Quality Record Number/Version: QP11G03R01/2.

eCL 8000 LIS protocol

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 Quality Record Number/Version: QP11G03R01/2.0

Table of Contents

eCL8000 LIS Protocol....................................................................................3

1. Lifotronic ASTM Protocol........................................................................... 3
1.1. Sending and Receiving Processes in the Protocol............................... 3
2. Application................................................................................................... 3
2.1. Introduction of ASTM Protocol........................................................... 4
2.2. Data Frame Format...............................................................................5
2.2.1. Data Record Format.................................................................5
2.2.2. ASTM Communication Options..............................................5
3. Introduction of ASTM Record Types...........................................................6
3.1. Header Record -“H”............................................................................. 6
3.2. Patient Record – "P".............................................................................7
3.3. Test Order Record –“ O”......................................................................9
3.3.1. Specimen Item Results.............................................................9
3.3.2. QC Item Results..................................................................... 11
3.3.3. Calibration Item Results........................................................ 12
3.3.4. Test Result Record- "R".........................................................12
3.4. Request Information Record-“ Q”..................................................... 13
3.5. Terminator Record- "L"..................................................................... 14
4. Examples of Communication Processes and Messages............................ 14
4.1. Send Test Result of Specimen............................................................14
4.2. Specimen Inquiry Request................................................................. 15
4.3. Return of Specimen Inquiry Request.................................................15

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eCL8000 LIS Protocol

1. Lifotronic ASTM Protocol
The ASTM protocol is a standard developed by the American Society for
Testing and Materials (ASTM) for the transmission of information between
instruments and computer systems in medical clinical laboratories. This standard
involves multiple versions. The version mentioned herein is E1394-97 (the
ASTM version mentioned hereinafter is ASTM E1394-97), which was
determined in 1997.
Since the Lifotronic ASTM interface only uses partial data, only partial message
types, record types, and other data as specified in ASTM are used in this
interface.
1.1. Sending and Receiving Processes in the Protocol
The operating mode for ASTM protocol link is a simplex mode, i.e., the
transmission of data at a time point can always only be achieved in one direction.
See the following table for the specific hexadecimal value:
Operational character ASCII encoded hexadecimal value
<STX> 0x02
<LF> 0x0A
<CR> 0x0D
<ETX> 0x03

2. Application
Including:
Obtain the specimen request information and transmit the specimen and QC test
results.
The transmission of test results mainly refers to the transmission of test data
from Automatic Chemiluminescence Analyzer to external system (such as LIS).
The modes of data transmission include the automatic transmission after
completion of test and the batch transmission of historical results. The
acquisition of specimen request information refers to the acquisition of required
specimen request information by the Automatic Chemiluminescence Analyzer
from the LIS to the local terminal for test. The acquisition modes include real-
time transmission (can only be used on the Automatic Chemiluminescence
Analyzer configured with specimen scanning system, using specimen barcode to
match, and acquired after scanning) and batch acquisition (using the rack as the
unit, click Acquisition to realize the batch acquisition of current racks).

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2.1. Introduction of ASTM Protocol

This chapter explains the use of the Lifotronic ASTM interface, and the general
grammatical rules are described below.
The ASTM Protocol defines six major message records, which are:
No. Record Type Record Description
1 H Message Header Record
2 P Patient Information Record
3 O Test Order Record
4 R Result Record
5 Q Request Information Record
6 L Message Terminator Record

ECL8000 implemented all data sheets

The sent data will contain some or all of the above-mentioned 6 message records.
For example:
● Data frame structure of specimen test results
Message Header Record
Patient Information Record
Test Order Record
Result Record
Result Record
...
Message Terminator Record
● Data frame structure of specimen inquiry request
Message Header Record
Request Information Record
Message Terminator Record
● Data frame structure of inquiry request response
Message Header Record
Patient Information Record
Test Order Record
Test Order Record
...
Message Terminator Record
Each ASTM message consists of a few message records that end with <CR>.
Each record is composed of a 1-character record name and a certain number of
fields, which are composed of some components. The separator of each
composition unit is defined in the H record of each message.

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Where: the four characters after H define the separator used to distinguish the
fields, repeatability and components. Lifotronic ASTM interface uses the
characters described in the table below:
Character Definition
| Field separator
\ Repetition
separator
^ Component
separator
& Escape character

When the field content contains the characters described in the above table, it is
necessary to use the escape character for escape. In the Lifotronic ASTM
standard, ”|”becomes ”&|” after escape.
2.2. Data Frame Format
2.2.1. Data Record Format
All ASTM data is sent in the following format:
Frame Format: < STX > < FRAME > < CR > < ETX > < CS > < CR > < LF >
Where:
<STX>: Start Frame Header (0 x 02)
<FRAME>: Frame Data (with field separator |)
<CR>: Frame Data Terminator (0 x 0D)
<ETX>: Frame Terminator (0 x 03)
<CS>: Checksum of ASCII codes from <FRAME> to before <ETX> and
(<STX> <CS> and <ETX> <CR> <LF> in the tail are not involved in the
calculation of the checksum) obtained by 0xFF remainder after division (the
check digit is ignored during actual debugging)
<CR>: ASCII Carriage Return (0 x 0D)
<LF> ：ASCII Line Feed (0 x 0A)
2.2.2. ASTM Communication Options
Application- > System Setting- > Lis Network Settings, there are two methods
for Lifotronic LIS connection:
1. TCP/IP client
Instrument serves as a client and is connected to a given TCP/IP server
2. Serial port

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Serial data connection

Option Specification
Com port
BR 4800, 9600, 19200, 34800, 57600, 115200
DA B 8
CHK B None
ST B 1

3. Acquire LIS data

Input the specimen number, click Request interface - > Acquire, send request to
LIS server
3. Introduction of ASTM Record Types
Fields labeled with "#" are used in Lifotronic LIS
3.1. Header Record -“H”
Any message is sent with "H" message record as the message header. In the
second field of the H message, a separator is required in the message, so a H
message header must be included in each message.
Field Max
ASTM Field Name Field Contents Field Description Double
No. Length
1# Record Type ID H 1 Record type ID Yes
| Field separator
Repetition
\
separator
2# Delimiter Definition 4 Yes
Component
^
separator
& Escape separator
Left blank,
3 Message Control ID - -
reserved
Left blank,
4 Password - -
reserved
Sender Name or ID ECL8000 30 Device name
Device software
5# Software Version 00.00.03.68415 20 Yes
version
Serial Number I05A16100023 20 Device S/N
Sender Street Left blank,
6 - -
Address reserved
Left blank,
7 Reserved field - -
reserved

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Field Max
ASTM Field Name Field Contents Field Description Double
No. Length
Sender Telephone Left blank,
8 - -
Number reserved
Characteristics of Left blank,
9 - -
sender reserved
Left blank,
10 Receiver ID - -
reserved
Comment or Special Left blank,
11 - -
Instructions reserved
PR: Patient test results
QR: Quality control results
RQ: specimen request
inquiry
12# Processing ID 2 Message types Yes
QA: specimen inquiry
response
SA: specimen application
information
Protocol version
Supports strings and
13# Version Number 12 number, fixed as Yes
numbers
1394-97
The date and time
14# Date and Time YYYYMMDDHHMMSS 14 the message was Yes
created

3.2. Patient Record – "P"

In sending the specimen test results information, the patient information is
necessary, since it is a part of the specimen information.
Field Max
Field Name Field Contents Field Description Double
No. Length
1# Record Type ID P 1 Record type ID Yes
Sequence
2# String 10 Specimen test S/N
Number
Practice
3 - - Left blank, reserved
Assigned
4# Patient ID String 25 Patient ID
5 Patient ID #3 - - Left blank, reserved
6# Patient Name String 20 Patient name
7 Reserved field - - Left blank, reserved
Birth date - - Left blank, reserved
8#
Age String 6 Age

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Field Max
Field Name Field Contents Field Description Double
No. Length
Age Unit String 10 Age unit
9# Patient Sex String 8 Patient gender
10# Patient Race String 20 Nationality
11 Patient Address - - Left blank, reserved
12 Reserved Field - - Left blank, reserved
Patient
13 - - Left blank, reserved
Telephone
Attending
14 - - Left blank, reserved
Physician Name
15 Special field 1 - - Left blank, reserved
Yes
Body Surface Medical insurance account
16# String 20 (specimen
Area (M2) number
type)
Patient Height - - Left blank, reserved
17 Patient Height
- - Left blank, reserved
Unit
Patient Weight - - Left blank, reserved
18 Patient Weight
- - Left blank, reserved
Unit
Patient
19# String 50 Clinical diagnosis
Diagnosis
Patient
20# String 20 Patient classification
Medications
21 Patient Diet - - Left blank, reserved
Practice Field
22 - - Left blank, reserved
#1
Practice Field
23 - - Left blank, reserved
#2
Admission and
24 - - Left blank, reserved
discharge dates
Admission
25 - - Left blank, reserved
Status
26 Location - - Left blank, reserved
Nature of alt.
27# Diag.Code and String 10 Bed No.
Class.
Alt. Diag. Code
28 - - Left blank, reserved
and Class
29 Patient Religion - - Left blank, reserved

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Field Max
Field Name Field Contents Field Description Double
No. Length
30 Marital Status - - Left blank, reserved
31 Isolation Status - - Left blank, reserved
32 Language - - Left blank, reserved
33 Hospital Service - - Left blank, reserved
Hospital
34 - - Left blank, reserved
Institution
Dosage
35 - - Left blank, reserved
Category

3.3. Test Order Record –“ O”

Test order records are used to transmit the information about test results of items.
3.3.1. Specimen Item Results
Field ASTM Field Max
Field Contents Field Description Double
No. Name Length
1# Record Type ID O 1 Record type ID Yes
Sequence
2# String 10 Empty
Number
Sample ID String 25 Specimen No.
3# String
Sample Pos 6 Specimen position
Position: 1-30
Instrument
4# String - Left blank, reserved Yes (specimen No.)
SpecimenID
ItemName String - Left blank, reserved
5# Dilution Rate String - Left blank, reserved Yes
TestNums Number 2 Test number
R (Routine) S
6# Priority 1 Emergency? Yes
(Emergency)
Requested Date
7 - - Left blank, reserved
and Time
Specimen
8 Collection Date - - Left blank, reserved
and Time
Collection end
9 - - Left blank, reserved
Time
Collection
10 - - Left blank, reserved
Volume
11 Collected by (ID - - Left blank, reserved

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Field ASTM Field Max

Field Contents Field Description Double
No. Name Length
or Name)
12 Action Code - - Left blank, reserved
13 Danger Code - - Left blank, reserved
Relevant Clinical
14 - - Left blank, reserved
Information
Date/Time
Specimen String Time of sample
15# 14
Received in the yyyyMMddHHmmss received for test
Lab.
Serum = 0
Plasma = 1
16# Specimen type Amniotic = 2 1 Specimen type
Urine = 3
Other = 4
Ordering Submitting
17# String 30
Physician physician
Physician Phone
18# String 30 Inspection dept.
number
Offline Dilution Yes (pre-dilution
19# - - Left blank, reserved
factor ratio)
20# Test Physician String 30 Test physician
Laboratory field
21 - - Left blank, reserved
#1
Laboratory field
22 - - Left blank, reserved
#2
Date/Time
23 Results - - Left blank, reserved
Reported/Mod
Instrument
24 Charge to - - Left blank, reserved
computer system
Instrument
25 - - Left blank, reserved
Section ID
O: Request from LIS
Q: Response to
26# Report Type 1 Report type
inquiry
F: Final result
27 Reserved Field - - Left blank, reserved
Location
28 Specimen - - Left blank, reserved
Collected

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Field ASTM Field Max

Field Contents Field Description Double
No. Name Length
Nosocomial
29 - - Left blank, reserved
Infection flag
Specimen
30 - - Left blank, reserved
Service
Specimen
31 - - Left blank, reserved
Institution

3.3.2. QC Item Results

Field Max
ASTM Field Name Field Contents Field Description
No. Length
1# Record Type ID O 1 Record type ID
2# Sequence Number - - Left blank, reserved
Sample ID String 20 Specimen No.
3# String
Sample Pos 5 Specimen position
Position: 1-30
4 Instrument SpecimenID - - Left blank, reserved
ItemName - - Left blank, reserved
5 Dilution Rate - - Left blank, reserved
TestNums - - Left blank, reserved
6# Priority - - Left blank, reserved
Requested Date and
7 - - Left blank, reserved
Time
Specimen Collection
8 - - Left blank, reserved
Date and Time
9 Collection end Time - - Left blank, reserved
10 Collection Volume - - Left blank, reserved
Collected by (ID or
11 - - Left blank, reserved
Name)
NO. String 10 Left blank, reserved
Name String 10 Control name
Batch No. String 20 Control batch
Period of validity String 8 Left blank, reserved
12#
Average Concentration Number 9 Target value
Level High-H; Low-L 1 Control concentration level
Standard Diff. Number 9 Control SD
Concentration Number 9 Left blank, reserved

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Field Max
ASTM Field Name Field Contents Field Description
No. Length
13 Danger Code - - Left blank, reserved
Relevant Clinical
14 - - Left blank, reserved
Information
Date/Time Specimen
15 - - Left blank, reserved
Received in the Lab.
16 Specimen type - - Left blank, reserved
17 Ordering Physician - - Left blank, reserved
18 Physician Phone number - - Left blank, reserved
19 Offline Dilution factor - - Left blank, reserved
20 Test Physician - - Left blank, reserved
21 Laboratory field #1 - - Left blank, reserved
22 Laboratory field #2 - - Left blank, reserved
Date/Time Results
23 - - Left blank, reserved
Reported/Mod
Instrument Charge to
24 - - Left blank, reserved
computer system
25 Instrument Section ID - - Left blank, reserved
O: Request from LIS
26# Report Type Q: Response to inquiry 1 Report type
F: Final result
27 Reserved Field - - Left blank, reserved
Location Specimen
28 - - Left blank, reserved
Collected
Nosocomial Infection
29 - - Left blank, reserved
flag
30 Specimen Service - - Left blank, reserved
31 Specimen Institution - - Left blank, reserved

3.3.3. Calibration Item Results

Calibration can only be tested on the instrument without implementation of LIS
interface
3.3.4. Test Result Record- "R"
Field Max
Field Name Field Contents Field Description
No. Length
1# Record Type ID R 1 Record type ID

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2# Total Dilution factor String 4 Total dilution factor

Assay No. String 12 Item code
Item Name String 20 Item name
3#
I: Qualitative results
Result Type 1 Result type
F: Quantitative results
Measurement Value String (quantitative) 12 Final quantitative test results
4#
Interpretation - - Left blank, reserved
Remark String 10 Result identification
5# Units String 10 Result unit
Lower limit of reference range
Reference Ranges L 12
(QC result: No)
6#
Upper limit of reference range
Reference Ranges H 12
(QC result: No)
Result Abnormal
7# - - Left blank, reserved
Flags
Nature of Abnormality
8# - - Left blank, reserved
Testing
N: Normal
9# Result Status 1 Result status
E: No result
10 Measurement Value - - Left blank, reserved
Operator
11 - - Left blank, reserved
Identification
12# Date/time test started String 14 Time the test started
Date/Time Test
13# String 14 Time the test completed
Completed
Instrument
Device model
Identification String 16
14# (eCL8000)
(Sender Name)
Device ID String 10 Device S/N

The Result Record contains one test result of an inspection item, that is to say, a
test result will have a Result Record, which is only included in the message sent
from the instrument to the LIS service end
3.4. Request Information Record-“ Q”
The Request Information Record is used to inquiry specimen request
information from the LIS server. It is a message sent from the instrument end to
the LIS service side that contains inquiry condition(s) for the specified specimen
number.

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Field
Field Name Field Contents Max Length Field Description
No.
1# Record Identifier Q 1 Record type ID
2 Sequence Number - - Left blank, reserved
Patient ID String 25 Specimen No.
3#
Specimen ID - - Left blank, reserved
4 Ending Range ID - - Left blank, reserved
5 Universal Test Id - - Left blank, reserved
Nature of Request
6 - - Left blank, reserved
Time Limits
Beginning Request
7 - - Request time
results data/time
Ending Request
8 - - Request end time
results data/time
Requesting Physician
9 - - Left blank, reserved
name
Requesting Physician
10 - - Left blank, reserved
telephone
11 User field # 1 - - Left blank, reserved
12 User field # 2 - - Left blank, reserved
Request Information
13 - - Left blank, reserved
status Codes

3.5. Terminator Record- "L"

Max
Field No. Field Name Field Contents Field Description
Length
1# Record Identifier L 1 Record type ID
2# Sequence Number 1-n 3 Serial number (default 1)
N=normal termination
I=No information
available from the last
3# Terminator code 1 End code (default N)
e query.
Q=Error for in last
request for information

The Terminator Record is recorded at the end of each message to indicate the
end of the message.
4. Examples of Communication Processes and Messages
4.1. Send Test Result of Specimen

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INSTRUMENT <STX>H|\^&|||eCL8000^00.00.03^I05A16100023|||||||PR|1394-
97|20191105184909<CR>
P|N149||12345||Zhang San||^23^years old|Male|Han
nationality||||||465687990||||Hospitalization |||||||23||||||||<CR>
O||11^A-9||^^1|R|||||||||20181006000000|0|Doctor Li|Surgery||Doctor
Wang||||||F|||||<CR>
R||0^PCT^F|1.563^^|ng/ml|0.000^748.9|||N|||20191022152654|20191022154711|eCL8
000^I05A16100023<CR>
R||0^HCG^F|5000^^|mIU/mL|0.000^10000|||N|||20191022152754|20191022154811|e
CL8000^I05A16100023<CR>
...
L|1|N<CR><ETX><CS><CR><LF>

4.2. Specimen Inquiry Request

INSTRUMENT <STX>H|\^&|||eCL8000^00.00.03^I05A16100023|||||||RQ|1394-
97|20191105190721<CR>
Q||123^||||||||||<CR>
L|1|N<CR><ETX><CS><CR><LF>

4.3. Return of Specimen Inquiry Request

INSTRUMENT <STX>H|\^&|||^^|||||||QA|1394-97|20191105071546<CR>
P|||||||^^||||||||0|||||||||||||||||||<CR>
O||^|123|PCT^1^1|R|||||||||||||1||||||||||||<CR>
O||^|123|HCG^1^1|R|||||||||||||1||||||||||||<CR>
...
L|1|N<CR><ETX><CS><CR><LF>

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