TOSOH CORPORATION BIOSCIENCE DIVISION

Transcription

1 Host Communication Specifications Rev.1 TOSOH CORPORATION BIOSCIENCE DIVISION

2 Contents 1 OVERVIEW LOW LEVEL CONTROL COMMUNICATION SPECIFICATIONS CONNECTION PIN ASSIGNMENT COMMUNICATION PROCEDURE AND CONTROL CODE HIGHER LEVEL CONTROL DELIMITER STANDARD COMMUNICATION SPECIFICATIONS MESSAGE HEADER RECORD (H) PATIENT INFORMATION RECORD (P) TEST ORDER RECORD (O) RESULT RECORD (R) CONCENTRATION RESULT RECORD (R) SECOND R RECORD (RATE VALUE) COMMENT RECORD (C) PATIENT COMMENT COMMENT RECORD (C) FLAG USED ON THE REQUEST INFORMATION RECORD (Q) MESSAGE TERMINATOR RECORD (L) SCIENTIFIC RECORD (S) MANUFACTURER INFORMATION RECORD (M) COMMUNICATION EXAMPLE (HIGH-LEVEL LAYER) Download of order Batch query to and response from the host Query to and response from the host for one specimen Measurement result transmission to the host COMMUNICATION EXAMPLE (LOW-LEVEL LAYER) AIA-600II COMPATIBLE COMMUNICATION SPECIFICATIONS MESSAGE HEADER RECORD (H) PATIENT INFORMATION RECORD (P) TEST ORDER RECORD (O) Processing at Omission Definition of the word Specimen type RESULT RECORD (R) COMMENT RECORD (C) REQUEST INFORMATION RECORD (Q) MESSAGE TERMINATOR RECORD (L) SCIENTIFIC RECORD (S) MANUFACTURER INFORMATION RECORD (M) COMMUNICATION EXAMPLE (HIGH-LEVEL LAYER) Download of order Batch query to and response from the host Query to and response from the host for one specimen Measurement result transmission to the host EXAMPLE FOR COMMUNICATION(LOW LEVEL) Order Query Results Page 2/27

3 Revision History Rev Revision Date Description of Revision Newly prepared Page 3/27

4 1 Overview This document prescribes the standard communication specifications (Communication specifications compatible with a model except AIA-600II) and the communication specifications that kept compatibility with AIA-600II for connecting a host computer to the. The specifications can be selected with STANDARD/AIA-600II buttons of ASTM on the HOST screen. The both common contents are mentioned in an opening chapter, and the different point is mentioned individually by the latter half. The specifications of communication interface for comply with ASTM E and E This document describes the detail specifications, which ASTM does not specify. 2 Low level control 2.1 Communication specifications Parameter Specification Transmission RS232C, Start-Stop, Half Duplex Baud Rate 300,600,1200,2400,4800,9600bps Transmission Code ASCII Data Length / Parity 7bit/Even 7bit/Odd 8bit/None Stop bit 1bit,2bit Under bars show default parameters. 2.2 Connection D-sub 9-pin connector Female connector Cable Host computer The border of responsibility 2.3 Pin Assignment LIS(example:25-pin) Signal name Pin No Pin No Signal name 1 Frame GND Received Data RXD 2 2 Transmit Data Transmit Data TXD 3 3 Received Data Data Terminal DTR 4 4 Request to Ready Send Signal GND SG 5 5 Clear to Send Data Set DSR 6 6 Data Set Ready Ready Request to RTS 7 7 Signal GND Send Clear to Send CTS 8 20 Data Terminal Ready On the,dtr is always ON. DSR is not used. Page 4/27

5 2.4 Communication procedure and control code The summary of the communication procedure and the control code are as follows. Please refer to E for the details. /Host Computer Host Computer/ <ENQ> -> <STX><FN><TEXT><ETX><C1><C2><CR><LF> -> <STX><FN><TEXT><ETX><C1><C2><CR><LF> -> <STX><FN><TEXT><ETX><C1><C2><CR><LF> -> <EOT> -> Control Character <ENQ>:0x05 The code to send so that the transmitter side establishes a link. (Start of the communication) <ACK>:0x06 The code which the receiver side of data sends to the transmitter side for reasons of the following. (1) Preparations to receive data were completed when ENQ was received. (2) Data were received definitely. <NAK>:0x15 The code which the receiver side of data sends to the transmitter side for reasons of the following. (1) Data can not be received when ENQ was received. (2) Data were not received definitely. <STX>:0x02 The code to add to the top of a frame. <ETB>:0x17 The code to add to the end of text of the frame when there is a following frame. <ETX>:0x03 The code to add to the end of text of a last frame. <EOT>:0x04 The code to send to close the Link. (The end of the communication) <CR>:0x0D The code to add to a frame. <LF>:0x0A The code to add to a frame. <FN>:ASCII The number that added to each frame. This number starts from 1, and by 1 increases to 7. The next of 7 is 0. And this fashion is continued. In the case of the retransmission, the same number is used. <TEXT>:ASCII The ASCII text which divided the main body of the message. One TEXT must be equal to or less than 240 characters. <C1>:ASCII The high rank figure of the check sum. <C2>:ASCII The low rank figure of the check sum. Check sum The check sum expresses the addition result (hexadecimal) of transmission data as 0, 1, -,9, A, B, -, F in ASCII. The <FN>, <TEXT> and <ETX> are computed by summation. Page 5/27

6 For example <STX>1H \^& <CR><ETX><C1><C2><CR><LF> In this case the check sum becomes higher figure C1 = "F", lower figure C2 = "E". The receiver side performs the check sum calculation of the received data and replies ACK when agreed with received C1, C2, or replies NAK when not agreed. Frame structure The frame begins with STX and is over with CRLF. TEXT must be less than 240 characters by ASCII code. A case more than 240 characters, an intermediate frame are made, and TEXT is transmitted. About the intermediate frame, ETB is transmitted just after TEXT. When TEXT is equal to or less than 240 characters, ETX is transmitted just after TEXT like a last frame. Page 6/27

7 3 Higher level control complies with the following specifications. (1) Processing at Reception shows the processing at the time when receives Records from Host computer. Transmitted data shows the data, which sends to Host computer. (2) For record transmission, store a single record in one low-level frame (do not store more than one record in one frame). (3) Fields and Components, which are specified in ASTM but in not this document, are sent without blank. (4) In the following explanations, "Omit" indicates whether data may be omitted or not when the host computer transmits a record to the. If data is omitted, the value will be determined according to the rules of the side. (5) Put numeral character from right side and alphabetical character from left side. Sample ID is from left side. (6) Less than 15 of Sample ID are recommended. Because some 16 can be recognized as QC sample in. (7) For record transmission from the host, ensure that the maximum allowable digit number for each item will not be exceeded. 3.1 Delimiter In Delimiter to show below, the following ASCII characters are used by fixation at the time of the transmission of a message from. Delimiter at the time of the reception obeys a definition of Message Header Record except Record Delimiter, but the following ASCII characters are recommended. Record Delimiter CR carriage return (0Dh) Field Delimiter vertical bar (7Ch) Repeat Delimiter back slash (5Ch) Component Delimiter ^ caret(5eh) Escape Delimiter & ampersand(26h) Page 7/27

8 4 Standard Communication Specifications Standard communication specifications and compatible communication specifications of AIA- 600II are selectable in. Each record in standard communication specifications is explained here. When a communication system is built newly, please choose this way. In the case of the use by this way, please choose the STANDARD in the ASTM on the HOST screen. 4.1 Message header record (H) 1 Record Type ID 1 H Record No H 2 Delimiter Definition 4 Definition of delimiter No ^& 3 Message Control ID 0 -Ignore Access Password 0 -Ignore Sender Name or ID 32 -Ignore- Yes Device name set in Ignore Date and Time of Message 14 -Ignore- Yes Date and time of transmission YYYYMMDDHHMNSS Ignore Patient information record (P) 1 Record Type ID 1 P Record No P 2 Sequence Number 6 -Ignore- No Serial number (from 1) 3 Practice Assigned Patient 0 -Ignore- - - ID 4 Laboratory Assigned 0 -Ignore- - - Patient ID 5 Patient ID No.3 0 -Ignore Patient Name Last: 0 First: 0 -Ignore- - -,(The delimiter ^ dividing the name is transmitted.) 7 Mother s Maiden Name 0 -Ignore Birth Date 0 -Ignore Patient Sex 0 -Ignore Ignore Test order record (O) 1 Record Type ID 1 O Record No O 2 Sequence Number 6 -Ignore- No Serial number (from 1) 3 Specimen ID 16 Specimen ID No Specimen ID 4 Instrument Specimen ID 0 -Ignore Universal Test ID Manufacturer s or Local Code Analyte: 3 Dilution: 4 Lot. 3 Analyte ( ), Dilution (1-1000) -Ignore- No Yes - Analyte (000 to 999), Dilution(1-1000), Lot.( ) (*1) Add delimiter "^^^" before the analyte. The analyte, dilution and lot are divided with delimiter "^" Ignore Specimen Type 7 Material {Sp.1, Sp.2, Control} Yes Material {Sp.1, Sp.2, Control} Ignore- - - Note: (*1) The can transmit the Lot number of a test cup when the LOT of UPLOAD OPTION on the HOST screen is selected. The Lot number in the transmit data will be set to 000 when the assay completes with an error such as short sample and so on. The host must not transmit the Lot number to the. Page 8/27

9 4.4 Result record (R) Concentration 1 Record Type ID 1 R 2 Sequence Number 6 Serial number (from 1) 3 Manufacturer s or Local 3 Analyte (000 to 999) Code 4 Data or Measurement Value 8 Concentration ZZZZZZ9 to (Z for zero suppression, decimal point position fixed for each analytical item) 5 Units 6 does not Unit (X6) 6 Reference Ranges Low: 8 High: 8 28 max including "to" receive this record (*1) - Normal lower limit(low) Normal upper limit(high) ZZZZZZ9 to (Z for zero suppression, decimal point position fixed for each analytical item) 7 Result Abnormal Flags 2 Flag(See Table 1) 8 Nature of Abnormality 0 - Testing 9 Result Status 1 Status F: Final P: Pending X: Rejected I: Not measured 10 Date of Change in Instrument Normative Values or Units 0-11 Operator Identification 32 Finalizing operator name. Omitted for Pending or Rejected. 12 Date/Time Test Started 0-13 Date/Time Test Completed 14 Date and time of test completed YYYYMMDDHHMNSS 14 Instrument Identification 0 - Note: (*1)The host must not transmit this Result Record to the. Transmitted result value is selectable when the concentration was not calculated or when the <L or >H flag is reported. (1) When the result was not provided, the result value of transmission is selectable in the NO RESULT on the HOST screen. Besides, the unit is blank. ZERO : outputs 0 NULL : outputs blank (2) When the flag <L or >H with the result was not provided, the result value of transmission is selectable in the >H <L RESULT on the HOST screen. Besides, the unit is output. ZERO : outputs 0 NULL : outputs blank ASSAY RANGE : outputs assay range value ASSAY RANGE <> : outputs assay range value with < or > (*2) When the ASSAY RANGE is selected in the >H <L RESULT on the HOST screen, if a result value is reported with <L or >H flag, the value of the ASSAY.L or ASSAY.H in the TEST FILE is output as a result value. (Refer to the following examples) (Example) In the case of assaying in following conditions; ASSAY.H:400, default dilution factor: 1, concentration of specimen is about 1000 ng/ml. Page 9/27

10 Dilution Transmitted Flag Transmitted Result One-fold dilution(default) > 400 Five-fold dilution H 1000 In case that dilution is performed before being assayed, when a result exceeds the assay range, transmitted result reflects concentration of diluted specimen. Please take account of treatment for results in such case. (Example) In the case of assaying in following conditions; ASSAY.H: 36.4, default dilution factor: 11, measurement concentration range for undiluted specimen: 1-400, concentration of specimen is about 700 ng/ml. Dilution Transmitted Flag Transmitted Result Eleven-fold dilution(default) > 36.4 Twenty-two-fold dilution H 700 Although a result has several flags, only the highest-priority ASTM flag (A) is transmitted. For example, when <L (or >H) flag and another higher-priority flag are added to a result, transmitted ASTM flag is A not < (nor >). Therefore, when the ASSAY RANGE is selected in the >H <L RESULT on the HOST screen, it is difficult to determine whether the transmitted result value from the is assay range or concentration. It is recommended that the NULL or ASSAY RANGE <> is selected in the >H <L RESULT on the HOST screen. Table 1 shows a cross-reference between flags used in the and for ASTM communications. ASTM flag Meaning AIA-2000 internal flag L Lower than normal L,RL H Higher than normal H,RH HH Abnormally high None LL Abnormally low None < Outside the measuring range <L > Outside the measuring range >H N Normal Blank A Measurement error SE,AE,LE,ME,IS,IM, MF, RF, SP, PS, SS, RS, ES, TS, NB, LS, WS, WU, BS, DS, SC, UC, IO,MA,NS, DL, DO, BH, CE, NC, CV, DH,UH(*3) U - None D - None B - None W - None Table 1 Note (*3) The DH and UH flags can be transmitted only when the FT3 CHECK is set on the SPECIFICATIONS screen. Page 10/27

11 4.5 Result record (R) Second R record (Rate value) 1 Record Type ID 1 R 2 Sequence Number 6 Serial number (from 1) 3 Manufacturer s or Local 4 Rate Code 4 Data or Measurement Value 7 does not receive this record (*1) Rate value 5 Units 4 - nm/s 6 Reference Ranges 0-7 Result Abnormal Flags 1 Flag (See Table 2) 8 Nature of Abnormality 0 - Testing 9 Result Status 0-10 Date of Change in Instrument Normative Values of Units 0-11 Operator Identification 32 Finalizing operator name. Omitted for Pending or Rejected. 12 Date/Time Test Started 0-13 Date/Time Test Completed 14 Date and time of test completed YYYYMMDDHHMNSS 14 Instrument Identification 0 - Notes: (*1) The host must not transmit this Result Record to the. (*2) NA is transmitted in the case of no measurement (due to an error) and >667 in the case of DO flag (rate exceeding 667 nm/s). (*3) The transmits this record (second R record) when the RATE of UPLOAD OPTION on the HOST screen is selected. Table 2 describes each flag. Flag N A Meaning Rate value valid Rate value is not valid. This A flag is reported when the rate value is NA or >667. Table Comment record (C) Patient comment 1 Record Type ID 1 2 Sequence Number 6 does not does not 3 Comment Source 1 receive this record. transmit this record. 4 Comment Text 32 5 Comment Type 1 Page 11/27

12 4.7 Comment record (C) flag used on the 1 Record Type ID 1 C 2 Sequence Number 6 Serial number (from 1) 3 Comment Source 1 does not - Fixed to I 4 Comment Text 2 fixed or 8 fixed(*2) receive this record (*1) Flag used on 5 Comment Type 1 Fixed to I Notes: (*1) The host must not transmit this Comment Record to the. (*2) The "Comment Text" (flag) is fixed to 2. This is filled with two space characters when the flag is null; with H followed by one space character for flag H; with L followed by one space character for flag L. The transmits this Comment Record only when the INSTRUMENT FLAG of UPLOAD OPTION on the HOST screen is selected. When the HIGHEST of UPLOAD OPTION on the HOST screen is selected, one flag(2) is transmitted based on the priority(compatible with AIA-NexIA). When the ALL of UPLOAD OPTION on the HOST screen is selected, all three flags (2 each) divided by the delimiter are transmitted. 4.8 Request information record (Q) 1 Record Type ID 1 Q Record No Q 2 Sequence Number 6 -Ignore- No Serial number (from 1) 3 Starting Range ID Number 16 Corresponding to specimen ID "ALL" for all No Corresponding to specimen ID "ALL" for all 4 Ending Range ID Number 16 Corresponding to specimen ID Yes Corresponding to specimen ID 5 Manufacturer s or Local 3 Analyte ( ) No ALL Code ALL for all Ignore Message terminator record (L) 1 Record Type ID 1 L Record No L 2 Sequence Number 1 -Ignore- No Fixed to 1 3 Termination Code 0 -Ignore Scientific record (S) Not used 4.11 Manufacturer information record (M) Not used Page 12/27

13 4.12 Communication Example (High-level layer) Download of order H,P(,C),O,L Order Host Computer Processing of downloading orders from host computer is shown as below. Download from host computer with H,P(,C),O,L (1) can receive 100 specimens(24 analytes/specimen) at a time. (2)When plural specimens are downloaded in succession, do not take time between specimens more than 3 seconds. (Sample response 1) When order records are collated H \^&<CR> O ^^^001^51\^^^002\^^^003^100 Sp.1<CR> (Sample response 2) When order records are not collated H \^&<CR> O ^^^001^51 Sp.1<CR> O ^^^002<CR> O ^^^003^100 Sp.1<CR> (Sample response 3) When there are order records for plural specimens H \^&<CR> O ^^^001^51\^^^002\^^^003^100 Sp.1<CR> P 2 ^ <CR> O ^^^001^51 Sp.1<CR> O ^^^002<CR> O ^^^003^100 Sp.1<CR> P 3 ^ <CR> O ^^^001^51\^^^002\^^^003^100 Sp.1<CR> Batch query to and response from the host (1) (2) (2) H,Q,L Query H,P(,C),O,L Order H,L No Order Host Computer Page 13/27

14 This section describes processing for a batch query from the side to the host.( This is done when the DOWNLOAD button of FUNCTION on the ORDER screen is pressed. ) Query to the host by H, Q, and L "ALL" is set to Starting Range ID Number and Manufacturer's or Local Code in Q. Then response will be obtained from the host with H, P, (C), O, and L (1) can receive 100 specimens(24 analytes/specimen) at a time. (2)When plural specimens are downloaded in succession, do not take time between specimens more than 3 seconds. (Sample query) H \^& <CR> Q 1 ^ALL ALL<CR> (Sample response 1) When order records are collated H \^&<CR> O ^^^001^51\^^^002\^^^003^100 Sp.1<CR> (Sample response 2) When order records are not collated H \^&<CR> O ^^^001^51 Sp.1<CR> O ^^^002<CR> O ^^^003^100 Sp.1<CR> (Sample response 3) When there are no order records H \^&<CR> (Sample response 4) When there are order records for several specimens H \^&<CR> O ^^^001^51\^^^002\^^^003^100 Sp.1<CR> P 2 ^ <CR> O ^^^001^51 Sp.1<CR> O ^^^002<CR> O ^^^003^100 Sp.1<CR> P 3 ^ <CR> O ^^^001^51\^^^002\^^^003^100 Sp.1<CR> (Supplement 1) The order record Dilution will be processed as follows: 1. When the Dilution is specified, that value is used. 2. When the Dilution is not specified but Material is set, the Dilution value stored in the corresponding to the specified Material is used. 3. When neither the Dilution nor the Material is specified, 1 is used for the Dilution (this is the case when Material is other than Sp.1, Sp.2, or Page 14/27

15 Control) 4. In the case of Example 2, response, it is suspected that the Material may not match even for the same specimen (same specimen ID) due to a setting error. In such a case, the Material for the first record will be used for all the records. (Supplement 2) If the receives no response from the host within 30 seconds(changeable with TIMEOUT on the HOST screen) of transmitting a query to the host with H, Q, and L, a timeout event is triggered and it will be processed as in the case with no order Query to and response from the host for one specimen (1) (2) (2) H,Q,L Query H,P(,C),O,L Order H,P,O,L / H,Q,L No Order Host Computer This section describes processing for a query from the side to the host for one specimen. Query to the host with H, Q, and L The Specimen ID is set to Starting Range ID Number, and "ALL" is set to the Manufacturer's or Local Code in Q. Then response will be obtained from the host with H, P, (C), O, and L (Sample query) H \^& <CR> Q 1 ^ ALL<CR> (Sample response 1) When order records are collated H \^&<CR> O ^^^001^51\^^^002\^^^003^100 Sp.1<CR> (Sample response 2) When order records are not collated H \^&<CR> O ^^^001^51 Sp.1<CR> O ^^^002<CR> O ^^^003^100 Sp.1<CR> (Sample response 3) When there is a patient comment (The comment is ignored.) H \^&<CR> C 1 L Test Record G<CR> O ^^^001^51\^^^002\^^^003^100 Sp.1<CR> Page 15/27

16 (Sample response 4) When there is no order (1) H \^&<CR> P 1<CR> O <CR> (Sample response 5) When there is no order (2) H \^&<CR> Q 1 ^ ALL<CR> Measurement result transmission to the host H,P,O,R(,2 nd R)(,C),L Measurement Result Host Computer Measurement results are transmitted to the host with H, P, O, R, (second R) (, C), L. The O and R records are transmitted as a pair. If a Comment Record C used for flags is added, the R and C records are transmitted as a pair. (Transmission example 1) When plural measurement results are selected on the Result screen and uploaded, the results are transmitted in the following format: H \^& <CR> O ^^^001^51 Sp.1<CR> R 1 ^^^ mg/ml to N F Operator <CR> H \^& <CR> O ^^^002^1 Sp.1<CR> R 1 ^^^ ng/ml 0.10 to 5.00 N F Operator <CR> H \^& <CR> O ^^^003^100 Sp.1<CR> R 1 ^^^ ug/ul 100 to 500 H F Operator <CR> (Transmission example 2) When a C record is added (by selecting HIGHEST of UPLOAD OPTION on the HOST screen). H \^& <CR> O ^^^001^51 Sp.1<CR> R 1 ^^^ mg/ml to N F Operator <CR> C 1 I I<CR> Page 16/27

17 (Transmission example 3) When a second R record is added(by selecting RATE of UPLOAD OPTION on the HOST screen). H \^& <CR> O ^^^001^51 Sp.1<CR> R 1 ^^^ mg/ml to N F Operator <CR> R 2 ^^^Rate nm/s N Operator <CR> (Transmission example 4) When a C record of flag is added(by selecting ALL and RATE of UPLOAD OPTION on the HOST screen). H \^& <CR> O ^^^001^51 Sp.1<CR> R 1 ^^^ mg/ml to N F Operator <CR> R 2 ^^^Rate nm/s N Operator <CR> C 1 I \ \ I<CR> (Transmission example 5) When a Lot number of a test cup is added (by selecting LOT of UPLOAD OPTION on the HOST screen). H \^& <CR> O ^^^001^51^068 Sp.1<CR> R 1 ^^^ mg/ml to N F Operator <CR> 4.13 Communication Example (Low-level layer) The Transmission example 2 of [ Measurement result transmission to the host] including the low-level layer of ASTM is shown as follows. Host Computer <ENQ> -> <STX>1H ^& <CR><ETX>12<CR><LF>-> <STX>2<ETX>85<CR><LF> -> <STX>4O ^^^001^51 Sp.1<CR><ETX>4A<CR><LF> -> <STX>5R 1 ^^^ mg/ml to N F Operator <CR><ETX>64<CR><LF> -> <STX>6C 1 I I<CR><ETX>7C<CR><LF> -> <STX>7<ETX>40<CR><LF> -> <EOT> -> Page 17/27

18 5 AIA-600II Compatible Communication Specifications Standard communication specifications and compatible communication specifications of AIA- 600II are selectable in. Each record in compatible communication specifications of AIA-600II is explained here. In the case of the use by this way, please choose AIA-600II in ASTM on the HOST screen. 5.1 Message Header Record (H) 1 Delimiter Definition 4 Delimiters are used No ^& 2 Sender Name or ID 9 -Ignore- Yes Device Name" " 3 Date and Time Date and Time or Message 14 -Ignore- Yes (Year,Month,Day,Hour,Second) YYYYMMDDHHMMSS 5.2 Patient Information Record (P) 1 Sequence Number 1 -Ignore- No Fixed at 1 2 Practice Assigned Patient ID 16 -Ignore- Yes Sample ID 5.3 Test Order Record (O) 1 Sequence Number Max.2 -Ignore- No Sequence Number from1 2 Specimen ID 16 Sample ID Yes Sample ID 3 Instrument Specimen ID 4 2 -Ignore- -Ignore- Yes Yes Sequence Number Subsequence Number 4 Universal Test ID (Manufacturer s or Local Code) 5 Specimen Descriptor (Specimen Type) Analyte:3 Dilution:4 Lot:3 Analyte Name: Ignore- -Ignore- 1:Patient 2:QC No Yes Yes Yes No Analyte Code( ) Dilution(1-1000) Lot Analyte Name 1:Patient 2:QC Processing at Omission When a dilution ratio was omitted, a dilution ratio is decided according to the following rule. To order a dilution ratio definitely, setting the dilution ratio to the O record that is transmitted from the host is recommended. Decision rule of the dilution ratio at omission In the case of setting 1(patient specimen) to Specimen Descriptor, according to a set mode (DIL.PRTY of TEST FILE), the DIL.SP1 or DIL.SP2 (as serum or urine) every analyte of TEST FILE is used for the dilution ratio. DIL.PRTY Dilution Ratio 1 Serum(SP1) 2 Urine(SP2) 3 Serum(SP1) 4 Urine(SP2) In the case of setting 2(control specimen) to Specimen Descriptor, the DIL.CNTL every analyte of TEST FILE is used for the dilution ratio. Page 18/27

19 As for DIL.PRTY, please refer to the TEST FILE of Section 10 in the operator s manual Definition of the word (1) Sequence Number The Sequence Number is a serial number generated by when an Order record is received from Host computer. (2) Subsequence Number The Subsequence Number is a number of tests in each sample Specimen type Even STAT which is ordered on the ORDER screen is expressed as a specimen. Please distinguish the QC specimen in Specimen Descriptor. Page 19/27

20 5.4 Result Record (R) 1 Sequence Number 1 Fixed to1 2 Universal Test ID (Manufacturer s or Local Code) 3 Analyte Code( ) 3 Data or Measurement Value 8 Result ZZZZZZ9 to (Z=0 Suppress. Decimal place is fixed in TEST FILE Screen. does not - 4 Units 6 receive this record Unit 5 Result Abnormal Flags 2 Flag(See Flag Table3) 6 Result Status 1 F: ASTM Flag is not A. I: ASTM Flag is A. 7 Operator Identification 10 Operator Name 8 Date Time Completed Date/Time Test Completed 14 YYYYMMDDHHMMSS Transmitted result value is selectable when the concentration was not calculated or when the <L or >H flag is reported. (1) When the result was not provided, the result value of transmission is selectable in the NO RESULT on the HOST screen. Besides, the unit is blank. ZERO : outputs 0 NULL : outputs blank (2) When the flag <L or >H with the result was not provided, the result value of transmission is selectable in the >H <L RESULT on the HOST screen. Besides, the unit is output. ZERO : outputs 0 NULL : outputs blank ASSAY RANGE : outputs assay range value ASSAY RANGE <> : outputs assay range value with < or > (note) As to assay range value, please refer to note (*2) of [4.4Result record (R) Concentration] Table3 shows a cross-reference between flags used in the and for ASTM communications. ASTM flag Meaning AIA-2000 internal flag L Lower than normal L,RL H Higher than normal H,RH HH Abnormally high None LL Abnormally low None < Outside the measuring range <L > Outside the measuring range >H N Normal Blank A Measurement error SE,AE,LE,ME,IS,IM, MF, RF, SP, PS, SS, RS, ES, TS, NB, LS, WS, WU, BS, DS, SC, UC, IO,MA,NS, DL, DO, BH, CE, NC, CV, DH,UH(*1) U - None D - None B - None W - None Table 3 Note (*1) The DH and UH flags can be transmitted only when the FT3 CHECK is set on the SPECIFICATIONS screen. Page 20/27

21 5.5 Comment Record (C) 1 Sequence Number 1 Fixed tot1 2 Comment Source 1 Always I 3 Comment Text (12) 4 Flag1 2 Flag 5 Flag2 2 6 Rate Value 8 7 Comment Type 1 does not receive this record - (See Flag Table 3) Result ZZZZZZ9 to (Z for zero suppression, decimal point position fixed for each analytical item) Always I (1) C Record must be put after R Record. (2) Host computer doesn t transmit Comment Record. (3) The Rate Value is set when the RATE of UPLOAD OPTION on the HOST screen is selected. If not set, the Rate Value is blank. 5.6 Request Information Record (Q) Sequence Number 1 does not Fixed to1 Starting Range ID Number 16 receive this record - Corresponding to specimen ID "ALL" for all 5.7 Message Terminator Record (L) 1 Sequence Number 1 -Ignore- No Fixed to1 5.8 Scientific record (S) Not Used 5.9 Manufacturer information record (M) Not Used Page 21/27

22 5.10 Communication Example (High-level layer) Download of order H,P,O,L Order Host Computer (1) can receive 100 specimens(24 analytes/specimen) at a time. (2)When plural specimens are downloaded in succession, do not take time between specimens more than 3 seconds. (Example 1) H \^& <CR> P 1 SAMPLE-ID16DIG00<CR> O 1 SAMPLE-ID16DIG00 ^ ^^^004^ 51^ ^BMG 1<CR> O 2 SAMPLE-ID16DIG00 ^ ^^^001^ ^ ^CEA 1<CR> O 3 SAMPLE-ID16DIG00 ^ ^^^002^ ^ ^AFP 1<CR> (Example 2) H \^& <CR> P 1 SAMPLE-ID <CR> O 1 SAMPLE-ID ^ ^^^017^ ^ ^FOL 1<CR> O 2 SAMPLE-ID ^ ^^^004^ 51^ ^BMG 1<CR> The sample program of is made as follows. SAMPLE-ID16DIG00 STC BMG*51 CEA AFP SAMPLE-ID STC FOL STC BMG* Batch query to and response from the host (1) (2) (2) H,Q,L Query H,P,O,L Order H,L No Order Host Computer This section describes processing for a batch query from the side to the host.( This is done when the DOWNLOAD button of FUNCTION on the ORDER screen is pressed. ) When plural specimens are downloaded in succession, do not take time between specimens more than 3 seconds. Query to the host by H, Q, and L "ALL " is set to Starting Range ID Number in Q. Page 22/27

23 (Sample query) H \^& <CR> Q 1 ^ALL <CR> (Sample response 1) When plural specimens are ordered H \^& <CR> P 1 SAMPLE-ID16DIG00<CR> O 1 SAMPLE-ID16DIG00 ^ ^^^004^ 51^ ^BMG 1<CR> O 2 SAMPLE-ID16DIG00 ^ ^^^001^ ^ ^CEA 1<CR> O 3 SAMPLE-ID16DIG00 ^ ^^^002^ ^ ^AFP 1<CR> H \^& <CR> P 1 SAMPLE-ID <CR> O 1 SAMPLE-ID ^ ^^^017^ ^ ^FOL 1<CR> O 2 SAMPLE-ID ^ ^^^004^ 51^ ^BMG 1<CR> (Sample response 2) When no specimen is ordered H \^& <CR> Query to and response from the host for one specimen (1) (2) (2) H,Q,L Query H,P,O,L Order H,Q,L / H,P,L No Order Host Computer The host computer transmits the all order information (H,P,O,L) that queries with Specimen ID(H,Q,L). If there is no order information in the host computer, the host computer transmit H,P,L records. If no response from Host within 30 seconds (chageable with TIMEOUT on the HOST screen) after queries (H,Q,L), a timeout is generated and additional processing of generating sample program is finished. And prepares for next query. (Sample query) H \^& <CR> Q 1 ^SAMPLE-ID16DIG00<CR> (Sample response 1) When plural analytes are ordered H \^& <CR> P 1 SAMPLE-ID16DIG00<CR> O 1 SAMPLE-ID16DIG00 ^ ^^^001^ ^ ^CEA 2<CR> O 2 SAMPLE-ID16DIG00 ^ ^^^002^ ^ ^AFP 2<CR> Page 23/27

24 The sample program is made as follows. SAMPLE-ID16DIG00 CEA AFP (Sample response 2) When no analyte is ordered H \^& <CR> Q 1 ^SAMPLE-ID16 <CR> (Sample response 3) When no analyte is ordered H \^& <CR> P 1 SAMPLE-ID16 <CR> Measurement result transmission to the host H,P,O,R,C,L Measurement Result Host Computer (1) The sequence (H,P,O,R,C,L) of result transmitting is done every result. Therefore in batch transmission, the sequence is repeated when the sample has plural analyte results. (2) When the real time transfer of the measurement result to the host computer occurred during a query (H,Q,L) to the host computer, performs the transfer of the result after having received the order from the host computer. (3) In real time transmission mode, if there is an error during data transmission, the result will be no longer transmitted automatically. (Example 1) H \^& <CR> P 1 SAMPLE-ID16DIG01<CR> O 1 SAMPLE-ID16DIG ^01 ^^^092^ 1^022^IgE 1<CR> R 1 ^^^092 A I Operator <CR> C 1 I SE^ ^ I<CR> (Example 2) H \^& <CR> P 1 SAMPLE-ID16DIG02<CR> O 1 SAMPLE-ID16DIG ^01 ^^^001^ 1^033^CEA 1<CR> R 1 ^^^ mg/ml N F Operator <CR> C 1 I ^ ^ I<CR> (4) The transmission example when concentration result was not provided is shown below. a. When blank was output (NULL was selected with NO RESULT on the HOST screen) H \^& <CR> P 1 SMPL1 <CR> O 1 SMPL1 0012^04 ^^^072^ 1^001^#TSH 1<CR> Page 24/27

25 R 1 ^^^072 A I AAA <CR> C 1 I SS^ ^ I<CR> b. When 0 (zero) was output (ZERO was selected with NO RESULT on the HOST screen) H \^& <CR> P 1 SMPL1 <CR> O 1 SMPL1 0012^04 ^^^072^ 1^001^#TSH 1<CR> R 1 ^^^ A I AAA <CR> C 1 I SS^ ^ I<CR> (5) The transmission example when concentration result was >H is shown below. a. When a blank was output (NULL was selected with >H <L RESULT on the HOST screen H \^& <CR> P 1 SMPL1 <CR> O 1 SMPL1 0009^02 ^^^072^ 1^074^#TSH 1<CR> R 1 ^^^072 uiu/ml > F AAA <CR> C 1 I >H^ ^ I<CR> b. When 0 (zero) was output (ZERO was selected with >H <L RESULT on the HOST screen H \^& <CR> P 1 SMPL1 <CR> O 1 SMPL1 0009^01 ^^^072^ 1^074^#TSH 1<CR> R 1 ^^^ uiu/ml > F AAA <CR> C 1 I >H^ ^ I<CR> c. When an assay range was output (ASSAY RANGE was selected with >H <L RESULT on the HOST screen H \^& <CR> P 1 SMPL1 <CR> O 1 SMPL1 0009^01 ^^^072^ 1^074^#TSH 1<CR> R 1 ^^^ uiu/ml > F AAA <CR> C 1 I >H^ ^ I<CR> d. When an assay range with < or > was output (ASSAY RANGE <> was selected with >H <L RESULT on the HOST screen H \^& <CR> P 1 SMPL1 <CR> O 1 SMPL1 0009^01 ^^^072^ 1^074^#TSH 1<CR> R 1 ^^^072 > uiu/ml > F AAA <CR> C 1 I >H^ ^ I<CR> Page 25/27

26 5.11 Example for Communication(Low Level) Order Plural order can be put in between<enq>and<eot>(at most 100 samples) Query Computer <ENQ> -> <STX>1H <CR><ETX>C1C2<CR><LF> -> <STX>2Q 1 <CR><ETX>C1C2<CR><LF> -> <STX>3L 1 <CR><ETX>C1C2<CR><LF> -> <EOT> -> Host Computer <- <ENQ> <- <STX>1H <CR><ETX>C1C2<CR><LF> <- <STX>2P 1 <CR><ETX>C1C2<CR><LF> <- <STX>3O 1 <CR><ETX>C1C2<CR><LF> <- <STX>4O 2 <CR><ETX>C1C2<CR><LF> <- <STX>5L 1 <CR><ETX>C1C2<CR><LF> <- <STX>6H <CR><ETX>C1C2<CR><LF> <- <STX>7P 1 <CR><ETX>C1C2<CR><LF> <- <STX>0O 1 <CR><ETX>C1C2<CR><LF> <- <STX>1L 1 <CR><ETX>C1C2<CR><LF> Host <- <EOT> <- <ENQ> <- <STX>1H <CR> <ETX>C1C2<CR><LF> <- <STX>2P 1 <CR> <ETX>C1C2<CR><LF> <- <STX>3O 1 <CR><ETX>C1C2<CR><LF> <- <STX>4O 2 <CR><ETX>C1C2<CR><LF> <- <STX>5O 3 <CR><ETX>C1C2<CR><LF> <- <STX>6L 1 <CR><ETX>C1C2<CR><LF> <- <EOT> Page 26/27

27 Results <ENQ> -> <STX>1H <CR><ETX>C1C2<CR><LF> -> <STX>2P 1 <CR><ETX>C1C2<CR><LF> -> <STX>3O 1 <CR><ETX>C1C2<CR><LF> -> <STX>4R 1 <CR><ETX>C1C2<CR><LF> -> <STX>5C 1 <CR><ETX>C1C2<CR><LF> -> <STX>6L 1 <CR><ETX>C1C2<CR><LF> -> <EOT> -> <ENQ> -> <STX>1H <CR><ETX>C1C2<CR><LF> -> <STX>2P 1 <CR><ETX>C1C2<CR><LF> -> <STX>3O 1 <CR><ETX>C1C2<CR><LF> -> <STX>4R 1 <CR><ETX>C1C2<CR><LF> -> <STX>5C 1 <CR><ETX>C1C2<CR><LF> -> <STX>6L 1 <CR><ETX>C1C2<CR><LF> -> <EOT> -> Host Computer Page 27/27