data content
2010
1010
LSM
Ref. 8.1.
Field
Comments
P | 8.1.
admission and discharge dates admission status
24 25
d {\d} char[2] (OP), (PA), (IP), (ER)
OP: PA: IP: ER: outpatient preadmit inpatient emergency room
location nature of alternative diagnostic code and classifiers alternative diagnostic code and classification patient religion
26 27
text text
DRG or AVG
28
text
29
char[1] or text
(P), (C), (M), (J), (L), (H) (M), (S), (D), (W), (A)
P: Protestant C: catholic M: Mormon J: Jewish L: Lutheran H: Hindu or text for other M: S: D: W: A: married single divorced widowed separated
marital status
30
char[1]
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 hospital service hospital institution dosage category
32 33 34 35
text text text text
A: P1: P2: ADULT PEDlATRlC (1-6 months) PEDIATRIC (6 months - 3 years)
Table 4-21: Patient Information Record
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4.3.6.4 Test Order Record (Level 2) (O Record)

Data Type
Data content
2010
1010
LSM
Ref. 9.4.
Field
Comments
O | 9.4.
record type ID (O) 1
char[1]
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 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. Sequence # ^carrier # (carrier is rack or disk) ^Position in carrier ^format ^data carrier type (CONTROL, SAMPLE) ^container type (NORMAL, REDUCED) ^container cap type înitial 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 4 or more part field: universal test ID ûniversal test name ûniversal 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). âuto-dilution fact.(Table 4-23 /Table 5-2) ^pre dilution înstrument identification universal test ID = ALL for order record in a result message
sequence number specimen ID
2 3
pos_int text
instrument specimen ID
text {^text} {^text} {^text} {^text} {^text}
universal test ID
5 text ^text ^text ^text
{^text} \...
4-90
Data Type
Data content
2010
1010
LSM
Ref. 9.4.
Field
Comments
O | 9.4.
universal test ID (continued...)
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.
priority
requested/ordered 7 date and time 8 Specimen collection date and time collection end time collection volume(in ml) collector ID action code 9 10 11 12
d_t d_t
d_t int {ûnit} text char[1] 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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Data Type
Data content
2010
1010
LSM
Ref. 9.4.
Field
Comments
O | 9.4.
action code (continued...)
12
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 samples type (see Table 4-25) text text d_t text ^text text text text text text text d_t type: blood, urine, serum, ...; source: left arm, right lung, ...
danger code relevant clinical informat.
13 14
date/time 15 specimen received specimen 16 descriptor (type & source) ordering physician 17 physicians 18 telephone number user field No.1 user field No.2 laboratory field No.1 laboratory field No.2 date/time results reported or last modified instr. charge to computer system 19 20 21 22 23
24
text text char[1] {\...} O, I, Z, Q, F, Y
see Table 4-26
instrument section 25 ID report types 26
reserved field location or ward of specimen collection nosocomial infection flag specimen service specimen institution
27 28 text
29 30 31
text text text
Table 4-22: Test Order Record
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Sample Type
Protocol
Tests
Quantitative Tests
Auto Dilution from Instrument

[NONE]
Auto Dilution from Host

NOT Available (Use Default auto-dilution ratio) NOT Available (Use Default auto-dilution ratio) Available (assigning auto-dilution ratio is possible) NOT Available (assigning auto-dilution ratio is impossible) NOT Available (Use Default auto-dilution ratio)
Diluent Protocol or Pretreatment Protocol
Qualitative Tests
[NONE] [NONE] or Reference No. in Reference Table is responding to assigned auto-dilution ratio [NONE]
Sample Other Protocol (Not Diluent Protocol) (Not Pretreatment Protocol) Quantitative Tests
Qualitative Tests
Control
[NONE]
Table 4-23: Auto Dilution Factor is set corresponding to this table
Field Name
priority 9.4.6
ID
R S
Option
routine STAT (short turn around time) Instrument does not overwrite this priority if this specimen has already been assigned priority different.
Registration
already assigned priority

Normal
priority (sent from Host)

R S [NONE] R
priority
Normal IMPOSSIBLE ! Normal IMPOSSIBLE ! STAT STAT Normal STAT Normal
Update STAT
S [NONE] R
New
S [NONE]
*** RS System ----- Can not assign STAT priority. ( = S ) Table 4-24: Priority for sample registration Elecsys 2010
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Field Name
action code 9.4.12
ID
N
Option
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. add the requested tests to an already existing sample cancel request for the battery or tests named Instrument deletes this specimen from data base. treat specimen as a Q/C test specimen. Elecsys 2010: In case of control samples following two characters are added \Q specimen or test already in process.
A C Q
Registration
already assigned samples type

Sample
action code (sent from Host)

N or A N\Q or A\Q [NONE] N or A
samples type
Sample IMPOSSIBLE ! Sample IMPOSSIBLE ! Control Control Sample IMPOSSIBLE ! Sample
Update Control
N\Q or A\Q [NONE] N or A
New
Sample or Control
N\Q or A\Q [NONE]
Table 4-25: Sample registration and update Elecsys 2010
Field Name
report types 9.4.26
ID
O I Z Q F Y
Option
order record; user asking that analysis be performed in instrument pending no record of this patient (in response to query) response to query (this record is a response to a request-information query) final result 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
1 2
Search
Registration
Comment
Sample Seq No. ID

Disk No./ RackID & Key Position No.

Seq No. Sample ID Disk No./ Rack ID & Position No.
Upd. New
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. 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.
Seq No.
Sample ID or Disk No./ Rack ID & Position No.
Seq No.
Seq No.
: [space]:
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 2 3 4 5 6 7
Comment
Disk No./ RackID & Key Position No.

Seq No. Sample ID Disk No./ Rack ID & Position No. Seq No. Sample ID Seq No. Seq No. Sample ID is ignored. Disk No./Rack ID & Position No. are ignored. Disk No./Rack ID & Position No. are ignored. Sample ID and Disk No./Rack ID & Position No. are ignored.
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4.3.6.5 Result Record (Level 3) (R Record)

Data Type
Data content
2010
1010
Ref, 10,1.
LSM
Field
Comments
R | 10.1.
record type ID (R) 1 sequence number universal test ID 2 3
char[1] pos_int text ^text ^text ^text
result transfer record; can be requested using ASTM Request Information Record see Test Order universal test ID, ûniversal test name, ûniversal 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) âuto-dilution factor (see Table 5-2) ^pre dilution înstrument identification Further details see Order Record. 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: < For quantitative tests : a value corresponds to the analyte concentration For qualitative tests: data1 ^data2 data1 = 1 : corresponds to positive 0 : corresponds to borderline -1 : corresponds to negative data2 = Cut-off index When result status = X (No Value), no data is set in this field ([NONE]). ISO 2955 or actually used unit normal/panic ranges for test result; target value/ranges for QC lower limit ûpper limit (see Table 4-28) refer to Table 4-29 The instrument warnings assigned to specific result will be sent with comment record to this Result record For Elecsys 2010 software versions <1.4 instead of these flags alarm codes are sent (see Table 5-3 chapter 4.3.7 ). A: S: R: N: age, sex, race, generic normal range
^ ^ ^Test No.
{^text} Âuto Dil.
data or measurement value
text {^...}
e.g.: 1,97; -1; <0.05 >=1.0 >10.0
units reference ranges
5 6
text text ^text {\...} char[1] or char[2] N, L, H, <, >, A;
result abnormal flags
nature of abnormality testing result status
char[1] {\...}
char[1] {\...}
F, X, Q, V, Y, '+' N, I
see Table 4-30 LSM might have multiple status separated by repeat delimiter.
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Data Type
Data content
2010
1010
Ref, 10,1.
LSM
Field
Comments
R | 10.1.
date of change in instrument normative values or units operator identification date/time test started date/time test completed instrument identification
10
11 12 13 14
text d_t d_t text
if the later versions of instrument software supports the Operator Name this field should be transmitted for Elecsys 2010: sampling time for Elecsys 2010: ready time Elecsys 1010: User defined instrument name LSM : instrument identification
Table 4-27: Result Record
Samples Type
Tests
Quantitative Tests Qualitative Tests
Normal Range Check Not Available

[NONE] [NONE] Lower Limit Ûpper Limit Lower Limit Ûpper Limit
Available
Lower Limit Ûpper Limit [NONE] Lower Limit Ûpper Limit Lower Limit Ûpper Limit
Sample
RD Control Foreign Control
Table 4-28: Reference Ranges
Field Name
result abnormal flags 10.1.7
ID
L H < > A N
Option
below low normal above high normal below absolute low that is off low scale on an instrument above absolute high, that is off high scale on an instrument abnormal normal
Table 4-29: Result abnormal flags
2010 Data Alarm

48 49 50 51
4-99
Field Name
result status 10.1.9
ID
F X I R Q V Y +
Option
final results results cannot be done, request will not be honored in instrument, results pending this result was previously transmitted this result is a response to an outstanding query operator verified/approved result; see E1394-91 10.1.9 system blocked user blocked "result status" is set as follows: normal data [F], edited data [V, Y, +], other data [X]
Table 4-30: Result Status
4-100
4.3.6.6 Comment Record (Level 0...3) (C Record)

Data Type
Data content
2010
1010
LSM
Ref. 11.1
Field
Comments
C | 11.1.
record type ID (C) 1
char[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. I: clinical instrument system
Sequence number comment source comment text
2 3 4
pos_int char[1] text{^...} {\...^...} I
Elecsys: In case of instrument flag: Instrument Flag # ^comment for abnormal flag (refer to Alarm Flags Elecsys 2010 Table 5-3) LSM: In case of instrument flag: LSM Flag # In case of generic free text: ^comment I: instrument flag(s) G: generic/free text comment, For versions > 1.35 G will be replaced by I.
comment type
char[1]
I, G
()
Table 4-31: Comment Record
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4.3.6.7 Request Information Record (Level 1) (Q Record)

Data Type
Data content
2010
1010
Ref. 12.1.
LSM
Field
Comments
Q | 12.1.
record type ID (Q) 1
char[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 starting range ID number (patient ID/specimen ID/instrument specimen ID)
2 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 universal test ID nature of request time limits beginning request results date and time ending request results date and time requesting physician name
4 5 6 7 text char[1] d_t ALL
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
d_t
text text
10 requesting physician telephone number
4-102
Data Type
Data content
2010
1010
Ref. 12.1.
LSM
Field
Comments
Q | 12.1.
user field No. 1 user field No. 2
11 12
text text char[1] O, F, N X, I, R, A
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
Table 4-32: Request Information Record
Field Name
starting range ID number 12.1.3 universal test ID 12.1.5
ID
ALL
Option
all specimen results ordered by the inquiring system (current implementation supports ALL only) signifies a request for all results on all tests requesting test orders and demographics only (no results)
ALL
request O information status codes 12.1.13 F N X A
final results requesting new or edited result only results cannot be done, request canceled abort/cancel last request criteria (allows a new request to follow)
Table 4-33: Field Options for Request Information Record
4-103
NOTES: 1. Sample/Result Handling - Behavior: The instrument queries for test selections depending on the following conditions:
ASTM field 12.1.3 component
Query (disk version) Case 1: Bar-coded sample: Case 2: No BC, but SID assigned: Case 3: No BC, no SID assigned: Case 4: empty position: 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
ID
^3
Seq# no query
^4
Rack/Disk# ** no query ** **
^5
Pos# no query
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), Sequence Number (Seq #), Rack Identification (RID), and Position Number (Pos #). 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. ASTM field 9.4.3 ASTM field 9.4.4 component 1 ASTM field 9.4.4 component 2 ASTM field 9.4.4 component 3
4-104
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. 4.3.7.1 Action Confirmation Record (Level 1) Data Type
Data content
2010
1010
Ref. AC
Field
Comments
BM.AC
record type ID (M) 1
char[1]
Confirmation of processing actions. (This record is not used by the Roche Diagnostics implementation) Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010) ^version # STOP or START O: A: T: action processed; not allowed in current system state; Could not be processed within timeout
sequence number
pos_int char[2] ^text ^text ^text AC ^BM Ê1 ^1

STOP, START,
record type sub-ID 3 (AC)
command processing status
4 5
text char[1]
O, A, T
additional action result
text
optional field for several action that can deliver a result, e.g., maintenance operation results of self test
Table 4-35: Action Confirmation Record
4-105
4.3.7.2 Action Request Record (Level 1) Data Type
Data content
2010
1010
Ref. AR
Field
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 record type sub-ID (AR)
2 3
pos_int char[2] ^text ^text ^text text AR ^BM Ê1 ^1 STOP, START; STOP_ SAMPLING; PAUSE; RESUME; DO_MAINT; DO_SELFTEST; INITIALIZE; SHUT_DOWN; STAND_BY; TESTRUN; SCAN
Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010) ^version # STOP; START; STOP_SAMPLING; PAUSE; RESUME; DO_MAINT; DO_SELFTEST; INITIALIZE; SHUT_DOWN; STAND_BY; TESTRUN; SCAN
command
time out additional parameters
5 6
int int {înt}
in seconds
Table 4-36: Action Request Record
4-106
4.3.7.3 Calibrator Parameters Record (Level 2) Data Type
Data content
Query*
2010
1010
Ref. CP
Field
Comments
BM.CP
record type ID (M) sequence number
1 2
* *
calibrator parameters definition; this record should follow the general substance data for calibrators Roche specific record identifier ^BM înstrument 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
record type sub-ID 3 (CP)
CP(Q) ^BM Ê1 ^1
test number calibrator level
4 5
text char[1] A, B, C, D, E (P), (N), (R)
target value / unit
text {ûnit}
reference value ^current unit; empty for qualitative tests. Elecsys 1010: value and unit!
reagent lot number reagent package number
7 8
int int {înt}
test reagent lot for which the calibrator is valid e.g. corresponding reagent individual package number
Table 4-37: Calibrator Parameters Record
*For Elecsys 2010 only
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4.3.7.4 Calibration Result Record (Level 2)

Data Type Data content
2010
1010
Ref. CR
Field
Comments
BM.CR
record type ID (M) 1 sequence number 2
char[1] pos_int char[2] ^text ^text ^text
(This record is not used by the Roche Diagnostics implementation) Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010) ^version # test No.., blank set No.; not relevant for instrument calibration reagent lot No./ blank set lot No. actual unit of the test field components: carrier type, ^carrier ID, ^position in carrier; Elecsys 2010: carrier type = RD (Reagent Disk); e.g. corresponding reagent; individual reagent pack number (for Elecsys 2010 reagent pack & optional pretreatment) N: L: M: R: I: quantitative, qualitative, master (LINC), recalibration (renewed), instrument calibration (not relevant for Elecsys 1010)
record type sub-ID 3 (CR)
CR ^BM Ê1 ^1
test number test lot numb. Unit test container description
4 5 6 7
text int unit text ^text ^text e.g.: RD ^1 ^5
test package number
int {înt} char[1] ^char[1] N^R, L^R, N^M, L^M, I^
calibration method 9
replication number 10 date/time calibration completed result states 11
int d_t
as overwriting of the default set by test conditions date/time when result is ready
12
char[1]
O, Q, F, (X), A I, M, S, R, D, L, B, F, T, C
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 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) 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]
result characteristics
13 char[1] ^char[1] ^text {\...}
curve parameters
14
text{\...}
4-108
Data Type
Data content
2010
1010
Ref. CR
Field
Comments
BM.CR
calibrators container description
15 text ^text ^text ^text ^text
e.g.: SD ^1 ^7
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
{\...} calibrators result 16 text {^ ... } {\...}
Table 4-38: Calibration Result Record
[For Quantitative tests] Criteria

Missing values
characteristic ID
I
text1
0 (OK), 1 (Question), 2 (Fail) 0 (OK), 1 (Question), 2 (Fail) 0 (OK), 1 (Question), 2 (Fail) 0 (OK), 1 (Question), 2 (Fail)
text2
ex. AA--CC----
Monotony of curve
ex. A---E
Minimum signal
ex. AA--CC----
Calibration factor Deviation of dupl. Measurement
R D
Value of Calibration factor [NONE] ex. A---E
[For Qualitative tests] Criteria

Missing values
characteristic ID
I
text1
0 (OK), 1 (Question), 2 (Fail) [NONE] [NONE] [NONE] 0 (OK), 1 (Question), 2 (Fail) 0 (OK), 2 (Fail) 0 (OK), 1 (Question), 2 (Fail) 0 (OK), 2 (Fail)
text2
ex. AA--
Monotony of curve Minimum signal Calibration factor Deviation of dupl. Measurement
M S R D
[NONE] [NONE] [NONE] ex. -B
Slope Min/Max signal
L B
OK or NG ex. >-<-
Minimum acceptable difference
OK or NG
4-109
[For Blank Set] Criteria

Achievement of Targets Comparison to last valid BlankCell
characteristic ID
T C
text1
0 (OK), 2 (Fail) 0 (OK), 2 (Fail)
text2
OK or NG OK or NG
Table 4-39: Calibration Result Characteristics
4.3.7.5 Diluent Parameters Record (Level 2)

Data Type
Data content
2010
1010
Ref. DP
Field
Comments
BM.DP
record type ID (M) 1 sequence number 2
Diluent parameters definition; this record should follow the general substance information for diluent packs. Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version # test No. for which the diluent is valid test lot for which the diluent is valid
record type sub-ID 3 (DP)
DP ^BM Ê1 ^1
test number test lot number Endogenous content / unit
4 5 6
text int text {ûnit}
Table 4-40: Diluent Parameters Record
4-110
4.3.7.6 Instrument Configuration Record Data Type
(Level 1)
Data content
Query
2010
1010
Ref. IC
Field
Comments
BM.IC
record type ID (M) 1 sequence number record type sub-ID (IC) 2 3
char[1] pos_int char[2] ^text ^text ^text
M IC ^BM Ê1 ^1
instrument specific configuration Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version #
predilution factor printing option
4 5
int char[1] S, T, M
printing of results online: S: automatic in sampling order, T: automatic in results order, M: manual printout upload of results: S: automatic in sampling order, T: automatic in results order, M: manual upload (for V1 SW only if all results of a sample are available) result gets status documented by: P: print, U: upload to Host/LSM, B: both instrument name, language specific sending additional data Possible contents: No^^^^, Âll^^^, Âll^SD^^, Âll^^RC^, Âll^^^RR, Âll^SD^RC^, Âll^SD^^RR, Âll^SD^RC^RR, Âll^^RC^RR e.g., No^^^^ means send no MSRs at all; Âll^SD^^RR means send all MSRs but SD record and RR record. Note: After Power Off this is set to the default No^^^^. Elecsys 1010 Host/Interface data configuration: 1st component: No: no automatic upload of MSRs except that defined in following components (Host mode). 2nd component: All: Automatic upload of MSRs as specified except that defined in following components (LSM mode). 3rd component: empty. 4th component: RC: [M-RC] result context. 5th component: RR: [M-RR] raw result. 6th component: PM: [M-PM] processing messages.
uploading option
char[1] S, T, M
documentation request
char[1] P U, B No^^^^, Âll^^^, Âll^SD^^, Âll^^RC^, Âll^^^RR, Âll^SD^RC^, Âll^SD^^RR, Âll^SD^RC^ RR Âll^^RC^RR
user defined instrument name sending additional data
8 9
text
text ^text ^text ^text ^text ^text
4-111
Data Type
Data content
Query
2010
1010
Ref. IC
Field
Comments
BM.IC
system clock
10
this time is sent to synchronize instrument time to LSM time triggered by instrument calibration start when (day time) the automatic instrument calibration should be performed (for Elecsys 1)
instrument information
11 text ^d ^text ^text 12 text
e.g.: 1234567. ^19950208. ^1.00 ^14455
instrument serial number înstallation date ^software version ôverall test counter Sample order keep function (on or off), 0 - off; 1 - on; function always on for Elecsys 1010. country (GER, ENG, FRA, ESP, ITA, JPN) ^date format ^time format - 12, 24 (hour format) date format: DDMMYYYY, MMDDYYYY, or YYYYMMDD Elecsys 1010: no Japanese language printer: (I internal, E - external, B - both; not relevant for Elecsys 2010) êxternal printer type: HP/EPSON êxternal printer paper size in inches Elecsys 1010: Printout on both printers (B) is not possible. HC: MC: PT: 1 to 6 Hitachi cup, Hitachi micro cup, small tube
keep function
0, 1
language information
13 text ^text ^text
e.g.: GER ^DDMM. ^12
printer setup
14 char[1] ^text înt
e.g.: E ÊPSON ^11
secondary cup type 15
text
HC, MC, PT
number of 16 secondary adapters
int
bar-code reader configuration
17 char[1] ^char[1] ^char[1] ^char[1] înt ^char[1] ^char[1] {\...}
e.g. y ^n ^n ^n ^0 ^n ^n ^\n ^^^^^\y^n^n ^y^10^y\y^y^ n^n^0^n
bar code configuration structure {enable code (y/n); check character required (y/n); transmit check character (y/n); fixed length used (y/n); fixed length size (3..14); ignore leading zero (y/n, 2/5 only); check character calculation mode 16 (y/n) for each possible code type : NW7 (Codabar), Code 39, Interleaved 2/5, Code 128 A/C (in this order)
4-112
Data Type
Data content
Query
2010
1010
Ref. IC
Field
Comments
BM.IC
other configuration 18 data
text {^...}
collection of component of ASCII coded configuration elements. Elecsys 1010: Host query timeout (in seconds) ^waiting time for reagent substance data download (in minutes) ^cup on tube (y/n) ^tube height (in mm) if cup on tube is on ^secondary adapter for STAT positions (y/n)
Table 4-41: Instrument Configuration Record
4-113
4.3.7.7 Instrument Status Record (Level 1) Data Type
Data content
Query
2010
1010
Ref. IS
Field
Comments
BM.IS
1 2
only for fast general information
record type sub-ID 3 (IS)
IS ^BM Ê1 ^1
Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version # see Table 4-43 see Table 4-44 O: W: E: O: W: E: OK, warning, error OK, warning, error
instrument state alarm level of processing alarm level of inventory alarm level of QC
4 5 6
char[1] char[1] char[1]
O, W, E
char[1]
O, W, E
alarm level of calibration
char[1]
O, W, E
O: OK, W: warning, E: error (for Elecsys 2010 incl. instrument calibration) of current workload, useful for batch or slow instrument
last result ready date and time next STAT ready date and time walk away date and time operator identification STAT drawer available at
9 10 11 12 13
d_t d_t d_t text text
Run finished. if the later versions of instrument software supports the Operator Name this field should be transmitted Time STAT drawer available (sample pipetting finished) Elecsys 1010: current time if available; empty if schedule not calculated yet.
Table 4-42: Instrument Status Record
4-114
Instrument Status
Initialize Stand By Preparation Operation S. STOP P. STOP STOP E. STOP T/M S. Scan (incl. Restart) R. Scan SLEEP C. Scan Finalization R.Stop L.Stop A.Stop A.Stop & R.Stop A.Stop & L.Stop Line Only A.Line Stop I.Line Stop A.Line Stop\R.Stop I.Line Stop\R.Stop FD Access
Table 4-43: Instrument Status Flags
Disk
I B A O H T S E M N R P C F D
Rack Sampler
I B A O S E M R P C F V W Y Z D
CLAS
I B A O S E M R P C F V W Y Z Q G J K D
U/I Headline
No Alarm Alarm (Warning) Alarm (P.STOP) Alarm (STOP) Alarm (E.STOP) Alarm (S.Stop) Alarm (L.Stop) Alarm (A.Stop) Alarm (L.Stop & A.Stop) Alarm (R.Stop) Alarm (A.Line Stop) Alarm (I.Line Stop)
Table 4-44: Alarm Level of processing
Disk
0 W E F R H -
RS
0 W F R L X Z S -
CLAS
0 W F R L X Z S Q G
4-115
S.Stop: In case of Sample Stop occurs no more new sample will be pipetted. P.Stop: Partial Stop occurs in case if any hard ware module does not work any more. Depending on the importance of the module the run will be finished or stopped. Stop: After the Stop key was pressed the actual time step will be performed before the system stops in a defined status. E.Stop: In case of a hardware crash the Emergency Stop stops the system in an undefined status. L.Stop: The Line Stop occurs when the rack sampler or conveyer line does not work (A-line = input buffer; B-line = bar-code reader line; C-line = output buffer). R.Stop: Rack Supply Stop occurs when there are no more racks to be fed. S.Scan: During Sample Scan samples are registered into the data base. R.Scan: During Reagent Scan reagents are registered into the data base. C.Scan: During Calibrator Scan calibrator bar code cards are registered into the data base.
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4.3.7.8 Log File Record (Level 1)

1010* (upload only on query)
Data Type
Data content
Query
2010
Ref. LF
Field
Comments
BM.LF
record type ID (M) sequence number record type subID (LF)
char[1]
for transfer of message information, amount of log messages in one frame is determined by protocol frame length; multiple frames are used for long files Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version # in case of more log files, if only one is available than this field can be omitted
2 3
pos_int text ^text ^text ^text LF ^BM Ê1 ^1
file name start date/time end date/time message category
4 5 6 7
text d_t d_t char[1] I, E, W, A, F, R, H, L, X, Z, S, Q, G
I: E: W
information (normal events), partial stop, warnings,
A: all, F: stopped by operator, R: emergency stop, H: sample stop, L: line stop, X: A. stop, Z: A. stop and line stop, S: rack supply stop, Q: A. line stop, G: I. line stop. Elecsys 1010: alarm level; empty = A; uploaded as in query message category ôccurrence date and time ^message code ^message sub code ^ message string (language dependent) Elecsys 1010: no message sub code
message(s)
char]1} d_t înt înt ^text {\...}

Table 4-45: Log File Record
4-117
4.3.7.9 Processing Message Record

Data Type
(Level 1)
Data content
2010
1010
Ref. PM
Field
Comments
BM.PM
record type ID (M) sequence number record type subID (PM)
char[1]
for fast errors/warnings and other system events signalization; should be transferred asynchronous from the instrument Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version #
2 3
pos_int text ^text ^text ^text PM ^BM Ê1 ^1
occurrence date and time message code
4 5
d_t int înt text char[1] for Elecsys 2010: alarm code âlarm sub code (empty for Elecsys 1010) for Elecsys 2010 and 1010: alarm string (language dependent) see Table 4-47 Elecsys 1010: alarm level
message name message category
6 7
Table 4-46: Processing Message Record
Alarm Level
Warning P.STOP STOP E.STOP S.STOP L.STOP A.STOP L.STOP & A.STOP R.STOP A.Line STOP I.Line STOP All Level
Table 4-47: Alarm Level
Disk
W E F R H A
RS
W F R L X Z S A
CLAS
W F R L X Z S Q G A
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4.3.7.10 Control Parameters Record Data Type
(Level 2)
Data content
Query
2010
1010
Ref. QP
Field
Comments
BM.QP
1 2
control parameter definition; this record should follow the general substance information for control Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010) ^version # Test No. for which the control is valid Test lot for which the controls are target values; target value ûnit target range lower limit target range upper limit A: N: active, not active
record type sub-ID 3 (QP)
QP ^BM Ê1 ^1
test number reagent lot number target value / unit
4 5 6
text int text {ûnit} text text char[1] {\...} A, N
lower limit upper limit flags
7 8 9
Table 4-48: Control Parameters Record
4-119
4.3.7.11 Result Context Record (Level 1) Data Type
Data content
2010
1010
Ref. RC
Field
Comments
BM.RC
record type ID (M)
char[1]
for information about reagent lot number used for this measurement; information about the calibration/QC context could be retrieved, e.g., through time linking; this record can be sent without previous Result Record This sequence number and the sequence number of the Raw Result Record (BM.RR) are counted together because they have the same record ID and are on the same level.
sequence number
pos_int
record type subID (RC)
text ^text ^text ^text
RC ^BM Ê1 ^1
Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version # see Test Order, e.g.: 121 Test name, e.g.: TSH = substance lot number, e.g.: 12345678
BM test number reagent identifier reagent lot number reagent pack number control identifier
4 5 6 7 8
text text int int text
for Elecsys 2010 this is the control number; this field is only filled out if this context is control results related; empty for non Roche results -" O, F, Q, L -"O: F: Q: L: Okay, Failed, Questionable (result was generated with a user released calibration), (Result was generated with) last valid calibration
control lot number control pack number Calibration status
9 10 11
int int char[1]
Table 4-49: Result Context Record
4-120
4.3.7.12 Raw Result Record (Level 4) Data Type
Data content
2010
1010
Ref. RR
Field
Comments
BM.RR
record type ID (M)
char[1]
for transfer of raw results (more values - array - for one measurements); this record can not be sent without previous Result Record depending on the configuration settings (see Instrument Configuration record) This sequence number and the sequence number of the Result Context Record (BM.RC) are counted together because they have the same record ID and are on the same level.
sequence number
pos_int
record type subID (RR)
RR ^BM Ê1 ^1
Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version # if increment is constant; otherwise empty (optional field); starting point is offset (in ms) from the beginning of the measurement time List of raw result values effective signal (only one value per single measurement)
starting value; increment value list effective signal
int
5 6
int {\...} text

Table 4-50: Raw Result Record
4-121
4.3.7.13 Service Data Record (Level 1)

1010* (upload only on query) Query Data Type
Data content
2010
Ref. SD
Field
Comments
BM.SD
record type ID (M)
char[1]
instrument specific service data, e.g., alignments, module commands. The amount of trace data in one record is determined by maximum record length; multiple records should be used for long trace files. Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version # Structure {action type; ^time interval; ^count interval } for each maintenance action. Valid action codes are : CL1: Cleaning 1; CL2: Cleaning 2; SRV: Service; REP: replacement of measuring cell collection of component of ASCII coded service data elements date of installation, ^Power On time in hours, ôperation time in hours repeat field of trace lines (language dependent of the CAN-communication (extra lines for trace header information: trace number, alarm number, etc.) Each line of the trace screen / trace printout / floppy disk trace file should be transmitted as one repeat field. Additional records should be used if necessary.
sequence number
pos_int text ^text ^text ^text SD ^BM Ê1 ^1
record type sub-ID 3 (SD)
maintenance schedule service data
4 text înt ^long {\^...}
operation log
d ^long ^long text {\...}
120594 ^3876 ^1365
Trace
4-122
1010* (upload only on query) Query
Data Type
Data content
2010
Ref. SD
Field
Comments
BM.SD
service data
text {^...}
collection of component of ASCII coded service data elements Clot Detection: Sample Type \Seq No. \Test No. \Pipetting Pos \Pressure Sensor Value ^Pressure Sensor Value ^... Sample type: Sample Control Calibrator BlankCell Pipetting Pos: R1 R2 Diluent Sample Beads PS RM DL1 DL2 ADC Raw Data: Action Pattern ^Raw Data \ Raw Data Action Pattern: AB Level Check Measuring Cell System Volume Clot detection; ADC Raw Data left space for determination in an instruments data base
kind of service data left space for determination in an instruments data base
8 9
text int
Table 4-51: Service Data Record
4-123
4.3.7.14 Sample Status Record (Level 1)

Data Type
Data content
Query
2010
1010
Ref. SS
Field
Comments
BM.SS
1 2
(This record is not used by the Roche Diagnostics implementation) Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010) ^version # unique sample ID (same as in Test Order) If both field data ('Sample ID' and 'Position No.) are set, 'Sample ID' is used as Key data. position description (same as in Test Order): Sequence No. ^Disk (carrier) No. ^Position in carrier No. ^format ^data carrier type ^container type ^container cap type înitial volume in ml. combination of several flags from following set: I: identified (PSID), A: available to remove, C: all results completed, P: in process, N: requirement not available, G: pending requisition X: results cannot be done R: removed, M: multiple processing (rerun), see Table 4-53 when sample was recognized by the instrument (e.g., PSID BC was read) when the sample can be removed from the instrument, e.g., after end of run or availability of STAT sample repeat field of components: [test number ^ready time]
record type sub-ID 3 (SS)
SS ^BM Ê1 ^1
specimen ID
text
instrument specimen ID
5 text ^text ^text ^text ^text ^test ^test ^test 6 char[1] {\...}
status
I, A, C, P, N, G, X, (R), (M)
identification date 7 and time availability time 8
d_t t
result ready time
9 text ^t {\...}
Table 4-52: Sample Status Record
4-124
Case
No Sample on this position Sample is set on this position before pipetting now pipetting all tests completed some tests can not be done prepare for next start/restart
status
N
I P A\C A\X G
(regist status)
Table 4-53: Sample Status
4-125
4.3.7.15 Test Application Record (Level 1) Data Type
Data content
2010
1010
Ref. TA
Field
Comments
BM.TA
record type ID (M)
char[1]
only manufacturer accessible part of application; this record content can vary for different instrument types but the existence of this record is important for all future Roche instrument communication protocols; for detailed explanation see Data Lists for Roche-Data Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version # With this record the pure Matrix bar code (MBC) content is transferred. All types can be transferred, without any extra code of the type (MBC - for tests, diluents, etc.; MBC card (MBCC) - for calibrators and controls). Elecsys 1010: First component: The three characters MBC. Second component: 586 digit MBC string; empty for empty channels. Only three characters ('MBC') should be added to the 586 digit MBC string (first three characters). In this case when Instrument or LSM receives a Test Application record and finds 'MBC' as the three first characters, it should handle the remaining 586 digits as if it had read a Matrix Bar code.
sequence number record type subID (TA)
2 3
pos_int text ^text ^text ^text TA ^BM Ê1 ^1
application data
char[3]^te xt
Table 4-54: Test Application Record
4-126
4.3.7.16 Test Conditions Record (Level 1)

1010* (upload only on query)
Data Type
Data content
Query
2010
Ref. TC
Field
Comments
BM.TC
char[1]
explicit accessible part of test processing (part of the application editable by the user) for setting up of default values Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version # Query: If there are no data an instrument sends all test conditions records to host. name, e.g., TSH actual used unit; in universal format as in Result record (user selected unit); other format as in application record in fixed point format; conversion factor = user selected unit divided by Roche default unit; empty if default unit is used. component field for definition of these replication factors; for setting of default value(s) samples controls calibrators Elecsys 1010: fixed to 1^1^2. default value for sample dilution for Elecsys 1010 only 2 limit (one range) are relevant: lower limit ûpper limit
pos_int text ^text ^text ^text TC ^BM Ê1 ^1
record type sub-ID 3 (TC)
test number test code unit name
4 5 6
int text unit
conversion factor
text
replication 8 number for samples/controls/c alibrators
int înt înt
1 ^1 ^3
auto-dilution reference No. reference range lower/upper limit
9 10
int int înt {\...}
test specific inventory thresholds automatic rerun rerun dilution reference No. batch calibration range check
11
text {\...}
12 13 14 15
char[1] int char[1] char[1]
A, X
A: X:
application, exclusion
dilution for automatic rerun Calibration before every batch Reference range defined or not
A, X A, X
Table 4-55: Test Conditions Record
4-127
4.3.7.17 Substance Data Record (Level 1)

Data Type
Data content
Query*
2010
1010
Ref. XT
Field
Comments
BM.XT
record type ID (M)
char[1]
general substance information used for: reagents, diluents, pretreatments, system reagents (AB/CC), calibrators, instrument calibrators, controls, waste Elecsys 1010: for TR, PR, DR: up- and download, for AB, CC, VS, DW, LW, RC, CS: upload but ignored on download. Elecsys 1010: for TR, PR, DR: up- and download, for AB, CC, VS, DW, LW, RC, CS: upload but ignored on download. Roche specific record identifier ^BM înstrument type abbreviation (E1 for Elecsys 2010, E2 for Elecsys 1010) ^version # Elecsys 1010: for TR, PR, DR: up- and download, for AB, CC, VS, DW, LW, RC, CS: upload but ignored on download. TR: DR: PR: BS: RC: CS: AB: CC: TP: VS: DW: LW: SW: Test Reagent, Diluent, Pretreatment, BlankCell, (not relevant for Elecsys 1010) Reagent Calibrator, Control Serum, Assay Buffer (ProCell), Cell Cleaner (CleanCell), Tip, (not relevant for Elecsys 1010) Cup, Distilled Water, Liquid Waste, Solid Waste, (not relevant for Elecsys 1010)
sequence number
pos_int
record type subID (XT)
XT ^BM Ê1 ^1
substance type
char[2]
TR, DR, PR, BS, RC, CS, AB, CC, TP, VS, DW, LW, SW
substance identifier
text
TR, PR: test #; DR: diluent #; CS: control # (empty for non Roche controls); AB, CC: ABCC1/ABCC2 Elecsys 1010: for TR, PR, DR: up- and download, for AB, CC, CS: upload but ignored on download. TR, PR: test name; DR: diluent name; CS: control name Elecsys 010: for TR, PR, DR, CS: upload but ignored on download. could be also a list of tests or "ALL" if substance is generally valid e.g. tips BC: MBC: MBCC: CH: empty: 1DBC, matrix bar code (2DBC), matrix bar code card, electronic chip, empty not relevant
substance name
text
test number(s) data carrier type
7 8
text {\...} text
BC, MBC, MBCC, (CH) RP, PV, SV, HV
container type
text
RP: reagent pack, PV: primary vial, SV: secondary vial, HV: hook on vial, empty: not relevant Elecsys 1010: for TR, PR, DR: upload but ignored on download.
4-128
Data Type
Data content
Query*
2010
1010
Ref. XT
Field
Comments
BM.XT
container cap type
10
text
SCE1
e.g. for decapping mechanism, SCE1-snap cap Elecsys 2010, empty: not relevant Elecsys 1010: for TR, PR, DR: upload but ignored on download. volume filled by Roche production, default unit: number of tests Unit Elecsys 1010: TR, PR: number of tests; DR: l; Units uploaded but ignored on receive . Elecsys: lot # of controls, calibrators, diluents, pretreatments, instrument calibrators (not for Elecsys 1010), test reagents, AB/CC (entered in inventory screen) Elecsys 1010: for TR, PR, DR: up- and download, for AB, CC, RC, CS: upload but ignored on download. e.g. individual bottle number, and/or individual package number (more containers) Elecsys 1010: for TR, PR, DR: up- and download. for calculation of the stability on board Elecsys 1010: for TR, PR, DR: upload but ignored on download. for calculation of the stability on board not relevant for the Elecsys 1010 stability on the instrument in days depends on production date. Format Elecsys 1010: YYYYMM00 Elecsys 1010: for TR, PR, DR, RC, CS: upload but ignored on download. for reagent packs: real liquid level, default unit: number of tests; for Tips and cups: real number of tips or cups in the rack; for AB/CC: percentage number; for LW: 0 for O.K. and 1 for full; or SW: percentage number; for DW: 0 for O.K. and 1 for empty Unit Elecsys 1010: TR, PR: number of tests; DR: Ml; AB, CC, DW, LW: percentage number; VS: number; Units uploaded but ignored on receipt. Elecsys 1010: for TR, PR, DR: up- and download, for AB, CC, VS, DW, SW: upload but ignored on download. = actual level - already planned test consumption, default unit: number of tests. Unit Elecsys 1010: see actual level Elecsys 1010: for TR, PR, DR: upload but ignored on download.
initial volume
11
int {ûnit}
substance lot number
12
int
container/packag 13 e number
int
container registration date & time container first opening/usage date & time stability on board expiring date
14
d_t
15
d_t
16 17
int d
actual level
18
int {ûnit}
available level
19
int {ûnit}
4-129
Data Type
Data content
Query*
2010
1010
Ref. XT
Field
Comments
BM.XT
container carrier 20 type
text
SRD, STAT,S D, RD, R1, TR, VR
SRD: sample and reagent disk, STAT: STAT sample, SD: sample disk, RD: reagent disk, R1: rack type 1, TR: tip rack, VR: cup rack; empty: not relevant Elecsys 1010: for TR, PR, DR, VS, DW, LW: upload but ignored on download. where the container is placed, e.g., disk No., rack No. (also for tips and cups) Elecsys 1010: Channel A to F are uploaded as Position 1 to 6 Elecsys 1010: for TR, PR, DR: upload but ignored on download. e.g. status of the channel: C: calibration required, R: removed item from this position, A: actualizing of the levels only, M: masked, N: new item (never seen before), X: exchanged item (new reagent container on this position) If calibration request has been generated, following two characters are added. '\C' Elecsys 1010: for TR, PR, DR: up- and download, for AB, CC, VS, DW, LW: upload but ignored on download.
container carrier 21 ID container position in carrier substance status 22
text text
23
char[1] {\...}
C, R, A (M), (N), (X),
Table 4-56: Substance Data Record
*Query only for Elecsys 2010
4-130
4.3.8 Error States and Error Recovery

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.
Line #
Record Type
Header Patient 1 Order 1 Result 1 Order 2 Order 3 Patient 2 Order 1 Comment 1 Result 1 Comment Result 2 Order 2 Patient 3 Order 1 Result 1 Message Terminator
(Level) Increment
(Level 0)+0 (Level 1)+1 (Level 2)+1 (Level 3)+1 (Level 2)-1 (Level 2)+0 (Level 1)-1 (Level 2)+1 (Level 3)+1 (Level 3)+0 (Level 4)+1 (Level 3)-1 (Level 2)-1 (Level 1)-1 (Level 2)+1 (Level 3)+1 (Level 0)-3
Action
{Save A-D} {Save E-F}
{Save G-K} {Save L} {Save M}
{Save N-P}
Table 4-57: Information Storage Requirements, Transmission Example
Note 1:
In this example, permanent storage of data, by the receiver, should occur at points; E, G, L, M, N, Q.
Note 2:
Q is assumed as saved by virtue of the record type function
If a transmission failure occurs, transmission will restart at the last logical record not presumed saved. 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 Table 4-57, the following record recovery examples would be valid:
4-131


Table 4-58: Error Recovery Requirements, Transmission Example
4-132
4.4
Application Layer
4.4.1 Message Priorities

Priority
High
Sending Order
1 2 3 4 5 6 7
Types of messages
Response (re-send) Response Report the received message situation (re-send) Report the received message situation Inquiry (re-send) Inquiry Upload (re-send) Upload
Low
8
Table 4-59: Message Priorities
4.4.2 Types of Messages
4.4.2.1 Test Order Message Purpose of this message: Instrument Query Host Answer
Purpose
Query after reading sample bar code (in case that Host answers positively) (Query Test order for specimens that have no Test order.) Query after completion of scanning of Sample Disk (in case that Host answers negatively) (Query Test order for specimens that have no Test order.)
Host
(M-2)
Instrument
(M-1)
(M-2)
(M-1)
Event:
Sample scanning The instrument queries for test requisitions for each sample that has no test requisitions using 1 message/ 1 sample. Host must answer these queries for each sample by a certain time while system begins to make schedule for the sample. Even if the Host answers these queries after the certain time out limit, the instrument accepts these responses. In this case, the instrument regards these responses as batch download (ignores these responses as answers to previous queries).
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Host Query Instrument Answer

Purpose
Query for Information of Test order (in case that Instrument answers positively) (Answer Information of Test Order that were requested from Host.)
Host
(M-1)
Instrument
(M-2)
Query for Information of Test order (in case that Instrument answers (M-1) negatively) (Answer negatively when there is no Information of Test Order that were requested from Host.)
(M-2)
Event:
The instrument receives a Test Order Message Query. The instrument answers the query (positively or negatively). Host queries for test selection information for a sample (or for some samples). The instrument always answers 1 message/1 sample even if Host queries for test selection information for some samples using one message.
Host Download
Purpose
Ordering of tests and canceling of tests (Order tests for specimens and cancel the tests.)
Host
(M-2)
Instrument
Event:
The instrument receives a Test Order Message. The instrument acts as following. - new registration for unknown sample. - overwriting known sample. Host downloads a Test Order Message for one sample (or for some samples).
Instrument Cancel Query

Purpose
Canceling of the previous Query (Cancel the previous Query because of time out.)
M-*: refer to "Construction of Message"
Host
Instrument
(M-1)
Construction of Message:
Pattern 1 Level
0 1 0 L
(M-1) Record
H Q
Pattern 2 Level
0 1 2 0
(M-2) Record
H P O L
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4.4.2.2 Result Message Purpose of this message: Host Query Instrument Answer
Purpose
Query for Information of Result (Final Result) (in case that Instrument answers positively) (Answer Information of Result that were requested from Host.) Query for Information of Result (Edited or Normal Result) (in case that Instrument answers positively) (Answer Information of Result that were requested from Host.) Query for Information of Result (in case that Instrument answers negatively) (Answer negatively in case that all results of this specimen have not been calculated yet.)
Host
(M-1)
Instrument
(M-2)
(M-1)
(M-2)
(M-1)
(M-3)
Event:
The instrument receives a Result Message Query. The instrument answers to the query. Host queries for result information for one sample.(or for some samples) The instrument always answers with 1 message/1 sample even if Host queries for result information for some samples using one message.
Instrument
Purpose
Host Upload
Host Instrument
(M-4)
Upload after all results of this specimen are calculated Upload after pressing <DOC> key on Results screen. (Upload Information of Result of this specimen.) Upload after Instrument Power on. (Upload Information of Result of this specimen.)
(M-2)
Event:
a) Automatic output of all the test results is generated (including No Value results) The instrument uploads a Result Message for this sample. Normal samples and Control samples are applied. This is done in automatic upload mode. b) Pressing <DOC> key on the Results Screen. The instrument uploads a Result Message for the sample that is displayed on the current screen. This is done even if all the test results are not yet generated. c) Turn on the power switch of the instrument. The instrument uploads messages for undocumented results of samples. The instrument uploads 1 message/1 sample.
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Pattern 1 Level
0 1 0 L
(M-1) Record
H Q
<< more than one query may occur >>
Pattern 2 Level
0 1 2 3 * 3 *
(M-2) Record
H P O R C R C : : : : } max. 60 results
<< 1 Message / 1 Sample >>
Pattern 3 Level
0 1 2 0
(M-3) Record
H P O L
Pattern 4 Level
0 1 2 3 * 4 4 3 * 4 4
(M-4) Record
H P O R C M-RR M-RC R C M-RR M-RC : : : : } max. 60 results
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4.4.2.3 Substance Data Message Purpose of this message: Instrument

Purpose
Upload after completion of scanning of the reagent disk (Test Reagent, Pretreatment, BlankCell) [(Upload Information of reagent packs that are on the reagent disk. (18 positions)] Upload after completion of scanning of the reagent disk (There is no reagent pack on this position.) [(Upload Information of reagent packs that are on the reagent disk. (18 positions)9 Upload after completion of scanning of the reagent disk (Diluent) [(Upload Information of reagent packs that are on the reagent disk. (18 positions)] Upload after completion of checking of liquid level of System Reagent [Upload Information of System Reagent reagent packs. (4 positions)] Upload after completion of scanning of tip and cup racks (Upload Information of Tips and Cups on the racks.) Upload constantly (Instrument Host) Upload when actual level becomes zero (Instrument (Upload Information of reagent packs) Upload when going to Stand-by status (Upload inventory Information with actual numbers.) Upload after manual input of reagent packs Information (Upload Information of reagent packs that are on the reagent disk.) Upload after occurring Solid Waste Full Alarm (Upload Information of solid waste.) Upload after reset Solid Waste Counter (Upload Information of solid waste.) Host) (M-3) (M-1) (M-1) (M-1)
Host Upload
Host Instrument
(M-4)
(M-4)
(M-5)
(M-1) (M-1) (M-1)
Event:
a) Scan of reagent disk The instrument uploads Substance Data Messages for the reagent packs on the reagent disk. The following reagent packs are applied. - Test Reagent, Pretreatment, Diluent, BlankCell The instrument uploads 1 message/18 positions. b) Liquid level check of the system reagents (PC/CC). The instrument uploads Substance Data Messages for system reagent packs. The instrument uploads 4 messages for PC1, CC1, PC2 and CC2. c) Scan tip and vessel magazines The instrument uploads Substance Data Messages for tips and cups. The instrument uploads 1 messages for tips and cups. d) Upload constantly during an operation The instrument uploads Substance Data Messages constantly with a certain step distance. Following substances are applied. - Test Reagent, Pretreatment, Diluent, BlankCell, System Reagent (PC/CC) - Tips & Cups, Distilled Water, Liquid Waste The instrument uploads 1 message/1 substance. e) Upload if liquid level is zero during an operation The instrument uploads Substance Data Messages of reagent packs for which the liquid level became zero.
4-137
Following reagent packs are applied. - Test Reagent, Pretreatment, Diluent, BlankCell, System Reagent (PC/CC) The instrument uploads 1 message/1 reagent pack. f) Going to Stand-by status after executing something functions. The instrument uploads Substance Data Messages Following substances are applied. - Test Reagent, Pretreatment, Diluent, BlankCell, System Reagent (PC/CC) - Tips & Cups, Distilled Water, Liquid Waste g) Manual input of a reagent pack No. on inventory screen The instrument uploads information for the reagent pack. h) Occurrence of Solid Waste Full alarm The instrument uploads information for solid waste. Host Query Instrument Answer
Purpose
Query for Information of reagent packs that are on the reagent disk (Test Reagent, Pretreatment, BlankCell) (Answer Information of reagent pack on the reagent disk position that was requested from Host. Answer parameter Information also for Diluent reagent pack.) Query for Information of reagent packs that are on the reagent disk (Diluent) (Answer Information of reagent pack on the reagent disk position that was requested from Host. Answer parameter Information also for Diluent reagent pack.) Query for Information of reagent packs that are on the reagent disk (There is no reagent pack on this position.) (Answer Information of reagent pack on the reagent disk position that was requested from Host. Answer parameter Information also Diluent reagent pack.) Query for Information of System reagent reagent packs (Answer actual level of each substances at this time.) Query for Information of Distilled Water, Liquid and Solid Waste (Answer actual level of each substances at this time.) Query for Information of Tips and Cups (Answer actual level of each substances at this time.)
Host
(M-1)
Instrument
(M-1)
(M-1)
(M-2)
(M-1)
(M-1)
(M-1) (M-1) (M-1)
(M-1) (M-1) (M-1)
Event:
The instrument receives a Substance Message Query The instrument answers to the Host Host queries for Substance Data information for a specific substance (or for some substances). The instrument always answers with 1 message/1 substance.
Host Download
Purpose
Download Information of reagent packs (actual level) (Test Reagent, Pretreatment, BlankCell, Diluent) *1)
M-*: *1) refer to "Construction of Message" Download only actual level of each substance. Downloading actual level of following substances not available. system reagent ... (actual level is set by checking liquid level) Distilled Water, Liquid Waste ... (actual level is set by detector) Tips, Cups ... (actual level is set by mechanical scanning)
Host
(M-1)
Instrument
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Event:
The instrument receives a Substance Data Message. The instrument overwrites information of the specific substance data. Host downloads 1 message/1 substance (or 1 message/some substances). If the Substance Data that was sent from Host is for a substance that the instrument does not know, then these data are not valid (will be ignored).
Pattern 1 Level
0 1 0 L
(M-1) Record
H M-XT
Pattern 2 Level
0 1 2
(M-2) Record
H M-XT M-DP : : } max. 40 records
Pattern 3 Level
0 1
(M-3) Record
H M-XT ...: ...: Reagent pack information for reagent packs on a reagent disk *) In case of a diluent reagent pack the parameter information record (M-DP) is added.
0 0 1 1 0 0 1 1 1 1 0 0 1 1 0
L H M-XT M-XT L H M-XT M-XT M-XT M-XT L H M-XT M-XT L Distilled Water information Liquid Waste information System reagent information (Pos 2) System reagent information (Pos 1) Tip information Cup information
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Pattern 4 Level
0 1
(M-4) Record
H M-XT ...: ...: Reagent pack information
Pattern 5 Level
0 1 2
(M-5) Record
H M-XT M-DP : : ...: ...: } max. 40 records } Reagent pack information
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4.4.2.4 Calibrator Parameters Message Purpose of this message: Upload Instrument

Purpose
Upload after completion of scanning of the Bar code Card. (Upload information of Bar code Card.)
Host
Host Instrument
(M-1)
Event:
Scan bar code card of a calibrator. The instrument uploads a Calibrator Parameters Message for the bar code card. The instrument uploads 1 message/1 calibrator bar code card.

Purpose
Query for information of Calibrator Parameters (Answer information of Calibrator Parameters that were requested from Host.)
Host
(M-2)
Instrument
(M-1)
Event:
The instrument receives a Calibrator Parameters Message Query. -----> The instrument answers to the query. The Host queries for Calibrator Parameters information for one test (or some test). The instrument always answers with 1 message/1 test. Instrument
Host
(M-2)
Download Host
Purpose
Instrument
Download Information of Calibrator Parameters (Download only target value of each Calibrator Parameters.) (If an instrument has never seen the Calibrator Parameters before, the downloading becomes invalid.)
Event:
The instrument receives a Calibrator Parameters Message. The instrument overwrites information of the calibrator parameter. The Host downloads 1 message/1 test (or 1 message/ some tests). If the calibrator parameters that were sent from Host are data that the instrument does not know, then these data are not valid (will be ignored).
Pattern 1 Level
0 1 2
(M-1) Record
H M-XT M-CP : : }max. 25 records
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Pattern 2 Level
0 1 2 0
(M-2) Record
H M-XT M-CP L
4.4.2.5 Control Parameters Message Purpose of this message: Instrument

Purpose
Upload after completion of scanning of the Bar code Card (Upload Information of Bar code Card.)
Host Upload
Host Instrument
(M-1)
Event:
Scan bar-code card for a control. The instrument uploads a Control Parameters Message of the bar code card. The instrument uploads 1 message/1 control bar-code card.

Purpose
Query for Information of Control Parameters (Answer Information of Control Parameters that were requested from Host.)
Host
(M-2)
Instrument
(M-3)
Event:
The instrument receives a Control Parameters Message Query. The instrument answers to the query. The Host queries for Control Parameters information for one (or some) control No. The instrument always answers 1 message/1 control No.
Host Download
Purpose
Download Information of Control Parameters (Download only target value/unit and target range of each Control Parameters.) (If an Instrument has never seen the Control Parameters before, the downloading becomes invalid.)
M-*: refer to Construction of Message
Host
(M-2)
Instrument
Event:
The instrument receives a Control Parameters Message. The instrument overwrites the information of Control Parameters. The Host downloads 1 message/1 control (or 1 message/ some controls). A control is identified by control No. and control lot ID. If the Control Parameters that were sent from the Host are data that the instrument does not now, then these data are not valid (will be ignored).
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Pattern 1 Level
0 1 2
(M-1) Record
H M-XT M-QP : : } max. 28 records
Pattern 2 Level
0 1 2 0
(M-2) Record
H M-XT M-QP L
Pattern 3 Level
0 1 2
(M-3) Record
H M-XT M-QP : : } max. 25 records } max. 5 pairs
M-XT : :
4.4.2.6 Calibration Data Message Purpose of this message: Instrument

Purpose
Upload after completion of Lot Calibration (Upload Information of Result of Lot Calibration.) Upload after completion of Reagent Pack Calibration (Upload Information of Result of Reagent Pack Calibration.) Upload after completion of BlankCell (Upload Information of Result of BlankCell.) Upload after releasing Calibration data (Upload Information of Result of Reagent Pack or Lot Calibration.)
Host Upload
Host Instrument
(M-1) (M-1) (M-1) (M-1)
Event:
Output the measured calibration results of the test. The instrument uploads a Calibration Result Message of this test. The instrument uploads 1 message/1 test.
4-143
Pattern 1 Level
0 1 0 L
(M-1) Record
H M-CR
Purpose to use this message: Host Query Instrument Answer

Purpose
Query for Information of Sample Status on the Sample Disk (Answer Information of Sample Status on the Sample Disk that was requested from Host.)
Host
(M-1)
Instrument
(M-1)
Event:
The instrument receives a Sample Status Message Query. The instrument answers to the query. The Host queries for Sample Status information for one (or some) position on the sample disk. The instrument always answers 1 message/1 position.
Pattern 4 Level
0 1 0 L
(M-4) Record
H M-SS
Note: There are no result queries (for patient data or calibration data) for Elecsys 1010.
4.4.2.7 Instrument Status Message Purpose of this message: Host Query Instrument Answer
Purpose
Query for Information of instrument status and alarm level (Answer Information of instrument status and alarm level.)
Host
(M-1)
Instrument
(M-1)
Event:
The instrument receives a Instrument Status Message Query. -----> The instrument answers the query. Host Upload
Host Instrument
(M-1)
Instrument
Purpose
Upload when an instrument status changes (Upload Information of instrument status and alarm level.)
4-144
Event:
Change of instrument status The instrument uploads information for instrument status.
Pattern 1 Level
0 1 0 L
(M-1) Record
H M-IS
4.4.2.8 Log File Message Purpose of this message: Host Query Instrument Answer
Purpose
Query for Information of Log File (Answer information of Log File within time range that was requested from Host.)
Host
(M-1)
Instrument
(M-1)
Event:
The instrument receives a Log File Message Query. The instrument answers the query.
4-145
Pattern 1 Level
0 1 0 L
(M-1) Record
H M-LF
4.4.2.9 Test Conditions Message Purpose of this message: Instrument

Purpose
Upload when press <close> button after editing data at a Test Conditions Screen (Upload Information of Test Conditions)
Host Upload
Host Instrument
(M-1)
Event:
Edit data of test condition on the test condition screen and update the data base by pressing Close button. The instrument uploads a Test Conditions Message for the test that is displayed on the current screen.

Purpose
Query for Information of Test Conditions (Answer Information of Test Conditions that were requested from Host.)
Host
(M-1)
Instrument
(M-1)
Event:
The instrument receives a Test Conditions Message Query. The instrument answers to the query. The Host queries for Test Conditions information for one (or some) test. The instrument always answers with 1 message/1 test.
Host Download
Purpose
Download Information of Test Conditions (Download only reference range lower/upper limit of each Test Conditions Information. If an instrument has never seen the Test Conditions information before, the downloading becomes invalid.)
Host
(M-1)
Instrument
Event:
The instrument receives a Test Conditions Message The instrument overwrites the information of the Test Conditions. The Host downloads a message of Test Conditions for one (or some) test. If the Test Conditions that were sent from the Host are data for a test that the instrument does not know, then these data are not valid (will be ignored).
4-146
Pattern 4 Level
0 1 0 L
(M-4) Record
H M-TC
4.4.2.10 Test Application Message Purpose of this message: Instrument

Purpose
Upload after executing C. Scan [(Upload MBCC Information (586digits)] Upload after executing R. Scan [(Upload MBC Information (586digits)]
Host Upload
Host Instrument
(M-1) (M-2)
Event:
a) Reagent disk scan The instrument uploads MBC information (586 digits) of the reagent packs on the reagent disk. The instrument uploads 1message/18 positions. b) Calibrator/control bar code card scan. The instrument uploads MBCC information (586 digits) of this bar code card. The instrument uploads 1 message/1 calibrator (or control) bar code card.
Pattern 1 Level
0 1 0
(M-1) Record
H M-TA L
Pattern 1 Level
0 1
(M-2) Record
H M-TA : :
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4.4.2.11 Instrument Configuration Message Purpose of this message: Host Query Instrument Answer
Purpose
Query for Information of Instrument Configuration (Answer Information of Instrument Configurations that were requested from Host.)
Host
(M-1)
Instrument
(M-1)
Event:
The instrument receives an Instrument Configuration Message Query. The instrument answers to the query.
Host Download
Purpose
Download Information of Instrument Configuration (printing option, uploading option, sending additional data) (Download only printing option, uploading option, and sending additional data and system clock.)
Host
(M-1)
Instrument
Event:
The instrument receives an Instrument Configuration Message. The instrument overwrites the information of the instrument configuration. Host Upload
Host Instrument
(M-1)
Instrument
Purpose
Upload Information of Instrument Configuration when they are changed (printing option, uploading option, system clock) (Upload Information of Instrument Configurations.)
Event:
Change of instrument configuration The instrument uploads data of the instrument configuration.
Pattern 1 Level
0 1 0 L
(M-1) Record
H M-IC
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4.4.2.12 Service Data Message Purpose of this message: Instrument

Purpose
Upload when an instrument detects Clot Detection (Upload pressure sensor values.) Upload when ADC module works (Upload ADC Raw Data.)
Host Upload
Host Instrument
(M-1) (M-1)
Event:
The instrument receives a Service Data Message Query. The instrument answers to the query.

Purpose
Query for information of Service Data (Answer information of Service Data that was requested from Host.)
Host
(M-1)
Instrument
(M-1)
Event:
a) Clot detection in operation The instrument uploads pressure sensor values. b) ADC module works in operation The instrument uploads the ADC raw data.
Pattern 1 Level
0 1 0 L
(M-1) Record
H M-SD
4.4.2.13 Processing Message Purpose of this message: Instrument

Purpose
Upload after generating alarm message (Upload Information of alarms that were generated.)
Host Upload
Host Instrument
(M-1)
Event:
An alarm or some alarms are generated in the instrument. The instrument uploads one ore more Processing Messages. The instrument uploads 1 message/1 alarm.
4-149
Pattern 1 Level
0 1 0 L
(M-1) Record
H M-PM
4.4.2.14 Action Request / Action Confirmation Message Purpose of this message: Host Request Instrument Confirmation
Purpose
Request START/STOP Upload confirmation record response to an action request that was requested by Host.
M-* : refer to "Construction of Message"
Host
(M-1)
Instrument
(M-2)
Event:
The instrument receives an Action Request Message (Start/Stop) The instrument uploads Confirmation Message in response to the Action Request message.
Pattern 1 Level
0 1 0 L
(M-1) Record
H M-AR
Pattern 2 Level
0 1 0
(M-2) Record
H M-AC L
Note: Not used for Elecsys 1010.
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4.4.3 Trigger events (Overview)

If the transmission of Upload Messages is asynchronous, i.e. it is not requested by an Inquiry of the Host it is triggered by events: Substance data: After executing the reagent disk scanning, the instrument uploads the changed information from the reagent pack information of the reagent disk. The reagent pack information is uploaded one-by-one. After carrying out the system reagent level checking, the instrument uploads the system reagent information. (This is performed in parallel when executing the reagent disk scanning.) Whenever each reagent on the reagent disk is pipetted five times, the instrument uploads the reagent pack information. When the calibration is requested (Prio 1, Prio 2), the instrument uploads the reagent pack information necessary for the calibration. When the remaining reagent volume becomes "0", the instrument uploads the reagent pack information. Measured data: When all the measured data of normal and control samples are output, the instrument uploads the data under the condition that "auto upload' is requested on the DOCUMENTATION SETUP screen. When pressing the DOC key on the RESULTS screen, the instrument uploads the measured data. After turning on the power switch, the instrument is in stand-by. The instrument uploads all the remaining measured data which have not been uploaded before. Calibration results: When outputting the calibration data, the instrument uploads the valid calibration data and the calibration curves. When touching the "Release" key on the CALIBRATION DATA screen, the instrument uploads the applicable calibration data and the calibration curve. After turning on the power switch, the instrument is in stand-by. The instrument uploads all the remaining calibration data which have not been uploaded before. Alarm information: When the instrument alarm is issued, the instrument uploads the alarm information.
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Test conditions: When pressing the DOC key on the TEST CONDITIONS screen, the instrument uploads the test conditions information.

normal There is response data. There is no response data. Not all data in records are in accordance with the rules. (Improper message error) abnormal Receive error Hardware error Application error All data in records are not as ruled. (Improper message error) Message refusal Receive error (*) Hardware error (*) Application error (*) The last record is not the Termination record. Improper message error Receive error Hardware error Application error (*)
Termination code
F I Q E no message
Inquiry
normal
Response & Download
abnormal
Invalid attribution
abnormal
* : The instrument reflects the valid record data on the data base. Table 4-60: Termination Codes to different Error States
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The following table summarizes the reaction of the Instrument to different messages received during the possible states of analyzing process. A cross indicates that the Data Base cannot be updated with the received data during that specific operation status:
Prepare for operation
Operation
Received message
Stand-by
Initialize
S. Scan (restart)
R. Scan
S. Scan
S. Stop
P. Stop
E. Stop

Test selection information Request cancel Substance data Calibration parameters Control parameters Diluent parameters Test conditions Application data
* (
Instrument configuration
*: Although the instrument reflects the test selection information of the sample which status is under pipetting or after pipetting on the data base, the analysis is not affected by the T/S information. This T/S information is used when the sample disk is scanned at the next time. Table 4-61: Ability to Renew Data Base
Alarm Name
Communication re-sending occurred Communication re-sending failed Communication message acceptance error Communication application error Communication message format illegal error
Contents
When sending a message, re-sending the message occurred Re-sending a message failed Impossible to renew the data base using the message. Application error happened. 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 which did not meet the rule Re-sending a message failed at the low level Time out happened at the lower level Time out happened at the lower level Hardware error happened. Sending a message was aborted Receiving a message is aborted
Table 4-62: List of Alarm Conditions
Cause of Alarm
Re-sending a message succeeded
Source Layer
Application
Re-sending a message failed Application Picked up the message acceptance error. Picked up the application error. The last record was not the Termination record Picked up the improper message errors. Application Application Presentation
Communication sending error Communication sending error Communication receiving error Communication device error Communication sending message aborted Communication receiving message aborted
Picked up sending error Picked up sending error Picked up receiving error Picked up the hardware error. Received the Termination code = R Received the Termination code = T
Data Link Data Link Data Link Physical Any, from Host (Presentation) Any, from Host (Presentation)
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Sleep
Stop
T/M
4.5
Test Selection via Specific Test Number

To request a test at the Elecsys 2010 via host the Roche Diagnostics test number must be used. This number is an unique identifier in the range 1-999 for Roche Diagnostics assays and cannot be changed. Usually, you can get the specific test number from the application sheets. If the host wants to get the relation between the application name and the Roche Diagnostics test number an easy way is to request the instrument's test conditions (MTC record) and create a cross reference automatically (test number BM.TC.04 via test code BM.TC.05; 4.3.7.16). Another possibility is that the host analyzes the data of a reagent scan and builds the cross reference from these data (records with substance type BM.XT.04 = TR; substance identifier BM.XT.05 via substance name BM.XT.06; see 6).
4.5.1 Get Test Numbers from Test Condition Message:

Host sends Test Condition Query to the instrument:
H|\^&|||ASTM-Host M|1|TCQ^BMÊ1^1|||||||||||| L|1|N
Instrument sends back tests available:

H|\^& M|1|TC^BMÊ1^1|10|TSH|uIU/ml||1^1^2||0.230^3.80|| M|2|TC^BMÊ1^1|20|T4|nmol/l||1^1^2||58.80^151.0|| M|3|TC^BMÊ1^1|170|HCG|mIU/ml||1^1^2||10.00^10000|| M|4|TC^BMÊ1^1|300|CEA|ng/ml||1^1^2||0.000^4.60|| L|1|F
The following cross reference list can be built out of this information:
Test Number
10 20 170 300
Test Code
TSH T4 HCG CEA
Unit
IU/ml nmol/l mIU/ml ng/ml
Reference Range lower limit

0.230 58.80 10.00 0.000
upper limit
3.80 151.0 10000 4.60
Table 4-63: Cross reference list test code and test number
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Tables
5
5.1
Tables
Assay Reference Table Version 1.48
test No. = xx g
g : one character generation code; host should ignore on receipt xx : two-character test code
ref. Range: * = check in package insert
Useful information on generation handling on Elecsys 1010 and host: 1. 2. Use a host that ignores the last number (generation code, g). If this is not possible and if orders are performed manually on Elecsys 1010, set the test number such that it corresponds to the first generation in the host. 3. If orders are not performed manually on Elecsys 1010, the test numbers (including the generation code) must the same on both sides (what is recognized by the bar code reader on Elecsys and in the host).
5-155
Tables
test test code No.
unit 1
unit 2
unit 3
conv. factor unit 1 to unit 2

1.0000+0
conv. ref. no. factor to result unit 1 to msg unit 3 1 2 3
Measuring range
Reference range
0.27-4.20 U/ml
010 011 012 020 021 022 030 031 032 040 041 042 050 051 052 060 061 062 100 101 110 111 120 121 130 131 140 141 150 151 160 161 170 171 172 180 181 182 200 201 202 210 211 212 220 221 222 230 231 232 240 241 250 251
TSH
IU/ml
mlU/l
0.005-100 U/ml
T4
nmol/l
g/dl
g/l
7.7688-2
7.7688-1
3-320 nmol/l 0.23-24.86 g/dl 0.3-100 pmol/l 0.023-7.77 ng/dl 0.2-1.9 TBI
66.0-174 nmol/l 5.10-13.5 g/dl 13.0-23.0 pmol/l 1.01-1.79 ng/ml 0.8-1.3 TBI
FT4
pmol/l
ng/dl
ng/l
7.7688-2
7.7688-1
T-UP
TBI
T3
nmol/l
ng/ml
ng/dl
6.5100-1
6.5100+1
0.3-10 nmol/l 0.195-6.51 ng/ml 0.40-50.0 pmol/l 0.26-32.55 pg/ml 36.7-16882 pmol/l 10-4600 pg/ml 0.069-52 nmol/l 0.02-15 ng/ml 0.48-318 nmol/l 0.15-100 ng/ml 10-10000 IU/ml 0.472-472 ng/ml 0.1-200 mIU/ml 0.1-200 mIU/ml
1.30-3.10 nmol/l 0.85-2.00 ng/ml 4.00-7.80 pmol/l 2.60-5.10 pg/ml * * * * * *
FT3
pmol/l
pg/ml
ng/dl
6.5100-1
6.5100-2
E2 TESTO PROG PRL LH FSH CORT HCGSTAT
pg/ml ng/ml ng/ml U/ml
pmol/l nmol/l nmol/l ng/ml
ng/l g/l g/l mIU/l
3.6700+0 3.4700+0 3.1800+0 4.7000-2 1.0000+0 1.0000+0
1.0000+0 1.0000+0 1.0000+0 1.0000+0
mIU/ml IU/l mIU/ml IU/l nmol/l g/dl g/l
3.6250-2 1.0000+0
3.6250-1 0.5-10000 mU/ml *
mIU/ml IU/l
HCG
mIU/ml IU/l
1.0000+0
0.5-10000 mU/ml
TNTSTAT
ng/ml
g/l
1.0000+0
0.01-25 ng/ml
0-0.10 ng/ml
CKMBSTAT
ng/ml
g/l
1.0000+0
0.15-500 ng/ml
0-5.0 ng/ml
TN-T
ng/ml
g/l
1.0000+0
0.01-25 ng/ml
0-0.10 ng/ml
CK-MB
ng/ml
g/l
1.0000+0
0.15-500 ng/ml
0-5.0 ng/ml
MYO MYO-STAT
ng/ml ng/ml
g/l g/l
1.0000+0 1.0000+0
5-156
Tables
test test code No.
unit 1
unit 2
unit 3

1.0000+0
conv. ref. no. factor to result unit 1 to msg unit 3 1 2 3
Measuring range
Reference range
300 301 310 311 320 321 330 331 340 341 350 351 360 361 370 371 380 381 390 391 400 401 410 411 420 421 430 431 440 441 450 451 460 461 470 471 480 481 490 491 500 501 510 511 520 521 530 531 540 541 550 551
CEA AFP PSA CA 15-3 CA 125 CA 19-9 CA 72-4 CYFRA FERR FPSA HBSAG A-HBS A-HCV A-HBE HBEAG A-HBC A-HBCIGM A-HAV A-HAVIGM A-HIV HIVAG APS4 A-TOXIGG A-TOXIGM A-RUBIGG A-RUBIGM
ng/ml U/ml ng/ml U/ml U/ml U/ml U/ml ng/ml ng/ml ng/ml COI IU/l COI COI COI COI COI IU/l COI COI COI COI IU/ml COI IU/ml COI
g/l ng/ml g/l kU/I kU/I kU/I kU/I g/I g/l g/l kIU/l
0.2-1000 ng/ml 1.0000+0 0.5-1000 U/ml 0.604-1210 ng/ml 0.01-100 ng/ml
0-4.6 ng/ml 0-5.1 U/ml 0-6.2 ng/ml age dependent
1.2100+0 1.0000+0 1.0000+0 1.0000+0 1.0000+0 1.0000+0 1.0000+0 1.0000+0 1.0000+0
0.600-5000 U/ml
0-35 U/ml
0.01-50.00 ng/ml 0 1 0
0 0 0 0 0
1 1 1 1 1
0 0 0 0 0
0 0 ng/l 1.0000+0 0 0 kIU/l 1.0000+0 0 kIU/l 1.0000+0 0
1 1 1 1
0 0 2 0
5-157
Tables
test test code No.
unit 1
unit 2
unit 3
conv. ref. no. factor to result unit 1 to msg unit 3 1 2

1 1 1
Measuring range
Reference range
3
0 0 0
560 561 570 571 580 581 600 601 610 611 620 621 630 631 640 641 650 651 660 661 670 671 680 681 690 691 700 701 710 711 720 721 730 731 740 741 750 751 760 761 770 771
HIVCOM A-HGVENV A-HELICO B12 FOL DIG IGE HBA1C INSULIN OSTEOC CROSSL PTH CYCLO-A TG A-TG A-TPO A-TSHR DHEA-S SHBG HCG-BETA NSE
COI COI COI pg/ml ng/ml ng/ml IU/ml % U/ml ng/ml ng/ml pg/ml ng/ml ng/ml IU/ml IU/ml U/ml g/dl g/ml g/l kIU/l kIU/l kUI/l mol/l nmol/l 1.0000+0 1.0000+0 1.0000+0 1.0000+0 2.7000-2 3.4700+1 1.0000+0 pmol/l g/l pg/ml pmol/l pmol/l 6.9450+0 1.0000+0 1.0000+3 1.0600-1 5.102+2 pmol/l nmol/l nmol/l ng/ml kIU/l 7.3800-1 2.2700+0 1.2800+0 2.4000+0 1.0000+0
0 0 0
mIU/ml IU/l g/l
Table 5-1: Assay Reference Table
Note:
In the future this table will be language specific.
5-158
Tables
5.2
Auto Dilution Reference Table

Elecsys 2010 and 1010 have the possibility of diluting samples when required. This dilution ratio is defined within the universal test ID found in the Test Order Record O (9.4.5), Result Record R (10.1.3) and the Request Information Record Q (12.1.5). The field universal test ID has the following components: universal test ID ûniversal test name ûniversal test ID type ^manufacturer defined test code (see RD Assay Reference Number) âuto dilution factor (see Reference No. in the following table)
5.2.1 General Specification:

Ref. No.
0 ... 15
Ratio
1 ... 1000 (integer)
5.2.2 Detailed Specification

Ref. No. Ratio Pipetting Volumes 1st dilution sample [volume]
0 1 2 3 5 7 9 1 2 5 10 20 50 100 50 l 40 l 20 l 20 l 20 l 20 l 50 l 160 l 180 l 180 l 180 l 180 l
2nd dilution diluent [volume] diluted sample [volume]

no sample dilution 100 l 40 l 20 l 100 l 160 l 180 l
diluent [volume]
Table 5-2: Auto Dilution Ratio Reference Table
Note:
Ratio X is equal to dilution 1 : X or 1 + ( X - 1 ); e. g.: (ration 20) = 1:20 = 1+19. If Ref. No. = 0 (ratio = 1) then no sample dilution is required by the test application.
5-159
Tables
5.3
Data Alarm
no alarm
Alarm Flags Elecsys 2010

Flag
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 6 6 8 S B R 6 6 6 7 7 7 7 7 7 ------------ ------ ------A premature LLD signal was detected during sample pipetting. A premature LLD signal was detected during reagent pipetting. A premature LLD signal was detected during diluent pipetting. ------------Internal calculation error occurred. No valid calibration data are available. Previous calibration data are used for result calculation. 1 2 3 4 4 5 6 6 6 6
Level
Result
---
System Block
Explanation
No flag is attached to the result. Test cancelled due to power failure or power off. Test cancelled due to E. Stop. Test cancelled due to Stop. Test cancelled due to P. Stop, A. Stop or L. Stop. Sampling is stopped due to S. Stop. Test cancelled due to error recovery process. The sample volume is insufficient. The assay reagent volume is insufficient. The diluent volume is insufficient. The pretreatment reagent volume is insufficient.
Power failure-operation stopped E. Stop-operation stopped Stop-operation stopped P. Stop/A. Stop-operation stopped S. Stop-operation stopped Error handling-operation stopped Sample short Assay reagent short Diluent short Pretreatment reagent short <Reserved> Reagent disk temperature out of range Incubator temperature out of range Measuring cell temperature out of range PC/CC temperature out of range PC/CC short ADC data abnormal <Reserved> <Reserved> <Reserved> <Reserved> <Reserved> <Reserved> Calculation error No calibration data Previous calibration used System blocked User blocked User released Premature LLD signal-Sample Premature LLD signal-R. Disk Premature LLD signal-R. Disk
-- Reagent disk temperature is out of range. Incubator temperature is out of range. Measuring cell temperature is out of range. ProCell/CleanCell temperature is out of range. ProCell/CleanCell volume is insufficient. Analog to digital converter data (ADC) is abnormal.
5-160
Tables
Data Alarm
Premature LLD signal-R. Disk <Reserved> Assay reagent bubble detected Diluent bubble detected Pretreatment bubble detected PC/CC bubble detected <Reserved> PC level out of range PC level check failed Measuring cell current out of range
Flag
33 34 35 36 37 38 39 40 41 42
Level
6
Result
---
System Block
Explanation
A premature LLD signal was detected during pretreatment reagent pipetting.
--A bubble was detected during reagent pipetting. A bubble was detected during diluent pipetting. A bubble was detected during pretreatment pipetting. -- During run preparation, the ProCell count level was out of range. ProCell signal level check failed. The measuring cell current was out of range when checked during run preparation. The measuring cell current check failed. PC/CC temperature was unstable. Either the sample volume was insufficient or a clot was detected during sample pipetting. Carryover from the previous sample may have occurred. The sample ID that was scanned just prior to pipetting is different from the ID scanned during the sample scan. The sample concentration was below the lower limit of the expected values. The sample concentration was above the upper limit of the expected values. The sample concentration was below the lower limit of the measuring (reportable) range. The sample concentration was above the upper limit of the measuring (reportable) range. An expired reagent pack was used for the determination. A bubble was detected during PC/CC pipetting.
6 6 6
-----
6 6 6
Measuring cell current check failed PC/CC temperature unstable Abnormal aspiration
43 44 45
6 6 6
Potential carryover Bar code sample ID error
46 47
6 6
Below expected value range Above expected value range Below measuring range
48 49 50
6 6 6
Above measuring range
51
Expired reagent pack
52
Table 5-3: List of Alarm Flags for Elecsys 2010
5-161
Tables
5.4
Alarm Flags Elecsys 1010

For other alarm codes and alarm messages of Elecsys 1010 please refer to the Operator's Manual.
Message
Description
Level
Possible Causes
Remedy
Result Value N/A
0060
Host / LSM Interface: OEM master - host Host / LSM interface does not answer to enquire, acknowledge, not acknowledge OEM master - host Gaps in Host interface / LSM message OEM master - host Checksum interface error in Host / LSM message
1..5: W 6: E
0061 0062
E 1..5: W 6: E
0063
OEM master - host Checksum interface error in Instrument message frame
0070
OEM master - host LSM interface response with termination code E OEM master - host LSM query interface response with termination code Q OEM master - host interface OEM master - host interface Record not implemented Query not implemented
0071
0072 0073
E E
0074
OEM master - host Syntax error interface in ASTM record
a. Switch analyzer off/on b. Check HOST ready c. Check HOST connection cable d. Check interface settings (UTILITIES -> 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 its Support contents is not in accordance with the Host/LSM interface specification.
Host / LSM; cable PC9; cable to Host / LSM; PCB OEM master
N/A N/A
N/A
N/A
N/A
N/A N/A
N/A
5-162
Tables
Message
Description
Level
Possible Causes
Remedy
Result Value N/A
0080
Host / LSM Interface: OEM master - host Sample / interface control memory full
No memory available in database for requested sample/control.
0081
OEM master - host Sample / interface control order memory full
0082
OEM master - host Position is interface occupied by pending sample 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 OEM master - host Control not interface useable for required test
0083 0084
E E
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 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 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
N/A
N/A N/A
0085
N/A
0086
N/A
0087
OEM master - host Dilution not interface available for requested test
0088
0089
0090
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
Host/LSM tried to send instrument configuration data during operation Download of reagent substance data after run initialization.
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 a. Call Technical Support
N/A
N/A
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
5-163
Examples
6
6.1
Examples
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 [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]
ELEC HOST ELEC HOST
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 [ENQ] [ACK] [STX]1H|\^&||||||||||P[CR][ETX]0D[CR][LF]
6-165
Examples
ELEC HOST ELEC HOST
ELEC HOST ELEC HOST
[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 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]
ELEC HOST ELEC HOST
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 [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]
6-166
Examples
ELEC HOST ELEC
[STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]

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]
ELEC HOST ELEC HOST
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 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]
ELEC HOST ELEC HOST
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).
6-167
Examples
ELEC HOST ELEC HOST ELEC
[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 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]
ELEC HOST ELEC HOST
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 [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]
ELEC HOST ELEC HOST
6-168
Examples
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 [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]
ELEC HOST
ELEC
6-169
Examples
HOST
ELEC HOST
ELEC HOST ELEC HOST
[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] <EOT>
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 [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]
HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
6-170
Examples
Instrument sends results for control PC U1 (In that example Raw Results are switched on.):
ELEC HOST ELEC HOST ELEC HOST ELEC [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^BMÊ1^1||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^BMÊ1^1|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]
HOST ELEC HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC HOST ELEC HOST
6-171
Examples
ELEC .. .. ELEC HOST ELEC HOST ELEC HOST ELEC .. .. ELEC HOST ELEC HOST ELEC HOST ELEC .. .. ELEC HOST ELEC HOST ELEC HOST ELEC
[STX]5M|1|RR^BMÊ1^1||13104\13200\13457\13463\1 3195\13161\.....
[STX]2321\35302\35259|196679[CR][ETX]57[CR][LF] [ACK] [STX]3M|1|RC^BMÊ1^1|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^BMÊ1^1||14010\14245\13863\13399\1 3671\13047\.....
[STX]2592\38558\38544|457109[CR][ETX]65[CR][LF] [ACK] [STX]3M|1|RC^BMÊ1^1|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^BMÊ1^1||13277\13330\13316\13684\1 3247\13300\.....
[STX]2033\28004\28064|28403[CR][ETX]0F[CR][LF] [ACK] [STX]3M|1|RC^BMÊ1^1|30|FT4|192882|1228|1|19059 9||[CR][ETX]2C[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT]
6-172
Examples
6.2
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|Assayreagentshort|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]

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||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|Assayreagentshort|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]
6-173
Examples
HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[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]

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|Assayreagentshort|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]

ELEC HOST ELEC HOST ELEC HOST ELEC [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]
6-174
Examples
HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[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|Assayreagentshort|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|Concentrationoutofexpectedvaluera 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|Lowsamplesignal|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 [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]
6-175
Examples
HOST
[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^BMÊ1^1|19960613114441|863^0|Interfac eacceptanceerror: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^BMÊ1^1|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 [ENQ] [ACK]
6-176
Examples
ELEC HOST ELEC HOST ELEC HOST ELEC
[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]

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 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||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]
6-177
Examples

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 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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BMÊ1^1|||||||||||||||||RD||1|R[CR][E TX]7D[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|||||||||||||||||RD||5|R[CR][E TX]89[CR][LF] [ACK]
HOST ELEC
HOST ELEC
HOST ELEC HOST .. .. ELEC
[STX]3M|18|XT^BMÊ1^1|BS|1|BlankCel|||RP|SCE1|225| 93|121219|19960531085131|||00000000|201||RD||18|A[ CR][ETX]69[CR][LF]
6-178
Examples
HOST ELEC HOST ELEC
[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^BMÊ1^1|TP||||||||||||||170||TR|||A[C R][ETX]87[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|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^BMÊ1^1|AB|ABCC1|||||||||||||36|||||A [CR][ETX]CB[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|CC|ABCC1|||||||||||||32|||||A [CR][ETX]CC[CR][LF] [ACK] [STX]4M|3|XT^BMÊ1^1|AB|ABCC2|||||||||||||42|||||A [CR][ETX]CD[CR][LF] [ACK] [STX]5M|4|XT^BMÊ1^1|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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BMÊ1^1|DW||||||||||||||0|||||A[CR][E TX]70[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|LW||||||||||||||0|||||A[CR][E TX]7A[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF]
6-179
Examples
HOST ELEC
[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^BMÊ1^1|B|O|||||||1[CR][ETX]C2[CR][LF ] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
6-180
Examples
6.3
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^BMÊ1^1|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^BMÊ1^1|19960614141329|790^0|Celltem 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^BMÊ1^1|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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BMÊ1^1|CC|ABCC1|||||||||||||32|||||A [CR][ETX]CA[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK]
6-181
Examples
ELEC
[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^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BMÊ1^1|VS||||||||||||||66||VR|||A[CR ][ETX]62[CR][LF] [ACK] [STX]3L|1[CR][ETX]3C[CR][LF] [ACK] [EOT]
6-182
Examples
Instrument sends inventory for 18 Reagent Positions (M-XT):

ELEC HOST ELEC HOST ELEC HOST ELEC [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BMÊ1^1|||||||||||||||||RD||1|R[CR][E TX]7D[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|TR|30|FT4|||RP|SCE1|200|19087 5|786|19960612095136|||00000000|186||RD||4|A[CR][E TX]68[CR][LF] [ACK]
HOST ELEC
HOST ELEC
HOST
Empty positions 5 to 17:

ELEC HOST .. .. ELEC [STX]6M|5|XT^BMÊ1^1|||||||||||||||||RD||5|R[CR][E TX]89[CR][LF] [ACK]
HOST ELEC HOST ELEC
[STX]3M|18|XT^BMÊ1^1|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):

Empty positions 1:
ELEC HOST [STX]2M|1|TA^BMÊ1^1|MBC^[CR][ETX]49[CR][LF] [ACK]
MBC for positions 2 to 4:

ELEC [STX]3M|2|TA^BMÊ1^1|MBC^0004514016752096128364300 04296908900174602025175435786365866398139504296327 52030331313115480247516883730983098553876935784453 82004153507853507660848583220488619479825085536708 4320964973604965125278948118558160581935329323[ETB ]7F[CR][LF] [ACK] [STX]490446089435965546297871967355802095015406094 21525215360044880174602025175435786365866398139504 29632752030331313115480247516883730983098553876935 78445382004153507853507660848583220488619479825085
HOST ELEC
6-183
Examples
HOST ELEC
HOST .. ..
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^BMÊ1^1|MBC^[CR][ETX]4F[CR][LF] [ACK]
MBC for positions 18:

ELEC [STX]1M|18|TA^BMÊ1^1|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]
HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC
Instrument sends inventory for 18 Reagent Positions (M-XT):

ELEC HOST ELEC HOST ELEC HOST ELEC [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BMÊ1^1|||||||||||||||||RD||1|R[CR][E TX]7D[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|TR|30|FT4|||RP|SCE1|200|19087 5|786|19960612095136|||00000000|186||RD||4|A[CR][E TX]68[CR][LF] [ACK]
HOST ELEC
HOST ELEC
HOST
6-184
Examples
ELEC HOST ELEC
HOST ELEC HOST ELEC
[STX]6M|5|XT^BMÊ1^1|||||||||||||||||RD||5|R[CR][E TX]89[CR][LF] [ACK] [STX]3M|18|XT^BMÊ1^1|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^BMÊ1^1|TP||||||||||||||170||TR|||A[C R][ETX]87[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|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^BMÊ1^1|AB|ABCC1|||||||||||||36|||||A [CR][ETX]CB[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|CC|ABCC1|||||||||||||32|||||A [CR][ETX]CC[CR][LF] [ACK] [STX]4M|3|XT^BMÊ1^1|AB|ABCC2|||||||||||||42|||||A [CR][ETX]CD[CR][LF] [ACK] [STX]5M|4|XT^BMÊ1^1|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):

6-185
Examples
ELEC HOST
[STX]2M|1|XT^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|||||||||||||||||||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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BMÊ1^1|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]
HOST ELEC HOST ELEC
6-186
Examples
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^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BMÊ1^1|||||||||||||||||RD||1|R<CR >[ETX]7D[CR][LF] [ACK]
6-187
Examples
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]3M|2|XT^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|||||||||||||||||RD||5|R<CR >[ETX]89[CR][LF] [ACK] [STX]7M|6|XT^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|TR|210|CKMBSTAT|||RP|SCE1| 100|190557|75|19970424161411|||19970500|54||RD||8|A [CR][ETX]CB[CR][LF] [ACK] [STX]2M|9|XT^BMÊ1^1|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^BMÊ1^1|||||||||||||||||RD||10|R< CR>[ETX]DE[CR][LF] [ACK] [STX]4M|11|XT^BMÊ1^1|||||||||||||||||RD||11|R< CR>[ETX]E1[CR][LF] [ACK] [STX]5M|12|XT^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|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^BMÊ1^1|TR|200|TNTSTAT|||RP|SCE1| 100|190560|78|19970424161411|||19970500|18||RD||15| A[CR][ETX]FB[CR][LF] [ACK] [STX]1M|16|XT^BMÊ1^1|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^BMÊ1^1|||||||||||||||||RD||17|R< CR>[ETX]EB[CR][LF]
6-188
Examples
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
[ACK] [STX]3M|18|XT^BMÊ1^1|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^BMÊ1^1|10||[CR][ETX]73[CR][LF] [ACK] [STX]5M|2|DP^BMÊ1^1|20||[CR][ETX]76[CR][LF] [ACK] [STX]6M|3|DP^BMÊ1^1|30||[CR][ETX]79[CR][LF] [ACK] [STX]7M|4|DP^BMÊ1^1|40||[CR][ETX]7C[CR][LF] [ACK] [STX]0M|5|DP^BMÊ1^1|50||[CR][ETX]77[CR][LF] [ACK] [STX]1M|6|DP^BMÊ1^1|60||[CR][ETX]7A[CR][LF] [ACK] [STX]2M|7|DP^BMÊ1^1|100||[CR][ETX]A7[CR][LF] [ACK] [STX]3M|8|DP^BMÊ1^1|110||[CR][ETX]AA[CR][LF] [ACK] [STX]4M|9|DP^BMÊ1^1|120||[CR][ETX]AD[CR][LF] [ACK] [STX]5M|10|DP^BMÊ1^1|130||[CR][ETX]D7[CR][LF] [ACK] [STX]6M|11|DP^BMÊ1^1|140||[CR][ETX]DA[CR][LF] [ACK] [STX]7M|12|DP^BMÊ1^1|150||[CR][ETX]DD[CR][LF] [ACK] [STX]0M|13|DP^BMÊ1^1|160||[CR][ETX]D8[CR][LF] [ACK] [STX]1M|14|DP^BMÊ1^1|170||[CR][ETX]DB[CR][LF] [ACK] [STX]2M|15|DP^BMÊ1^1|180||[CR][ETX]DE[CR][LF] [ACK] [STX]3M|16|DP^BMÊ1^1|200||[CR][ETX]D9[CR][LF] [ACK] [STX]4M|17|DP^BMÊ1^1|210||[CR][ETX]DC[CR][LF] [ACK] [STX]5M|18|DP^BMÊ1^1|220||[CR][ETX]DF[CR][LF] [ACK] [STX]6M|19|DP^BMÊ1^1|230||[CR][ETX]E2[CR][LF] [ACK] [STX]7M|20|DP^BMÊ1^1|300||[CR][ETX]D9[CR][LF] [ACK] [STX]0M|21|DP^BMÊ1^1|310||[CR][ETX]D4[CR][LF] [ACK] [STX]1M|22|DP^BMÊ1^1|320||[CR][ETX]D7[CR][LF] [ACK] [STX]2M|23|DP^BMÊ1^1|330||[CR][ETX]DA[CR][LF] [ACK] [STX]3M|24|DP^BMÊ1^1|340||[CR][ETX]DD[CR][LF] [ACK]
6-189
Examples
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 ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC ELEC HOST ELEC HOST
[STX]4M|25|DP^BMÊ1^1|350||[CR][ETX]E0[CR][LF] [ACK] [STX]5M|26|DP^BMÊ1^1|360||[CR][ETX]E3[CR][LF] [ACK] [STX]6M|27|DP^BMÊ1^1|370||[CR][ETX]E6[CR][LF] [ACK] [STX]7M|28|DP^BMÊ1^1|380||[CR][ETX]E9[CR][LF] [ACK] [STX]0M|29|DP^BMÊ1^1|390||[CR][ETX]E4[CR][LF] [ACK] [STX]1M|30|DP^BMÊ1^1|400||[CR][ETX]D5[CR][LF] [ACK] [STX]2M|31|DP^BMÊ1^1|410||[CR][ETX]D8[CR][LF] [ACK] [STX]3M|32|DP^BMÊ1^1|420||[CR][ETX]DB[CR][LF] [ACK] [STX]4M|33|DP^BMÊ1^1|430||[CR][ETX]DE[CR][LF] [ACK] [STX]5M|34|DP^BMÊ1^1|440||[CR][ETX]E1[CR][LF] [ACK] [STX]6M|35|DP^BMÊ1^1|450||[CR][ETX]E4[CR][LF] [ACK] [STX]7M|36|DP^BMÊ1^1|460||[CR][ETX]E7[CR][LF] [ACK] [STX]0M|37|DP^BMÊ1^1|470||[CR][ETX]E2[CR][LF] [ACK] [STX]1M|38|DP^BMÊ1^1|480||[CR][ETX]E5[CR][LF] [ACK] [STX]2M|39|DP^BMÊ1^1|490||[CR][ETX]E8[CR][LF] [ACK] [STX]3M|40|DP^BMÊ1^1|500||[CR][ETX]D9[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|XT^BMÊ1^1|TP||||||||||||||254||TR||| A[CR][ETX]8A[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|VS||||||||||||||126||VR||| A[CR][ETX]91[CR][LF] [ACK] [STX]4L|1[CR][ETX]3D[CR][LF] [ACK] [EOT] [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK]
6-190
Examples
ELEC
HOST ELEC
HOST ELEC HOST ELEC HOST ELEC HOST ELEC ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[STX]2M|1|XT^BMÊ1^1|AB|ABCC1|||||||||||||110| ||||A [CR][ETX]F4[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|CC|ABCC1|||||||||||||107| ||||A [CR][ETX]FF[CR][LF] [ACK] [STX]4M|3|XT^BMÊ1^1|AB|ABCC2|||||||||||||19||| ||A[CR][ETX]D1[CR][LF] [ACK] [STX]5M|4|XT^BMÊ1^1|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^BMÊ1^1|DW||||||||||||||0|||||A<CR >[ETX]70[CR][LF] [ACK] [STX]3M|2|XT^BMÊ1^1|LW||||||||||||||0|||||A<CR >[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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BMÊ1^1|RC||||||||190763|||||19971 100|||||| [CR][ETX]CF[CR][LF] [ACK] [STX]3M|1|CP^BMÊ1^1|20|A|47.50|99999999|[CR]<E TX>71[CR][LF] [ACK] [STX]4M|2|CP^BMÊ1^1|20|B|74.70|99999999|[CR]<E TX>76[CR][LF] [ACK] [STX]5M|3|CP^BMÊ1^1|20|C|0.000|99999999|[CR]<E TX>67[CR][LF] [ACK] [STX]6M|4|CP^BMÊ1^1|20|D|0.000|99999999|[CR]<E TX>6A[CR][LF] [ACK]
HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST
6-191
Examples
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]7M|5|CP^BMÊ1^1|20|E|0.000|99999999|[CR]<E TX>6D[CR][LF] [ACK] [STX]0M|6|CP^BMÊ1^1|20|A|46.80|190619|[CR]<ETX >E7[CR][LF] [ACK] [STX]1M|7|CP^BMÊ1^1|20|B|139.0|190619|[CR]<ETX >E5[CR][LF] [ACK] [STX]2M|8|CP^BMÊ1^1|20|C|0.000|190619|[CR]<ETX >DB[CR][LF] [ACK] [STX]3M|9|CP^BMÊ1^1|20|D|0.000|190619|[CR]<ETX >DE[CR][LF] [ACK] [STX]4M|10|CP^BMÊ1^1|20|E|0.000|190619|[CR]<ET X>08[CR][LF] [ACK] [STX]5M|11|CP^BMÊ1^1|20|A|50.40|190764|[CR]<ET X>10[CR][LF] [ACK] [STX]6M|12|CP^BMÊ1^1|20|B|147.0|190764|[CR]<ET X>16[CR][LF] [ACK] [STX]7M|13|CP^BMÊ1^1|20|C|0.000|190764|[CR]<ET X>0D[CR][LF] [ACK] [STX]0M|14|CP^BMÊ1^1|20|D|0.000|190764|[CR]<ET X>08[CR][LF] [ACK] [STX]1M|15|CP^BMÊ1^1|20|E|0.000|190764|[CR]<ET X>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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|XT^BMÊ1^1|CS|6|PCTM1||||||190475||||| 19980500||||||[CR][ETX]8F[CR][LF] [ACK] [STX]3M|1|QP^BMÊ1^1|300||5.07|21.00|21.00|[CR] [ETX]D1[CR][LF] [ACK] [STX]4M|2|QP^BMÊ1^1|310||0.000|30.00|30.00|<CR >[ETX]F8[CR][LF] [ACK] [STX]5M|3|QP^BMÊ1^1|320||1.89|21.00|21.00|[CR] [ETX]DD[CR][LF]
6-192
Examples
HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[ACK] [STX]6M|4|QP^BMÊ1^1|330||0.000|21.00|21.00|<CR >[ETX]FE[CR][LF] [ACK] [STX]7M|5|QP^BMÊ1^1|340||0.000|48.00|48.00|<CR >[ETX]13[CR][LF] [ACK] [STX]0M|6|QP^BMÊ1^1|350||0.000|36.00|36.00|<CR >[ETX]08[CR][LF] [ACK] [STX]1M|7|QP^BMÊ1^1|360||0.000|30.00|30.00|<CR >[ETX]FF[CR][LF] [ACK] [STX]2M|8|QP^BMÊ1^1|370||0.000|36.00|36.00|<CR >[ETX]0E[CR][LF] [ACK] [STX]3M|9|QP^BMÊ1^1|380||0.000|27.00|27.00|<CR >[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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|CR^BMÊ1^1|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]
HOST ELEC
HOST ELEC HOST ELEC
6.3.6 Trace: Instrument Status Message

Query from the HOST:
HOST ELEC HOST [ENQ] [ACK] [STX]1H|\^&||||||||||P||[CR][ETX]05[CR][LF]
6-193
Examples
ELEC HOST ELEC HOST ELEC HOST
[ACK] [STX]2M|1|ISQ^BMÊ1^1||||||||||[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^BMÊ1^1|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^BMÊ1^1||||||||||||[CR][ETX]C0<CR >[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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|TC^BMÊ1^1|10|TSH|uIU/ml||1^1^2||0.23 0^3.80|||||y[CR][ETX]BD[CR][LF] [ACK] [STX]3M|2|TC^BMÊ1^1|20|T4|ug/dl|0.078|1^1^2||5 .13^13.52|||||y[CR][ETX]1A[CR][LF] [ACK] [STX]4M|3|TC^BMÊ1^1|30|FT4|ng/dl|0.078|1^1^2|| 1.01^1.79|||||y[CR][ETX]2B[CR][LF] [ACK] [STX]5M|4|TC^BMÊ1^1|40|T-UP|TBI||1^1^2||0.780^1.36 |||||y[CR][ETX]CA[CR][LF] [ACK]
6-194
Examples
ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[STX]6M|5|TC^BMÊ1^1|50|T3|ng/ml|0.651|1^1^2|| 0.846^2.02|||||y[CR][ETX]23[CR][LF] [ACK] [STX]7M|6|TC^BMÊ1^1|60|FT3|pg/ml|0.651|1^1^2|| 2.60^5.08|||||y[CR][ETX]3D[CR][LF] [ACK] [STX]0M|7|TC^BMÊ1^1|170|HCGSTAT|mIU/ml||1^1^2| |10.00^10000|||||y[CR][ETX]33[CR][LF] [ACK] [STX]1M|8|TC^BMÊ1^1|200|TNTSTAT|ng/ml||1^1^2|| 0.000^0.100|||||y[CR][ETX]1A[CR][LF] [ACK] [STX]2M|9|TC^BMÊ1^1|210|CKMBSTAT|ng/ml||1^1^2| |0.000^5.00|||||y[CR][ETX]18[CR][LF] [ACK] [STX]3M|10|TC^BMÊ1^1|300|CEA|ng/ml||1^1^2|| 0.000^4.60|||||y[CR][ETX]B6[CR][LF] [ACK] [STX]4M|11|TC^BMÊ1^1|310|AFP|ng/ml|1.21|1^1^2| |0.000^7.74|||||y[CR][ETX]91[CR][LF] [ACK] [STX]5M|12|TC^BMÊ1^1|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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|TA^BMÊ1^1|MBC^[CR][ETX]49[CR][LF] [ACK] [STX]3M|2|TA^BMÊ1^1|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 ]
HOST ELEC
HOST ELEC
6-195
Examples
HOST .. .. HOST ELEC HOST ELEC
[ACK]
HOST ELEC
HOST ELEC
HOST ELEC HOST ELEC
[ACK] [STX]2M|17|TA^BMÊ1^1|MBC^[CR][ETX]80[CR][LF] [ACK] [STX]3M|18|TA^BMÊ1^1|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^BMÊ1^1|||||||||||||||[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 [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|IC^BMÊ1^1||S|S|B|ELEC1|Âll^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]
HOST ELEC HOST
6-196
Examples
ELEC ELEC HOST ELEC HOST ELEC HOST ELEC HOST ELEC
[EOT] [ENQ] [ACK] [STX]1H|\^&||||||||||P||[CR][ETX]05[CR][LF] [ACK] [STX]2M|1|IC^BMÊ1^1|||||ELEC1|Âll^SD^^|133711 ||||||||[CR][ETX]7A[CR][LF] [ACK] [STX]3L|1|N[CR][ETX]06[CR][LF] [ACK] [EOT]
6.3.10 Trace: Service Data Message

Instrument sends Service Data:
ELEC HOST ELEC HOST ELEC [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|SD^BMÊ1^1||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^BMÊ1^1||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
HOST ELEC
HOST ELEC HOST ELEC HOST ELEC ELEC HOST ELEC HOST ELEC
HOST ELEC
6-197
Examples
HOST ELEC HOST ELEC
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]
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]2M|1|SD^BMÊ1^1||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]
6-198
Examples
6.3.11 Trace: Processing Message

Instrument sends Alarm Message:
ELEC HOST ELEC HOST ELEC [ENQ] [ACK] [STX]1H|\^&[CR][ETX]E5[CR][LF] [ACK] [STX]2M|1|PM^BMÊ1^1|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]
HOST ELEC HOST ELEC
6-199
Examples
6-200
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 () 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.
7-201
7.1
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.
7-202
7.2
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.
7-203
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.
7-204
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 4.01 Version 11/00 7-205
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:
Contact No. 1 2 3 7 EIA Circuit ... BA BB AB
Connector Contact Assignments

Direction Description Shield Transmitted Data Received Data Signal Ground ... Output Input ... Instrument Computer No connection Input Output ...
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 4.01 Version 11/00 7-206
Instrument Domain
Computer Domain
Instrument
(DTE)
Computer (DCE)
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
(DTE)
Computer (DCE)
Extension Cable
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 <ENQ> transmission control character to the intended receiver. Upon receiving the <ENQ>, the receiver prepares to receive information. All other characters are ignored. It replies with the <ACK> 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 <NAK> transmission control character. Upon receiving <NAK>, the sender must wait at least 10 s before transmitting another <ENQ>. Systems not having the ability to receive information always reply to an <ENQ> with a <NAK>. Systems not having the ability to send information never transmit an <ENQ>. Contention Should both systems simultaneously transmit an <ENQ>, 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 <ENQ> to its transmitted <ENQ>, the computer system must stop trying to transmit; it must prepare to receive. When the next <ENQ> is received, it replies with an <ACK> or <NAK> depending on its readiness to receive. (b) Upon receiving a reply of <ENQ> to its transmitted <ENQ>, the instrument must wait at least 1 s before sending another <ENQ>.
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 <ETB>, checksum, <CR> and <LF>. End frames terminate with the characters <ETX>, checksum, <CR> and <LF>. 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: <STX> FN text <ETB> C1 C2 <CR> <LF> intermediate frame <STX> FN text <ETX> C1 C2 <CR> <LF> end frame where: <STX> FN text <ETB> <ETX> C1 C2 <CR> <LF> Frame Number The frame number permits the receiver to distinguish between new and retransmitted frames. It is a single digit sent immediately after the <STX> 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 <ETB> or <ETX> 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 <STX> 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 <STX>, the checksum characters, or the trailing <CR> and <LF>. 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. Start of Text transmission control character single digit Frame Number 0 to 7 Data Content of Message End of Transmission Block transmission control character End of Text transmission control character most significant character of checksum 0 to 9 and A to F least significant character of checksum 0 to 9 and A to F Carriage Return ASCII character Line Feed ASCII character
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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 <ACK> 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 <NAK> signifies the last frame was not successfully received and the receiver is prepared to receive the frame again. A reply of <EOT> 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 <EOT> in place of the usual <ACK>, the sender must interpret this reply as a receiver interrupt request. The <EOT> 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 <EOT>, 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 <EOT> transmission control character and then regards the data link to be in a neutral state. Upon receiving <EOT>, 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 <NAK> is transmitted for invalid frames. Upon receiving the <NAK>, 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 <STX> or after the end of the block character (the <ETB> or <ETX>) 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 <NAK> or any character except an <ACK> or <EOT> (a <NAK> 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 <ENQ>. If a reply of an <ACK>, <NAK>, or <ENQ> 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 <ENQ> 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 <EOT> 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 <LF> 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 <LF> format effector control character, or four device control characters may appear in message text. The restricted characters are: <SOH>, <STX>, <ETX>, <EOT>, <ENQ>, <ACK>, <DLE>, <NAK>, <SYN>, <ETB>, <LF>, <DC1>, <DC2>, <DC3>, and <DC4>.
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7.7
Appendix 1: STATE DIAGRAM

Receiving Device
Busy Send <NAK> Receive <ENQ>
Sending Device
Idle Data to Send
Send <EOT>
Awake
Send <ACK> Set %8 Count to 1 Timer := 30
Receive <EOT> or Time Out Time Out
Set %8 Count to 1 Send <ENQ> Timer := 15
Contention or Busy Timer Running

Receive <ENQ> or <NAK> Contention Timer(Inst) := 1 or (Comp) := 20 or Busy Timer := 10
Send <EOT> Send <ACK> Timer := 30
Waiting
Waiting
Get Frame Bad Frame Send <NAK> Timer := 30 Send <EOT> Timer := 30 Retries = 6 Send <EOT>
Receive <ACK> Zero Retry Count
Next Frame Set up

Increment %8 Count
Done
Increment %8 Count
Good Repeat Frame Good New Frame
Frame Received
Time Out Retries < 6 Accept Ignore Zero Retry Count Increment %8 Count
Frame ok
New Frame Increment %8 Count Repeat Frame
Frame Ready
Send Frame Timer := 15
Interrupt Requested
Have Data to Send
Old Frame Set up

Receive <NAK> Increment Retries (Receiving any character except <ACK> or <EDT>)
Waiting
Receive <EOT>
Figure 7-3: State Diagram
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Note 1 Note 2
"%8 represents modulo 8. "= 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 () 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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8.2
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 4.01 Version 11/00 8-220
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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8.6
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 . , S, P, R, C L, H, <, >, N, U, D, B, W C, P, F, X, I, O
record type IDs decimal point (period) comma priority codes result codes result status
For the purpose of providing examples, the following delimiters are used in this specification: Record Delimiter carriage return (<CR>) 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.
&H& &N& &F& &S& &R& &E& &Xhhhh&
start highlighting text normal text (end highlighting) imbedded field delimiter character imbedded component field delimiter character imbedded repeat field delimiter character imbedded escape delimiter character hexadecimal data
&Zcccc&
Local (manufacturer defined) escape sequence
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Note 1
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 patients 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. Manufacturers 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^ChicagoÎL^60305ÛSA. 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 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.
th
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 4.01 Version 11/00 8-232
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|\^&<CR> P|1<CR> O|1|||^^Â1<CR> R|1||0.356<CR> P|2|<CR> O|1|||^^Â2<CR> R|1||1.672<CR> . . P|96<CR> O|1|||^^^H12<CR> R|1||0.402<CR> L|1<CR>
Note 1 Note 2
This sample is not recommended for implementation. Direction: instrument to computer system.
No Patient ID; Specimen ID and Multiple Results Shown Figure 4:

H|\^&<CR> P|1<CR> O|1|927529||^^Â1\^^Â2<CR> R|1|^^Â1|0.295||||||||19890327132247<CR> R|2|^^Â2|0.312||||||||19890327132248<CR> P|2|<CR> O|1|927533||^^Â3\^^Â4<CR> R|1|^^Â3|1.121||||||||19890327132422<CR> R|2|^^Â4|1.097||||||||19890317132422<CR> L|1<CR>
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<CR> Q|1|^032989325|^032989327|ALL||||||||O<CR>
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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<CR> P|1|2734|123|306-87-4587|BLAKE^LINDSEYÂNN^MISS<CR> O|1|032989325||^^^BUN|R<CR> O|2|032989325||^^ÎSE|R<CR> O|3|032989325||^^^HDL\^^^GLU|R<CR> P|2|2462|158|287-17-2791|POHLÂLLEN^M.<CR> O|1|032989326||^^^LIVER\^^^GLU|S<CR> P|3|1583|250|151-37-6926|SIMPSONÂLBERT^MR<CR> O|1|032989327||^^^CHEM12\^^^LIVER|R<CR> L|1|F<CR>
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<CR> P|1|2734|123|306-87-4587|BLAKE^LINDSEYÂNN^MISS<CR> C|1|L|Notify IDC if tests positive|G<CR> O|1|032989325||^^^BUN|R<CR> R|1|^^^BUN|8.71<CR> C|1|I|TGP^Test Growth Positive|P<CR> C|2|I|colony count >10,000|P<CR> O|2|032989325||^^ÎSE|R<CR> R|1|^^ÎSE^NA|139\mEq/L<CR> R|2|^^ÎSE^K|4.2\mEq/L<CR> R|3|^^ÎSE^CL|111\mEq/L<CR> O|3|032989325||^^^HDL|R<CR> R|1|^^^HDL|70.29<CR> O|4|032989325||^^^GLU|R<CR> R|1|^^^GLU|92.98<CR> C|1|I|Reading is Suspect|I<CR> P|2|2462|158|287-17-2791|POHLÂLLEN^M.<CR> O|1|032989326||^^^LIVER|S<CR> R|1|^^^LIVERÂST|29<CR> R|2|^^^LIVERÂLT|50<CR> R|3|^^^LIVER^TBILI|7.9<CR> R|4|^^^LIVER^GGT|29<CR> O|2|032989326||^^^GLU|S<CR> R|1|^^^GLU|91.5<CR> P|3|1583|250|151-37-6926|SIMPSONÂLBERT^MR<CR> O|1|032989327||^^^LIVER|R<CR> R|1|^^ÂST|28<CR> (Test ID field Implicitly Relates to LIVER order) R|2|^^ÂLT|49<CR> R|3|^^^TBILI|7.3<CR> R|4|^^^GGT|27<CR>
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O|2|032989327||^^^CHEM12|R<CR> R|1|^^^CHEM12ÂLB-G|28<CR> (Test ID field Explicitly Relates to CHEM12 order) R|2|^^^CHEM12^BUN|49<CR> R|3|^^^CHEM12^CA|7.3<CR> R|4|^^^CHEM12^CHOL|27<CR> R|5|^^^CHEM12^CREAT|4.2<CR> R|6|^^^CHEM12^PHOS|12<CR> R|7|^^^CHEM12^GLUHK|9.7<CR> R|8|^^^CHEM12^NA|138.7<CR> R|9|^^^CHEM12^K|111.3<CR> R|10|^^^CHEM12^CL|6.7<CR> R|11|^^^CHEM12ÛA|7.3<CR> R|12|^^^CHEM12^TP|9.2<CR> L|1<CR>
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<CR> Q|1|^032989326|ALL||||||||O<CR> L|1<CR>
Reply to Result Request Figure 5e:

H|\^&||PSWD|Harper Labs|2937 Southwestern Avenue^Buffalo^NY^73205||319 4129722||||P|2.5|19890314<CR> P|1|2462|158|287-17-2791|POHLÂLLEN^M.<CR> O|1|032989326||^^^LIVER|S<CR> R|1|^^ÂST|29<CR> R|2|^^ÂLT|50<CR> R|3|^^^TBILI|7.9<CR> R|4|^^^GGT|29<CR> O|2|032989326||^^^GLU|S<CR> R|1|^^^GLU|91.5<CR> L|1<CR>
Microbiology Order and Result Download of Demographics and Order Figure 6a:
H|\^&||Password1|Micro1|||||LSI1||P|1.20|19890501074500<CR> P|1||52483291||Smith|John|Samuels|19699401|M|W|4526 C Street^Fresno^CA^ 92304||(402)7823424x242|542^Dr.Brown|||72în.|175^lb.||Penicilin|||| 19890428|IP|Ward1||C|M|WSP||ER|PC^Prompt Care<CR> O|1|5762^01||^^^BC^BloodCulture^POSCOMBO|R|198905011530| 198905020700||| 456^Farnsworth|W|||198905021130|BL^Blood| 123^Dr.Wirth|||||||Instrument#1||ER|N<CR> R|1|^^Ôrg#|51^Strep Species||||N<CR>
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R|2|^^^Bio|BH+^Beta Hemolytic|||N<CR> L|1<CR>
Microbiology Order and Result Upload of Finalized Results Figure 6b:

H|\^&||Password1|Micro1|||||LSI1||P|1.20|19890501074500<CR> P|1||52483291<CR> O|1|5762^01||^^^BC^^|||||||||||BL||||||||||F<CR> R|1|^^ÔRG#|103^Group D Entero<CR> R|2|^^ÂM^MIC|>16<CR> R|3|^^ÂMÎNTERP1|++<CR> R|4|^^ÂM^DOSAGE1|PO 250-500 mg Q6h<CR> R|5|^^ÂM^DOSAGE1^COSTCODE|$25<CR> R|6|^^ÂMÎNTERP2|+++<CR> R|7|^^ÂM^DOSAGE2|IV 1.0-2.0 gm Q4h<CR> R|2|^^^P^MIC|<0.25<CR> R|3|^^^PÎNTERP1|++<CR> R|4|^^^P^DOSAGE1|PO 250-500 mg Q6h<CR> R|5|^^^P^DOSAGE1^COSTCODE|$25<CR> R|6|^^^PÎNTERP2|+++<CR> R|7|^^^P^DOSAGE2|IM 0.9-1.2 MIL U Q6-12h<CR> . . . R|90|^^^BIOTYPE|102-34021<CR> L|1<CR>
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8.7
Message Header Record

The header shall contain identifiers of both the sender and the receiver. The message header is a level zero record and must be followed at some point by a message terminator record before ending the session or transmitting another header record. This record type must always be the first record in a transmission. Record Type ID The following record types are available:
H P O R C Q L S M message header record. patient information record. test order record result record comment record request information record message terminator record scientific record manufacturer information record
Delimiter Definition The five ASCII characters that immediately follow the H (the header ID) define the delimiters to be used throughout the subsequent records of the message. The second character in the header record is the field delimiter, the third character is the repeat delimiter, the fourth character is the component delimiter, and the fifth is the escape character. A field delimiter follows these characters to separate them from subsequent fields. Another way to view this is that the first field contains H and the second field contains the repeat, component and escape delimiters. Using the example delimiters, the first six characters in the header record would appear as follows: H | \ ^ & |. Message Control ID This is a unique number or other ID that uniquely identifies the transmission for use in network systems that have defined acknowledgement protocols that are outside of the scope of this specification. Note that this is the third field. Access Password This is a level security/access password as mutually agreed upon by the sender and receiver. If this security check fails the transmission will be aborted and the sender will be notified of an access violation.
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Sender Name or ID The purpose of this field is to define the manufacturer/instrument(s) specific to this line. Using repeat and/or component delimiters this field may reflect software or firmware revisions, multiple instrument available on the line, etc. Sender Street Address This text value shall contain the street address of the sender as specified in section Addresses (see 8.6.6). Reserved Field This field is currently unused but reserved for future use. Sender Telephone Number This field identifies a telephone number for voice communication with the sender as specified in section Telephone Numbers (see 8.6.6). Characteristics of Sender This field contains any characteristics of the sender such as parity, checksums, optional protocols, etc. necessary for establishing a communication link with the sender. Receiver ID This text value includes the name or other ID of the receiver. Its purpose is verification that the transmission is indeed for the receiver. Comment or Special Instructions This text field shall contain any comments or special instructions relating to the subsequent records to be transmitted. Processing ID indicates how this message is to be processed:
P T D Q
Production: Treat message as an active message to be completed according to standard processing. Training: Message is initiated by a trainer and should not have an effect on the system. Debugging: Message is initiated for the purpose of a debugging program. Quality Control: Message is initiated for the purpose of transmitting quality control/quality assurance or regulatory data.
Version No. This value identifies the version level of the specification. This value is currently one.
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Date and Time of Message This field contains the date and time that the message was generated using the format specified in section Dates and Times (see 8.6.6).
8.8
Patient Information Record

Each line of the patient record shall begin with a record type and end with a carriage return. Record Type ID The following record types are available:
Sequence Number Practice Assigned Patient ID This identifier shall be the unique ID assigned and used by the practice to identify the patient and his/her results upon return of the results of testing. Laboratory Assigned Patient ID This identifier shall be the unique processing number assigned to the patient by the laboratory. Patient ID No. 3 This field shall be optionally used for additional, universal or manufacturer defined identifiers (such as Social Security Account No.), as arranged between transmitter and receiver. Patient Name The patient's name shall be presented in the following format: last name, first name, middle name or initial, suffix, and title, and each of these components shall be separated by a component delimiter as described in section Provider and User IDs (see 8.6.6).
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Mother's Maiden Name The optional mother's maiden name may be required to distinguish between patients with the same birthdate and last name when registry files are very large. This name shall be presented as the mother's maiden surname, for example, Thompson. Birthdate The birthdate shall be presented in the standard format specified in section Dates and Times (see 8.6.6). Patient Sex This field shall be represented by M, F, or U. Patient Race-Ethnic Origin The following examples may be used:
W B 0 NA H white black asian/pacific islander native american/alaskan native Hispanic
Full text names of other ethnic groups may also be entered. Note that multiple answers are permissible, separated by a component delimiter. Patient Address This text value shall record the street address of the patient's mailing address as defined in section Addresses (see 8.6.6). Patient Telephone Number Patient's telephone number formatted as defined in section Telephone Numbers (see 8.6.6). Attending Physician ID This field shall identify the physician(s) caring for the patient as either names or codes, as agreed upon between the sender and the receiver. Identifiers or names, or both, should be separated by component delimiters as specified in section Provider and User IDs (see 8.6.6). Multiple physician names (for example, Ordering physician, attending physician, referring physician) shall be separated by repeat delimiters. Special Field 1 An optional text field for vendor use (each laboratory can use this differently).
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Special Field 2 An optional text field for vendor use. Patient Height (Default in cms.) An optional numeric field containing the patient's height. The default units are centimeters. If measured in terms of another unit, the units should also be transmitted as specified in section Fixed Measurements and Units (see 8.6.6). Patient Weight An optional numeric field containing the patient's weight. The default units are kilograms. If measured in terms of another unit, for example, pounds, the unit name shall also be transmitted as specified in section Fixed Measurements and Units (see 8.6.6). Height and weight information is not currently required by all laboratories but is of value in estimating normative values based upon body surface area. Patient's Known or Suspected Diagnosis This value should be entered either as an ICD-9 code or as free text. If multiple diagnoses are recorded, they shall be separated by repeat delimiters. Patient Active Medications Or those suspected, in overdose situations. The generic name shall be used. This field is of use in interpretation of clinical results. Patients Diet This optional field in free text should be used to indicate such conditions that affect results of testing, such as 16 hr fast (for triglycerides), no red meat (for Hemoccult testing) Practice Field No. 1 A text field for use by the practice, the optional transmitted text will be returned with the results. Practice Field No. 2 same as section Practice Field No. 1 (see above). Admission and Discharge Dates These values shall be represented as specified in section Character Codes (see 8.6.1). The discharge date, when included, follows the admission date and is separated from it by a repeat delimiter.
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Admission Status This value shall be represented by the following minimal list or by extensions agreed upon between the sender and receiver:
OP PA IP ER outpatient, preadmit, inpatient, emergency room.
Location This text value shall reflect the general clinic location or nursing unit, or ward or bed or both of the patient in terms agreed upon by the sender and receiver. Nature of Alternative Diagnostic Code and Classifiers This field relates to Alternative Diagnostic Code and Classification (see below). It identifies the class of code or classifiers that are transmitted, for example, DRGs, or in the future, AVGs (ambulatory visitation groups), etc. Alternative Diagnostic Code and Classification Alternative diagnostic codes and classifications, for example, DRG codes, can be included in this field. The nature of the diagnostic code is identified in section Nature of Alternative Diagnostic Code and Classifiers (see above). If multiple codes are included, they should be separated by repeat delimiters. Individual codes can be followed by optional test descriptors (when the latter are present) and must be separated by component delimiters. Patient Religion When needed, this value shall include the patient's religion. Codes or names may be sent as agreed upon between the sender and the receiver. Full names of religions may also be sent as required. A list of sample religious codes follows:
P C M J L H Protestant Catholic Church of the Latter Day Saints (Mormon) Jewish Lutheran Hindu
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Marital Status When required, this value shall indicate the marital status of the patient as follows:
M S D W A married single divorced widowed separated
Isolation Status Isolation codes indicate precautions that must be applied to protect the patient or staff against infection. The following are suggested codes for common precaution. Multiple precautions can be listed when separated by repeat delimiters. Full text precautions may also be sent.
ARP BP ENP NP PWP RI SE SI WSP antibiotic resistance precautions blood and needle precautions enteric precautions precautions for neutropenic patient precautions for pregnant women respiratory isolation secretion/excretion precautions strict isolation wound and skin precautions
Language The value of this field indicates the patient's primary language. This may be needed when the patient is not fluent in the local language. Hospital Service This value indicates the hospital service currently assigned to the patient. Both code and text may be sent when separated by a component delimiter as in section Provider and User IDs (see 8.6.6). Hospital Institution This value indicates the hospital institution currently assigned to the patient. Both code and text may be sent when separated by a component delimiter as in section Provider and User IDs (see 8.6.6). Dosage Category This value indicates the patient dosage group.
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For example,
A P1 P2 ADULT, PEDlATRlC (1-6 months), PEDIATRIC (6 months -3 years),
etc. Sub-components of this field may be used to define dosage sub-groups.
8.9
Test Order Record

The test order record defines the attributes of a particular request for a clinical instrument's services and contains all specimen information. An order record will be generated by the computer system to request a given test, battery, or set of tests. The information in an order record will usually apply to a single specimen. However, there is not necessarily a one-to-one relationship between specimen and tests ordered. Different test batteries will usually be ordered within different order records even when they can be performed on a single specimen. In this case, the specimen information is duplicated in each of the order records that employ that specimen.
8.9.1 Multiple Orders

More than one test or test battery may be ordered on a single order record by using repeat delimiters between the individual tests ordered in that record. However, in such cases, all other attributes stored within the order record must be the same for all the tests ordered within that record. Thus, if one wishes to order one test as a STAT or immediate test and another as a routine test, two separate order records would be required. In the case that a test battery requires more than one specimen, such as is true for creatinine clearances, information about each of the test specimens may be included in the single order record identifying multiple specimens using the repeat delimiter within the specimen ID field. Though multiple tests or test batteries can be on a single order record, when reporting the results, the instrument shall produce a separate order record for each unique battery, copying the appropriate specimen information from the original order record into each of the new order records. In the event that a test battery cannot be performed, for example, because of hemolysis, the order record will be returned to the computer system with the report type indicator X to indicate that it was not done. In this case, no result records will be transmitted. When test analyses are successfully performed, the message returned to the computer system will include the order record followed by result records for each separate observation requested by that order. The number of such result records will depend upon the number of individual measurements performed in the
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analysis. Four test result records would follow the order record for an electrolytes test. Twelve result records will follow the order record for an SMA12. Test batteries that require multiple specimens for their performance would similarly be followed by a series of result records corresponding to the number of individual measurements obtained. The manufacturer must ensure that the test ID field within each result record contains sufficient information to relate the individual test measurements to the specific tests, batteries and specimens ordered. Microbiological culture results are different. A new order record should be created for each panel of antimicrobial sensitivities, although multiple batteries/panels may be ordered on a single order record if desired. The series of antimicrobial sensitivities for any single sensitivity analysis will be reported as separate result records, one for each result element or combination of elements (antimicrobic, MIC, interpretation, etc.). Thus, the antimicrobial sensitivity appears logically very much like an extended SMA12 result with separate result records for each separate result from each antibiotic tested. Once again, the test ID field within the result records must contain sufficient information to relate the individual test measurements with the appropriate antibiotic test and battery ordered. STAT Short Turn Around Time
8.9.2 General Applications

The order record may be used in four different circumstances: It is sent by the computer system to request a particular set of instrument tests. It is transmitted back to the computer system as part of the results. If the ordered instrument analyses can be completed, the instrument sends back the order record along with the result records according to the hierarchy described in this specification. If results cannot be produced, for example, because the specimen is hemolyzed, the lab transmits the order with an appropriate report type (see section Report Types in 8.9.2) to indicate this problem, but no result records are transmitted. The order record is transmitted back to the computer system in response to a request information query. In this case, it has the same form as in 8.9.2. The instrument is requesting demographic or tests ordered information from the computer system.
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Record Type ID The following record types are available:

Sequence Number Specimen ID This text field shall represent a unique identifier for the specimen assigned by the computer system and returned by the instrument. If the specimen has multiple components further identifying cultures derived from it, these component identifiers will follow the specimen ID and be separated by component delimiters. For example, the specimen ID may contain the specimen number followed by the isolate number, well or cup number (for example, 10435A^01^64). Instrument Specimen ID This text field shall represent a unique identifier assigned by the instrument, if different from the computer system identifier, and returned with results for use in referring to any results. Priority Test priority codes are as follows:
S A R C P stat as soon as possible routine call-back preoperative
If more than one priority code applies, they must be separated by repeat delimiters. Requested/Ordered Date and Time The contents of this field shall be represented as specified in section Dates and Times (see 8.6.6) and will denote the date and time the test order should be considered ordered. Usually this will be the date and time the order was recorded. This is the date and time against which the priorities should be considered. If the ordering service wants the test performed at a specified time in the future, for example, a test to be V 4.01 Version 11/00 8-246
drawn two days in the future at 8 p.m., the future date and time should be recorded here. Note that the message header data and the future date and time should be recorded here. Further, note that the message header record date and time (see section Date and Time of Message in 8.7) indicates the time the order was transmitted to or from the instrument. Specimen Collection Date and Time This field shall represent the actual time the specimen was collected or obtained. Collection End Time This field shall contain the end date and time of a timed specimen collection, such as 24-h urine collection. The value shall be specified according to section Dates and Times (see 8.6.6). Collection Volume This value shall represent the total volume of specimens such as urine or other bulk collections when only aliquot is sent to the instrument. The default unit of measure is milliliters. When units are explicitly represented, they should be separated from the numeric value by a component delimiter, for example, 300^g. Units should follow the conventions given in section Fixed Measurements and Units (see 8.6.6). Collector ID This field shall identify the person and facility which collected the specimen. If there are questions relating to circumstances surrounding the specimen collection, this person will be contacted. Action Code This field shall indicate the action to be taken with respect to the specimens that accompany or precede this request. The following codes shall be used:
C A N P L X Q cancel request for the battery or tests named add the requested tests or batteries to the existing specimen with the patient and specimen identifiers and date-time given in this record new requests accompanying a new specimen pending specimen reserved specimen or test already in process. treat specimen as a Q/C test specimen.
Danger Code This field representing either test or a code shall indicate any special hazard associated with the specimen, for example, a hepatitis patient, suspected anthrax.
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Relevant Clinical Information Additional information about the specimen would be provided here and used to report information such as amount of inspired O2 for blood gasses, point in menstrual cycle for cervical pap tests or other conditions that influence test interpretations. Date/Time Specimen Received This optional field shall contain the actual log-in time recorded in the laboratory. The convention specified in section Dates and Times (see 8.6.6) shall be used. Specimen Descriptor This field may contain two separate elements, specimen type and specimen source as defined in 8.9.2. The components must be separated by component delimiters. Specimen Type Samples of specimen culture types or sources would be blood, urine, serum, hair, wound, biopsy, sputum, etc. Specimen Source This is always the second component of the specimen descriptor field and is used specifically to determine the specimen source body site (for example, left arm, left hand, right lung). Ordering Physician This field shall contain the name of the ordering physician in the format outlined in section Provider and User IDs (see 8.6.6). Physician's Telephone Number This field shall contain the telephone number of the requesting physician and will be used in responding to call-back orders and for critically abnormal results. Uses the format given in section Telephone Numbers (see 8.6.6). Users Field No. 1 Text sent by the requester should be returned with the sender along with the response. Users Field No. 2 similar to section Users Field No. 1 (see 8.9.2) Laboratory Field No. 1 An optional field definable for any use by the laboratory. Laboratory Field No. 2 similar to section Laboratory Field No. 1 (see 8.9.2).
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Date/Time Results Reported or Last Modified This field is used to indicate the date and time the results for the order are composed into a report, or into this message or when a status as defined in section Report Types (see 8.9.2 or 8.10) is entered or changed. When the computer system queries the instrument for untransmitted results, the information in this field may be used to control processing on the communications link. Usually, the ordering service would only want those results for which the reporting date and time is greater than the date and time the inquiring system last received results. Dates and times should be recorded as specified in section Dates and Times (see 8.6.6). Instrument Charge to Computer System This field contains the billing charge or accounting reference by this instrument for tests performed. Instrument Section ID This identifier may denote the section of the instrument where the test was performed. In the case where multiple instruments are on a single line or a test was moved from one instrument to another, this field will show which instrument or section of an instrument performed the test. Report Types The following codes shall be used:
O C P F X I Y Z Q order record; user asking that analysis be performed correction of previously transmitted results preliminary results final results results cannot be done, request cancelled in instrument, pending no order on record for this test (in response to query) no record of this patient (in response to query) response to query (this record is a response to a request-information query)
Location or Ward of Specimen Collection This field defines the ward of specimen collection if different from the patient ward. Nosocomial Injection Flag This field is used for epidemiological reporting purposes and will show whether the organism identified is the result of a nosocomial (hospital acquired) infection.
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Specimen Service In cases where an individual service may apply to the specimen collected, and the service is different from the patient record service, this field may be used to define the specific service responsible for such collection. Specimen Institution In cases where the specimen may have been collected in an institution, and the institution is different from the patient record institution, this field may be used to record the institution of specimen collection.
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8.10 Result Record

The result record shall include the following fields: Record Type ID The following record types are available:
Sequence Number Data or Measurement Value Whether numeric text, or coded values, the data shall be recorded in ASCII text notation. If the data result contains qualifying elements of equal stature, these should be separated by component delimiters. This applies strictly to results of identical nature (that is, this field may not contain implied sub-values). Use of components within this field should be avoided whenever possible. Multiple results or values, observed, calculated or implied, for a single test order (for example, MIC or interpretation codes from a single antibiotic sensitivity test) must be reported in separate result records with each result definition defined uniquely by the test ID field as given in section Universal Test ID (see 8.10). Correspondingly, the test ID field (8.10) must be sufficiently descriptive to determine the placement of the data value with reference to the original test order record and to other result records associated with said test order record. Units The abbreviation of units for numeric results shall appear here. ISO standard abbreviations in accordance with ISO 2955 should be employed when available, for example, use mg rather than milligrams. Units can be reported in upper or lower case. Reference Ranges: This value shall be reported in the following sample format: (lower limit to upper limit; example: 3.5 to 4.5). The range definition can be included by text description (see section Reference Ranges in 8.10). If a toxic substance, then the upper limit of the range identifies the toxic limit. If the substance being measured is a drug, the
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lower limits identify the lower therapeutic bounds and the upper limits represent the upper therapeutic bounds above which toxic side effects are common. A result may have multiple ranges, for example, an observation may have a physiologic and a therapeutic range, for example, serum magnesium is being used to treat eclampsia. When multiple ranges are sent, they shall be separated by repeat delimiters. Each range can also have a text description. The test description follows immediately after the range and is separated from it by a component delimiter. Most results will only have one normal range transmitted. Result Abnormal Flags This field shall indicate the normalcy status of the result. The characters for representing significant changes either up or down or abnormal values shall be:
L H LL HH < > N A U D B W below low normal above high normal below panic normal above panic high below absolute low that is off low scale on an instrument above absolute high, that is off high scale on an instrument normal abnormal significant change up significant change down better, use when direction not relevant or not defined worse, use when direction not relevant or not defined
When the instrument can discern the normal status of a textual report, such as microbiologic culture, these should be reported as N when normal and A when abnormal. Nature of Abnormality Testing The kind of normal testing performed shall use the following representation:
A S R N denotes that an age based population was tested, sex based population, and a race based population. implies that generic normal range was applied to all patient specimens.
As many of the codes as apply shall be included. For example, if sex, age, and race normals were tested, an (A\S\R) would be transmitted.
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Result Status The following codes shall be used.

C P F X I S M R N Q V correction of previously transmitted results preliminary results final results results cannot be done, request will not be honored in instrument, results pending partial results this result is a MIC level this result was previously transmitted this result record contains necessary information to run a new order this result is a response to an outstanding query operator verified/approved result
Note 5
For example, when ordering a sensitivity, the computer system may download a result record containing the organism type, or species, identified in a previous test.
Date of Change in Instrument Normative Values or Units This field shall remain empty if there are no relevant normals or units. Otherwise, it shall be represented as in section Dates and Times (see 8.6.6). A change in this data from that recorded in the receiving system's dictionary indicates a need for manual review of the results to detect whether they can be considered the same as preceding ones. Operator Identification The first component identifies the instrument operator who performed the test. The second component identifies the verifier for the test. Date/Time Test Started Date and time the instrument started the test results being reported. Date and times should be reported as specified in section Dates and Times (see 8.6.6). Date/Time Test Completed Date and time the instrument completed the test results being reported. Dates and times should be reported as specified in section Dates and Times (see 8.6.6). Instrument identification Identifies the instrument or section of instrument that performed this particular measurement.
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8.11 Comment Record

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. The comment record shall include the following fields: Record Type ID The following record types are available:
Sequence Number Comment Source Comment origination point:

P L I practice computer system clinical instrument system
Comment Text Where comment codes/mnemonics are used, the code should be sent first, followed, if desired, by the comment text and separated by a component delimiter as given in section Addresses (see 8.6.6).
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Comment Type The following codes may be used to qualify comment record types:
G T P N I generic/free text comment test name comment positive test comment negative test comment instrument flag(s) comment
8.12 Request Information Record

The request information record is used by either clinical instrument or computer system to remotely request information from the reciprocal system. Note 6 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. Record Type ID The following record types are available:
Sequence Number Starting Range ID Number This field may contain three or more components to define a range of patients/specimens/manufacturers selection criteria. The first component is the computer system patient ID No. The second component is the computer system specimen ID No. Any further components are manufacturer defined and for use in request subresult information (that is, an individual isolate/battery for a specimen number). These components are position dependent.
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When ALL is entered, and the computer system is sending the request record, it is taken to mean all specimen results ordered by the inquiring system. If the instrument is generating the request record, then it is taken to mean all demographics and tests being ordered should be sent to the instrument at this time. The request is then interpreted for that identified subset of specimens as further modified by the test specifications and date ranges as described below. This specification does not address how long data is to be retained by an instrument, nor does it require that the instrument provides the search services implied by some of the field contents. The appropriate response for a request for results is simply the return of a subset of results that are currently in storage and can be practically retrieved by the instrument as mutually agreed upon between the instrument and laboratory or external computer system. Ending Range ID Number Similar to section Starting Range ID Number (see 8.12). If a single result or specimen demographic or test order is being requested then this field may be left blank. Nature of Request Time Limits Specify whether the date and time limits specified in section Beginning Request Results Date and Time and section Ending Request Results Date and Time (see both 8.12) refer to the specimen collect or ordered date (see section Specimen Collection Date and Time in 8.9.2) or test date (see section Date Time Results Reported or Last Modified in 8.9.2):
S R indicates the specimen collect date; indicates the result test date.
If nothing is entered, the date criteria are assumed to be the result test date. Beginning Request Results Date and Time This field shall represent either a beginning (oldest) date and time for which results are being requested or a single date and time. The field may contain a single date and time or multiple individual dates and times separated by repeat delimiters. Each date and time shall be represented as specified in section Dates and Times (see 8.6.6). If no date and time is included, the instrument should assume that the computer system wants results going as far into the past as possible and consistent with the criteria specified in other fields. Ending Request Results Date and Time This field, if not null, specifies the ending or latest (or most recent) date and time for which results are being requested. Date and time shall be represented as in section Dates and Times (see 8.6.6).
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Requesting Physician Name This field identifies the individual physician requesting the results. The identity of the requesting physician is recorded as specified in section Provider and User IDs (see 8.6.6). User Field No. 1 User defined field. User Field No. 2 User defined field. Request Information Status Codes The following codes shall be used:
C P F X I S M R A N O D correction of previously transmitted results preliminary results final results results cannot be done, request cancelled request results pending request partial/unfinalized results result is a MIC level this result was previously transmitted abort/cancel last request criteria (allows a new request to follow) requesting new or edited result only requesting test orders and demographics only (no results) requesting demographics only (for example, patient record)
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8.13 Message Terminator Record

This is the last record in the message. A header record may be transmitted after this record signifying the start of a second message. Record Type ID The following record types are available:
Sequence Number Termination Code Provides explanation of end of session.

Nil,N T R E Q I F normal termination sender aborted receiver requested abort unknown system error error in last request for information no information available from last query last request for information processed
Note 7
F, I, or Q will terminate a request and allow processing of a new request record.
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8.14 Scientific Record

The scientific record exchanges the test data on clinical laboratory/instrument performance, quality assurance, or method development. It contains information in addition to the analyte measures found in the result record, although there are common elements in the two records. Record Type ID The following record types are available:
Sequence Number Analytical Method This text field shall conform to Appendix I of Elevitch and Boroviczeny. Instrumentation This text field shall be represented by an ID composed of the manufacturer and instrument codes connected by a dash (ASCII 45). These codes shall conform to Appendix I of Elevitch and Boroviczeny. Reagents This text field shall include a list of constituent reagent codes, separated by subfield ID. These codes shall conform to the scheme of The American Chemical Society. Units of Measure The units of measure shall be represented as specified in section Units (see 8.10). Quality Control Specifications to be developed. Container Specifications to be developed.
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Analyte Specifications to be developed. Result This numeric field shall represent the determined value of the analyte. Result Units This field shall be represented as described in section Units (see 8.10). Collection Date and Time This field shall be represented in accordance with section Dates and Times (see 8.6.6). Result Date and Time This field shall be represented in accordance with section Dates and Times (see 8.6.6). Analytical Preprocessing Steps This text field shall contain the description of any Preprocessing steps. Patient Diagnosis This field shall be represented as IDC-9-CM Codes. Patient Birthdate This should be represented as specified in section Birthdate (see 8.8). Patient Race This should be represented in accordance with section Patient Race Ethnic Origin (see 8.8).
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8.15 Manufacturer Information Record

This record is provided solely for custom use by the instrument or computer system manufacturer. It has no inherent hierarchical level and may be inserted at any point except immediately following a message terminator record. It is recommended that this record type is not to be implemented unless all other possibilities have been exhausted. This record shall include the following: Record Type ID The following record types are available:
Sequence Number
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8.16 APPENDIX - Non mandatory Information

8.16.1 X1. Comparison of Specifications E1238 and E1394
Table X1.1 shows the major differences in requirements between Specifications E1238 and E 1394. Other modifications and additions have been made. Not all of the fields required in Specification E1238 are required in this specification. It is the responsibility of the user of this standard to compare the requirements of these two specifications and the changes that have been incorporated since the this last issue.
Table 8-3: Requirement Comparison Between Specifications E1238 and E1394 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. Use is 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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Host Interface Simulator for the ASTM Protocol

Supported Instruments: Elecsys 2010/1010, STA, STA-C, STA-R, LSM, PSM, Modular, Cardiac Reader, Aliquoter VS II, Amplilink Version 3.8 (December 1999)
Short Guide
9.1
Purpose of the ASTM Interface Test Tool

The ASTM host interface test tool allows to simulate the host communication for all Roche analyzers that are equipped with an ASTM host protocol. The tool may simulate the analyzer or the host. It was developed with the programming language Visual Basic 5.0 and requires a 32-bit operating system (Windows 95 or NT). The tool has instrument-independent features ... low-level communication trace recording messages may be created with a record editor, saved as so-called record files (*.DAT) and sent to the connected device error simulation by sending wrong checksums free timer setting and instrument specific features ... the extracted info of received messages is stored in instrument-specific MS ACCESS databases realtime request mode may be simulated with this database the meaning of the record fields may be displayed in the lower part of the record editor
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9.2
Main Screen of the Test Tool
Figure 9-1: Main Screen of the Test Tool
The Main Screen contains the following items (top down): Title line (containing the selected instrument, the programs name and version) Pull-down menu system Local Device setting (HOST or INST) and their names The Operating Mode setting screen can be accessed by clicking on this field. Symbolic indication of the local device (blue frame) A click on the corresponding icon selects the local device. actual Date and Time actual RS232-Parameter setting The RS232 Parameter setting screen can be accessed by clicking on this field. Step-Mode status (visible or invisible means enabled or disabled)
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Last Sent/Received messages If activated on the Mode of Operation screen an info line is appended to the list for each sent and received message. The list may be cleared with the Clear List button. actually opened Trace file name The file selection mask for trace files can be accessed by clicking on this field. Size of the actually opened trace file in bytes. actually opened Record file name The file selection mask for record files can be accessed by clicking on this field. Number of messages to send Communication Trace Window Sent messages are displayed in green, received messages in blue and error messages in red color. If the space character (code 20hex) within records is replaced by another character, this is indicated above the trace window. The icon right to the Communication Trace Window allows to enter a comment line which is written to the trace file. Status line Indication of the actual transition state (Idle, Transfer, Receive) and the active keys with time counter, if STEP mode is enabled).
9.3
Main Menu System
Record File
Open for Recording Close Delete Display/Edit/Parser/ Create Send Exit A file can be opened where all received records are stored. The file which was opened with the above option can be closed again. Record files which are no longer needed can be deleted from the hard disk. A record file (*.DAT) can be displayed, printed, searched, ... with a multi-functional text editor (see 3.1 for a description of the editor options). For starting the record editor you need to open an already existing DAT file. Any previously created record file can be sent via the serial interface. This option quits the program.
Trace File
Open for Recording Close Delete Display/Edit Extract Records Insert Comment Clear Window A file can be opened where the complete communication in both directions is stored with time and sender information. The above opened trace file can be closed with this option. Trace files which are no longer needed can be deleted from the hard disk. Any trace file can be displayed, printed, searched, ... with a multi-functional text editor (see 3.1 for a description of the editor options). All records of any trace file are extracted and written to a record file by this option. This option allows to enter a comment which is written to the actually open trace file. This option clears the trace window.
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Options
Interface Settings The tool may communicate via RS232 or TCP/IP. For the RS232 interface the baud rate, data-, stopbits, parity, COM port and kind of handshaking can be set on this screen. The TCP/IP communication is not yet evaluated ! This screen can also be opened by clicking on the RS232 parameter field on the main screen. The following settings can be done on this screen: the connected instrument enter the operators name the local device (HOST or INSTRUMENT) incl. the device names the colors for the trace messages enable/disable step mode enable/disable acoustical error signal enable/disable storage of received records in the instrument-specific database display one line for each sent or received message in a list control on the main screen definition what to send in case of host if there is no TS available in the database for a received request definition of a space replacement character for the trace display For Elecsys, the following settings can be done: decision which sample info items shall be echoed on a test request enable/disable storage of received manufacturer records in the database enable/disable storage of manufacturer records in the trace file For Modular, the following settings can be done: decision which sample info items shall be echoed on a test request activation of rules for a reflex testing if working as host Timer Settings Delimiters Low-Level Errors DB Access All timing and retry adjustments can be done on this screen. The four delimiter characters of the ASTM protocol can be selected with this option. Different kind of error simulation can be activated for testing the interface software of the connected device. This screen allows to take a look at the different database tables which contain the received data. Test selections and test selection requests can be generated and sent to the connected device. There are two options for the database in a pull-down menu available: Compress DB eliminates holes in the database file and decreases the file size. Store Column Width stores the actual column width of the displayed table after a manual adaptation. Create Report creates result reports, if the result table is displayed. The programs desktop language can be selected (German or English). This option initiates a short [ENQ] - [ACK] - [EOT] sequence for testing the communication, if the test program is connected to itself. This test is supported by the STA Compact, it is not supported by the Elecsys 2010 interface!
Mode of Operation
Desktop Communication Test
?
Help About This option gives access to the integrated online help for the test program itself as well as the two ASTM specification documents. An info window is displayed which also includes a button for displaying system information.
Clear Send Buffer
Clears all messages that are to be sent.
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9.4
Multifunctional text editor

For displaying record and trace files there is a text editor window which looks as follows:
Figure 9-2: Multifunctional text editor
The upper window displays the contents of the record or trace file. The lower window is an option of the record editor where the meaning and contents of the fields are displayed. The record/trace editor has a pull-down menu with the following options:
File
Open Save as Print Send Exit Another record/trace file can be opened. The modified file or a selected part of it can be stored in another file. The whole file, a selected part of it or the parser information (only for record files) can be written to the printer, a text file or the clipboard. (only available, if record files are displayed) The contents of the text window is sent to the other device. This option quits the text editor.
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Edit
Cut Copy Paste Delete Insert Trace Comment Insert Delay Provoke Wrong Checksum Provoke Wrong Frame Number The selected part of the text is cut and copied to the clipboard. The selected part of the text is copied to the clipboard. The contents of the clipboard is inserted at the cursor position. The selected part of the text is deleted. Enters !C at the actual cursor position. The text which may be entered after that expression is not sent but displayed in the trace file. Enters !D at the actual cursor position. The time in seconds which may be entered after that expression causes a delay during sending. Enters !S at the actual cursor position. This expression causes a checksum error in the following record during sending. Enters !F at the actual cursor position. This expression causes a wrong frame number in the following record during sending.
Search
Search text Search again Any expression can be searched in the text file. The above specified search is repeated.
Options
Parser (only available, if record files are displayed) If a record file is displayed the text window is divided into two parts. In the upper part, the record file is displayed, in the lower part the field information of the selected record is displayed. If the Parser option is deactivated, the text window increases to full height. (only visible, if record files are displayed and the program works as instrument simulator) All messages that the instrument can send during operation are offered in a option box. The selected message is displayed with default values in the text editor window and can be modified. (only visible, if record files are displayed and the program works as host simulator) All messages that the host sends during operation are offered in a option box. The selected message is displayed with default values in the text editor window and can be modified. On this screen the test selection default profile can be displayed, modified and stored in a separate file. With this option, the text editor window can be reduced to the half height. So it is possible to observe the trace window on the main screen while the text editor is open. If a record file is displayed and the small window is selected, the parser option is disabled.
Instrument Messages
Host Messages
Small/Large Window
?
Help Test List This option gives access to the integrated online help and the System Information window. If working as Elecsys or Modular the list of tests with test codes is displayed in a small list control.
9.5
Technical Details
9.5.1 Record editor rules

The record text file can contain more than one message (a message starts with the Header record, contains several data records and ends with the Termination record).
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Each message has to start with a Header record; otherwise it is not sent. The time delay between messages can be specified on the Timer Settings screen.
9.5.2 TCP/IP Communication

Beside the communication via the serial interface RS232 the simulator may also communicate via TCP/IP network. The corresponding setting is done on the Options/Interface Settings screen. Here you select between RS232 and Network interface. If RS232 is selected, the baud rate, port number, data-, stopbits and parity check may be selected. If Network is selected, there are three further options: Device works as ... TCP/IP Server (the other device needs to be TCP/IP Client) TCP/IP Client (the other device needs to be TCP/IP Server) TCP/IP UDP = User Datagram Protocol (the other device needs the same setting) According to the above listed options, you have to enter additional settings. If Server is selected, the local port number needs to be entered. This must be the same number than the remote port number of the client. After re-starting the simulator, a dialog is displayed which indicates the network options and the simulator as server waiting for a client to connect before he gives access to the program features. If Client is selected, the remote port number needs to be entered. This must be the same number as the local port number of the server. In addition the server's IP address (format: aaa.bbb.ccc.ddd) must be entered. After re-starting the simulator, a dialog is displayed which indicates the network options and the simulator as client needing to be connected to a listening server by pressing the [Connect] buttons. The User Datagram Protocol (UDP) is a connectionless protocol. Unlike TCP operations, computers do not establish a connection. Also, a UDP application can be either a client or a server. You have to enter the other device's IP address, the local port number (which must be entered as remote port number at the other device) and the remote port number (which must be entered as local port number at the other device). After re-starting the simulator, a dialog is displayed which indicates the network options and both devices needing to be connected before you get access to the program features.
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9.6
Data Flow of ASTM Test program
9.6.1 ELECSYS 2010

The tables on the following pages list the data flow options of the test program for the ELECSYS 2010 analyzer. Depending on whether the program works as Host or Instrument simulator it is shown which messages can be generated, modified and sent with which option. (mm) (mr) (sr) each selected DB entry is sent in a separate message each selected DB entry is sent in a separate record within one message if more than one entry is selected only the first will be sent
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INSTrument Mode:
Messages Records Record Editor (Requests) RecordEditor (Data)
Edit and send Edit and send
Send out of DB
answer requests
DB write
Calibration Result Calibration Parameters Control Parameters Diluent Parameters Instrument Config Instrument Status Log File
CR XT, CP XT, QP XT, DP IC IS LF
Store received data Store received data Store received data Store received data
Edit and send Edit and send Edit and send Edit and send
Select DB and send (sr) Select DB and send (sr) Select DB and send (lf) Select DB and send (sr)
send 1. entry of DB on request send 1. entry of DB on request send on request with date and category check
Store received data Store received data Store received data
Processing Message Request Cancel Sample Status Service Data Substance Data Test Application Test Conditions Test Results
PM
Store received data
SS SD XT TA TC
Select DB and send (sr) Select DB and send (sr)
send 1. entry of DB on request send 1. entry of DB on request
Select DB and send (sr) Edit and send Edit and send Select DB and send (mr) Select DB and send (mr) send 1. Entry or all of DB on request
Store received data Store received data
P, O, R
Result Context RC Raw Result Test Selection RR Q, P, O edit and send TS Requests Select Request DB and send (mm)
store received TS data create No. of requests
Table 9-1: Data flow options for the ELECSYS 2010 analyzer; Instrument Mode
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HOST Mode:
Messages Records Record Editor (Requests) RecordEditor (Data) DB read DB write
Calibration Result Calibration Parameters Control Parameters Diluent Parameters Instrument Config Instrument Status Log File Processing Message Request Cancel Sample Status Service Data
CR XT, CP XT, QP XT, DP IC IS LF PM Edit and send request SS SD Edit and send request Edit and send request Edit and send request Edit and send request Edit and send request Edit and send request Edit and send request Edit and send request Edit and send request Edit and send Edit and send Edit and send
Store received data Store received data Store received data Store received data Store received data Store received data Store received data Store received data
Substance Data XT Test Application Test Conditions Test Results Result Context Raw Result Test Selection TA TC P, O, R RC RR Q, P, O
Edit and send request Edit and send request
Edit and send
Edit and send
select DB and send (mm) store received request send on request, if create No. of TS available, or default TS if enabled
Table 9-2: Data flow options for the ELECSYS 2010 analyzer; Host Mode
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9.6.2 ELECSYS 1010

The tables on the following pages list the data flow options of the test program for the ELECSYS 1010 analyzer. Depending on whether the program works as Host or Instrument simulator it is shown which messages can be generated, modified and sent with which option. (mm) (mr) (sr) each selected DB entry is sent in a separate message each selected DB entry is sent in a separate record within one message if more than one entry is selected only the first will be sent
INSTrument Mode:
Messages Records Record Editor (Requests) RecordEditor (Data)
Edit and send
Send out of DB
answer requests DB write
Calibration Parameters Control Parameters Diluent Parameters Instrument Config Instrument Status Log File
XT, CP XT, QP XT, DP IC IS LF
Edit and send Edit and send Edit and send Edit and send Edit and send
Select DB and send (sr) Select DB and send (sr) Select DB and send (lf) Select DB and send (sr) Select DB and send (sr)
send 1. entry of DB on request send 1. entry of DB on request
send on request with Store received data date and category check Store received data send 1. entry of DB on request Store received data Store received data
Processing Message Service Data Substance Data Test Application Test Conditions Test Results
PM SD XT TA TC P, O, R
Select DB and send (sr) Edit and send Edit and send Edit and send Edit and send edit and send TS Requests Select Request DB and send (mm) Select DB and send (mr) Select DB and send (mr) send 1. Entry or all of DB on request
Store received data Store received data Store received data Store received data Store received data store received TS data create No. of requests
Result Context RC Raw Result Test Selection RR Q, P, O
Table 9-3: Data flow options for the ELECSYS 1010 analyzer; Instrument Mode
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HOST Mode:
Messages Records Record Editor (Requests) RecordEditor (Data) DB read DB write
Calibration Parameters Control Parameters Diluent Parameters Instrument Config Instrument Status Log File Processing Message Service Data Substance Data
XT, CP XT, QP XT, DP IC IS LF PM SD XT Edit and send request Edit and send request Edit and send request Edit and send request Edit and send request Edit and send request Edit and send request Edit and send
Store received data Store received data Store received data Store received data Store received data Store received data Store received data Store received data Store received data Store received data Store received data Store received data Store received data Store received data Edit and send select DB and send (mm) send on request, if available, or default TS if enabled store received request create No. of TS
Test Application TA Test Conditions Test Results Result Context Raw Result Test Selection TC P, O, R RC RR Q, P, O
Table 9-4: Data flow options for the ELECSYS 1010 analyzer; Host Mode
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9.6.3 STA, STA-C, STA-R

The tables on this page list the data flow options of the test program for the STA analyzer. Depending on whether the program works as Host or Instrument simulator it is shown which messages can be generated, modified and sent with which option. INSTrument Mode:
Messages
Worklist Worklist Request Result
Records
P,O Q P,O,R,M
Send out of RecordEditor
Send out of DB
answer requests
DB write
Store received data
Table 9-5: Data flow options for the STA analyzer; Instrument Mode
HOST Mode:
Messages
Worklist Worklist Request Result
Records
P,O Q P,O,R,M

Edit and send
Send out of DB
Edit and send
answer requests
DB write
Send worklist if available
Table 9-6: Data flow options for the STA analyzer; Host Mode
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9.6.4 Cardiac Reader

The tables on the following pages list the data flow options of the test program for the Cardiac Reader. Depending on whether the program works as Host or Instrument simulator it is shown which messages can be generated, modified and sent with which option. INSTrument Mode:
Messages
TS Request Test Selection Result Request Result Action Request Inst Config Request Inst Configuration Inst Status Request Inst Status Proc Message Request Proc Message Subst Data Request Substance Data
Records
Q P,O Q P,O,R,C AR
Send out of Record-Editor
Send out of DB
Edit and send
answer requests
DB write
Store received data
Edit and send Send confirmation Edit and send Send first DB entry if available
Action Confirmation AC ICQ IC ISQ IS PMQ PM XTQ XT
Edit and send
Edit and send Send first DB entry if available
Store received data
Edit and send
Edit and send Send first DB entry if available
Store received data
Edit and send
Edit and send Send DB entry if available
Store received data
Edit and send

Table 9-7: Data flow options for the Cardiac Reader; Instrument Mode
Store received data
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HOST Mode:
Messages
TS Request Test Selection Result Request Result Action Request Inst Config Request Inst Configuration Inst Status Request Inst Status Proc Message Request Proc Message Subst Data Request Substance Data
Records
Q P,O Q P,O,R,C AR ICQ IC ISQ IS PMQ PM XTQ XT
Send out of DB
Edit and send
answer requests
DB write
Edit and send Store received data Edit and send Edit and send Edit and send Edit and send Store received data Edit and send Store received data Edit and send Edit and send
Table 9-8: Data flow options for the Cardiac Reader; Host Mode
Edit and send
Send confirmation Store received data
Action Confirmation AC Edit and send
Store received data
Store received data
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9.6.5 Modular
The tables on this page list the data flow options of the test program for the Modular analyzer. Depending on whether the program works as Host or Instrument simulator it is shown which messages can be generated, modified and sent with which option. INSTrument Mode:
Messages Records Send out of Record-Editor
Edit and send
Send out of DB
Edit and send
answer requests
DB write
Realtime TS Request P,Q Routine Test Selection Result Request Routine Result Photo Calib Result ISE Calib Result Absorbance Result P,O P,Q P,O,R,C M M P,O,R,C,M
Store received data Send result if available Edit and send Edit and send Edit and send Edit and send Edit and send Edit and send Edit and send Edit and send Store received data Store received data Store received data Store received data Store received data
Table 9-9: Data flow options for the Modular analyzer; Instrument Mode
HOST Mode:
Messages Records Send out of Record-Editor
Edit and send Edit and send Store received data Store received data Store received data Store received data
Send out of DB
Edit, send and create
answer requests
Send TS if available
DB write
Store received data
Realtime TS Request P,Q Routine Test Selection Result Request Routine Result Photo Calib Result ISE Calib Result Absorbance Result P,O P,Q P,O,R,C M M P,O,R,C,M
Table 9-10: Data flow options for the Modular analyzer; Host Mode
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9.6.6 VS II
The tables on this page list the data flow options of the test program for the Aliquoter VS II. Depending on whether the program works as Host or Instrument simulator it is shown which messages can be generated, modified and sent with which option. INSTrument Mode:
Messages
Test Selection TS Request Sort List
Records
P,O Q LI
Send out of DB
answer requests
DB write
Store received data
Table 9-11: Data flow options for the Aliquoter VS II; Instrument Mode
HOST Mode:
Messages
Test Selection TS Request Sort List
Records
P,O Q LI

Edit and send
Send out of DB
Edit and send
answer requests
DB write
Send TS if available
Table 9-12: Data flow options for the Aliquoter VS II; Host Mode
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9.6.7 LSM
The tables on this page list the data flow options of the test program for the LSM. Depending on whether the program works as Host or Instrument simulator it is shown which messages can be generated, modified and sent with which option. INSTrument Mode:
Messages
Test Selection TS Request Test Results
Records
P,O Q P,O,R,C
Send out of DB
answer requests
DB write
Store received data
Table 9-13: Data flow options for the LSM; Instrument Mode
HOST Mode:
Messages
Records
P,O Q P,O,R,C

Edit and send
Send out of DB
Edit and send
answer requests
DB write
Send all TS if ALL request
Table 9-14: Data flow options for the LSM; Host Mode
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9.6.8 PSM
The tables on this page list the data flow options of the test program for the PSM. Depending on whether the program works as Host or Instrument simulator it is shown which messages can be generated, modified and sent with which option. INSTrument Mode:
Messages
Records
P,O Q P,O,R
Send out of DB
answer requests
DB write
Store received data
Table 9-15: Data flow options for the PSM; Instrument Mode
HOST Mode:
Messages
Test Selection TS Request
Records
P,O Q

Edit and send
Send out of DB
Edit and send
answer requests
DB write
Send all TS if ALL request search sampleID search patientID, if sampleID is empty
Store received data
Test Results
P,O,R
Store received data
Table 9-16: Data flow options for the PSM; Host Mode
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9.6.9 Amplilink
The tables on this page list the data flow options of the test program for the Amplilink. Depending on whether the program works as Host or Instrument simulator it is shown which messages can be generated, modified and sent with which option. INSTrument Mode:
Messages
Test Selection Result Request Test Results
Records
P,O Q P,O,R
Send out of DB answer requests
DB write
Edit and send
Edit and send
As answer to result request
Table 9-17: Data flow options for the Amplilink; Instrument Mode
HOST Mode:
Messages
Test Selection Result Request Test Results
Records
P,O Q P,O,R

Send out of DB answer requests

DB write
Store received data
Table 9-18: Data flow options for the Amplilink; Host Mode
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9.7
Software Updates of the ASTM Host Interface Test Tool

Version 1.01 Distributed to the participants of the Host Interface Training from 22.4. to 26.4.96 in Mannheim Version 1.02
BUG BUG BUG BUG NEW NEW NEW
If in the 'Low-Level Errors' screen the 'Send [ENQ]' or 'Send [NAK]', close and open again before the error simulation takes place, the program aborts with an error message (Error No. 5). When sending a test selection out of the database the first test number and dilution factor were '^^^N^R' because of accessing the wrong table columns. When sending a test selection out of the database and a test number is set but the corresponding dilution factor cell is empty, a '0' is sent. The font style for the editor print option is set to 'Courier New'. The parser also lists the contents of components within a field. If enabled on the 'Record Editor/Options/Parser' screen an additional list box appears within the parser window where the field name and, if available the different options of that field are displayed. The use of a TS default profile can be enabled on the 'Options/Operating Mode' screen. The default profile can be generated with the Record Editor and stored with the 'Store TS default profile' button on the 'Host Messages' screen. On this screen there is also the option to display the actual TS default profile. With the Record editor the following control lines may be inserted before any record: !C ccccc ... = Trace comment line ccccc !D d = Delay time d seconds !F f = Wrong frame number f !S x = Wrong Checksum x times; 1 time if x is missing A new option on the 'Mode of Operation' screen allows to specify a character by entering the character code, which replaces the space (20hex) within records when displaying them in the trace window or storing them in the trace file. A new option on the 'Mode of Operation' screen allows to disable the storage of manufacturer defined records in the trace file. The records are still displayed in the trace window but not stored in the trace file. When sending result entries as INSTrument out of the database, there is the option of sending all results of the selected sample in the result table or only the selected results. Implementation of all test program features for the STA/STA Compact coagulation analyzer. Parser, Access DB, Record-Editor Message generation support, realtime requests. The instrument is selected on the Mode of Operation screen. Each instrument has its own host and instrument names for the trace file in the ASTM.INI file.
NEW
NEW
NEW NEW NEW
Version 1.03
BUG
If a large trace or record file (> 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. 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.
NEW
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Version 1.04
BUG BUG BUG
On the Options > RS232 Parameters screen the handshake options Xon/Xoff and RTS/CTS were exchanged. If a TA frame with empty application data was received the program was terminated with an error message. 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. There are menu options for opening help files that contain the ASTM Specifications 1394 and 1381 in the Help menu. There are different device names (host and instrument) stored for each supported instrument.
NEW NEW
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. 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. The records of the trace file of the CAEV evaluation system can also be extracted with the trace extract function.
NEW NEW
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 NEW NEW
The delimiter definition within the Header record was misinterpreted in the parser window. The two ASTM Specification help files have been updated. 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 BUG BUG 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. 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. The TS Request/TS Info handling after Contention was improved. 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 BUG
If the Editor screen was left via the Close menu option of the Control box, the software crashed. 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. 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. 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. On the Operation Mode screen the colors for host and instrument trace messages can be selected. Different instrument icons on the main screen. There is an additional System Info window available on the Info screen.
NEW NEW
NEW NEW NEW
Version 1.11
NEW NEW
The Elecsys 1010 is implemented. It can be selected on the Operation Mode screen. There is a separate database and parser info file. 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. 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. 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.
NEW NEW
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Version 1.2
BUG BUG NEW NEW NEW NEW
In the German version, the Parity options Gerade and Ungerade have been exchanged. The software crashed, if in Host mode DB Access was disabled and requests have been received. The instrument icons are integrated in the software. They are no longer included as ICO files. The sequence No. is echoed within the test selection message from host to the ELECSYS. 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. The actual trace file size is displayed below the trace file name.
Version 1.3
NEW 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. 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. A comment above the trace window indicates an active error simulation. 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. 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.
NEW NEW
NEW
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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. 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). In Elecsys 2010-Host mode, the tool displayed an error message as soon as it received a Request Record with empty ID field.
BUG BUG
Version 1.7
BUG
There were invalid time values within the Communication Trace when the tool was activated over midnight.
Version 2.0
BUG BUG NEW NEW
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. The Parser Information files for the Elecsys 2010 is adapted to Host Manual version 3.x. 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. 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 BUG BUG
When working as host the simulator sent two L records within the test selection message as answer to a realtime request. The trace time is now identical with the system time. The cancel request message (Status A) really cancels a previous TS request (=> the TS message is not sent). The Modular was added as new instrument. The tool was developed with VB 5.0 and therefore needs a 32-bit operating system like Windows 95 or Windows NT. TCP/IP was implemented as an alternative to the RS232 interface.
NEW NEW NEW
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 BUG BUG
All BM Test Number fields in all tables of database E20_DATA.MDB (Elecsys 2010) have been enlarged to 4 characters. Simulator as Modular Host appends all component delimiters in the third field of the order record. 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. It is possible to start more than one instance of the program. The main screen of the program may be minimized.
NEW NEW

BUG
The Operation Mode screen is displayed again.

BUG BUG BUG
When sending TS request as Modular the P record was missing. When sending TS request as Modular the ID field is enlarged to 13 characters by leading spaces. 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 NEW NEW NEW NEW NEW NEW
For serial communication COM ports 1 to 10 may be selected (if available via interface board and Windows configuration). The selection of the type of handshake was removed from the Interface Setting screen. No handshake is taken as default. The TCP/IP functionality was improved. 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. If the Modular TS request has an empty ID field the TestSelection database is searched for matching sequence number. If the result message from the Modular contains Absorbance data, they are written to the database. !!!! Structure of MOD_DATA.MDB was changed !!!! 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 NEW
The simulator as LSM host stores all results of a multi-order result message. 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 NEW
When working as Modular host it is possible to activate and define rules for a reflex testing. The Trace File / Extract Records function also extract records from Modular communication trace files.

NEW NEW
Length of port numbers on the TCP/IP setting screen was increased from 4 to 5 digits. Address on the About window was changed.

BUG BUG NEW NEW
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. Within the record editor the key combination Crtl+V inserted the clipboard text two times. Cardiac Reader as instrument option implemented. 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 !!! 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. 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. The line wrap feature within the record editor window was disabled so that each complete record is displayed in one line.
NEW NEW NEW
Version 3.5 April 1999

BUG BUG
After sending two messages out of the database table the main menu options remained disabled. 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 NEW
The Aliquoter VS II is supported. 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 NEW NEW NEW NEW NEW NEW NEW NEW
The software does not hang up anymore if a message only consists of [NUL] characters. The PSM is supported. The Roche ASTM Standard as Instrument was removed. Manufacturer records for Elecsys 1010 are implemented. Frames around the device icons and the date/time on the main screen. 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. 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. The database tables may be sorted by clicking on the header of the corresponding column. 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. 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. The Amplilink is supported.
NEW
NEW
Databases incompatible with former version !!! Full Installation necessary !!!
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Indexes
10
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 4.01 Version 11/00 10-291
Indexes
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
10-292
Indexes
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
10-293
Indexes
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 4.01 Version 11/00 10-294
Indexes
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
10-295
Indexes
10-296
Glossary
11
Glossary
ASTMReference Description
Definition
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^ChicagoÎL^60305ÛSA. The country needs only to be transmitted when it cannot be assumed from the context. The components of this field are position dependent. 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. 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 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. 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. 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. 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.
battery
3.1.02
component field
3.1.07
data record usage overview
6.5
dates and times
6.6.02
delimiter, component delimiter
6.4.05
delimiter, escape delimiter
6.4.06
11-1
Glossary
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. Carriage return (ASCII 13) is the delimiter for the end of any of the defined record types. 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. 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. 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. Data transmitted from a computer system to a clinical instrument. One specific attribute of a record which may contain aggregates of data elements further referring the basic attribute. 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 patients 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.
delimiter, record delimiter delimiter, repeat delimiter
6.4.02 6.4.04
delimiter, specification of delimiters
6.4.07
delimiters for null values
6.4.08
download field fields of no concern to the receiving system
3.1.09 3.1.05 6.4.09
fields with null values
6.4.10
11-2
Glossary
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. 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 A textual body of information. 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. 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. An aggregate of fields describing one aspect of the complete message. 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). 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. 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.
manufacturer's or local code (part 4)
6.6.01.4
message multiple phone numbers provider and user IDs
3.1.01 6.6.03.1
6.6.06
record record sequence number
3.1.04 6.6.07
record, comment (C)
6.5.05
record, manufacturer information (M)
6.5.08
11-3
Glossary
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. This record type contains information about an individual patient. 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. Each result contains the results of a single analytic determination. This record is used to exchange results between clinical sites for the purposes of proficiency testing or method development. 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). 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. Phone numbers are recorded as free text, which may contain extensions such as area code, country code, beeper number, hours to mail, etc. 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. 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. 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.
record, patient identifying (P) record, request information (Q)
6.5.02 6.5.06
record, result record, scientific (S) record, test order (O)
6.5.04 6.5.07 6.5.03
repeat field
3.1.06
telephone numbers test
6.6.03 3.1.03
time zone
6.6.02.1
universal test ID
6.6.01
11-4
Glossary
Definition
ASTMReference
Description
universal test ID (part 1) universal test ID name (part 2) universal test ID type (part 3) Upload
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. This would be the test or battery name associated with the universal test ID code described in 6.6.1.1. 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. Data transmitted from a clinical instrument to a computer system.
6.6.01.2 6.6.01.3
3.1.08
11-5
Glossary
Personal Notes:
11-6
Glossary
Personal Notes:
11-7
Glossary
Personal Notes:
11-8
Glossary
Personal Notes:
11-9

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Roche Diagnostics GmbH Elecsys Analyzer Host Interface Manual

Elecsys Analyzer Host Interface Manual ID No. 1804022-001

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Document: RDElec4_01 Final.doc

Elecsys Host Interface Manual

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TRADEMARKS AND COPYRIGHTS

released not released

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HOW TO ... ...................................................................................................................2-15

THEORY OF OPERATION ..........................................................................................3-29

ENGINEERING REFERENCE ......................................................................................4-69

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EXAMPLES ............................................................................................................... 6-165

ASTM DESIGNATION: E 1381 - 91...................................................................... 7-201

Elecsys Host Interface Manual

7.6.2 7.6.3 7.6.4 7.6.5 7.6.6 7.7

ASTM DESIGNATION: E 1394 - 91.......................................................................8-217

HOST INTERFACE SIMULATOR FOR THE ASTM PROTOCOL.........................9-263

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Multifunctional text editor .........................................................................................................9-267

INDEXES .............................................................................................................. 10-291

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How to read this Manual

1.1.1 Intended Audience

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1.1.2 Documentation Conventions

Table 1-1: Special Typefaces

1.1.3 Further Help

+49 621 / 759-4204 +49 621 / 759-4394

E-Mail: peter.centner@roche.com thomas.meckel@roche.com guenter.knoop@roche.com

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Short Description of Elecsys 2010

Top Cover (left)

Top Cover (right)

Distilled Water Bar Code Reader Tips Sample Disk Cups

Operation Switch Figure 1-1: Elecsys 2010 Disk Version

Floppy Disk Drive & Solid Waste

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Figure 1-2: Elecsys 2010 Rack Version

Short Description of Elecsys 1010

ProCell & CleanCell

Distilled water container

Liquid Waste Container

Control unit Printer

Figure 1-3: Elecsys 1010

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Features of the Elecsys Host Interface