ELECTROLYTE

ANALYZER

LIS
Interface
Description
Manufacturer
EXIAS Medical GmbH Telefon: +43 (316) 922953
Kratkystraße 2 E-Mail: [email protected]
8020 Graz – Austria www.exias-medical.com
Document Information

Document version Software version Revision date Remark

Version 1.0 min. 2.00 Oct 2020 1st Release

Version 1.1 Min. 2.01.00 Jun 2021 processing ID extended for

exhibition mode.

Copyright
© 2021, EXIAS Medical GmbH. All rights reserved.
The contents of this document may not be reproduced in any form or communicated to any third party without the
prior written consent of EXIAS.
All documents are protected in terms of copyright law. The transfer and duplication of documents, even in extracts,
as well as the utilization and communication of their contents are not permitted unless expressly granted in writing.
Violations are punishable and require compensation.
All rights to exercise industrial property rights are reserved for EXIAS.

Brand Name
EXIAS Medical is a trademark of EXIAS Medical GmbH.

Edition
Version 1.1, Jun 2021
 Table of content

Table of content
Document information ..................................................................................................................................................... 3
Copyright ............................................................................................................................................................................. 3
Brandname ......................................................................................................................................................................... 3
Edition.................................................................................................................................................................................. 3

General description ........................................................................................................................................................... 6

Introduction ................................................................................................................................................................... 7
Restricted characters.................................................................................................................................................... 7

Message structure ............................................................................................................................................................. 8

Structure description .................................................................................................................................................... 9

Delimiters ..................................................................................................................................................................... 9
Field delimiter .................................................................................................................................................... 9
Repeat delimiter ................................................................................................................................................ 9
Component delimiter ....................................................................................................................................... 9
Escape delimiter ................................................................................................................................................ 9
Record delimiter ................................................................................................................................................ 9
Null values .................................................................................................................................................................. 10
General note .............................................................................................................................................................. 10
Records.......................................................................................................................................................................... 11
Message header record ............................................................................................................................................. 11
Example .............................................................................................................................................................. 11
Patient information record ........................................................................................................................................ 12
Example .............................................................................................................................................................. 13
Test order record ....................................................................................................................................................... 13
Example .............................................................................................................................................................. 14
Result record .............................................................................................................................................................. 15
Example .............................................................................................................................................................. 16
Comment record ........................................................................................................................................................ 17
Example .............................................................................................................................................................. 17
Message terminator record ....................................................................................................................................... 18
Example .............................................................................................................................................................. 18
Examples ....................................................................................................................................................................... 18
Measurement records: .............................................................................................................................................. 18
Quality Control Measurement records: ..................................................................................................................... 19

e|1 Analyzer
LIS Interface Description, Vers. 1.1 5
 Chapter 1

General description
 1 General description

Introduction
This document describes the communication interface for transmitting specific data from the
EXIAS e|1 Analyzer to a Laboratory Information System (LIS). The communication is based on
the CLSI LIS2-A2 standard protocol but is not a complete implementation of the standard.

Restricted characters
This standard requires 8-bit transmission ISO 8859-1:1987/Latin1.

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LIS Interface Description, Vers. 1.1 7
 Chapter 2

Message structure
 2 Message structure

Structure description
Each message has several records. A message is a group of records that begins with a Header
Record and ends with a Message Terminator Record. Each record has several fields.
Each field is by default separated by the vertical bar | character (the actual definition of which
character is used for field separation is done with the Header Record).
Following is a description of the records and the fields within each record:

ID Record Types
H Header Record
P Patient Record
O Test Order Record
R Result Record
M Manufacturer Record
Q Request Information Record
L Message Terminator Record
Table 1 - Record Types

Delimiters

Delimiters are ASCII characters used to separate fields within a record and to separate sub-
components within fields. Below is a description of the delimiters and how they are commonly
used:

Character Name Used as:

| vertical bar Field delimiter
\ backslash Repeat delimiter
^ caret Component delimiter
& ampersand Escape delimiter
<CR> carriage return Record delimiter
Table 2 - Delimiters

Field delimiter
The field delimiter is used to separate adjacent fields. |Field1|

Repeat delimiter
The repeat delimiter must be defined in the message header and is used to separate various
numbers of descriptors for the same field. A multiple range information:
|5.240^6.130^reference\3.120^8.200^critical|

Component delimiter
The component delimiter is used to separate data elements within a field that has a
hierarchical or qualifier nature. The components of a name field would be separated.
|Smith^John^Thomas^^|

Escape delimiter
The escape delimiter is used to include special characters.
| EXIAS^e&F&1 Analyzer

Record delimiter
The Carriage Return “<CR>” signifies the end of the record.

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 2 Message structure

Null values

All fields are position dependent and are obtained by counting field delimiters by their
position starting from the beginning of the record. This means if a field is null (no information
available), the field delimiters must be included in the record.
This ensures that the nth field can be identified by counting n-1 delimiters. Trailing null fields
do NOT need to be included. Delimiters are not needed after the last field containing data.

Null values may be sent for the following reasons:

- the value is not known.
- the sender knows the field is irrelevant to the receiving system.

General note

For all records, fields up to and including the last field with data needs to be transmitted.
Fields not used at the end of the record may be truncated.

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 2 Message structure

Records
Message header record

This record must always be the first record in a transmission. This record contains information
about the sender and receiver, instruments, and computer systems whose records are being
exchanged. It also identifies the delimiter characters.
The minimum information that must be sent in a Header record is:
H|\^&<CR>
The “H” corresponds to the record type. The “|” (vertical bar) is used as the field delimiter.
The \ (backslash) is the repeat delimiter. The “^” (caret) is the component delimiter.
The “&” (ampersand) is the Escape delimiter. The “<CR>” is identified as a Carriage Return (ASCII
decimal 13). The entire header record consists of the following fields:
1|2|3|4|5|6|7|8|9|10|11|12|13|14<CR>.

Field No Field Name Comment

1 Record Type ID Required, always "H"
2 Delimiter Definition: Required, always "\^&"
Repeat
Component
Escape
3 Message Control ID Not used by the instrument.
4 Access Password Not used by the instrument.
5 Sender Name or ID --
5.1 Name Instrument name
5.2 Manufacturer Required, always "EXIAS"
5.3 Instrument Type Required, always "e|1 Analyzer"
5.4 SW Version SW-Version
5.5 Protocol Version Required, always "1"
5.6 Serial Number Serial number
5.7 IP Address Not used by the instrument.
6 Sender Street Address Not used by the instrument.
7 Reserved Field Not used by the instrument.
8 Sender Telephone Number Not used by the instrument.
9 Characteristics of Sender Not used by the instrument.
10 Receiver ID Not used by the instrument.
11 Comment or Special Instructions -
11.1 Message Type - “M” = measurement result
- “QC” = quality control result
11.2 Cause of Message Required, always "AUTO"
12 Processing ID Indicates how message should be
processed
- “P” = Normal operation mode
- "T" = Training mode
- "S" = Exhibition mode
(simulated results)
- “E” = Performance evaluation mode
13 Version Number Required, always "LIS2-A2"
14 Date and Time of Message Date and Time of Message
Format = YYYYMMDDhhmmss
Table 3 – Message Header

Example
H|\^&|||ISE-Analyzer10^EXIAS^e&F&1
Analyzer^2.00^1^00011||||||M^AUTO|P|LIS2-A2|20200714143647

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 2 Message structure

Patient information record

This record contains information about an individual patient. Patient information records are
only actively used in a Measurement Report. The Patient Information record consists of the
following fields:
1|2|3|4|5|6|7|8|9|10|11|12|13|14|15|16|17|18|19|20
|21|22|23|24|25|26|27|28|29|30|31|32|33|34|35<CR>.

Field Field Name Field Content

No
1. Record Type ID Required, always "P"
2. Sequence Number Sequence Number
3. Practice-Assigned Patient ID Not used by the instrument.
4. Laboratory-Assigned Patient ID Patient ID
5. Patient ID Number 3 Insurance code
6. Patient Name --
6.1. Last Name Last name
6.2. First Name First name
6.3. Middle Name Middle name
6.4. Suffix Suffix
6.5. Title Title
7. Mother’s Maiden Name Maiden name
8. Birthdate Date of birth
Format = YYYYMMDD
9. Patient Sex Patient Sex
10. Patient Race-Ethnic origin Ethnic origin
11. Patient Address Address
12. Reserved Field Not used by the instrument.
13. Patient Telephone Number Phone no.
14. Attending Physician ID Not used by the instrument.
15. Special Field 1 Not used by the instrument.
16. Special Field 2 Not used by the instrument.
17. Patient Height Patient height
18. Patient Weight Patient weight
19. Patient’s Known or Suspected Diagnosis Diagnosis
20. Patient Active Medications Medication
21. Patient's Diet Diet
22. Practice Field Number 1 Not used by the instrument.
23. Practice Field Number 2 Not used by the instrument.
24. Admission or Discharge Dates Admission date/time \
Discharge date/time
25. Admission Status Not used by the instrument.
26. Location Location, Ward
27. Nature of Alternative Diagnostic Code and Not used by the instrument.
Classifiers
28. Alternative Diagnostic Code and Classification Not used by the instrument.
29. Patient Religion Not used by the instrument.
30. Marital Status Marital status
31. Isolation Status Not used by the instrument.
32. Language Patient language
33. Hospital Service Hospital service
34. Hospital Institution Clinic
35. Dosage Category Not used by the instrument.
Table 4 – Patient information record

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 2 Message structure

“Patient Sex”: Patient sex is defined using the following abbreviations:

- “F”: female
- “M”: male

“Patient Race-Ethnic origin”: This input field allows free alphanumeric input on the analyzer. No
coding of ethnic origin is used.

“Patient Height” and “Patient Weight” are sent as value and unit, separated by the component
delimiter, e.g. “180^cm”.

"Admission or Discharge Dates": in this field the input fields "admission_date_time" and
"discharge_date_time" are sent separated by the repeat delimiter, e.g. “20200501\20200504”.

“Patient’s Known or Suspected Diagnosis”: The diagnosis input field allows free alphanumeric
input on the analyzer.

"Location": the input fields "Location" and "Ward" are sent separated using comma “,”, e.g. “LKH
Graz, nephrology”.

All input fields can be selected separately in the LIS settings. For further information see
Instruction for use.

Example
P|1||102208|6255|Moser^Maria^Luise^Dr|Huber|19500502|F||Lilienweg 17, 8020
Graz||+43664123456789||||160^cm|70^kg|||||20200501\20200504||||||M

Test order record

The order record defines the concrete tests performed for a specimen. The order record for
the is transmitted to the host computer as part of the measurement report.

The Test order record consists of the following fields:

1|2|3|4|5|6|7|8|9|10|11|12|13|14|15|16|17|18|19|20|21|22|23|24|25|26|27|28
|29|30|31<CR>.

Field No Field Name Field Content

1. Record Type ID Required, always "O"
2. Sequence Number Sequence Number
3. Specimen ID Specimen ID
4. Instr. Specimen ID --
4.1. Order ID /Sequence # Order ID
4.2. Rack ID / Carrier ID Not used by the instrument.
4.3. Position on Rack/Carrier Not used by the instrument.
4.4. Tray ID / Location ID Not used by the instrument.
4.5. Rack/Carrier type Not used by the instrument.
4.6. Tube/Cont. type Container
5. Universal Test ID --
5.1. Universal Test ID Not used by the instrument.
5.2. Universal Test ID Name Not used by the instrument.
5.3. Universal Test ID Type Not used by the instrument.
5.4. Manufacturer’s Test ID Name Not used by the instrument.
5.5. Treatment type (and value) Not used by the instrument.
5.6. Pre-Treatment type (and Not used by the instrument.
value)
5.7. Result Type Not used by the instrument.
5.8. Manufacturer’s Test ID Not used by the instrument.

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 2 Message structure

Field No Field Name Field Content

6. Priority Not used by the instrument.
7. Requested Date and Time Not used by the instrument.
8. Specimen Collection Date Date/time drawn
and Time
9. Collection End Time Not used by the instrument.
10. Collection Volume Not used by the instrument.
11. Collector ID Not used by the instrument.
12. Action Code Not used by the instrument.
13. Danger Code Not used by the instrument.
14. Relevant Clinical Information Not used by the instrument.
15. Date/Time Specimen Not used by the instrument.
Received
16. Specimen Descriptor --
16.1. Specimen Type Sample Type
16.2. Puncture Site/Specimen Not used by the instrument.
source
16.3. Material Name Material name
16.4. Level Level
16.5. Lot Lot
16.6. Base Not used by the instrument.
17. Ordering Physician Doctor
18. Physician’s Phone Not used by the instrument.
19. User Field No. 1 Not used by the instrument.
20. User Field No. 2 Not used by the instrument.
21. Lab. Field No. 1 Not used by the instrument.
22. Lab. Field No. 2 Not used by the instrument.
23. Date/Time Results Reported Not used by the instrument.
24. Instrument Charge Not used by the instrument.
25. Instr. Section ID Not used by the instrument.
26. Report Type Not used by the instrument.
27. Reserved Field Not used by the instrument.
28. Location or Ward of Not used by the instrument.
Specimen Collection
29. Nosocomial Infection Flag Not used by the instrument.
30. Specimen Service Not used by the instrument.
31. Specimen Institution Not used by the instrument.
Table 5 – Test order record

„Tube/Cont. Type“: The Container type is given in caps:

- “CAPILLARY” Used for measurement workflow.
- “SYRINGE” Used for measurement workflow.
- “SAMPLETUBE” Used for measurement workflow.
- “QC” for QC-Material. Used for oQC and mQC workflow.

„Specimen Type“: The contents of „Sample Type“ field are entered, cannot be deselected.

Example
O|1||||||||||||||QC3^^e&F&1 oQC-1^1^2019032900

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 2 Message structure

Result record

The result record is used to send actual patient results and quality control results, that were
performed on an instrument.

The Result record consists of the following fields:

1|2|3|4|5|6|7|8|9|10|11|12|13|14<CR>.

Field No Field Name Field Content

1. Record Type ID Required, always "R"
2. Sequence Number Sequence Number
3. Universal Test ID --
3.1. Universal Test ID Not used by the instrument.
3.2. Universal Test ID Name Not used by the instrument.
3.3. Universal Test ID Type Not used by the instrument.
3.4. Manufacturer’s Test ID Name Parameter
3.5. Treatment type (and value) Not used by the instrument.
3.6. Pre-Treatment type (and Not used by the instrument.
value)
3.7. Result Type Result record type
3.8. Manufacturer’s Test ID Not used by the instrument.
4. Data/Measurement Value Measurement value
5. Units Measurement unit
6. Reference Ranges --
6.1. Lower Limit Lower_Limit
6.2. Upper Limit Upper_Limit
6.3. Range type "reference", "critical" or "QC"
7. Result Abnormal Flags Abnormal flag
8. Nature of Abnormality Not used by the instrument.
9. Result Status Required, always "F"
10. Date of Change in Instrument Not used by the instrument.
Normative Values
11. Operator Identification Login Name
12. Date/Time Test Started Date/Time Test Started,
Format=YYYYMMDDHHMMSS
13. Date/Time Test Completed Date/Time Test Completed,
Format=YYYYMMDDHHMMSS
14. Instrument Identification Not used by the instrument.
Table 6 – Result record

There are three kinds of result records:

- „M“ for measured parameter values (Na, Ca, K, Cl, pH, Hct). Used for measurements
and Quality Control measurements.
- „C“ for calculated parameter values (tHb(c), nCa).
- „I“ for manually entered parameter values (MCHC).

The result records for each parameter are always sent in this order: Na, K, Cl, Ca, pH, Hct,
tHb(c), nCa, MCHC.
For a measurement only the active parameters and calculated values are sent (enabled in
Settings). “MCHC” is sent only if the corresponding input field (in the Data Input) is active.
Parameter deselected for only one measurement in the main screen are sent nevertheless and
marked with „Parameter deselected (2511)“.

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 2 Message structure

For Quality Control measurements all measured parameters are sent and the disabled ones
are marked with „Parameter disabled (2510)“. Calculated parameters and “MCHC” are
never sent for QC measurements.
“Reference ranges“: The reference ranges are always sent, it cannot be configured in the LIS
Settings.

„Range type“: The range types are sent separated by a repeat delimiter character using the
following order: |^^reference\^^critical\^^QC_range|
All range types are always sent regardless of whether a measurement or a QC measurement
was performed. in the case of a measurement the QC ranges are not filled out.
|135^145^reference\120^155^critical\^^QC_range|
In the case of a QC measurement reference and critical ranges are not filled out.
|^^reference\^^critical\132.2^140.4^QC_range|

„Result Abnormal Flags “:

- “N” for normal (within lower and upper reference limit)
- “A” for abnormal (in case of errors)
- “L” for below lower reference limit
- “H” for above upper reference limit
- “LL” for below lower critical limit
- “HH” for below lower critical limit

The error number and description are sent in a comment record.

Example
R|2|^^^K^^^M|1.92|mmol/L|^^reference\^^critical\1.33^3.01^QC_range|
N||F||System|20200805004051|20200805004118

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 2 Message structure

Comment record

The Comment record consists of the following fields:

1|2|3|4|5<CR>.

Field No Field Name Field Content

1. Record Type ID Required, always "C"
2. Sequence Number Sequence Number
3. Comment Source Required, always "I"
4. Comment Text --
4.1. Comment/Flag Text Comment, Error text or additional
measurement information.
4.2. Comment Code Error number in case of Error text
5. Comment Type "G" or "I"
Table 7 – Comment record

Comment records are used for different purposes:

a. To send the input field "Comment" of the measurement. This record is send after the
Test order record. In this case, the comment data record is filled in with the following
attributes:
- 4.1. „Comment/Flag Text“: content of the “Comment”
- 4.2 „Comment Code“: empty
- 5. „Comment Type“: „G“

b. To send error text of the parameter. This comment option cannot be configured using
the LIS Settings on the analyzer. This record is send after the result record of the
parameter. In this case, the comment data record is filled in with the following
attributes:
- 4.1. „Comment/Flag Text“: error text of the parameter
- 4.2 „Comment Code“: parameter’s error number
- 5 „Comment Type“: „I“

c. To send additional measurement information of the parameter, like “user correlations

applied”. This comment option cannot be configured using the LIS Settings on the
analyzer. This record is send after the result record of the parameter. In this case, the
comment data record is filled in with the following attributes:
- 4.1. „Comment/Flag Text“: „user correlations applied”
- 4.2 „Comment Code“: „c“
- 5 „Comment Type“: „I“

Example
C|1|I|Not calibrated (2681)^2681|I

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 2 Message structure

Message terminator record

This is the last record in the message. A header record may be transmitted after this
record to signify the start of another message.
The Message Terminator record consists of the following:
1|2|3<CR>

Field No Field Name Field Content

1. Record Type ID Required, always "L"
2. Sequence Number Sequence Number
3. Termination Code Required, always "N"
Table 8 – Message terminator record

Example
L|1|N

Examples

Measurement records:

H|\^&|||ISE-Analyzer10^EXIAS^e&F&1 Analyzer^2.00^1^00011||||||M^AUTO|P|LIS2-A2|20200714143647
P|1|||||||U|||||||||^kg
O|1||^^^^^SYRINGE||||||||||||BLD

R|1|^^^Na^^^M|154|mmol/L|135^145^reference\120^155^critical\^^QC_range|H||F|||20200714143512|20200714143541

R|2|^^^K^^^M|4.3|mmol/L|3.5^5.1^reference\2.5^6.2^critical\^^QC_range|N||F|||20200714143512|20200714143541

R|3|^^^Cl^^^M|112|mmol/L|98^107^reference\80^120^critical\^^QC_range|H||F|||20200714143512|20200714143541

R|4|^^^Ca^^^M|5.09|mg/dL|4.49^5.29^reference\3.29^6.21^critical\^^QC_range|N||F|||20200714143512|20200714143541

R|5|^^^pH^^^M|7.612||7.32^7.43^reference\7.2^7.6^critical\^^QC_range|HH||F|||20200714143512|20200714143541
R|6|^^^Hct^^^M|||0.36^0.53^reference\0.2^0.6^critical\^^QC_range|A||F|||20200714143512|20200714143541
C|1|I|Result out of range (1721)^1721|I
R|7|^^^MCHC^^^I|34|g/dL||||F|||20200714143512|20200714143541
L|1|N

H|\^&|||ISE-Analyzer10^EXIAS^e&F&1 Analyzer^2.00^1^00011||||||M^AUTO|P|LIS2-A2|20200707131315
P|1|||||||U|||||||||^kg
O|1||^^^^^SYRINGE||||||||||||BLDA

R|1|^^^Na^^^M|149.8|mmol/L|135^145^reference\120^155^critical\^^QC_range|H||F|||20200707131228|20200707131306

R|2|^^^K^^^M|4.26|mmol/L|3.5^5.1^reference\2.5^6.2^critical\^^QC_range|N||F|||20200707131228|20200707131306

R|3|^^^Cl^^^M|106.6|mmol/L|98^107^reference\80^120^critical\^^QC_range|N||F|||20200707131228|20200707131306

R|4|^^^Ca^^^M||mmol/L|1.12^1.32^reference\0.821^1.549^critical\^^QC_range|A||F|||20200707131228|20200707131306
C|1|I|QC locked (2691)^2691|I
R|5|^^^pH^^^M|7.423||7.32^7.43^reference\7.2^7.6^critical\^^QC_range|N||F|||20200707131228|20200707131306
R|6|^^^Hct^^^M|||0.36^0.53^reference\0.2^0.6^critical\^^QC_range|A||F|||20200707131228|20200707131306
C|1|I|Result out of range (1721)^1721|I
R|7|^^^MCHC^^^I|34|g/dL||||F|||20200707131228|20200707131306
L|1|N

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 2 Message structure

Quality Control Measurement records:

H|\^&|||ISE-Analyzer10^EXIAS^e&F&1 Analyzer^2.00^1^00011||||||QC^AUTO|P|LIS2-A2|20200707130919
P|1
O|1||||||||||||||QC3^^e&F&1 oQC-2^2^2020050500

R|1|^^^Na^^^M|136.6|mmol/L|^^reference\^^critical\132.2^140.4^QC_range|N||F|||20200707130844|20200707130912
R|2|^^^K^^^M|4.46|mmol/L|^^reference\^^critical\4.01^4.83^QC_range|N||F|||20200707130844|20200707130912

R|3|^^^Cl^^^M|101.4|mmol/L|^^reference\^^critical\95.4^107.4^QC_range|N||F|||20200707130844|20200707130912

R|4|^^^Ca^^^M|1.13|mmol/L|^^reference\^^critical\0.948^1.268^QC_range|N||F|||20200707130844|20200707130912
R|5|^^^pH^^^M|7.4||^^reference\^^critical\7.342^7.46^QC_range|N||F|||20200707130844|20200707130912
R|6|^^^Hct^^^M|0.45||^^reference\^^critical\0.409^0.489^QC_range|N||F|||20200707130844|20200707130912
L|1|N

H|\^&|||ISE-Analyzer10^EXIAS^e&F&1 Analyzer^2.00+m-n-20200707^1^00011||||||QC^AUTO|P|LIS2-A2|20200708171522
P|1
O|1||||||||||||||QC3^^e&F&1 oQC-1^1^2020022600

R|1|^^^Na^^^M||mmol/L|^^reference\^^critical\116.5^124.7^QC_range|A||F||System|20200708171349|20200708171521
C|1|I|Internal fluidics error (1312)^1312|I

R|2|^^^K^^^M||mmol/L|^^reference\^^critical\1.59^2.41^QC_range|A||F||System|20200708171349|20200708171521
C|1|I|Internal fluidics error (1312)^1312|I

R|3|^^^Cl^^^M||mmol/L|^^reference\^^critical\78.1^90.1^QC_range|A||F||System|20200708171349|20200708171521
C|1|I|Internal fluidics error (1312)^1312|I

R|4|^^^Ca^^^M||mmol/L|^^reference\^^critical\1.34^1.66^QC_range|A||F||System|20200708171349|20200708171521
C|1|I|Internal fluidics error (1312)^1312|I
R|5|^^^pH^^^M|||^^reference\^^critical\7.083^7.201^QC_range|A||F||System|20200708171349|20200708171521
C|1|I|Internal fluidics error (1312)^1312|I
R|6|^^^Hct^^^M|||^^reference\^^critical\0.537^0.617^QC_range|A||F||System|20200708171349|20200708171521
C|1|I|Internal fluidics error (1312)^1312|I
L|1|N

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