RX ASTM Spec Prelim
RX ASTM Spec Prelim
Software Specifications
Part 4: CA180 and CA400 Host Interface
(Preliminary version)
Host Interface Specifications Version 9
Revision History
Revision 04 to Revision 09
Table of Contents
1. Introduction............................................................................................................. 1
1.1 System configuration...................................................................................................... 1
2. Low level control..................................................................................................... 2
2.1 Physical Layer ................................................................................................................ 2
2.1.1 Communication specifications ................................................................................ 2
2.1.2 Connectors.............................................................................................................. 2
2.1.3 Pin assignment ....................................................................................................... 2
2.1.4 Interface signals...................................................................................................... 2
2.1.5 Cable specifications ................................................................................................ 3
2.2 Data Link Layer................................................................................................................... 4
2.2.1 Summary of transmission control characters ......................................................... 4
2.2.2 Message composition ............................................................................................. 4
2.2.3 Transmission procedure ......................................................................................... 5
2.2.4 Status transition table.................................................................................................. 6
3. High level control .................................................................................................... 7
3.1 Command Record .......................................................................................................... 7
3.2 Data Character Code ..................................................................................................... 7
3.3 Sequence Number ......................................................................................................... 7
3.4 H: Message Header Record .......................................................................................... 8
3.5 P: Patient Information Record........................................................................................ 9
3.6 O: Test Order Record ................................................................................................... 10
3.7 R: Result Record.......................................................................................................... 12
3.8 C: Comment Record .................................................................................................... 20
3.9 Q: Request Information Record ................................................................................... 20
3.10 L: Message Terminator Record.................................................................................... 21
3.11 S: Scientific Record...................................................................................................... 21
3.12 M: Manufacturer Information Record ........................................................................... 21
4. Communication sequence .................................................................................... 22
4.1 Communication Modes ..................................................................................................... 22
5. Communication Sequence.................................................................................... 24
5.1 Batch Sequence........................................................................................................... 24
5.1.1 Batch transmission of result to Host ..................................................................... 24
5.1.2 Inquiry to host for order and response.................................................................. 25
5.2 Real-time Sequence..................................................................................................... 26
5.2.1 Real-time inquiry to Host for one sample and its response.................................. 26
5.2.2 Real-time transmission of result to Host for one sample...................................... 27
6. Error Handling ...................................................................................................... 28
6.1 Transmission error ....................................................................................................... 28
6.2 Reception Error ............................................................................................................ 30
6.2.1 Error during batch order inquiry and its response ................................................ 30
6.2.2 Error during test order inquiry for a sample at real-time mode ............................ 31
6.3 Abnormal data .............................................................................................................. 32
6.3.1 Sequence Number ................................................................................................ 32
6.3.2 Abnormal data....................................................................................................... 32
6.3.3 Expired retries....................................................................................................... 32
Host Interface Specifications Version 9
1. Introduction
This document specifies the communication scheme between the Desktop Clinical Chemistry Analyzer
(hereinafter called Analyzer) and the Host Computer (hereinafter called Host). The construction of this
on-line system enables communication between the Analyzer and the Host, and retrieval of the
measurement results from the Analyzer in response to an external order. This on-line system defines each
item as a protocol within the conformity of the following standards:
Lower level (Low level control): ASTM E1381-95
High level (High level control): ASTM E1394-91
On Line System
Host Computer
Clinical Chemistry
Analyzer
RS232C
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2.1.2 Connectors
Connector on the Analyzer is a D-sub 9pin Male.
Connector at the Analyzer side of cable is a D-sub 9pin Female.
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The cable for host communication is RS-232C with the following cable connection.
CD 1 CD
RD 2 RD
TD 3 TD
DTR 4 DTR
GND 5 GND
DSR 6 DSR
RTS 7 RTS
CTS 8 CTS
RI 9 RI
Analyzer Host
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Note 1: FN is the sequence number assigned to each frame and the ASCII text (0, 1, 2, 3, 4, 5, 6and 7) is
cyclically used. For re-transmission, the same sequence number is used.
At reception of message with same sequence number, handle as duplicate of re-transmission and
discard the message.
Messages divided with ETB will have new sequence number. Initial value shall be “1”.
Note 2: TEXT is the division of ASCII text message itself and the number of characters for one text is
limited to less than 240 characters (including “CR”) and below. Addition of “CR” is optional
settings. It is possible to set with the details setting on System Parameters => System (F9).
Note 3: ETX code (ASCII code: 03H) or ETB code (ASCII code: 17H).
Note 4: In the checksum (Hex) frame, calculate the sum of bits of each message from FN to ETX but
excluding STX. When check sum do not match, discard the message.
Where the text exceeds 240 bytes, it can be divided with ETB (ASCII code: 17H).
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S E S E
C C C L C C C L
T ..... T
1 2 R F
T ..... T
1 2 R F
X B X B
S E
C C C C L
.......... T .... R
T
1 2 R F
X X
The control codes are shown in < > in the following figure.
Host Analyzer
<ENQ> 1) <ENQ>
<ACK> 2) <ACK>
Data 1 3) <STX><FN><TEXT><ETB><C1><C2><CR><LF>
<ACK> 4) <ACK>
<STX><FN><TEXT><ETB><C1><C2><CR><LF>
<ACK>
1) THE data transmit side transmits ENQ in order to establish a data link.
2) Permission for transmit is sent from the receive side to the transmit side responding to ENQ after
completion of preparation to receive at the receive side.
3) Data 1 (intermediate frame)
4) When the receive side has received the data correctly, ACK is sent to the transmit side.
5) End of data (last frame)
6) Link is opened.
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Data reception
Send data Data reception
Sending data ENQ ETX EOT ACK NAK Timer timeout interruption
Status No sending data Data reception timeout timeout
exist reception reception reception reception reception T1: 15 sec timeout
T2: 15 sec T3: 30 sec
T4: 15 sec
Send ENQ
Send ACK
Start T1 timer
Start T3 timer
Initialization Status to No action No action No action No action No action No action No action No action No action No action
Status to “Data
“Establishing
reception”
connection”
Stop T1 timer
Stop T1 timer Stop T1 timer
Send data
Establishing Wait 1 sec. Send ENQ Send EOT
No action No action No action No action Start T2 timer No action No action No action No action
connection Send ENQ Restart T1 timer Status to
Status to “Waiting
Start T1 timer “Initialization”
response”
Send data
Send EOT
Start T2 timer
Connected Status to No action No action No action No action No action No action No action No action No action No action
Status to “Waiting
“Initialization”
response”
Stop T2 timer Stop T2 timer
Stop T2 timer
Send EOT Send EOT
Waiting Status to Send data again
No action No action No action No action Start T4 timer No action No action Return data No action No action
response “Establishing Restart T2 timer
Status to Status to
connection”
“Initialization-2” “Initialization”
Stop T3 timer
Restart T3 timer
Stop T3 timer Restart T3 timer Discard corrupted
Status to
Data reception No action No action No action Status to No action No action Data reception No action No action received data No action
“Completing data
“Initialization” Send ACK/NAK Status to
reception”
“Initialization”
Stop T3 timer
Stop T3 timer Discard corrupted
Completing data
No action No action No action No action Status to No action No action No action No action No action received data No action
reception
“Initialization” Status to
“Initialization”
Stop T4 timer
Send ACK Stop T4 timer
Initialization-2 No action No action Start T3 timer No action No action No action No action No action No action No action No action Status to
Status to “Data “Initialization”
reception”
Note 1: Wait timer between characters are 100ms. At time out, the action will be the same as receiving NAK.
Note 2: At data re-transmission, sequence number should be the same as original data transmission.
Note 3: At data reception, characters before STX and after ETB and ETX should be discarded.
Note 4: All received data without sequential sequence number should be discarded.
Note 5: Retry of data re-transmission must be seized after fifth try. In this case, send EOT and change status to Initialization at the same time generate error.
Note 6: Host should return status to Initialization after no connection for 20 seconds from the analyzer.
Note 7: Maximum retry for ENQ is ten. After the tenth retry, generate an error then start over.
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Process
Max. upon This system Process on transmission
Field # Designation Omission
digits reception used/unused from Analyzer
from Host
1) Record type 1 Abandoned used disapproved Record type "H"
Delimiters established in
2) Delimiter 4 Abandoned used disapproved this system (|, back slash, ^
and &)
Message
3) 0 - unused - -
control ID
Access
4) 0 - unused - -
password
Name of Name of Analyzer defined
5) 32 Abandoned used disapproved
Analyzer in this system
Address of
6) 0 - unused - -
sender
Reserved
7) 0 - unused - -
field
Telephone
8) number of 0 - unused - -
sender
Characteristic
9) 0 - unused - -
of sender
10) Recipient ID 0 - unused - -
Note or
11) special 0 - unused - -
instruction
12) Process ID 0 - unused - -
13) Version No. 0 - unused - -
Date and time at
14) Date & time 14 Abandoned used disapproved transmission.
YYYYMMDDHHMMSS
Meanings of “used/unused”:
used: data available at transmit side;
unused: no data at transmit side.
Meanings of “Omission”:
disapproved: omission is not approved;
approved: omission is approved.
-: The item is not used in this system and thus must be omitted.
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*1 Universal Test ID for test order record when ISE of ASTM is separated.
Universal Test ID Description
00 No order
01 – 60 Clinical Chemistry (*Note)
61 ISE (Na)
62 ISE (K)
63 ISE (Cl)
64 Diluted ISE (Na)
65 Diluted ISE (K)
66 Diluted ISE (Cl)
81 Serum Information (H, L, I)
91 - 98 Profile 1 to 8
Universal Test ID for test order record when ISE of ASTM is not separated.
Universal Test ID Description
00 No order
01 – 60 Clinical Chemistry
61 ISE (Na, K, Cl)
62 Diluted ISE (Na, K, Cl)
81 Serum Information (H, L, I)
91 - 98 Profile 1 to 8
*Note. Analyzer transmit Universal Test ID with zero suppress when Universal Test ID is from “1” to “9”.
Use delimiter “^” for delimiting test ID and use “¥” for multiple entry of test ID.
(Example 1) In case of order test ID No.1
O|1|001||^^^01
Describe test ID on the each part which is delimited by “^” when ASTM is not complied.
(Example 1) In case of order test ID No.1
O|1|001||01
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*1 Universal Test ID for test order record when ISE of ASTM is separated.
Universal Test ID Description
00 No order
01 – 60 Clinical Chemistry (*Note)
1001 ISE (Na)
1002 ISE (K)
1003 ISE (Cl)
1004 Reserve
1005 Diluted ISE (Na)
1006 Diluted ISE (K)
1007 Diluted ISE (Cl)
1008 Serum Information (H, L, I)
2001 SI (H,L,I)
Universal Test ID for test order record when ISE of ASTM is not separated.
Universal Test ID Description
1001 ISE (Na, K, Cl)
1005 Diluted ISE (Na, K, Cl)
*Note. Analyzer transmit Universal Test ID with zero suppress when Universal Test ID is from “1” to “9”.
Use delimiter “^” for delimiting test ID and use “¥” for multiple entry of test ID.
(Example 1) In case of order test ID No.1
O|1|001||^^^01
Describe test ID on the each part which is delimited by “^” when ASTM is not complied.
(Example 1) In case of order test ID No.1
O|1|001||01
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Host Interface Specifications Version 9
Process
Process on
Max. upon This system
Field # Designation Omission transmission from
digits reception used/unused
Analyzer
from Host
1) Record type 1 Abandoned used disapproved Record type “R”
Sequence
2) 6 Abandoned used disapproved Serial number (1 –)
number
Universal Test Method code 00 – 99
3) 5 Abandoned used disapproved
ID Refer to the table below
zzzzzzzzzz9.99999
Test results
Decimal place which is
4) (Concentration 17 Abandoned used disapproved
entered in Chemistry
value)
parameter.
5) Unit 8 Abandoned used disapproved Unit for results
Range of
6) 0 - unused - -
reference value
Followings will be sent.
Technical range code,
Normal range code,
Error flag code,
7) Flag 42 Abandoned used disapproved
Rerun result flag code,
QC flag code
Use “^” as delimiter.
Refer to the table below
Conditions for
8) the range of 0 - unused - -
reference value
9) Status 0 - unused - -
Date when
10) reference value 0 - unused - -
is changed
Operator
11) 0 - unused - -
identification
Date and time
of
12) 0 - unused - -
commencement
of test
Date and time
13) of completion 14 Abandoned used disapproved YYYYMMDDHHMMSS
of test
Instrument
14) 0 - unused -
Identification
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Transmission
Description Priority Display
code
A Error occurred 1 Error flag
> Techinical range over "High" 2 >
< Techinical range over "Low" 2 <
H Normal range over "High" 3 H
L Normal range over "High" 3 L
N Normal 4 N/A
LL Unused - -
HH Unused - -
U Unused - -
D Unused - -
B Unused - -
W Unused - -
Note: The length of data is varies with the details setting on System Parameters => System (F9)
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3.7.1.3
Error flag code for CA400
Code Display
00 (none) normal
60 IE1 Requirement of ISE measurement is abnormal
61 IE2 Not received ISE measurement result data
62 IE ISE unit abnormal
38 SPS SPT clot
01 SS Sample short
02 SS Sample liquid level detection out of range at aspiration
03 SI1 Sample liquid level not detected at aspiration
04 SI1 Sample liquid level detection out of range at dispensation
05 SI2 Sample short (diluted sample)
06 SI2 Sample liquid level detection out of range at aspiration (diluted sample)
07 R1S R1 short
08 R1S R1 liquid level detection out of range at aspiration
09 R2S R2 short
10 R2S R2 liquid level detection out of range at aspiration
15 DS Diluent short
16 DS Diluent liquid level detection out of range at aspiration
17 WS Wash solution short
18 WS Wash solution liquid level detection out of range at aspiration
19 R1B R1 bottle not registered
20 R1S R2 Reagent reached zero volume
21 R2B R2 bottle not registered
22 R2S R2 reagent reached zero volume
27 DB No dilution bottle
28 DS Dilution reached zero volume
29 WB No wash solution bottle
30 WS Wash solution reached zero volume
32 LOT Lot inconsistency
33 SPW Failed SPT wash
34 R1W Failed RPT 1 wash
35 R2W Failed RPT 2 wash
40 TE1 IRU temperature less than 35 degrees centigrade.
41 TE2 IRU temperature more than 39 degrees centigrade.
42 TE3 RCU temperature more than 15 degrees centigrade.
43 TE4 ASP temperature more than 10 degrees centigrade.
31 EST Anomalous measurement
50 EXP Over reagent expire date.
51 STB Reagent stability expired
52 CTO Calibration expired
53 CXP Control expired
54 SXP Calibrator expired
70 CA? Absorbance measurement error
71 OVR Calibrator range over
72 LIN Linearity limit error
73 PRO Prozone limit error
74 AB1 Absorbance limit error 1
75 AB2 Absorbance limit error 2
83 CLT Reagent lot different from calibration lot
82 STM Sample type inconsistent
76 DUP Duplicate limit error
77 SEN Sensitivity Limit error
78 CAL Calibration failed
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3.7.1.4
Error flag code
Code Display
00 (none) normal
01 SS Sample short
02 SS Sample liquid level detection out of range at aspiration
03 SI1 Sample liquid level not detected at aspiration
04 SI1 Sample liquid level detection out of range at dispensation
05 SI2 Sample short (diluted sample)
06 SI2 Sample liquid level detection out of range at aspiration (diluted sample)
07 R1S R1 short
08 R1S R1 liquid level detection out of range at aspiration
09 R2S R2 short
10 R2S R2 liquid level detection out of range at aspiration
11 DS Diluent short
12 DS Diluent liquid level detection out of range at aspiration
13 WS Wash solution short
14 WS Wash solution liquid level detection out of range at aspiration
15 TE1 IRU temperature less than 35 degrees centigrade.
16 TE2 IRU temperature more than 39 degrees centigrade.
17 TE3 RCU temperature more than 15 degrees centigrade.
20 R1B R1 reagent bottle not registered.
21 R1S R1 reagent no inventory
22 R2B R2 reagent bottle not registered.
23 R2S R2 reagent no inventory
24 DB Diluent bottle not registered.
25 DB Diluent no inventory
26 WB Wash solution bottle not registered.
27 WB Wash solution no inventory
28 IE1 No response from ISE module.
29 IE2 No measurement result from ISE module.
30 EST Sampling stop due to error
31 LOT Reagent lot number mismatch
32 R1W RPT wash between methods failed (R1)
34 R2W RPT wash between methods failed (R2)
35 EXP Measured with expired reagent
36 STB Measured with expired onboard stability reagent
60 DUP Duplicate limit error
61 SEN Sensitivity limit error
62 CAL Calibration failed
63 CA? No valid calibration curve
64 FIT Fit limit error
65 LIN Linearity limit error
66 PRO Prozone limit error
67 AB1 Only 1 point is within absorbance limit
68 AB2 Not all but more than 2 points are within absorbance limit
69 CTO Terms of validity of calibration is expired
70 OVR Calibrator out of valid range error
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QC flag code
The QC flag code consists of 10 fields. The fields will be separated by delimiter”^”.
Field Description QC flag code
1 Current result exceeds 2SD 00: Normal, 01: Warning, 02: Error
2 Current result exceeds 3SD 00: Normal, 01: Warning, 02: Error
3 Current result exceeds 4SD 00: Normal, 01: Warning, 02: Error
4 Last two results exceed 2SD range 00: Normal, 01: Warning, 02: Error
5 2 results out of 3 last results exceed 2SD 00: Normal, 01: Warning, 02: Error
6 Range for a defined period exceeds 4SD 00: Normal, 01: Warning, 02: Error
7 Any 3 results for a defined period exceed 1SD 00: Normal, 01: Warning, 02: Error
8 Any 4 results for a defined period exceed 1SD 00: Normal, 01: Warning, 02: Error
9 Last 10 results higher or lower than mean 00: Normal,
01: Warning (higher), 02: Error (higher),
03: Warning (lower), 04: Error (lower)
10 Last 7 results trend 00: Normal,
01: Warning (increasing), 02: Error (increasing),
03: Warning (decreasing), 04: Error (decreasing)
Note: All items set to “Inactive” at QC, QC settings screen will be set to “00”.
Note: Results for non QC measurements such as normal, emergency and standards will have “00” for
all 10 fields.
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4. Communication sequence
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The following table describes the result output functions for each communication mode.
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5. Communication Sequence
Following is the example of communication at On-line batch-1 and batch–2 modes with result transmission
operation.
Example of communication
Host Analyzer
1. Message Header Record
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
P|1|PID2734|||Last^Middle^First||19630501|M|Race1|||| 2. Patient Information Record
AttenPhID|1234567890123<CR>
←
O|1|001||^^^1<CR> 3. Test Order Record
←
C|1|I|TestOrder1|G<CR> 4. Comment Record
←
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The following is an example of communication when test order acquisition operation was done at test
ordering screen at online batch mode.
The test order acquired will be added or over written to the existing order after it is confirmed and edited if
necessary.
Example of communication
Host Analylzer
Inquiry from Analyzer to
Host
1. Message Header Record
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
Q|1|ALL||||||||||N<CR> 2. Request Information
← Record
L|1<CR> 3. Message Terminator
← Record
Response from Host
4. Message Header
Record H|¥^&|||Host|||||||||20010111055303<CR>
→
5. Patient Information P|1|PID2734|||Last^Middle^First||19630501|M|Race1||||
Record AttenPhID|1234567890123<CR>
→
6. Test Order Record O|1|001||^^^01¥^^^^03<CR>
→
7. Comment Record C|1|I|TestOrder1|G<CR>
→
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Host Interface Specifications Version 9
The inquiry is made at online real-time mode during run to obtain test order from Host.
Example of communication
Host Analyzer
Inquiry from Analyzer to
Host
1. Message Header Record
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
Q|1|910000000001||||||||||N<CR> 2. Request Information
← Record
L|1<CR> 3. Message Terminator
← Record
Response from Host
4. Message Header
Record H|¥^&|||Host|||||||||20010111055303<CR>
→
5. Patient Information P|1|PID2734|||Last^Middle^First||19630501|M|Race1||||
Record AttenPhID|1234567890123<CR>
→
6. Test Order Record O|1|910000000001||^^^01¥^^^03<CR>
→
7. Comment Record C|1|I|TestOrder1|G<CR>
→
8. Message L|1<CR>
Terminator Record →
Note: When there is no order for inquired sample, return order information with empty universal test ID
field
Note: When rerun is not required at host rerun mode, rerun order information with empty universal test ID
field (“00”). However, auto rerun is performed on the method of which the setting is auto rerun.
Note: Comment information can be omitted.
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The result is transmitted to Host when results for a sample is obtained during run. This transmission is
performed at online real-time mode and online batch mode-2.
Example of transmission
Host Analyzer
1. Message Header Record
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
P|1|PID2734|||Last^Middle^First||19630501|M|Race1|||| 2. Patient Information Record
AttenPhID|1234567890123<CR>
←
O|1|910000000001||^^^01<CR> 3. Test Order Record
←
C|1|I|TestOrder1|G<CR> 4. Comment Record
←
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6. Error Handling
6.1 Transmission error
When transmission of a message has caused an error, re-transmission of the message will be carried out
from a message one level above the message.
The buffered data will be save at reception of higher level message.
Host Analyzer
1. Message Header Record
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
P|1|PID2734|||Last^Middle^First||19630501|M|Race1|||| 2. Patient Information Record
AttenPhID|1234567890123<CR>
←
O|1|001||^^^1<CR> 3. Test Order Record
←
C|1|I|TestOrder1|G<CR> 4. Comment Record
←
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5) 1) 2) 3) 4) 5)
6) 1) 2) 3) 4) 5) 6)
7) 1) 2) 3) 4) 5) 6) 7)
8) 1) 2) 3) 4) 5) 6) 7) 8)
9) 1) 8) 9)
10) 1) 8) 9) 10)
11) 1) 8) 9) 10) 11)
12) 1) 8) 9) 10) 11) 12)
13) 1) 12) 13)
14) 1) 12) 13) 14)
15) 1) 12) 13) 14) 15)
16) 1) 12) 13) 14) 15) 16)
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When message “4)” is not received for T1 time out time after transmitting “3)”, it will be handled as
described on the table below. For the messages 5) to 14) will be handled as an error in case message is not
received for T2 time out time.
Host Analyzer
4. Message Header
Record H|¥^&|||Host|||||||||20010111055303<CR>
→
5. Patient Information P|1|PID2734|||Last^Middle^First||19630501|M|Race1||||
Record AttenPhID|1234567890123<CR>
→
6. Test Order Record O|1|001||^^^01¥^^^03<CR>
→
7. Comment Record C|1|I|TestOrder1|G<CR>
→
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6.2.2 Error during test order inquiry for a sample at real-time mode
Host Analyzer
4. Message Header
Record H|¥^&|||Host|||||||||20010111055303<CR>
→
5. Patient Information P|1|PID2734|||Last^Middle^First||19630501|M|Race1||||
Record AttenPhID|1234567890123<CR>
→
6. Test Order Record O|1|910000000001||^^^01¥^^^03<CR>
→
7. Comment Record C|1|I|TestOrder1|G<CR>
→
8. Message L|1<CR>
Terminator Record →
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End.
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