0932209B

ASTM V3 Protocol
DIAGNOSTICA STAGO S.A.S.
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ASTM V3 Protocol

Table of contents
1 Introduction.................................................................................................. 5
1.1 Physical characteristics ............................................................................................5
1.2 Standards ................................................................................................................6
1.3 Terminology .............................................................................................................6
1.3.1 Global definitions .....................................................................................................6
1.3.2 Character definition ..................................................................................................7
2 Exchange protocol ...................................................................................... 8
2.1 Definition of Line Modes on the analyzer .................................................................8
2.2 Definition of Communication phases ........................................................................8
2.3 Host computer to analyzer .......................................................................................8
2.4 Analyzer to Host computer exchanges .....................................................................9
2.4.1 Setting up Phase .....................................................................................................9
2.4.2 Transfer phase (analyzer to host computer) .............................................................9
2.4.3 Termination Phase (Analyzer to Host Computer) ...................................................10
2.4.4 Example of exchanges...........................................................................................10
3 Record Definitions......................................................................................11
3.1 Message Header Record (H) .................................................................................11
3.2 Patient Information Record (P) ...............................................................................12
3.3 Test Order Record (O) ...........................................................................................13
3.4 Result Record (R) ..................................................................................................14
3.5 Manufacturer Information Record (M) .....................................................................16
3.6 Request Information Record (Q) ............................................................................19
3.7 Message Terminator Record (L) ............................................................................20
3.8 Comment and Alarms Record (C) ..........................................................................20
3.9 Units table..............................................................................................................22
4 Typical Contents of Some Messages .......................................................23
4.1 Result Transmission (Analyzer to Host) .................................................................23
4.2 Request for a Working List .....................................................................................23
4.3 Working List Return ...............................................................................................23
5 Flowcharts (ASTM) .....................................................................................24
5.1 Sequencing of Reception/Transmission .................................................................24
5.2 Acquisition of a Record from the Host Computer ...................................................25
5.3 Establishment Phase (Analyzer to Host Computer) ...............................................26
5.4 Transfer Phase (Analyzer to Host Computer) ........................................................27
5.5 Termination Phase (Analyzer to Host Computer) ...................................................28
6 Not contractual examples of traces (ASTM V3) .......................................29
6.1 Transmission of Patient File (Analyzer to Host Computer) .....................................29
6.2 Request for Working List (Analyzer to Host Computer) ..........................................30
6.3 Working List Return (Host Computer to Analyzer) ..................................................30
6.4 Transmission of a Quality Control Result (Analyzer to Host Computer)..................31
6.5 On-Line Test ..........................................................................................................31

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 ASTM V3 Protocol

Revision table

Reference Date Description

0932209 03/2015 Version not released

0932209A 08/2015 First release

0932209B 09/2016 Addition of semi-analyzer STart Max

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1 Introduction
This manual describes the communication between the analyzer and the host, using RS232-C interface,
it is applicable for STA Compact Max®, STA R Max® and STart Max.

1.1 Physical characteristics

Interface Series type, RS232C standard

Connections - DB-9: male plug on the analyzer

- Pin 2: reception input
- Pin 3: transmission output
- Pin 5: ground
Connection to SIL: type nil simple

Exchange protocol No hardware control line is connected

STA Compact Max®

Baud rate1 110, 300, 600, 1200, 2400, 4800, 9600 (default value),
14400, 19200, 38400, 56000, 57600 or 115200 bauds
STA R Max®
300, 600, 1200, 2400, 4800, 9600 (default value) bauds

STart Max
1200, 2400, 4800, 9600 (default value), 19200, 54000, 115200 bauds

Parity1 STA Compact Max®

Even, odd, mark, space or none (default value)
STA R Max®
Even, odd or none (default value)
STart Max
Even, odd or none (default value)

Data bit1 STA Compact Max®

5, 6, 7 or 8 (default value)

STA R Max®
7 or 8 (default value)

STart Max
8 (default value) or 9

Stop bit1 STA Compact Max®

1 (default value), 1.5 or 2

STA R Max®
1 (default value) or 2

STart Max
0,1 (default value) or 2

1: These parameters have to be specified in the menu of the analyzer

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1.2 Standards
The ASTM V3 connection protocol is based on the 2 following standards:
- LIS01-A2 : Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory
Instruments and Computer Systems; Approved Standard - Second Edition,
- LIS2-A2 : Specification for Transferring Information Between Clinical Laboratory
Instruments and Information Systems; Approved Standard - Second Edition.

1.3 Terminology
1.3.1 Global definitions
Definition Description
The device that has a message to send and that initiates transmission
Sender
process.
Upload (U) In this document, data transmitted from the analyzer to the host computer
Receiver The device that receives the message transmitted by the sender.
Download (D) In this document, data transmitted from the host computer to the analyzer.
Frame Framing required to data transmission. 2 kinds:
 [STX] [Frame number] [DATA] [ETB] [C1] [C2] [CR] [LF].
 [STX] [Frame number] [DATA] [ETX] [C1] [C2] [CR] [LF].
Frame number allows the receiver to distinguish between new and
Frame number
retransmitted frames.
(Fn)
ASCII digit ranging from 0 to 7. The frame number begins at 1with the
first frame of transfer phase. It is incremented by one for every new
frame transmitted. After 7, the frame number rolls over to 0, and continue
in this fashion.
Message A group of records that begins with a Header record, and ends with
a Terminator record.

If the message is composed of more than 240 characters, the message

must be divided into several messages where the size of each message
is 240 characters max. [ETB] must be used to define each message
block.

For example: a message (Msg) of 489 characters will be composed like

that:

Msg : Data1+Data2+Data3

where

Data1 is composed of characters 1 to 240

Data2 is composed of characters 241 to 480

Data3 is composed of characters 481 to 489

Messages to send:

[STX] [Frame number] [DATA1] [ETB] [C1] [C2] [CR] [LF]

[STX] [Frame number] [DATA2] [ETB] [C1] [C2] [CR] [LF]

[STX] [Frame number] [DATA3] [ETX] [C1] [C2] [CR] [LF]

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Definition Description
Record List of used records:
- H: Header data of the message
- P: Patient information data
- O: Order data
- R: Result data
- Q: Query request data
- M: Manufacturer information data
- L: Message terminator data
- C: Comment/alarm data
Checksum Checksum of a frame: binary sum of all characters except [STX], [C1],
[C2], [CR] and [LF]. The 8 less significant bits only are showed in two
hexadecimal characters. (For example, a checksum equal to 122 will be
showed as 7A in hexadecimal, the two ASCII characters 7 [C1] and A [C2]
will be sent one after the other).

1.3.2 Character definition

Character Definition

[ACK] (06h) Acknowledge without error

[NAK] (15h) Acknowledge with error

[STX] (02h) Start of text transmission

[ETX] (03h) End of text transmission

[C1] Most significant character of checksum

[C2] Least significant character of checksum

[ENQ] (05h) Request for line (enquiry)

[ETB] (17h) End of transmission block

[EOT] (04h) End of transmission

[CR] (0Dh) Carriage return

[LF] (0Ah) Line feed

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2 Exchange protocol
2.1 Definition of Line Modes on the analyzer
- Idle = no communication in progress
- Tx = transmission by analyzer, upload from the analyzer to the host
- Rx = reception by analyzer, download from the host to the analyzer

2.2 Definition of Communication phases

ASTM V3 communication is composed of three phases:
- Establishment phase: line picked up by the host computer or the analyzer
- Transfer phase: transmission of the different records making up the message (see chapter 3, Record
Definitions)
- Termination phase: the line is released.

2.3 Host computer to analyzer

Responses of the analyzer to characters transmitted by the host computer:

1 Reception of the [ENQ] character transmitted by the host computer

- If the analyzer is in the Idle line mode, it transmits an [ACK] character (06h) and then changes to reception
line mode Rx.
- If after 30 seconds, no character is received, then the analyzer returns to the Idle line mode.

2 Reception of the [EOT] character transmitted by the host computer

- If the analyzer is in the Rx reception line mode and a header record has been received, the analyzer then
changes to Idle line mode (releasing the line).
The analyzer then analyses the records received.
- If the analyzer is in Tx transmission line mode, the [EOT] character is regarded as an acknowledgement.

3 Reception of other characters transmitted by the host computer

The analyzer acquires the characters received. After the acquisition of a complete frame, the analyzer
verifies the checksum.
- If this is satisfactory, the analyzer acknowledges by returning an [ACK] character (06h).
- If not, a [NAK] character (15h) is returned.

Following the upload of the characters [ACK] or [NAK], if after 30 seconds, no character is received, then
analyzer returns to the Idle line mode.

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2.4 Analyzer to Host computer exchanges
2.4.1 Setting up Phase
The analyzer sends an [ENQ] character (enquiry).
Possible responses from the host computer:

1 Transmission of an [ACK] character by the host computer

The analyzer changes to Tx transmission line mode and initiates:
- The record transfer phase if it is in normal mode.
- The termination phase if it is in line test mode.

2 Transmission of an [ENQ] character by the host computer

The analyzer waits 5 seconds and then returns an [ENQ] character.

3 Transmission of other characters by the host computer

The analyzer waits 10 seconds and then returns the [ENQ] character. When the value of the "Number of
Retries on Error" is reached, the analyzer changes to termination phase and displays an error message.

4 No response from the host computer

The analyzer waits 15 seconds, then changes to termination phase and displays an error message.

2.4.2 Transfer phase (analyzer to host computer)

Transmission of the first record by the analyzer.
The following are the possible responses of the host computer:

1 Transmission of the [ACK] or [EOT] character by the host computer

The analyzer sends the next record.

The analyzer regards the [EOT] character as an acknowledgement character and

continues to transmit records.

2 Transmission of other characters by the host computer

The analyzer waits 10 seconds before returning the record. If the number of "on Error Retries" is
reached, the analyzer changes to termination phase and displays an error message.

3 No response from the host computer

The analyzer waits 15 seconds and then changes to termination phase and displays an error message.

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2.4.3 Termination Phase (Analyzer to Host Computer)
The analyzer transmits an [EOT] character and does not wait for any return character.
The analyzer changes to Idle line mode.
2.4.4 Example of exchanges
# Direction
1 Analyzer  Host computer
2 Analyzer  Host computer
3 Host computer  Analyzer
4 Analyzer  Host computer
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ASTM V3 Protocol
Record sequence in the
Description Comment
ASTM messages used
The analyzer requests this query to ask
Workload the workload to apply to a patient identity.
H.Q.L
request
NA for STart Max
The analyzer uses the whole of records to
communicate information of given results
(Patient, QC).
The records between square brackets are
Test result optional.
H.P[.C].O.R.M.C[.R.M.C]…..L
transmission All records R correspond to a single
parent methodology and each of them
includes the result in one of units (main
and/or secondary unit) configured with a
transmission rank.
It is transmitted either following a
Workload sending#1
H.P[.C].O[.O]…L
communication
NA for STart Max
Manufacturer
Record used to communicate
information H.M[.M]…L
manufacturer information
exchange
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3 Record Definitions
3.1 Message Header Record (H)
Purpose: to identify the sender.
Example of a message header record
H|\^&|||STA R Max^99^3.00|||||||P|LIS2-A2|20150724111220

Description of the Message Header Record:

ASTM field
Field
CLSI LIS2- Definition Transmitted data U D Comments
size
A2 Standard
6.1 Record type ID H 1  
6.2 Delimiter Definition 4  

Field delimiter (7Ch) ‘|’

Repeat field delimiter (5Ch) ‘\’
Component delimiter (5Eh) ‘^’
Escape delimiter (26h) ‘&’
6.3 Identity for message control Ignored NA
Message
6.4 Access code Ignored NA
6.5 Sender Name or ID Name^Num. 16+2+4   In the direction Analyzer to
station^3.00 LIS, the analyzer name is
indicated: STA R Max for
STA R Max® analyzer,
STA Compact MAX for
STA Compact Max® and
STart for STart Max.
In the direction LIS to
analyzer, the LIS name is
expected.

Number of station for the

analyzer (from 1 to 99).
Number of version of
ASTMV3 protocol on the
analyzer is equal to 3.00
6.6 Sender street address Ignored NA
6.7 Reserved field Ignored NA
6.8 Sender Telephone number Ignored NA
6.9 Characteristics of sender Ignored NA
6:10 Receiver Id Ignored NA
6:11 Comments or Special Instructions Ignored NA
6:12 Processing Id P (Production) 1  
Q (Quality Control) 
6:13 Version number LIS2-A2 10   Identifies the specification
version. (By default =
LIS2-A2)
6:14 Date and time of message YYYYMMDDHHMMSS 14  

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3.2 Patient Information Record (P)
Purpose: to give information on the patient

Example of information record on the analyzer:

P|1||||LORD^PAT^M|ROY|

Example of information record on the host computer:

P|1||||SMITH^Lisa^|POWEL|19841228

ASTM field
Field
CLSI LIS2- Definition Transmitted data U D Comments
size
A2 Standard
7.1 Record type ID P 1  
7.2 Sequence number 1, 2, 3, … 1  
7.3 Patient identification Field ignored
Practitioner assigned Patient ID
7.4 Patient identification Field ignored
Laboratory assigned Patient ID
7.5 Patient identification Field ignored
number 3
7.6 Patient information Name 20   POHL^ALLEN^M
^First Name 20
^Initial 1 Optional field: the STA R
Max® analyzer can send 4
characters instead of 1.
Empty field/ not applicable
on STart Max.
7.7 Maiden name 20   Optional field.
Empty field/ not applicable
on STart Max.

7.8 Birth date YYYYMMDD 8   Optional field

19941213 for 13
December 1994
For STA Compact Max®,
this field is ignored in
download.
Empty field/ not applicable
on STart Max.

Fields 7.9 to 7.35 as defined in the CLSI LIS2-A2 standard are not supported. In
downloading mode (host to analyzer), if these fields exist, they are ignored. In uploading
mode (analyzer to host), the short record format described above is used.

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3.3 Test Order Record (O)
Purpose:
- In downloading mode (Host to analyzer), this record is used by the host computer to give orders to the
analyzer: list of tests to be run.
- In uploading mode (analyzer to Host), this record is used by the analyzer to give the sample
identification.

Implementation example for download (Host to analyzer):

O|1|20150804||^^^1\^^^4\^^^3\^^^2|R

Implementation example for upload (Patient) (analyzer to Host):

O|1|20150804^202105^1^^|||R

Implementation example for upload (Quality Control) (analyzer to Host):

O|1|12354^^^111516^|8||R

Description of a Test Order Record:

ASTM field
Field
CLSI LIS2- Definition Transmitted data U D Comments
size
A2 Standard
8.4.1 Record type ID O 1  
8.4.2 Sequence number 1, 2, 3, … 1  
8.4.3 Sample identification Barcode ID 32  
^Rack barcode 6  Rack barcode: to fill if
^ Position (Rack or drawer or 5  the analyzer is equipped
measurement well) 16  with Racks.
^Lot QC 255  See Note 1
^Information on HIL and Position: corresponds to
check Volume the measurement well
for STart Max.
HIL and Volume check
information: empty fields
on STart Max.
8.4.4 Sample identification on the Sunquest sequence number 4  See Note 2
analyzer

8.4.5 Universal test identification ^^^  Cf. Note 3

Rank Tx Test1 3 Rank Tx Test
\^^^ Rank Tx Test2 corresponds to
\^^^ Rank Tx Test3 transmission ranks to
configure in the
analyzer. Each code is
on 3 characters max.

See Note 4
8.4.6 Priority code S or R 1   S for Urgent
R for Routine

Note 1: The HIL and check volume are transmitted by the analyzer in the form H^x^I^x^L^x^V^x with x is a value from 0
to 9 by increment of 1. Under field optional
Note 2: A number between 1 and 9999 is generated by the analyzer and is placed in the field 8.4.4. The analyzer will
assign the same number generated for all results of a given sample. The analyzer will generate a new number for each
result of a new sample according to a setting of the analyzer. The current value of the number is stored in the analyzer
and the incrementation of the number goes on at each sample analyzed and for each QC transmitted to the LIS. The

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analyzers STAGO are configured to transmit or not a sequence number (type Sunquest)
Note 3: On the analyzer, these identifications correspond to rank transmission defined for main and secondary units of each test.
Note 4: The analyzer STA Compact Max® accepts 12 Tx rank per Order record. It is recommended to transmit the tests ranks in
main units. The multi frames are not accepted. The analyzer STA Compact Max® accepts only the ranks Tx from 1 to 255.
The analyzer STA R Max® accepts the multi frames Order and does not have limitation on Tx rank number per Order record.

Field 8.4.7 to 8.4.31 as defined in the CLSI LIS2-A2 standard are not supported. In
downloading mode (Host to analyzer), if these fields exist, they are ignored. In uploading
mode (analyzer to Host), the short record format described above is used.

3.4 Result Record (R)

Purpose: To send Results to the host computer.
Result record example:

R|1|^^^1^PT10^2^F^64^1^|100|%||||F||||20150803152706

Description of a Result Record:

CLSI LIS2-
Field
A2 Standard Definition Transmitted data U D Comments
size
ASTM field
9.1 Record type ID R 1 
9.2 Sequence number 1, 2, 3, … 1 
9.3 Universal test ID ^^^ 
Tx Test Rank 3  See Note 1
^Abbreviation test Name 8  See Note 2
^Calib. Internal number 5  See Note 3
^Result type 1  See Note 4
^Fluid type 2  See Note 5
^Correction factor 7  See Note 6
^Origin of the request 1  See Note 7
9.4 Data or measurement Text 9  When a result is not valid
value = Test result due to an error, the field
contains the text: 'NO
RESULT'
9.5 Units See chapter 3.9 20 
9.9 Result status F 1  Only 'Final Result= F' is
supported
9.13 Date and time of end of YYYYMMDDHHMMSS 14 
realization of the test by
the analyzer

Note 1: The rank transmission value for each test unit is defined in the methodology.

Note 2: the abbreviation of a test is the Stago abbreviation test.

Note 3: Number generated by the analyzer between 1 and 99999. In the case of final result given by the analyzer with 2 calibrations,
this field will be empty for the final result (See Note 4). But will be filled for results with duplicate determination. The field “Calib. Internal
number” is a Stago reserved field.

Note 4: The flag F (Final Result) is used to notify that a result is obtained by calculation of the 2 measurement values mean in case of
duplicate determination in main unit. In single determination, the final result is the measurement value. The flag F is also used for
results in secondary unit.

Note 5: '48' for a control plasma (QC), '64' for patient plasma and '80' for total blood

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Note 6: Factor 0,001 and 999,999 applied to the final result. Default value is 1. Non-significant decimals are optional.
Note 7: O for Operator, I for Instrument and L for LIS
The table hereafter shows the result type combination:

Record R : Value Comments STA R Max® STart Max STA Compact Max®
under the field
Result Type
'F' Result in main or secondary Yes Yes Yes
units. In single determination,
the result corresponds to the
measurement value. In
duplicate determination, the
result corresponds to the mean
of the 2 measurements.
'F' + ' 1' + '2' Final result in main units with Yes Yes Yes
result for replicate #1 and
replicate #2 in main units.
'F' + ' 1' + '3' STA Compact Max®: Final result Yes No Yes
of the calculated test with result
in main units for the first test and
for the second test in single
determination.
STA R Max®: Final result of
the calculated test with result in
main units for the first test
and/or for the second test in
duplicate determination.
'F' + ' 1' + '2' + ' 3' + Final result of the calculated test No No Yes
'4' with result in main units for the
first test and for the second test in
duplicate determination.
'F' + ' 1' + '2' + ' 3' Final result of the calculated test No No Yes
with result in main units for the
first test in duplicate
determination and for the second
test in single determination.
'F' + ' 1' + ' 3' + '4' Final result of the calculated test No No Yes
with result in main units for the
first test in single determination
and for the second test in
duplicate determination.

One record is used for each result. If for a requested test, result can be expressed in 3
different units, then there will be 3 records.

A Result Record is always followed by a Manufacturer Information Record (see chapter

3.5 below) and a Comment Record (see chapter 3.8 below).

Field 9.14 as defined in the CLSI LIS2-A2 standard is not supported. In downloading
mode (Host to analyzer), if this field exists, it is ignored. In uploading mode (analyzer to
Host), the short record format described above is used.

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3.5 Manufacturer Information Record (M)
Purpose: To transmit tracking information linked to the given result.

Implementation example of product tracking linked to the results:

M|1|RER|D.0|0|1||12.5^Sec.||||||12300^STA-NEO CI^111834||A40414|CLEANER^STA-
CLEANER^999999|

Description of product tracking linked to the results:

The uploading of a patient file consists in communicating to the host computer the whole of the results for a given patient. This
emission can be repeated several times for the same patient.
Case of test results except calculated tests
For a measurement result to communicate to the host computer in single determination, the analyzer transmits an ASTM message
according to the following sequence of recording: H.P[.C].O R M C [R M C] [R M C] L.
For a measurement result to communicate to the host computer in duplicate determination, the analyzer transmits an ASTM
message according to the following sequence of recording: H.P[.C].O R M C R1 M1 C1 R2 M2 C2 [R M C] [R M C] L.
R M C: This continuation of recording is intended to communicate the result in main unit.
 The record R contains the result in main unit.
 The record M contains the detail of the measurement in raw unit as well as the technical data (products and consumables)
according to the determination:
- single determination: For measurement, it is the raw measurement in raw unit which is communicated. For the
technical data, all fields are indicated.
- duplicate determination: For measurement, it is the 2 replicates raw measurements mean. For the technical data,
fields that are not indicated: measurement channel, each product consumable lot number, calibration number (see Note
1). These technical data are indicated for each replicate.
Note 1: The calibration number is not to indicate when the analyzer uses a different calibration by replicate.
 The record C contains according to the measurement determination:
- single determination: the error code and all alarm codes associated with the result in main unit.
- duplicate determination: for the error code, it is the summary of the 2 replicates error codes (managed by the analyzer)
and for alarm codes, this is concatenation of the alarm codes of the 2 replicates without duplicate.
R M C: This continuation of recording is intended to communicate the result in secondary unit.
 The record R contains the result in secondary unit.
 The record M is identical to the record M of the result in main unit.
 The record C is identical to the record C of the result in main unit.
R1 M1 C1: This continuation is intended to communicate the result of the first replicate when the determination is in duplicate.
 The record R1 contains the result in main unit of the first replicate.
 The record M1 contains the result in raw unit as the technical data of the first replicate.
 The record C1 contains the error code and alarm codes of the first replicate.

R2 M2 C2: This continuation is intended to communicate the result of the second replicate when the determination is in duplicate.
 The record R2 contains the result in main unit of the second replicate.
 The record M2 contains the result in raw unit as the technical data of the second replicate.
 The record C2 contains the error code and alarm codes of the second replicate.

CLSI LIS2-
A2 Standard Definition Transmitted data Field size U D Comments
ASTM field
14.1 Record type ID M 1 
14.2 Sequence number 1, 2, 3, … 1 
14.3 Query code RER 3 
14.4 Version D.0 3 
14.5 Type of methodology 0 to 4 1  Type of methodology: 0 = Main,
1 = Dependent, 2 = Derived,

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CLSI LIS2-
A2 Standard Definition Transmitted data Field size U D Comments
ASTM field
3 = Calculated,
4 or 0 = Supporting

For a support test: STA R Max®

sends 4 and STA Compact Max®
sends 0
For STart Max, only type 0 is
supported
14.6 Transmission rank 1 to 999 3  For STA Compact Max®, possible
values of transmission ranks: 1 to
255
14.7 Measurement well 0 to 99 2  If the measurement well is
unknown, the field is empty. In
case of duplicate determination:
for the final result, this field is
empty, the measurement well will
be mentioned in the replicates.

The information of measurement

well is optional
14.8 Raw measurement Value 9  Raw measurement for Patient or
^ QC
Unit 20 
Unit according to the
measurement method
chronometry : Sec photometry 2
points : DDO photometry Do per
minute : DO/Mn

In case of duplicate determination,

the raw measurement corresponds
to the raw measurement mean.
14.9 QC Min-Max threshold Text 255  To use for a QC.
Example of min max thresholds for
the Id 12354: ''88 – 124"
14.10 QC threshold units Text 20  To use for a QC result
Example : "%"
14.11 Ra Product ID 8  First intermediate reagent
^ See Note 1 for the lot
Product name 16 
^
Lot number 8 
14.12 Rb Product ID 8  Second intermediate reagent
^ See Note 1 for the lot
Product name 16 
^
Lot number 8 
14.13 Rc Product ID 8  Third intermediate reagent
^ See Note 1 for the lot
Product name 16 
^
Lot number 8 
14.14 Rd Product ID 8  Start reagent
^ Example :
Product name 16  12300^STA-NEO CI ^655951

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CLSI LIS2-
A2 Standard Definition Transmitted data Field size U D Comments
ASTM field
^ See Note 1 for the lot
Lot number 8 
14.15 Diluent Product ID 8  See Note 1 for the lot
^ Empty field for STart Max
Product name 16 
^
Lot number 8 
14.16 Cuvette Lot number 255  See Note 1 for the lot
Empty field for STart Max
14.17 Cleaner Product ID 8  See Note 1 for the lot
^ Empty field for STart Max
Product name 16 
^
Lot number 255 
14.18 Desorb Product ID 8  The repetition character '\' enables
^ to separate Desorbs by reagents
Product name 16  (Ra to Rd).
^
Lot number 8  Example : the Desorb is used for
Ra and Rd
12227^STA
Desorb^99999\^^\^^\12227^STA
Desorb^99999

See Note 1 for the lot

Empty field for STart Max
Note 1: In case of duplicate determination of an analysis of a principal test and only for the record M associated with the result in
main unit

 The measurement well is not to inform

 The raw measurement in the mean of raw measurements
 Product lots are not indicated

Note 2: The record M associated with the final result of the calculated test in a reduced record M that only contains the following
data:

 Type of methodology initialized to 3 (code for a calculated test)

 Transmission rank of a calculated test
 The other fields are not indicated (Initialized with empty field)

For all the received recordings others that of the type M with a request code
different of RER, LIS has to ignore the contents and validate by a message [ACK].

A Manufacturer Information Record M RER always follows a Result Record.

Example:
R|1|^^^1^PT10^1^F^64^1^|100|%||||F||||20150724112339
M|1|RER|D.0|0|1||12.5^Sec.||||||12300^STA-NEO CI^111834||000000|CLEANER^STA-
CLEANER^999999|

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3.6 Request Information Record (Q)

Purpose: Request of the working list (tests to be run) (analyzer to Host).

Implementation example:
Q|1|^20150804

Description of Request Information Record:

Paragraph number
Field
of CLSI LIS2-A2 Transmitted data Transmitted data U D Comments
size
Standard
11.1 Record type ID Q 1
11.2 Sequence number 1, 2, 3, … 1
11.3 Starting Range ID Number ^Barcode ID 255

Field 11.4 to 11.13 as defined in the CLSI LIS2-A2 standard are not supported.
In downloading mode (Host to analyzer), if these fields exist, they are ignored. In
uploading mode (analyzer to Host), the short record format described above is used.

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3.7 Message Terminator Record (L)

Purpose: To indicate the end of message.

Implementation example (analyzer to Host):

L|1|N

Description of a Terminator message:

Paragraph
number of Transmitted
Definition Field size U D Comments
CLSI LIS2- data
A2 Standard
12.1 Record type ID L 1
12.2 Sequence number 1 1
12.3 Termination code N 1 N for normal termination

3.8 Comment and Alarms Record (C)

Purpose:
- To transmit result error code and result alarm code (Record C after couples of record R and M).
- To transmit comments linked to the patient information (Record C after the record P)

Example of a record Comment with multiple alarms:

C|4||3^C\^J|I

Example of a record Comment:

C|1||Result to validate|G

Description of a Comment and Alarms Record:

Paragraph
number of
Definition Transmitted data Field size U D Comments
CLSI LIS2-
A2 Standard
10.1 Record type ID C 1
10.2 Sequence number 1, 2, 3, … 1
10.3 Comment Source Ignored NA
10.4 Comments text Text 255 This record when it follows the
record P indicates a patient
Note.
This record when it follows the
record R indicates the couple
error code and alarms codes
separated by a ^. Several
couples are separated by a \
For example A^C\^J means
Result Validated (A) with out
of range QC or not done (C)
and Rerun test Result (J)
10.5 Comment type I or G 1 I for Alarm
G pour Generic/free text

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Definition of error codes:
Characters ASCII Code Error codes definition

1 31h To be validated
2 32h Tech error
3 33h >Mmax
4 34h <Mmin
6 36h QNS (insufficient quantity of plasma)
8 38h Linearity
A 41h Validated

For "2", "3", "4", "6" or "8" error codes, the value "NO RESULT" is transmitted to the LIS in the
Result record.
For "1" or "A" error codes, a result is transmitted.

Definition of Alarm Codes:

STA
ASCII STA R
Characters Alarm code definition Compact STart Max
Code Max®
Max®
@ 40h No alarm code Yes Yes Yes
A 41h Result Confirmed with T > Tmax Yes Yes No
Quality Control Out of range or
C 43h Yes Yes Yes
not done
44h Quality Control Forced
D Yes Yes Yes
confirmation
45h Level detection number 3 not
E Yes Yes No
managed
Level detection number 2 not
F 46h Yes Yes No
managed
Level detection number 1 not
G 47h Yes Yes No
managed
Result Value in primary units
H 48h Yes Yes Yes
skewed
I 49h Result Dilution change Yes Yes No
J 4Ah Result Rerun test Yes Yes No
Reagent drawer Temperature out
K 4Bh Yes Yes No
of limit
Syringe Arm #3 Maintenance
Yes No No
date overdue
L 4Ch
Syringe Maintenance date
No Yes No
overdue
Syringe Arm #2 Maintenance
M 4Dh Yes No No
date overdue
Syringe Arm #1 Maintenance
N 4Eh Yes No No
date overdue
O 4Fh Double measurement tolerance Yes Yes Yes

Refer to the Reference manual for more details of the meaning of the errors and the alarms.

On Start Max, the alarms order in the Result record is not always respected.

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3.9 Units table
Characters to transmit Units definition
% Percentage
mg/dl Milligram per deciliter
Sec. Second
Tém. Reference time in second
g/l Gram per liter
ng/ml Nanogram per milliliter
U/ml Unit per milliliter
UI/ml International unit per milliliter
INR International normalized ratio
Ratio Report measured time / reference time
µg/ml Microgram per milliliter
DDO Optical density Variation (Delta Optical Density)
DO/mn Optical density Variation per minute (Optical
Density per minute)
mDo/sec Milli Do (Optical Density) per second
Programmable Arbitrary unit (Up to three arbitrary units can be
( 1 to 5 characters) defined)

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4 Typical Contents of Some Messages

4.1 Result Transmission (Analyzer to Host)
Each message refers to only one sample:
- Header record,
- Patient record,
- Test Order record,
- Result record,
- Manufacturer Information record,
- Message Terminator record.

4.2 Request for a Working List

Each message refers to only one sample:
- Header record,
- Request Information record,
- Message Terminator record.

4.3 Working List Return

Each message refers to only one sample:
- Header record,
- Patient record,
- Test Order record,
- Message Terminator record.

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5 Flowcharts (ASTM)
These flowcharts are available for all analyzers.

5.1 Sequencing of Reception/Transmission

Fig. 1 – Sequencing Reception/Transmission
Refer to §3.1 for line mode definition

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5.2 Acquisition of a Record from the Host Computer

Fig. 2 - Acquisition of a Record from the Host Computer

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5.3 Establishment Phase (Analyzer to Host Computer)

Fig. 3 - Establishment Phase (Analyzer to Host Computer)

* n: Number of Retries if Error.

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5.4 Transfer Phase (Analyzer to Host Computer)

Fig. 4 - Transfer Phase (Analyzer to Host Computer)

* n: Number of Retries if Error.

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5.5 Termination Phase (Analyzer to Host Computer)

Fig. 5 - Termination Phase (Analyzer to Host Computer)

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6 Not contractual examples of traces (ASTM V3)

6.1 Transmission of Patient File (Analyzer to Host Computer)

<ENQ>
<ACK>
<STX>1H|\^&|||STA R Max^99^3.00|||||||P|LIS2-A2|20141124145701<CR ><ETX>0F<CR ><LF >
<ACK>
<STX>2P|1||||Nom^Prenom^||20131225<CR ><ETX>C5<CR ><LF >
<ACK>
<STX>3C|1||Resultat a valider|G<CR ><ETX>1C<CR ><LF >
<ACK>
<STX>4O|1|123456-2^344848^2^^|||S<CR ><ETX>00<CR ><LF >
<ACK>
<STX>5R|1|^^^6^AT3^25^F^64^1.005^|54|%||||F||||20141124145338<CR ><ETX>8A<CR ><LF >
<ACK>
<STX>6M|1|RER|D.0|0|6||1.266^DO/mn|||12327^ATIIITHROMBIN^|||12328^ATIII
SUBSTRAT^|11361^OWRENKOLLER^||
CLEANER^STA-CLEANER^|12227^STA-DESORB U^\\\12227^STA-DESORB U^<CR
><ETX>73<CR ><LF >
<ACK>
<STX>7C|1||1^C\^O\^N|I<CR ><ETX>D7<CR ><LF >
<ACK>
<STX>0R|2|^^^6^AT3^25^1^64^1.005^|71|%||||F||||20141124145158<CR ><ETX>70<CR ><LF >
<ACK>
<STX>1M|2|RER|D.0|0|6||1.000^DO/mn|||12327^ATIII THROMBIN^112672|||12328^ATIII
SUBSTRAT^112672|11361^OWREN-KOLLER^215487|S30411|CLEANER^STACLEANER^
999999|12227^STA-DESORB U^999999\\\12227^STA-DESORB U^999999<CR ><ETX>50<CR
><LF >
<ACK>
<STX>2C|2||1^C\^O\^N|I<CR ><ETX>D3<CR ><LF >
<ACK>
<STX>3R|3|^^^6^AT3^25^2^64^1.005^|37|%||||F||||20141124145338<CR ><ETX>77<CR ><LF >
<ACK>
<STX>4M|3|RER|D.0|0|6||1.532^DO/mn|||12327^ATIII THROMBIN^112672|||12328^ATIII
SUBSTRAT^112672|11361^OWREN-KOLLER^215487|S30411|CLEANER^STACLEANER^
999999|12227^STA-DESORB U^999999\\\12227^STA-DESORB U^999999<CR ><ETX>5E<CR
><LF >
<ACK>
<STX>5C|3||1^C\^O\^N|I<CR ><ETX>D7<CR ><LF >
<ACK>
<STX>6R|4|^^^16^AT3^25^F^64^1.005^|1.266|DO/mn||||F||||20141124145338<CR><ETX>CB<CR
><LF >
<ACK>
<STX>7M|4|RER|D.0|0|16||1.266^DO/mn|||12327^ATIII THROMBIN^|||12328^ATIII
SUBSTRAT^|11361^OWREN-KOLLER^||CLEANER^STA-CLEANER^|12227^STA-DESORB
U^\\\12227^STADESORB
U^<CR ><ETX>A8<CR ><LF >
<ACK>

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<STX>0C|4||1^C\^O\^N|I<CR ><ETX>D3<CR ><LF >
<ACK>
<STX>1L|1|N<CR ><ETX>04<CR ><LF >
<ACK>

6.2 Request for Working List (Analyzer to Host Computer)

<ENQ>
<ACK>
<STX>1H|\^&|||STA R Max^99^3.00|||||||P|LIS2-A2|20141124144630<CR ><ETX>0F<CR ><LF >
<ACK>
<STX>2Q|1|^123456-2<CR ><ETX>AE<CR ><LF >
<ACK>
<STX>3L|1|N<CR ><ETX>06<CR ><LF >
<ACK>
<EOT>

6.3 Working List Return (Host Computer to Analyzer)

<ENQ>
<ACK>
<STX>1H|\^&|||SCE^99^3.00|||||||P|LIS2-A2|20150224161824<CR ><ETX>4F<CR ><LF >
<ACK>
<STX>2P|1||||1000^^||<CR ><ETX>A4<CR ><LF >
<ACK>
<STX>3O|1|1000||^^^2\^^^3\^^^4\^^^1\^^^21\^^^22\^^^7\^^^6\^^^8\^^^37\^^^36\^^^38|R<CR
><ETX>E2<CR
><LF >
<ACK>
<STX>4O|2|1000||^^^41\^^^42\^^^26\^^^27|R<CR ><ETX>5C<CR ><LF >
<ACK>
<STX>5L|1|N<CR ><ETX>08<CR ><LF >
<ACK>
<EOT>

This message "Working List Return" can also be used to add tests, to rerun tests.
To add tests, Test Order record has to include the local codes of tests to be added.
To rerun tests, it has to include the local codes of the tests to be rerun.

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6.4 Transmission of a Quality Control Result (Analyzer to Host
Computer)
<ENQ>
<ACK>
<STX>1H|\^&|||STA R Max^99^3.00|||||||Q|LIS2-A2|20141124104746<CR ><ETX>14<CR ><LF >
<ACK>
<STX>2P|1||||||<CR ><ETX>27<CR ><LF >
<ACK>
<STX>3O|1|12354^^^111516^|8||R<CR ><ETX>5F<CR ><LF >
<ACK>
<STX>4R|1|^^^6^AT3^25^F^64^1.000^O|98|%||||F||||20141121151453<CR ><ETX>D3<CR ><LF >
<ACK>
<STX>5M|1|RER|D.0|0|6||0.580^DO/mn|87.00-117.00|%|12327^ATIII
THROMBIN^112672|||12328^ATIII
SUBSTRAT^112672|11361^OWREN-KOLLER^999|S30411|CLEANER^STA-
CLEANER^999999|12227^STADESORB
U^999999\\\12227^STA-DESORB U^999999<CR ><ETX>45<CR ><LF >
<ACK>
<STX>6C|1||A^@|I<CR ><ETX>D2<CR ><LF >
<ACK>
<STX>7L|1|N<CR ><ETX>0A<CR ><LF >
<ACK>
<EOT>

6.5 On-Line Test

<ENQ>
<ACK>
<EOT>

0932209B 31/31