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Document: RDElec4_01 Final.doc
Roche Diagnostics GmbH
Elecsys
Analyzer
Host Interface Manual
Elecsys
Analyzer Host Interface Manual
ID No. 1804022-001
V 4.01 Version 11/00
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Elecsys
Host Interface Manual
V 4.01 Version 11/00 I
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 19428-
2959, U.S.A
VERSIONSVersion Date Software Modi ficat ions
1.0 June 96 released corrections by RD as regard contents;re-format
1.4 May 97 not released 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)
2.0 Aug. 97 released review to version 2.x (mainly chapter 4)
3.0 Mar. 98 not released update to version 2.x (chapter 4.3.6, 4.3.7)- protocol changes Elecsys 2010- add LSM- Assay Reference Table 5.1- Auto Dilut ion Reference Table 5.2
4.0 August 00 update to version 4.0, changes in CI,add new features of Elecsys 1010 (batch, query modeand MSRs)
4.01 Nov. 00 inclusion of minor corrections
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.
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Elecsys
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Table of Contents
1 INTRODUCTION ...........................................................................................................1- 9
1.1 How to read this Manual ................................................................................................................1- 9
1.1.1 Intended Audience..................................................................................................................................................1-91.1.2 Documentation Conventions.............................................................................................................................1-101.1.3 Further Help.............................................................................................................................................................1-10
1.2 Short Descr ipt ion of Elecsys 2010 .............................................................................................1-11
1.3 Short Descr ipt ion of Elecsys 1010 .............................................................................................1-12
1.4 Features of the Elecsys Host Interface......................................................................................1- 13
2 HOW TO ... ...................................................................................................................2- 15
2.1 ... use the Interface for Elecsys 2010.........................................................................................2-152.1.1 ... connect the Interface for Elecsys 2010.....................................................................................................2-15
2.1.2 ... set up the Interface for Elecsys 2010........................................................................................................2-152.1.3 ... operate the Interface of Elecsys 2010.......................................................................................................2-18
2.2 ... use the Interface for Elecsys 1010.........................................................................................2-202.2.1 ... connect the Interface for Elecsys 1010.....................................................................................................2-202.2.2 ... set up the Interface for Elecsys 1010........................................................................................................2-202.2.3 ... operate the Interface of Elecsys 1010.......................................................................................................2-26
2.3 ... do Troubleshooting and Maintenance ..................................................................................2- 27
3 THEORY OF OPERATION ..........................................................................................3- 29
3.1 Overview of the Interface.............................................................................................................3- 29
3.2 Descript ion of Transmission Protocol .......................................................................................3-293.2.1 Basics..........................................................................................................................................................................3-293.2.1.1 OSI model.............................................................................................................................................................3-293.2.1.2 ASTM......................................................................................................................................................................3-313.2.1.3 Description of Terms Specific to ASTM...................................................................................................3-33
3.2.2 Application Layer...................................................................................................................................................3-343.2.2.1 Types of Events..................................................................................................................................................3-343.2.2.2 Event Related Data Processing...................................................................................................................3-383.2.2.3 Message Priorities............................................................................................................................................3-393.2.2.4 Events.....................................................................................................................................................................3-393.2.2.5 Error Detection and Recovery......................................................................................................................3-41
3.2.3 Presentation Layer.................................................................................................................................................3-453.2.3.1 Message Structure: Records........................................................................................................................3-45
3.2.3.2 Message Structure: Fields.............................................................................................................................3-513.2.3.3 Common Field Types:......................................................................................................................................3-54
3.2.4 Data Link Layer.......................................................................................................................................................3-553.2.4.1 General Description.........................................................................................................................................3-553.2.4.2 Establishment Phase (Link Connection)..................................................................................................3-563.2.4.3 Transfer Phase....................................................................................................................................................3-613.2.4.4 Termination Phase (Link Release) .............................................................................................................3-643.2.4.5 Frame Format......................................................................................................................................................3-64
3.2.5 Physical Layer..........................................................................................................................................................3-66
3.3 Example ...........................................................................................................................................3- 663.3.1 Test Selection for New Sample ID..................................................................................................................3-663.3.2 Upload Results after Tests are Performed...................................................................................................3-67
4 ENGINEERING REFERENCE......................................................................................4- 69
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4.4.2.12 Service Data Message............................................................................................................................4-1494.4.2.13 Processing Message................................................................................................................................4-1494.4.2.14 Action Request / Action Confirmation Message.........................................................................4-150
4.4.3 Trigger events (Overview)...............................................................................................................................4-151
4.5 Test Select ion via Specific Test Number ................................................................................4-1544.5.1 Get Test Numbers from Test Condition Message:................................................................................4-154
5 TABLES...................................................................................................................... 5- 155
5.1 Assay Reference Table Version 1.48.......................................................................................5-155
5.2 Auto Di lut ion Reference Table..................................................................................................5-1595.2.1 General Specification:.......................................................................................................................................5-1595.2.2 Detailed Specification.......................................................................................................................................5-159
5.3 Alarm Flags Elecsys 2010 ..........................................................................................................5-160
5.4 Alarm Flags Elecsys 1010 ..........................................................................................................5-162
6 EXAM PLES ............................................................................................................... 6- 1656.1 Trace Examples Standard Records ..........................................................................................6-165
6.1.1 Trace: Test Selection Disk Version..............................................................................................................6-1656.1.2 Trace: Test Selection Rack Version (1st sample without bar-code)..............................................6-1666.1.3 Trace: Test Selection Batch Mode (Elecsys 1010).................................................................................6-1696.1.4 Trace: Test Selection Batch Mode (Elecsys 2010).................................................................................6-1696.1.5 Trace: Result Message......................................................................................................................................6-170
6.2 Trace Examples Standard Records ..........................................................................................6-1736.2.1 Trace: Batch Result Upload from Result Screen....................................................................................6-1736.2.2 Trace: Host Cancels Test Selections (Example for Contention) ......................................................6-1756.2.3 Trace: Sample Scan............................................................................................................................................6-176
6.3 Trace Examples Manufacturer Specific Records..................................................................6-1816.3.1 Trace: Reagent Scan..........................................................................................................................................6-1816.3.2 Trace: Substance Data Message..................................................................................................................6-1866.3.3 Trace: Calibrator Parameters Message......................................................................................................6-1916.3.4 Trace: Control Parameters Message...........................................................................................................6-1926.3.5 Trace: Calibration Data Message.................................................................................................................6-1936.3.6 Trace: Instrument Status Message..............................................................................................................6-1936.3.7 Trace: Test Conditions Message...................................................................................................................6-1946.3.8 Trace: Test Application Message.................................................................................................................6-1956.3.9 Trace: Instrument Configuration Message...............................................................................................6-1966.3.10 Trace: Service Data Message........................................................................................................................6-1976.3.11 Trace: Processing Message............................................................................................................................6-199
7 ASTM DESIGNATION: E 1381 - 91 ...................................................................... 7-201
7.1 Scope .............................................................................................................................................7- 202
7.2 Referenced Documents..............................................................................................................7-203
7.3 Terminology..................................................................................................................................7-203
7.4 Significance and Use..................................................................................................................7-204
7.5 Physical Layer ..............................................................................................................................7-2047.5.1 Overview Physical Layer...................................................................................................................................7-2047.5.2 Electrical Characteristics..................................................................................................................................7-2057.5.3 Mechanical Characteristics............................................................................................................................7-206
7.6 Data Link Layer ............................................................................................................................7-2087.6.1 Overview Data Link Layer...............................................................................................................................7-208
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7.6.2 Establishment Phase (Link Connection) ....................................................................................................7-2087.6.3 Transfer Phase......................................................................................................................................................7-2097.6.4 Termination Phase (Link Release)................................................................................................................7-2117.6.5 Error Recovery.......................................................................................................................................................7-2127.6.6 Restricted Message Characters.....................................................................................................................7-213
7.7 Appendix 1: STATE DIAGRAM ..................................................................................................7-214
7.8 Appendix 2: Seven-Bit ASCII Code Charts ............................................................................7- 2157.8.1 Appendix 2.1: Decimal Character Code.....................................................................................................7-2157.8.2 Appendix 2.2: Hexadecimal Character Code............................................................................................7-216
8 ASTM DESIGNATION: E 1394 - 91.......................................................................8-217
8.1 Scope.............................................................................................................................................8- 217
8.2 Referenced Documents .............................................................................................................8-218
8.3 Terminology .................................................................................................................................8- 2188.3.1 Description of Terms Specific to this Standard:......................................................................................8-218
8.4 Significance and Use .................................................................................................................8-2198.4.1 General Information:...........................................................................................................................................8-219
8.5 Information Requirements in Clinical Testing ......................................................................8-2218.5.1 General Approach...............................................................................................................................................8-2218.5.2 Logical Structure of the Message Level Protocol ..................................................................................8-223
8.6 Message Content - General Considerations.........................................................................8-2258.6.1 Character Codes ..................................................................................................................................................8-2258.6.2 Maximum Field Lengths...................................................................................................................................8-2268.6.3 Maximum Record Length.................................................................................................................................8-2268.6.4 Delimiters................................................................................................................................................................8-2268.6.5 Data Record Usage Overview.........................................................................................................................8-2298.6.6 Common Field Types..........................................................................................................................................8-2308.6.7 Examples of Basic Record Types...................................................................................................................8-232
8.7 Message Header Record...........................................................................................................8- 237
8.8 Patient Information Record.......................................................................................................8-239
8.9 Test Order Record .......................................................................................................................8-2448.9.1 Multiple Orders.....................................................................................................................................................8-2448.9.2 General Applications..........................................................................................................................................8-245
8.10 Result Record ..............................................................................................................................8- 251
8.11 Comment Record ........................................................................................................................8- 254
8.12 Request Informat ion Record.....................................................................................................8-255
8.13 Message Terminator Record ....................................................................................................8- 258
8.14 Scient if ic Record.........................................................................................................................8- 259
8.15 Manufacturer Informat ion Record ..........................................................................................8-261
8.16 APPENDIX - Non mandatory Information ..............................................................................8-2628.16.1 X1. Comparison of Specifications E1238 and E1394.............................................................................8-262
9 HOST INTERFACE SIM ULATOR FOR THE ASTM PROTOCOL.........................9-263
9.1 Purpose of the ASTM Interface Test Tool ..............................................................................9-263
9.2 Main Screen of the Test Tool....................................................................................................9-264
9.3 Main Menu System ....................................................................................................................9-265
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9.4 Mult ifunctional text editor .........................................................................................................9-267
9.5 Technical Details .........................................................................................................................9-2689.5.1 Record editor rules.............................................................................................................................................9-2689.5.2 TCP/IP Communication....................................................................................................................................9-269
9.6 Data Flow of ASTM Test program ............................................................................................9-270
9.6.1 ELECSYS 2010......................................................................................................................................................9-2709.6.2 ELECSYS 1010......................................................................................................................................................9-2739.6.3 STA, STA-C, STA-R.............................................................................................................................................9-2759.6.4 Cardiac Reader....................................................................................................................................................9-2769.6.5 Modular...................................................................................................................................................................9-2789.6.6 VS II...........................................................................................................................................................................9-2799.6.7 LSM ..........................................................................................................................................................................9-2809.6.8 PSM ..........................................................................................................................................................................9-2819.6.9 Amplilink.................................................................................................................................................................9-282
9.7 Software Updates of the ASTM Host Interface Test Tool ...................................................9-283
10 INDEXES ..............................................................................................................10-291
10.1 Tables..........................................................................................................................................10-291
10.2 Figures ........................................................................................................................................ 10-293
10.3 Record Names........................................................................................................................... 10-294
11 GLOSSARY...............................................................................................................11- 1
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1 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 M anual1.1.1 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
facil itate information retr ieval 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 operat ion" 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" i s 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 wil l most likely refer to this section.
Section 5 "Tables" is reference oriented. It contains addit ional information to all
sections.
Section 6 "Examples" contains traces recorded with a simulator and/or host test
tools.
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1.1.2 Documentation Conventions
This manual uses the following special typefaces:
Typeface Meaning
Special font This font is used for system and screen output,such as prompt signs and screen messages.
Italic and special font This font is used for user input, such ascommands, options to commands andarguments.
Table 1-1: Special Typefaces
1.1.3 Further Help
In case of questions or diff iculty 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: + 49 621 / 759- 4204
Fax: +49 621 / 759-4394
E-Mail: [email protected]
US Roche Response Center Customer Technical Support:
Tel: 800428 - 236
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1.2 Short Descriptio n of Elecsys 2010Elecsys 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 handl ing 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 stabili ty. 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.
Figure 1-1: Elecsys 2010 Disk Version
Elecsys 2010 is especially suited for use in medium to large size laboratories. By means
of theLaboratory-System-M anager (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).
User Interface
Top Cover (left)Top Cover (right)
Sample Disk
Operation Switch
Circuit breaker
Incubator
System Reagents
Distilled Water
Liquid Waste
Floppy Disk Drive &Solid Waste
Tips
Cups
Reagent Disk
Bar Code Reader
Interface Connector
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Figure 1-2: Elecsys 2010 Rack Version
1.3 Short Descrip tion o f Elecsys 1010The 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.
Figure 1-3: Elecsys 1010
S/R Arm
Disti lled watercontainer
S/R Disk
Printer
Liquid Waste
Container
Control unit
ProCell & CleanCell
MeasuringCell
Sipper armIncubator
S/R
Probe
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Operation of the analyzer is easy and intuitive. The reagents are stable and can
generally be directly loaded on to the analyzer system. The consistent use of bar-coded
reagents greatly reduces the need for time consuming manual inputs when performing
the daily routine. Additional automation can be achieved by connecting a laboratory
EDP system.
Serum and plasma samples in primary tubes or secondary cups on tubes can be used.
Bar-coded sample tubes are recognized. There are also two STAT positions available
for STAT samples.
Results are produced either qualitative or quantitative depending on the test. The
typical test throughput is 50 results per hour.
1.4 Features of the Elecsys Host Int erface 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 thehost (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, quali ty control
and calibration data.
Combined with the Laboratory Systems Manager (not available in US) you can
take full control of those available data in a comfortable way. Since there is no need
for interpretation the host ignores this data according to the ASTM specifications.
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2 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 20102.1.1 ... 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 i s 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 forcommunication setup
Figure 2-1: UTIL Screen
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The DOCUMENTATION SETUP screen offers the operator options for managing
results: Print and/or Upload to the Host. This setup influences what should be
performed when the DOC key or the document all button is touched or when
automatic documentation i s performed.
To set up automatic upload of test results to the host computer
touch the UTIL screen button
touch the DOCUMENTATION SETUP screen
touch the "Print/Upload" or "Upload" button.
touch the "Automatic ON" to receive requests as soon as they are available or the
"Automatic OFF" button to manually send results.
Figure 2-2: DOCUMENTATION SETUP screen
To enter or change the setup parameters
touch the UTIL screen button
touch the INTERFACE SETUP screen button
touch the "Communication Off" button if communication is on.
touch the buttons for setting the correct values (color must be cyan)
Baud Rate 2400, 4800, 9600, 19200
Data Bits 7,8
Stop Bits 1,2
Parity none, odd, even and
Sync on, off
touch the "Communication On" button to reini tialize communication.
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Figure 2-3: INTERFACE SETUP screen
Note: Only the buttons that are actually colored cyan (light blue) are active, i.e.
can be selected.
Figure 2-4: Screen "Communication Confirmation"
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2.1.3 ... operate the Interface of Elecsys 2010
The need for operator interaction during up- and downloads depends on the mode in
which the interface is running.
In general all pending information, mostly manufacturer specific information will be
sent when the communication is switched on. While the host can download test
selections any time as batch or as response to an inquiry, the handling of results
depends on the DOCUMENTATION SETUP setting.
Both communication partners can send whenever they have data to send. In case that
both want to transfer simultaneously the instrument has higher priori ty 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 posit ion number (which is carrier number and posit ion 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
posit ion number for non bar-coded samples for identification.
It is necessary to perform the sample programming at the host prior to thatprocedure.
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 theDOC key initiali zes 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. Thisinformation can be ignored by the host.
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Figure 2-5: Manual trigger to upload results
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2.2 ... use the Inter face for Elecsys 10102.2.1 ... connect the Interface for Elecsys 1010
To connect the Elecsys 1010 analyzer to a laboratory EDP system (host) use a serialconnection 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
Utilities
Interface Setup
Figure 2-6: UTILITIES Screen
Press the UTILITIES key to open the UTILITIES main menu.
The arrow keys can be used to navigate between the input fields.
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Figure 2-7: INTERFACE Setup Screen
Press the soft key to open the INTERFACE SETUP screen. Use the arrow keys to
navigate between the fields.
Select the field HOST PROTOCOL. Press ENTERto open the pop-up window
with selectable options. Use the arrow keys to select the appropriate host protocol.
Press the ENTER key when complete. Refer to Fig. 2-8.
Figure 2- 8: Select Host Protocol
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OFF: A host is not connected.
HOST: A host is connected.
LSM: A host with a Laboratory Systems Manager is connected
(not available in the US).
INTERNAL: Not a customer option. Only for service personnel.
HOST QUERY:
Indicates whether host query mode is on or off. This field is only active if a setting
other than OFF is selected for HOST PROTOCOL. The default setting is ON. If the
setting is OFF, the host works in batch mode.
Input Instrument Network name:
Displays the name of the analyzer as used in a network. The default setting is
ELECSYS 1010. This name can be changed.
Select SERIAL INTERFACE HOST and touch the buttons for setting the correct
values
Baud Rate 1200, 2400, 4800, 9600, 19200
Data Bits 7,8
Stop Bits 1,2
Parity none, odd, even
COMMENT: The Elecsys 1010 works without handshake.
BAUD RATE:
Displays the used communication speed in bits per second.
When ENTER is pressed, a pop-up window opens where a communication speed can
be selected.
DATA BITS:
Displays the number of bits per data word that is used for communication.
When ENTER is pressed, a pop-up window opens where the number of data bits can
be selected.
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STOP BITS:
Displays the number of stop bits per data word that is used for
communication.
When ENTER is pressed, a pop-up window opens where the number of stop bits can
be selected.
PARITY:
Displays the pari ty 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 containsgeneral 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 di luent parameter record is added for
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diluent packs. After the upload after the run preparation scan the instrument should
not use reagent pack inventory for inventory check or run calculation until a
configurable time-out has run down. The respective action should be delayed. The
time-out should be different from the time-out for order queries. The instrument
should accept a reagent pack data download in every instrument state and use theinformation for all further actions. I f the instrument receives such a download after
the time-out has run down, a warning should be generated and added to the message
history.
HOST QUERY TIMEOUT:
Specifies the timeout for the host query mode.
A number between 0 and 99 can be entered. The default setting is 99.
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SAMPLE BAR CODES:
This area is used to specify the types of sample bar codes most frequently used
on the analyzer. This reduces the read time significantly.
DELETE LEADING ZEROS:
Displays whether the sample bar code is processed with (YES) or without
(NO) a fixed cut leading zero.
AUTOMATIC POSITIONING:
This mode is used when working with non-bar-coded samples and the host
download is without a position number. Select YES or NO using the
horizontal soft key at the bottom right of the screen.
OPTIMIZED BATCH SEQUENCING:
Selects the sequence change for complementary tests. Select YES or NO using
the horizontal soft key at the bottom right of the screen.
Figure 2- 9: Instrument Setup Screen
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DOCUMENTATION OPTION:
Displays the Documentation Options which defines the behavior of result
print out and/or upload to the Host.
AUTOMATIC, RESULT ORDER:
Results are uploaded automatically in the order in which the results of individual test
were measured.
AUTOMATIC, SAMPLE ORDER:Results are uploaded automatically when all tests for a sample have been measured.
MANUAL
When this option is selected, the UPLOAD RESULT key displayed in the TEST
REPORT screen. This option allows individual results to be sent to the host.
OFF
Results are not uploaded.
Note: Results must be either printed out, stored on a floppy disk or sent to the
laboratory EDP (host). If one of these functions has been performed, theresult 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 sett ing.
Both communication partners can send whenever they have data to send. In case that
both want to transfer simultaneously the instrument has higher priori ty so the host
must wait until the instrument is ready.
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2.3 ... do Troub leshooting and M aintenanceThe 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
fi les to be analyzed off-line in a very convenient way supported by extensive helpfi les. I f you require this program, please contact your local Roche representative.
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3 Theory of Operation
This section contains
an overview of the Interface
a description of Transmission Protocol
an example
3.1 Overview o f the InterfaceAs 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 functionsneeded for such a message exchange using hierarchical layers. Once you are familiar
with the OSI model you wi ll 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 Descript ion of Transmission Proto col3.2.1 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 higherlayer. The layers do not interpret the messages. They just add t ransportation services
like cutting the message in port ions, put ting 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 i ts
partner layer on the other end of the communication link at equal hierarchical
posit ion 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 downcomplex
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 theData 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 classificationof 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:
Applicati on layersvirtually exchangemessages(e.g. test results)
Presentation layersvirtually exchangerecords. One message consists of multiple
records.
Data li nk layersvirtually exchange frames. One record consists of one or more
frames.
Physical layersphysically exchange 8 bit ASCI codesthrough standard serial
interfaces. One frame consists of max. 240 record letters (bytes) and 7 bytes of
delimiter and checksum data.
Record
Frame
Message
Record
Frame
Frame
Frame
Record
Frame
Record
Frame
FrameRecord
Frame
Send/Receive
Send/Receive
Send/Receive
Send/Receive
Send/Receive
Send/Receive
Send/Receive
Send/Receive
Communication Data
Build Message
Analy ze Message
Figure 3-2: Correlation between Message Record Frame
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Figure 3- 3: Layers of the ASTM-Protocol
The ASTM protocol definition is divided into a low level and a high level protocol. The
ASTM low level protocol defines the data communication method by frames and is
described in sections 3.2.4 and 3.2.5. The ASTM high level protocol defines the
message structure, message resending process, record structure and types of records
and their use. It is described in sections 3.2.2 and 3.2.3.
Details of the ASTM protocol can be found in the Annual Book of ASTM Standards.Copyright American Society for Testing and Materials, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959, U.S.A
ASTM E1381-94 Low Level Protocol:
Specification for Low Level Protocol to Transfer Messages Between Clinical
Laboratory Instruments and Computer Systems.
ASTM E1394-91 High Level Protocol:
Standard Specification for Transferring Information Between Clinical Instruments
and Computer Systems.
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3.2.1.3 Description of Terms Specific to ASTM
To clarify some terms this chapter defines some specific wording according to the
ASTM specifications (see also Glossary).
message- a textual body of information. Example: The test results of all orders for a
group of patients and the related data.
battery- a group of tests ordered together, for example, an admitting battery. The
term batteryis used in the document synonymously with the term profileor 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 f ields 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 att ribute 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 pr iority 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
li sted 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 theHost(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:
Inqui ry 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
Message Terminator L
Request Information Q
Figure 3- 4: Inquiry to Host
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Response from Host
Example: The Host receives the inquiry for test selections. I t reacts by sending the
data using a test order message from Host.
L Message Terminator
P Patient Information
H Message Header
O Test Order
Figure 3-5: Response from Host
Inqui ry to Instrument
Example: The Host needs the results of a specific sample. I t 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 Message Header
L Message Terminator
Q Request Information
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
Patient Information P
Test Order O
Result R
Message Terminator L
Figure 3- 7: Response from Inst rument
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 init ializes manually to send all test results without prior reception of
an inquiry from the Host.
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Message Header H
Patient Information P
Test Order O
Result R
Message Terminator L
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.
L Message Terminator
P Patient Information
H Message Header
O Test Order
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 "AutoRequest 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 tr iggers 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.
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Instrument requests from the Host
After having received the response from the Host the instrument updates the data
base (DB) based on this response.
(The update of the DB based on the response depends on the instrument status.
When the DB is not updated the instrument reports this status to the Host as analarm 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 (seeTable 3-1).
Priority SendingOrder
Types of messages
High 1 Response (re-send)
2 Response
3 Report the received message situation (re-send)
4 Repor t the received message si tuation
5 Inquiry (re-send)
6 Inquiry
7 Upload (re-send)
Low 8 Upload
Table 3-1: Message Priorities
3.2.2.4 Events
Table 3-2 to Table 3-7 summarize the messages used by the Elecsys analyzer with their
events. The column "Records" shows the record types mentioned earl ier 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 noti fication they are not listed
in the following tables but for completeness in chapter 4.3
Messages Records Trigger Events
Inquiry of test selection information Q sample disk scanning
Table 3-2: Request from instrument to Host
Messages Records Reception byInstrument
Test selection information P, O 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 Records Reception byInstrument
Inquiry of test selection information Q any time
Inquiry of measured data Q any time
Table 3-4: Request from Host to instrument
Messages Records Trigger Events
Test selection information P, O Inquiry from Host
Measured data P, O, R, C Inquiry from Host
Table 3-5: Response from instrument to Host
The transmission of upload messages is asynchronous, i.e. it is not requested by an
inquiry of the Host but tr iggered 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 condit ion that "Upload Options:
Automatic ON" is requested on the DOCUMENTATION SETUP screen. This
is configurable on Elecsys 1010 and the data can be sent automatically, in result
order, or sample order.
When pressing the "Print All" button key on the Results screen on Elecsys 2010,the instrument uploads the measured data under the condition that "Upload
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Options" and "Print Options" are set to "Automatic OFF" on the
DOCUMENTATION SETUP screen.
After turning on the power switch, the instrument is in the stand-by status. The
instrument uploads all the remaining measured data which have not been
uploaded before.
Messages Records Trigger Events
Measured data P, O, R, C, Completion of Tests, pressing"Print All "-button, power on
Table 3-6: Upload from instrument to Host
Messages Records Reception by Instrument
Test selection information P, O any time
Request cancel Q any time
Table 3-7: Download from Host to instrument
Please note that on Elecsys 2010 according to the ASTM specifications only one
request record may be outstanding at a time, the receiver of a request record must
terminate the request, when finished, via the message terminator record, or the sender
must cancel the request before sending a second logical request. Therefore the "Request
Information Record" (Q)can be used by the Host for canceling requests previously
transmitted to the instrument. This is done by leaving fields 3 to 12 empty, f ield 1 is
"Q", 2 is "1" and 13 is "A" (see 4.3.6.7).
Canceling / deleting of samples in the data base wil l 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 togenerate 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
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is detected.
Recovery: Sending of the appropriate termination code for "receiving message
failed" in the Termination Record of the receipt message (seeTable 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 (seeTable 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 impossibili tyof 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 pickedup.
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 notreport the message receiving situation to the Host.
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Attribute ofmessage
Message receiving situation Terminationcode
There is a response data. Fnormal
There is no response data. I
Not all data in records are in accordance to the rules.(Improper message error)
QInquiry
abnormal Receive error
Hardware error
Application error
E
normal no message
All data in records are not as ruled.
(Improper message error)
Message refusal
Receive error (*)
Hardware error (*)
Application error (*)
EResponse & Downloadabnormal
The last record is not the Termination record. R
Invalid attri bution abnormal
Improper message errorReceive error
Hardware error
Application error (*)
E
* The instrument reflects the valid record data on the data base.
Table 3-8: Termination Codes to different Error States
The occurrence of communication errors which cannot be corrected (e.g. by
retransmission) results in an alarm condit ion 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 Contents Cause of Alarm Source Layer
Communication re-sendingoccurred
When sending a message, re-sending ofthe message occurred
Re-sending a messagesucceeded
Application
Communication re-sendingfailed
Re-sending a message failed Re-sending a messagefailed
Application
Communication message
acceptance error
Impossible to update the data base using
the message.
Picked up the message
acceptance error.
Application, Message
Acceptance error
Communication messageformat illegal error
There was a valid record, but noTermination Record.
There was no valid record.
The first record was not a headerrecord.
There was an undefined record.
There was a record that was not inaccordance to the rules.
The last record was notthe Termination record
Picked up the impropermessage errors.
Presentation,Improper MessageError
Communicationapplication error
Application error happened. Picked up theapplication error.
Data Link,Application Error
Communication sending
error
Re-sending a message failed at the low
level
Picked up sending error Data Link,
Send ErrorCommunication sendingerror
Time out happened at the lower level Picked up sending error Data Link,Send Error
Communication receivingerror
Time out happened at the lower level Picked up receiving error Data Link,Receive Error
Communicat ion device error Hardware error happened. Picked up thehardware error.
Physical,Hardware Error
Communication sendingmessage aborted
Sending a message has been aborted Received theTermination code = R
Any, from Host(Presentation)
Communication receivingmessage aborted
Receiving a message has been aborted Received theTermination code = T
Any, from Host(Presentation)
Table 3-9: List of Alarm Conditions
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3.2.3 Presentation Layer
3.2.3.1 Message Structure: Records
The typical message contains a set of information. E.g. the response message to a test
result inquiry contains four levels (0-3) of information:
Data relating to the patients 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. Mult iple
comments can belong to one test result. Multiple test results can belong to one order
(requested test profile). Mult iple orders can belong to one patient. Mult iple 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 l ike 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 identificationand 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 , scienti fic 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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Addit ional 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) HEADER
(Level 1) MANUFACTURER INFORMATION 1
(Level 1) PATIENT 1 (general information about patient)
(Level 2) | COMMENT 1 Record (relates to previous patient PATIENT 1)
(Level 2) | ORDER 1 (information about the first battery requested)
(Level 3) | | COMMENT 1 Record (relates to previous order ORDER 1 )
(Level 3) | | RESULT 1 (information about the first result of battery 1)
(Level 3) | | RESULT 2 (information about the second result of battery 1)
(Level 4) | | | COMMENT 1 Record (Relates to RESULT 2)
(Level 4) | | | COMMENT 2 Record (Relates to RESULT 2)
(Level 4) | | |
(Level 4) | | |
(Level 4) | | |
(Level 3) | | RESULT n (information about the last result of battery 1)
(Level 2) | ORDER 2 (information about battery 2)
(Level 3) | | RESULT 1 (information about the first result of battery 2)
(Level 3) | | RESULT 2 (information about the second result of battery 2)
(Level 3) | |
(Level 3) | |
(Level 3) | |
(Level 3) | | RESULT n (information about the last result of battery 2)
(Level 2) | ORDER n (information about the last battery for the first patient)
(Level 3) | | RESULT 1 (first result of the last order)
(Level 3) | | (Level 3) | |
(Level 3) | |
(Level 3) | | RESULT n (information about the last result of battery n)
(Level 4) | | | COMMENT 1 Record (Relates to RESULT n)
(Level 1) PATIENT 2 (all of the structure repeats)
(Level 1)
(Level 1)
(Level 1) PATIENT n
(Level 0) 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
(seeTable 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 scientif ic record. At level
two is the test order record. At level three is the result record. The comment records
do not have an assigned level.
Level Record Name Identifier
0 Message Header Record H
1 Patient Information Record P
2 Test Order Record O
3 Result Record R
0..3 Comment Record C
0..3 Manufacturer Information Record M
0 Message Terminator Record L
1 Request Information Record Q
1 Scientific Record(Thi s record is not used by the Roche Diagnosticsimplementation)
S
Table 3-10: Standard Record Types and Levels
The Roche Diagnostics specific records (MSR) follow the levels described below.
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Level Record Name Identifier
1 MSR - Action Confirmation (This record is not used by theRoche Diag