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KONELAB LIMS AND LAS INTERFACES Code: 895304-4301 Manual version: H Date: 1.10.2003 The CE mark attached on Konelab indicates the conformity with the EMC (electromagnetic compatibility) directive 89/336/EC. Thermo Electron Oy, Clinical Diagnostics Clinical Chemistry & Automation Systems Ratastie 2, P.O. Box 100 FIN-01621 VANTAA, Finland Tel.: +358 9 329 100 Fax: +358 9 3291 0300 www.thermo.com/konelab Information in this manual is subject to change without prior notice.

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Page 1: KONELAB LIMS AND LAS INTERFACES - yeec.com · 10/01/2003 · KONELAB LIMS AND LAS INTERFACES ... Information in this manual is subject to change ... or Child (C) Konelab ignores this;

KONELABLIMS AND LASINTERFACESCode: 895304-4301Manual version: HDate: 1.10.2003

The CE mark attached on Konelab indicates the conformity withthe EMC (electromagnetic compatibility) directive 89/336/EC.

Thermo Electron Oy, Clinical DiagnosticsClinical Chemistry & Automation SystemsRatastie 2, P.O. Box 100FIN-01621 VANTAA, FinlandTel.: +358 9 329 100Fax: +358 9 3291 0300

www.thermo.com/konelab

Information in this manual is subject to change withoutprior notice.

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KonelabLIMS and LAS Interfaces

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I LIMS INTERFACE

1. HARDWARE INTERFACE .......................................................................................................... 1

1.1 HOW TO INSTALL AND CONFIGURE THE ASTM SOFTWARE ..............................................21.1.1 INSTALLATION..........................................................................................................................21.1.2 CONFIGURATION.....................................................................................................................3

2. Konelab ONLINE (=KONE ONLINE) PROTOCOL................................................................... 4

2.1 BI-DIRECTIONAL MODE ...............................................................................................................42.1.1 COMMUNICATION RECORDS ................................................................................................5

2.1.1.1 INITIALISATION RECORDS..............................................................................................................52.1.1.2 PATIENT INFORMATION RECORD .................................................................................................62.1.1.3 SAMPLE INFORMATION RECORD ..................................................................................................72.1.1.4 TEST ANALYSIS RECORD ................................................................................................................72.1.1.5 RESULT RECORD................................................................................................................................82.1.1.6 FINISHING RECORD...........................................................................................................................8

2.1.2 BI-DIRECTIONAL PROTOCOLS ..............................................................................................92.1.3 DATA VALIDITY CHECK........................................................................................................14

2.1.3.1 CHECK SUM ......................................................................................................................................142.1.4 TIMING REQUIREMENTS ......................................................................................................14

2.2 EXAMPLES OF COMMUNICATION ...........................................................................................152.2.1 SAMPLE AND TEST DATA ENTRY.........................................................................................152.2.2 RECEIVING NEW READY RESULTS......................................................................................162.2.3 RECEIVING ALL READY RESULTS .......................................................................................172.2.4 RECEIVING RESULTS FOR A SPECIFIC SAMPLE ..............................................................172.2.5 SENDING TEST DATA FOR OLD SAMPLES .........................................................................182.2.6 ENQUIRING TESTS IN USE IN THE ANALYSER ..................................................................19

2.3 ERROR HANDLING.......................................................................................................................202.3.1 ERROR RECORD.....................................................................................................................202.3.2 RESULT ERROR CODES.........................................................................................................212.3.3 COMMUNICATION ERROR CODES......................................................................................212.3.4 ON LINE ERROR CODES........................................................................................................222.3.5 EXAMPLES OF ERROR HANDLING......................................................................................24

2.4 REQUESTING A CALCULATED TEST .......................................................................................25

3. ASTM PROTOCOL ................................................................................................................... 27

3.1 FEATURES......................................................................................................................................273.2 ASTM IN KONELAB ..........................................................................................................................28

3.2.1 ASTM 1394 – 91 STRUCTURE OF MESSAGES .....................................................................283.2.1.1 Header record (level 0).........................................................................................................................283.2.1.2 Message terminator record (level 0).....................................................................................................293.2.1.3 Patient information record (level 1) .....................................................................................................293.2.1.4 Test order record (level 2) ....................................................................................................................313.2.1.5 Result record (level 3) ..........................................................................................................................333.2.1.6 Comment record (level 4) used with the Result Record .......................................................................353.2.1.7 Comment record (level 3) used with transmission related error conditions .........................................363.2.1.8 Request information record (level 1)....................................................................................................37

3.2.2 FIELD LENGTHS USED BY Konelab .....................................................................................383.2.3 EXAMPLES OF COMMUNICATION BETWEEN Konelab AND THE HOSTCOMPUTER.............................................................................................................................................39

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II LAS INTERFACE

4. KONELAB / LAS INTERFACE .................................................................................................. 44

4.1 HARDWARE INTERFACE ............................................................................................................444.2 GENERAL DESCRIPTION.............................................................................................................44

4.2.1 MESSAGE RECORD FORMAT ...............................................................................................444.2.2 CALCULATION OF CHECKSUM...........................................................................................454.2.3 SEQUENCE FOR INITIALISING THE COMMUNICATION INTERFACE............................464.2.4 ANALYSER BOOT SEQUENCE...............................................................................................464.2.5 KUSTI STATES AND ERROR RECOVERY .............................................................................47

4.3. COMMUNICATION RECORDS ....................................................................................................494.3.1 INITIALISATION RECORD .....................................................................................................494.3.2 ILLEGAL COMMAND RECORD.............................................................................................494.3.3 ANALYSER STATUS QUERY RECORD ..................................................................................494.3.4 ANALYSER STATUS RECORD................................................................................................504.3.5 ASPIRATE SAMPLE RECORD................................................................................................504.3.6 SAMPLE DISPENSING COMPLETE RECORD......................................................................514.3.7 REINITIALISE COMMUNICATION RECORD .......................................................................51

4.4 COMMUNICATION EXAMPLES .................................................................................................524.4.1 INITIALISATION SEQUENCE.................................................................................................524.4.2 SAMPLE ASPIRATION SEQUENCE FOR TWO SAMPLES ...................................................524.4.3 SAMPLE ASPIRATION FAILS, RECOVERY SUCCESSFUL 1 ...............................................534.4.4 SAMPLE ASPIRATION FAILS, RECOVERY SUCCESSFUL 2 ...............................................544.4.5 SAMPLE ASPIRATION FAILS, RECOVERY UNSUCCESSFUL ............................................55

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1. HARDWARE INTERFACEThe Konelab LIMS hardware interface works through serial communication channel.

Figure 1: The connectors for serial communication channels are at the back of theKonelab workstation. The connectors are 9-pin male D-connectors.

The channel (COM1,COM2) as well as the LIMS protocol (Konelab Online orASTM) and communication parameters (baud rate, number of bits in character,number of start and stop bits and the use of parity) to be used can be configured inthe Konelab LIMS Configuration window.

LIMS Configuration

Main window

F8/F1Configuration

Configuration

F7LIMS

Configuration

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The signals needed at the Konelab end of cable

Pin 2 Receive Data

Pin 3 Transmit Data

Pin 5 Ground

An example of the cabling between Konelab and LIMS

Konelab and a PC (RS-232)

Konelab PC

Pin 2 RxD--------------------------- TxD

Pin 3 TxD----------------------------- RxD

Pin 5 Gnd ----------------------------- Gnd

1.1 HOW TO INSTALL ANDCONFIGURE THE ASTM SOFTWARE

1.1.1 INSTALLATIONThe ASTM software can be taken into use after the Konelab V3.0 software isinstalled. If Konelab application is running, close the application by selectingManagement and Exit. Select Start->Programs->Konelab Lims Selection and selectASTM from there. Now the LIMS interface will use ASTM software instead ofKonelab Online software. The ASTM configurations should be checked afterstarting the Konelab application again, because the configuration file is updated instart of the application.

The cable should bemade according to thedocumentation of LIMSsystem in use.

This example describesthe minimum cableconnections needed.Some computer systemsmay require someadditional signalsconnected locally withinconnector. Please referto your LIMSdocumentation forfurther information.

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1.1.2 CONFIGURATIONASTM software has additional configurations as compared to Konelab Onlinesoftware. The configuration file is Konelab.ini and it is in folder C:\Konelab\Config.

The changes to the configuration are:

LimsProtocol = ASTM- This is a new choice for protocol.

LimsAutomaticResultSending = YES- When YES the new results are automatically send to Laboratory computer.

LimsThreadPriority = LOW- This enables the Lims thread to use lower priority and give other softwareprocesses more time.

LimsInterruptible = NO- When YES the ASTM protocol allows the receiver to ask for interruption ofsending information.

LimsHostQuery =YES- When YES the Konelab software will automatically send a query for sampleinformation and requests when new sample is introduced into Konelab.

SentryWaitsLimsRequests = YES- When YES the sample entry function waits for the response to a query when newsample is introduced.

ASTMControlResultSending = NO- When YES the new control sample analysis results are automatically send toLaboratory computer.

ASTMStandardResultSending = NO- When YES the new calibrator sample analysis results are automatically send toLaboratory computer.

SampleIdSendingDelay = 0- If value is not 0, Konelab will use this delay between successive sending of new

sample Id's. This can be used to ease the burden on Laboratory computer whene.g. a full segment with 14 samples is introduced. The value is expressed inmilliseconds.

ResultSendingDelay = 0- If value is not 0, Konelab will use this delay between successive sending of newsample results. This can be used to ease the burden on Laboratory computer. Thevalue is expressed in milliseconds.

In order to take ASTM protocol in use the configuration file should be editedmanually. Close the Konelab application by selecting MANAGEMENT and EXITfrom there. Wait for the Konelab application to shut down. Start Windows NTExplorer by selecting Start-> Programs->Windows NT Explorer. Select the folderC:\Konelab\Config and on the right side of Explorer display should be seen filesKonelab and UserText. Double click with mouse on Konelab file. Now the Notepadprogram should open with the Konelab.ini file. Change the configuration manuallyand after that save the modified file selecting File->Save. Now the Konelab softwarecan be started again with ASTM configurations.

The ASTM softwaresupports sending resultson ready sample or onready request basis. Thesending of results onready request basis willload the interface heavilyand it is recommendedthat sending results byready sample should beused. This selection canbe done through theKonelab Configurationfunction.

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2. Konelab ONLINE (=KONEONLINE) PROTOCOL

2.1 BI-DIRECTIONAL MODEKonelab uses bi-directional data communication between the analyser and theexternal computer i.e. both an external computer and the analyser can communicatewith each other. For example, the external computer can send test requests toKonelab and the analyser can send completed results to the computer.

Bi-directional mode consists of seven different functions:

� Function 1 is used when Patient data, Sample data and Test data is sent tothe analyser.

� Function 2 is used to send Sample and Test data only to the analyser.Control and Calibrator sample data can also be sent to the analyser using thisfunction.

� Function 3 is used when a laboratory computer wishes to receive all newlycompleted results which have not already been sent.

� Function 4 is used when a laboratory computer wishes to receive allresults completed that day.

� Function 5 is used when a laboratory computer wishes to receive allresults for a particular sample. Complete and incomplete tests are sent by theanalyser.

� Function 6 is used for request inquiry i.e. a laboratory computer wishes toknow which patient samples exist in the database of the analyser. The laboratorycomputer can then send new requests.

� Function 7 is used when a laboratory computer wishes to know which testsexist in the database of the analyser.

These functions are activated using the initialisation records. Refer to section 2.1.1.1.

The analyser is alwaysacting as co-operatorand the computer is thehost.

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2.1.1 COMMUNICATION RECORDSThe following records are used when the analyser and the host computercommunicates with each other.

2.1.1.1 INITIALISATION RECORDS

Initialisation records are activating commands which the host computer sends to theanalyser when the communication begins.

INITIALISATION RECORD 1

This record is used when Patient data, Sample data and Test data is sent to theanalyser.

:I:PR1/C/

C = check sum, refer to section 2.1.3.1.

INITIALISATION RECORD 2

This record is used to send Sample and Test data only to the analyser. Control andCalibrator sample data can also be sent to the analyser using this initialisation record.

:I:PR2/C/

INITIALISATION RECORD 3

This record is used when a laboratory computer wishes to receive all newlycompleted results which have not already been sent.

:I:PR3/C/

INITIALISATION RECORD 4

This record is used when a laboratory computer wishes to receive all resultscompleted that day.

:I:PR4/C/

INITIALISATION RECORD 5

This record is used when a laboratory computer wishes to receive all results for aparticular sample. Complete and incomplete tests are sent by the analyser.

:I:PR5/C/

INITIALISATION RECORD 6

This record is used when a laboratory computer wishes to know which patientsamples exist on the database of the analyser. The laboratory computer can then sendnew requests.

:I:PR6/C/

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INITIALISATION RECORD 7

This record is used when a laboratory computer wishes to know which tests exist onthe database of the analyser.

:I:PR7/C/

2.1.1.2 PATIENT INFORMATION RECORD

:P:nn..n/ii..i/M or F/A or C/b..b/ss..s/n or o/C/

P - identifies the record to be aPatient Information Record

nn..n - Patient Name (up to 24 characters)

ii..i - Patient Identification (up to 16 characters)

M - Male (M) or Female (F) Konelab ignores this; referenceclass is always 0

A - Adult (A) or Child (C) Konelab ignores this; referenceclass is always 0

bb..b - Age or Date of Birth (up to 8 characters)

ss..s - Sender name (up to 24 characters)

n or o - New (n) or Old (o) (1 character)

C - check sum, refer to section2.1.3.1.

The slash (/) must be entered into the string, since it is the field delimiter. Thismeans that the number of slashes in a record is always constant. Note that the slash isa forbidden character inside a field.

For example, if no sender information and no age information is sent, the Data Stringlooks like:

:P:nn..n/ii..i/M/A///n or o/C/

New or Old: If theswitch is N or n - theanalyser expects thepatient to be new. Ifalready present, an errormessage is sent to thecomputer. If the switch isO or o and the patientdoes not exist in theanalyser, again an errormessage is sent. If theswitch is omitted thepatient is accepted ineither case

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2.1.1.3 SAMPLE INFORMATION RECORD

:S:ii..i/pn/pp/st/nn/dd..d/tt..t/rrr/n or o/C/

S - identifies the record to be a sampleinformation record

ii..i - sample identification (up to 16 characters)

pn - sample segment number (up to 2 characters)

pp - sample segment position (up to 3 characters)

st - sample type (up to 2 characters)

nn - sample note data e.g. icteric (ic),haemolysed (HE), a user defined charactercode, handled only as an information string

(up to 2 characters)

dd..d - collection date, a user defined charactercode, handled only as an information string

(up to 8 characters)

tt..t - collection time, a user defined charactercode, handled only as an information string

(up to 5 characters)

rrr - dilution ratio (format is 1 + rrr) (up to 3 characters)

n or o - new/old (1 character)

C - check sum, refer to section 2.1.3.1.

2.1.1.4 TEST ANALYSIS RECORD

:A:xx..x/!/yy..y/..../C/

A - identifies the record to be the test analysisrecord

! - STAT identifier for following request (1 character)

xx..xyy..y,etc

- test identification (up to 8 characters)

C - Check sum, refer to section 2.1.3.1.

The STAT identifier indicates that the following request must be performed urgently.This is valid only for one request following the STAT identifier. If there is a STATprofile to be sent, each test identification must have its separate STAT identifier. Ifthe '!' is omitted then the request is performed routinely,i.e. :A:xx..x/yy..y/.../C/

Sample Type:If the type is @S, acalibrator name (i.e.S0...S19) is expected as theid. If the identification is nota calibrator name, an errormessage will be sent.If the type is @C, a controlname (i.e. C1...C19) isexpected as the id. If theidentification is not acontrol name, an errormessage will be sent.

New or Old:If the switch is N or n - theanalyser expects the sampleto be new. If alreadypresent, an error message issent to the computer.If the switch is O or o andthe sample does not exist inthe analyser, again an errormessage is sent. If the switchis omitted, the sample isaccepted in either case.

Use the same testidentification as in test'sparameters.

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2.1.1.5 RESULT RECORD

:R:ii..i/aa..a/rr..r/ddd/ee..e/aa..a/rr..r///.../C/

R - identifies the record to be a result type record

ii..i - sample identification, a shorter identification isfilled with blanks by the analyser

(16 characters)

aa..a - analysis identification, a shorter identificationis filled with blanks by the analyser

(8 characters)

rr..r - result, right justified, field is filled with blanksby the analyser. A possible minus sign is leadingthe most significant character. The 6 charactersmight include a decimal point which position isdefined by the parameter 'Number of decimals'in the TEST DEFINITION window.

(6 characters)

ddd - dilution ratio (format is 1+ddd), total dilutionincluding both manual and automatic dilution

(up to 3characters)

ee..e - result error codes, refer to section 2.3.2. (up to 10characters)

If the result was obtained without a dilution, the dilution field is skipped (/ remains).If the result has no error, the error field is skipped, (/ remains).

2.1.1.6 FINISHING RECORD

Finishing record is used in data sending as the last record to indicate to receiver thatcommunication is over. The receiver must always acknowledge finishing record by<ACK>.

Finishing record has always the same format:

:F:PR/C/

where C is the check sum. Refer to section 2.1.3.1 for the calculation of the checksum.

SPECIAL NOTE:The most significantdigit is lost if theresult includes morethan 6 characters.

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2.1.2 BI-DIRECTIONAL PROTOCOLS

PROTOCOL FOR SENDING PATIENT, SAMPLE AND TEST DATATO THE ANALYSER

*A number of Test Analysis records may follow, which must be acknowledged by(ACK)

LABORATORY COMPUTER ANALYSER

(Initialization record 1)(CR)(LF)

(ACK)

(Patient info record)(CR)(LF)

(ACK)

(Sample info record)(CR)(LF)

(ACK)

(Test analysis record)*(CR)(LF)

(ACK)

(Sample info record)(CR)(LF)

(ACK)

(Test analysis record)*(CR)(LF)

(ACK)

(Patient info record)(CR)(LF)

(ACK)

(Sample info record)(CR)(LF)

(ACK)

(Test analysis record)*(CR)(LF)

(ACK)

(Finishing record)(CR)(LF)

(ACK)

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PROTOCOL FOR SENDING SAMPLE AND TEST DATA TO THEANALYSER

* A number of Test Analysis records may follow, which must be acknowledged by(ACK).

PROTOCOL FOR RECEIVING NEWLY COMPLETED RESULTSFROM THE ANALYSER

* A number of Result Records may follow, which must be acknowledged by(ACK).

LABORATORY COMPUTER ANALYSER

(Initialization record 3)(CR)(LF)

(ACK)

(Result record)*(CR)(LF)

(ACK)

(Finishing record)(CR)(LF)

(ACK)

LABORATORY COMPUTER ANALYSER

(Initialization record 2)(CR)(LF)

(ACK)

(Sample info record)(CR)(LF)

(ACK)

(Test analysis record)*(CR)(LF)

(ACK)

(Sample info record)(CR)(LF)

(ACK)

(Test analysis record)*(CR)(LF)

(ACK)

(Finishing record)(CR)(LF)

(ACK)

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PROTOCOL FOR RECEIVING ALL COMPLETED RESULTS FROMTHE ANALYSER, I.E. RECOVERY WHEN THE ANALYSER ORCOMPUTER GOES DOWN

* A number of Result Records may follow, which must be acknowledged by (ACK).

LABORATORY COMPUTER ANALYSER

(Initialization record 4)(CR)(LF)

(ACK)

(Result record)*(CR)(LF)

(ACK)

(Finishing record)(CR)(LF)

(ACK)

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PROTOCOL FOR RECEIVING RESULTS ON A SPECIFIC SAMPLE,I.E. STAT SAMPLE

* A number of Result Records may follow, which must be acknowledged by(ACK).

** A short delay (10 ms) must exist in these phases.

LABORATORY COMPUTER ANALYSER

(Initialization record 5)(CR)(LF)

(ACK)

(Sample info record)(CR)(LF)

(ACK)

(Result record)*(CR)(LF)

(ACK)

(Finishing record)(CR)(LF)

(ACK)

***

(Sample info record)(CR)(LF)

(ACK)

(Result record)*(CR)(LF)

(ACK)

(Finishing record)(CR)(LF)

(ACK)

***(Finishing record)(CR)(LF)

(ACK)

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PROTOCOL FOR SENDING REQUESTS FOR OLD SAMPLES

* A number of Test Analysis Records may follow, which must be acknowledged by(ACK).

** A short delay must exist in these phases.

PROTOCOL FOR ENQUIRING TESTS IN USE IN THE ANALYSER

* A number of Test Analysis Records may follow, which must be acknowledged by(ACK).

LABORATORY COMPUTER ANALYSER

(Initialization record 6)(CR)(LF)

(ACK)

= = 1 = =

(Sample info record)*(CR)(LF)

(ACK)

**(Test analysis record)(CR)(LF)

(ACK)

(Finishing record)(CR)(LF)

(ACK)

= = 2 = =

(Finishing record)(CR)(LF)

(ACK)

Sample info record isidentical to the recordused by the laboratorycomputer to send sampleinfo.The part between '== 1==' and '== 2 ==' isrepeated until all thesamples in the analyser'sdatabase have beenprocessed, excludingcalibrators and controls.

LABORATORY COMPUTER ANALYSER

(Initialization record 7)(CR)(LF)

(ACK)

(Test analysis record)*(CR)(LF)

(ACK)

(Finishing record)(CR)(LF)

(ACK)

Test analysis record isidentical to the recordused by the host to sendrequests, except it nevercontains the STATidentifier ('!').

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2.1.3 DATA VALIDITY CHECKThe communication is full duplex and ASCII characters are used, but the user canselect the number of data bits, stop bits, parity and speed in the Configurationwindow.

Each record begins with a colon ':' and ends with a check character 'C' followed by aslash '/', carriage return and line feed.

Maximum record length is 132, including check sum.

2.1.3.1 CHECK SUM

The check sum is calculated from the colon to the last slash before the check sumcharacter.

The check sum is defined by the following formula (decimal system):

C = Σi (Ci - 32) mod64 + 32

where Ci = each character

EXAMPLE OF CALCULATING A CHECK SUM

String without check sum

: I : P R 2 /

ASCII VALUE 58 73 58 80 82 50 47

SUBTRACT 32 26 41 26 48 50 18 15

TOTAL 26 67 93 141 191 209 224

MODULUS 64 26 3 29 13 63 17 32

ADD 32 64

CHARACTER @

String with check sum and delimiter

: I : P R 2 / @ /

2.1.4 TIMING REQUIREMENTSThe host computer has max. 60 seconds time for answering by (ACK) or (NAK).Otherwise the protocol has to be restarted.

The time the analyser needs for validation of a record depends on the situation and inthe worst case it may take few minutes. Recommended time out value is at least 3minutes when waiting the response from the analyser.

When the host computer asks results from the analyser with certain intervals, therecommended minimum time between consecutive asking is at least 5 minutes.

The string begins withthe : character andincludes all charactersup to, and including,the / character beforethe check sumcharacter.

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2.2 EXAMPLES OF COMMUNICATIONThis section gives brief examples of the protocol as it would be used in practice.The examples are only intended to give an indication of the stages involved in eachoperation, the data transmitted is arbitrary.

The direction in which the message is going.

means from the computer to the analyser

means from the analyser to the computer

2.2.1 SAMPLE AND TEST DATA ENTRY

WITH PATIENT DATA

LABORATORY COMPUTER ANALYSER

:I:PR1/?/

ACK

:P:SMITH JOHN/4///30/2/N/8/

ACK

:S:6///PL/HA/97-12-18/12:13/0/N/7/

ACK

:A:ISE/ALB/ALK.PH/ALT/DBIL/GGT/PROT/T/

ACK

:P:JONES SUSAN/23423///97-12-08/3/O/_/

ACK

:S:12/2/1/SE//97-12-07/09:45/0/O/)/

ACK

:A:!/ALB/!/ALK.PH/!/ALT/!/DBIL/!/GGT/@/

ACK

:F:PR/+/

ACK

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WITHOUT PATIENT DATA

2.2.2 RECEIVING NEW READY RESULTS

LABORATORY COMPUTER ANALYSER

:I:PR2/@/

ACK

:S:6///PL/HA/97-12-18/12:13/0/N/7/

ACK

:A:ISE/ALB/ALK.PH/ALT/DBIL/GGT/PROT/T/

ACK

:S:12/2/1/SE//97-12-07/09:45/0/O/)/

ACK

:A:!/ALB/!/ALK.PH/!/ALT/!/DBIL/!/GGT/@/

ACK

:F:PR/+/

ACK

Sample number 12 hasbeen allocated to position1 on segment 2, but samplenumber 6 will be allocatedto a position when thesample is entered to theanalyser. Also, the tests forsample number 12 are tobe performed as STATtests.

LABORATORY COMPUTER ANALYSER

:I:PR3/A/

ACK

:R:2/ K / 4.7///NA /136//102; 137/CL///002;/-/

ACK

:R:2 /ALB / 43.3///PROT / 48.4//102; 60/^/

ACK

:F:PR/+/

ACK

Results which hadbeen transmittedpreviously will not besent again.

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2.2.3 RECEIVING ALL READY RESULTS

2.2.4 RECEIVING RESULTS FOR A SPECIFICSAMPLE

LABORATORY COMPUTER ANALYSER

:I:PR4/B/

ACK

:R:1/ LDH / 600/5.0//CREA /67///G/

ACK

:R:2 /K / 4.7///NA / 136//102; 137/CL ///002;/-/

ACK

:R3 /ALB / 43.3///PROT / 48.4//102; 60/^/

ACK

:F:PR/+/

ACK

The results forsample 1 had beentransmittedpreviously but weresent again alongwith new results forsamples 2 and 3.

LABORATORY COMPUTER ANALYSER

:I:PR5/C/

ACK

:S:6/// PL/HA/97-12-18/12:13/0/N/7/

ACK

:R:6 /ALB ///001;/PROT / 48.4//102; 60.0/C/

ACK

:F:PR/+/ACK

:F:PR/+/

ACK

The error messageagainst the ALBtest indicates thatthe result is notready.

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2.2.5 SENDING TEST DATA FOR OLDSAMPLES

LABORATORY COMPUTER ANALYSER

:I:PR6/D/

ACK

:S:6 / 1/ 19/PL/HA/97-12-19/14:55/ 0//D/

ACK

:A:GLUC/CREA/CA/ALB/CHOL/_/

ACK

:F:PR/+/

ACK

:S:12 / 1/20/SE/CO/97-12-13/11:35/ 0//N/ACK

:A:CA/ALB/CHOL/;/

ACK

:F:PR/+/

ACK

:F:PR/+/

ACK

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2.2.6 ENQUIRING TESTS IN USE IN THEANALYSER

LABORATORY COMPUTER ANALYSER

:I:PR7/E/

ACK

:A:ALT /ALB / ALP /AMYL / AST/CA /CHOL /CL /CPK /CREA/CRP / FE / GGT /F/

ACK

:A:GLUC /K /LDH /LI / MG /NA /P/PH / TBIL/ TPROT / TRIGLY /URAC /J/

ACK

:F:PR/+/

ACK

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2.3 ERROR HANDLINGIn the event of an error in the data transmission, the analyser returns an error recordinstead of ACK. This situation could arise for instance when the laboratorycomputer sends a test analysis record for a test which does not exist in the analyser.

For example:

When the laboratory computer receives an error record, the analyser expects afinishing record to be sent back to acknowledge the error situation. The analyseracknowledges this by sending back an ACK. After this, the protocol begins againwith the laboratory computer starting the bidding with the initialisation record. Alldata up to the ACK sent by the analyser prior to the error is saved in the analyser,including also the requests at the beginning of an analysis record up to the wrong testidentification.

2.3.1 ERROR RECORD:E:xx..x/C/

E - identifies the record to be an error record

xx..x - communication error code, refer to section 2.3.3 (up to 30 characters)

LABORATORY COMPUTER ANALYSER

(Initialization record 1)(CR)(LF)

(ACK)

(Patient info record)(CR)(LF)

(ACK)

(Sample info record)(CR)(LF)

(ACK)

(Test analysis record)(CR)(LF) - error in this record

(Error record)(CR)(LF)

(ACK)

(Finishing record)(CR)(LF)

(ACK)

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2.3.2 RESULT ERROR CODESERROR CODE EXPLANATION

001; result not ready, in this case result is skipped in result record

002; result rejected, result will never come, e.g. one ISE electrodewas disabled

003; screening test not measurable, condition due to screening testrejection

101;xx..x result over reference, xx..x is the limit

102;xx..x result under reference, xx..x is the limit

2.3.3 COMMUNICATION ERROR CODESERROR CODES EXPLANATION

001; format error, this error occurs when the laboratory computerhas three times sent a record which either has wrong checksum or is too long (> 132 characters)

003; invalid initialisation record

004; invalid record identification

005; protocol error

101;x..xx invalid sender identification, x..xx means the invalid sender id

103;x..xx invalid sample identification, x..xx means the invalid sampleid

104;x..xx invalid sample plate position, x..xx means the invalid position

105;x..xx invalid analysis identification, x..xx means the invalid id

106;x..xx calibrator or control name does not exist, x..xx is the name

107;x..xx invalid sample type, x..xx is the type- this error occurs when @C or @S is the sample type wheninitialisation record 1 is used

108; number of samples / patient exceeded, max nbr is 10

201;x..xx sample segment position is reserved, x..xx is the samplesegment position

210;x..xx patient already exists, x..xx is the patient name

211;x..xx patient does not exist, x..xx is the patient name

220;x..xx sample already exists, x..xx is the sample id

221;x..xx sample does not exist, x..xx is the sample id

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2.3.4 ON LINE ERROR CODESThe message 'Online' is given on the Main window during data transmission. If thereare errors on the transmission, error messages are given via the analyser.

32 WRONG DATA FROM AN OTHER PROCESS (LIMS)

� Internal software problem in the database. Restart the workstation.

401 SERIAL LINE PARAMETER ERROR (LIMS)

� Check the serial interface parameters in the Configuration window.

402 WRONG SERIAL PORT (LIMS)

� Check the serial interface parameters in the Configuration window.

403 WRITE ERROR (LIMS)407 TRANSMISSION ERROR (LIMS)409 MESSAGE BUFFER ERROR (LIMS)

External computer has received the data but transmission has been detected to beincorrect.

� Possible causesE.g. electronic malfunction, software error,initialisation error or power failure.Check the cable and cable connection. If the problempersists, print the reports and call service.

404 READ ERROR (LIMS)

The analyser has received the data but transmission has been recognised to beincorrect.

� Possible causesE.g. electronic malfunction, software error,initialisation error or power failure.Check the cable and cable connection. If the problempersists, print the reports and call service.

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405 SYNCRONIZATION ERROR (LIMS)

The analyser received a data record1 while it was expecting an ACK character or itreceived ACK/NAK while expecting a data record.

� Possible causesE.g. faulty cable, electronic malfunction, softwareerror.Check the cable and cable connection. If the problempersists, print the reports and call service.

1) A data record is a string of any characters beginning with ':' and ending with(0D hex) or a string of any characters whose length exceeds the size of input buffer(currently 132).

406 COMMUNICATION TIMEOUT (LIMS)

External computer did not answer in the allowed time.

� Possible causesE.g. faulty cable, electronic malfunction or wronginitialisation data.Check the cable and cable connection. If the problempersists, print the reports and call service.

408 ERROR WHEN DOING DATABASE OPERATION(LIMS)

� Warning about internal software problem in the database. Analysiscontinues. If the problem persists restart the workstation.

410 LIMS TYPE MISMATCH BETWEEN LIMS PROCESSAND KONELAB.INI

� To continue using the Konelab program, first exit from it by selectingF8/F3 in the Management window. Then select the correct LIMS process fromStart: Programs: lims selection. Finally, start the Konelab program again byclicking the konelab –icon.

999 LIMS ERROR MESSAGE (%u)- %u MEANS THE ERROR NUMBER

- Software problem. Analysis continues.

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2.3.5 EXAMPLES OF ERROR HANDLING

INVALID CHECK SUM

ERROR IN DATA TRANSMITTED

LABORATORY COMPUTER ANALYSER

:I:PR2/?/

NAK

:I:PR2/@/

ACK

The check sum in thefirst message wasincorrect, so theanalyser requested themessage to be sentagain.

LABORATORY COMPUTER ANALYSER

:I:PR2/@/

ACK

:S:126///SE//97-12-18/12:13/0/N/O/

ACK

:A:XXX/PROT/@/

:E:105;XXX /A/

ACK

:F:PR/+/

ACK

The analyser does notrecognise XXX as a validtest id and so it sendserror message 105 whichthe computeracknowledges. Thecomputer wouldprobably now try to sendthe other tests forsamples and inform theuser of the problem.

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2.4 REQUESTING A CALCULATEDTESTCalculated tests can be requested online. All needed test requests belonging to thecalculated test are generated automatically. The analyser is trying to use the latestintroduced samples. If it doesn't success in that it uses the older ones.

The following requirements for requesting calculated testsonline must be fulfilled:

1) Tests

All tests including into the calculated test and the calculated test itselfmust be defined in use.

All tests including into the calculated test and the calculated test itselfmust have the online name.

This concerns also external tests belonging to the calculated test.

To define a calculated test refer to Konelab Reference manual, chapter 4.1.4.

2) Samples

First introduce samples with the right sample types, after that give the test request forthe calculated test.

The right sample type here means the sample type belonging to the calculated testrequest.

A

B

A

B

If requirements arenot fulfilled the errormessage '105:Analysing error' isappearing.

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An example of requesting a calculated (patient) test (=CC)anda calculated (sample) test (=LDL) via LIMS:

:I:PR1/?/

:P:Patient1///////3/

:S:Sample1///S//////4/

:S:Sample2///U//////7/

:A:CC/J/

:F:PR/+/

:I:PR2/@/

:S:Sample3///S//////6/

:A:LDL/@/

:F:PR/+/

Reporting

Reporting gives result of calculated (patient) test according to a patient. In additionthe external test is reported according to a patient. Results of tests including into thecalculated test are reported separately according to samples.

When a calculated(patient) test has beenrequested there mustbe a PR1-record or thepatient must have beenintroduced in thePatient entry windowin the user interface.

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3. ASTM PROTOCOLThe ASTM Laboratory Information Management System interface is based on thefollowing ASTM standards: ASTM 1394-91 "Standard Specification forTransferring Information Between Clinical Instruments and Computer Systems" andASTM 1381-95 "Standard Specification for Low-Level Protocol to TransferMessages Between Clinical Laboratory Instruments and Computer Systems.

3.1 FEATURESThe physical transmission layer is implemented according to ASTM 1381. The cableconnector is a 9-pin male connector instead of the standard 25-pin male connector.

The logical layer contains selected portions of ASTM 1394. The detailed recordstructure is described in section 3.2.1 ASTM in Konelab: ASTM 1394-91 Structureof messages.

The main features are:

- automatic request for sample information when new sample is introduced to theinstrument (configurable ON/OFF)

- automatic sending of results either on ready sample or ready request basis(configurable reporting basis and ON/OFF)

- automatic sending of control sample results (configurable ON/OFF)

- automatic sending of calibrator sample results (configurable ON/OFF)

- response to sample information requests from Laboratory computer

- response to control sample information requests from Laboratory computer

- response to sample information received from Laboratory computer

- cancelling of requests through ASTM by Laboratory computer

- error situation management

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3.2 ASTM in Konelab

3.2.1 ASTM 1394 – 91 STRUCTURE OFMESSAGESFollowing sections show the ASTM records used by Konelab. The tables in sectionsinclude field name and number, next two fields has the information about the fieldsusage by the host or the instrument, and a comment on use of the field. If the field isoptional the mark at usage information is between brackets. Host can send all fields,but only the ones with mark are processed.

3.2.1.1 Header record (level 0)

Field Name No Host Instr. Comment

Record typeID

1 X X Always H. Starts every message. Note: nodelimiter between the first and the secondfield

Delimiterdefinition

2 X X Field, repeat, component and escapedelimiters

Messagecontrol ID

3 - -

Accesspassword

4 - -

Sender nameor ID

5 ---

XXX

Instrument type 60/30/20^instrument ID InstrumentData.iId^software version Get_version ?

Sender streetaddress

6 - -

Reservedfield

7 - -

Sendertelephonenumber

8 - -

Characteristics of sender

9 - -

Receiver ID 10 - -

Comment orspecialinstructions

11 - -

ProcessingID

12 XXXX

XXXX

P –productionT –trainingD –debuggingQ –QC

Version No. 13 - -

Date and timeof message

14 - (X) Form YYYYMMDDHHMMSS. Only indebug mode

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3.2.1.2 Message terminator record (level 0)

Field Name No Host Instr. Comment

Record type ID 1 X X Always L. Ends every message.

Sequencenumber

2 X X Always 1. One terminator per message.

Terminationcode

3 (X)XXX--

-

(X)XXXXX

X

N or missing –normal terminationT –sender abortedR –receiver requested abortE –unknown errorQ –error in last request for informationI –no information available from lastqueryF –last request for information processed

3.2.1.3 Patient information record (level 1)

Field Name No Host Instr. Comment

Record type ID 1 X X Always P.

Sequencenumber

2 X X Running number within Message. Startswith 1.

Practiceassigned patientID

3 (X) (X) If no code is given, this gets the value ofPatient name.PatientData.sCode

Laboratoryassigned patientID

4 - -

Patient ID No.3

5 - -

Patient name 6 (X)----

(X)----

Last name^First name^middle name or initial^suffix^titleOnly one text field. The whole nameshould be given there. Optional if nopatient relates to sample.PatientData.sName

Mothersmaiden name

7 - -

Date of birth 8 (X) (X) Form YYYYMMDD.PatientData.acBirthDate

Patient sex 9 (X) - RefClassData.sName

Patient race-ethnic origin

10 - -

Patient address 11 - -

Reserved field 12 - -

Patienttelephonenumber

13 - -

Attendingphysician ID

14 - -

Special field 1 15 - -

Special field 2 16 - -

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Patient height 17 - -

Patient weight 18 - -

Patient’s knownor suspecteddiagnosis

19 - -

Patient activemedications

20 - -

Patient’s diet 21 - -

Practice field 1 22 - -

Practice field 2 23 - -

Admission ordischarge dates

24 - -

Admissionstatus

25 - -

Location 26 (X) (X) SenderData.sID

Native ofalternativediagnostic codeand classifiers

27 - -

Alternativediagnostic codeandclassification

28 - -

Patient religion 29 - -

Marital status 30 - -

Isolation status 31 - -

Language 32 - -

Hospitalservice

33 - -

Hospitalinstitution

34 - -

Dosagecategory

35 - -

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3.2.1.4 Test order record (level 2)

Field Name No Host Instr. Comment

Record type ID 1 X X Always O.

Sequencenumber

2 X X Running number within Patientinformation. Starts with 1.

Specimen ID 3 (X) (X) SpecimenID^ManualDilution^Segment^PositionOptional if no sample in order.Mapping to Konelab internal presentation:SpecimenID PatientSampleData.sIDManualDilution PatientSampleData.fManualDilRatioSegment StorageCollectionData.iIdPosition StorageItemData.ucPositionIf ManualDilution, Segment and Positioninformation is omitted, the value of 0 willbe used for each. Segment value 0 withposition value 0 refer to a virtualcollection and can be used safely, when noactual position is known.

Instrumentspecimen ID

4 - -

Universal testID

5 ---X

-

---X

X

Universal test ID^universal test name^universal test ID type^manufacturer defined test codeTestData.sOnlineName^auto-dilution factorMultiple tests can be ordered separated byrepeat delimiter.

Priority 6 (X)(X)(X)--

(X)(X)(X)--

S –stat REQ_PRIOR_STATA –asap REQ_PRIOR_ASAPR –routine REQ_PRIOR_NORMALC –callbackP –preoperative*.ucPriorityOptional if no sample or sample iscalibrator or control.

Requested/ordered date andtime

7 - -

Specimencollection dateand time

8 (X) (X) Form YYYYMMDDHHMMSSPatientSampleData.sCollectionInfo

Collection endtime

9 - -

Collectionvolume

10 - -

Collector ID 11 - -

If even one test isrequested as stat thepriority of test orderrecord is set to stat (S)when results arereported by samples.When results arereported by requeststhe right test priority isalways seen.

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Action code 12 XXX---X

X--X-XX

C –cancelA –add test requests to existing specimenN –new test requests + new specimenP –pending specimenL –reservedX –specimen or test in processQ –QC specimenMultiple action codes can be givenseparated by repeat delimiter. For exampleX\Q.

Danger code 13 - -

Relevantclinicalinformation

14 (X) (X) PatientSampleData.osComment

Date/timespecimenreceived

15 - -

Specimendescriptor (typeand source)

16 X-

X-

Type^SourceType is coded as: 1 –Serum, 2 –Plasma, 3–Urine, 4 –CSF, 5 –OtherPatientSampleData.ucSampleType

Orderingphysician

17 - -

Physicianstelephonenumber

18 - -

User field No.1 19 - -

User field No.2 20 - -

Laboratory fieldNo.1

21 - -

Laboratory fieldNo.2

22 - -

Date/timeresults reportedor last modified

23 - -

Instrumentcharge tocomputersystem

24 - -

Instrumentsection ID

25 (X) (X) Optional if no sample. InstrumentData.iId

Report types 26 X--XX---X

--XXXXXXX

O –orderC –correction to previously transmittedresultsP –preliminary resultsF –final resultsX –requests cancelledI –in instrument pendingY –no order for test (response to query)Z –no record of this patient (response toquery)Q –response to query (info)Multiple report types can be givenseparated by repeat delimiter. For exampleY\Z.

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Reserved field 27 - -

Location orward ofspecimencollection

28 - -

Nosocomialinfection flag

29 - -

Specimenservice

30 - -

Specimeninstitution

31 - -

3.2.1.5 Result record (level 3)

Field Name No Host Instr. Comment

Record type ID 1 X X Always R.

Sequencenumber

2 X X Running number within Test order.Starts with 1.

Universal testID

3 ---X

(X)

---X

X

Universal test ID^universal test name^universal test ID type^manufacturer defined test codeTestData.sOnlineName^dilution factor used in calculation

Data ormeasurementvalue

4 X (X) If result status is X (cancelled) or resultis UNSTABLE, no result is given.*.fResultThe range of result will be [99999.9 …0.00000] and [-0.00000 … -99999.9]. Ifactual result exceeds these values, thenearest value will be shown.

Units 5 X X TestData.sResultUnit

Referenceranges

6-

-

-

X

X

-

Components:LowTRCLimitsData.fLowerlimit^HighTRCLimitsData.fUpperlimit^Description

Resultabnormal flags

7 ---

---

XXX

X/---

L/H –below/above normalLL/HH –below/above panic normal</> -below/above absolute low/high (offthe scale of instrument)N/A –normal/abnormalU/D –significant change up/down (delta)B/W –better/worse (used when directionis not relevant)*.ulErrorFlags

Nature ofabnormalitytesting

8 - -

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Result status 9 --X------

--

-XXXX--X-

X-

C –correctionP –preliminaryF –finalX –cancelled,I –pendingS –partialM –MIC levelR –reportedN –contains necessary information to run anew orderQ –response to queryV –verifiedMultiple status flags can be given separatedby repeat delimiter. For example F\Q.REQ_ASKED ~ I, REQ_FIXABLE ~ IREQ_FIXED ~ I , REQ_CALCULATED~ P, REQ_MEASURED ~ P,REQ_XXX_ACC ~ F, REQ_XXX_REJ ~X

Date of changein instrumentnormativevalues or units

10 - -

Operatoridentification

11 - (X) User login name if User levels have beenset on

Date/time teststarted

12 - -

Date/time testcompleted

13 (X) (X) Form YYYYMMDDHHMMSS. No valueif test is not completed. *.iResultDateTime

Instrumentidentification

14 - X InstrumentData.iId

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3.2.1.6 Comment record (level 4) used with the Result Record

Field Name No Host Instr. Comment

Record type ID 1 - X Always C. Used to transfer instrumentflags after Result record.

SequenceNumber

2 - X Always 1, because of the use.

Commentsource

3 ---

--X

P –practiceL –computer systemI –clinical instrument system

Comment text 4 - X Error condition identified with a numberand a text in English1 Init abs.2 Bichr. net abs.3 Linearity4 Unstable5 Instr, error6 Addl. meas. error7 Sample blank error8 Dil. limit low9 Dil. limit high10 Test limit low11 Test limit high12 Antigen limit high13 Out of limit14 QC15 Calc. error16 Outlier17 Cut curve18 Bias corr. limit19 Antigen limit low20 AE meas error21 Blank resp. low22 Blank resp. high23 Blank init abs. low24 Blank init abs. High25 Critical limit low26 Critical limit high27 Instrument abs. Limit28 Not measurableMultiple flags can be given separatedwith repeat delimiter.*.ulErrorFlags

Comment type 5 -----

----X

G –generic/free text documentT –test name commentP –positive test commentN –negative test commentI –instrument flag(s) comment

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3.2.1.7 Comment record (level 3) used with transmissionrelated error conditions

Field Name No Host Instr. Comment

Record type ID 1 - X Always C. Used to transfer instrumentflags after Result record.

SequenceNumber

2 - X Always 1, because of the use.

Commentsource

3 ---

--X

P –practiceL –computer systemI –clinical instrument system

Comment text 4 - X Error condition identified by 'E' followedby a numberE3 - wrong initialising character in

recordE4 - wrong termination code or

request code in recordE5 - records found in wrong orderE104 - invalid sample plate position

sample position alreadyreserved in analyzer by anothersample or calibrator or control.The new sample was wronglypositioned by LIS. Use position0^0 for any sample when theposition is defined at a latermoment with sample insertioninto the Konelab.

E105 - problems with analysis request,request could not be created

E108 - maximum number of samples/patient exceeded

E201 - sample segment position isreserved

E210 - problems with updating patientinformation

E211 - patient information could not befound

E220 - sample already existsE221 - problems with sample

informationComment type 5 -

----

X----

G –generic/free text documentT –test name commentP –positive test commentN –negative test commentI –instrument flag(s) comment

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3.2.1.8 Request information record (level 1)

Field Name No Host Instr. Comment

Record type ID 1 X X Always Q. Used by Instrument to askexternal test results or orders to newsamples, and by host for requestingresults and orders that are ininstrument’s database.

Sequencenumber

2 X X Always 1. Only one request may beoutstanding at a time.

Starting rangeID number

3 (X)(X)(X)(X)

(X)(X)(X)(X)

patient ID or ALL^ sample ID or ALL^segment^positionPatient ID and sample ID are text fields,so field is not used as range. Multiplepatients or samples can be requestedseparated by repeat delimiter.

Ending rangeID number

4 - -

Universal testID

5 ---(X)

-

---(X)

-

Universal test ID^universal test name^universal test ID type^manufacturer defined test codeTestData.sOnlineName^auto-dilution factorMultiple tests can be requested separatedby repeat delimiter.

Nature ofrequest timelimits

6 -(X)

-(X)

S –specimen collect dateR result test dateAccording to standard R is taken asdefault, so it is optional.

Beginningrequest resultsdate and time

7 (X) (X) Form YYYYMMDDHHMMSS

Ending requestresults date andtime

8 (X) (X) Form YYYYMMDDHHMMSS

Requestingphysician name

9 - -

Requestingphysiciantelephonenumber

10 - -

User field No.1 11 - -

User field No.2 12 - -

Requestinformationstatus codes

13 -XXXX--X-

-XXXX--X-

C –correctionP –preliminaryF –finalX –cancelledI –pendingS –unfinalized resultsM –MIC level,R –previously transmittedA –cancel last request criteria

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X

X

-

X

X

-

N –requesting new or edited results only,O –requesting test orders only (noresults)D –requesting demographics onlyNote: not repeated.

3.2.2 FIELD LENGTHS USED BY Konelab

Field Length in charactersInstrument type 3instrument ID 2software version 16Date and time of message 14Laboratory assigned patient ID 16Patient name 24Date of birth 8Patient sex 10Hospital institution 24Specimen ID 16Instrument specimen ID Segment , Position integers max 6

charactersUniversal test ID 30Specimen collection date and time 14Relevant clinical information 30Instrument section ID 2Data or measurement value 8Units 10Reference ranges Low 6, High 6Date/time test completed 14Beginning request results date andtime

14

Ending request results date and time 14

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3.2.3 EXAMPLES OF COMMUNICATIONBETWEEN Konelab AND THE HOSTCOMPUTERExamples of transmissions between Konelab and the host computer, when Konelabis configured to use automatic sample ID sending and automatic result sending. Thecontrol characters are presented between '<>'. For example <enq> means an ASCIIcharacter ENQ which hexadecimal value is 05. These examples give only anoverview, the actual communication may vary.

1) New sample is introduced to Konelab. Example of thecommunication sequence:

Konelab:<enq>Host: <ack>Konelab:<stx>1H|\^&|||60^1^5.0|||||||P||20010502105431<cr><etx>96<cr><lf>Host: <ack>Konelab:<stx>2Q|1|^TestSample^^||^^^ALL^||||||||O<cr><etx>50<cr><lf>Host: <ack>Konelab:<stx>3L|1|N<cr><etx>06<cr><lf>Host: <ack>Konelab:<enq>

2) The host computer responds:

Host: <enq>Konelab:<ack>Host: <stx>1H|\^&|||60^Host^5.0|||||||P||20010502105446<cr><etx>09<cr><lf>Konelab:<ack>Host: <stx>2P|1|112233-4455|||TestPatient|||Adult|||||||||||||||||||||||||<cr><etx>59<cr><lf>Konelab:<ack>Host: <stx>3O|1|TestSample||^^^Ca^0.0|R||||||X||||1|||||||||1|Q\O<cr><etx>93<cr><lf>Konelab:<ack>Host: <stx>4L|1|F<cr><etx>FF<cr><lf>Konelab:<ack>Host: <eot>

Note the reference classAdult. This must havea perfect match withone of the referenceclasses defined inKonelab

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3) Konelab has analysed the sample and sends the results tohost computer.

Konelab:<enq>Host: <ack>Konelab:<stx>:1H|\^&|||60^1^5.0|||||||P||20010502105626<cr><etx>9C<cr><lf>Host: <ack>Konelab:<stx>:2P|1|112233-4455|||TestPatient|||Adult|||||||||||||||||||||||||<cr><etx>59<cr><lf>Host: <ack>Konelab:<stx>:3O|1|TestSample^0.0^1^1||^^^ALL^|R||||||X||||1|||||||||1|F<cr><etx>8E<cr><lf>Host: <ack>Konelab:<stx>:4R|1|^^^Ca^0.0|2.3|mmol/l|2.2^2.7^Adult|L||F||||20010502105628|1<cr><etx>02<cr><lf>Host: <ack>Konelab:<stx>:5L|1|N<cr><etx>08<cr><lf>Host: <ack>Konelab:<eot>

4) New sample is introduced to Konelab. Konelab sendrequest for information of the sample:

Konelab:<enq>Host: <ack>Konelab:<stx>1H|\^&|||60^1^5.0|||||||P||20010502124646<cr><etx>9F<cr><lf>Host: <ack>Konelab:<stx>2Q|1|^S1234^^||^^^ALL^||||||||O<cr><etx>6B<cr><lf>Host: <ack>Konelab:<stx>3L|1|N<cr><etx>06<cr><lf>Host: <ack>Konelab:<eot>

5) The host computer responds:

Host: <enq>Konelab:<ack>Host: <stx>1H|\^&|||60^Host^5.0|||||||P||20010502124702<cr><etx>12<cr><lf>Konelab:<ack>Host: <stx>2P|1|123456-789A|||LastNameFirstName|||Adult|||||||||||||||||||||||||<cr><etx>C2<cr><lf>Konelab:<ack>Host: <stx>3O|1|S1234^3.0||^^^Ca^0.0|R||||||X||||1|||||||||1|Q\O<cr><etx>9D<cr><lf>Konelab:<ack>Host: <stx>4L|1|F<cr><etx>FF<cr><lf>Konelab:<ack>Host: <eot>

Note the referenceclass limit and namepresentation in R-record(Min^Max^Name)and the 'L'-flag forvalue 2.3 in rangefrom 2.2 to 2.7.

Note that the samplehas been manuallydiluted with dilution1 + 3.0!

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6) Analysing the sample is completed. Konelab sends theresults:

Konelab:<enq>Host: <ack>Konelab:<stx>1H|\^&|||60^1^5.0|||||||P||20010502124833<cr><etx>9D<cr><lf>Host: <ack>Konelab:<stx>2P|1|123456-789A|||LastNameFirstName|||Adult|||||||||||||||||||||||||<cr><etx>C2<cr><lf>Host: <ack>Konelab:<stx>3O|1|S1234^3.0^1^2||^^^ALL^|R||||||X||||1|||||||||1|F<cr><etx>AD<cr><lf>Host: <ack>Konelab:<stx>4R|1|^^^Ca^3.0|9.2|mmol/l|2.2^2.7^Adult|HH||F||||20010502124835|1<cr><etx>50<cr><lf>Host: <ack>Konelab:<stx>5L|1|N<cr><etx>08<cr><lf>Host: <ack>Konelab:<eot>

7) New sample is introduced to Konelab. Communicationsequence:

Konelab:<enq>Host: <ack>Konelab:<stx>1H|\^&|||60^1^5.0|||||||P||20010502125526<cr><etx>9D<cr><lf>Host: <ack>Konelab:<stx>2Q|1|^ICU Sample^^||^^^ALL^||||||||O<cr><etx>B1<cr><lf>Host: <ack>Konelab:<stx>3L|1|N<cr><etx>06<cr><lf>Host: <ack>Konelab:<eot>

8) The host computer responds. Communication sequence:

Host: <enq>Konelab:<ack>Host: <stx>1H|\^&|||60^Host^5.0|||||||P||20010502125551<cr><etx>15<cr><lf>Konelab:<ack>Host: <stx>2P|1|223311-9876|||ICU Patient||||||||||||||||||||||||||||<cr><etx>CC<cr><lf>Konelab:<ack>Host: <stx>3O|1|ICUSample||^^^ISE.Na^0.0|R||||||X||||1|||||||||1|Q\O<cr><etx>0E<cr><lf>Konelab:<ack>Host: <stx>4L|1|F<cr><etx>FF<cr><lf>Konelab:<ack>Host: <eot>

Note the referenceclass 'HH'-flag in R-record.

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9) Konelab has analysed the sample and sends the results tohost computer.

Konelab:<enq>Host: <ack>Konelab:<stx>1H|\^&|||60^1^5.0|||||||P||20010502125610<cr><etx>97<cr><lf>Host: <ack>Konelab:<stx>2P|1|223311-9876||ICU Patient||||||||||||||||||||||||||||<cr><etx>50<cr><lf>Host: <ack>Konelab:<stx>3O|1|ICUSample^0.0^1^4||^^^ALL^|R||||||X||||1|||||||||1|F<cr><etx>F2<cr><lf>Host: <ack>Konelab:<stx>4R|1|^^^ISE.Na^0.0|9999999.9|mmol/l|^^|>||F||||20010502125556|1<cr><etx>50<cr><lf>Host: <ack>Konelab:<stx>5C|1|I|11 Test limit high\15 Calc. error|I<cr><etx>29<cr><lf>Host: <ack>Konelab:<stx>6L|1|N<cr><etx>09<cr><lf>Host: <ack>Konelab:<eot>

10) New sample is introduced to Konelab. Communicationsequence:

Konelab:<enq>Host: <ack>Konelab:<stx>1H|\^&|||60^1^5.0|||||||P||20010502125238<cr><etx>9D<cr><lf>Host: <ack>Konelab:<stx>2Q|1|^SomeSample^^||^^^ALL^||||||||O<cr><etx>44<cr><lf>Host: <ack>Konelab:<stx>3L|1|N<cr><etx>06<cr><lf>Host: <ack>Konelab:<eot>

11) The host computer responds. Communication sequence:

Host: <enq>Konelab:<ack>Host: <stx>1H|\^&|||60^Host^5.0|||||||P||20010502125239<cr><etx>0B<cr><lf>Konelab:<ack>Host: <stx>2P|1|221121-6655|||SomePatient||||||||||||||||||||||||||||<cr><etx>54<cr><lf>Konelab:<ack>Host:<stx>3O|1|SomeSample||^^^TestTest^0.0|R||||||X||||1|||||||||1|Q\O<cr><etx>23<cr><lf>Konelab:<ack>Host: <stx>4L|1|F<cr><etx>FF<cr><lf>Konelab:<ack>Host: <eot>

Note the result value of9999999.9, whichrepresents the maximumvalue for result. This isdue to calculation errorcausing the value toreach the maximuminternal presentation.Please check always theexistence of C-recordafter a R-record forerror conditions. Notealso the '>'-flag in R-record. This is due to theresult exceeding the testmaximum limit.

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12) The request 'TestTest' is invalid, because Konelab's testrepertoire does not contain any test with OnlineName'TestTest'. Error condition sequence:

Konelab:<enq>Host: <ack>Konelab:<stx>1H|\^&|||60^1^5.0|||||||P||20010502125240<cr><ext>96<cr><lf>Host: <ack>Konelab:<stx>2P|1|221121-6655|||SomePatient||||||||||||||||||||||||||||<cr><ext>54<cr><lf>Host: <ack>Konelab:<stx>3O|1|SomeSample||^^^TestTest^0.0|R||||||C||||1|||||||||1|X<cr><ext>6A<cr><lf>Host: <ack>Konelab:<stx>4C|1|I|E105|G<cr><ext>13<cr><lf>Host: <ack>Konelab:<stx>5L|1|Q<cr><ext>0B<cr><lf>Host: <ack>Konelab:<eot>

13) Sending of control sample analysis results is enabled andKonelab performs Ca analysis on control sample Nortrol.Communication sequence:

Konelab:<enq>Host: <ack>Konelab:<stx>1H|\^&|||60^1^5.0|||||||Q||20010502130025<cr><etx>94<cr><lf>Host: <ack>Konelab:<stx>2P|1||||||||||||||||||||||||||||||||<cr><etx>BF<cr><lf>Host: <ack>Konelab:<stx>3O|1|Nortrol||^^^Ca^0.0|R||||||Q||||1|||||||||1|<cr><etx>C4<cr><lf>Host: <ack>Konelab:<stx>4R|1|^^^Ca^0.0|2.3|mmol/l|^^|N||F||||20010502130024|0<cr><etx>D4<cr><lf>Host: <ack>Konelab:<stx>5L|1|N<cr><etx>08<cr><lf>Host: <ack>Konelab:<eot>

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4. KONELAB / LAS INTERFACEThe communication interface between Konelab analyser and a LaboratoryAutomation System (LAS) is described in the following sections.

4.1 HARDWARE INTERFACECommunication between the analyser and LAS is performed using standard three-wire RS 232- interface. Maximum cable length is 15 meters and the cable should beshielded. The pins used in 9-pin male D-connector on analyser side are:

Signal PinRxD (received data) 2TxD (transmitted data) 3GND (ground) 5

Communication parameters are 9600 baud, 8 bit, 1 start bit, 1 stop bit, no parity. Nohardware or software flow control is used.

4.2 GENERAL DESCRIPTIONWhen debug log is on, all messages between analyser and LAS are recorded to thelog file C:\Konelab\tmp\ksdebug.txt.

4.2.1 MESSAGE RECORD FORMATThe following abbreviations are used in this document for some specialcommunication characters.

STX 0x02ETX 0x03ACK 0x06NACK 0x15

Start of transmission (STX) character is used at the beginning of communicationrecord and End of transmission (ETX) character is used at the end of communicationrecord.

Each communication record contains checksum. After communication record hasbeen received, an acknowledgement is always sent by the analyser or LAS. Theanalyser or LAS sends positive acknowledgement character (ACK), if the checksumin message is correct and negative acknowledgement character (NACK), if thechecksum in message is incorrect. Analyser waits for ACK or NACK up to 1 second.If the analyser receives NACK, it tries to re-send the record max two times.

You can set debug onby F8/F1 function inthe Konelabprogram’sManagementwindow. With thesame button it is alsoset off.

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Each communication record contains also field for message length. Message lengthdoesn’t include STX and ETX characters.

The general format of a message record is:

Byte Field Comment1 STX2 Message length3 Message id4 - n Message data Optionaln+1 Checksumn+2 ETX

4.2.2 CALCULATION OF CHECKSUMThe calculation of checksum does not include the STX-character, the checksum itselfor the ETX-character. The calculation starts with zeroing the checksum. Everycharacter of the message is added to the checksum (modulo 256) excluding the abovementioned characters and the result is an 8-bit checksum. For example the charactersin normal Analyser Status record are 0x02 0x04 0x04 0x00 0x08 0x03, where 0x02is the STX-character, 0x04 is the length of message, 0x04 is message id, 0x00 is thestatus, 0x08 is the checksum and 0x03 is the ETX-character.

The example for calculation of the checksum in C language:

unsigned char CalculateChecksum( unsigned char * pString, int iNumOfChars )

{unsigned char ucChecksum;unsigned char ucTemp;int iIndex;

ucChecksum = 0;for (iIndex = 0; iIndex < iNumOfChars; iIndex++){

ucTemp = pString[iIndex];ucChecksum = ucChecksum + ucTemp;

}return ucChecksum;

}

When calling CalculateChecksum function, pointer pString should point to the‘Message length’ - field and iNumOfChars variable should contain value Messagelength - 1.

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4.2.3 SEQUENCE FOR INITIALISING THECOMMUNICATION INTERFACEWhen the communication between analyser and LAS is restarted, the initialisationsequence described in this chapter has to be performed. Communication is restartedevery time, when LAS has sent Reinitialise communication record or a fatalcommunication error occurs.

Analyser starts the initialisation sequence by sending Initialisation record. Analysersends Initialisation record every 5 seconds as long as LAS responses by sendingACK.

After that LAS sends Analyser status query record to the analyser. Analyser waitsfor this record up to 10 seconds. If the record is received in time, analyser responseswith ACK and sends Analyser status record to LAS. LAS sends ACK to the analyserto finish the initialisation sequence.

4.2.4 ANALYSER BOOT SEQUENCEWhen analyser has been booted and it is ready to aspirate a sample, it starts listeningthe communication line. LAS can check the connection by sending a status query orit can directly start a sample aspiration sequence. If the analyser is down or booting,it will not acknowledge the message and LAS can then start the initialisationsequence.

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4.2.5 KUSTI STATES AND ERROR RECOVERY

Dispensingcomplete status

Status record status LAS status

0 ok 0 ok1 no free

sampleposition

2 duplicatesample id

3 timeout5 short sample

Free to move tubes and retry aspiratesample.

4 fatal error Not allowed to move sample tubes.Re-check status with status query.

2 out oforder

Not allowed to move sample tubes.Konelab requires operator actionsbefore it will retry aspirate sample.

6 not in use 3 not in use Allowed to move sample tubes.Konelab requires operator actionsbefore it will retry aspirate sample.

7 busy 1 busy Not allowed to move sample tubes.Wait for a couple of seconds and checkstatus again.

When ‘busy’ response is received from Konelab either as response to status query orto aspirate sample –command, Konelab is either initializing or recovering from anerror situation. This is a temporary state and LAS should start polling with statusquery (or aspirate sample –command) until status value other than ‘busy’ is received.Typically this will take 10-20 seconds and shouldn’t take more than a minute. Untilthen sample tubes must not be moved as KUSTI dispenser may be extended at theLAS position. If status value ‘ready’ is received, the recovery was successful andanother aspirate sample –command may be sent. If the recovery was unsuccessful,status ‘out of order’ or ‘not in use’ is returned.

Konelab does not automatically try to recover from states ‘out of order’ or ‘not inuse’.

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The diagram below explains the possible states and transitions of the Konelab LASinterface and when LAS is allowed to move sample tubes.

State Status response Aspirate response 1 0 (ready) starts dispensing 2 1 (busy) protocol error 3 1 (busy) 7 (busy) 4 2 (out of order) 4 (fatal error) 5 3 (not in use) 6 ( not in use)

1. Analyser is ready for sample aspirationLAS status : moving allowed

analyzer status: ok

2. Analyser is busyLAS status : moving not allowed

analyzer status: ok

4. Analyser has fatal error situationLAS status : moving not allowed

analyzer status: not ok

5. Analyser not inuseLAS status : moving allowed

analyzer status: not ok

ASPIRATESAMPLERECORDsended

SAMPLE DISPENSING COMPLETE

RECORD,status=0,1,2,3 or 5

received

SAMPLE DISPENSINGCOMPLETERECORD,

status=4 or 7received

3. Fatal error when aspirationLAS status : moving not allowed

analyzer status: unknown

ANALYSER STATUS RECORD,

status=3 (not in use)received

ANALYSER STATUS RECORD,

status=2 (fatal error)received

ANALYSER STATUS RECORD,

status=0 (ok)received

ANALYSER STATUS RECORD,

status=0 (ok)received

ANALYSER STATUSRECORD,

status=0 (ok)received

SAMPLE DISPENSINGCOMPLETERECORD,

status=6 (not in use)received

ANALYSER STATUS RECORD,

status=1(busy)received

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4.3 COMMUNICATION RECORDS

4.3.1 INITIALISATION RECORDThis record in sent by analyser to inform LAS, that analyser is ready to start thecommunication.

Byte Field Comment1 STX2 Message length3 Message id (0x01)4 Checksum5 ETX

4.3.2 ILLEGAL COMMAND RECORDThis record in sent by analyser or LAS to inform that data of the received messagehas not been valid.

Byte Field Comment1 STX2 Message length3 Message id (0x02)4 Error type 0x00 = message id not valid

0x01 = unexpected record0x02 = invalid message data

5 Error info1 Message id in receivedmessage

6 Error info2 0x00 = no additionalinformation0x01 = invalid sample id

7 Checksum8 ETX

4.3.3 ANALYSER STATUS QUERY RECORDThis record in sent by LAS to ask the status of the analyser. LAS can send this recordat any time after the initialisation sequence has been successfully performed.

Byte Field Comment1 STX2 Message length3 Message id (0x03)4 Checksum5 ETX

Note! All the fieldsin the records, thatare not used, shouldbe set to 0x00.

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4.3.4 ANALYSER STATUS RECORDThis record in sent by the analyser as a response to Analyser status query record.

Byte Field Comment1 STX2 Message length3 Message id (0x04)4 Status 0x00 = analyser is ready for

sample aspiration0x01 = analyser is busy (i.e.initialising or dispensingsample). Sample tubes may notbe moved.0x02 = analyser has fatal errorsituation and sample aspirationcan’t be performed. Sampletubes may not be moved.0x03 = analyser is not in use andsample aspiration can’t beperformed. Sample tubes may bemoved.

5 Checksum6 ETX

4.3.5 ASPIRATE SAMPLE RECORDThis record in sent by LAS to inform that there’s a sample to be aspirated.

Byte Field Comment1 STX2 Message length3 Message id (0x05)4 Sample tube type 0x00 (Not used at the moment)5 Sample ID length6 – n Sample ID Maximum length of sample ID is

16 charactersn+1 Checksumn+2 ETX

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4.3.6 SAMPLE DISPENSING COMPLETERECORDThis record in sent by the analyser to inform the LAS, that sample dispensing iscompleted. If Status- field in the message is not 0, the sample dispensing hasn’t beenperformed successfully.

Byte Field Comment1 STX2 Message length3 Message id (0x06)4 Status 0x00 = OK

0x01 = No empty samplepositions in the sample disk forsample dispensing0x02 = Duplicate sample id0x03 = Timeout in sampledispensing0x04 = Analyser couldn’tperform operation due to a fatalerror situation. Sample tubesmay not be moved.0x05 = Not enough samplefound in sample tube0x06 = Analyser not in use andsample aspiration can’t beperformed. Sample tubes may bemoved.0x07 = Analyser is busy andsample aspiration can’t beperformed. Sample tubes maynot be moved.

5 Sample ID length6 – n Sample ID Maximum length of sample ID is

16 charactersn+1 Checksumn+2 ETX

4.3.7 REINITIALISE COMMUNICATIONRECORDThis record in sent by the LAS to reinitialise the communication.

Byte Field Comment1 STX2 Message length3 Message id (0x07)4 Checksum5 ETX

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4.4 COMMUNICATION EXAMPLES

4.4.1 INITIALISATION SEQUENCE

LAS ANALYSER

Initialisation record

5 s timeout

Initialisation record

ACKMax 10 s

Status query recordACK

Status Record

ACK

4.4.2 SAMPLE ASPIRATION SEQUENCE FORTWO SAMPLES

LAS ANALYSER

Aspirate sample recordACK

Sample dispensing complete record

ACK

Aspirate sample recordACK

Sample dispensing complete record

ACK

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4.4.3 SAMPLE ASPIRATION FAILS, RECOVERYSUCCESSFUL 1

LAS ANALYSER

Aspirate sample recordACK

sample dispensing completerecordstatus = FATAL ERROR

ACKwait 10 s

Status query recordACK

status recordstatus = BUSY

ACK

wait 10 sStatus query record

ACK

status recordstatus = BUSY

ACK

wait 10 sStatus query record

ACK

status recordstatus = READY

ACK

Aspirate sample recordACK

sample dispensing completerecordstatus = OK

ACK

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4.4.4 SAMPLE ASPIRATION FAILS, RECOVERYSUCCESSFUL 2

LAS ANALYSER

Aspirate sample recordACK

sample dispensing completerecordstatus = FATAL ERROR

ACKwait 10 s

Aspirate sample recordACK

sample dispensing completerecordstatus = BUSY

ACK

wait 10 sAspirate sample record

ACK

sample dispensing completerecordstatus = BUSY

ACK

wait 10 sAspirate sample record

ACK

sample dispensing completerecordstatus = OK

ACK

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4.4.5 SAMPLE ASPIRATION FAILS, RECOVERYUNSUCCESSFUL

LAS ANALYSER

Aspirate sample recordACK

Sample dispensing completerecordStatus = FATAL ERROR

ACKwait 10 s

Status query recordACK

Status recordStatus = BUSY

ACK

wait 10 sStatus query record

ACK

Status recordStatus = BUSY

ACK

wait 10 sStatus query record

ACK

Status recordStatus = NOT IN USE orStatus = OUT OF ORDER

ACK

Error message to operator,cannot recover automatically