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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

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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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Host Interface Manual Table of Contents

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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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Host Interface Manual Introduction

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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]

[email protected]

[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 ...


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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Host Interface Manual Theory of Operation

V 4.01Version 11/00 3-29

3 Theory of Operation


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


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


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


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.


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


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.


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