Biolis 50i Bi-Directional ASTM (Ver.1.01)

Automated Clinical Analyzer
BiOLiS 50i Superior
Bi-directional Communication
Specifications
Version 1.01
BiOLiS 50i superior Bi-directional Communication Specificetions
Table of Contents
1. Preface -------------------------------------------------------------------------------------- 1
2. Connection Codition --------------------------------------------------------------------- 2
3. Protocal of Data Link Layer------------------------------------------------------------ 3
3.1. Frame-------------------------------------------------------------------------------- 3
3.2. Transition of States-------------------------------------------------------------- 4
3.2.1. Idle State--------------------------------------------------------------------- 4
3.2.2. Establishment Phase ----------------------------------------------------- 4
3.2.3. Transfer Phase ------------------------------------------------------------- 7
3.2.4. Termination Phase -------------------------------------------------------- 8
4. Record -------------------------------------------------------------------------------------- 9
4.1. Delimiter---------------------------------------------------------------------------- 10
4.2. Usable Character Code --------------------------------------------------------- 10
4.3. The maximum Length of Record--------------------------------------------- 11
4.4. The Record to be transmitted from BiOLiS to Host-------------------- 11
4.4.1. Message Header Record (From BiOLiS to Host) ----------------- 11
4.4.2. Patient Information Record (From BiOLiS to Host)------------- 12
4.4.3. Measurement Order Record (From BiOLiS to Host) ------------ 13
4.4.4. Enquiry Record (From BiOLiS to Host)----------------------------- 14
4.4.5. Comment Record (From BiOLiS to Host)--------------------------- 15
4.4.6. Measurement Result Record (From BiOLiS to Host) ----------- 16
4.4.7. Message Terminator Record (From BiOLiS to Host) ------------ 17
4.5. The Record to be transmitted from Host to BiOLiS-------------------- 18
4.5.1. Message Header Record (From Host to BiOLiS) ----------------- 18
4.5.2. Patient Information Record (From Host to BiOLiS)------------- 19
4.5.3. Measurement Order Record (From Host to BiOLiS) ------------ 20
4.5.4. Enquiry Record (From Host to BiOLiS)----------------------------- 22
4.5.5. Comment Record (From Host to BiOLiS)--------------------------- 23
4.5.6. Measurement Result Record (From Host to BiOLiS) ----------- 23
4.5.7. Message Terminator Record (From Host to BiOLiS) ------------ 23
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5. Message -------------------------------------------------------------------------------------24
5.1. Enquiry Message (From BiOLiS to Host) ---------------------------------24
5.1.1. Transmission Timing------------------------------------------------------24
5.1.2. Record Configuration -----------------------------------------------------24
5.2. Measurement Order Message (From Host to BiOLiS)-----------------26
5.2.3. Test order cancellation-----------------------------------------------------28
5.2.4. Order entry for control sample------------------------------------------28
5.2.5. Order entry for STAT sample--------------------------------------------29
5.2.6. Measurement Order Refusal (From BiOLiS to Host)------------30
5.3. Measurement Result Message (From BiOLiS to Host) ----------------31
5.3.3. Measuring Failure ---------------------------------------------------------32
5.3.4. Measurement by Simple Operation Mode --------------------------33
Appendix A Error Code List------------------------------------------------------------34

Appendix B BiOLiS side Configuration ----------------------------------------------35
Appendix C Sample Bar Code -----------------------------------------------------------36
C-1 Sample Bar Code Specifications---------------------------------------------36
C-2 Label Paste Position -----------------------------------------------------------37
Appendix D ASTM Batch Transmission of Previous Data --------------------------38
BiOLiS ASTM Batch Transmission of Previous Data -------------------------------38
Appendix E ISE Error Code List ---------------------------------------------------------41
Appendix F Analyzer setting and movement--------------------------------------------41
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1. Preface
Bi-directional communication between BiOLiS 50i superior (BiOLiS) and the host
computer
(Host) is specified here.
Bi-directional communication is based on ASTM1381-91 and ASTM1394-91.
There are the following Sample ID mode and Requast setting for BiOLiS.
Sample ID mode
By Sample No. mode: This is a method to inquire to Sample tray No.
By Sample ID mode: This is a method to inquire to barcode attached with sample.
Requent
All (Batch): enquire by “ALL” orders of host.
Appoint (individually): In case enquire by barcode or position No.
Normally, select “Appoint” in case of “by Sample ID (barcode)”mode operation.

On the other hand, select “All” in case of “by Sample No. (tray No.)” mode operation.
(It is unable to set “Appoint” when “by Sample No (tray No.)” is selected.)
Please kindly decide this setting as customers need.

Please note that there is a possibility to modify host side in case operation system is
modified.
The specifications may change without notice.
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2. Connection Condition
BiOLiS uses the cross cable of RS-232C for connection to Host.

The connector of BiOLiS side is D-SUB (9 pins).
Assignment of pins
1 1
Rx 2 2 Rx
Tx 3 3 Tx
DTR 4 4 DTR
SG 5 5 SG
DSR 6 6 DSR
RTS 7 7 RTS
CTS 8 8 CTS
9 9
No. Setting items Available setting value

1 Transmission speed 1200 bps
2400 bps
9600 bps (default)
14400 bps
19200 bps
2 Parity None (default)
Odd
Even
3 Data bits 7
8 (default)
4 Stop bits 1 (default)
2
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3. Protocol of Data Link Layer
The protocol of data link layer is defined by ASTM 1381-91.
The protocol of data link layer uses the following transmission control codes.
No. Transmission Transmission Explanation

control code control code
name
1 <STX> 2(02h) Code to show the beginning of text.
2 <ETB> 23(17h) Code to show the interruption of text.
When the text to be transmitted is too large, the text is
split into multiple frames, using <ETB>.
3 <ETX> 3(03h) Code to show the end of text.
4 <CR> 13(0Dh) Carriage return
5 <LF> 10(0Ah) Line feed code
6 <ENQ> 5(05h) Enquiry
7 <ACK> 6(06h) Acknowledge
8 <NAK> 21(15h) Not acknowledge
9 <EOT> 4(04h) End of transmission
10 [FN] - Frame number
ASCII numbers from 0 to 7. The first frame begins with
1.
11 [C1][C2] - Checksum
3.1. Frame
<STX>[FN][TEXT]<ETB>[C1][C2]<CR><LF> Intermediate frame

<STX>[FN][TEXT]<ETX>[C1][C2]<CR><LF> Termination frame
[STX]3O|1|01040218001|^1^1|^^^1^T-BIL^0・・・¥^^^18^CPK^0¥^^^19[ETB]??[CR][LF]
[STX]4ÂMY^0|R||||||N||||Serum||||||||||F[CR][ETX]??[CR][LF]
Note: All the example of check sam value is invalid.
[TEXT] is the text data to be transmitted.

In BiOLiS, [TEXT] corresponds to the record (ASTM 1394-91).
240 characters are the maximum in [TEXT]. (240 octets)
The text, which exceeds 240 octets, uses multiple frames, using <ETB>.
Checksum is the least 8 bits of the value, that is gotten when the sum of character codes
from [FN] to <ETB>, <ETX>. (Modulo 256).
[C1] and [C2] are ASCII alphanumeric hexadecimal notations of the upper 4 bits and the
lower 4 bits of checksum, respectively.
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3.2. Transition of States
There are the following four states in data link layer.
Idle state
Establishment Termination
phase phase
Transfer phase
3.2.1. Idle State
The idle state is the state that transmission is not performed between BiOLiS and Host.
3.2.2. Establishment Phase
The establishment phase determines the direction of information flow.
The system with information to send transmits the <ENQ>, after transforming the state
into the establishment phase.
1) A reply of <ACK>
The system that received <ENQ> transmits <ACK>, if it is ready to receive

information.
The state is transformed from the establishment phase to the transfer phase.
Sender Direction of information flow Receiver

<ENQ>
<ACK>
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2) A replay of <NAK>
The system that received <ENQ> transmits <NAK>, if it cannot immediately receive
information.
The system, which received a reply of <NAK> to its transmitted <ENQ>, transmits
<ENQ> again after 10 seconds.
In case that the system received a reply of <NAK> six times successively, the state is
transformed into the termination phase.

<ENQ> The first transmission
<NAK>
WAIT for 10 sec.
<ENQ>
<NAK>
：：
<ENQ> The sixth transmission
<NAK>
<EOT>
3) No response/response delay
In case that there is no response within 15 seconds after transmitting of <ENQ>, the
state is transformed into the termination phase.

<ENQ>
No response for 15 sec.
<EOT>
4) Contention of <ENQ>
When both systems simultaneously transmit <ENQ>, BiOLiS has priority.
In case that BiOLiS received a reply of <ENQ> to its transmitted <ENQ>, it

interprets that the data link is in contention, and transmits <ENQ> again after
waiting for one second.
Upon receiving a reply of <ENQ> to its transmitted <ENQ>, Host waits for a replay
of <ENQ> from BiOLiS.

<ENQ> <ENQ>
WAIT for one sec.
<ENQ>
<ACK>
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5) Defective response
Upon receiving a code except <ACK>, <NAK>, <EOT> and <ENQ>, the state is
transformed into the termination phase.

<ENQ>
Data
<EOT>
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3.2.3 Transfer Phase
The transfer phase transmits the data from the sender to the receiver.
The data are transmitted in frames.
1) Data delay/no response to the transfer phase

In case that the first data are not transferred within 20 seconds after transformed
into the transfer phase, the state is transformed into the termination phase.

<ENQ>
<ACK>
WAIT for 20 sec.
<EOT>
2) A replay of <ACK>
Upon receiving the data adequately, the system replies with <ACK>.

<ENQ>
<ACK>
Data
<ACK>
3) A replay of <NAK>
Upon not receiving the data adequately, the system replies with <NAK>.
In case of receiving a reply of <NAK> to its transmitted data, the system re-transmits
the same data (frames).
The sender transmits the same frame six times.

In case of receiving a reply of <NAK> to its sixth transmitted data, the sender
transforms the state into the termination phase.

<ENQ>
<ACK>
Data The first transmission
<NAK>
WAIT for 10 sec. :
Data The sixth transmission
<NAK>
<EOT>
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The conditions that BiOLiS replies with <NAK> are as follows.
No. Condition of a reply of <NAK> Explanation

1 Error signal Parity error, frame error, port overrun, etc.
2 Checksum discord In case that the values of frame checksums, [C1] and
[C2], are in discord.
3 Defective frame number The frame except 0 – 7, the smaller frame number
than the number received before, and so on.
4 Frame length over The frame exceeds the maximum length.
4) No response/ response delay

In case of receiving no response within 15 seconds after the sender transmitted the
data, the state is transformed into the termination phase.

<ENQ>
<ACK>
Data
No response for 15 sec.
<EOT>
5) Defective response
Upon receiving a replay except <ACK>, <NAK> and <EOT> to the transmitted data,
the system re-transmits the same frame.
The system transmits the same frame six times, and then transforms the state into
the termination phase.

<ENQ>
<ACK>
Data The first transmission
Defective response
: :
Data The sixth transmission
Defective response
<EOT>
Note: Process that each one sample transmits result within 20 seconds.
(For “ACK” response, rerurn within 1.0 second (100msec).)
3.2.4 Termination Phase
Transmitting <EOT>, the system transforms the state into the idle state.
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4. Record
The records are defined by ASTM1394-91.

The records supported by BiOLiS are as follows.
No. Record ID Record

1 H Message Header Record
2 P Patient Information Record
3 O Measurement Order Record
4 Q Enquiry Record
5 C Comment Record
6 R Measurement Result Record
7 L Message Terminator Record
Any record except the above is ignored.
To clear the extensive data, a hierarchical structure is adopted for the message.
The relationship between the hierarchical level supported by BiOLiS and the
hierarchical level of record is as follows.
level 0 level 1 level 2 level 3 level 4

Message Header Record (H) * -- -- -- --
Patient Information Record (P) -- * -- -- --
Measurement Order Record (O) -- -- * -- --
Enquiry Record (Q) -- * -- -- --
Comment Record (C) -- * * * *
Measurement Result Record (R) -- -- -- * --
Message Terminator Record (L) * -- -- -- --
* Level supported
-- Level not supported
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4.1. Delimiter
The setting of the delimiter used by the record that is transmitted from BiOLiS can be
changed.
The delimiters at initialization are as follows.
No. Delimiter Explanation

1 | Field Delimiter
Used to partition a field from a field.
2 ¥ Repeat Delimiter
Used to repeat to define a particular field.
For BiOLiS, it cannot be used without any notice.
3 ^ Component Delimiter
Used to partition a component in the field.
4 & Escape Delimiter
Used within text fields to signify certain special
characteristics of portions.
For BiOLiS, the following escape characters can be used.
“&F&” : The same character as the field delimiter
“&S&” : The same character as the component delimiter
“&R&” : The same character as the repeat delimiter
“&E&” : The same character as the escape delimiter
The escape characters except the above are deleted.
To terminate the record, <CR> (13(ODh) in ASCII code) is used.
4.2. Usable Character Code
The character codes, 20h – 7Eh and 80h – FFh, can be used in the records.
When the records includ the character codes that cannot be shown, they are likely to
disturb the screen of BiOLiS
In case that the records includ the same codes as the codes defined for the delimiters,
use the escape characters.
For BiOLiS, the fields in which the escape characters can be used are settled.
The fields in which the escape characters can be used are as follows.
No. Field name Notes

1 Patient name (Family name, First name) Patient Information Record
2 Doctor in charge Patient Information Record
3 Patient ID Patient Information Record
4 Sample ID Measurement Order Record
5 Comment Text Comment Record
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4.3. The Maximum Length of Record
The maximum length of record is a record that includes 1024 characters (1024 octets).
The escape characters are counted for the characters after escape.
(For example, “&F&” is counted as three characters.)
4.4. The Record to be transmitted from BiOLiS to Host
In this chapter, the definition for each record to be transmitted from BiOLiS to Host is
explained.
In the field of each record, the necessity of transmission means as follows.
No. Necessity of Explanation

transmission
1 Indispensable It is always needed to set.
It is dealt as an invalid record, if this setting is
omitted.
2 Optional Set when needed.
Refer to the explanation of each message.
3 Not supported Set blank.
When the value is set, BiOLiS ignores it.
Refer to Appendix B of the specifications for the maximum length of each field.
4.4.1. Message Header Record (From BiOLiS to Host)
Field No. Field name Explanation Necessity of

transmission
1 Record ID “H” Indispensable
2 Delimiter definition BiOLiS initial values are as follows. Indispensable
Field delimiter | （Setting is possible.）
Repeat delimiter ¥
Component delimiter ^
Escape delimiter &
5 Sender ID Indispensable
Sender’s name BiOLiS 50i Indispensable
System ID The fixed system ID is set. Indispensable
（Setting is possible.）
10 Receiver ID Indispensable
Receiver’s name The fixed system name is set. Indispensable
System ID The fixed system ID is set. Indispensable
12 Process ID “P” : Production Indispensable
13 Version No. “1” Indispensable
14 Date & time of message The date when this record is generated is set. Indispensable
Example of transmission
H|¥^&|||BIOLIS NEO^System1|||||Host^P_1||P|1|20000530192631<CR>
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Patient Information Record (From BiOLiS to Host)

transmission
1 Record ID The character to discriminate this record Indispensable
“P”
2 Sequence No. Sequence No. of patient information record Indispensable
3 Patient ID ID that doctor in charge put to identify the patient Optional
6 Patient’s name Patient’s name Optional
Family name Patient’s family name Optional
First name Patient’s first name Optional
8 Date of birth Date of birth Optional
In the form of “YYYYMMDD”
9 Sex “M” : Male Optional
“F” : Female
“U” : Unknown
14 Doctor in charge It is impossible to partition the name by component. Optional
When the patient information is in BiOLiS, the optional items of patient information
record are set.
Example of transmission in case there is no patient information in BiOLiS

P|1<CR>
Example of transmission in case there is any patient information in BiOLiS

P|1|1234|||Matt^Thomson||19731022|M|||||Breat Boone<CR>
Analyzer printer prints out name of patient.
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4.4.2. Measurement Order Record (From BiOLiS to Host)
Field Field name Explanation Necessity of

No. transmission
1 Record ID “O” Indispensable
2 Sequence No. Sequence number of measurement order record Indispensable
3 Sample ID Barcode value or sample ID transmitted from Host is set. Indispensable
If there is no the barcode value and host control No.,
blanck is transmitted.
Even Pos mode, barcode value is transmitted when
barcode is read.
4 System sample ID Indispensable
Micro sample Set micro sample flag. Normal: “0” Micro sample: “1” Not supported
identification
Sample round No. Sample round number is set. Indispensable
Sample position Sample positions are set. Indispensable
In case of STAT sample positions, “E1” – “E50” are set.
In case of control sample positions,“C1” – “C66” are set.
5 Test item ID When there are multiple test items, the repeat delimiters Indispensable
are used.
Test ID Blank is set. Not supported
Test name Blank is set. Not supported
Test type Not supported
Test item No. Test item number Indispensable
Test item name Test item name Indispensable
Dilution rate “0” : No dilution (default) Optional
“1” : 1 : 6 “7 “ : 1 : 60
“2” : 1 : 10 “8” : 1 : 70
“3” : 1 : 20 “9” : 1 : 80
“4” : 1 : 30 “10” : 1 : 90
“5” : 1 : 40 “11” : 1 : 100
“6” : 1 : 50
BiOLiS always sets one of the above mentioned dilution
rates.
6 Priority “S” : STAT Optional
“R” : Routine
BiOLiS always sets either of the above.
12 Action code “Q” : A sample which is used for QC. Optional
In case of patient or STAT sample test results transfer,
Blank is set.
16 Sample “Serum” ：Serum Indispensable
information “Urine” :Urine
（Sample kind） “Plasma” :Plasma
“CSF” : Marrow fluid
“Dialysis” : Dialysis fluid
“Other” :Other
26 Report form “F” : Final result Indispensable
In case of transmission of measurement result.
In case an error occurred during measurement.
“X” : No result obtained, or order cancelled
In case of rejecting of measurement order message
from Host.
By sample No.
O|1||0^123^12|^^^1^GOT^0¥^^^2^GPT^1¥^^^3ÂLP^0|R||||||N||||Serum||||||||||F<CR>
By barcode
O|1|12345|0^1^1|^^^1^GOT^0¥^^^2^GPT^1¥^^^3ÂLP^0|R||||||N||||Serum||||||||||F<CR>
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4.4.3. Enquiry Record (From BiOLiS to Host)

transmission
1 Record ID “Q” Indispensable
2 Sequence No. Sequence number of enquiry record Indispensable
3 Start range ID In case “ALL” (Batch) is set at system parameter, Indispensable
“ALL”
“by Position mode(by sample No.) is this setting.
In case of “Appoint” mode is set at the system parameter,

“^by sample ID” (^ is nessesary before ID.)
“by sample ID(barcode)” is this setting.
“^Position No.” or “Start posirion No.”
4 End range ID Ênd sample ID Option
Range specification is available only when batch
transmission is set.
Ênd position No.”
Range specification is available only when batch
transmission is set. “ALL” is not available together.
5 Test item ID “ALL” Indispensable
13 Condition code “O”: Order of measurement and of patient information Indispensable
only
Example of All (bath) transmission

Q|1|ALL||ALL||||||||O<CR>
The “All” (Batch) enquiry timing is when “Start” button is pressed, “Stat” button is pressed,
ASTM transmittion in order screen and “Order” button is pressed.
Specification ID (barcode) request & Range specification sample ID (barcode) request.

Q|1|^0001||ALL||||||||O<CR> Fixing request (by barcode)
Q|1|^0001|^0010|ALL||||||||O<CR> Range specification request
(Only batch request from order screen)
The specified ID enquiry timing is when BiOLiS reads sample ID.
In case of “All” (batch) request, please transmit measurement order enquory when order is
decided on host side. The order can accept under state of run.
In case of “Appoint” (individually) request, please transmit enquory without order. (Refer to
Example of response No. 3 : in case of no measurement order page 25.)
Select system parameter setting and Sample ID mode from as follows.
By Sample No.(tray No.): Select “All” at host communication request.

By Sample ID (barcode): Select “Appoint”.
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4.4.4. Comment Record (From BiOLiS to Host)

No. transmission
1 Record ID “C” Indispensable
2 Sequence No. Sequence number of comment record Indispensable
3 Comment source “I” : Clinical inspection system Indispensable
4 Comment text Measurement result comment by operator and error Indispensable
codes by system errors are set.
In case that there are multiple error causes, error codes
are set in the form of separated by “，”.
Refer to the error code list in Appendix A.
5 Comment type “G”：General test comment Indispensable
Comment of operator for measurement result
“I”：System flag comment
Error code for no result because of system error
C|1|I|1|I<CR>
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4.4.5. Measurement Result Record (From BiOLiS to Host)

transmission
1 Record ID “R” Indispensable
2 Sequence No. Sequence number of measurement result record Indispensable
3 Test item ID Indispensable
Test ID Not supported
Test name Not supported
Test item No. Test item number Indispensable
Test item name Test item name Indispensable
Dilution rate “0” : No dilution (default) Indispensable
“1” : 1 : 6 “7 “ : 1 : 60
“2” : 1 : 10 “8” : 1 : 70
“3” : 1 : 20 “9” : 1 : 80
“4” : 1 : 30 “10” : 1 : 90
“5” : 1 : 40 “11” : 1 : 100
“6” : 1 : 50
4 Measurement Measurement value is written by ASCII text. Indispensable
value In case the condition of result is “X” or “I”, blank is set.
5 Unit In case unit is registered in BiOLiS, it is set. Optional
6 Reference range In the form of “the lower limit to the higher limit” Optional
In case that sex is “U” (unknown) or is omitted in
patient information record, reference range for man is
set.
This is set when normal range is registered in BiOLiS.
7 Abnormal result “L” : lower than the lower limit. Indispensable
flag “H” : higher than the higher limit.
“N” : normal
“PL” : lower then the panic range.
“PH” : higher then the panic range.
In case of measurement failure, “N”is set, too.
9 Condition of “F” : final result Indispensable
result Measurement result is transmitted.
“I” : in instrument, result pending
This test item is for automatic re-measurement and
in the waiting state for measurement, or is in the
measurement waiting state when STAT is cutting in.
（No measurement value）
As measurement is completed, this is retransmitted
as the final result of “F”.
“P” : preliminary result
When measurement ended in failure, it is set.
（With a measurement value.）
“X” : No result
When measurement ended in failure, it is set.
（No measurement value）
The cause of failure (error code) is set to the
comment record, following to this record.
13 Date & time of Date and time when measurement was over. Indispensable
ending of test （In the form of YYYYMMDDHHMMSS）
Example of transmission when measurement succeeded
R|1|^^^1^GOT^0|54.5143|IU/L|8 TO 38|H||F||||20010618145805<CR>
R|1|^^^1^GOT^0|９９９９９９９|IU/L|8 TO 38|N||Ｆ||||20010618145805<CR>
When the conc. value can not be calculated even measurement was succeeded, the results
transmit as “9999999”.
Example of transmission when measurement failed

R|1|^^^1^GOT^0||IU/L|8 TO 38|N||X||||20010618145805<CR>
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4.4.6. Message Terminator Record (From BiOLiS to Host)

transmission
“L”
2 Sequence No. Sequence number of message terminator record Indispensable
3 Termination code “N” : normal termination Indispensable
NOTE: Transmission at Automatic Remeasurement

The result data will be transmitted twice: at the time when all the results of the
ordinary measurement are assembled and at the time when all the results of the
automatic remeasurement are assembled.
Transmission at STAT
STAT sample will cut in between the items of the sample measurement.
The result data will be transmited twice: at the time when all the item
measurement results are assembled before STAT sample cuts in and at the time
when all the measurement results are assembled after STAT sample has cut in.
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4.5. The Record to be transmitted from Host to BiOLiS
4.5.1. Message Header Record (From Host to BiOLiS)

transmission
“H”: The field with only one character, H
2 Delimiter definition BiOLiS initial values are as follows. Indispensable
Field delimiter |
Repeat delimiter ¥
Component delimiter ^
Escape delimiter &
5 Sender ID Indispensable
Sender’s name The name of Host is set. Indispensable
System ID System ID of Host is set. Indispensable
10 Receiver ID Indispensable
Receiver’s name “BIOLIS NEO” Indispensable
System ID System ID of BiOLiS is set. Indispensable
12 Process ID “P” : Production Indispensable
13 Version number “1” Indispensable
14 Date & time of The date and time that the message was generated. Indispensable
message In the form of YYYYMMDDHHMMSS.
（year/month/day/hour/min./sec.）
There is no discrimination between capital letters and small letters in Sender ID and
Receiver ID.
H|¥^&|||Host^P_1|||||BIOLIS NEO^System1||P|1|20000530192631<CR>
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4.5.2. Patient Information Record (From Host to BiOLiS)

transmission
“P”
2 Sequence No. Sequence number of patient information record Indispensable
3 Patient ID ID that doctor in charge put to identify the patient. ＊Optional
6 Patient’s name Patient’s name Optional
Family name Patient’s family name Optional
First name Patient’s first name Optional
8 Date of birth Date of birth Optional
In the form of “YYYYMMDD”
9 Sex “M” : Male Optional
“F” : Female
“U” : Unknown
14 Doctor in charge It is impossible to partition the name with component. Optional
In case it is partitioned with component, the first
component is used.
In case there is no patient information to transmit, leave the optional item blank.
In case the patient ID is blank, other optional items are ignored.
In case there is no patient information to transmit

P|1<CR>
In case there is any patient information to transmit

P|1|1234|||Michael^Parmer||19680222|M|||||Matt Thomson<CR>
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4.5.3. Measurement Order Record (From Host to BiOLiS)

No. transmission
1 Record ID “O” Indispensable
2 Sequence No. Sequence number of measurement order record Indispensable
3 Sample ID Sample ID managed by barcode value or Host Indispensable
4 System sample In case that sample application mode is position mode, be Indispensable
ID sure to set it.
In case that sample application mode is ID mode, set
blank.（Even if value is set, it is ignored.）
Micro sample Set micro sample flag. Normal: “0” Micro sample: “1” Indispensable
identification
Sample round Set sample round number. Indispensable
No. You can ignore zero “0” and “space” to put close.
Sample Set sample positions. Indispensable
position STAT sample positions, “E1” – “E50” and control sample *1
positions, “C1” - ”C66” can be set.
You can ignore zero “O” and “space” to put close.
5 Test item ID Either test item number or test item name can be used to Indispensable
designate. *2
If both are used, they have to designate the same test
item.
In case that there are multiple test items, designate items
as one order record using repeat delimiter.
Test ID Not supported
Test name Not supported
Test item No. Set test item number. (Note 2) Indispensable
Test item name Set test item name. (Note 2) Indispensable
Dilution rate “0” : No dilution (default) Optional
“1” : 1 : 6 “7 “ : 1 : 60
“2” : 1 : 10 “8” : 1 : 70
“3” : 1 : 20 “9” : 1 : 80
“4” : 1 : 30 “10” : 1 : 90
“5” : 1 : 40 “11” : 1 : 100
“6” : 1 : 50
6 Priority “R” : routine (default) Indispensable
“S” : STAT
12 Action code “C” : Measurement order is cancelled. Indispensable
Measurement order that was transmitted to BiOLiS
before is cancelled.
Test order of patient, STAT and control samples can be
cancelled.
But measurement order that can be cancelled is only
for samples before measurement.
“N” : New measurement order (default)
Set this code when test orders of patient and STAT
samples are transmitted. (Note 1)
“A” : Additional test item
Add test items to the test order, which is already
registered. (Note 1)
“Q” : Quality Control sample
Transferring control sample test order, set this code.
16 Sample “Serum” :Serum “Urine” :Urine Indispensable
information “Plasma” :Plasma “CSF” : Marrow fluid
(sample kinds) “Dialysis” : Dialysis fluid “Other” :Other
In this item, there is no discrimination between capital
letters and small letters.
Also, space cannot be used to fill digit.
26 Report form “O” : Measurement order Indispensable
*1 *2 : In case of “by Sample No.”: Indispensable. In case of “by Sample ID”: Not supported.
Tokyo Boeki Medisys Inc. ２０

Note 1: The difference between “N” and “A” action codes.

For the new test order, both “N” and “A” can be registered as action code.
But for the registered test order, the difference is the following.
A) Action code “N”

Test order is over written by the transferred test order from host.
If designated sample is under testing or already tested, BiOLiS returns test order
refusal response to host.
Please use action code “N” for the host system, which transfers test orders of
already transferred, as the response of BiOLiS inquiry message.
B) Action code “A”

If the test item transferred from host is the new test item, the test item is
additionally registered.
If the test item is already registered, the test item is overwritten.
If designated sample is under testing, test refusal response is transffered to host.
If already tested, it is registered as a rerun test item.
Note 2: Test item number and test item name.

Either item number or item name can be omitted. If both number and name are
registered, these should be consistent.
As test item number and item name are set or modified by each laboratory, they are
not defined in the specifications. Host system should have compatible item number
and item name list registered in BiOLiS. Please get the list from the person in the
laboratory.
Example of transmission in case that sample application mode is “Sample ID mode”
O|1|12345|＾1＾1|^^^78^Na^0|R||||||N||||Serum||||||||||O<CR>
Example of transmission in case that sample application mode is “Position mode”
O|1|12345|^1^10|^^^78^Na^0|R||||||A||||Serum||||||||||O<CR>
Note:
In case of measurement of urine sample, ISE (Na, K and Cl) can not be measured with other
items at the same time.
The urine of ISE measurement is measured with 6 times diluated sample by urine diluent.
Same procedure as
The result which is 6 times diluted is transmitted.
For dialysis of ISE measurement, select “Dialysis” at specimem of order screen
Tokyo Boeki Medisys Inc. ２１

Example of discrimination of test item

(The following three records mean the same meaning.)
O|1|12345|^1^1|^^^22^^0|R||||||N||||Serum||||||||||O<CR> *Omitted test item name
O|1|12345|^1^1|^^^^PTT^0|R||||||N||||Serum||||||||||O<CR> *Omitted test item No.
O|1|12345|^1^1|^^^22^PTT^0|R||||||N||||Serum||||||||||O<CR>
The following record is null in case that the test item name of test item No. 78 is “Na”.
O|1|12345|^1^1|^^^40^Na^0|R||||||N||||Serum||||||||||O<CR>
4.5.4. Enquiry Record (From Host to BiOLiS)
In case that Host rejects an enquiry from BiOLiS, this record is transmitted.
If the condition code of the enquiry record is not “X”, this record is ignored.

transmission
1 Record ID “Q” Indispensable
2 Sequence No. Sequence number of enquiry record Indispensable
3 Start range ID “ALL” Indispensable
5 Test item ID “ALL” Indispensable
13 Condition code “X” : Can get no result. The order is cancelled. Indispensable
Example of transmission in case of rejecting an enquiry from BiOLiS

Q|1|ALL||ALL||||||||X<CR>
Q|1|＾123456||ALL||||||||X<CR>
Caution: If request rejection is transferred, communication protocol error occurs.
Tokyo Boeki Medisys Inc. ２２

4.5.5. Comment Record (From Host to BiOLiS)
BiOLiS ignores the comment record from Host.

transmission
1 Record ID “C” Indispensable
2 Sequence No. Sequence number of the comment record Indispensable
3 Comment source “L” : computer system Indispensable
4 Comment text No limit is given. Indispensable
But do not exceed the maximum length.
5 Comment type Select the most suitable one out of the followings. Indispensable
“G” : General test comment
“T” : Text name comment
“P” : Positive test comment
“N” : Negative test comment
“I” : System flag comment
C|1|L|Not in Service|G<CR>
4.5.6. Measurement Result Record (From Host to BiOLiS)
The measurement result record is not transmitted from Host.

BiOLiS ignores the measurement result record from Host.
4.5.7. Message Terminator Record (From Host to BiOLiS)

No. transmission
1 Record ID “L” Indispensable
2 Sequence No. Sequence number of the message terminator record Indispensable
3 Termination code “N”：Normal termination Indispensable
L|1|N<CR>
Tokyo Boeki Medisys Inc. ２３

5. Message
Message is a gathering of records from the message header record to the message
terminator record.
Message Header Record (H)

Patient Information Record(P)
Measurement Order Record (O)
Patient Information Record (P) Massage
Message Terminator Record (L)
5.1. Enquiry Message (From BiOLiS to Host)
The enquiry message is the message that BiOLiS inquires of Host about the
measurement order.
5.1.1. Transmission Timing
BiOLiS can send inquiry message by the following 3 cases.
1) Upon pressing the measurement start button of BiOLiS

BiOLiS transmits an inquiry message to host, when measurement button is pressed.
2) Upon pressing the STAT start button of BiOLiS

BiOLiS transmits an inquiry message to host, when STAT start button is pressed.
3) When BiOLiS inquiry button is pressed.

When an operator presses inquiry button, BiOLiS sends an inquiry message to host.
4) When BiOLiS reads sample barcode (Only when “Appoint” is selected)

Whenever BiOLiS reads barcode, BiOLiS transfers inquiry message individually.
If the inquiry failed, BiOLiS queries only one time. After that, BiOLiS shifts to next
sample.
NOTE
Do not transmit all the measurement orders every time BiOLiS inquires.
Except the case of changing the contents of measurement order, you do not have to
transmit the measurement order which has been once transmitted.
If you transfer requests by “ALL” setting, BiOLiS is not able to receive the request fully.
Please transfer a request each time when the request is decided in Host.
Please transmit text without request to BiOLiS against “ALL” request.
Tokyo Boeki Medisys Inc. ２４

5.1.2. Record Configuration
Message record configuration
Level Message record

0 Message Header Record (H)
1 Enquiry Record (Q)
0 Message Terminator Record (L)
Example of transmittion No. 1: Enquiry Message from BiOLiS (ALL)

Q|1|ALL||ALL||||||||O<CR>
OR Q|1|^123456||ALL||||||||O<CR> （In case “by Sample ID” is selected.）
OR Q|1||^^l^l|ALL||||||||O<CR> （In case “by Sample No.” is selected.）
L|1|N<CR>
Example of response No. 1 : in case of designating multiple measurement items with

repeat delimiters
P|1<CR>
O|1|123456|^1^20|^^^1^GOT^0¥^^^11^LDH^0¥^^^42^Ca^0|R||||||N||||Serum|||||||
|||O<CR>
L|1|N<CR>
Example of response No. 2 : in case of designating measurement items using multiple

measurement order records
P|1<CR>
O|1|123456|^1^20|^^^1^GOT^0|R||||||N||||Serum||||||||||O<CR>
O|2|123456|^1^20|^^^11^LDH^0|R||||||N||||Serum||||||||||O<CR>
O|3|123456|^1^20|^^^42^Ca^0|R||||||N||||Serum||||||||||O<CR>
L|1|N<CR>
NOTE
In this example of transmission, only the first measurement order record is effective.
The measurement item of sample ID 123456 is only 1 (GOT).
When requesting measurement items 1 (GOT), 11 (LDH) and 42 (Ca), request them
by a single measurement order record using repeat delimiters.
Example of response No. 3 : in case of no measurement order

L|1|N<CR>
Tokyo Boeki Medisys Inc. ２５

Example of response No. 4 : in case of refusing the enquiry from BiOLiS

Q|1|ALL||ALL||||||||X<CR>
C|1|L|some reason|I<CR>
L|1|N<CR>
In case that there is no measurement order to be transmitted to the enquiry from

BiOLiS, transmit either the example of response No. 3 or No. 4.
Tokyo Boeki Medisys Inc. ２６

5.2. Measurement Order Message (From Host to BiOLiS)
The measurement order message is a message to inform BiOLiS of measurement items

for samples from Host.
In the measurement message, you can register the measurement request and cancel the
measurement request.
In case that the sample application mode is “Sample ID mode” (the barcode application
mode), you cannot designate a sample round number.
The measurement request that can be used in “Sample ID mode” is only for samples
with the present sample round numbers in BiOLiS.
The followings are the timings for Host to transmit the measurement order messages.
1) The response to the enquiry message from BiOLiS

Host transmits the measurement request of the sample about which BiOLiS
inquires.
2) A package transmission of measurement request

Host transmits the measurement request before BiOLiS inquires.
BiOLiS is always able to receive the measurement request from Host.
When Host transmits the measurement request, which has been transmitted to BiOLiS
before, with the same sample ID again, the defferent registration action will be taken
depending on the action code of the measurement order record.
The first measurement order

P|1|<CR>
O|1|1234|^1^1|^^^1^GOT^0¥^^^2^GPT^0|R||||||N||||Serum||||||||||O<CR>
L|1|N<CR>
The second measurement order (In case of action code is “N”)
P|1|<CR>
O|1|1234|^1^1|^^^1^GOT^0¥^^^79^K^0|R||||||N||||Serum||||||||||O<CR>
L|1|N<CR>
If transmitted under action code “N”, the registration is over written by the second
measurement request transmitted.
The measurement items of the sample ID 1234 transmitted first are changed into “GOT”,
“K” from “GOT”, “GPT” by the measurement request transmitted for the second time.
But if designated sample is under testing or has already been tested, no registration
renewal occures and measurement request is refused.
Tokyo Boeki Medisys Inc. ２７

The second measurement order (In case of action code is “A”)

P|1|<CR>
O|1|1234|^1^1|^^^1^GOT^0¥^^^79^K^0|R||||||A||||Serum||||||||||O<CR>
L|1|N<CR>
If transmitted under action code “A”, the measurement request of the second
transmittion is registered additionally.
The measurement items of the sample ID 1234 transmitted for the first time are
changed into “GOT”, “GPT”, “K” from “GOT”, “GPT” by the measurement request
transmitted for the second time. (“GOT” is over written, “K” is new registeration.)
If the measurement requested first has finished when second request is transmitted, the
second request is registered as the rerun order. The measurement request items, that
will be registered as rerun order items, are “GOT” and “K” of the second transmission.
If the measurement request of the first transmission is under testing, the second
measurement request is refused.

1 Patient Information Record (P)
2 Measurement Order Record (O)
: :
Example of transmission No. 1 : no patient information

P|1|<CR>
O|1|1234||^^^1^GOT^0¥^^^2^GPT^0¥^^^3ÂLP^0|R||||||||N|||||Serum||||||||||
|O<CR>
O|2|1235|^1^1|^^^1^GOT^0|R||||||N||||Serum||||||||||O<CR>
O|3|1236|^1^1|^^^1^GOT^0|R||||||N||||Urine||||||||||O<CR>
L|1|N<CR>
Example of transmission No. 2 : with patient information
P|1|123|||Guillen^Carlos||20000101|M<CR>
O|1|1234|^1^1|^^^1^GOT^0¥^^^2^GPT^0¥^^^3ÂLP^0|R||||||N||||Serum||||||||||O<CR>
P|2|124|||MartinezÊdgar||19991231|M|||||Mark McLemore<CR>
O|1|1235|^1^1|^^^1^GOT^0|R||||||N||||Serum||||||||||O<CR>
O|2|1236|^1^1|^^^1^GOT^0|R||||||N||||Urine||||||||||O<CR>
L|1|N<CR>
Tokyo Boeki Medisys Inc. ２８

Example of transmission No. 3 : the measurement orders not gathered for each patient
P|1|<CR>
P|2|<CR>
P|3|123|||Olerud^John||20000101|M<CR>
O|1|1236|^1^1|^^^1^GOT^0|R||||||N||||Serum||||||||||O<CR>
P|4|123|||Olerud^John||20000101|M<CR>
O|1|1237|^1^1|^^^1^GOT^0|R||||||N||||Serum||||||||||O<CR>
P|5|123|||Olerud^John||20000101|M<CR>
O|1|1238|^1^1|^^^1^GOT^3|R||||||||N|||||Serum|||||||||||O<CR>
L|1|N<CR>
5.2.3. Test order cancellation
Host can cancel registered measurment request in BiOLiS.
NOTE
Cancellation of measurement request means to cancel all the measurement items for
the sample which measurement request is cancelled.
If sample operation mode is sample ID mode, the sample to be cancelled is to be the
sample of the present sample round in BiOLiS.
When the sample is under measurement or has been completed to measure, the
measurement request cannot be cancelled.
If designated sample is not exsisting, measurement request (cancel request) is refused.
Example of transmission No. 1: cancellation of measurement order

P|1|<CR>
O|1|1234|^1^1|^^^1^GOT^0¥^^^2^GPT^0|R||||||C||||Serum||||||||||O<CR>
L|1|N<CR>
5.2.4. Order entry for control sample
It is possible to enter control sample measurement request for the samples at the
ordinary positions (1 – 400).
But for the positions C1 – C66, only control sample measurement request is accepted.
If patient sample or STAT sample measurement request is entered for the samples at C1
– C66 positions, an error occurs.
Example of transmittion:
P|1|<CR>
O|1|QC001|^1^C7|^^^1^GOT^0¥^^^2^GPT^0|R||||||Q||||Serum||||||||||O<CR>
O|2|QC002|^1^C8|^^^1^GOT^0¥^^^2^GPT^0|R||||||Q||||Serum||||||||||O<CR>
O|3|QC003|^1^20|^^^1^GOT^0¥^^^2^GPT^0|R||||||Q||||Serum||||||||||O<CR>
L|1|N<CR>
Tokyo Boeki Medisys Inc. ２９

5.2.5. Order entry for STAT sample
It is possible to enter STAT sample measurement request for the samples at the ordinary
positions (1 – 400).
But for the positions E1 – E50, only STAT sample measurement request is accepted.
If patient sample or control sample measurement request is entered for the samples at
E1 – E50 positions, an error occurs.
Example of transmittion:
P|1|<CR>
O|1|STAT_001|^1Ê1|^^^1^GOT^0¥^^^2^GPT^0|S||||||N||||Serum||||||||||O<CR>
O|2|STAT_002|^1Ê2|^^^1^GOT^0¥^^^2^GPT^0|S||||||N||||Serum||||||||||O<CR>
O|3|STAT_003|^1^8|^^^1^GOT^0¥^^^2^GPT^0|S||||||N||||Serum||||||||||O<CR>
L|1|N<CR>
Tokyo Boeki Medisys Inc. ３０

5.2.6. Measurement Order Refusal (From BiOLiS to Host)
BiOLiS can refuse the measurement request from Host.
The conditions to refuse the measurement request are as follows.

1) In case that the wrong values are included in the measurement order message.
2) In case that the sample to be cancelled is under measurement or has been finished
to measure.
3) In case that the sample with the repeated measurement request is under
measurement or has been finished to measure.
Example of transmission from Host :

O|1|SAMPLE_1||^^^1^GOT^0|R||||||N||||Serum||||||||||O<CR>
P|1|<CR>
O|1|SAMPLE_2|^1^1|^^^1^GOT^0|R||||||N||||Serum||||||||||O<CR>
O|1|SAMPLE_3|^1^1|^^^1^GOT^0|R||||||N||||Serum||||||||||O<CR>
O|2|SAMPLE_4|^1^C1|^^^1^GOT^0|R||||||N||||Urine||||||||||O<CR>
O|3|SAMPLE_5|^1^C1|^^^1^GOT^0|S||||||Q||||Urine||||||||||O<CR>
O|4|SAMPLE_6|^1Ê1|^^^1^GOT^0|R||||||N||||Urine||||||||||O<CR>
O|5|SAMPLE_7|^1Ê1|^^^1^GOT^0|S||||||Q||||Urine||||||||||O<CR>
L|1|N<CR>
Example of response
P|1|<CR>
O|1|SAMPLE_1|^1^1|^^^1^GOT^0|R||||||N||||Serum||||||||||X<CR>
C|1|I|ASTM_9_4_1|I<CR> … SAMPLE_1 message level abnormal
O|2|SAMPLE_3|^1^1|^^^1^GOT^0|R||||||N||||Serum||||||||||X<CR>
C|1|I|ASTM_9_4_2|I<CR> … SAMPLE_3 sequence number abnormal
O|3|SAMPLE_4|^1^C1|^^^1^GOT^0|R||||||N||||Urine||||||||||X<CR>
C|1|I|A3|I<CR> … SAMPLE_4 sample position abnormal
O|4|SAMPLE_5|^1^C1|^^^1^GOT^0|S||||||Q||||Urine||||||||||X<CR>
O|5|SAMPLE_6|^1Ê1|^^^1^GOT^0|R||||||N||||Urine||||||||||X<CR>
O|6|SAMPLE_7|^1Ê1|^^^1^GOT^0|S||||||Q||||Urine||||||||||X<CR>
L|1|N<CR>
Tokyo Boeki Medisys Inc. ３１

5.3. Measurement Result Message (From BiOLiS to Host)
The measurement result message is a message to transmit the measurement results

of samples.
The timing for BiOLiS to transmit the measurement result message is the followings.
1) At the time when the measurement of sample is completed

In case that the measurement result transmission mode is the real-time
transmission mode, BiOLiS transmits the measurement result of the sample at
the time when the measurement of the sample is completed.
2) Batch transmission
The measurement results designated by an operator of BiOLiS will be
transmitted as a package. (It is unable to cencel.)

3 Measurement Result Record (R)
4 Comment Record (C)
3 Measurement Result Record (R)
: :
P|1|<CR>
O|1||^1^30|^^^1^GOT^0¥^^^2^GPT^0¥^^^27^TG^0|R||||||N||||Serum||||||||||O<CR>
R|1|^^^1^GOT^0|21.5143|IU/L|8 TO 38|N||F||||20010530192515<CR>
R|2|^^^2^GPT^0|8.5793|IU/L|4 TO 44|N||F||||20010530192517<CR>
C|1|I|Operator's Comment|G<CR>
R|3|^^^27^TG^0|381.596|mg/dl|50 TO 130|H||F||||20010530192520<CR>
L|1|N<CR>
For the measurement record, one record is by each measurement item.

When an operator put a comment to the measurement result, the comment record is
transmitted.
Tokyo Boeki Medisys Inc. ３２

Example of transmission: in case that there are remeasured data.
H|¥^&|||BIOLIS NEO^System1|||||Host^PC1||P|1|20000530192631<CR>
P|1|<CR>
O|1||^1^30|^^^1^GOT^0¥^^^2^GPT^0¥^^^27^TG^0|R||||||N||||Serum||||||||||F
<CR>
R|1|^^^1^GOT^0|21.5143|IU/L|8 TO 38|N||F||||20010530192515<CR>
R|2|^^^2^GPT^0||IU/L|4 TO 44|N||X||||20010530192517<CR>
R|3|^^^2^GPT^1||IU/L|4 TO 44|N||X||||20010530192931<CR>
R|4|^^^2^GPT^2|8.6212|IU/L|4 TO 44|N||F||||20010530193551<CR>
R|5|^^^27^TG^0|381.596|mg/dl|50 TO 130|H||F||||20010530192520<CR>
L|1|N<CR>
The measurement item “GPT” is remeasured.

In case of remeasurement, the ordinary measurement result and all the remeasured
data are transmitted.
Please recognize the newest remeasurement data by the measurement ending date
and time.
Transmission example of the waiting state for automatic remeasurement:
“State of result” of the measurement result record for the item which is in the waiting
state is transmitted as the waiting result of “I”. (Without measurement result)
When the measurement is completed, the measurement result will be retransmitted
with the state of result, “F”.
H|¥^&|||BIOLIS NEO^System1|||||Host^PC1||P|1|20000530192631<CR>
P|1|<CR>
O|1||^1^30|^^^1^GOT^0¥^^^2^GPT^0¥^^^27^TG^0|R||||||N||||Serum||||||||||F<CR>
R|1|^^^1^GOT^0|21.5143|IU/L|8 TO 38|N||F||||20010530192515<CR>
R|2|^^^2^GPT^1|230.5687|IU/L|4 TO 44|N||F||||20010530192931<CR>
R|3|^^^2^GPT^2||IU/L|4 TO 44|N||I||||<CR>
R|4|^^^27^TG^0|381.596|mg/dl|50 TO 130|H||F||||20010530192520<CR>
L|1|N<CR>
5.3.3. Measuring Failure
In case of the measuring failure of sample, the following measurement result comes on.
And the cause of the measuring failure is included in the comment record.
P|1|<CR>
O|1||^1^30|^^^1^GOT^0¥^^^2^GPT^0|R||||||N||||Serum||||||||||F<CR>
R|1|^^^1^GOT^0|0.02|IU/L|8 TO 38|N||P||||20010530192515<CR>
C|1|I|1|I<CR>
R|2|^^^2^GPT^0||IU/L|4 TO 44|N||X||||20010530192517<CR>
C|1|I|2|I<CR>
L|1|N<CR>
Tokyo Boeki Medisys Inc. ３３

5.3.4. Measurement by Easy Operation Mode
Sample which measured by simple operation mode is transferred as sample round No.
991-999.
Sample No. is transferred as sample No. 1-72.
The result is not transferred automatically.
You have to do transfer (Batch) from R&E screen in normal operation mode.
P|1|<CR>
O|1||^1^1601|^^^1^GOT^0¥^^^2^GPT^0|R||||||N||||Serum||||||||||F<CR>
R|1|^^^1^GOT^0|30.0224|IU/L|8 TO 38|N||F||||20010530192515<CR>
R|2|^^^2^GPT^0|25.2268|IU/L|4 TO 44|N||F||||20010530192517<CR>
L|1|N<CR>
Tokyo Boeki Medisys Inc. ３４

Appendix A Error Code List
No. Error code Explanation

1 1 A shortage of R1 reagent
2 2 A shortage of R2 reagent
3 0 Shortage of R1 and R2
4 A Shortage of sample, R1 and R2
5 3 Shortage of sample and R1
6 4 Shortage of sample and R2
7 S A shortage of sample
8 C The cell blank value is over 0.3700 Abs. or lower than 0.001 Abs.
(The cuvette is unreliable.)
9 P The value exceeded the upper limit/the lower limit by prozone check.
10 E The value exceeded the end point limit in the end point assay.
11 B All the points of the measurement range (main wavelength) or the
absorbance of the first point is lower than the ABS limit Low.
12 G All the points of the measurement range (main wavelength) or the
absorbance of the first point is higher than the ABS limit High.
13 T The temperature of the reaction tray under measurement exceeded ±1℃
to the set temperature.
14 t The measurement data under warming up.
15 L The value exceeded the linearity limit in the rate assay.
16 V Highest concentration in multi-point calibration is beyond STD Abs..
17 ISE Error 5 digits error code. Refer to Appendix E

(In case ISE module is assembled)
18 ASTM_x_y_z The value of specific field is defective.
“x, y, z” are the chapter numbers of “ASTM E1394-91 Standard
Specification for Transferring Information Between Clinical Instruments
and Computer Systems Approved April 2, 1991, Published June 1991”.
“ASTM_7_1_x” : Message Header Record
“ASTM_8_1_x” : Patient Information Record
“ASTM_9_4_x” : Measurement Order Record
“ASTM_10_1_x” : Measurement Result Record
“ASTM_11_1_x” : Comment Record
“ASTM_12_1_x” : Enquiry Record
“ASTM_13_1_x” : Message Terminator Record
In case that “x” is “1”, it means the abnormal message level, the
maximum record length over.
Other than this means the field number of the corresponding record.
19 A1 The measurement order registration error (system error)
20 A2 The designated sample for which measurement order entry was done is
under measurement, or has been finished to measure.
21 A3 Sample position error.
Measurement order entry of patient sample or control sample was
performed to STAT sample position.
Measurement order entry of patient sample or STAT sample was
performed to control sample position.
22 A4 No designated sample.
Cancelation for un-registered measurement order in BiOLiS was done.
Tokyo Boeki Medisys Inc. ３５

Appendix B BiOLiS side Configuration

BiOLiS control PC needs a COM port for communication.
If there is not, you need to add on the PC.
B－１ How to Set up

・ In Comm. Setting screen of system screen, select “ON” at host request communication.
・ Select and set “Sample ID mode” as user needs. (by Sample No. or by Sample ID)
・ Select “Request”. (In case of batch enquiry = “ALL”, in case of individual enquiry =
“Appoint” ）
Please select “All” in case of using tray position, then select ”Appoint” or ”All” when using
barcode.
・ Confirm that “Host send” button is appers on the sample order screen.
・ Click Comm. “Parameter” button at Comm. Settings screen, then input systrm
communication configuration.
Communications conditions settings screen （Default）

Default settings
Port No. : 3 (This is not automated discovery. Please set on your side.)
Baud Rate: 9600bps
Date Bit: 8
Parity Bit: None
Stop Bit: 1
Tokyo Boeki Medisys Inc. ３６

・ Please restart the PC after you have changed.
You can set END Barcode value as follows.

System screen Comm. Setting button Sample ID Mode Click >> button
Click here.
When “END Barcode” is read, the sampling will be stoped.
Appendix C Sample Bar Code
Ｃ-1 Sample Bar Code Specifications
・Readable Codeｓ（4 types）

1. CODE 39 2. ITF
3. CODE 128 4. NW-7
・Read bar width
0.2-1.0mm
・Maxmum read label width
50mm
・PCS ((White reflectance – Black reflectance) / White reflectance)
0.45 or over (white reflectance 75 % or over )
・Read digit number
Maximum 18 digits
・Label tilt range
Within ± 10°
・Label direction
No direction.
・Label paste position

Refer to the next page.
・Barcode reader poisition

Set the barcode reader to the readable position from cut of sample tray.
・Upper and down side white space

Need enough space that more than 10 times of the read bar.
(5mm target)
Tokyo Boeki Medisys Inc. ３７

Note:
This specification is made based on barcode reader specification.
Please note there is a possibility that the barcode reader do not read if you edit this barcode to
be widening or narrowing. This barcod reader is a fixing type.
There is also possibility if this thermal transfer printer has some probrems with printer paper
or condition of head temperature.
C-2 Label paste position
1 Usable Blood Collecting Tubes

The following blood collecting tubes can be used for this system.
1. 5 mL 12.4 x 75 mm
2. 7 mL 12.4 x 100 mm
3. 7 mL 15.4 x 75 mm
4. 10 mL 15.4 x 100 mm
2 Barcode Label Position Upper limit

７
１３
６４
５５ Lower limit
３５
２０
１４
１００ｍｍ７５ｍｍ
Note
Affix the barcode label with its bottom to be more than 20mm upper from
the bottom of the blood collecting tube.
In case of using a 12.4 x 100 mm tube, affix the label with its bottom to be
lower than 35mm from the bottom of the tube to avoid turning of tube.
Tokyo Boeki Medisys Inc. ３８

Appendix D BiOLiS ASTM Batch Transmission of Previous Data
When transmitting the past data to your host computer, you need to change a date of the system
date on BiOLiS 50i superior.
Procedures:
Click System
Click Date/Print.
The following screen appears.
Chose a date here
Chose a date of the data you wish to transmit on the displayed calendar..
Click Save. Then the system date has been changed to the date you wish.
Click Save in system parameter screen.
Click R & E button.
Click HOST Send button at upper left position of the screen.
The following screen shows.
Tokyo Boeki Medisys Inc. ３９

In case of “ALL” In case of “Appointment”
Input the first sample number or first sample ID of data that you wish to transmit in the Start
Sample No. or Start Sample ID box.
Input the last sample number or last sample ID of data that you wish to transmit in the End
Sample No. or Start Sample ID box.
Click Send Result button.
Please note that it takes some time to transmit data to the host computer. Three minutes are
roughly estimated in transmitting data of 10 samples with 10 test items. If the system is under
operation, it might take more time.
Inportant Note:
・ After the transmission of the past date is finished, repear the same prodcedures to return
the system date to the current date manually.
・ In case you transmit the results which measured by simple mode, input No. 41-51 to “Tray
No.”
Clicking Order button,

In case of “All”: Transmited to host inquiry of “ALL”.
In case of “Appoint”: Taransmited the enquiry of “Start sample No.” to “End sample No.”
Tokyo Boeki Medisys Inc. ４０

BiOLiS 50i superior ASTM Batch Transmission of Current Data.
Procedures:
Click R & E button.
Click HOST Send button at upper left position of the screen.
The following screen shows.
In case of “ALL” In case of “Appointment”
Input the first sample number or sample ID that you wish to transmit to the Start Sample No.
or Start Sample ID box.
Input the last sample number or sample ID that you wish to transmit to the End Sample No. or
Start Sample ID box.
Clicking “Send Result” button, the set date at the Sys. Param. screen and the results of
assigned sample No. or ID are transmitted.
Please note that it takes time to transmit data to the host computer. Three minutes are roughly
estimated in transmitting data of 10 samples with 10 test items. If the system is under
operation, it might take more time.
Inportant Note:
・ After the transmission of the past date is finished, repear the same prodcedures to return
the system date to the current date manually.
・ In case you transmit the results which measured by simple mode, input No. 41-51 to “Tray
No.”
Clicking Send result button,

In case of “All” (bath): Enquiry inquiry of “ALL” are transmitted to the host.
In case of “Appoint” (individually): The enquiry of “Start No.” to “End No.” are transmitted to
the host.
Tokyo Boeki Medisys Inc. ４１

Appendix E ISE Error Code List
Code Contents
At measurement of samole or
100000 Noise error of Na electrode ：
Calibrator 2
200000 Noise error of K electrode ：
Calibrator 2
Noise error of Na and K At measurement of samole or
300000 ：
electrodes Calibrator 2
400000 Noise error of Cl electrode ：
Calibrator 2
Noise error of Na and Cl At measurement of samole or
500000 ：
Electrodes Calibrator 2
Noise error of K and Cl At measurement of samole or
600000 ：
Noise error of Na, K and Cl At measurement of samole or
700000 ：
S00000 Air detected by the sensor ： At measurement of sample
B00000 Air detected by the sensor ： At measurement Calibrator 2
Defective drainage detected by At measurement of sample or
E00000 ：
the flow senosor Calibrator 2
010000 Noise error of Na electrode ： At measurement of Calibrator 1
020000 Noise error of K electrode ： At measurement of Calibrator 1
Noise error of Na and K
030000 ： At measurement of Calibrator 1
electrodes
040000 Noise error of Cl electrode ： At measurement of Calibrator 1
Noise error of Na and Cl
Electrodes
Noise error of K and Cl
electrodes
Noise error of Na, K and Cl
electrodes
0A0000 Air detected by the sensor ： At measurement of Calibrator 1
Defective drainage detected by the
0E0000 ： At measurement of Calibrator 1
flow sensor
Electric potential drift error at
Na electrode.
K electrode.
Na and K electrodes.
Cl electrode.
Na and Cl electrodes.
K and Cl electrodes.
Na, K and Cl electrodes.
Electric potential over range of Na
000100 ： Out of range
electrode
Tokyo Boeki Medisys Inc. ４２

Code Contents
Electric potential over range of
K electrode
Na and K electrodes
Cl electrodes
Na and Cl electrodes
K and Cl electrodes
Na, K and Cl electrodes
000010 Slope error of Na electrode ： Out of slop range, slop drift
000020 Slope error of K electrode ： Out of slop range, slop drift

Slope error of Na and K
000030 ： Out of slop range, slop drift
electrode
000040 Slope error of Cl electrode ： Out of slop range, slop drift
Slope error of Na and Cl
electrodes
Slope error of K and Cl
electrodes
Slope error Na, K and Cl
electrodes
Pulse over error of return
000001 movement to home position
(nozzle X axis)
Pulse over error of return
000002 movement to home position
(nozzle Z axis)
Timeout error of movement
000003
(nozzle X axis)
Timeout error of movement
000004
(nozzle Z axis)
Not movement error of nozzle X
000007
axis
000008 IC error of pulse motor controller
000009 IC error of pulse motor driver
00000N Samp_OK Timeout error
Tokyo Boeki Medisys Inc. ４３

Note
There is a possibility to occur multiple errors at the same moment.

For example, 00101 is organized by 00100 and 00001.
This means occuring multiple errors “00100 Na Electric potential drift error” and “00001 Na
slope error error”.
The following is each error code.
Na: 1
K: 2
Cl: 4
When multiple items occur errors, the error code is displayed as adding each electrode error
code.
In case of all items, Na + K + Cl > 1 + 2 + 4 = 7
Tokyo Boeki Medisys Inc. ４４

Appendix F System Parameter SettingASTM Communication Setting Procedures

System parameter setting
Parameter
Open System screen and set from Sys. Param. button.
For online switch, if “ON” is selected at host commucication section as following, it

will be communication with host. In case of “OFF”, it will be out of communication.
Request designation
Online switch Sample mode set
Communication classification
Sample ID Mode (There is no connection to online directly.)
by Tray No.: This method makes order useing the position which is written in
sample tray.
by Sample ID: This method makes order reading sample barcode which pasted on
sample tube.
Request (Select an enquiry method)
All (batch): Only requests of “All”.

Appoint (individually): Go to request by barcode or position.
Analyzer movement with the combination
-Sample ID Mode: “by Sample No”.

-Request: “ＡＬＬ”
Tokyo Boeki Medisys Inc. ４５

↓
Note : inquiry
Clicking Start button.
↓
Detected container If thre is sample cup or tube, it starts measurement.
If no, it occurs error message.
↓
Resutlts are transmeted to the host when information gathers full of each one
sample.
Note:
Enquiry is ”ALL” inquiry. Please transmit text without request to BiOLiS.
Transmit it to BiOLiS when request is decided BiOLiS. It is available to receivean
any time.
-Sample ID Mode: “by Sample ID”

-Request: “ＡＬＬ”
Request from HOST is transmeted as needed.
↓
Click “Start” button.
↓
Sample barcode is read, then if thre is order of barcode value on BiOLiS, starts
measurement. If there is none, it occurs error message.
↓
If there is none, it occurs error message.
↓
Resutlts are transmeted to the host when information gathers full of each one
sample.
Note:
Enquiry is “ALL” inquiry. Tranmit text without request to BiOLiS.
When the request is decided, ｔransmit to the BiOLiS. It can be received at any
time.
-Sample ID Mode: “by Sample ID”

-Request: “ＡPPOINT”
Click “Start” button.
Tokyo Boeki Medisys Inc. ４６

↓
Sample ID (barcode) enquiry
*In case the ID can not be read at 5 times or the End barcode is read,
sampling will be stop.
↓
Transmit ID (barcode) requested from host to BiOLiS.
↓
If there is none, it occurs error message.
↓
Resutlts are transmeted to the host when information gathers full of each one sample.
Note:
In case of press start button after state of “sampling stop”, it inquires from the nest sample
number.
If you press start button after state of “End of run”, it inquires from the first number of sample
tray.
APPENDIX G Specification of Serum information
Item numbers of Serum info. are as follows.
Item number 96 “L” Lipemic

Item number 97 “H” Hemolyic
Item number 98 “I” Icteric
Please order by only item number 96

The results of three items (96-98) are teransfered.
Tokyo Boeki Medisys Inc. ４７

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Automated Clinical Analyzer

BiOLiS 50i Superior

Tokyo Boeki Medisys Inc.

Appendix A Error Code List------------------------------------------------------------34

Tokyo Boeki Medisys Inc.

Normally, select “Appoint” in case of “by Sample ID (barcode)”mode operation.

Please kindly decide this setting as customers need.

The specifications may change without notice.

Tokyo Boeki Medisys Inc. １

BiOLiS uses the cross cable of RS-232C for connection to Host.

No. Setting items Available setting value

Tokyo Boeki Medisys Inc. ２

3. Protocol of Data Link Layer

The protocol of data link layer is defined by ASTM 1381-91.

No. Transmission Transmission Explanation

<STX>[FN][TEXT]<ETB>[C1][C2]<CR><LF> Intermediate frame

Note: All the example of check sam value is invalid.

[TEXT] is the text data to be transmitted.

Tokyo Boeki Medisys Inc. ３

3.2. Transition of States

There are the following four states in data link layer.

3.2.1. Idle State

3.2.2. Establishment Phase

The establishment phase determines the direction of information flow.

The system that received <ENQ> transmits <ACK>, if it is ready to receive

Sender Direction of information flow Receiver

Tokyo Boeki Medisys Inc. ４

Sender Direction of information flow Receiver

Sender Direction of information flow Receiver

When both systems simultaneously transmit <ENQ>, BiOLiS has priority.

In case that BiOLiS received a reply of <ENQ> to its transmitted <ENQ>, it

Sender Direction of information flow Receiver

Tokyo Boeki Medisys Inc. ５

Sender Direction of information flow Receiver

Tokyo Boeki Medisys Inc. ６

3.2.3 Transfer Phase

1) Data delay/no response to the transfer phase

Sender Direction of information flow Receiver

Sender Direction of information flow Receiver

The sender transmits the same frame six times.

Sender Direction of information flow Receiver

Tokyo Boeki Medisys Inc. ７

The conditions that BiOLiS replies with <NAK> are as follows.

No. Condition of a reply of <NAK> Explanation

4) No response/ response delay

Sender Direction of information flow Receiver

Sender Direction of information flow Receiver

3.2.4 Termination Phase

Tokyo Boeki Medisys Inc. ８

The records are defined by ASTM1394-91.

No. Record ID Record

Any record except the above is ignored.

level 0 level 1 level 2 level 3 level 4

Tokyo Boeki Medisys Inc. ９

The delimiters at initialization are as follows.

No. Delimiter Explanation

To terminate the record, <CR> (13(ODh) in ASCII code) is used.

4.2. Usable Character Code

No. Field name Notes