implementation-reference astm records v3-x

Document: IMPREF3x.DOC

Boehringer Mannheim GmbH

Elecsys® 2010 Analyzer

Host Interface

Elecsys® 2010 - Host Interface

Implementation Reference ASTM Records

V 3.x - February 98

Revision Comments Author DateThis document is based on Mr.Mashiko´s (HID) implementationdocumentation

1.4 Changes from 1.3x to 1.4xindicated in blue color

Centner May 5, 97

2.x Changes from 1.4 to 2.xNone due to version was renamedNo extra document

Centner

3.x Changes from 2.x to 3.xindicated in dark green color

Centner Feb. 3, 98

3.x Correctionsindicated in dark green color

Centner Feb. 13, 98

Implementation Reference - ASTM Records

Elecsys® 2010 - Host Interface

Contents 1

Elecsys® 2010 - Host Interface Contents

1. Contents1. Contents....................................................................................................................................... 1

2. Test Order Message - Q/P/O ...................................................................................................... 4Purpose to use this message: ............................................................................................................... 4

Instrument Query — Host Answer ...................................................................................................... 4Host Query — Instrument Answer ..................................................................................................... 4Host Download.................................................................................................................................... 4Instrument Cancel Query .................................................................................................................... 5

Construction of Message:...................................................................................................................... 5Trace Example: ..................................................................................................................................... 5Details of Records: ................................................................................................................................ 6

3. Result Message - Q/P/O/R/C/RR/RC ........................................................................................ 18Purpose to use this message: ............................................................................................................. 18

Host Query — Instrument Answer .................................................................................................... 18Instrument à Host Upload................................................................................................................ 18

Construction of Message:.................................................................................................................... 19Trace Example: ................................................................................................................................... 19Trace Example: ................................................................................................................................... 20Details of Records: .............................................................................................................................. 21

4. Substance Data Message - XT/DP ........................................................................................... 30Purpose to use this message: ............................................................................................................. 30

Instrument à Host Upload................................................................................................................ 30Host Query — Instrument Answer .................................................................................................... 31Host Download.................................................................................................................................. 32

Construction of Message:.................................................................................................................... 32Trace Example: ................................................................................................................................... 32Trace Example: ................................................................................................................................... 35Details of Records: .............................................................................................................................. 38

5. Calibrator Parameters Message - XT/CP................................................................................. 43Purpose to use this message: ............................................................................................................. 43

Upload Instrument à Host................................................................................................................ 43Host Query — Instrument Answer .................................................................................................... 43Download Host à Instrument ........................................................................................................... 43

Construction of Message:.................................................................................................................... 44Trace Example: ................................................................................................................................... 44Details of Records: .............................................................................................................................. 45

6. Control Parameters Message - XT/QP .................................................................................... 48Purpose to use this message: ............................................................................................................. 48

Instrument à Host Upload................................................................................................................ 48Host Query — Instrument Answer .................................................................................................... 48Host Download.................................................................................................................................. 48


7. Calibration Data Message - CR................................................................................................ 54Purpose to use this message: ............................................................................................................. 54

Instrument à Host Upload................................................................................................................ 54Construction of Message:.................................................................................................................... 54

2 Contents

Contents Elecsys® 2010 - Host Interface

Trace Example:....................................................................................................................................54Details of Records: ..............................................................................................................................55

8. Sample Status Message - SS ...................................................................................................58Purpose to use this message: .............................................................................................................58

Host Query — Instrument Answer ....................................................................................................58Construction of Message: ....................................................................................................................58Details of Records: ..............................................................................................................................58

Instrument Sending Record Pattern..................................................................................................58

9. Instrument Status Message - IS ...............................................................................................61Purpose to use this message: .............................................................................................................61

Host Query — Instrument Answer ...................................................................................................61Instrument à Host Upload................................................................................................................61

Construction of Message: ....................................................................................................................61Trace Example:....................................................................................................................................61Details of Records: ..............................................................................................................................62

10. Log File Message - LF...............................................................................................................65Purpose to use this message: .............................................................................................................65

Host Query — Instrument Answer ....................................................................................................65Construction of Message: ....................................................................................................................65Details of Records: ..............................................................................................................................65

11. Test Conditions Message - TC.................................................................................................68Purpose to use this message: .............................................................................................................68

Instrument à Host Upload................................................................................................................68Host Query — Instrument Answer ....................................................................................................68Host Download..................................................................................................................................68


12. Test Application Message - TA ................................................................................................73Purpose to use this message: .............................................................................................................73

Instrument à Host Upload................................................................................................................73Trace Example:....................................................................................................................................73Details of Records: ..............................................................................................................................74

13. Instrument Configuration Message - IC ..................................................................................75Purpose to use this message: .............................................................................................................75

Host Query — Instrument Answer ...................................................................................................75Host Download..................................................................................................................................75Instrument à Host Upload................................................................................................................75

Construction of Message: ....................................................................................................................75Trace Example.....................................................................................................................................75Details of Records: ..............................................................................................................................76

14. Service Data Message - SD ......................................................................................................80Purpose to use this message: .............................................................................................................80

Instrument à Host Upload................................................................................................................80Host Query — Instrument Answer ....................................................................................................80


15. Processing Message - PM ........................................................................................................84

Contents 3

Elecsys® 2010 - Host Interface Contents

Purpose to use this message: ............................................................................................................. 84Instrument à Host Upload................................................................................................................ 84


16. Action Request / Action Confirmation Message - AR/AC...................................................... 86Purpose to use this message: ............................................................................................................. 86

Host Request — Instrument Confirmation ........................................................................................ 86Construction of Message:.................................................................................................................... 86Details of Records: .............................................................................................................................. 86

17. Header - H .................................................................................................................................. 88Details of Records: .............................................................................................................................. 88

18. Termination - L .......................................................................................................................... 89Details of Records: .............................................................................................................................. 89

19. Receive Acceptance Status...................................................................................................... 90When does Elecsys accept messages from host? (Disk Type) .......................................................... 90When does Elecsys accept messages from host? (Rack Type) ......................................................... 90

20. Data Alarm List .......................................................................................................................... 91

21. Index........................................................................................................................................... 94

4 Test Order Message - Q/P/O

Test Order Message - Q/P/O Elecsys® 2010 - Host Interface

2. Test Order Message - Q/P/O

Purpose to use this message:

Instrument Query — Host Answer

Purpose Host InstrumentQuery after reading sample bar-code(in case that Host answers positively)(Query Test order for specimens that have no Test order.)

L-11, L-21(M-2)

I-1(M-1)

Query after reading sample bar-code(in case that Host answers negatively)(Query Test order for specimens that have no Test order.)

L-11, L-22(M-2)

I-1(M-1)

Event: Sample rotor scanningà The instrument queries for test requisitions for each sample that has no testrequisitions using 1 message/ 1 sample.Host must answer these queries for each sample by a certain time while systembegins to make schedule for the sample.Even if the Host answers these queries after the certain time out limit, the instrumentaccepts these responses. In this case, the instrument regards these responses asbatch download. (ignores these responses as answers to previous queries)

Host Query — Instrument Answer

Purpose Host InstrumentQuery for Information of Test order(in case that Instrument answers positively)(Answer Information of Test Order that were requested fromHost.)

L-1(M-1)

I-11, I-21(M-2)

Query for Information of Test order(in case that Instrument answers negatively)(Answer negatively when there is no Information of TestOrder that were requested from Host.)

L-1(M-1)

I-11, I-22(M-2)

Event: The instrument receives a Test Order Message Query.à The instrument answers the query. (positively or negatively).Host queries for test selection information for a sample.(or for some samples).The instrument always answers 1 message/1 sample even if Host queries for testselection information for some samples using one message.

Host Download

Purpose Host InstrumentOrdering of tests and canceling of tests(Order tests for specimens and cancel the tests.)

L-11, L-23(M-2)

Event: The instrument receives a Test Order Message.à The instrument acts as following.

- new registration for unknown sample.- overwriting known sample.

Host downloads a Test Order Message for one sample.(or for some samples)

Test Order Message - Q/P/O 5

Elecsys® 2010 - Host Interface Test Order Message - Q/P/O

Instrument Cancel Query

Purpose Host InstrumentCanceling of the previous Query(Cancel the previous Query because of time out.)

I-2(M-1)

L-*, I-*: refer to "Details of Records"M-*: refer to "Construction of Message"

Construction of Message:

Pattern 1 (M-1)Level Record

0 H1 Q0 L


0 H1 P2 O0 L

Trace Example:

Instrument queries test selections for sample ‘000004’: <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2Q|1|^000004^40^0^4^^SAMPLE^NORMAL||ALL

||||||||O<CR><ETX>C5<CR><LF> <ACK> <STX>3L|1<CR><ETX>3C<CR><LF> <ACK> <EOT>

Host sends back test selections for sample ‘000004’: <ENQ> <ACK> <STX>1H|\^&||||||||||P<CR><ETX>0D<CR><LF> <ACK> <STX>2P|1<CR><ETX>3F<CR><LF> <ACK> <STX>3O|1|000004|40^0^4^^SAMPLE^NORMAL|^^^10\^^^50\^^^20\

^^^30|R|19970425085218|||||N||||||||||||||Q<CR><ETX>01<CR><LF>

<ACK> <STX>4L|1|F<CR><ETX>FF<CR><LF> <ACK> <EOT>

Instruments queries for test selections for control ‘PC U1’: <ENQ>



<ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2Q|1|^PC U1^37^0^1^^CONTROL^NORMAL||ALL

|||||||190599|O<CR><ETX>7D<CR><LF> <ACK> <STX>3L|1<CR><ETX>3C<CR><LF> <ACK> <EOT>

Host sends back test selections and reduces volume: <ENQ> <ACK> <STX>1H|\^&||||||||||P<CR><ETX>0D<CR><LF> <ACK> <STX>2P|1<CR><ETX>3F<CR><LF> <ACK> <STX>3O|1|PC U1|37^0^1^^CONTROL^REDUCED|^^^10\^^^50\^^^20\^^^30|

R|19970403110957|||||N\Q||||||||||||||Q<CR><ETX>53<CR><LF>

<ACK> <STX>4L|1|F<CR><ETX>FF<CR><LF> <ACK> <EOT>

Details of Records:

Instrument Sending Record Pattern

Request Information Record [Q Record] Pattern Pattern

Field Data Type Content I-1 I-2

1 Record type ID (Q) char[1] Q Q Q

2 Sequence number pos_int

3 Starting range ID number(patients/specimen Id/instrument specimen ID)

text^text^text

^text{^text}{^text}{^text}

^Sample ID^Sequence No.^S.Rotor No. or

RackID^Position No.

^^data carrier

type *5)^container

type *6)


RackID^Position No.

^^data carrier

type *5)^container

type *6)

4 ending range ID number [NONE] [NONE]

5 universal test ID text ALL ALL

6 nature of request timelimits

char[1] [NONE] [NONE]

7 beginning request resultsdate and time

d_t [NONE] [NONE]

8 ending request resultsdate and time

d_t [NONE] [NONE]

9 requesting physicianname

text [NONE] [NONE]

10 requesting physician text [NONE] [NONE]




Field Data Type Content I-1 I-2telephone number

11 user field NO.1 text [NONE] [NONE]

12 user field NO.2 text Control Lot No Control Lot No

13 request informationstatus codes

char[1 O O A

Patient Information Record [P Record] Pattern

Field Data Type Content I-11

1 record type ID (P) char[1] P P

2 sequence number pos_int

3 practice assigned patientID

text [NONE]

4 laboratory assignedpatient ID

text patient ID

5 patient ID No.3 text [NONE]

6 patient name text^text^text^text

[NONE]

7 mothers maiden name text [NONE]

8 date of birth d [NONE]

9 patient sex char[1] [NONE]

10 patient race-ethnic origin text [NONE]

11 patient address text [NONE]

12 reserved field [NONE]

13 patient telephone number text [NONE]

14 attending physician ID text [NONE]

15 special field 1 text [NONE]


17 patient height (in cm) int{^unit}

[NONE]

18 patient weight in (kg) int{^unit}

[NONE]

19 patient's known orsuspected diagnosis

text [NONE]

20 patient activemedications

text [NONE]

21 patient's diet text [NONE]

22 practice field No.1 text [NONE]






24 admission and dischargedates

d{\d}

[NONE]

25 admission status char[2] [NONE]

26 location text [NONE]

27 nature of alternativediagnostic code andclassifiers

text [NONE]

28 alternative diagnosticcode and classification

text [NONE]

29 patient religion char[1] ortext

[NONE]

30 marital status char[1] [NONE]

31 isolation status char[3] ortext

[NONE

32 language status text [NONE]

33 hospital service text [NONE]

34 hospital institution text [NONE]

35 dosage category text [NONE]

Test Order Record [O Record] Pattern Pattern


1 record type ID (O) char[1] O O O


3 specimen ID text Sample ID Sample ID

4 instrument specimen ID text

{^text}{^text}{^text}{^text}{^text}

Sequence No.^S. Rotor No.

or RackID^Position No

^^data carrier

type *5)^container

type *6)



^^

^

5 universal test ID text^text^text^text

{^text}

{^text}

{\ }

^^

^Test No.^ Auto Dil.

Reference *7)^Predilutionfactor *10)

{\ }

[NONE]

6 priority Char[1] S, R S: STATR: routine

[NONE]



Test Order Record [O Record] Pattern Pattern


7 request/ordered date andtime

d_t ordered date &time

[NONE]

8 specimen collection dateand time

d_t [NONE] [NONE]

9 collection end time d_t [NONE] [NONE]

10 collection volume (in ml) int{^unit}

[NONE] [NONE]

11 collector ID text [NONE] [NONE]

12 action code char[1]{\...}

C, N, Q N *4) [NONE]

13 danger code text [NONE] [NONE]

14 relevant clinicalinformation

text [NONE] [NONE]

15 date/time specimenreceived

d_t [NONE] [NONE]

16 specimen descriptor(type & source)

text^text

[NONE] [NONE]

17 ordering physician text [NONE] [NONE]

18 physician’s telephonenumber

text [NONE] [NONE]

19 user field No.1 text [NONE] [NONE]

20 user field No.2 text [NONE] [NONE]

21 laboratory field No.1 text [NONE] [NONE]

22 laboratory field No.1 text [NONE] [NONE]

23 date/time results reportedor last modified

d_t [NONE] [NONE]

24 instrument change tocomputer system

text [NONE] [NONE]

25 instrument section ID text [NONE] [NONE]

26 report types char[1]{\...}

Q, Z, O Q Z

27 reserved field [NONE] [NONE]

28 location or ward ofspecimen collection

text [NONE] [NONE]

29 nosocomial infection flag text [NONE] [NONE]

30 specimen service text [NONE] [NONE]

31 specimen institution text [NONE] [NONE]



Host Sending Record Pattern

Request Information Record [Q Record] Pattern

Field Data Type Content L-1

1 record type ID (Q) char[1] Q Q


3 starting range ID number(patients/specimen Id/instrument specimen ID)

text^text^text

{^text}{^text}


RackID^Position No.

4 ending range ID number [NONE]

5 universal test ID text ALL


char[1] [NONE]


d_t [NONE]


d_t [NONE]


text [NONE]

10 requesting physiciantelephone number

text [NONE]

11 user field NO.1 text [NONE]

12 user field NO.2 text [NONE]


char[1 O O






text [NONE


text patient ID



[NONE]
















[NONE]


[NONE]

19 patient’s known orsuspected diagnosis

text [NONE]


text [NONE]

21 patient’s diet text [NONE]




d{\d}

[NONE]




text [NONE]


text [NONE]


[NONE]



[NONE







Test Order Record [O Record] Pattern Pattern Pattern

Field Data Type Content L-21 L-22 L-23

1 record type ID (O) char[1] O O O O


3 specimen ID text Sample ID *3) Sample ID *3) Sample ID *3)


{^text}{^text}{^text}{^text}{^text}



^^

^containertype *6)



^^

^containertype *6)



^^

^containertype *6)

5 universal test ID Text^text^text^text

{\ }

^^


Reference *8){\ }

[NONE] ^^


Reference *8){\ }

6 priority char[1 S, R S: STATR: routine *2)

[NONE] S: STATR: routine *2)

7 request/ordered dateand time

d_t [NONE] [NONE] [NONE]

8 specimen collectiondate and time


9 collection end time d_t [NONE] [NONE] [NONE]

10 collection volume (inml)

int{^unit}

[NONE] [NONE] [NONE]

11 collector ID text [NONE] [NONE] [NONE]

12 action code char[1]{\ }

C, N, Q, A *1) *4) *9) [NONE] *1) *4) *9)

13 danger code text [NONE] [NONE] [NONE]


text [NONE] [NONE] [NONE]




text^text


17 ordering physician text [NONE] [NONE] [NONE]

18 physician's telephonenumber


19 user field No.1 text [NONE] [NONE] [NONE]


21 laboratory field No.1 text [NONE] [NONE] [NONE]





Field Data Type Content L-21 L-22 L-23

23 date/time resultsreported or lastmodified




25 instrument section ID text [NONE] [NONE] [NONE]


Q, Z, O Q Z *11) O

27 reserved field [NONE] [NONE] [NONE]



29 nosocomial infectionflag


30 specimen service text [NONE] [NONE] [NONE]

31 specimen institution text [NONE] [NONE] [NONE]

*1) N: Instrument replaces the existing test order information to a new test order informationbelonging to this specimen.

A: Instrument adds this new test order information to the existing test order informationbelonging to this specimen.Note: The behavior here now is adopted to the original ASTM standard specifications.

C: Instrument deletes this specimen from data base.

*2) In case of a registration update (no new registration, sample is already in the data base) it isimpossible to change the priority.(Example: Host is not allowed to change a sample from Routine to STAT or vice versa.)

Registration already assigned

priority

priority

(sent from Host)

priority

R „Normal“

„Normal“ S IMPOSSIBLE !

Update [NONE] „Normal“

R IMPOSSIBLE !

„STAT“ S „STAT“

[NONE] „STAT“

R „Normal“

New S „STAT“

[NONE] „Normal“

*** Rack Sampler/Rack Conveyer System (Query Mode)----- Can not assign „STAT“ priority. ( = S)

*3) Maximum length of Sample ID is 22.It is impossible to set below strings in this field as Sample ID. The instrument treats thesestrings as „Stop Bar-code“.



If there is any additional character (unless space) the number will be treated as a sample ID.„000“„000 „ [ „000“ + some spaces ]„ 000“ [ some spaces + „000“ ]„ 000 „ [ some spaces + „000“ + some spaces ]

*4) In case of control samples following two characters are added „\Q“

*5) data carrier type: „CONTROL“, „SAMPLE“

*6) container type: „NORMAL“, „REDUCED“

*7) Auto Dilution FactorReference no. in reference table corresponding to auto-dilution ratio is set in this field.Auto dilution factor is set as follows.

sample’s type Protocol Tests Auto Dil. factor

Diluent Protocol or Quantitative Tests [NONE]**

PretreatmentProtocol

Qualitative Tests [NONE]

„Sample“ Other Protocol

auto-dilution ratiois not assigned

[NONE]

(NOT DiluentProtocol)

(NOT PretreatmentProtocol)

Quantitative Tests auto-dilution ratiois assigned

Reference No. inReference Table iscorresponding toassigned auto-

dilution ratio


„Control“ [NONE]

**That means that the auto dilution factor (=component 5 of the Universal test ID) isnow empty instead of 0.

*8) Auto Dilution FactorReference No. in reference table corresponding to auto-dilution ratio is set in this field.Instrument treats this auto dilution factor as follows (available or NOT available).

Sample’s type Protocol Tests Auto Dil. factor

Diluent Protocolor

Quantitative Tests NOT Available(Use Default auto-dilution ratio)


Qualitative Tests NOT Available(Use Default auto-dilution ratio)

„Sample“ Other Protocol(NOT Diluent

Protocol)

Quantitative Tests Available(assigning auto-dilution ratio is possible)


Qualitative Tests NOT Available(assigning auto-dilution ratio is

impossible)

„Control“ NOT Available(Use Default auto-dilution ratio)



*9) In case of a registration update (no new registration, sample is already in the data base), it isimpossible to change the sample’s type. .(Example: Host is not allowed to change a sample from Sample to Control or vice versa.)

Registration already assigned

sample’s type

action code

(sent from Host)

sample’s type

N or A „Sample“

„Sample“ N\Q or A\Q IMPOSSIBLE !

Update [NONE] „Sample“

N or A IMPOSSIBLE !

„Control“ N\Q or A\Q „Control“

[NONE] „Control“

N or A\ „Sample“

New N\Q or A\Q IMPOSSIBLE !

[NONE] „Sample“

*10) Pre dilution factor0: This sample has NOT been pre diluted.1: This sample has been pre diluted.

*11) In this case, the instrument deletes this specimen from Data Base. ( V03-06 ~ )

[NOTES]

1. It is impossible to download test selections for a new „CONTROL“ sample (For aCONTROL sample it is only possible to download test selections when it is alreadyregistered.)

2. In case that the Host answers with a test selection for an outstanding query, it is necessaryto set the same Sequence No and Sample ID as the instrument asked for in the QueryMessage. If these data (Sequence No and Sample ID) are not same as asked for from theinstrument, the instrument ignores this message as the answer to the Query and continueswaiting for the correct answer from Host.

In case no Sample ID was sent from the instrument („specimen ID“ field is empty), the Hostcan set the correct Sample ID in the answering Test Order Message. Also in this case, it isnecessary to answer with the same Sequence No as the instrument queried for.

3. The instrument registers test selections from Host as follows.

Contents in „specimen ID“field and „Instrument

specimen ID“ field

(sent from Host)Search

Registration

Comment

Patt. SeqNo

SampleID

RotorNo/RackID &

Position No

Key Update New

1 O Seq No O

2 O Sample ID O O If the same sample ID is assigned for



Contents in „specimen ID“field and „Instrument

specimen ID“ field

(sent from Host)Search

Registration

Comment

Patt. SeqNo

SampleID

RotorNo/RackID &

Position No

Key Update New

different samples, the instrument onlyupdates the sample which was found firstaccording to the search algorithm.

3 O RotorNo/RackID &

Position No

O O In case of a new registration, the instrumentassigns „@SeqNo“ as Sample IDautomatically.

4 O O Seq No O If the Host does not answer to a query withthe same Sample ID, the instrument doesnot update this sample.However if „@SeqNo“ was assigned assample ID (sample without bar-code), theinstrument overwrites this sample ID withthe one which was sent from Host.

5 O O Sample IDor

RotorNo/RackID &

Position No

O O If the instrument can not find acorresponding sample in database bysearching with „Sample ID“ key, then theinstrument searches the sample again byusing „RotorNo/ RackID & Position No“ key.If „@SeqNo“ was assigned as sample ID(sample without bar-code), the instrumentoverwrites this sample ID with the one whichwas sent from Host.In case of a registration update (button onthe screen), the instrument overwritesRotorNo/ RackID & Position No to the onethat were sent earlier from Host.

6 O O Seq No O Instrument does not overwrite RotorNo/RackID & Position No to the one that weresent from Host.

7 O O O Seq No O If the host does not answer to a query withthe corresponding Sample ID, theinstrument does not update the sample.If „@SeqNo“ was assigned as sample ID(sample without bar-code), the instrumentoverwrites this sample ID with the one whichwas sent from Host.The instrument does not overwrite RotorNo/RackID & Position No to the one that weresent from Host.

O: Set or Available,[space]: Not Set or NOT Available



4. When the Host queries for test selections of a sample, the instrument searches the testselections of the sample by using „Search Key“. „Search Key“ is as follows.

Contents in „starting rangeID number“ field

(sent from Host) Search Comment

Patt. SeqNo

SampleID

RotorNo/RackID &

Position No

Key

1 O Seq No

2 O Sample ID

3 O RotorNo/RackID &

Position No

4 O O Seq No „Sample ID“ is ignored.

5 O O Sample ID „RotorNo/RackID & Position No“ are ignored.

6 O O Seq No „RotorNo/RackID & Position No“ are ignored.

7 O O O Seq No „Sample ID“ and „RotorNo/RackID & Position No“ areignored.

18 Result Message - Q/P/O/R/C/RR/RC

Result Message - Q/P/O/R/C/RR/RC Elecsys® 2010 - Host Interface

3. Result Message - Q/P/O/R/C/RR/RC



Purpose Host InstrumentQuery for Information of Result (Final Result)(in case that Instrument answers positively)(Answer Information of Result that were requested fromHost.)

L-1(M-1)

I-1, I-11I-21, I-31

(M-2)

Query for Information of Result (Edited or Normal Result)(in case that Instrument answers positively)(Answer Information of Result that were requested fromHost.)

L-2(M-1)

I-1, I-11I-21, I-31

(M-2)

Query for Information of Result(in case that Instrument answers negatively)(Answer negatively in case that all results of this specimenhave not been calculated yet.)

L-1(M-1)

I-1, I-12(M-3)

Event: The instrument receives a Result Message Query.à The instrument answers to the query.Host queries for result information for one sample.(or for some samples)The instrument always answers with 1 message/1 sample even if Host queries forresult information for some samples using one message.

Instrument à Host Upload

Purpose Host InstrumentUpload after all results of this specimen are calculatedUpload after pressing <DOC> key on Results screen.(Upload Information of Result of this specimen.)

I-1, I-13I-22, I-31I-41, I-51

(M-4)Upload after Instrument Power on.(Upload Information of Result of this specimen.)

I-1, I-13I-22, I-31

(M-2)L-*, I-*: refer to "Details of Records"M-*: refer to "Construction of Message"

Event: a) Automatic output of all the test results is generated (including ‘No Value”results)à The instrument uploads a Result Message for this sample.Normal samples and Control samples are applied.This is done in automatic upload mode.

b) Pressing <DOC> key on the Results Screen.à The instrument uploads a Result Message for the sample that is displayed on thecurrent screen.This is done even if all the test results are not yet generated.

c) Turn on the power switch of the instrument.à The instrument uploads messages for undocumented results of samples.The instrument uploads 1 message/1 sample.

Result Message - Q/P/O/R/C/RR/RC 19

Elecsys® 2010 - Host Interface Result Message - Q/P/O/R/C/RR/RC



0 H1 Q0 L

<< more than one query may occur >>


0 H1 P2 O3 R* C3 R } max. 60 results* C

: :: :

0 L<< 1 Message / 1 Sample >>

Trace Example:

Instrument sends results for control sample ‘000004’: <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2P|1<CR><ETX>3F<CR><LF> <ACK> <STX>3O|1|000004|40^0^4^^SAMPLE^REDUCED|ALL|R|

19970425120322|||||X||||||||||||||O|||||<CR><ETX>6C<CR><LF> <ACK> <STX>4R|1|^^^10^^0|0.016|uIU/ml|0.230^3.80|L||F|||

19970425120351|19970425122213|<CR><ETX>D7<CR><LF> <ACK> <STX>5C|1|I|48^Below normal(expected)range|I<CR><ETX>57<CR><LF> <ACK> <STX>6R|2|^^^50^^0|1.17|ng/ml|0.846^2.02|||F|||

19970425120557|19970425122419|<CR><ETX>3CDE<CR><LF> <ACK> <STX>7R|3|^^^20^^0|4.41|ug/dl|5.13^13.52|L||F|||

19970425120433|19970425122255|<CR><ETX>7A<CR><LF> <ACK> <STX>0C|1|I|48^Below normal(expected)range|I<CR><ETX>52<CR><LF> <ACK> <STX>1R|4|^^^30^^0|0.091|ng/dl|1.01^1.79|L||F|||

19970425120515|19970425122337|<CR><ETX>71<CR><LF> <ACK> <STX>3C|1|I|48^Below normal(expected)range|I<CR><ETX>55<CR><LF> <ACK> <STX>2R|7|^^^400^^0|-1^0.001|COI|^|N||F|||19971215150922|

19971215152744|<CR><ETX>D9<CR><LF> <ACK> <STX>4L|1<CR><ETX>3D<CR><LF> <ACK> <EOT>




0 H1 P2 O0 L

<< 1 Message / 1 Sample >>


0 H1 P2 O3 R* C4 M-RR4 M-RC3 R } max. 60 results* C4 M-RR4 M-RC

: :: :

0 L<< 1 Message / 1 Sample >>

Trace Example:

Instrument sends results for control ‘PC U1’: <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2P|1<CR><ETX>3F<CR><LF> <ACK> <STX>3O|1|PC U1|37^0^1^^CONTROL^REDUCED|ALL|R|

19970425115705|||||X\Q||||||||||||||O|||||<CR><ETX>99<CR><LF> <ACK> <STX>4R|1|^^^10^^0|1.99|uIU/ml|1.69^2.43|||F|||

19970425115733|19970425121555|<CR><ETX>50<CR><LF> <ACK> <STX>5M|1|RR^BM^E1^1||14242\13924\14154\13391\12613\12836\

13062\13757\13053\13469\13147\12980\13312\13396\13501\13563\13639\13351\13155\12979\12857\13264\13391\13492\13343\13791\13345\13346\13752\12821\12993\13695\13696\14166\13736\13114\12690\12<ETB>9C<CR><LF>

<ACK> <STX>6517\13395\13264\12968\13375\13029\13117\13465\13267\

13507\12716\13380\13316\13145\12736\12679\12555\13334\13347\13635\13291\13372\13694\13063\13278\13166\13523\12749\12977\13293\12872\12550\12815\12657\12718\13367\13141\13495\13466\13869\13<ETB>06<CR><LF>

<ACK> <STX>7520\13464\13565\22636\29929\33176\34453\34874\34951\

34859\34748\34606\34414\34273\34127\33971\33799\33657\33534\33408\33303\33197\33114\32970\32860\32637\32585\32472\32434\32



285\32210\32150\32101\31976\31815\31758\31693\31590\31552\31396\31<ETB>3D<CR><LF>

<ACK> <STX>0296\31256\31194\31103\31156\31026\30899\30894\30786\

30742\30696\30591\30502\30582\30470\30363\30369\30350\30191\30183\30096\30065\30026\29933\29920\29881\29832\29783\29822\29769\29712\29527\29492\29499\29531\29487\29444\29403\29317\29248\29<ETB>5E<CR><LF>

<ACK> <STX>1190\29177\29196\29128\29081\29051\28995\29032\29019\

29002\29034\28952\28864\28814\28819\28791\28825\28762\28709\28655\28563\28528\28514\28488\28344\28360\28345\28352\28260\28343\28275\28286\28276\28344\28308\28255\28157\28067\28031\28130\28<ETB>AB<CR><LF>

<ACK> <STX>2156\28122\28175|28083<CR><ETX>1D<CR><LF> <ACK> <STX>3M|1|RC^BMÊ1^1|10|TSH|190524|487|1|190599||<CR><ETX>18<CR><LF> <ACK> <STX>4R|2|^^^50^^0|1.45|ng/ml|1.11^1.70|||F|||

19970425115939|19970425121801|<CR><ETX>02<CR><LF> <ACK> <STX>5M|1|RR^BMÊ1^1||13104\13200\13457\13463\13195\13161\..... .. .. <STX>2321\35302\35259|196679<CR><ETX>57<CR><LF> <ACK> <STX>3M|1|RC^BMÊ1^1|50|T3|192955|240|1|190599||<CR><ETX>B1<CR><LF> <ACK> <STX>4R|3|^^^20^^0|10.49|ug/dl|8.10^12.41|||F|||

19970425115815|19970425121637|<CR><ETX>68<CR><LF> <ACK> <STX>5M|1|RR^BMÊ1^1||14010\14245\13863\13399\13671\13047\..... .. ..<STX>2592\38558\38544|457109<CR><ETX>65<CR><LF> <ACK> <STX>3M|1|RC^BMÊ1^1|20|T4|190764|257|1|190599||<CR><ETX>B3<CR><LF> <ACK> <STX>4R|4|^^^30^^0|1.52|ng/dl|1.36^1.84|||F|||

19970425115857|19970425121719|<CR><ETX>0A<CR><LF> <ACK> <STX>5M|1|RR^BMÊ1^1||13277\13330\13316\13684\13247\13300\..... .. .. <STX>2033\28004\28064|28403<CR><ETX>0F<CR><LF> <ACK> <STX>3M|1|RC^BMÊ1^1|30|FT4|192882|1228|1|190599||<CR><ETX>2C<CR><LF> <ACK> <STX>4L|1<CR><ETX>3D<CR><LF> <ACK> <EOT>

Details of Records:











text [NONE]


text patient ID



[NONE]












[NONE]


[NONE]

19 patient's known orsuspected diagnosis

text [NONE]


text [NONE]

21 patient's diet text [NONE]




d{\d}

[NONE]




text [NONE]


text [NONE]


[NONE]







[NONE






Field Data Type Content I-11 I-12 I-13

1 record type ID (O) char[1] O O O O


3 specimen ID text Sample ID Sample ID Sample ID


{^text}{^text}{^text}{^text}



^^data carrier

type *6^container

type *7)

[NONE] Sequence No.^S. Rotor No.


^^data carrier

type *6^container

type *7)


{^text}{^text}{^text}{\ }

ALL ALL ALL

6 priority char[1 S, R S: STATR: routine

[NONE] S: STATR: routine

7 request/ordered dateand time

d_t ordered date& time

[NONE] ordered date& time

8 specimen collectiondate and time


9 collection end time d_t [NONE] [NONE] [NONE]

10 collection volume (inml)

int{^unit}


11 collector ID text [NONE] [NONE] [NONE]

12 action code char[1] X, Q X *3) X *3) X *3)

13 danger code text [NONE] [NONE] [NONE]










text^text


17 ordering physician text [NONE] [NONE] [NONE]

18 physician's telephonenumber






23 date/time resultsreported or lastmodified




25 instrument section ID text [NONE] [NONE] [NONE]


Q, I, O Q I O

27 reserved field [NONE] [NONE] [NONE]



29 nosocomial infectionflag


30 specimen service text [NONE] [NONE] [NONE]

31 specimen institution text [NONE] [NONE] [NONE]

Result Record [R Record] Pattern Pattern


1 record type ID (R) char[1] R R R



{^text}{^text}

^^^Test No.^Auto Dil.

Reference *9)^PredilutionFactor *11)

^^^Test No.^Auto Dil.

Reference *9)^PredilutionFactor *11)

4 data or measurementvalue

text{^...}

results *5) results *5)

5 units text units units



Result Record [R Record] Pattern Pattern


6 reference ranges text^text{\...}

Lower LimitÛpper Limit

*10)

Lower LimitÛpper Limit

*10)

7 result abnormal flags char[1] orchar[2]

*8) *8)

8 nature of abnormalitytesting

char[1]{\...}

[NONE] [NONE]

9 result status char[1]{\...}

F, X, Q, V,Y, +

*1) *2)

10 date of change ininstrument normativevalues or units

d [NONE] [NONE]

11 operator identification text [NONE] [NONE]

12 date/time test started d_t sampling time sampling time

13 date/time test completed d_t ready time ready time

14 instrument identification text [NONE] [NONE]

Comment Record [C Record] Pattern


1 record type ID (C) char[1] C C


3 comment source char[1] I I

4 comment text text{^...}

Instrumentresult flag

(integer 1...50)^Comment forabnormal flags

5 comment type char[1] G I

Raw Result Record [M-RR Record] Pattern


1 record type ID (M) char[1] M M


3 record type sub-ID(RR)

char[2]^text^text^text

RR^BMÊ1^1 RR^BMÊ1^1

4 starting value int [NONE]

5 value list int{\...}

value list

6 effective signal text effective signal



Result Context Record [M-RC Record] Pattern




3 record type sub-ID(RC)


RC^BM^E1^1 RC^BM^E1^1

4 BM test number text Test No.

5 reagent identifier text Test name

6 reagent lot number int lot number

7 reagent pack number int Rack Pack No.

8 control identifier text control No.

9 control lot number int control lotnumber

10 control pack number int [NONE]

11 Calibration status char[1] [NONE]



Field Data Type Content L-1 L-1

1 record type ID (Q) char[1] Q Q Q


3 starting range ID number(patients/specimen Id/instrument specimen ID)

text^text^text

^Sample ID^Sequence #

^Sample ID^Sequence #

4 ending range ID number text^text^text

[NONE] [NONE]

5 universal test ID text ALL ALL


char[1] R [NONE] [NONE]


d_t [NONE] [NONE]


d_t [NONE] [NONE]


text [NONE] [NONE]

10 requesting physiciantelephone number

text [NONE] [NONE]

11 Specimen Type char[1] N, Q *4) *4)

12 user field NO.2 text [NONE] [NONE]






char[1 F, N F N

*1) result status

No Value SystemBlocked

UserBlocked

UserReleased

Others

'F'request

set 'Q\X' set 'Q\Y' set 'Q\+' set 'Q\V' set 'Q\F'

'N'request

set 'Q\Y' set 'Q\+' set 'Q\V' set 'Q\F'

*2) result status:X : No ValueY : System Blocked+ : User BlockedV : User ReleasedF : Others

*3) In case of control samples the following two characters are added: ‘\Q’

*4) In case of normal samples set 'N'.In case of control samples set 'Q'.

*5) In case that a result is above upper limit (measuring range) the followingcharacter is added in the front of the result: ‘>’In case that a result is under lower limit (measuring range) the followingcharacter is added in the front of the result: ‘<’

For quantitative tests : a value corresponds to the analyte concentrationFor qualitative tests: data1 ^data2

data1 = ‘1’ : corresponds to „positive“ ‘0’ : corresponds to „border line“‘-1’ : corresponds to „negative“

data2 = Cut-off indexWhen „result status“ = ‘X’ (No Value), no data is set in this field ([NONE]).

*6) data carrier type : „CONTROL“, „SAMPLE“

*7) container type : „NORMAL“,“REDUCED“



*8) result abnormal flagsL : Below normal range (data alarm No = 48)H : Above normal range (data alarm No = 49)< : Below measuring range (data alarm No = 50)> : Above measuring range (data alarm No = 51)A : System Blocked (data alarm No = 1-11,17-22,24,30-37,45,47)N : All other flags

*9) Auto Dilution FactorReference no. in reference table corresponding to auto-dilution ratiois set in this field.Auto dilution factor is set as follows.

Sample’s type Protocol Tests Auto Dil. factor

Diluent Protocol or Quantitative Tests [NONE]**



„Sample“ Other Protocol

auto-dilution ratiois not assigned

[NONE]

(NOT DiluentProtocol)


Quantitative Tests auto-dilution ratiois assigned

Reference No. inReference Table iscorresponding toassigned auto-

dilution ratio


„Control“ [NONE]

**That means that the auto dilution factor (=component 5 of the Universal test ID) isnow empty instead of 0.

*10) reference rangesreference ranges are set as follows.

Normal Range Check

Sample’s Type Tests Not Available Available

„Sample“

Quantitative Tests [NONE] Lower Limit

Ûpper Limit

Qualitative Tests [NONE] [NONE]

„BM Control“ Lower Limit

Ûpper Limit

Lower Limit

Ûpper Limit

„Foreign Control“ Lower Limit

Ûpper Limit

Lower Limit

Ûpper Limit

*11) Pre dilution factor0: This sample has NOT been pre diluted.1: This sample has been pre diluted.



[NOTES]

1. When Host queries for the results of a sample the instrument searches the results of thesample by using „Search Key“.„Search Key“ is as follows.

Contents in „starting rangeID number“ field

(sent from Host) Search Comment

Patt. SeqNo

SampleID

RotorNo/RackID &

Position No

Key

1 O Seq No

2 O Sample ID

3 O - IMPOSSIBLE ! (can not search by this pattern)

4 O O Seq No „Sample ID“ is ignored.

5 O O Sample ID „RotorNo/RackID & Position No“ are ignored.

6 O O Seq No „RotorNo/RackID & Position No“ are ignored.

7 O O O Seq No „Sample ID“ and „RotorNo/RackID & PositionNo“ are ignored.

30 Substance Data Message - XT/DP

Substance Data Message - XT/DP Elecsys® 2010 - Host Interface

4. Substance Data Message - XT/DP



Purpose Host InstrumentUpload after completion of scanning of the reagent rotor(Test Reagent, Pretreatment, Blank Set)(Upload Information of rack packs that are on the reagentrotor. (18 positions))

I-1(M-4)

Upload after completion of scanning of the reagent rotor(There is no rack pack on this position.)(Upload Information of rack packs that are on the reagentrotor. (18 positions))

I-2(M-4)

Upload after completion of scanning of the reagent rotor(Diluent)(Upload Information of rack packs that are on the reagentrotor. (18 positions))

I-1, I-11(M-5)

Upload after completion of checking of liquid level of SystemReagent(Upload Information of System Reagent rack packs. (4positions))

I-3(M-1)

Upload after completion of scanning of Tip and Vesselmagazines(Upload Information of Tips and Vessels on the magazines.)

I-5(M-1)

Upload constantly (Instrument à Host)Upload when actual level becomes zero (Instrument à Host)(Upload Information of rack packs)

I-1I-3I-4I-5

(M-1)Upload when going to Stand-by status(Upload inventory Information with actual numbers.)

I-1I-3I-4I-5

I-11(M-3)

Upload after manual input of rack packs Information(Upload Information of rack packs that are on the reagentrotor.)

I-1(M-1)

Upload after occurring ‘Solid Waste Full’ Alarm(Upload Information of solid waste.)

I-4(M-1)

Upload after reset of Solid Waste Counter(Upload Information of solid waste.)

I-4(M-1)

Event: a) Scan of reagent rotorà The instrument uploads Substance Data Messages for the rack packs on thereagent rotor.The following rack packs are applied.

- Test Reagent, Pretreatment, Diluent, Blank SetThe instrument uploads 1 message/18 positions.

b) Liquid level check of the system reagents (AB/CC).à The instrument uploads Substance Data Messages for system reagent rack packs.

Substance Data Message - XT/DP 31

Elecsys® 2010 - Host Interface Substance Data Message - XT/DP

The instrument uploads 4 messages for AB1, CC1, AB2 and CC2.

c) Scan tip and vessel magazinesà The instrument uploads Substance Data Messages for tips and vessels.The instrument uploads 1 messages for tips and vessels.

d) Upload constantly during an operationà The instrument uploads Substance Data Messages constantly with a certain stepdistance.Following substances are applied.

- Test Reagent, Pretreatment, Diluent, Blank Set, System Reagent (AB/CC)- Tips & Vessel, Distilled Water, Liquid Waste

The instrument uploads 1 message/1 substance.

e) Upload if liquid level is zero during an operationà The instrument uploads Substance Data Messages of rack packs for which theliquid level became zero.Following Rack Packs are applied.

- Test Reagent, Pretreatment, Diluent, Blank Set, System Reagent (AB/CC)The instrument uploads 1 message/1 Rack Pack.

f) Going to Stand-by status after executing something functions.à The instrument uploads Substance Data MessagesFollowing substances are applied.

- Test Reagent, Pretreatment, Diluent, Blank Set, System Reagent (AB/CC)- Tip & Vessel, Distilled Water, Liquid Waste

g) Manual input of a rack pack no. on inventory screenà The instrument uploads information for the rack pack.

h) Occurrence of “Solid Waste Full” alarmà The instrument uploads information for solid waste.


Purpose Host InstrumentQuery for Information of rack packs that are on the reagentrotor(Test Reagent, Pretreatment, Blank Set)(Answer Information of rack pack on the reagent rotor positionthat was requested from Host. Answer parameter Informationtoo for Diluent rack pack.)

L-2(M-1)

I-1(M-1)

Query for Information of rack packs that are on the reagentrotor (Diluent)(Answer Information of rack pack on the reagent rotor positionthat was requested from Host. Answer parameter Informationtoo for Diluent rack pack.)

L-2(M-1)

I-1, I-11(M-2)

Query for Information of rack packs that are on the reagentrotor(There is no rack pack on this position.)(Answer Information of rack pack on the reagent rotor positionthat was requested from Host. Answer parameter Informationtoo for Diluent rack pack.)

L-2(M-1)

I-2(M-1)

Query for Information of System reagent rack packs(Answer actual level of each substances at this time.)

L-3(M-1)

I-3(M-1)

Query for Information of Distilled Water, Liquid and SolidWaste

L-4(M-1)

I-4(M-1)



(Answer actual level of each substances at this time.)Query for Information of Tips and Vessels(Answer actual level of each substances at this time.)

L-5(M-1)

I-5(M-1)

Event: The instrument receives a Substance Message Queryà The instrument answers to the HostHost queries for Substance Data information for a specific substance (or for somesubstances).The instrument always answers with 1 message/1 substance.

Host Download

Purpose Host InstrumentDownload Information of rack packs (actual level)(Test Reagent, Pretreatment, Blank Set, Diluent) *1)

L-1(M-1)


*1) Download only actual level of each substance.Downloading actual level of following substances not available.system reagent ...

(actual level is set by checking liquid level)Distilled Water, Liquid Waste ...

(actual level is set by detector)Tips, Vessels ...

(actual level is set by mechanical scanning)

Event: The instrument receives a Substance Data Message.à The instrument overwrites information of the specific substance data.Host downloads 1 message/1 substance (or 1 message/some substances).If the Substance Data that was sent from Host is for a substance that the instrumentdo not know, then this data is not valid (will be ignored).



0 H1 M-XT0 L

Trace Example:

Host queries for Substance Data at container position 12: <ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|XTQ^BM^E1^1|||||||||||||||||||12|<CR><ETX>18<CR><LF> <ACK> <STX>3L|1|I<CR><ETX>01<CR><LF> <ACK> <EOT>



Instrument sends back Substance Data for position 12: <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|XT^BMÊ1^1|TR|30|FT4|||RP|SCE1|200|192882|

1228|19970423094333|||19970800|196||RD||12|A<CR><ETX>DB<CR><LF>

<ACK> <STX>3L|1|F<CR><ETX>FE<CR><LF> <ACK> <EOT>

Host queries for Substance Data at container position 2: <ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|XTQ^BMÊ1^1|||||||||||||||||||2|<CR><ETX>E7<CR><LF> <ACK> <STX>3L|1|I<CR><ETX>01<CR><LF> <ACK> <EOT>

Instrument sends back Substance Data for position 2: <ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|XT^BMÊ1^1|TR|170|HCGSTAT|||RP|SCE1|100|170459|

1295|19971211162313|||19961200|96||RD||2|A<CR><ETX>DD<CR><LF> <ACK> <STX>3L|1|F<CR><ETX>FE<CR><LF> <ACK> <EOT>

Instruments actualizes Substance Data: <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|XT^BMÊ1^1|AB|ABCC1|||||||0||||||100|||||A

<CR><ETX>23<CR><LF> <ACK> <STX>3L|1<CR><ETX>3C<CR><LF> <ACK> <EOT>

<ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|XT^BMÊ1^1|CC|ABCC1|||||||0||||||100|||||A


<ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF>



<ACK> <STX>2M|1|XT^BM^E1^1|TP||||||||||||||303||TR|||A


<ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|XT^BM^E1^1|VS||||||||||||||150||VR|||A

<CR><ETX>8C<CR><LF> <ACK> <STX>3L|1<CR><ETX>3C<CR><LF> <ACK> <EOT>


0 H1 M-XT2 M-DP

: } max. 40 records :

0 L


0 H1 M-XT Rack pack Information of rack packs on a reagent rotor

...: *) in case of a diluent rack pack the parameter informationrecord (M-DP) is added.

...:0 L0 H1 M-XT à Tip information1 M-XT à Vessel information0 L0 H1 M-XT à system reagent information (Pos 1)1 M-XT1 M-XT à system reagent information (Pos 2)1 M-XT0 L0 H1 M-XT à Distilled Water information1 M-XT à Liquid Waste information1 M-XT à Solid Waste information0 L



Trace Example:

Instrument sends update for Substance Data <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|XT^BMÊ1^1|||||||||||||||||RD||1|R<CR><ETX>7D<CR><LF> <ACK> <STX>3M|2|XT^BMÊ1^1|TR|40|T-UP|||RP|SCE1|200|190543|

17|19970424161410|||19970400|169||RD||2|A<CR><ETX>8C<CR><LF> <ACK> <STX>4M|3|XT^BMÊ1^1|TR|310|AFP|||RP|SCE1|100|189872|

178|19970424161410|||19970400|96||RD||3|A<CR><ETX>83<CR><LF> <ACK> <STX>5M|4|XT^BMÊ1^1|TR|10|TSH|||RP|SCE1|200|190524|

487|19970424161411|||19970800|182||RD||4|A<CR><ETX>92<CR><LF> <ACK> <STX>6M|5|XT^BMÊ1^1|||||||||||||||||RD||5|R<CR><ETX>89<CR><LF> <ACK> <STX>7M|6|XT^BMÊ1^1|TR|320|PSA|||RP|SCE1|100|192831|

446|19970424161411|||19970500|89||RD||6|A<CR><ETX>91<CR><LF> <ACK> <STX>0M|7|XT^BMÊ1^1|TR|170|HCGSTAT|||RP|SCE1|100|190554|

100|19970424161411|||19970500|75||RD||7|A<CR><ETX>A7<CR><LF> <ACK> <STX>1M|8|XT^BMÊ1^1|TR|210|CKMBSTAT|||RP|SCE1|100|190557|

75|19970424161411|||19970500|54||RD||8|A<CR><ETX>CB<CR><LF> <ACK> <STX>2M|9|XT^BMÊ1^1|TR|60|FT3|||RP|SCE1|200|190884|

158|19970424161411|||19970400|182||RD||9|A<CR><ETX>7C<CR><LF> <ACK> <STX>3M|10|XT^BMÊ1^1|||||||||||||||||RD||10|R<CR><ETX>DE<CR><LF> <ACK> <STX>4M|11|XT^BMÊ1^1|||||||||||||||||RD||11|R<CR><ETX>E1<CR><LF> <ACK> <STX>5M|12|XT^BMÊ1^1|TR|50|T3|||RP|SCE1|200|192955|

240|19970424161411|||19970700|184||RD||12|A<CR><ETX>8A<CR><LF>

<ACK> <STX>6M|13|XT^BMÊ1^1|TR|20|T4|||RP|SCE1|200|190764|

257|19970424161411|||19971100|184||RD||13|A<CR><ETX>8A<CR><LF>

<ACK> <STX>7M|14|XT^BMÊ1^1|TR|30|FT4|||RP|SCE1|200|192882|

1228|19970424161411|||19970800|184||RD||14|A<CR><ETX>0C<CR><LF>

<ACK> <STX>0M|15|XT^BMÊ1^1|TR|200|TNTSTAT|||RP|SCE1|100|190560|

78|19970424161411|||19970500|18||RD||15|A<CR><ETX>FB<CR><LF> <ACK> <STX>1M|16|XT^BMÊ1^1|TR|300|CEA|||RP|SCE1|100|192838|

577|19970424161411|||19970500|96||RD||16|A<CR><ETX>DA<CR><LF> <ACK> <STX>2M|17|XT^BMÊ1^1|||||||||||||||||RD||17|R<CR><ETX>EB<CR><LF> <ACK> <STX>3M|18|XT^BMÊ1^1|DR|1|DilUni2|||RP|SCE1|40000|7878787|

777|19970424161411|||19991200|40000||RD||18|A<CR><ETX>6B<CR><LF>

<ACK> <STX>4M|1|DP^BMÊ1^1|10||<CR><ETX>73<CR><LF> <ACK> <STX>5M|2|DP^BMÊ1^1|20||<CR><ETX>76<CR><LF> <ACK> <STX>6M|3|DP^BMÊ1^1|30||<CR><ETX>79<CR><LF> <ACK>




0 H1 M-XT

...: Rack pack Information

...:0 L


0 H1 M-XT2 M-DP

: } max. 40 records } Rack pack Information :

...:

...:0 L

Details of Records:


Substance Data Record [M-XT Record] Pattern Pattern Pattern Pattern Pattern

Field DataType

Content I-1 *1) I-2 *1) I-3 I-4 I-5

1 record type ID (M) char[1] M M ß ß ß ß


3 record type sub-ID(XT)


XT^BM^E1^1

XT^BM^E1^1

ß ß ß ß

4 substance type char[2] TR, DR,PR, BS,AB, CC,TP, VS,

DW, LW,SW

TR:Test Reagent

DR:Diluent

PR:Pretreatment

BS:Blank Set

[NONE] AB:Assay Buffer

CC:Cell Cleaner

DW:Distill. Water

LW:Liquid Waste

SW:Solid Waste

TP:TipVS:

Vessel

5 substanceidentifier

text Test ReagentPretreatment

Test No.Diluent

Diluent No.Blank Set

Blank Set No.

[NONE] ABCC1,ABCC2

[NONE] [NONE]

6 substance name text Test ReagentPretreatment

Test CodeDiluent

Blank SetName

[NONE] [NONE] [NONE] [NONE]




Field DataType

Content I-1 *1) I-2 *1) I-3 I-4 I-5

7 test number(s) text{\...}

[NONE] [NONE] [NONE] [NONE] [NONE]

8 data carrier type text BC,MBC,MBCC


9 container type text RP RP [NONE] [NONE] [NONE] [NONE]

10 container cap type text SCE1 SCE1 [NONE] [NONE] [NONE] [NONE]

11 initial volume int{ûnit}

Test ReagentPretreatment

Blank SetNo. of tests

DiluentVolume


12 substance lotnumber

int Lot No. [NONE] Lot No. [NONE] [NONE]

13 container/packagenumber

int{înt}

Rack PackNo.


14 containerregistrationdate & time

d_t Rack Packfirst

registrationdate & time


15 container firstopening/usagedate & time

d_t [NONE] [NONE] [NONE] [NONE] [NONE]

16 stability on board int [NONE] [NONE] [NONE] [NONE] [NONE]

17 expiring date d expiringdate of lot

*6)


18 actual level int{ûnit}


Blank Setreal # of tests

*4)Diluent real

volume

[NONE] percent.number

DistilledWater: 0: OK 1: EmptyLiquid Waste: 0: OK 1: FullSolid Waste: percentagenumber *5)

real numberof tips orvessels

19 available level int{ûnit}


20 container carriertype

text RD, VR,TR

RD RD [NONE] [NONE] *3)

21 container carrier ID text [NONE] [NONE] [NONE] [NONE] [NONE]

22 container positionin carrier

int Position inthe reagent

rotor

Position inthe reagent

rotor


23 substance status char[1]{\...}

A, R, C A *2) R A A A



*1) I-1: in case that there is a Rack Pack in the position on thereagent rotor.I-2: in case that there is not a Rack Pack in the position onthe reagent rotor.

*2) If calibration request has been generated the following twocharacters are added. '\C'

*3) TR: Tip RackVR: Vessel Rack

*4) In case of pre treatment RackPack, if there is no AssayRackPack which corresponds to this pre treatment RackPack,no character is set in this field. ([NONE])

*5) In case of „Solid Waste Counter No Check Mode“, ‘0’ is set inthis field as a number of items of Solid Waste.

*6) In case that it is no need to check expiring date for thisRackPack, ‘000000’ is set in this field.

Diluent Parameters Record [M-DP Record] Pattern




3 record type sub-ID(DP)


DP^BMÊ1^1 DP^BMÊ1^1

4 test number text Test No.

5 test lot number int [NONE]

6 Endogenous content /unit

text{ûnit}

[NONE]



Field DataType

Content L-1 L-2 L-3 L-4 L-5

1 record type ID (M) char[1] M M ß ß ß ß



(XTQ)


XT^BMÊ1^1

XTQ^BMÊ1^1

XT^BMÊ1^1

XTQ^BMÊ1^1

ß ß ß




Field DataType


4 substance type char[2] TR, DR,PR, BS,AB, CC,TP, VS,

DW, LW,SW

TR:Test Reagent

DR:Diluent

PR:Pretreatment

BS:Blank Set

[NONE] AB:Assay Buffer

CC:Cell Cleaner

DW:Distill. Water

LW:Liquid Waste

SW:Solid Waste

TP:TipVS:

Vessel

5 substanceidentifier

text Test ReagentPretreatment

Test No.Diluent

Diluent No.Blank Set

Blank Set No.

[NONE] ABCC1,ABCC2

[NONE] [NONE]

6 substance name text [NONE] [NONE] [NONE] [NONE] [NONE]



8 data carrier type text BC,MBC,MBCC


9 container type text RP [NONE] [NONE] [NONE] [NONE] [NONE]

10 container cap type text SCE1 [NONE] [NONE] [NONE] [NONE] [NONE]



12 substance lotnumber

int Lot No. [NONE] [NONE] [NONE] [NONE]


int{^unit}

Rack PackNo.


14 containerregistrationdate & time


15 container firstopening/usagedate & time


16 stability on board int [NONE] [NONE] [NONE] [NONE] [NONE]

17 expiring date d [NONE] [NONE] [NONE] [NONE] [NONE]



Blank Setreal # of testsDiluent real

volume




20 container carriertype

text RD [NONE] [NONE] [NONE] [NONE] [NONE]

21 container carrier ID text [NONE] [NONE] [NONE] [NONE] [NONE]

22 container positionin carrier

int [NONE] Position inthe reagent





Field DataType


rotor


A, R, C A [NONE] [NONE] [NONE] [NONE]

Calibrator Parameters Message - XT/CP 43

Elecsys® 2010 - Host Interface Calibrator Parameters Message - XT/CP

5. Calibrator Parameters Message - XT/CP


Upload Instrument à Host

Purpose Host InstrumentUpload after completion of scanning of the Bar-code Card.(Upload information of Bar-code Card.)

I-1, I-11(M-1)

Event: Scan bar-code card of a calibrator.à The instrument uploads a Calibrator Parameters Message for the bar-code card.The instrument uploads 1 message/1 calibrator bar-code card.


Purpose Host InstrumentQuery for information of Calibrator Parameters(Answer information of Calibrator Parameters that wererequested from Host.)

L-1, L-11(M-2)

I-1, I-11(M-1)

Event: The instrument receives a Calibrator Parameters Message Query.-----> The instrument answers to the query.The Host queries for Calibrator Parameters information for one test (or some test).The instrument always answers with 1 message/1 test.

Download Host à Instrument

Purpose Host InstrumentDownload Information of Calibrator Parameters(Download only target value of each Calibrator Parameters.)(If an instrument has never seen the Calibrator Parametersbefore, the downloading becomes invalid.)

L-2, L-12(M-2)


Event: The instrument receives a Calibrator Parameters Message.à The instrument overwrites information of the calibrator parameter.The Host downloads 1 message/1 test (or 1 message/ some tests).If the calibrator parameters that were sent from Host are data that the instrument doesnot know, then this data is not valid (will be ignored).

44 Calibrator Parameters Message - XT/CP

Calibrator Parameters Message - XT/CP Elecsys® 2010 - Host Interface



0 H1 M-XT2 M-CP

: }max. 50 records :

0 L

Trace Example:

Instrument read Calibrator Bar-code card: <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|XT^BMÊ1^1|RC||||||||190763|||||19971100||||||

<CR><ETX>CF<CR><LF> <ACK> <STX>3M|1|CP^BMÊ1^1|20|A|47.50|99999999|<CR><ETX>71<CR><LF> <ACK> <STX>4M|2|CP^BMÊ1^1|20|B|74.70|99999999|<CR><ETX>76<CR><LF> <ACK> <STX>5M|3|CP^BMÊ1^1|20|C|0.000|99999999|<CR><ETX>67<CR><LF> <ACK> <STX>6M|4|CP^BMÊ1^1|20|D|0.000|99999999|<CR><ETX>6A<CR><LF> <ACK> <STX>7M|5|CP^BMÊ1^1|20|E|0.000|99999999|<CR><ETX>6D<CR><LF> <ACK> <STX>0M|6|CP^BMÊ1^1|20|A|46.80|190619|<CR><ETX>E7<CR><LF> <ACK> <STX>1M|7|CP^BMÊ1^1|20|B|139.0|190619|<CR><ETX>E5<CR><LF> <ACK> <STX>2M|8|CP^BMÊ1^1|20|C|0.000|190619|<CR><ETX>DB<CR><LF> <ACK> <STX>3M|9|CP^BMÊ1^1|20|D|0.000|190619|<CR><ETX>DE<CR><LF> <ACK> <STX>4M|10|CP^BMÊ1^1|20|E|0.000|190619|<CR><ETX>08<CR><LF> <ACK> <STX>5M|11|CP^BMÊ1^1|20|A|50.40|190764|<CR><ETX>10<CR><LF> <ACK> <STX>6M|12|CP^BMÊ1^1|20|B|147.0|190764|<CR><ETX>16<CR><LF> <ACK> <STX>7M|13|CP^BMÊ1^1|20|C|0.000|190764|<CR><ETX>0D<CR><LF> <ACK> <STX>0M|14|CP^BMÊ1^1|20|D|0.000|190764|<CR><ETX>08<CR><LF> <ACK> <STX>1M|15|CP^BMÊ1^1|20|E|0.000|190764|<CR><ETX>0B<CR><LF> <ACK> <STX>2L|1<CR><ETX>3B<CR><LF> <ACK> <EOT>




0 H1 M-XT2 M-CP0 L

Details of Records:


Substance Data Record [M-XT Record] Pattern






XT^BMÊ1^1 XT^BMÊ1^1

4 substance type char[2] RC RC: Calibrator

5 substance identifier text [NONE]

6 substance name text [NONE]


[NONE]

8 data carrier type text [NONE]

9 container type text [NONE]

10 container cap type text [NONE]


[NONE]

12 substance lot number int Calibrator LotID


int{înt}

[NONE]

14 container registrationdate & time

d_t [NONE]

15 container firstopening/usage date &time

d_t [NONE]

16 stability on board int [NONE]

17 expiring date d expiring dateof lot


[NONE]


[NONE]

46 Calibrator Parameters Message - XT/CP

Calibrator Parameters Message - XT/CP Elecsys® 2010 - Host Interface



20 container carrier type text [NONE]

21 container carrier ID text [NONE]

22 container position incarrier

int [NONE]


[NONE]

Calibrator Parameters Record [M-CP Record] Pattern




3 record type sub-ID(CP)


CP^BMÊ1^1 CP^BMÊ1^1


5 calibrator level char[1] A, B, C, D, E A, B, C, D, E

6 target value / unit text{ûnit}

reference valueûnit

7 reagent lot number int Reagent LotNo.

8 reagent package number int{înt}

[NONE]


Substance Data Record [M-XT Record] Pattern Pattern


1 record type ID (M) char[1] M M M



(XTQ)


XT^BMÊ1^1

XTQ^BMÊ1^1 XTQ^BMÊ1^1

XT^BMÊ1^1

4 substance type char[2] RC RC: Calibrator RC: Calibrator

5 substance identifier text [NONE] [NONE]

6 substance name text [NONE] [NONE]


[NONE] [NONE]

8 data carrier type text [NONE] [NONE]

9 container type text [NONE] [NONE]





10 container cap type text [NONE] [NONE]


[NONE] [NONE]

12 substance lot number int [NONE] [NONE]


int{înt}

[NONE] [NONE]


d_t [NONE] [NONE]


d_t [NONE] [NONE]

16 stability on board int [NONE] [NONE]

17 expiring date d [NONE] [NONE]


[NONE] [NONE]


[NONE] [NONE]

20 container carrier type text [NONE] [NONE]

21 container carrier ID text [NONE] [NONE]


int [NONE] [NONE]


[NONE] [NONE]

Calibrator Parameters Record [M-CP Record] Pattern Pattern




3 record type sub-ID(CP)

(CPQ)


CP^BMÊ1^1

CPQ^BMÊ1^1 CPQ^BMÊ1^1

CP^BMÊ1^1

4 test number text Test No. Test No.

5 calibrator level char[1] A, B, C, D, E [NONE] A, B, C, D, E


[NONE] reference value

7 reagent lot number int [NONE] Reagent LotNo.

8 reagent package number int{înt}

[NONE] [NONE]

48 Control Parameters Message - XT/QP

Control Parameters Message - XT/QP Elecsys® 2010 - Host Interface

6. Control Parameters Message - XT/QP



Purpose Host InstrumentUpload after completion of scanning of the Bar-code Card(Upload Information of Bar-code Card.)

I-1, I-11(M-1)

Event: Scan bar-code card for a control.à The instrument uploads a Control Parameters Message of the bar-code card.The instrument uploads 1 message/1 control bar-code card.


Purpose Host InstrumentQuery for Information of Control Parameters(Answer Information of Control Parameters that wererequested from Host.)

L-1, L-11(M-2)

I-1, I-11(M-3)

Event: The instrument receives a Control Parameters Message Query.à The instrument answers to the query.The Host queries for Control Parameters information for one (or some) control No.The instrument always answers 1 message/1 control No..

Host Download

Purpose Host InstrumentDownload Information of Control Parameters(Download only target value/unit and target range of eachControl Parameters.)(If an Instrument has never seen the Control Parametersbefore, the downloading becomes invalid.)

L-2, L-12(M-2)

L-*, I-*: refer to „Details of Records“M-*: refer to „Construction of Message“

Event: The instrument receives a Control Parameters Message.à The instrument overwrites the information of Control Parameters.The Host downloads 1 message/1 control (or 1 message/ some controls).A control is identified by control no. and control lot ID.If the Control Parameters that were sent from the Host are data that the instrumentdoes not now, then this data is not valid (will be ignored).

Control Parameters Message - XT/QP 49

Elecsys® 2010 - Host Interface Control Parameters Message - XT/QP



0 H1 M-XT2 M-QP


0 L

Trace Example:

Instrument read Control Bar-code card: <ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|XT^BMÊ1^1|CS|1|PCU1||||||1997402|||||19991200||||||<CR>

<ETX>53<CR><LF> <ACK> <STX>3M|1|QP^BMÊ1^1|10||0.010ûIU/ml|0.008|0.012|N<CR>

<ETX>90<CR><LF> <ACK> <STX>4M|2|QP^BMÊ1^1|20||114.0^nmol/l|90.06|137.9|N<CR>

<ETX>E6<CR><LF> <ACK> <STX>5M|3|QP^BMÊ1^1|30||44.00^pmol/l|37.40|50.60|N<CR>

<ETX>E3<CR><LF> <ACK> <STX>6M|4|QP^BMÊ1^1|40||1.13^TBI|0.893|1.37|N<CR>

<ETX>15<CR><LF> <ACK> <STX>7M|5|QP^BMÊ1^1|310||12.60ÎU/ml|8.82|16.38|N<CR>

<ETX>47<CR><LF> <ACK> <STX>0L|1<CR><ETX>39<CR><LF> <ACK> <EOT>


0 H1 M-XT2 M-QP0 L




0 H1 M-XT2 M-QP


1 M-XT } max. 5 pairs : :

0 L

Details of Records:








XT^BMÊ1^1 XT^BMÊ1^1

4 substance type char[2] CS CS: Control

5 substance identifier text Control No.

6 substance name text Control Name


[NONE]

8 data carrier type text [NONE]

9 container type text [NONE]

10 container cap type text [NONE]


[NONE]

12 substance lot number int Control Lot No


int{înt}

[NONE]


d_t [NONE]


d_t [NONE]

16 stability on board int [NONE]

17 expiring date d expiring date oflot

18 actual level int [NONE]




Field Data Type Content I-1{ûnit}


[NONE]

20 container carrier type text [NONE]

21 container carrier ID text [NONE]


int [NONE]


[NONE]

Control Parameters Record [M-QP Record] Pattern




3 record type sub-ID(QP)

text^text^text^text

QP^BMÊ1^1 QP^BMÊ1^1


5 reagent lot number int [NONE]


target valueûnit

7 lower limit text Lower limit

8 upper limit text Upper limit

9 flags char[1] A, N *1)

*1) A: ActiveN: Not active







(XTQ)

text^text^text^text

XT^BMÊ1^1

XTQ^BMÊ1^1

XTQ^BMÊ1^1 XT^BMÊ1^1

4 substance type char[2] CS CS: Control CS: Control

5 substance identifier text Control No. Control No.





6 substance name text [NONE] [NONE]


[NONE] [NONE]

8 data carrier type text [NONE] [NONE]

9 container type text [NONE] [NONE]

10 container cap type text [NONE] [NONE]


[NONE] [NONE]

12 substance lot number int [NONE] Control lot No.


int{înt}

[NONE] [NONE]


d_t [NONE] [NONE]


d_t [NONE] [NONE]

16 stability on board int [NONE] [NONE]

17 expiring date d [NONE] [NONE]


[NONE] [NONE]


[NONE] [NONE]

20 container carrier type text [NONE] [NONE]

21 container carrier ID text [NONE] [NONE]


int [NONE] [NONE]


[NONE] [NONE]

Control Parameters Record [M-QP Record] Pattern Pattern




3 record type sub-ID(QP)

(QPQ)

text^text^text^text

QP^BMÊ1^1

QPQ^BMÊ1^1 QPQ^BMÊ1^1

QP^BMÊ1^1

4 test number text [NONE] Test No.

5 reagent lot number int [NONE] [NONE]


[NONE] target value



Control Parameters Record [M-QP Record] Pattern Pattern


7 lower limit text [NONE] target range*

8 upper limit text [NONE] [NONE]*

9 flags char[1] A, N [NONE] [NONE]

* No Changes. (Same as V02-XX)

54 Calibration Data Message - CR

Calibration Data Message - CR Elecsys® 2010 - Host Interface

7. Calibration Data Message - CR



Purpose Host InstrumentUpload after completion of Lot Calibration(Upload Information of Result of Lot Calibration.)

I-1(M-1)

Upload after completion of Rack Pack Calibration(Upload Information of Result of Rack Pack Calibration.)

I-2(M-1)

Upload after completion of Blank Set(Upload Information of Result of Blank Set.)

I-3(M-1)

Upload after releasing Calibration data(Upload Information of Result of Rack Pack or LotCalibration.)

I-1 or I-2(M-1)

I-*: refer to "Details of Records"M-*: refer to "Construction of Message"

Event: Output the measured calibration results of the test.à The instrument uploads a Calibration Result Message of this test.The instrument uploads 1 message/1 test.



0 H1 M-CR0 L

Trace Example:

Instrument sends Calibration Data: <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|CR^BM^E1^1|30|192882|ng/dl|RD^1^12|1228|N^M||

19970423103101|O|I^0^----------\M^0^-----\S^0^----------\R^1.00^0.000\D^0^-----|252858.000000^4.043450^1.316730^8366.690430^0.000000\-376.218567^1.254267\1.000000|SD^1^1^192881^0\SD^1^2^19288<ETB>9D<CR><LF>

<ACK> <STX>31^0\SD^1^^^\SD^1^^^\SD^1^^^|48008^49049\14824^14835\-0.000^-

0.000\-0.000^-0.000\-0.000^-0.000<CR><ETX>50<CR><LF> <ACK> <STX>4L|1<CR><ETX>3D<CR><LF> <ACK> <EOT>

<ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK>

Calibration Data Message - CR 55

Elecsys® 2010 - Host Interface Calibration Data Message - CR

<STX>2M|1|CR^BMÊ1^1|170|170459|mIU/ml|RD^1^2|1295|N^M||19971211164831|O|I^0^----------\M^0^-----\S^0^----------\R^1.00\D^0^-----|801.572021^42261.300781^1.012350^5922030.000000^0.000000\-60043.859375^3.530345\1.000000|SD^0^1^417333^0\SD^0^2^4173<ETB>64<CR><LF>

<ACK> <STX>333^0\SD^^^^\SD^^^^\SD^^^^|17635^17652\172243^171273\

^\^\^||1<CR><ETX>D6<CR><LF> <ACK> <STX>4L|1<CR><ETX>3D<CR><LF> <ACK> <EOT>

Details of Records:


Calibration Result [M-CR Record] Pattern Pattern Pattern


1 record type ID (M) char[1] M M M M


3 record type sub-ID(CR)


CR^BMÊ1^1

CR^BMÊ1^1 CR^BMÊ1^1 CR^BMÊ1^1

4 test number text Test No. Test No. Blank Set No

5 test lot number int Reagent LotNo.

Reagent LotNo.

Blank Set lotNo.

6 unit unit unit unit [NONE]

7 test containerdescription

text^text^text

RD^1

^position

RD^1

^position

RD^1

^position

8 test package number int Rack PackNo.

Rack PackNo.

Rack PackNo.

9 calibration method char[1]^char[1]

N^M, N^R,I^

N^M

N^R

I^

10 replication number int [NONE] [NONE] [NONE]

11 date/time calibrationcompleted

d_t result readydate/time

result readydate/time

result readydate/time

12 result status char[1] O,Q,F O: OKQ: Question

F: Failed

O: OKQ: Question

F: Failed

O: OKF: Failed

13 result characteristics char[1]^char[1]

^text{\...}

I, M, S, R,D, L, B, F,

T, C

*2) *2) *2)

14 curve parameters text{\...}

*1 *1 [NONE]

15 calibrators containerdescription

text^text

SD or RK *3)

^S.RotorNo.

SD or RK *3

^S.RotorNo.

[NONE]

56 Calibration Data Message - CR

Calibration Data Message - CR Elecsys® 2010 - Host Interface

Calibration Result [M-CR Record] Pattern Pattern Pattern

Field Data Type Content I-1 I-2 I-3^text^text^text{\...}

or RackID^position^lot No

^bottle No.{\...}

or RackID^position^lot No

^bottle No.{\...}

16 calibrators result text{^...}{\...}

1st signal^2nd signal

{\...}

1st signal^2nd signal

{\...}

1st signal^2nd signal^3rd signal^4th signal^5th signal^6th signal

17 Cut-off parameters text{^...} *4) *4) [NONE]

18 Expired RackPack Flag int *5) *5) [NONE]

*1) curve parameter[0]^curve parameter[1]^curve parameter[2]^curve parameter[3]^curve parameter[4]\2point correction parameter[0]^2point correction parameter[1]\1point correction parameter[0]

*** This field is used for quantitative tests. ***

*2) result characteristicscomponent : characteristicID ^ text1 ^ text2

[For Quantitative tests]

Criteria characteristicID text1 text2

Missing values I 0 (OK),1 (Question),

2 (Fail)

ex. AA--CC----

Monotony of curve M 0 (OK),1 (Question),

2 (Fail)

ex. A---E

Minimum signal S 0 (OK),1 (Question),

2 (Fail)

ex. AA--CC----

Calibration factor R Value ofCalibration

factor

[NONE]

Deviation of dupl.Measurement

D 0 (OK),1 (Question),

2 (Fail)

ex. A---E

[For Qualitative tests]


Missing values I 0 (OK),1 (Question),

2 (Fail)

ex. AA--

Monotony of curve M [NONE] [NONE]

Minimum signal S [NONE] [NONE]

Calibration Data Message - CR 57

Elecsys® 2010 - Host Interface Calibration Data Message - CR

Calibration factor R [NONE] [NONE]

Deviation of dupl.Measurement

D 0 (OK),1 (Question),

2 (Fail)

ex. -B

Slope L 0 (OK), 2 (Fail) OK or NG

Min/Max signal B 0 (OK),1 (Question),

2 (Fail)

ex. >-<-

Minimum acceptabledifference

F 0 (OK), 2 (Fail) OK or NG

[For Blank Set]


Achievement of Targets T 0 (OK), 2 (Fail) OK or NG

Comparison to last validBlankSet

C 0 (OK), 2 (Fail) OK or NG

*3) SD :SampleDiskRK : Rack

*4) cut-off parameter[0]^cut-off parameter[1]^cut-off parameter[2]^cut-off parameter[3]^cut-off parameter[4]^cut-off parameter[5]

*** This field is used for Qualitative tests. ***

*5) 0: Calibration performed with „Not Expired RackPack“1: Calibration performed with „Expired RackPack“

58 Sample Status Message - SS

Sample Status Message - SS Elecsys® 2010 - Host Interface

8. Sample Status Message - SS



Purpose Host InstrumentQuery for Information of Sample Status on the Sample Rotor(Answer Information of Sample Status on the Sample Rotorthat was requested from Host.)

L-1(M-1)

I-1(M-1)


Event: The instrument receives a Sample Status Message Query.à The instrument answers to the query.The Host queries for Sample Status information for one (or some) position on thesample rotor.The instrument always answers 1 message/1 position.



0 H1 M-SS0 L

Details of Records:


Sample Status Record [M-SS Record] Pattern




3 record type sub-ID(SS)


SS^BM^E1^1 SS^BM^E1^1

4 specimen ID text{^text}{^text}{^text}

Sample ID

Sample Status Message - SS 59

Elecsys® 2010 - Host Interface Sample Status Message - SS



5 position description text

^text^text^text^text

Sequence No^S.Rotor No or

RackID^Position No.

^^data carrier

type *3)^container

type *4)

6 status char[1]{\...}

I, A, P, N, G *1)

7 identification date andtime

d_t [NONE]

8 availability time t [NONE]

9 result ready time text^t

{\...}

Test No.^Result ready

time *5)

*1) Case status

No Sample on this position N

Sample is set on this position

before pipetting I

now pipetting P

all tests completed A\C

some tests can not be done A\X

prepare for next start/restart

(“regist” status)

G






3 record type sub-ID(SS)

(SSQ)

char[3}^text^text^text

SS^BMÊ1^1

SSQ^BMÊ1^1 SSQ^BMÊ1^1

60 Sample Status Message - SS

Sample Status Message - SS Elecsys® 2010 - Host Interface



4 specimen ID text{^text}{^text}{^text}

Sample ID

*2)

5 position description text

^text^text

^S. Rotor No &RackID

^Position No

*2)

6 status char[1]{\...}

I, A, C, P, N, X [NONE]

7 identification date andtime

d_t [NONE]

8 availability time t [NONE]

9 result ready time text^t

{\...}

[NONE]

*2) If both field data (‘Sample ID’ and ‘Position No.) are set then‘Sample ID’ is used as key data.

*3) data carrier type : „CALIBRATOR“, „CONTROL“, „SAMPLE“

*4) container type : „NORMAL“,“REDUCED“

*5) In case of calibrator no character is set in this field [NONE]

Instrument Status Message - IS 61

Elecsys® 2010 - Host Interface Instrument Status Message - IS

9. Instrument Status Message - IS



Purpose Host InstrumentQuery for Information of instrument status and alarm level(Answer Information of instrument status and alarm level.)

L-1(M-1)

I-1(M-1)

Event: The instrument receives a Instrument Status Message Query.-----> The instrument answers the query.


Purpose Host InstrumentUpload when an instrument status changes(Upload Information of instrument status and alarm level.)

I-1(M-1)


Event: Change of instrument statusà The instrument uploads information for instrument status.



0 H1 M-IS0 L

Trace Example:

Query from the Host: <ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|ISQ^BM^E1^1||||||||||<CR><ETX>CD<CR><LF> <ACK> <STX>3L|1|N<CR><ETX>06<CR><LF> <ACK> <EOT>

62 Instrument Status Message - IS

Instrument Status Message - IS Elecsys® 2010 - Host Interface

Answer from the Instrument: <ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|IS^BMÊ1^1|P|O||||19971210175024|||1<CR><ETX>A1<CR><LF> <ACK> <STX>3L|1|F<CR><ETX>FE<CR><LF> <ACK> <EOT>

Details of Records:


Instrument Status Record [M-IS Record] Pattern




3 record type sub-ID(IS)


IS^BMÊ1^1 IS^BMÊ1^1

4 instrument status char[1] B, O, S, H, R,P, M, I, A, T, E,

N, C, F,V, W, X, Y, Z, L

Q, G, J, K, D

*1)

5 alarm level of processing char[1] O, W, E, F, R,H, L, X, Z, S

Q, G

*2)

6 alarm level of inventory char[1] O, E [NONE]

7 alarm level of QC char[1] O, W, E [NONE]

8 alarm level of calibration char[1] O, W, E [NONE]

9 last result ready date andtime

d_t last result readydate and time

10 next STAT ready dateand time

d_t [NONE]

11 walk away data and time d_t [NONE]

12 operator identification Operator ID






Instrument Status Message - IS 63

Elecsys® 2010 - Host Interface Instrument Status Message - IS



3 record type sub-ID(IS)

(ISQ)


IS^BMÊ1^1

ISQ^BMÊ1^1 ISQ^BMÊ1^1

4 instrument status char[1] B, O, S, H, R,P, M, I, A, T, E,

N, C, FV, W, X, Y, Z,

L, Q, G, J, K, D

[NONE]

5 alarm level of processing char[1] O, W, E, F, R,H, L, X, Z, S

Q, G

[NONE]

6 alarm level of inventory char[1] O, E [NONE]

7 alarm level of QC char[1] O, W, E [NONE]

8 alarm level of calibration char[1] O, W, E [NONE]

9 last result ready date andtime

d_t [NONE]

10 next STAT ready dateand time

d_t [NONE]

11 walk away data and time d_t [NONE]

12 operator identification text [NONE]

*1 Instrument StatusInstrument Status Disk Rack

SamplerRack

ConveyerCLAS

Initialize I I I IStand By B B B BPreparation A A A AOperation O O O OS. STOP H - - -P. STOP T - - -STOP S S S SE. STOP E E E ET/M M M M MS. Scan (incl. Restart) N - - -R. Scan R R R RSLEEP P P P PC. Scan C C C CFinalization F F F FR.Stop - V V VL.Stop - W W WA.Stop - - X -A.Stop & R.Stop - Y Y YA.Stop & L.Stop - Z Z ZLine Only - - L -

64 Instrument Status Message - IS

Instrument Status Message - IS Elecsys® 2010 - Host Interface

*1 Instrument StatusA.Line Stop - - - QI.Line Stop - - - GA.Line Stop\R.Stop - - - JI.Line Stop\R.Stop - - - KFD Access D D D D

S.Stop:In case of Sample Stop occurs no more new sample will be pipetted.

P.Stop:Partial Stop occurs in case if any hard ware module does not work any more. Depending onthe importance of the module the run will be finished or stopped.

Stop:After the Stop key was pressed the actual time step will be performed before the systemstops in a defined status.

E.Stop:In case of a hardware crash the Emergency Stop stops the system in an undefined status.

L.Stop:The Line Stop occurs when the rack sampler or conveyer line does not work (A-line = inputbuffer; B-line = bar-code reader line; C-line = output buffer).

A.Stop:???

R.Stop:Rack Supply Stop occurs when there are no more racks to be fed.

S.Scan:During Sample Scan samples are registered into the data base.

R.Scan:During Reagent Scan reagents are registered into the data base.

C.Scan:During Calibrator Scan calibrator bar-code sheets are registered into the data base.

*2) alarm level of processingU/I Headline Disk RS RC CLASNo Alarm 0 0 0 0Alarm (Warning) W W W WAlarm (P.STOP) E - - -Alarm (STOP) F F F FAlarm (E.STOP) R R R RAlarm (S.Stop) H - - -Alarm (L.Stop) - L L LAlarm (A.Stop) - X X XAlarm (L.Stop & A.Stop) - Z Z ZAlarm (R.Stop) - S S SAlarm (A.Line Stop) - - - QAlarm (I.Line Stop) - - - G

Log File Message - LF 65

Elecsys® 2010 - Host Interface Log File Message - LF

10. Log File Message - LF



Purpose Host InstrumentQuery for Information of Log File(Answer information of Log File within time range that wasrequested from Host.)

L-1(M-1)

I-1(M-1)


Event: The instrument receives a Log File Message Query.à The instrument answers to the query.



0 H1 M-LF0 L

Details of Records:


Log File Record [M-LF Record] Pattern




3 record type sub-ID(LF)


LF^BM^E1^1 LF^BM^E1^1

4 file name text [NONE]

5 start date/time d_t start date/time

6 end date/time d_t end date/time

7 message category char[1] W, E, F, R, A,H, L, X, Z, S

Q, G

*1)

66 Log File Message - LF

Log File Message - LF Elecsys® 2010 - Host Interface



8 message(s) char[1]^d_tîntînt

^text{\...}

*2)






3 record type sub-ID(LF)

(LFQ)


LF^BMÊ1^1

LFQ^BMÊ1^1 LFQ^BMÊ1^1

4 file name text [NONE]

5 start date/time d_t start date/time

6 end date/time d_t end date/time

7 message category char[1] W, E, F, R, A,H, L, X, Z, S

Q, G

*1)

8 message(s) char[1]^d_tîntînt

^text{\...}

[NONE]

*1) Message categoryAlarm Level Disk RS RC CLASWarning W W W WP.STOP E - - -STOP F F F FE.STOP R R R RS.STOP H - - -L.STOP - L L LA.STOP - X X XL.STOP & A.STOP - Z Z ZR.STOP - S S SA.Line STOP - - - QI.Line STOP - - - GAll Level A A A A

Log File Message - LF 67

Elecsys® 2010 - Host Interface Log File Message - LF

*2) message categoryâlarm occurrence date and timeâlarm codeâlarm sub codeâlarm string{\...}

68 Test Conditions Message - TC

Test Conditions Message - TC Elecsys® 2010 - Host Interface

11. Test Conditions Message - TC



Purpose Host InstrumentUpload when press <close> button after editing data at a TestConditions Screen(Upload Information of Test Conditions)

I-1(M-1)

Event: Edit data of test condition on the test condition screen and update the database by pressing “Close” button.à The instrument uploads a Test Conditions Message for the test that is displayed onthe current screen.


Purpose Host InstrumentQuery for Information of Test Conditions(Answer Information of Test Conditions that were requestedfrom Host.)

L-1(M-1)

I-1(M-1)

Event: The instrument receives a Test Conditions Message Query.à The instrument answers to the query.The Host queries for Test Conditions information for one (or some) test.The instrument always answers with 1 message/1 test.

Host Download

Purpose Host InstrumentDownload Information of Test Conditions(Download only reference range lower/upper limit of eachTest Conditions Information. If an instrument has never seenthe Test Conditions information before, the downloadingbecomes invalid.)

L-2(M-1)


Event: The instrument receives a Test Conditions Messageà The instrument overwrites the information of the Test Conditions.The Host downloads a message of Test Conditions for one (or some) test.If the Test Conditions that were sent from the Host are data for a test that theinstrument does not know, then this data is not valid (will be ignored).



0 H1 M-TC0 L

Test Conditions Message - TC 69

Elecsys® 2010 - Host Interface Test Conditions Message - TC

Trace Example:

Host queries for Test Conditions: <ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|TCQ^BMÊ1^1||||||||||||<CR><ETX>C0<CR><LF> <ACK> <STX>3L|1|N<CR><ETX>06<CR><LF> <ACK> <EOT>

Instrument sends Test Conditions <ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|TC^BMÊ1^1|10|TSH|uIU/ml||1^1^2|0|0.270^4.20|

0||||y<CR><ETX>1C<CR><LF> <ACK> <STX>3M|2|TC^BMÊ1^1|20|T4|nmol/l||1^1^2|0|66.00^174.0|

0||||y<CR><ETX>27<CR><LF> <ACK> <STX>4M|3|TC^BMÊ1^1|30|FT4|pmol/l||1^1^2|0|13.00^23.00|

0||||y<CR><ETX>63<CR><LF> <ACK> <STX>5M|4|TC^BMÊ1^1|40|T-UP|TBI||1^1^2|0|0.800^1.30|

0||||y<CR><ETX>1D<CR><LF> <ACK> <STX>6M|5|TC^BMÊ1^1|60|FT3|pmol/l||1^1^2|0|4.00^7.80|

0||||y<CR><ETX>13<CR><LF> <ACK> <STX>7M|6|TC^BMÊ1^1|100|E2|pg/ml||1^1^2|0|10.10^3960|

0||||y<CR><ETX>A9<CR><LF> <ACK> <STX>0M|7|TC^BMÊ1^1|150|FSH|mIU/ml||1^1^2|0|0.110^198.0|

0||||y<CR><ETX>74<CR><LF> <ACK> <STX>1M|8|TC^BMÊ1^1|200|TNTSTAT|ng/ml||1^1^2|0|0.000^0.100|

0||||y<CR><ETX>7A<CR><LF> <ACK> <STX>2M|9|TC^BMÊ1^1|210|CKMBSTAT|ng/ml||1^1^2|0|0.000^4.00|

0||||y<CR><ETX>77<CR><LF> <ACK> <STX>3M|10|TC^BMÊ1^1|300|CEA|ng/ml||1^1^2|0|0.000^4.60|

0||||y<CR><ETX>16<CR><LF> <ACK> <STX>4M|11|TC^BMÊ1^1|310|AFP|IU/ml||1^1^2|0|0.000^6.40|

0||||y<CR><ETX>F0<CR><LF> <ACK> <STX>5M|12|TC^BMÊ1^1|340|CA125|U/ml||1^1^2|0|0.000^35.00|

0||||y<CR><ETX>1F<CR><LF> <ACK> <STX>6M|13|TC^BMÊ1^1|400|HBSAG|COI||1^1^2|0|^|

0||||<CR><ETX>88<CR><LF> <ACK> <STX>7M|14|TC^BMÊ1^1|410|A-HBS|IU/l||1^1^2|0|2.00^10.00|

0||||y<CR><ETX>F7<CR><LF> <ACK> <STX>0M|15|TC^BMÊ1^1|450|A-HBC|COI||1^1^2|0|^|

0||||<CR><ETX>5F<CR><LF> <ACK> <STX>1M|16|TC^BMÊ1^1|600|B12|pg/ml||1^1^2|0|0.270^4.20|

0||||y<CR><ETX>00<CR><LF>



<ACK> <STX>2M|17|TC^BMÊ1^1|670|CROSSL|ng/ml||1^1^2|0|0.270^4.20|

0||||y<CR><ETX>38<CR><LF> <ACK> <STX>3L|1|F<CR><ETX>FE<CR><LF> <ACK> <EOT>

Details of Records:


Test Condition Record [M-TC Record] Pattern




3 record type sub-ID(TC)


TC^BMÊ1^1 TC^BMÊ1^1


5 test code text Test Code

6 unit name unit unit name

7 conversion factor text conversionfactor

8 replication number forsamples / controls /calibrators

intîntînt

1^1^2

9 auto-dilution factor int auto-dilutionfactor

10 reference range lower /upper limit

intînt

lower limitûpper limit *3)

11 test specific inventorythresholds

text{\...}

test specificinventory

thresholds

12 automatic rerun char[1] A, X [NONE]

13 rerun dilution factor int [NONE]

14 batch calibration char[1] y, n [NONE]

15 range check char[1] y, n *2)


Test Condition Record [M-TC Record] Pattern Pattern




Test Conditions Message - TC 71

Elecsys® 2010 - Host Interface Test Conditions Message - TC

Test Condition Record [M-TC Record] Pattern Pattern


3 record type sub-ID(TC)

(TCQ)

text^text^text^text

TC^BMÊ1^1

TCQ^BMÊ1^1 TCQ^BMÊ1^1

TC^BMÊ1^1

4 test number text Test No. *1) Test No. *1)

5 test code text [NONE] [NONE]

6 unit name unit [NONE] [NONE]

7 conversion factor text [NONE] [NONE]

8 replication number forsamples / controls /calibrators

intîntînt

[NONE] [NONE]

9 auto-dilution factor int [NONE] [NONE]

10 reference range lower /upper limit

intînt

[NONE] lower limitûpper limit

*4) *5)

11 test specific inventorythresholds

text{\...}

[NONE] [NONE]

12 automatic rerun char[1] A, X [NONE] [NONE]

13 rerun dilution factor int [NONE] [NONE]

14 batch calibration char[1] y, n [NONE] [NONE]

15 range check char[1] y, n [NONE] *2)

*1) If there is no data (NONE) in this field, an instrument sends alltest condition records to Host.

*2) y : Normal Range Check Function is available.n : Normal Range Check Function is not available.

*3) reference range lower/upper limitreference range is set as follows.

Tests Normal Range Check reference range

Quantitative Tests Not Available [NONE]

Available lower limitûpper limit

Qualitative Tests Not Available [NONE]

Available [NONE]



*4) reference range lower/upper limitInstrument treats this reference range as follows. (Available orNOT Available)

Tests Normal Range Check reference range

Quantitative Tests Not Available Available

Available Available

Qualitative Tests Not Available Not Available

Available Not Available

*5) reference range lower/upper limitmust be „lower limit < upper limit“

Test Application Message - TA 73

Elecsys® 2010 - Host Interface Test Application Message - TA

12. Test Application Message - TA



Purpose Host InstrumentUpload after executing C. Scan(Upload MBCC Information (586digits).)

I-1(M-1)

Upload after executing R. Scan(Upload MBC Information (586digits).)

I-1(M-2)

I-*: refer to „Details of Records“M-*: refer to „Construction of Message“

Event: a) Reagent Rotor scanà The instrument uploads MBC information (586 digits) of the rack packs on thereagent rotor.The instrument uploads 1message/18 positions.

b) Calibrator/control bar-code card scan.à The instrument uploads MBCC information (586 digits) of this bar-code card.The instrument uploads 1 message/1 calibrator (or control) bar-code card.


0 H1 M-TA0 L


0 H1 M-TA

: :

0 L

Trace Example:

Instrument updates after Reagent Scan (18 positions): <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|TA^BM^E1^1|MBC^<CR><ETX>49<CR><LF> <ACK> <STX>3M|2|TA^BM^E1^1|MBC^00000730205414080734234082728689704

010242070881124257269955222784000856322317776692976084451884107236094338414945841240361996008673689794278600039392085856219117763315723249227720861959956379520410800716598208614910419697<ETB>6C<CR><LF>

<ACK> <STX>4281244402755585073992234858530726385149212575697955326

8125520102420708811242572699552227840008563223177766929760844

74 Test Application Message - TA

Test Application Message - TA Elecsys® 2010 - Host Interface

51884107236094338414945841240361996008673689794278600039392085856219117763315723249227720861959956379520410800716598208614910<ETB>6B<CR><LF>

<ACK> <STX>5419697281244402755585073992234858530726385149138788721

66048859935212345678901234567890123456789012345678901234567890123451438<CR><ETX>F6<CR><LF>

<ACK> .. .. <ACK> <STX>2M|17|TA^BMÊ1^1|MBC^<CR><ETX>80<CR><LF> <ACK> <STX>3M|18|TA^BMÊ1^1|MBC^0003337441710178000026414732728591

045325267028048148156811648469334886272364100044644335119969615949687503268926064220048276755682909531999213857776265762209519421793614664344749070091307666161922310535701565974500756030<ETB>65<CR><LF>

<ACK> <STX>4696229226883953448239873669669769270523386774728906135

693527228421717197678901234567890123456789012345678901234567890123456789012345678901234567890123456789012345678901234567890123456789012345678901234567890123456789012345678901234567890123<ETB>B1<CR><LF>

<ACK> <STX>5456789012345678901234567890123456789012345678901234567

890123456789012345678901234567890123456789012345678901234567890123455924<CR><ETX>1E<CR><LF>

<ACK> <STX>6L|1<CR><ETX>3F<CR><LF> <ACK> <EOT>

Details of Records:


Test Application Record [M-TA Record] Pattern




3 record type sub-ID(TA)


TA^BMÊ1^1 TA^BMÊ1^1

4 application data char[3]^text

MBC^MBC data *2)

*2) 586 digits

Instrument Configuration Message - IC 75

Elecsys® 2010 - Host Interface Instrument Configuration Message - IC

13. Instrument Configuration Message - IC



Purpose Host InstrumentQuery for Information of Instrument Configuration(Answer Information of Instrument Configurations that wererequested from Host.)

L-1(M-1)

I-1(M-1)

Event: The instrument receives an Instrument Configuration Message Query.à The instrument answers to the query.

Host Download

Purpose Host InstrumentDownload Information of Instrument Configuration (printingoption, uploading option, sending additional data)(Download only printing option, uploading option, and sendingadditional data and system clock.)

L-2(M-1)

Event: The instrument receives an Instrument Configuration Message.à The instrument overwrites the information of the instrument configuration.


Purpose Host InstrumentUpload Information of Instrument Configuration when they arechanged (printing option, uploading option, system clock)(Upload Information of Instrument Configurations.)

I-1(M-1)


Event: Change of instrument configurationà The instrument uploads data of the instrument configuration.



0 H1 M-IC0 L

Trace Example

Host queries for Instrument Configuration: <ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|ICQ^BM^E1^1|||||||||||||||<CR><ETX>29<CR><LF> <ACK>

76 Instrument Configuration Message - IC

Instrument Configuration Message - IC Elecsys® 2010 - Host Interface

<STX>3L|1|N<CR><ETX>06<CR><LF> <ACK> <EOT>

Instrument sends Instrument Configuration:

<ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|IC^BMÊ1^1||S|S|B||Âll^^^|122755|070110^19971209^03 -

04^185||^MMDDYYYY^24|^^11||||<CR><ETX>08<CR><LF> <ACK> <STX>3L|1|F<CR><ETX>FE<CR><LF> <ACK> <EOT>

<ENQ> <ACK> <STX>1H|\^&||||||||||P||<CR><ETX>05<CR><LF> <ACK> <STX>2M|1|IC^BMÊ1^1|||||ELEC2|Âll^SD^^|112415||||||||<CR>

<ETX>79<CR><LF> <ACK> <STX>3L|1|N<CR><ETX>06<CR><LF> <ACK> <EOT>

Details of Records:


Instrument Configuration Record [M-IC Record] Pattern




3 record type sub-ID(IC)


IC^BMÊ1^1 IC^BMÊ1^1

4 predilution factor int [NONE]

5 printing option char[1] S, M *1)

6 uploading option char[1] S, M *1)

7 documentation request char[1] P, U, B *3)

8 user defined instrumentname

text InstrumentName

9 sending additional data text^text^text

No^^^^,Âll^^^,

Âll^SD^^,Âll^^RC^,Âll^^^RR,

Âll^SD^RC^,Âll^SD^^RR,

Âll^SD^RC^RR,Âll^^RC^RR

*2)



Instrument Configuration Record [M-IC Record] Pattern


10 system clock t system clock

11 instrument information text^d

^text^text

serial no.înstall date

^version^test count

12 keep function text 0, 1 [NONE]

13 language information text^text^text

^date format *4)

14 printer setup char[1]^text^text

^^

external printerpaper size in

inches

15 secondary cup type text HC, MC, PT [NONE]

16 number of secondaryadapters

int [NONE]

17 bar-code readerconfiguration

char[1]^char[1]^char[1]^char[1]

înt^char[1]

{\...}

[NONE]

18 other configuration data text{^...}

[NONE]


Instrument Configuration Record [M-IC Record] Pattern Pattern




3 record type sub-ID(IC)

(ICQ)


IC^BMÊ1^1

ICQ^BMÊ1^1 ICQ^BMÊ1^1

IC^BMÊ1^1

4 predilution factor int [NONE] [NONE]

5 printing option char[1] S, M [NONE] *1)

6 uploading option char[1] S, M [NONE] *1)

7 documentation request char[1] P, U, B [NONE] *3)

8 user defined instrumentname

text [NONE] InstrumentName

9 sending additional data text^text

No^^^^,Âll^^^,

[NONE] *2)

78 Instrument Configuration Message - IC

Instrument Configuration Message - IC Elecsys® 2010 - Host Interface

Instrument Configuration Record [M-IC Record] Pattern Pattern

Field Data Type Content L-1 L-2^text Âll^SD^^,

Âll^^RC^,Âll^^^RR,

Âll^SD^RC^,Âll^SD^^RR,

Âll^SD^RC^RR,Âll^^RC^RR

10 system clock t [NONE] system clock

11 instrument information text^d

^text^text

[NONE] [NONE]

12 keep function text 0, 1 [NONE] [NONE]

13 language information text^text^text

[NONE] [NONE]

14 printer setup char[1]^textînt

[NONE] [NONE]

15 secondary cup type text HC, MC, PT [NONE] [NONE]

16 number of secondaryadapters

int [NONE] [NONE]

17 bar-code readerconfiguration

char[1]^char[1]^char[1]^char[1]

înt^char[1]

{\...}

[NONE] [NONE]

18 other configuration data text{^...}

[NONE] [NONE]

*1) only the two options below are availableprinting option = ‘S’ & uploading option = ‘S’printing option = ‘M’ & uploading option = ‘M’

Sampling order .......SManual.....................M



*2) sending additional dataPossible contents:

No^^^^,Âll^^^,Âll^SD^^,Âll^^RC^,Âll^^^RR,Âll^SD^RC^,Âll^SD^^RR,Âll^SD^RC^RR,Âll^^RC^RR

E.g., No^^^^ means send no MSR’s at all;Âll^SD^^RR means send all MSR’sbut SD record and RR record.

[NOTES]

When Host queries information with a MSR, the instrument sends MSRmessage for answer, regardless of this setting.

*3) documentation requestPrintout ...................PUpload ....................UBoth ........................B

*4) Date formatDDMMYYYY orMMDDYYYY orYYYMMDD

80 Service Data Message - SD

Service Data Message - SD Elecsys® 2010 - Host Interface

14. Service Data Message - SD



Purpose Host InstrumentUpload when an instrument detects Clot Detection(Upload pressure sensor values.)

I-1(M-1)

Upload when ADC module works(Upload ADC Raw Data.)

I-2(M-1)

Event: The instrument receives a Service Data Message Query.à The instrument answers to the query.


Purpose Host InstrumentQuery for information of Service Data(Answer information of Service Data that was requested fromHost.)

L-1(M-1)

I-3(M-1)


Event: a) Clot detection in operationà The instrument uploads pressure sensor values.

b) ADC module works in operationà The instrument uploads the ADC raw data.



0 H1 M-SD0 L

Trace Example:

Instrument send Service Data: <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|SD^BM^E1^1||19970409^^10119||Calibrator\165\30\

R1\119^123^142^159^162^158^155^155^156^155^150^145^141^139^137^134^131^129^127^126^124^123^122^121^120^119^118^118^118^118^118^118^119^119^119^119^118^102^88^88^91^90^84^80^79^80^78^77^76^7<ETB>86<CR><LF>

<ACK> <STX>36^75^75^75^75^75^76^76^76^76^77^77^79^79^79^80^81^81

^82^82^83^83^86^90^92^91^90^90^90^90^90^89^89^88^88^87^84^80^77^78^80^80^79^78^78^79^79^78^78^78^78^78^78^78^78^78^78^78^7

Service Data Message - SD 81

Elecsys® 2010 - Host Interface Service Data Message - SD

8^78^78^78^78^78^78^73^68^61^59^59^65^255^255^255^255^255^255^255^<ETB>35<CR><LF>

<ACK> <STX>4255|ClotDetection|<CR><ETX>09<CR><LF> <ACK> <STX>5L|1<CR><ETX>3E<CR><LF> <ACK> <EOT>

<ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|SD^BM^E1^1||19970409^^10119||Calibrator\165\30\

Sample\62^67^84^96^96^92^93^97^94^73^59^60^62^58^51^47^47^47^45^44^43^43^44^44^44^45^46^47^48^49^50^52^53^54^55^56^57^59^60^61^62^63^64^65^66^67^68^69^70^71^71^72^73^74^74^75^76^76^77^77^78<ETB>32<CR><LF>

<ACK> <STX>3^79^79^79^80^80^81^81^82^82^82^85^88^90^90^88^88^88^88

^87^87^86^85^84^83^82^81^81^80^79^78^77^77^76^75^72^68^65^66^68^67^66^66^66^66^66^66^66^65^66^65^65^66^65^68^70^72^70^66^65^255^255^255^255^255^255^255^255|ClotDetection|<CR><ETX>CA<CR><LF>

<ACK> <STX>4L|1<CR><ETX>3D<CR><LF> <ACK> <EOT>

<ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|SD^BM^E1^1||19970409^^10136||ABLevelCheck

^13874\13216\13330\13198\13477\13489\13397\13340\12850\13044\13900\13657\13112\13096\13342\13117\13547\13373\13052\13283\13361\13452\13642\13846\13536\13004\13103\13410\12896\13427\13014\12747\13<ETB>90<CR><LF>

<ACK> <STX>3077\13132\13810\13370\12833\13306\13462\14055\13522\

13696\13337\13187\13752\13710\13873\13349\13300\12898\13026\12903\13050\13221\12766\13550\13289\13350\13104\13380\13230\13710\13455\13220\13456\13090\12989\13167\14146\13911\13733\13509\13<ETB>A0<CR><LF>

<ACK> <STX>4619\12977\12868\13001\13390\13478\13448\13057\13432\

14641\16415\17284\17317\17861\17667\17546\17782\17874\18048\18406\18186\18509\18104\17859\18156\18099\18454\18838\18377\18915\18419\18539\18268\18281\17801\18205\18456\18332\18396\18459\18<ETB>90<CR><LF>

<ACK> <STX>5458\18435\18481\18481\18284\18477\18127\18303\18382\

18477\18298\17933\17959\18205\18087\18108\17851\18074\17893\17866\17966\17888\17871\18377\17986\18562\18445\18485\18543\18542\18212\18224\17834\17829\18090\18158\18004\17924\17873\17944\17<ETB>C7<CR><LF>

<ACK> <STX>6418\17616\17704\18022\17713\17793\17757\17821\17830\

18144\17823\17912\17866\17890\17997\17888\17601\17297\17514\18263\17525\17514\17236\17821\17896\18001\17691\18097\18398\18421\17848\18088\18243\17849\18216\17606\17701\18284\18186\18424\18<ETB>96<CR><LF>

<ACK> <STX>7078\17751\18581\18231\18079\18148\17791\18174|ADCRawData|

<CR><ETX>F6<CR><LF>

82 Service Data Message - SD

Service Data Message - SD Elecsys® 2010 - Host Interface

<ACK> <STX>0L|1|F<CR><ETX>FB<CR><LF> <ACK> <EOT>

Details of Records:


Service Data Record [M-SD Record] Pattern Pattern Pattern


1 record type ID (M) char[1] M M M M


3 record type sub-ID(SD)

text^text^text^text

SD^BMÊ1^1 SD^BMÊ1^1 SD^BMÊ1^1 SD^BMÊ1^1

4 maintenanceschedule service data

textînt

^long{\^...}


5 operation log d^long^long

install date^

ôperationtime

install date^

ôperationtime

install date^

ôperationtime

6 trace text{\...}

S,R,M [NONE] [NONE] [NONE]

7 service data text{\...}

*1) *2) [NONE]

8 kind of service data text Clot Detection ADC RawData

[NONE]

9 left space fordetermination in aninstrument’s database

int [NONE] [NONE] left space fordeterminationin aninstrument’sdata base

*1) Sample Type \ Seq No \ Test No \ Pipetting Pos \Pressure Sensor Value ^Pressure Sensor Value ^...Sample Type: Sample

ControlCalibratorBlank Set

Pipetting Pos: R1R2DiluentSampleBeadsPSRMDL1DL2

Service Data Message - SD 83

Elecsys® 2010 - Host Interface Service Data Message - SD

*2) Action Pattern ^Raw Data \ Raw Data...Action Pattern: AB Level Check

Measuring CellSystem VolumeCalibratorBlank Set

Service Data Record [M-SD Record] Pattern




3 record type sub-ID(SDQ)

text^text^text^text

SDQ^BMÊ1^1 SDQ^BMÊ1^1

4 maintenance scheduleservice data

textînt

^long{\^...}

[NONE]

5 operation log d^long^long

[NONE]

6 trace text{\...}

S,R,M [NONE]

7 service data text{\...}

[NONE]

8 kind of service data text [NONE]

9 left space fordetermination in aninstrument’s data base

int [NONE]

84 Processing Message - PM

Processing Message - PM Elecsys® 2010 - Host Interface

15. Processing Message - PM



Purpose Host InstrumentUpload after generating alarm message(Upload Information of alarms that were generated.)

I-1(M-1)

I-*: refer to "Details of Records"M-*: refer to "Construction of Message"

Event: An alarm or some alarms are generated in the instrument.à The instrument uploads one ore more Processing Messages.The instrument uploads 1 message/1 alarm.



0 H1 M-PM0 L

Trace Example:

Instrument sends Alarm Message: <ENQ> <ACK> <STX>1H|\^&<CR><ETX>E5<CR><LF> <ACK> <STX>2M|1|PM^BM^E1^1|19970525132822|858^0|

Communication Message Format Error : 44-01-08|W<CR><ETX>EA<CR><LF>

<ACK> <STX>3L|1<CR><ETX>3C<CR><LF> <ACK> <EOT>

Details of Records:


Processing Messages Record [M-PM Record] Pattern




Processing Message - PM 85

Elecsys® 2010 - Host Interface Processing Message - PM

Processing Messages Record [M-PM Record] Pattern


3 record type sub-ID(PM)


PM^BMÊ1^1 PM^BMÊ1^1

4 occurrence date and time d_t occurrencedate & time

5 message code intînt

alarm codeâlarm sub

code

6 message name text alarm namelanguage

dependand

7 message category char[1] W, E, F, R, H,L, X, Z, S

Q, G

*1

*1) Alarm Level Disk RS RC CLASWarning W W W WP. STOP E - - -STOP F F F FE. STOP R R R RS. STOP H - - -L. STOP - L L LA. STOP - X X XL. STOP & A. STOP - Z Z ZR. STOP - S S SA.Line STOP - - - QI.Line STOP - - - G

86 Action Request / Action Confirmation Message - AR/AC

Action Request / Action Confirmation Message - AR/ACElecsys® 2010 - Host Interface

16. Action Request / Action Confirmation Message - AR/AC


Host Request — Instrument Confirmation

Purpose Host InstrumentRequest START/STOPUpload confirmation record response to an action request thatwas requested by Host.

L-1(M-1)

I-1(M-2)

L-*, I-* : refer to "Details of Records"M-* : refer to "Construction of Message"

Event: The instrument receives an Action Request Message (Start/Stop)à The instrument uploads Confirmation Message in response to the Action Requestmessage.



0 H1 M-AR0 L


0 H1 M-AC0 L

Details of Records:


Action Request Record [M-AR Record] Pattern




3 record type sub-ID (AR) char[2]^text^text^text

AR^BM^E1^1 AR^BM^E1^1

Action Request / Action Confirmation Message - AR/AC 87

Elecsys® 2010 - Host InterfaceAction Request / Action Confirmation Message - AR/AC

Action Request Record [M-AR Record] Pattern


4 command text STOPSTART

STOP orSTART

5 time out int [NONE]

6 additional parameters int{înt...}

*2)

Instrument Sending Record Pattern:

Action Confirmation Record [M-AC Record] Pattern




3 record type sub-ID (AC) char[2]^text^text^text

AC^BMÊ1^1 AC^BMÊ1^1

4 command text STOPSTART

STOP orSTART

5 processing status char[1] O, A *1)

6 additional action result text [NONE]

*1) O: action processedA: not allowed in current system state

*2) command additional parametersSTART Rotor No.

88 Header - H

Header - H Elecsys® 2010 - Host Interface

17. Header - H

Details of Records:


Message Header Record [H Record] Pattern

Field Data Type Content I-1/L-1

1 record type ID (H) char[1] H H

2 delimiter definition char[4] |\^& |\^&

3 message control ID text [NONE]

4 access password text [NONE]

5 sender name or ID text{^...}

*1)

6 sender street address text [NONE]


8 sender telephonenumber

text [NONE]

9 characteristics of sender text [NONE]

10 receiver ID text *2)

11 comment of specialinstructions

text [NONE]

12 processing ID char[1] P, D *3)

13 version No. int 1 [NONE]

14 date and time ofmessage

d_t [NONE]

*1) text1^BM^E1^text2text1: Host defined instrument nametext2: Version # of the software

*2) text3text3: Host name

*3) processing IDP: ProductionD: Debugging

Termination - L 89

Elecsys® 2010 - Host Interface Termination - L

18. Termination - L

Details of Records:

Instrument / Host Sending Record Pattern

Message Terminator Record [H Record] Pattern

Field Data Type Content I-1/L-1

1 record type ID (L) char[1] L L

2 sequence number pos_int 1 1

3 termination code char[1] I,F,E,Q *1)

*1) null: for normal end of messageI: normal end of an empty message(no data found) sent in

response to a remote query messageF: normal end of message sent in response to a remote

query messageE: unknown system errorQ: for the response to an invalid remote query

90 Receive Acceptance Status

Receive Acceptance Status Elecsys® 2010 - Host Interface

19. Receive Acceptance StatusWhen does Elecsys accept messages from host? (Disk Type)

Instrument StatusM

essa

ges

from

Hos

t

Initi

aliz

e

Sta

ndB

y

Pre

Ope

ratio

n

Ope

ratio

n

S.S

top-

S.S

can

Sam

ple

Sto

p

Par

tial S

top

Fina

lizat

ion

Sto

p

Em

erge

ncy

Sto

p

Sle

ep

Sam

ple

Sca

n

Rea

gent

Sca

n

Car

d S

can

T/M

Test Order ü ü ü ü ü ü ü ü ü ü ü üSubstance Data ü üCalibrator Parameters ü üControl Parameters ü üTest Conditions ü üInstrument Configuration ü üAction Request(START) ü üAction Request(STOP) ü ü ü ü ü ü ü ü ü

When does Elecsys accept messages from host? (Rack Type)

Instrument Status

Mes

sage

s fro

m H

ost

Initi

aliz

e

Sta

ndB

y

Pre

Ope

ratio

n

Ope

ratio

n

Fina

lizat

ion

Sto

p

Em

erge

ncy

Sto

p

Sle

ep

Rea

gent

Sca

n

Car

d S

can

T/M

Rac

k S

uppl

y S

top

Line

Sto

p

Ana

lyze

r Sto

p

A.S

top&

R.S

top

A.S

top&

L.S

top

Line

Onl

y

Test Order ü ü ü ü ü ü ü ü ü ü ü ü ü üSubstance Data ü ü üCalibrator Parameters ü ü üControl Parameters ü ü üTest Conditions ü ü üInstrument Configuration ü ü üAction Request(START) üAction Request(STOP) ü ü ü ü ü ü ü ü ü ü ü

Data Alarm List 91

Elecsys® 2010 - Host Interface Data Alarm List

20. Data Alarm List

Data Alarm Flag Level Result SystemBlock

Explanation

0 Yes No No flag is attached to theresult

Power failure-operation stopped 1 1 No Yes Determination has beencanceled due to power fail orpower off.

E. Stop-operation stopped 2 2 No Yes Determination has beencanceled due toEMERGENCY STOP.

Stop-operation stopped 3 3 No Yes Determination has beencanceled due to STOP.

P. Stop-operation stopped 4 4 No Yes Determination has beencanceled due to PARTIALSTOP.

S. Stop-operation stopped 5 4 No Yes Determination has beencanceled due to SAMPLESTOP.

Error handling-operation stopped 6 5 No Yes Determination has beencanceled due to recoveryprocess.

Sample Short 7 6 No Yes The volume of sample isinsufficient.

Assay Reagent Short 8 6 No Yes The volume of assay reagentis insufficient.

Diluent Short 9 6 No Yes The volume of diluent isinsufficient.

Pretreatment Reagent Short 10 6 No Yes The volume of pretreatmentreagent is insufficient.

Diluted Sample Short 11 6 No Yes The volume of diluted sampleis insufficient.

Reagent disk temperature out ofrange

12 7 Yes No Reagent disk temperature isout of range.

Incubator temperature out ofrange

13 7 Yes No Incubator temperature is outof range.

Measuring cell temperature out ofrange

14 7 Yes No Measuring Cell temperature isout of range.

PC/CC temperature out of range 15 7 Yes No PC/CC temperature is out ofrange.

PC/CC short 16 7 Yes No The volume of PC/CC isinsufficient.

ADC data abnormal 17 7 No Yes ADC data abnormal.Peak out of range 18 6 No Yes The ratio of the maximum

signal to the minimum signalis out of range.

Blank ratio out of range 19 6 No Yes The ratio of the maximumblank signal to the minimumblank signal is out of range.

Signal peak position out of range 20 6 No Yes The position of the maximumsignal is out of range.

92 Data Alarm List

Data Alarm List Elecsys® 2010 - Host Interface


Explanation

Signal peak width out of range 21 6 No Yes Peak width is out of range.Signal out of range 22 6 No Yes Signal is out of range.Concentration out of expectedvalue range

23 6 --- --- Concentration is out of range.

Calculation Error 24 6 No Yes Internal calculation Error hasoccurred

No Calibration Data 25 6 No Yes During calibration is in processand no calibration data isavailable, this flag is attachedto all data.

Previous calibration used 26 8 Yes No Previous calibration data isused for this result calculation.

System blocked 27 --- --- The result is blocked by thesystem.

User blocked 28 --- --- The result is blocked by theuser.

User released 29 --- --- The result is released by theuser.

Premature LLD signal-SampleDisk

30 6 No Yes Hovering is detected atsample pipetting

Premature LLD signal-ReagentDisk (Assay reagent)

31 6 No Yes Hovering is detected at assayreagent pipetting

Premature LLD signal-ReagentDisk (Diluent reagent)

32 6 No Yes Hovering is detected at diluentpipetting

Premature LLD signal-ReagentDisk (Pretreatment reagent)

33 6 No Yes Hovering is detected atpretreatment pipetting

<reserve> 34 --- ---Assay reagent bubble detected 35 6 No Yes Film is detected at assay

reagent pipettingDiluent bubble detected 36 6 No Yes Film is detected at diluent

pipettingPretreatment bubble detected 37 6 No Yes Film is detected at

pretreatment pipetting<reserve> 38 --- ---<reserve> 39 --- ---PC level out of range 40 6 Yes No AB level is out of rangePC level check failed 41 6 Yes No AB level check failedMeasuring cell current out ofrange

42 6 Yes No Current is out of range

Measuring cell current checkfailed

43 6 Yes No Current check failed

PC/CC temperature unstable 44 6 Yes No AB/CC temperature isunstable

Abnormal aspiration 45 6 No Yes Clot is detected at samplepipetting

Potential carry over 46 6 Yes No Signal is lower than acalculated limit respective tothe prior measurement (carryover is possible)

Bar code sample ID error 47 6 No Yes During sample scan beforepipetting the sample ID couldnot be recognized

Data Alarm List 93

Elecsys® 2010 - Host Interface Data Alarm List


Explanation

Below expected value range 48 6 Yes No Below normal (expected)range

Above expected value range 49 6 Yes No Above normal (expected)range

Below measuring range 50 6 Yes No Below measuring rangeAbove measuring range 51 6 Yes No Above measuring rangeExpired Rack Pack 52 8 Yes No Expired Rack Pack

94 Index

Index Elecsys® 2010 - Host Interface

21. Index

Action Confirmation Record [M-AC Record] .......................................................................................................87Action Request Record [M-AR Record]................................................................................................................86

Calibration Result [M-CR Record] ........................................................................................................................55Calibrator Parameters Record [M-CP Record] ................................................................................................46, 47Comment Record [C Record] ................................................................................................................................25Control Parameters Record [M-QP Record] ....................................................................................................51, 52

Diluent Parameters Record [M-DP Record] ..........................................................................................................40

Instrument Configuration Record [M-IC Record]............................................................................................76, 77Instrument Status Record [M-IS Record]...............................................................................................................62

Log File Record [M-LF Record]......................................................................................................................65, 66

Patient Information Record [P Record] .......................................................................................................7, 10, 21Processing Messages Record [M-PM Record] ......................................................................................................84

Raw Result Record [M-RR Record] ......................................................................................................................25Request Information Record [Q Record] .....................................................................................................6, 10, 26Result Context Record [M-RC Record] .................................................................................................................26Result Record [R Record]......................................................................................................................................24

Sample Status Record [M-SS Record].............................................................................................................58, 59Service Data Record [M-SD Record] ..............................................................................................................82, 83Substance Data Record [M-TC Record] ................................................................................................................70Substance Data Record [M-XT Record]..................................................................................38, 40, 45, 46, 50, 51

Test Application Record [M-TA Record]..............................................................................................................74Test Order Record [O Record].....................................................................................................................8, 12, 23

implementation-reference astm records v3-x

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