Roche Cobas 4800 1.02

70
cobas 4800 system Host Interface Manual Software Version 1.02 r DRAFT ®

description

Roche Cobas 4800 1.02

Transcript of Roche Cobas 4800 1.02

cobas 4800 systemHost Interface ManualSoftware Version 1.02

r

DRAFT

®

March 2010Roche Diagnostics

Host Interface manualPage i

cobas® 4800 system Host interface Manual

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Table of Contents

General 1

.................................................................................... 1Target audience

.................................................................................... 1References

.................................................................................... 1Document Revision History

.................................................................................... 2Contacts, Trademarks

.................................................................................... 3Glossary

Overview 4

.................................................................................... 4Communication Overview

.................................................................................... 5Communication layers

Workflow 6

.................................................................................... 6Communication Scenarios

.................................................................................... 6Work Order Inquiry

.................................................................................... 8Result export

Message types 8

.................................................................................... 8General Information

.................................................................................... 8Full Run Inquiry

.................................................................................... 8Full Order Response

.................................................................................... 10Test Result Export

.................................................................................... 13FLAGS

Test Result Export workflow 16

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ASTM Protocol 17

.................................................................................... 19COBAS 4800 ASTM Record Definitions

.................................................................................... 20Inquiry records Mappings (ASTM)

.................................................................................... 20H Segment

.................................................................................... 21P Segment

.................................................................................... 21Q Segment

.................................................................................... 21L Segment

.................................................................................... 22Inquiry Response Mapping

.................................................................................... 22H Segment

.................................................................................... 23P Segment

.................................................................................... 23O Segment

.................................................................................... 24L Segment

.................................................................................... 25Inquiry/response examples

.................................................................................... 26Results Mapping (ASTM)

.................................................................................... 26H Segment

.................................................................................... 27P Segment

.................................................................................... 27O Segment

.................................................................................... 28R Segment

.................................................................................... 28L Segment

.................................................................................... 29Results Example ASTM

HL7 Protocol 31

.................................................................................... 32COBAS 4800 HL7 Record Definitions

.................................................................................... 33Inquiry Records mapping (HL7)

.................................................................................... 33Inquiry Mapping

.................................................................................... 35Inquiry Response Mapping

.................................................................................... 37Results Mapping (HL7)

.................................................................................... 40Result Example HL7

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Communication setup 42

.................................................................................... 42Network connection

.................................................................................... 42Instrument Setup

Simulator 43

.................................................................................... 43Installing simulators

.................................................................................... 43HL7 Simulator

.................................................................................... 46Setting up the simulator connection

.................................................................................... 49Connection test

.................................................................................... 50Sending an order to the system

.................................................................................... 54Receiving results from the system.

.................................................................................... 57ASTM Simulator

Troubleshooting / logfiles 58

Known restrictions 58

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General

General1

Target audienceThe intended audience for this manual is Host Interface programmers and the Roche Field engineers supporting thesystem.

References

[1] HL 7 Documentation Version 2.4, Health Level Seven, Ann Arbor MI, USA, www.HL7.org[2] ASTM Documentation 1394 LIS2

Note: Although ASTM and HL7 are the base of the data exchange, the result transmission is not a strict ASTM or HL7 format. The system presents CT/NG or HPV as global blocks of results and transmits them as such.

See the Result topics for the respective ASTM and HL7 formats for details.

Document Revision History

Document Version Revision Date

1.0 January 2009

1.02 Manual rev 02 March 2010

Copyright 2009, 2010, Roche Diagnostics Ltd. All rights reserved.

Rev 02: Corrected some errors and omissions.Clarified the target audience of manual and simulators.Added definition Client / server.Added complete results fields tablesAdded examples multiple flagsAdded information regarding media types Added information regarding order handling (Tubes without orders) at various places.Timeout for order response from LIS increased to 180 seconds.

This manual applies to Software Version 1.02

Information in this document is subject to change without notice. No part of this document may be reproduced ortransmitted in any form or by any means, electronic or mechanical, for any purpose, without the express writtenpermission of Roche Diagnostics GmbH.

Every effort has been made to ensure that all the information contained in this manual is correct at the time of publishing.However, Roche Diagnostics Ltd. reserves the right to make any changes necessary without notice as part of ongoingproduct development.

Document references

These are internal Roche referencesDVS Number: 05702950001Material Number: 10330010

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General

Contacts, Trademarks

Contact Addresses

Manufacturer Roche Diagnostics Ltd.ForrenstrasseCH-6343 RotkreuzSwitzerland

Distribution Roche Diagnostics GmbHSandhofer Straße 116D-68305 MannheimGermany

Distribution in the US Roche Diagnostics9115 Hague RoadPO Box 50457Indianapolis, IN 46250USA

Questions or comments regarding the contents of this manual can be directed to the address below or to your Rocherepresentative.

Roche Diagnostics Ltd.Global Service SupportForrenstrasse6343 Rotkreuz, Switzerland

email: [email protected]

Trademarks

cobas is a trademark of Roche.

Other brands or product names are trademarks of their respective holders.

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General

Glossary

MTS Medium Throughput System This name is sometimes used inside the protocol. Where the Acronym MTS is used, it means the cobas ®4800 system..

A&D Amplification and detection. The system will only perform Amplification and detection on alreadyprepared MWP, using the z 480 instrument.The A&D runs are not supported by the LIS workflow.

AnD Same meaning as A&D - Often used inside records as the "&" character would be interpreted asseparator and therefore cannot be used.

Full run Samples will be prepared into a MWP by the cobas x 480, then the plate will be transferred manuallyto the cobas z 480 for the A&D run.

GUID Stands for Global Unique Identifier. A unique identifier created by the system. It is a 128 bits number written in a pattern of hexadecimal

numbers similar to : 3F2504E0-4F89-11D3-9A0C-0305E82C3301 It is used to identify a unique run in the transmission records.

MWP Microwell plates.

Transformer A software module that conforms XML communication files to the communication server.

cobas x 480instrument

The cobas x 480 prepares the samples. The cobas x 480 is loaded with samples, consumables and reagents. After sample preparation, themultiwell plate with the PCR-ready samples is unloaded, sealed, and transferred to the cobas z 480 foramplification and detection.

cobas z 480analyzer

The cobas z 480 utilizes fluorescence to detect nucleic acids amplified by using realtimePCR methodology. the loading and unloading of the multiwell plate is done manually.

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General

Overview2The structure of the document is as follow

The topic General describes general functions of the subsystem or the unit having influence on the implementation. This chapter contains no specifications but provides background information and context information for thespecifications stated in the next chapter. The goal is to increase the legibility of the document.

Topic HL7 contains all the specifications for the HL7 protocol.

Topic ASTM contains all the specifications for the ASTM protocol.

Communication OverviewThe physical connection used by the cobas 4800 host interface is the standard network card (N.I.C) with Ethernet protocol.

The connection is TPC/IP over ethernet.The RS-232 connection is not supported by the system.

The cobas 4800 system offers two transmission protocols: -ASTM-HL 7

The communication is realized by xml files which are exchanged and evaluated between cobas 4800 sw <-> Transformerand Transformer <-> cobas 5000 IT Communications Server.

Client /Server structure

The communication is always established by the cobas 4800 control unit; the cobas 4800 system is always the TCP/IP clientand the LIS is always the TCP/IP server.

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Overview

Communication layersAs all the communication is based on network connections, this manual addresses mostly the upper layer (application)related topics.

This layer corresponds to the upper layer in the well known OSI model:

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Overview

Workflow3

Communication ScenariosThe following table shows the communication scenarios existing for the cobas 4800.

Table 1 Communications Scenarios

Name Description Input Output

Work OrderInquiry Full

The cobas 4800 ask the LISto get order details for oneor more Samples

Run Type, Test Type, SampleId’s

For each sample: SubTest Type, Media Type

Work OrderInquiry A&DOnly

This mode is not supportedby the LIS workflow

Run Type, Test Type, Id of theMWP

For each sample: SubTest Type, Media Type,MWP Position

Test ResultUpload

The cobas 4800 Systemsends the test result of a Runto the LIS

Run Id, Run Type, Test TypeSub Test Type, Media Type,Test Result, Flags, Sample Id,Test Time Stamp, Order TimeStamp, Accepted Flag

-

Once the LIS has been enable by Roche support, the LIS must always respond to order requests. There is no possibility to work with "results sending only" and manually ordering. If the LIS cannot respond to order requests, the system cannot run tests unless the LIS is disabled again to work completelyoffline.

Work Order Inquiry

Figure 1 Work Order Inquiry

The Work Order Inquiry Scenario is described In Figure 1. If a cobas 4800 user starts a run to test samples it loads the samples or the MWP plate. After the plate loading, the cobas4800 system starts the above inquiry sequence to the LIS server.

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Workflow

Missing orders:

When sample numbers are received that do not have a corresponding test request in the Host system, the whole samplerecord must be skipped.

No "empty" orders shall be sent to the cobas 4800, otherwise it will result into a complete order upload failure. See in Each protocol for details.

When order numbers are skipped, the mismatch will be signaled on the screen as shown below (1):(Mismatch occurred between loaded and expected samplesPlease press "Unload Sample" )

The sample positions are indicated in (2)

Possible correcting actions :

1. Unload the sample rack(s), remove the indicated sample tubes (2), reload the sample rack. or

2. Unload the sample rack, add orders to the indicated samples into the LIS system, reload the sample rack(s)

Work order inquiry timeout:

The timeout after a work order inquiry from the instrument is currently set at 180 seconds and cannot be changed.The complete work order list has to be completely transmitted within these 180 seconds, otherwise a timeout message willresult.

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Workflow

Result exportThe results can be manually exported to the LIS using the selected protocol (ASTM or HL7).

The LIS has to be enabled to be able to export the results. If the system works in offline mode and tests are ordered manually , results cannot be exported via LIS.

The total transmission time should not exceed 120 seconds otherwise the last results may not be transmitted.

Message types4

General InformationThe Full run, the A&D Only run and the result export have different data to transfer. The following tables show the detail of this data.

Full Run Inquiry

Table 2 Full Run Inquiry

cobas 4800 Query Example HL7-Mapping ASTM-Mapping

Run Type Full QPD-3-2 Q-5-6

Test Type CT/NG QPD-3-1 Q-5-4

Software MTS MSH-3 H-5-3

Version 0.9.1.0843 MSH-4 H-5-4

Sample Id’s (1-94) 100101001 QPD-4 Q-3

Full Order ResponseTable 3 Full Order Response

cobas 4800 Query Example HL7-Mapping ASTM-Mapping

Run Type Full OBR-4-3 O-5-6

Test Type CT/NG OBR-4-1 O-5-4

Software LIS MSH-3-1 H-5-3

Version 6.3 MSH-4-1 H-5-4

Sample Id 0010212 OBR-3-1 O-3-1

SubTestType NG OBR-4-2 O-5-5

Media Type UT OBR-15 O-16

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Message types

Table 4 Possible values SubTestType (order response)

Type Possible values for subtype field (order response)

CT/NG CT/NG

CT

NG

HPV HPV High Risk Panel + Genotyping

HPV High Risk Panel

Table 5 * Possible values media

Type Test subtype Possible value field Media Type

Media names

CT/NG CT UT UUT

= UniTrans= Urine UniTrans

NG

CT/NG

HPV HPV High RiskPanel

PCSP

= PreserveCyt= SurePath original tube is not validated on cobas 4800

PC and SP are used, whether the samples are in originalcontainers or in secondary tube round base 13mL

HPV16

HPV18

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Message types

Test Result ExportTable 6 Test Result Export

Test ResultExport

Example HL7Mapping

ASTMMapping

Start Time 2008-10-14T13:49:39 OBR-7 R-12

End Time 2008-10-14T13:50:45 OBR-8 R-13

Test Type CT/NG OBR-4 R-3

Run Type Full OBR-4 O-4

Run Id 83b6f32c-d31b-49a8-8239-13be65486ea3 MSH-10 O-4;H-5-1

User Id Laboperator OBX-16 R-11

Software MTS MSH-3 H-5-3

Version 0.9.3.0847 MSH-4 H-5-4

Created Admin ORC-10 O-17

Creation Date 2008-06-11T15:56:58 ORC-7-4 O-8

Plate Id (A&DOnly)

AD000012 OBX-3;OBR-3 O-3;H-5

For eachSample

Test Result Examples:Invalid ; CT POS, NG POS ;

See Test results combination tables for all possibilities.

OBX-5-1 R-4-1

Flag Pattern M1,M3 OBX-5-2 R-4-2

Sub Test Type CT OBR-4 R-3

Sample Id 100101001 OBX-3;OBR-3 O-3;H-5

Media Type UUT OBR-15 O-16

Order Date 2008-10-14T13:50:38 OBR-27 O-15

Accepted Flag False OBX-11 O-26

MWP Position A5 OBX-3;OBR-3 O-3;H-5

Test result Possible values (Samples)

invalid positive (POS) negative (NEG)

Test result Possible values (Controls)

invalid Valid

11

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Message types

Test results combination tables :

Table 7

cobas® 4800 CT/NG Test Result Report and Interpretation

CT POS, NG POS CT Positive, NG Positive. Specimen is positive for the presence of bothCT and NG DNA.

CT NEG, NG NEG CT Negative*, NG Negative*. Neither CT nor NG DNA, if present,could be detected.

CT POS, NG NEG CT Positive, NG Negative*. Specimen is positive for the presence of CTDNA. NG DNA, if present, could not be detected.

CT POS, NG Invalid CT Positive, NG Invalid. Specimen is positive for the presence of CT DNA. NG result is Invalid. Original specimen should be re-tested to obtainvalid NG result.

CT NEG, NG POS CT Negative*, NG Positive. CT DNA, if present, could not be detected.Specimen is positive for the presence of NG DNA. CT Invalid, NG Positive.

CT Invalid, NG POS CT result is Invalid. Original specimen should be re-tested to obtainvalid CT result. Specimen is positive for the presence of NG DNA.

CT Invalid, NG NEG CT Invalid, NG Negative*. CT result is Invalid. Original specimenshould be re-tested to obtain valid CT results. NG DNA, if present, could not be detected.

CT NEG, NG Invalid CT Negative*, NG Invalid. CT DNA, if present, could not be detected.NG result is Invalid. Original specimen should be re-tested to obtainvalid NG result.

Invalid CT Invalid, NG Invalid. Both CT and NG results are Invalid. Originalspecimen should be re-tested to obtain valid CT and NG results.

Failed No Result for Specimen Consult the cobas® 4800 system Operator’sManual for instructions to review run flags and recommended actions.Original specimen should be re-tested to obtain valid CT and NGresults.

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Message types

Table 8

cobas® 4800 HPV Test Result Report and Interpretation

SubTest “HPV High Risk Panel”:

HR HPV POS High Risk HPV Positive Specimen is positive for the DNA of any oneof, or combination of, the following high risk HPV types: 16, 18, 31,33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.

HR HPV NEG High Risk HPV Negative* HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52,56, 58, 59, 66 and 68 DNA were undetectable or below the pre-setthreshold.

Invalid High Risk HPV Invalid Results are invalid. Original specimen should bere-tested to obtain valid result.

Failed No Result for Specimen Consult the cobas® 4800 system Operator’sManual for instructions to review run flags and recommended actions.Original specimen should be re-tested to obtain valid result.

SubTest “HPV High Risk Panel Plus Genotyping”:

Other HR HPV POS, HPV16 POS, HPV18POS

Other High Risk HPV Positive, HPV16 Positive, HPV18 Positive.Specimen is positive for HPV types 16 and 18 DNA and the DNA ofany one of, or combination of, the following high risk HPV types: 31,33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.

Other HR HPV POS, HPV16 POS, HPV18NEG

Other High Risk HPV Positive, HPV16 Positive, HPV18 Negative*.Specimen is positive for HPV type 16 DNA and the DNA of any oneof, or combination of, the following high risk HPV types: 31, 33, 35,39, 45, 51, 52, 56, 58, 59, 66, 68. HPV type 18 DNA was undetectableor below the pre-set threshold.

Other HR HPV POS, HPV16 NEG, HPV18POS

Other High Risk HPV Positive, HPV16 Negative*, HPV18 Positive.Specimen is positive for HPV type 18 DNA and the DNA of any oneof, or combination of, the following high risk HPV types: 31, 33, 35,39, 45, 51, 52, 56, 58, 59, 66, 68. HPV type 16 DNA was undetectableor below the pre-set threshold.

Other HR HPV POS, HPV16 NEG, HPV18NEG

Other High Risk HPV Positive, HPV16 Negative*, HPV18 Negative*.Specimen is positive for the DNA of any one of, or combination of, thefollowing high risk HPV types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59,66, 68. HPV types 16 and 18 DNA were undetectable or below the pre-set threshold.

Other HR HPV NEG, HPV16 POS, HPV18POS

Other High Risk HPV Negative*, HPV16 Positive, HPV18 Positive.HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNA wereundetectable or below the pre-set threshold. Specimen is positive forHPV types 16 and 18 DNA.

Other HR HPV NEG, HPV16 NEG, HPV18POS

Other High Risk HPV Negative*, HPV16 Negative*, HPV18 Positive.HPV types 16, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNAwere undetectable or below the pre-set threshold. Specimen is positivefor HPV type 18 DNA.

Other HR HPV NEG, HPV16 POS, HPV18NEG

Other High Risk HPV Negative*, HPV16 Positive, HPV18 Negative*.HPV types 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 DNAwere undetectable or below the pre-set threshold. Specimen is positivefor HPV type 16 DNA.

Other HR HPV NEG, HPV16 NEG, HPV18NEG

Other High Risk HPV Negative*, HPV16 Negative*, HPV18 Negative*.HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68DNA were undetectable or below the pre-set threshold.

Invalid Invalid. The results are Invalid. Original specimen should be re-tested toobtain valid results.

Failed No Result for Specimen Consult the cobas® 4800 system Operator’sManual for instructions to review run flags and recommended actions.Original specimen should be re-tested to obtain valid results.

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Message types

FLAGSResult Interpretation Table 9

FlagCode

Source Severity Description

R1 RI Error General exception raised.

R2 RI Error The Well Result List is null or empty.

R3 RI Error The Well Result Node is invalid.

R4 RI Error The Result Interpretation Parameters Node is null.

R5 RI Error The Result Interpretation Parameters Node is invalid.

R6 RI Error Input Xml Nodes mapping failed.

R7 RI Error The Result Interpretation provides 4-dyes result interpretation.

R8 RI Error The test ingredients have not been specified.

R9 RI Error The test should have at least one target and at least one internal control.

R10 RI Error The probes have not been specified.

R11 RI Error The Well Result Node attributes are invalid.

R12 RI Error The Algorithm Results Node is incomplete.

R13 RI Error The Qualitative Interpretation Tables Node is invalid.

R14 RI Error The Result Table Node is invalid.

R15 RI Error The SubTest type or the ResultTable is invalid.

R16 RI Error The Intermediate-Result Interpretation failed.

R17 RI Error The Well-Result Interpretation failed.

R18 RI Error The Multi-Well Result Interpretation failed.

R19 RI Error The Ct ranges for the intermediate interpretation are invalid.

R20 RI Warning The positive external control is invalid.

R21 RI Warning The negative external control is invalid.

Multiple or other reason Table 10

FlagCode

Source

Severity Description

M1 SW Error Software error. Additional information can be found in messages and the tracelog files.

M2 Other Error Aborted by the user

M5 SW Warning PCR run only with a user defined sample preparation

M6 SW Warning The connection to the instrument was temporarily lost

Note: One Result can have several flags.

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Message types

Calculation Table 11

FlagCode

Source

Severity Description

C1 CP Error General exception raised.

C2 CP Error The RawData node is null.

C3 CP Error The CalculationParameters node is null.

C4 CP Error The RawData node is invalid.

C5 CP Error The CalculationParameters node is invalid.

C6 CP Error Input XmlNodes mapping failed.

C7 CP Error The HpvCtng-CalculationPackage provides 4-dyes result interpretation.

C8 CP Error The test ingredients have not been specified.

C9 CP Error The test should have at least one target and at least one internal control.

C10 CP Error The probes have not been specified.

C11 CP Error The computation algorithm has not been specified.

C12 CP Error The specified algorithm is not supported by this calculation package.

C13 CP Error The specified algorithm version is not supported by this calculation package.

C14 CP Error The calculation parameters for the numeric algorithm are incomplete.

C15 CP Error The fluorescence measurements data is incomplete.

C101 XT Error The CrossTalk compensation has failed.

C102 XT Error The CrossTalkMatrix is null.

C103 XT Error The Background vector is null.

C104 XT Error CrossTalk Matrix has invalid entries.

C105 XT Error The length of the background vector is not equal with CrossTalkMatrix filter combinations count.

C106 XT Error Matrix coefficients calculation has failed.

C107 XT Error Matrix inversion has failed.

C108 XT Error Resolution matrix size and channel count do not match.

C121 XT Error The RawData node is null.

C122 XT Error The CalculationParameters node is null.

C123 XT Error The RawData node is invalid.

C124 XT Error The CalculationParameters node is invalid.

C125 XT Error General exception raised.

C221 KA2 Error The RawData node is null.

C222 KA2 Error The AlgorithmParameters node is null.

C223 KA2 Error The RawData node is invalid.

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Message types

C224 KA2 Error The AlgorithmParameters node is invalid.

C225 KA/KA2 Error General exception raised.

C301 ELCA Warning CurvatureFailure

C302 ELCA Error InterceptOutOfRange

C303 ELCA Error SlopeOutOfRange

C304 ELCA Warning CurveFitFailure

C305 ELCA Warning AFIMinFailure

C306 ELCA Error DataRangeFailure

C307 ELCA Info InsufficientCurvature

C308 ELCA Info DeclineCorrected

C309 ELCA Error CTOutOfRange

C321 ELCA Error The RawData node is null.

C322 ELCA Error The CalculationParameters node is null.

A&D errors Table 12

FlagCode

Source

Severity Description

Z1 AnDI Error Hardware or software error from the instrument. The run was aborted.

SPI errors Table 13

FlagCode

Source

Severity Description

X1 SPI Error Hardware or software error from the instrument. The run was aborted.

X2 SPI Info Barcode was entered manually.

X3 SPI Error Clot detected for a sample. This sample will have an invalid result.

X4 SPI Error Not enough liquid while processing a sample. This sample will have an invalidresult.

X5 SPI Error Reagent onboard time exceeded when the user tried to start the samplepreparation process. The run was aborted.

X6 SPI Error Working Master Mix with extract timed out after sample preparation has finished.The run was aborted.

X7 SPI Error Error during processing of external control. Run results will be invalid.

X8 SPI Error Hardware or software error from the instrument. Processing of the sample wasaborted.

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Message types

Test Result Export workflow5

Figure 2 Test Result Export

After a test run the results are shown to the user and become available to be exported. Figure 2 shows this scenario.

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Test Result Export workflow

ASTM Protocol6

The cobas 4800 ASTM protocol also implements the ASTM E1381-91 Low Level Protocol, although this is not the focus ofthis manual. No changes can be made at this level and because the system is implemented over a network communication,it just acts as an intermediate level inside the application layer, transmitting the data to the upper ASTM layer.

The short description of the ASTM lower layer is here for information.

Message example with intermediate frame:

c4800 00:08:17,763 [ENQ]HOST 00:08:17,763 [ACK]c4800 00:08:17,883 [STX]1H|\^&|||MTS^c9507f52-37bc-43d4-bba6-360fb 74bd898^OrderFileValidator^1.0.0.0918^1394.LIS2 |||||LIS|TSREQ^REAL|P|1|20091001085217|[CR][ETX ]80[CR][LF]HOST 00:08:17,883 [ACK]c4800 00:08:17,983 [STX]2P|1|[CR][ETX]BB[CR][LF]HOST 00:08:17,983 [ACK]c4800 00:08:18,103 [STX]3Q|1|^RDR0003406\RDR0003408\RDR0003407\RDR 0003405\RDR0003404\RDR0003403\RDR0003424\RDR000 3423\RDR0003422\RDR0003421\RDR0003420\RDR000341 9\RDR0003418\RDR0003417\RDR0003416\RDR0003415\R DR0003414\RDR0003413\RDR0003412\RDR0003411\RDR0 003410\RDR0[ETB]5D[CR][LF]HOST 00:08:18,113 [ACK]c4800 00:08:18,203 [STX]4003409\RDR0000829\RDR0003494||^^^CT/NG^^F ull|[CR][ETX]FB[CR][LF]HOST 00:08:18,203 [ACK]c4800 00:08:18,314 [STX]5L|1|[CR][ETX]BA[CR][LF]HOST 00:08:18,314 [ACK]c4800 00:08:18,414 [EOT]

Frame Configurations

For Middle Frame

<STX> FN text <ETB>C1 C2 <CR><LF>

For Last Frame

<STX> FN text <ETX>C1 C2 <CR><LF>

C1C2 represent the checksum characters.

Control character (characters enclosed in < ><ENQ> is control character (HEX 05)<STX> is control character (HEX 02)<ETB> is control character (HEX 17)<CR> is control character (HEX 0D)<LF> is control character (HEX 0A)<ETX> is control character (HEX 03)<ACK> is control character (HEX 06)

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ASTM Protocol

Maximum Length of the Frame

For one frame, maximum of 240 characters for text, 7 characters for frame control characters (not included in the 240).

Messages equal to or less than 240 characters are transmitted as one final frame. Messages greater than 240 characters are split into frames that have character lengths that fall within the 240-characterlimit. The only or final remaining frame becomes the last frame and is indicated by <ETX>. All others are intermediate (middle)frames and are indicated by <ETB>.

Results timeout:

Timeout for messages sent by the cobas 4800 system: From the ENQ, the transmission including multiple frames shouldnot exceed 120 seconds. Intermediate frames sent past this time will not be sent, the system will close the transmission withan EOT,

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ASTM Protocol

COBAS 4800 ASTM Record Definitions

Message StructureThe Message structures are defined in the syntax also used in [2 ]

Work order inquiryH Record MESSAGE HEADER SEGMENT

P Record Patient Record (empty, needed by protocol)

Q Record Query information

L Record ASTM message closing record

Work order responseH Record MESSAGE HEADER SEGMENT

P Record Patient Record (empty, needed by protocol)

O Record Order information

::

Following O records until end of message

L Record ASTM message closing record

Test result exportH Record MESSAGE HEADER SEGMENT

P Record Patient Record (empty, needed by protocol)

O Record Order information

R Record Result information

O Record Order information

R Record Result information

::

Following O / R records until end of message

L Record ASTM message closing record

1

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ASTM Protocol

cobas 4800 – Field mappingsThe tables in topic Inquiry records Mappings (ASTM) are showing the mappings between the cobas 4800 xml file andthe xml file which the host interface needs to work with.

Inquiry records Mappings (ASTM)

H Segment

Table 14 ASTM Inquiry Message Header

SegmentName andNumber

Type Comment Values Required

H-1 String The character H identifies the record as a messageheader record

H Yes

H-2 String Component, Repetition, Escape and Subcomponentdelimiter – exactly in this order

|^ \ & Yes

H-5-1 String Name of the application which sent this message MTS Yes

H-5-2 GUID GUID representing the unique identifier of thismessage given from MTS by it’s xml-filename

128-Bit-IntegerMin. Value = 0Max. Value =FFFFFFFF-FFFF-FFFF-FFFF-FFFFFFFFFFFF

Yes

H-5-3 String The name or shortcut of the user which create themessage

Any string Yes

H-5-4 String The version of the sending software 0.9.4.0847 Yes

H-5-5 Number Protocol version – used as a version check to makesure that this message is interpreted correctly

1394.LIS2 Yes

H-10 String Name of the application which has to receive thismessage

LIS Yes

H-11-1 String Message type used to delegate the tasks to the analyzer

TSREQ (e.gTSREQ^REAL)

Yes

H-11-2 String Event trigger used to delegate the tasks to the analyzer

REAL (e.gTSREQ^REAL)

Yes

H-12 String Processing mode (processing priority)P = Production

P Yes

H-13 Number Version number – currently a constant number setto 1

1 Yes

H-14 DateTime DateTime of the message put by the creating systemon creation of this message

YYYYMMDDhhmmsse.g.20081122121212

Yes

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P Segment

The MTS software doesn’t have any patient informations – but the ASTM protocol does need a P record.

Table 15 ASTM Inquiry Patient Information

SegmentName andNumber

Type Comment Values Required

P-1 String The character P identifies the record as a patientrecord

P Yes

P-2 Number For the first patient transmitted, 1 shall be entered,for the second, 2, ... until the last as defined

1 Yes

Q Segment

Table 16 ASTM Inquiry Request Information

SegmentName andNumber

Type Comment Values Required

Q-1 String This field is coded as Q. Q Yes

Q-2 Number For the first patient transmitted, 1 shall be entered,for the second, 2, ... until the last as defined

1 Yes

Q-3-2 String List of specimens separated by \ or The Plate Id for AnD Only runs (AnD workflow notsupported)

020404~7890432~098398 orAD0000034

Yes

Q-5-4 String Test type. Example CT/NG or HPV ^^^CT/NG^^Full

Yes

Q-5-6 Run type - Can only be Full(Not supported SpiOnly, AnDiOnly)

^^^CT/NG^^Full

Yes

L Segment

ASTM Inquiry L Segment (Message Terminator)

SegmentName andNumber

Type Comment Values Required

L-1 String This field is coded as L. L Yes

L-2 int The Terminator field 1 Yes

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Inquiry Response Mapping

H Segment

This table is showing the field mappings between the MTS xml file / Transformer and the ASTM message header segment.

Table 17 ASTM Response Message Header

SegmentName andNumber

Type Comment Values Required

H-1 String The character H identifies the record as amessage header record

H Yes

H-2 String Component, Repetition, Escape andSubcomponent delimiter – exactly in this order

|^ \ & Yes

H-5-1 String Name of the application which sent this message LIS Yes

H-5-2 GUID GUID representing the unique identifier of thismessage given from MTS by it’s xml-filename

128-Bit-IntegerMin. Value = 0Max. Value = FFFFFFFF-FFFF-FFFF-FFFF-FFFFFFFFFFFF

Yes

H-5-3 String The name or shortcut of the user which createthe message

Any string Yes

H-5-4 String The version of the sending software 6.2 Yes

H-5-5 Number Protocol version – used as a version check tomake sure that this message is interpretedcorrectly

1394.LIS2 Yes

H-10 String Name of the application which has to receive thismessage

MTS Yes

H-11-1 String Message type used to delegate the tasks to the analyzer

TSREQ (e.gTSREQ^REAL)

Yes

H-11-2 String Event trigger used to delegate the tasks to the analyzer

REAL (e.gTSREQ^REAL)

Yes

H-12 String Processing mode (processing priority)P = Production

P Yes

H-13 Number Version number – currently a constant numberset to 1

1 Yes

H-14 DateTime DateTime of the message put by the creatingsystem on creation of this message

YYYYMMDDhhmmsse.g. 20081122121212

Yes

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P Segment The cobas 4800 software does not have any patient information – but the ASTM protocol does need a P record.

Table 18 ASTM Response Patient Information

SegmentName andNumber

Type Comment Values Required

P-1 String The character P identifies the record as a patientrecord

P Yes

P-2 Number For the first patient transmitted, 1 shall be entered,for the second, 2, ... until the last as defined

1 Yes

O SegmentThis table is showing the field mappings between the MTS xml file / Transformer and the ASTM test order segment.The test order segment is holding all information related to a sample.Note: Missing orders. For samples that do not have a corresponding test request in the Host system, the whole O segmentrecord must be skipped.

Table 19 ASTM Response Test Order

SegmentName andNumber

Type Comment Values Required

O-1 String The character assigned to the order record shallbe O

O Yes

O-2 Number Set ID – for each order which is transmitted aown number is set starting from 1 to n

Continuous ID starting by 11, 2, …n

Yes

O-3-1 String Unique identifier of the sample – usually abarcode assigned to the sample (Specimen ID)

0001301^AD0000013^A6 Yes

O-3-2 String Plate ID – only for "AnD Only" runs (seeNote 1)

0001301^AD0000013^A6 NO

O-3-3 String MWP Position only for "AnD Only" runs 0001301^AD0000013^A6 NO

O-5-4 String Identifies the ‘testtype’ of the sample Known values are:- CT/NG- HPV

^^^CT/NG^NG^Full Yes

O-5-5 String Identifies the sub test type of a sample. Can bedifferent for each sample but must be a sub typeof the TestType.Values, see Table

^^^CT/NG^NG^Full YES

O-5-6 String Identifies the ‘runtype’ of the sampleAllowed values are:- Full = Full run of all system components- AnDiOnly = AmpDetect only. See Note 1

^^^CT/NG^NG^Full Yes

O-8 DateTime Contents the Time when the order was created YYYYMMDDHHMMSSe.g. 20081203143400

Yes (Note see restriction

)

O-16 String Media Type. Allowed values, see Table String ex: UT Yes

O-17 String Contents the user who has created the order admin Yes

Note 1: A&D mode not supported by LIMS workflow

9

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L Segment

ASTM response L Segment (Message Terminator)

SegmentName andNumber

Type Comment Values Required

L-1 String This field is coded as L. L Yes

L-2 int The Terminator field 1 Yes

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Inquiry/response examples

outgoing - ASTM:H|\^&|||MTS^65745d86-7a00-49ae-98b3-8a67d18f8e31^none^0.9.8.0912^1394.LIS2|||||LIS|TSREQ^REAL|P|1|20090403081313|P|1|Q|1|^15200049\15200059\15200043\15200073\15200013\15200071\15200041\15200011\15200069\15200039\15200009\15200067\15200037\15200007\15200065\15200035\15200005\15200093\15200063\15200033\15200003\15200091\15200061\15200031\15200027||^^^CT/NG^^Full|L|1|

incoming - ASTM:H|\^&|||LIS^65745d86-7a00-49ae-98b3-8a67d18f8e31^none^0.9.8.0912^1394.LIS2|||||MTS|TSREQ^REAL|P|1|20090403083315|P|1O|1|15200049^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|noneO|2|15200059^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|noneO|3|15200043^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|noneO|4|15200073^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|noneO|6|15200071^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|noneO|7|15200041^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|noneO|8|15200011^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|noneO|9|15200069^^||^^^CT/NG^CT^Full|||20090403083315||||||||UT|noneO|10|15200039^^||^^^CT/NG^NG^Full|||20090403083315||||||||UT|noneO|11|15200009^^||^^^CT/NG^CT/NG^Full|||20090403083315||||||||UT|noneO|12|15200067^^||^^^CT/NG^CT/NG^Full|||20090403083315||||||||UUT|noneO|13|15200037^^||^^^CT/NG^NG^Full|||20090403083315||||||||UUT|noneO|14|15200007^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|noneO|15|15200065^^||^^^CT/NG^CT^Full|||20090403083315||||||||UUT|noneO|16|15200035^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|noneO|17|15200005^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|noneO|18|15200093^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|noneO|19|15200063^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|noneO|20|15200033^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|noneO|21|15200003^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|noneO|22|15200091^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|noneO|23|15200061^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|noneO|24|15200031^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|noneO|94|15200027^^||^^^CT/NG^CT^Full|||20090403083316||||||||UUT|noneL|1

Note: When sample numbers are received that do not have a corresponding test request in the Host system, the wholesample record must be skipped.No "empty" orders shall be sent to the cobas 4800, otherwise it will result into a complete order upload failure.

Example: If the sample numbers 15200065 and 15200027 do not have a test for cobas 4800, the lines marked in bold in theASTM response from the Host would not exist.

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Results Mapping (ASTM)

H Segment

This table is showing the field mappings between the MTS xml file / Transformer and the ASTM message header segment.

Table 20 ASTM Response Message Header

SegmentName andNumber

Type Comment Values Required

H-1 String The character H identifies the record as amessage header record

H Yes

H-2 String Component, Repetition, Escape andSubcomponent delimiter – exactly in this order

|^ \ & Yes

H-5-1 String Name of the application which sent this message LIS Yes

H-5-2 GUID GUID representing the unique identifier of thismessage given from MTS by it’s xml-filename

128-Bit-IntegerMin. Value = 0Max. Value = FFFFFFFF-FFFF-FFFF-FFFF-FFFFFFFFFFFF

Yes

H-5-3 String The name or shortcut of the user which createthe message

Any string Yes

H-5-4 String The version of the sending software 6.2 Yes

H-5-5 Number Protocol version – used as a version check tomake sure that this message is interpretedcorrectly

1394.LIS2 Yes

H-10 String Name of the application which has to receive thismessage

MTS Yes

H-11-1 String Message type used to delegate the tasks to the analyzer

TSREQ (e.gTSREQ^REAL)

Yes

H-11-2 String Event trigger used to delegate the tasks to the analyzer

REAL (e.gTSREQ^REAL)

Yes

H-12 String Processing mode (processing priority) P = Production Yes

H-13 Number Version number – currently a constant numberset to 1

1 Yes

H-14 DateTime DateTime of the message put by the creatingsystem on creation of this message

YYYYMMDDhhmmsse.g. 20081122121212

Yes

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P Segment The cobas 4800 software does not have any patient information – but the ASTM protocol does need a P record.

Table 21 ASTM Response Patient Information

SegmentName andNumber

Type Comment Values Required

P-1 String The character P identifies the record as a patient record P Yes

P-2 Number For the first patient transmitted, 1 shall be entered, forthe second, 2, ... until the last as defined

1 Yes

O SegmentThis table is showing the field mappings between the MTS xml file / Transformer and the ASTM test order segment.The test order segment is holding all information related to a sample.

Table 22 ASTM Test Order

SegmentName andNumber

Type Comment Values Required

O-1 String The character assigned to the order record shall be O O Yes

O-2 Number Set ID – for each order which is transmitted a ownnumber is set starting from 1 to n

Continuous ID starting by11, 2, …n

Yes

O-3-1 String Unique identifier of the sample – usually a barcodeassigned to the sample (Specimen ID)

0001301^AD0000013^A6 Yes

O-3-2 String Plate ID – only for AnD Only runs 0001301^AD0000013^A6 NO

O-3-3 String MWP Position only for AnD Only runs 0001301^AD0000013^A6 NO

O-4 String Run type of the test Full or AnD Only Yes

O-5-4 String Identifies the ‘testtype’ of the sample allowed values are:- CTNG- HPV

^^^CT/NG^NG^Full Yes

O-5-5 String Identifies the sub test type of a sample. Can bediffrent for each sampl but must be a sub type of theTestType. See Table

^^^CT/NG^NG^Full YES

O-5-6 String Identifies the ‘runtype’ of the sampleAllowed values are:- Full = Full run of all system components- AnDiOnly = AmpDetect only

^^^CT/NG^NG^Full Yes

O-8 DateTime Contents the Time when the order was created YYYYMMDDHHMMSSe.g. 20081203143400

Yes

O-16 String Media TypeAllowed values see Table

String ex: UT Yes

O-17 String Contents the user who has created the order admin Yes

O-26 String Type of Results: F=Final Results; P=preliminaryresults – depends of the result export flag“Áccepted”.F Means result was accepted P Means result was not accepted (yet)

F or P Yes

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.

R SegmentNote: The system presents CT/NG or HPV as global blocks of results and transmits them as such.The Host system may have to further parse the result block if a further separation of individual subcomponents is required. See the tables for details and possible combinations inside result blocks.

Table 23 ASTM Result Record

SegmentName andNumber

Type Comment Values Required

R-1 String The record type ID is coded as R. R Yes

R-2 Number Set ID – for each order which is transmitted a ownnumber is set starting from 1 to n

Continuous ID startingby 11, 2, …n

Yes

R-3-4 String Identifies the ‘testtype’ of the sample Known values are:- CT/NG- HPV

^^^CT/NG^NG^Full Yes

R-3-5 String Identifies the sub test type of a sample. Can be diffrentfor each sampl but must be a sub type of the TestType Ex:CT see table

^^^CT/NG^NG^Full YES

R-3-6 String Identifies the ‘runtype’ of the sampleAllowed values are:- Full = Full run of all system components- AnDiOnly = AmpDetect only

^^^CT/NG^NG^Full Yes

R-4-1 String Application package defined test result e.g. Positive, see table .

Positive^M1\M2 Yes

R-4-2 String Flags for the test result See example Positive^M1\M2 Yes

R-4-3 String CT-Values of the controls CT_DYE1^NaN^CT_DYE5^NaN^CT_DYE3^NaN^CT_DYE0^NaN

NO

R-11 String User who has run the test laboperator Yes

R-12 DateTime Time when the test was started on the instrument YYYYMMDDHHMMSSe.g. 20081203143400

Yes

R-13 DateTime Time when the test was finished on the instrument YYYYMMDDHHMMSSe.g. 20081203143400

Yes

L Segment

SegmentName andNumber

Type Comment Values Required

L-1 String This field is coded as L. L Yes

L-2 int The Terminator field 1 Yes

11

9

10

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Results Example ASTM(Simulator log)

outgoing - ASTM:

c4800 00:11:52,652 [ENQ]HOST 00:11:52,652 [ACK]c4800 00:11:52,762 [STX]1H|\^&|||MTS^e5052475-cdb3-4c13-97d4-2bb43 467e75f^^1.0.0.0918^1394.LIS2|||||LIS|TSREQ^REA L|P|1|20091001085550|[CR][ETX]FA[CR][LF]HOST 00:11:52,782 [ACK]c4800 00:11:52,872 [STX]2P|1|[CR][ETX]BB[CR][LF]HOST 00:11:52,872 [ACK]c4800 00:11:52,982 [STX]3O|1|0NCL010145A03DC^AD6002095^B1||CT/NG^F ull|||20090825020548|||||||20090825143017|NegCt rl||||||||||F|[CR][ETX]B0[CR][LF]HOST 00:11:52,992 [ACK]c4800 00:11:53,092 [STX]4R|1|^^^CT/NG^N/A^Full|Valid^^CT_DYE0\NaN\ CT_DYE5\34.949874877929688\CT_DYE1\NaN|||||||La bmanager|20090825140628|20090825170656|[CR][ETX ]7F[CR][LF]HOST 00:11:53,102 [ACK]c4800 00:11:53,203 [STX]5O|2|1C1M014196A012R^AD6002095^A1||CT/NG^F ull|||20090825020548|||||||20090825143017|PosCt rl||||||||||F|[CR][ETX]B4[CR][LF]HOST 00:11:53,213 [ACK]c4800 00:11:53,313 [STX]6R|1|^^^CT/NG^N/A^Full|Valid^^CT_DYE0\36.5 50521850585938\CT_DYE5\35.303115844726562\CT_DY E1\35.388565063476562|||||||Labmanager|20090825 140628|20090825170656|[CR][ETX]B4[CR][LF]HOST 00:11:53,323 [ACK]c4800 00:11:53,423 [STX]7O|3|RDR0003428^AD6002095^H1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]98[CR][LF]HOST 00:11:53,433 [ACK]c4800 00:11:53,533 [STX]0R|1|^^^CT/NG^CT/NG^Full|CT·POS,·NG·POS^|| |||||Labmanager|20090825140628|20090825170656|[ CR][ETX]B4[CR][LF]HOST 00:11:53,543 [ACK]c4800 00:11:53,643 [STX]1O|4|RDR0003430^AD6002095^G1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]8B[CR][LF]HOST 00:11:53,653 [ACK]c4800 00:11:53,753 [STX]2R|1|^^^CT/NG^CT/NG^Full|CT·POS,·NG·POS^|| |||||Labmanager|20090825140628|20090825170656|[ CR][ETX]B6[CR][LF]HOST 00:11:53,753 [ACK]c4800 00:11:53,854 [STX]3O|5|RDR0003432^AD6002095^F1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]8F[CR][LF]HOST 00:11:53,864 [ACK]c4800 00:11:53,964 [STX]4R|1|^^^CT/NG^CT/NG^Full|CT··NEG,·NG·POS^| ||||||Labmanager|20090825140628|20090825170656| [CR][ETX]C0[CR][LF]HOST 00:11:53,974 [ACK]c4800 00:11:54,074 [STX]5O|6|RDR0003433^AD6002095^E1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]92[CR][LF]HOST 00:11:54,084 [ACK]c4800 00:11:54,184 [STX]6R|1|^^^CT/NG^CT/NG^Full|CT·POS,·NG··NEG^|

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||||||Labmanager|20090825140628|20090825170656| [CR][ETX]C2[CR][LF]HOST 00:11:54,194 [ACK]c4800 00:11:54,294 [STX]7O|7|RDR0003435^AD6002095^C1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]95[CR][LF]HOST 00:11:54,304 [ACK]c4800 00:11:54,404 [STX]0R|1|^^^CT/NG^CT/NG^Full|CT··NEG,·NG··NEG^ X2|||||||Labmanager|20090825140628|200908251706 56|[CR][ETX]4E[CR][LF]HOST 00:11:54,414 [ACK]c4800 00:11:54,515 [STX]1O|8|RDR0003436^AD6002095^D1||CT/NG^Full|| |20090825020548|||||||20090825141222|UT|||||||| ||F|[CR][ETX]92[CR][LF]HOST 00:11:54,525 [ACK]c4800 00:11:54,625 [STX]2R|1|^^^CT/NG^CT/NG^Full|CT··NEG,·NG··NEG^ |||||||Labmanager|20090825140628|20090825170656 |[CR][ETX]C6[CR][LF]HOST 00:11:54,635 [ACK]c4800 00:11:54,725 [STX]3L|1|[CR][ETX]B8[CR][LF]HOST 00:11:54,735 [ACK]c4800 00:11:54,835 [EOT]

Note: The bullet character inside results is just a placeholder to visualize the spaces inside strings.example |CT·POS,·NG··NEG^| should look in reality: |CT POS, NG NEG^|The character used in the transmission is a regular space (Hex 20).

Example multiple flags (R segment only, simulator log)

outgoing - ASTM:

c4800 06:53:16,137 [STX]6R|1|^^^HPV^HPV·High·Risk·Panel·+·Genotypi ng^Full|Failed^X3\X4\X1|||||||GT|20091211133042 |20091211153236|[CR][ETX]69[CR][LF]

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HL7 Protocol7

Minimal Layer Protocol

The data framing uses the MLLP, Minimal Lower Layer Protocol defined in the HL7standard.

HL7 messages are embedded in block delimited by special (non printable) characters.

<start_block>data<end_block><CR>

The values of the special characters are <VT> for the start block and <FS> for the end block. See table below.

<start_block> Start Block character (1 byte) ASCII <VT>

Data (variable number of bytes) The HL7 data is comprised of any displayable ASCII characters and the carriage return character, <CR>.

<end_block> End Block character (1 byte) ASCII <FS>. .<CR> Carriage Return (1 byte)

Char (ASCII) Décimal Octal Hex Name

VT 011 013 0B Vertical Tab

FS 028 034 1C File Separator

CR 013 015 0D Carriage Return

Graphical representation of data framing:

<VT> HL7 data <FS><CR>

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COBAS 4800 HL7 Record DefinitionsThe tables in the topic Inquiry Records mapping (HL7) show the mappings between the cobas 4800 xml file and theHL7 segment / records file which the host interface needs to work with.

Message StructureThe Message structures are defined in the syntax also used in [1]

Work order inquiryMSH MESSAGE HEADER SEGMENT

QPD QUERY PARAMETER DEFINITION

RCP RESPONSE CONTROL PARAMETER SEGMENT

Work order responseMSH MESSAGE HEADER SEGMENT

{

ORC COMMON ORDER SEGMENT - Multiple times ORC + OBR

{

OBR OBSERVATION REQUEST SEGMENT

}

}

Test result exportMSH MESSAGE HEADER SEGMENT

{

ORC COMMON ORDER SEGMENT - Multiple times ORC + OBR + OBX

{

OBR OBSERVATION REQUEST SEGMENT

OBX OBSERVATION/RESULT SEGMENT

}

}

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Inquiry Records mapping (HL7)

Inquiry Mapping

MSH Segment (Message Header)

Table 24 HL7 Inquiry Message Header

SegmentName andNumber

Type Comment Values Required

MSH-1 String Field delimiter | Yes

MSH-2 String Component, Repetition, Escape and Subcomponentdelimiter – exactly in this order

^ ~ \ & Yes

MSH-3 String Name of the application which sent this message MTS Yes

MSH-4 String The version of the sending software e.g. 1.3.5 Yes

MSH-5 String Name of the application which has to receive this message LIS Yes

MSH-7 DateTime DateTime of the message YYYYMMDDhhmmsse.g.20081122121212

Yes

MSH-9-1 String Message type code – see HL7 Doc.:[1] Table 0076 - Message type

QBP (QBP^Q11) Yes

MSH-9-2 String Trigger event code – see HL 7 Doc.:[1] Table 0003 - Event type

Q21 (QBP^Q11) Yes

MSH-10 GUID Message Id – Generated by the Transformer Software 128-Bit-IntegerMin. Value = 0Max. Value =FFFFFFFF-FFFF-FFFF-FFFF-FFFFFFFFFFFF

Yes

MSH-11 String Processing mode (processing priority)see HL7 Doc.:[1] Table 0103 - Processing ID

P = Production Yes

MSH-12 Number HL7 Version ID – used as a version check to make sure thatthis message is interpreted correctlysee HL7 Doc.:[1] Table 0104 – Version ID

2.4 Yes

MSH-17 String Country ISO code used for currency-, datetime- and otherspecifications.[1] Table 0399 – Country code

[A-Z]{3}e.g. CHE =Switzerland, USA= United States

Yes

MSH-18 String Character char set used for the whole message - see HL7Doc.:[1] Table 0211 – Alternate character setsThe COBAS 4800 project has decided to use the notdocumented character set UTF-8

UTF-8 Yes

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QPD - Query Parameter Definition

Table 25 HL7 Inquiry Query Parameter Definition

SegmentName andNumber

Type Comment Values Required

QPD-1 String This field contains the name of the query FullRunQuery orAnDOnlyQuery

YES

QPD-3 String Test Specification contains the Test Type and the RunType (only "Full" supported)

CT/NG^FULL YES

QPD-4 String All Samples or the Plate ID of the MWP Plate AD0000012 or0001~0002~0003~0004

YES

RCP - Response Control Parameter Segment

Table 9 HL7 Inquiry Response Control Parameter Segment

SegmentName andNumber

Type Comment Values Required

RCP-1 String Query priority – For cobas 4800 always I=Immediate I YES

RCP-3 String Response modality – For cobas 4800 always R=Real Time R YES

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Inquiry Response Mapping

MSH Segment (Message Header)

Table 26 HL7 Response Message Header

SegmentName andNumber

Type Comment Values Required

MSH-1 String Field delimiter | Yes

MSH-2 String Component, Repetition, Escape and Subcomponentdelimiter – exactly in this order

^ ~ \ & Yes

MSH-3-1 String Name of the application which sent this message LIS Yes

MSH-4-1 String The version of the sending software 6.2 Yes

MSH-5-1 String Name of the application which has to receive this message MTS Yes

MSH-7 DateTime DateTime of the message YYYYMMDDhhmmsse.g.20081122121212

Yes

MSH-9-1 String Message type code – see HL7 Doc.:[1] Table 0076 - Message type

OML (OML^O21) Yes

MSH-9-2 String Trigger event code – see HL 7 Doc.:[1] Table 0003 - Event type

O21 (OML^O21) Yes

MSH-10 GUID Message Id – Generated by the Transformer Software 128-Bit-IntegerMin. Value = 0Max. Value =FFFFFFFF-FFFF-FFFF-FFFF-FFFFFFFFFFFF

Yes

MSH-11 String Processing mode (processing priority)see HL7 Doc.:[1] Table 0103 - Processing ID

P = Production Yes

MSH-12 Number Version ID – used as a version check to make sure thatthis message is interpreted correctlysee HL7 Doc.:[1] Table 0104 – Version ID

2.4 Yes

MSH-17 String Country ISO code used for currency-, datetime- and otherspecifications.The value is mapped from the current thread of theTransformer application[1] Table 0399 – Country code

[A-Z]{3}e.g. CHE =Switzerland, USA =United States

Yes

MSH-18 String Character char set used for the whole message - see HL7Doc.:[1] Table 0211 – Alternate character setsThe cobas 4800 project has decided to use the notdocumented character set UTF-8

UTF-8 Yes

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ORC Segment (Common Order)

Table 11 HL7 Response Common Order

SegmentName andNumber

Type Comment Values Required

ORC-1 Number Set ID – for each order which is transmitted a ownnumber is set starting from 1 to n

Continuous IDstarting by 11, 2, …n

Yes

ORC-7-4 DateTime This field contains the creation time of the order out ofthe cobas 4800 order file

20081202154500 YES

ORC-10 String This field contains the identity of the user who actuallycreated the order out of the cobas 4800 order file.

e.g ADMIN YES

OBR – Segment (Observation Request)This table is showing the field mappings between the cobas 4800 xml file / Transformer and the HL7 message version 2.4observation request segment.The observation request segment is holding all information related to a sample.

Table 12 HL7 Response Observation Request

SegmentName

Type Comment Values Required

OBR-1 Number Set ID – for each order which is transmitted aown number is set starting from 1 to n

Continuous ID starting by11, 2, …n

Yes

OBR-3-1 String Unique identifier of the sample – usually abarcode assigned to the sample

0001301^AD0000013^A6

YES

OBR-3-2 String Plate ID – only for A&D Only runs.See Note 1

0001301^AD0000013^A6

NO

OBR-3-3 String MWP Position only for A&D Only runs 0001301^AD0000013^A6

NO

OBR-4-1 String Identifies the ‘testtype’ of the sample Known values are:CTNG - HPV

CT/NG^NG^Full Yes

OBR-4-2 String The sub test type of a sample. Values, see Table

CT/NG^NG^Full YES

OBR-4-3 String Identifies the ‘runtype’ of the sampleAllowed values are: See Note 1- Full = Full run of all system components- SpiOnly = Sample Extraction only- AnDiOnly = AmpDetect only

CT/NG^NG^Full Yes

OBR-15 String Media TypeAllowed values : see Table

String ex: UT Yes

OBR-27 XMLDateTime

Xml DateTime of the message put by thecreating system on creation of this message

YYYYMMDDhhmmsse.g. 20081122121212

Yes

Note 1 : Only "Full" is supported by the HIF workflow.

Note 2 : Missing orders For samples that do not have a corresponding test request in the Host system, the whole ORC +OBR segment records pair must be skipped.

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Results Mapping (HL7)

MSH Segment (Message Header)

Table 13 HL7 Result Message Header

SegmentName andNumber

Type Comment Values Required

MSH-1 String Field delimiter | Yes

MSH-2 String Component, Repetition, Escape and Subcomponent delimiter– exactly in this order

^ ~ \ & Yes

MSH-3-1 String Name of the application which sent this message MTS Yes

MSH-4-1 String The version of the sending software 0.9.4.847 Yes

MSH-5-1 String Name of the application which has to receive this message LIS Yes

MSH-7 DateTime DateTime of the message YYYYMMDDhhmmsse.g.20081122121212

Yes

MSH-9-1 String Message type code – see HL7 Doc.:[1] Table 0076 - Message type

ORU(ORU^O21)

Yes

MSH-9-2 String Trigger event code – see HL 7 Doc.:[1] Table 0003 - Event type

O21 (ORU^O21) Yes

MSH-10 GUID Message Id – Generated by the Transformer Software TBD Yes

MSH-11 String Processing mode (processing priority)see HL7 Doc.:[1] Table 0103 - Processing ID

P = Production Yes

MSH-12 Number Version ID – used as a version check to make sure that thismessage is interpreted correctlysee HL7 Doc.:[1] Table 0104 – Version ID

2.4 Yes

MSH-17 String Country ISO code used for currency-, datetime- and otherspecifications. [1] Table 0399 – Country code

[A-Z]{3}e.g. CHE =Switzerland, USA= United States

Yes

MSH-18 String Character char set used for the whole message - see HL7 Doc.:[1] Table 0211 – Alternate character setsThe cobas 4800 project has decided to use the not documentedcharacter set UTF-8

UTF-8 Yes

ORC – Segment (Common Order)Table 14 HL7 Result Common Order

SegmentName andNumber

Type Comment Values Required

ORC-1 Number Set ID – for each order which is transmitted a own number isset starting from 1 to n

Continuous IDstarting by 11, 2, …n

Yes

ORC-7-4 DateTime This field contains the creation time of the order out of thecobas 4800 order file

20081202154500 YES

ORC-10 String This field contains the identity of the user who actually createdthe order out of the cobas 4800 order file.

e.g ADMIN YES

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OBR - Segment (Observation Request)

This table is showing the field mappings between the cobas 4800 xml file / Transformer and the HL7 message observationrequest segment.The observation request segment is holding all information related to a sample.

Table 15 HL7 Result Observation Request

SegmentName andNumber

Type Comment Values Required

OBR-1 Number Set ID – for each order which is transmitted a ownnumber is set starting from 1 to n

Continuous IDstarting by 11, 2, …n

Yes

OBR-3-1 String Unique identifier of the sample – usually a barcodeassigned to the sample

0001301^AD0000013^A6

YES

OBR-3-2 String Plate ID – only for AnD Only runs 0001301^AD0000013^A6

NO

OBR-3-3 String MWP Position only for AnD Only runs 0001301^AD0000013^A6

NO

OBR-4-1 String Identifies the ‘testtype’ of the sample Known values are:CT/NG - HPV

CT/NG^NG^FULL YES

OBR-4-2 String The sub test type of a sampleSee possible value table :

CT/NG^NG^FULL YES

OBR-4-3 String The run type of the test CT/NG^NG^FULL YES

OBR-7 DateTime Time the test was started on the instrument YYYYMMDDhhmmsse.g. 20081122121212

YES

OBR-8 DateTime Time the test was finished on the instrument YYYYMMDDhhmmsse.g. 20081122121212

YES

OBR-15 String Allowed values are:See table

UUT YES

OBR-27 DateTime Time when the order was created YYYYMMDDhhmmsse.g. 20081122121212

YES

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OBX - Segment (Observation / Result Segment)

Note: The system presents CT/NG or HPV as global blocks of results and transmits them as such.The Host system may have to further parse the result block if a further separation of individual subcomponents is required. See the tables for details and possible combinations inside result blocks.

Table 16 HL7 Result Observation / Result Segment

SegmentName andNumber

Type Comment Values Required

OBX-1 String Set ID – for each order which is transmitted a ownnumber is set starting from 1 to n

Continuous IDstarting by 11, 2, …n

Yes

OBX-2 String This field contains the format of the observationvalue in OBX – For the cobas 4800 the format is ST= String Data

ST YES

OBX-3-1 String Unique identifier of the sample – usually a barcodeassigned to the sample

0001301^AD0000013^A6

YES

OBX-3-2 String Plate ID – only for AnD Only runs 0001301^AD0000013^A6

NO

OBX-3-3 String MWP Position only for AnD Only runs 0001301^AD0000013^A6

NO

OBX-5-1 String Application package defined test result e.g. Postive,Failed, … See table

Positive^M1~M2 YES

OBX-5-2 String Flags for the test result Positive^M1~M2 YES

OBX-5-3 String CT-Values of the controls CT_DYE1^NaN^CT_DYE5^NaN^CT_DYE3^NaN^CT_DYE0^NaN

NO

OBX-11 String Accepted Flag possible values are: Final results = ‘F’or ‘Final results = ‘P’ it depends on the acceptedflags from the cobas 4800 result export fileF Means result was accepted P Means result was not accepted (yet)

F or P YES

OBX-16 String User of the instrument who run the test laboperator YES

11

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Result Example HL7

HL7 Result Export (Simulator log)c4800 10:14:27,257 [VT]c4800 10:14:27,257 MSH|^~\&|MTS|1.0.0.0918|LIS||20090918101319||OR U^O21|9a7b5dab-8049-4ba8-83b7-6e8aefcbbed1|P|2. 5.1|||||CHE|UTF-8|[CR]c4800 10:14:27,257 ORC|1||||||^^^20090826114803||||[CR]c4800 10:14:27,257 OBR|1||0NCL010145A037Y^AD6002084^B1|HPV^N/A^Ful l|||20090826120921|20090826154328|||||||NegCtrl ||||||||||||20090826114803|[CR]c4800 10:14:27,257 OBX|1|ST|0NCL010145A037Y^AD6002084^B1||Valid^^C T_DYE3~NaN~CT_DYE5~NaN~CT_DYE1~NaN~CT_DYE0~NaN| |||||P|||||Labmanager|[CR]c4800 10:14:27,273 ORC|2||||||^^^20090826114803||||[CR]c4800 10:14:27,273 OBR|2||R0000814^AD6002084^G1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ]c4800 10:14:27,273 OBX|2|ST|R0000814^AD6002084^G1||Other·HR·HPV·NE G,·HPV16·POS,·HPV18·NEG^||||||P|||||Labmanager| [CR]c4800 10:14:27,288 ORC|3||||||^^^20090826114803||||[CR]c4800 10:14:27,288 OBR|3||R0000815^AD6002084^F1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ]c4800 10:14:27,288 OBX|3|ST|R0000815^AD6002084^F1||Other·HR·HPV·NE G,·HPV16·NEG,·HPV18·POS^||||||P|||||Labmanager| [CR]c4800 10:14:27,288 ORC|4||||||^^^20090826114803||||[CR]c4800 10:14:27,304 OBR|4||R0000816^AD6002084^D1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ]c4800 10:14:27,304 OBX|4|ST|R0000816^AD6002084^D1||Other·HR·HPV·PO S,·HPV16·NEG,·HPV18·NEG^||||||P|||||Labmanager| [CR]c4800 10:14:27,304 ORC|5||||||^^^20090826114803||||[CR]c4800 10:14:27,304 OBR|5||R0000817^AD6002084^E1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ]c4800 10:14:27,320 OBX|5|ST|R0000817^AD6002084^E1||Other·HR·HPV·PO S,·HPV16·POS,·HPV18·NEG^||||||P|||||Labmanager| [CR]c4800 10:14:27,320 ORC|6||||||^^^20090826114803||||[CR]c4800 10:14:27,320 OBR|6||R0000819^AD6002084^C1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908 26154328|||||||PC||||||||||||20090826114803|[CR ]c4800 10:14:27,335 OBX|6|ST|R0000819^AD6002084^C1||Other·HR·HPV·PO S,·HPV16·POS,·HPV18·POS^||||||P|||||Labmanager| [CR]c4800 10:14:27,335 ORC|7||||||^^^20090826114803||||[CR]c4800 10:14:27,335 OBR|7||R0000818^AD6002084^H1|HPV^HPV·High·Risk· Panel·+·Genotyping^Full|||20090826120921|200908

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26154328|||||||PC||||||||||||20090826114803|[CR ]c4800 10:14:27,335 OBX|7|ST|R0000818^AD6002084^H1||Other·HR·HPV·In valid,·HPV16·Invalid,·HPV18·POS^||||||P|||||Lab manager|[CR]c4800 10:14:27,351 ORC|8||||||^^^20090826114803||||[CR]c4800 10:14:27,351 OBR|8||2H1M015776A02IG^AD6002084^A1|HPV^N/A^Ful l|||20090826120921|20090826154328|||||||PosCtrl ||||||||||||20090826114803|[CR]c4800 10:14:27,351 OBX|8|ST|2H1M015776A02IG^AD6002084^A1||Valid^^C T_DYE3~37.381362915039062~CT_DYE5~35.7265472412 10938~CT_DYE1~36.203384399414062~CT_DYE0~35.940 170288085938||||||

Note: The bullet character inside results is just a placeholder to visualize the spaces inside strings.example Other·HR·HPV·POS should look in reality: Other HR HPV POSThe character used in the transmission is a regular space (Hex 20).

Example multiple flags (OBX segment only, simulator log)

outgoing - HL7:

c4800 08:05:32,833 OBX|79|ST|A2482185^AD6201793^D3||Failed^X3~X4~X1|| ||||F|||||GT|[CR]

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Communication setup8

Network connectionThe physical connection used by the cobas 4800 host interface is the standard network card (N.I.C) with Ethernet protocol.

The network address of the instrument is normally determined by the installation of a cobas IT firewall.

To change the network address, you must log into the operating system as local Administrator. Please ask the Roche service representative.

Instrument SetupBy default the HIF modules are not installed, for the instrument setup, please refer to the Network Configuration Guidecobas 4800 system.This installation has to be performed by qualified Roche service personnel.

Once the software for host interface has been installed, some parameters can be changed to match the requirements of theLIS system.The default protocol after installation is HL7. To change to ASTM, or back to HL7, change the target IP (LIS system) or theport, see the the Network Configuration Guide cobas 4800 system.

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Simulator9

Installing simulators

Roche has developed specific host simulators to make simple testing of the ASTM or HL7 protocol, for the cobas 4800Instrument.

This software can be installed on Windows computers and are intended to be used only by Roche trained personnel.When used as an instrument simulator, the goal is to provide only a quick test tool for testing the transmission formats.Please keep in mind that the simulator does not react like a real instruments in all situations.

The simulator is intended to be used for several Roche instruments, periodically new ones willbe added.

From version 2.0 on, all the host interface tools come together in a common installation package.

They will be installed by default under Host Interface tools.

Requirements

The Roche ASTM/HL7 simulators can be installed on Windows XP computers.The user needs administrator rights to be able to install the host tools package properly.

After the basic installation of the "Host tools" package, some patches may be required depending on the simulator youintend to use.Please ask the Roche service representative for further information.

Software requirement:Windows XP professional SP2, with current patches.Access to network settings

Recommended hardware:Any computer able to run Windows XP professional.Network card

HL7 SimulatorRoche has developed a specific host simulator to make simple testing of the HL7 protocol, forthe cobas 4800 Instrument.

To start the simulator, simply select from the stat menu as shown.

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You must accept the disclaimer to be able to start the program.

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Setting up the simulator connectionSome parameters must be setup before the cobas 4800 system is able to communicate with the simulator.

The simulator must be set up as a server. That is, it will listen on a defined port. Port 5555 is often used as a default.

The server IP address is the address of the network card and cannot be changed for a server.It comes from the network settings of the computer hosting the simulator.This is the same as the LIS address that must be set on the cobas 4800 when installing or setting up the Host. See Instrument setup 42

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Select the Instrument "cobas 4800" from the drop down list and "Host" as shown. This has the effect of enabling thecorrect responses from the simulator to the selected type of instrument.

Note: The simulator can also simulate a cobas 4800 system, but this mode goes beyond the scope of this manual

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Once parameters are setup correctly the simulator will start listening on the defined port. Once every minute, the cobas4800 communication server will attempt a connection on the defined IP address and port.If the simulator is reached, the connection indicator will turn from yellow to green as shown.

Additionally, the IP address of the connected system will appear in the lower part of the blue box (Remote).

At this point the simulator can be used and will display the HL7 records received and sent.

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Connection testWhen the simulator is connected, the connection test gives a possibility to check the responsiveness of the client.

In some circumstances, the simulator may erroneously indicate an active connection.This can be the case if there are elements in the network that where temporarily disconnected.

If the LIS seems unresponsive although the connection is displayed as active, make the connection check.

In case of test failure, close the simulator and restart it. If the connection is not re-established within two minutes,shutdown the cobas 4800 system and restart it.

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Sending an order to the system

Actually, you cannot "send" an order, as the instrument is always master.

The simulator is able to reply to an order request. For this it must have certain information in itsdatabase. You can edit this database manually to prepare a correct answer to instrument queries.

Simulator Database:

The simulator has a small database where basic records can be stored. The simulator will use itsdatabase records to respond to the instrument requests.If the instrument sends a request related to a certain Sample ID, the simulator will search itsdatabase for a matching record.

If one is found, the simulator will attempt to generate an order upload, using the informationstored in the simulator database record.

To open the database on the simulator:

Then in the DB, select the table as shown.

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You can generate new records, either blank ones:

Or duplicate existing ones and editing them:

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Editing the duplicate record:

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There are further fields on the right that can be edited: (Use lower slide bar to view them).

Note: Be aware that the simulator does not perform any check on the type of data. Verify with theprotocol definitions that you enter valid data. For example, if you type a number where anothertype is required, an error will probably be generated at the instrument level and the order rejected.(see also restrictions )58

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Receiving results from the system.Once the LIS systems have been installed by a Roche engineer, the system must be configured to work with LIS:To configure cobas 4800 software for LIS communication, the user must first open cobas 4800 software and log in withusername FSE. Only a user with administrator rights to the application can switch the LIS on.

Go to 1)utilities tab, select 2) configuration tab, select 3) System Settings and 4) enable the checkbox LIS present.

Exit cobas 4800 software.

TO be able to transmit results, once the LIS has been activated, it is necessary to log in as

1. Open the cobas 4800 Software2. Login with user name FSEGo to 1) result tab, select 2) performed run, select 3) sample, click 4) Export

All results present in the page will be transmitted, even if only one is selected.

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Results received by the simulator will be stored in the database as shown below.

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ASTM SimulatorRoche has developed a specific host simulator to make simple testing of the ASTM protocol, forthe cobas 4800 Instrument.

This software can be used on Windows XP computers and can be delivered upon request.Contact your Roche Diagnostics representative.

The simulator is intended to be used for several Roche instruments, periodically new ones willbe added.

Requirements

The Roche ASTM simulator can be installed on Windows XP computers and is part of the complete host tools package.refer to the previous topic HL7 simulator, the ASTM simulator works in a very similar way and shares the loacl simulatordatabase with the HL7 simulator.

The user needs administrator rights to be able to install the host tools package properly.

Software requirement:Windows XP professional SP2, with current patches.Access to network settings

Recommended hardware:Any computer able to run Windows XP professional.Network card

Setting up and operating the ASTM simulator

To setup and operate the ASTM simulator as a host, read the HL7 simulator sections .The ASTM simulator operates in a very similar way and shares the simulator datatabase for cobas 4800.

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Troubleshooting / logfiles10Troubleshoting:

Most errors in the incoming communications i.e. a missing parameter in a filed, will result in a timeout message on theinstrument.

Errors generated by the conversion from incoming HTML or ASTM are not passed to the application, the Transformerprogram will only pass XML files if the parsing or the different fields succeeds. If any error occur it will just stop parsingthe information and do nothing, therefore if the application is awaiting an answer, it will just timeout. To find the sourceof the problem, see the logfiles section.

If the cobas 4800 system has an active connection to the host system but fails to request order information after loadingsample racks, one possible cause is the "operator" is not logged into the operating system of the cobas 4800 control unit.If an administrator is logged into the windows operating system, the LIS service will connect to the ASTM or HL7 serverbut the system will not be able to communicate. Corrective action: log off the administrator user in Windows, the system will automatically re-log as "operator"

Logfiles:

In the directory c:\data\log, the trafic for the selected protocol is logged:

Hl7_trace.log for the Hl7 data exchange.astm_trace.log for the astm data exchange.

The transformation activity of the transformer program .xml <=> active protocol is logged in the file cserver.log

cserver logfiles are collections of incremental files like cserver.log.1, cserver.log.2 .......

As soon as the cserver.log reaches a size of 1025 kB, a number is appended to the extension and a new cserver.log iscreated.

In the directory C:programm files\Roche diagnosticsAG\cobas_4800_v1.0.0.0918\bin\log\the file MTS-Transformer-session-trace-file.log contains the parsing activity for the active protocol.

To find the captured errors, open the file with the windows notepad program and make a search fro "ERROR".You may find some limited indications about protocol errors. (e.g an incorrect type or missing mandatory parameter).

Known restrictions11

Workflow:

Only the Full run is supported by LIS. The "A&D" and "Sample extraction only" modes are not supported by the LISsystem.

The timeout after an order request from the instrument is currently set at 30 seconds and cannot be changed.Because of this relatively short time out, it is recommended to use only direct network connections between the LIS andthe cobas 4800 system. Avoid any bottlenecks, i.e. converters to RS232 serial line. Order processing on the LIS should beoptimized to avois a timeout when loading the maximum samples.

Troubleshooting errors:

In case of protocol errors (i.e. the LIS sending an incorrect data type or unexpected values), the instrument will report “LIS system does not answer (timeout)” in most cases. This can be misleading, however some information might be available in the logfiles. See Troubleshooting

ASTM:

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Known restrictions

O segment in order response:

Field O-8 if left blank will not create a failure, although this is documented as “required” field.

HL7:

No Known problem

Keywords index

- A -A&D 3, 8, 13

A&D Only 6

active connection 49

AnD 3

ASCII 31

ASTM simulator 57

- C -Calculation 13

checksum 17

Client /Server structure 4

cobas x 480 3

cobas z 480 3

Control character 17

- D -data framing 31

- E -empty orders 6

error 13, 50

errors 58

- F -FLAGS 13

Frame

final frame 17

intermediate frame 17

Length of the Frame 17

Middle Frame 17

Full 6

Full run 3, 8

- G -GUID 3, 20, 22, 26, 33, 35

- H -host simulator 43

- I -inquiry timeout 6

installation Manual 42

- L -layer 5

Logfiles 58

- M -Media Type 8

Message Terminator 24

Micro Well Plate 3

Minimal Layer

Minimal Layer Protocol 31

Missing orders 6, 23, 35

MLLP 31

MTS 3

MWP 3

MWP plate 6

- N -Network Configuration Guide 42

- O -order request 50

OSI model 5

- P -patient information 23, 27

physical connection 4

- R -requirement 43

Requirements 43

reserveCyt 8

Results timeout 17

run 8

Run Type 6, 8

- S -server 6, 46

server IP address 46

simulator 43, 57

Database 50

Simulator database 50

Simulator Database 50

special characters

FS 31

VT 31

SPI 13

SubTestType 8

SurePath 8

- T -TCP/IP client 4

TCP/IP server 4

Test Type 6, 8

timeout 6, 58

Timeout (Results) 17

Transformer 4

transmit results 54

- U -UniTrans 8

Urine UniTrans 8

- W -Warning 13

Work Order 6

Work order inquiry timeout 6

Workflow 58

Personal notes:

Roche Diagnostics Ltd.ForrenstrasseCH-6343 RotkreuzSwitzerland© 2009 Roche Diagnostics Ltd.

19-M

ar-1

0