SH - BX4000 Online Interface

Host Interface Specifications Version SP-E7233-0A
Software Specifications
BX-4000 Host Interface
Revision History
REV DATE REVISION HIGHLIGHT
- Aug.,2011 Initial issue
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 .................................................................................................. 7
3. High level control .................................................................................................... 9
3.1 Command Record .......................................................................................................... 9
3.2 Data Character Code ..................................................................................................... 9
3.3 Sequence Number ......................................................................................................... 9
3.4 H: Message Header Record ........................................................................................ 10
3.5 P: Patient Information Record .......................................................................................11
3.6 O: Test Order Record ................................................................................................... 12
3.7 R: Result Record .......................................................................................................... 15
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.................................................................. 26
5.2 Real-time Sequence..................................................................................................... 27
5.2.1 Real-time inquiry to Host for one sample and its response.................................. 27
5.2.2 Real-time transmission of result to Host for one sample...................................... 28
5.4 Error Handling .............................................................................................................. 29
5.4.1 Transmission error ............................................................................................ 249
5.4.2 Reception Error ................................................................................................... 32
5.4.3 Retry over.............................................................................................................. 33
1. Introduction
This document specifies the communication scheme between the BX-4000 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
1.1 System configuration

The communication between the Analyzer and the external Host is conducted with the RS232C interface.
The interconnection between them is shown below:
On Line System
Host Computer
Clinical Chemistry
Analyzer
RS２３２C
Figure 1-1 Interconnection between Analyzer and Host
1/33
2. Low level control

The specifications of connectors, cables, protocol, etc. which are necessary for exchange of messages
between Host and Analyzer, are given in the following sub clauses.
2.1 Physical Layer

2.1.1 Communication specifications
Item Specifications Default value

1 Transmission mode Synchronous RS232C start-stop transmission
Half-duplex
2 Transmission rate 300/1200 / 2400 / 4800 / 9600 / 19200 9600
3 Transmission code ASCII
4 Date length 7 bits / 8 bits 8 bits
5 Parity Odd / even / none Even parity
6 Start bit 1 bit / 2 bits 1 bit
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.
2.1.3 Pin assignment
Pin number Signal

designation
1 CD
2 RD
3 TD
4 DTR
5 GND
6 DSR
7 RTS
8 CTS
9 RI
2.1.4 Interface signals

Table 1 Functions of interface signals
Abbreviation Signal designation Function

CD Carrier Detect Not monitored
RD Receive Data Pin for data reception
TD Transmit Data Pin for data transmission
DTR Data Terminal Ready Set to ON when host communication is ready
GND Signal Ground Ground
DSR Data Set Ready Monitor the host. When this is OFF, host may be turned off
or cable is broken.
RTS Request To Send Set to ON while data reception is available. Set to OFF when
the data buffer is full and cannot receive data.
CTS Clear To Send Wait data transmission till this becomes ON.
RI Ring Indicator Not monitored
2/33
2.1.5 Cable specifications
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
3/33
2.2 Data Link Layer

The information necessary to ensure the exchange of messages between Host and Analyzer is shown in the
following sub clauses.
2.2.1 Summary of transmission control characters

ASCII
Designation Meanings Remarks
code
ENQ Acknowledge 05H Request for transmission
EOT End of Transmission 04H Link opening
ACK Acknowledge 06H Positive acknowledgement
NAK Negative Acknowledge 15H Negative acknowledgement
STX Start of Text 02H Start of text
ETX End of Text 03H End of text in the final frame
ETB End of Transmission Block 17H End of text in the intermediate frame
2.2.2 Message composition

1 2 … n-1 n
Field # 1) 2) 3) 4) 5) 6) 7) 8) 9)
S E L
F C C C C (n ≤ 247)
Item T TEXT T F
N R 1 2 R
X X
Field # Item Data length Description

1) STX 1 To indicate the start of frame (ASCII code: 02H)
2) FN 1 Sequence number of frame (0 – 7) (Note 1)
3) TEXT 239 Text (Note 2)
4) CR 1 (ASCII code: 0DH)
5) ETX 1 To indicate the end of frame (ASCII code: 03H) (Note 3)
6) C1 1 The upper digit of checksum (Note 4)
7) C2 1 The lower digit of checksum
8) CR 1 (ASCII code: 0DH)
9) LF 1 (ASCII code: 0AH)
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. When divide by ETB,
it will be processed as new sequence number. Default setting is “1”.
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 from 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
excluding STX and use last two digits. When check sum do not match, discard the message.
4/33
Where the text exceeds 240 bytes, it can be divided with ETB (ASCII code: 17H).
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
2.2.3 Transmission procedure
2.3.3.1
Transmission of data from Analyzer to Host.
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>
Last data 5) <STX><FN><TEXT><CR><ETX><C1><C2><CR><LF>

<ACK> <ACK>
<EOT>
6) <EOT>
1) Analyzer transmits ENQ in order to establish a data link.

2) ACK is sent from Host after it is ready for communication.
3) Data 1 (intermediate frame)
4) When host has received the data correctly, ACK is sent to the analyzer.
5) End of data (last frame)
6) Link is opened.
5/33
2.3.3.2
Transmission of data from Host to analyzre
The control codes are shown in < > in the following figure.
Host Analyzer
1) <ENQ>
<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>
Last data 5) <STX><FN><TEXT><CR><ETX><C1><C2><CR><LF>

<ACK> <ACK>
<EOT>
6) <EOT>
1) Host transmits ENQ in order to establish a data link.

2) ACK is sent from analyzer after it is ready for communication.
3) Data 1 (intermediate frame)
4) When analyzer has received the data correctly, ACK is sent to the host.
5) End of data (last frame)
6) Link is opened.
6/33
2.2.4 Status transition table
Sending data No sending ENQ ETX EOT ACK

Status
exist data reception reception reception reception
Send ENQ
Send ACK
Start T1 timer
Start T3 timer
Initialization Status to No action No action No action No action
Status to “Data
“Establishing
reception”
connection”
Stop T1 timer
Stop T1 timer Send data
Establishing Wait 1 sec. Start T2 timer
No action No action No action No action
connection Send ENQ Status to
Start T1 timer “Waiting
response”
Send data
Start T2 timer Send EOT
Connected Status to Status to No action No action No action No action
“Waiting “Initialization”
response”
Stop T2 timer
Send EOT Stop T2 timer
Waiting Start T4 timer Status to
No action No action No action No action
response Status to “Establishing
“Initialization- connection”
2”
Restart T3
timer Stop T3 timer
Data
No action No action No action Status to Status to No action
reception
“Completing “Initialization”
data reception”
Completing Stop T3 timer
data No action No action No action No action Status to No action
reception “Initialization”
Stop T4 timer
Send ACK
Initialization-
No action No action Start T3 timer No action No action No action
2
Status to “Data
reception”
7/33
Data
Data
Send data reception
NAK Data Timer timeout reception
Status timeout interruption
reception reception T1: 15 sec timeout
T2: 15 sec timeout
T3: 30 sec
T4: 15 sec
Initialization No action No action No action No action No action No action
Stop T1 timer
Send ENQ
Establishing Send EOT
Restart T1 No action No action No action No action
connection Status to
timer
“Initialization”
Connected No action No action No action No action No action No action
Stop T2 timer
Send data
Send EOT
Waiting again
No action No action Return data No action No action
response Restart T2
Status to
timer
Stop T3 timer
Restart T3
Discard
timer
Data corrupted
No action Data reception No action No action No action
reception received data
Send
Status to
ACK/NAK
Stop T3 timer
Discard
Completing
corrupted
data No action No action No action No action No action
received data
reception
Status to
Stop T4 timer
Initialization-
No action No action No action No action No action Status to
2
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: Maximum retry of data re-transmission is five times. After the fifth retry, EOT will be sent and
change status to initialization. Error must be displayed in this condition.
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.
8/33
3. High level control

3.1 Command Record
Following table defines usage of the command record types.
Type Function name Level Transmission Reception

1 H Message Header Record 0 Used Used
2 P Patient Information Record 1 Used Used
3 O Test Order Record 2 Used Used
4 R Results Record 3 Used Used
5 C Comment Record - Used Used
6 Q Request Information Record - Used Not used
7 L Message Terminator Record 0 Used Used
8 S Scientific Record 1 Not used Not used
9 M Manufacturer Information Record - Not used Not used
*Level: 0(Higher) > 3(Lower)
3.2 Data Character Code

Following table defines availability of the characters
Code (Decimal system)
0 - 31 7, 9, 11, 12, 13 can be used.
13 Reserved as record terminator
32 - 90 Allowed
92 -126
128 - 254
92, 127, 255 Not allowed
Note: When double quotation (ASCII 34) is found, discard it (do not treat as data).
3.3 Sequence Number

The sequence number shall be generated for every message. Initial value shall be “1”. Every
transmission inclement the number by “1”. The number will set back to “1” at transmission of separate
command with same level or command with higher level.
9/33
3.4 H: Message Header Record

The string specifies the Analyzer and Host between which messages are exchanged. This also specifies
each delimiter character for field, repeat, component and escape delimiters.
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.
10/33
3.5 P: Patient Information Record

The string is sent from host to analyzer at ordering test requests. This is also sent from analyzer to host
when sending test results which as specified by host.
Process upon Process on
Field Max. This system
Designation reception from Omission transmission
# digits used/unused
Host from Analyzer
1) Record type 1 Abandoned used disapproved Record type “P”
2) Sequence number 6 Abandoned used disapproved
Send as received
Used for When ID is
3) Patient ID 13 transmission, used disapproved NULL, “P” will
display, print be added sample
ID.
Laboratory assigned
4) 0 - unused - -
Patient ID
5) Patient ID #3 0 - unused - -
Characters:
6) Patient Name 36 used approved Send as received
within 18 letters
7) Mother’s Maiden Name 0 - unused -
approved
8) Date of Birth 8 YYYYMMDD used Send as received
(*1)
M: Male
approved
9) Sex 1 F: Female used Send as received
(*2)
U: Unknown
10) Race 16 used approved Send as received
11) Patient Address 0 - unused -
12) Reservation 0 unused -
13) Phone Number 0 unused -
Used for
14) Attending Physician ID 32 transmission, used approved Send as received
display, print
Used for
transmission,
15) Special Field 1 13 used approved Send as received
display, print
Social Security #
Used for
1
transmission,
See
display, print
16) Special Field 2 note used approved Send as received
belo
Blood Type
w(*3)
17) Patient Height 0 - unused -
18) Patient Weight 0 - unused -
Patient Known or
19) 0 - unused -
suspected Diagnosis
Patient Active
20) 0 - unused -
Medications
21) Patient Diet 0 - unused -
22) Practice Field #1 0 - unused -
23) Practice Field #2 0 - unused -
Admission and
24) 0 - unused -
Discharge Dates
25) Admission Status 0 - unused -
43 Used for
26) Location See transmission, used approved Send as received
note display, print as
11/33
belo Classification,
w(*4) Location, Ward and
Bed No.
Nature of Alternative
27) Diagnostic Code and 0 - unused -
Classifiers
Alternative Diagnostic
28) 0 - unused -
Code and Classifiers
29) Patient Religion 0 - unused -
30) Marital Status 0 - unused -
31) Isolation Status 0 - unused -
32) Language 0 - unused -
33) Hospital Service 0 - unused -
34) Hospital Institution 0 - unused -
35) Dosage Category 0 - unused -
*1 When “Date of Birth” is abbreviated, “G2” will be used for normal range.
*2 When “Sex” is abbreviated, “Unknown” will be used for “Sex”.
When “Unknown” is selected as “Sex”, “Male” will be used for normal range
*3 Blood type should be as follows;
Code No. Blood type

1 A Rh+
2 A Rh-
3 B Rh+
4 B Rh-
5 O Rh+
6 O Rh-
7 AB RH+
8 AB Rh-
*4 Format of (Classification), (Location), (Ward) and (Bed No.) should be as follows;

(Classification)^(Location)^(Ward)^(Bed No.)
3.6 O: Test Order Record

Order for test items are transmitted from Host to Analyzer.
The measurement results of test items requested are transmitted from Analyzer to Host.
3.6.1 Test Order Record for CA400
Max. This system
Field # Designation reception from Omission transmission
digits used/unused
Host from Analyzer
1) Record type “O” 1 abandoned used disapproved Record type “O”
2) Sequence number 6 abandoned used disapproved
Sample ID
001 to
999999999999999
(Except for
3) Sample ID 15 used disapproved Send as received
89990001 to
8999999,
91000001 to
99999999)
4) Equipment specimen ID 0 - unused -
5) Universal Test ID 100 See note below *1 used disapproved Send as received
6) Priority 0 - unused -
7) Date and time of order 0 - unused -
12/33
Send as received
8) Date and time of sample YYYYMMDDHH
14 used disapproved or manually
extraction MMSS
entered
Date and time of
9) completion of sample 0 - unused -
extraction
10) Extracted volume 0 - unused -
Name who extracted
11) 0 - unused -
sample
12) Treatment code 0 - unused -
13) Danger code 0 - unused -
Relevant clinical
14) 0 - unused -
information
Date and time of receipt
15) 0 - unused -
of sample
16) Specimen Descriptor 0 - unused -
17) Specimen Type 0 See note below *2 used approved Send as received
18) Specimen Source 0 - unused -
19) Ordering Physician 0 - unused -
Physician’s Telephone
20) 0 - unused -
Number
21) Users Field No.1 0 - unused -
22) Users Field No.2 0 - unused -
Date/Time Results
23) Reported or Last 0 - unused -
Modified
Instrument Charge to
24) 0 - unused -
Computer System
25) Instrument Section ID 0 - unused -
26) Report Types 0 - unused -
27) Reserved Field 0 - unused -
Location or Ward of
28) 0 - unused -
Specimen Collection
Nosocomial Infection
29) 0 - unused -
Flag
30) Specimen Service 0 - unused -
31) Specimen Institution 0 - unused -
*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.
00 No order
01 – 60 Clinical Chemistry
61 ISE (Na, K, Cl)
13/33
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||^^^1
(Example 2) In case of order test ID No.15, 21 and 30

O|1|001||^^^15¥^^^21¥^^^30
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||1
(Example 2) In case of order test ID No.15, 21 and 30

O|1|001||15^21^30
*2 Specimen Type
Specimen Type Description
01 COMMON
02 SERUM
03 URINE
04 PLASMA
When “Specimen Type” is abbreviated, “Common” will be used.
14/33
3.7 R: Result Record

Test results of test items are notified.
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 0 - 3999
ID Refer to the table below
zzzzzzzzzz9.99999
Decimal place which is
entered in Chemistry
Test results
parameter.
4) (Concentration 17 Abandoned used disapproved
value)
“*****” should be
transmitted when result is
“*****”.
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,
7) Flag 42 Abandoned used disapproved Error flag code,
Rerun result flag code,
QC flag code 1 – 10.
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
15/33
Universal Test ID for test result record

01 – 60 Clinical Chemistry
61 ISE (Na)
62 ISE (K)
63 ISE (Cl)
64 Diluted ISE (Na)
65 Diluted ISE (K)
66 Diluted ISE (Cl)
71 – 80, 3011 - 3040 Method-to-method computation
81 Serum Information (H)
82 Serum Information (L)
83 Serum Information (I)
In case “Full compliance with ASTM rules”.

Use delimiter “^” for delimiting test ID.
(Example 1) In case of transmission of test result for test ID No. 61 to the host.
R|1|^^^61||346|mmol/l/||00^01^00||||||20040119143714
In case “Non compliance with ASTM rules”.

(Example 2) In case of transmission of test result for test ID No. 61 to the host.
R|1|61||346|mmol/l/||00^01^00||||||20040119143714
16/33
3.7.1 Test result error flag code
3.7.1.1 Full compliance with ASTM rules
Transmission
Description Priority Display
code
A Error occurred 1 Error flag
> Technical range over "High" 2 >
< Technical range over "Low" 2 <
H Normal range over "High" 3 H
L Normal range over "High" 3 L
N Normal 4 no display
LL Unused - -
HH Unused - -
U Unused - -
D Unused - -
B Unused - -
W Unused - -
3.7.1.2 Non compliance with ASTM rules
The “flag” consists of the following 5 codes. The format of flag is

99^99^99^99^99^99^99^99^99^99^99^99^99^99 in the order corresponding to Technical range code,
Normal range code, Error flag code, Rerun result code and QC flag code from 1 to 10.
Note: The length of data varies with the details setting on System Parameters => System (F9)
Technical range code

Code Display Description
00 (None) Within technical range.
01 > Technical range over “High”
02 < Technical range over “Low”
Normal range code

Code Display Description
00 (None) Within normal range.
01 H Normal range over “High”
02 L Normal range over “Low”
17/33
Error flag code
Code Display
00 － 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
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 reagent bottle not registered.
20 R1S R1 reagent no inventory
21 R2B R2 reagent bottle not registered.
22 R2S R2 reagent no inventory
27 DB Diluent bottle not registered.
28 DS Diluent no inventory
29 WB Wash solution bottle not registered.
30 WS Wash solution no inventory
31 EST Sampling stop due to error
32 LOT Reagent lot number mismatch
33 SPW SPT wash failure
34 R1W RPT wash between methods failed (R1)
35 R2W RPT wash between methods failed (R2)
38 SPS SPT clot
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.
50 EXP Measured with expired reagent
51 STB Measured with expired onboard stability reagent
52 CTO Terms of validity of calibration is expired
53 CXP Control expired
54 SXP Calibrator expired
60 IE1 No response from ISE module.
61 IE2 No measurement results from ISE module.
62 IE ISE unit abnormal
70 CA? Concentration calculation failure
71 OVR Calibrator out of valid range error
72 LIN Linearity Limit error
73 PRO Prozone Limit error
74 AB1 Absorbance Limit1 error
75 AB2 Absorbance Limit2 error
18/33
Code Display
76 DUP Duplicate Limit error
77 SEN Sensitivity Limit error
78 CAL Calibration failed
82 STM Sample type mismatch
83 CLT Reagent lot mismatch
84 CLM Measurement is not performed due to reagent mismatch.
Rerun result code

Code Description
00 First result
01 Rerun result
The QC flag code consists of 10 fields.

Field Description QC flag code
1 Current result exceeds 2SD 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: Only methods that are set as “Warning” or “Error” on QC -> QC setting of UI software will be
valid. All items set as “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.
19/33
3.8 C: Comment Record

Comment record can be sent following the records below;
Patient Information record, Test Order record, Result record, Scientific record and Manufacturer
Information record. The level of the comment record will be one level higher than the previous level.
Max. This system
Field # Designation reception from Omission transmission from
digits used/unused
Host Analyzer
1) Record type 1 Abandoned used disapproved Record type “C”
Sequence
number
Source of
3) 1 Fixed to “L” used disapproved Fixed to “1”
comment
Text of Status of Analyzer
4) 50 See below used disapproved
comment (separately defined)
Type of
5) 1 See below used disapproved Set to “G”
comment
Preceding message Comment type Usage of comment text

Patient G Abandon
Order G Reflect sample information
Result - Unused
Scientific G Abandon
Manufacturer G Abandon
3.9 Q: Request Information Record

On real time mode, this string will be used on every order inquiry. On batch mode, this string will be used
when acquiring test.
Max. This system
digits used/unused
Host Analyzer
1) Record type 1 Abandoned used disapproved Record type “Q”
2) Sequence number 1 Abandoned used disapproved Fixed to “1”
Fixed to “ALL” for
3) Starting Range ID # 12 Abandoned used disapproved
batch
4) Ending Range ID # 0 - unused -
5) Universal Test ID 0 - unused -
Nature of Request
6) 0 - unused -
Time Limits
Beginning Request
7) Results Date and 0 - unused -
Time
Ending Request
8) Results Date and 0 - unused -
Time
Request Physician
9) 0 - unused -
Name
Request Physician
10) 0 - unused -
Telephone Number
11) User Field No.1 0 - unused -
12) User Field No.1 0 - unused -
Request Information
13) 1 Abandoned used disapproved Fixed to “N”
Status Code
20/33
3.10 L: Message Terminator Record

This string will be used when termination of transmission.

Max. This system
digits used/unused
Host Analyzer
1) Record type 1 Abandoned used disapproved Record type “L”
Sequence
2) 1 Abandoned used disapproved Fixed to “1”
number
Termination
3) 0 - unused -
Code
3.11 S: Scientific Record

Field Max. This system
Designation reception Omission transmission
# digits used/unused
from Host from Analyzer
Record type
1) Type 1 Abandoned used disapproved
"S"
2) Sequence number 1 Abandoned used disapproved Fixed to "1"
3) Analytical Method 0 - unused -
4) Instrumentation 0 - unused -
5) Reagents 0 - unused -
6) Units of Measure 0 - unused -
7) Quality Control 0 - unused -
8) Specimen Descriptor 0 - unused -
9) Reserved Field 0 - unused -
10) Container 0 - unused -
11) Specimen ID 0 - unused -
12) Analyte 0 - unused -
13) Result 0 - unused -
14) Result Units 0 - unused -
Collection Date and
15) 0 - unused -
Time
Result Date and
16) 0 - unused -
Time
Analytical
17) 0 - unused -
Preprocessing Steps
18) Patient Diagnosis 0 - unused -
19) Patient Birth date 0 - unused -
20) Patient Sex 0 - unused -
21) Patient Race 0 - unused -
3.12 M: Manufacturer Information Record

The manufacturer information record can be sent following the records below;
Patient Information record, Test Order record, Result record, Scientific record and Manufacturer
Information record. The level of the comment record will be one level higher than the previous level.
Max. This system
digits used/unused
Host Analyzer
1) Record type 1 Abandoned used disapproved Record type "M"
Sequence
2) 1 Abandoned used disapproved Fixed to "1"
number
21/33
4. Communication sequence
4.1 Communication Modes

The following table describes the test ordering functions for each communication mode.
Mode Status Local Batch Real time

Real time During RUN Normal and - Inquire orders for
Emergency samples normal samples.
can be entered and Emergency samples
edited manually. can only be handled
locally.
Stand-by Normal and - -
Emergency samples
can be entered and
edited manually.
Batch- (Note-1) During RUN Normal and - -
Emergency samples
can be entered and
edited manually.
Stand-by Normal and Acquire test orders for -
Emergency samples normal sample from
can be entered and host by clicking on
edited manually. “Acquire” button on
screen.
Off line During RUN Normal and - -
Emergency samples
can be entered and
edited manually.
Stand-by Normal and - -
Emergency samples
can be entered and
edited manually.
Note 1: The batch mode is a batch mode with real time result transmission to the host.
Note 2: An emergency sample should be handled locally not via host.
Note 3: The result for normal, emergency, online and control samples can be sent to host.
Note 4: All result obtained at off line, batch and real time modes will be stored in one database.
22/33
The following table describes the result output functions for each communication mode.
Mode Status Local Batch Real time

Real time During RUN Search, Edit and Disapproved Send result to host as
printout available soon as available
Stand-by Search, Edit and Send test results to No action
printout available host by choosing
“Host” as destination.
Batch-1 (Note-1) During RUN Search, Edit and Disapproved Send result to host as
printout available soon as available
Stand-by Search, Edit and Send test results to No action
printout available host by choosing
“Host” as destination.
Off line During RUN Search, Edit and - -
printout available
Stand-by Search, Edit and - -
printout available
Note 1: The batch mode is a batch mode with real time result transmission to the host.
Note 2: An emergency sample should be handled locally not via host.
Note 3: The result for normal, emergency, online and control samples can be sent to host.
Note 4: All result obtained at off line, batch and real time modes will be stored in one database.
23/33
5. Communication Sequence
5.1 Batch Sequence

5.1.1 Batch transmission of result to Host
Following is the example of communication on On-line batch mode with result transmission operation.
5.1.1.1 Analyzer will check communication status with Host at beginning of each round.
Host Analyzer
Communication check from
Analyzer to Host
<ENQ>
1. Reply inquiry (initial
<-------------------------------------------------- communication check *1)
<ACK>
2. Reply from host
---------------------------------------------------->
<EOT>
3. Link open
<---------------------------------------------------
*1 When reply from the host is <NAK> or no response, analyzer will re-try for 6 times. If <NAK> or no
reply continues for 6 times, analyzer will generate error message and will not proceed with the round.
5.1.1.2 Example of communication
Host Analyzer
1. Message Header Record

H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
P|1|PID2734|||Patient Name||19630501|M|Race1|||| 2. Patient Information
AttenPhID|1234567890123<CR> Record
←
O|1|001||^^^1<CR> 3. Test Order Record
←
C|1|I|TestOrder1|G<CR> 4. Comment Record
←
R|1|^^^1|15.265|mg/ml||||||||20010110121530<CR> 5. Result Record

←

←
←

←
←
←

←

←
24/33

←
←

←
L|1<CR> 16. Message Terminator

← Record
Note: Comment information can be omitted.

Note: There can be multiple messages of test order and test result for one patient information.
Note: Result record with error flag is not transmitted when it is set not to transmit result record when error
occurred.
25/33
5.1.2 Inquiry to host for order and response
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.
Example of communication
Host Analylzer
Inquiry from Analyzer to
Host
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
Q|1|ALL||||||||||N<CR> 2. Request Information
← Record
← Record
Response from Host
4. Message Header
H|¥^&|||Host|||||||||20010111055303<CR>
Record
→
5. Patient Information P|1|PID2734|||Patient Name||19630501|M|Race1||||
Record AttenPhID|1234567890123<CR>
→
6. Test Order Record O|1|001||^^^1¥^^^^03<CR>
→
7. Comment Record C|1|I|TestOrder1|G<CR>
→

→
9. Test Order Record O|1|890051||^^^5<CR>
→
→

→
→
→
14. Message Terminator L|1<CR>

Record →

Note: There can be multiple messages of test order and test result for one patient information.
26/33
5.2 Real-time Sequence

5.2.1 Real-time inquiry to Host for one sample and its response
The inquiry is made at online real-time mode during run to obtain test order from Host.
5.2.1.1 Analyzer will check communication status with Host at beginning of each round.
Host Analyzer
Communication check from
Analyzer to Host
<ENQ> 1. Reply inquiry (initial

<-------------------------------------------------- communication check *1)
<ACK> 2. Reply from host
---------------------------------------------------->
<EOT> 3. Link open
<---------------------------------------------------
*1 When the reply from the Host is <NAK> or no response, analyzer will re-try for 6 times. If <NAK> or
no reply continues for 6 times, analyzer will generate error message and will not proceed with the round.
5.2.1.2 Example of communication
Host Analyzer
Host
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
Q|1|910000000001||||||||||N<CR> 2. Request Information
← Record
← Record
Response from Host
4. Message Header
Record H|¥^&|||Host|||||||||20010111055303<CR>
→
5. Patient Information P|1|PID2734|||Patient Name ||19630501|M|Race1||||
→
6. Test Order Record O|1|910000000001||^^^01¥^^^3<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, return order information with empty universal test ID
field (“00”). However, auto rerun is performed for the method which is set as auto rerun.
27/33
5.2.2 Real-time transmission of result to Host for one sample
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.
Example of transmission
Host Analyzer
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
←
←
←

←

← Record
Note: Result is sent for one method per sample at a time.

Note: Universal test ID for test order record is transmitted as ID with the result.
Note: In case of result with an error, lines “H” to “L” are not transmitted if the setting is not transmitted
result record when error occurred.
28/33
5.4. Error Handling

5.4.1 Transmission error
When transmission of a message has caused an error, re-transmission of the message will be carried out
from high level message.
The buffered data will be save at reception of higher level message.
Host Analyzer
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
←
←
←
R|^^^1|15.265|mg/ml||||||||20010110121530<CR> 5. Result Record

←

←
←

←
←
←

←

←
←
←

←

← Record
Error occurring Re-transmission message

message
1) 1)
2) 1) 2)
3) 1) 2) 3)
4) 1) 2) 3) 4)
29/33
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)
30/33
5.4.2 Reception Error
5.4.2.1 Error during batch order inquiry and its response
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

Host
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
Q|1|ALL||||||||||N<CR> 2. Request Information
← Record
← Record
Response from host
4. Message Header
Record H|¥^&|||Host|||||||||20010111055303<CR>
→
→
→
→

→
→
→

→
→
→
14. Message L|1<CR>

Terminator Record →
Error occurring Error handling

message
4) to 14) Re-transmit 1), 2) and 3)
Note: Maximum re-transmission is three. When retry time over occurs, popup menu appears on the
screen to check connection.
Note: T1=10 seconds, T2= 5 seconds
31/33
5.4.2.2 Error during test order inquiry for a sample at real-time mode
Host Analyzer

Host
H|¥^&|||Analyzer|||||||||20010111055300<CR>
←
Q|1|910000000001||||||||||N<CR> 2. Request Information
← Record
← Record
Response from Host
4. Message Header
Record H|¥^&|||Host|||||||||20010111055303<CR>
→
→
→
→
8. Message Terminator L|1<CR>

Record →
Error occurring Error handling

message
4) to 8) Re-transmit 1), 2) and 3)
32/33
5.4.3 Abnormal data
Followings are the error handling when abnormal data is found.
5.4.3.1 Sequence Number

A duplicate sequence number will discarded and missing sequence number will inquired.
5.4.3.2 Abnormal data

Type of Message Type of Field Description
Message Header Delimiter When invalid character is assigned, the system used default
delimiters.
Patient Information Patient ID When patient ID with new information such as name, date of
birth, sex, Attending physician ID and SS# is received, all data
process after the reception will be based on new information.
Test Order Sample ID Test orders with invalid sample ID will be ignored. No
warning nor error message is displayed.
Method Tests ordered with methods not registered, short reagent or no
reagent will not be run. Message will be shown on screen to
notify operator.
Other available tests ordered together with invalid methods will
be run.
5.4.3.3 Retry over

Sequence Process
Batch transmission of results to Host Display error on screen.
Other operation other than host communication will be
continued.
Inquiry for test orders to Host Display error on screen.
Operation other than host communication will be
continued.
Real time inquiry for test order for a sample Generate an error. Transmit “No order” to analyzer.
Operation other than host communication will be
continued.
Real time result transmission to Host Generate an error. Results that ware not transmitted to
the host will be saved in data base. Saved results can be
transmitted manual from result search screen.
End.
33/33

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Host Interface Specifications Version SP-E7233-0A

1.1 System configuration

Figure 1-1 Interconnection between Analyzer and Host

2. Low level control

2.1 Physical Layer

Item Specifications Default value

2.1.3 Pin assignment

Pin number Signal

2.1.4 Interface signals

Abbreviation Signal designation Function

2.1.5 Cable specifications

2.2 Data Link Layer

2.2.1 Summary of transmission control characters

2.2.2 Message composition

Field # Item Data length Description

2.2.3 Transmission procedure

Last data 5) <STX><FN><TEXT><CR><ETX><C1><C2><CR><LF>

1) Analyzer transmits ENQ in order to establish a data link.

Last data 5) <STX><FN><TEXT><CR><ETX><C1><C2><CR><LF>

1) Host transmits ENQ in order to establish a data link.

2.2.4 Status transition table

Sending data No sending ENQ ETX EOT ACK

3. High level control

Type Function name Level Transmission Reception

3.2 Data Character Code

3.3 Sequence Number

3.4 H: Message Header Record

3.5 P: Patient Information Record

Code No. Blood type

*4 Format of (Classification), (Location), (Ward) and (Bed No.) should be as follows;

3.6 O: Test Order Record

62 Diluted ISE (Na, K, Cl)

(Example 2) In case of order test ID No.15, 21 and 30

(Example 2) In case of order test ID No.15, 21 and 30

3.7 R: Result Record

Universal Test ID for test result record

In case “Full compliance with ASTM rules”.

In case “Non compliance with ASTM rules”.

3.7.1 Test result error flag code

3.7.1.1 Full compliance with ASTM rules

3.7.1.2 Non compliance with ASTM rules

The “flag” consists of the following 5 codes. The format of flag is

Technical range code

Normal range code

Error flag code

Rerun result code

The QC flag code consists of 10 fields.

3.8 C: Comment Record

Preceding message Comment type Usage of comment text

3.9 Q: Request Information Record

3.10 L: Message Terminator Record

Process upon Process on

3.11 S: Scientific Record

3.12 M: Manufacturer Information Record

4.1 Communication Modes

Mode Status Local Batch Real time

Mode Status Local Batch Real time

5.1 Batch Sequence

5.1.1.2 Example of communication

1. Message Header Record