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Host Interface Specifications

UniCel® DxC Synchron® Clinical Systems

This manual is intended for use with: UniCel® DxC 600 UniCel® DxC 800 UniCel® DxC 600i UniCel® DxC 880i

PN A16150AE May 2008 Beckman Coulter, Inc. 4300 N. Harbor Blvd. Fullerton, CA 92835

Host Interface Specifications UniCel DxC Synchron Clinical Systems PN A16150AE (May 2008) Copyright © 2008 Beckman Coulter, Inc. All rights reserved. No part of this document may be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from Beckman Coulter, Inc. Trademarks Following is a list of Beckman Coulter trademarks · AccuTnI® · CX® · Hybritech® · OSTASE® · PrepLinkTM · Synchron® · Synchron LX® · UniCel® All other trademarks are the property of their respective owners. Find us on the World Wide Web at: www.beckmancoulter.com

Beckman Coulter Ireland Inc. Mervue Business Park, Mervue, Galway, Ireland (353 91 774068) Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda Estr dos Romeiros, 220 - Galpao G3 - Km 38.5 zip code 06501-001 - Sao Paulo - SP - Brasil CNPJ: 42.160.812/0001-44

Revision History

This document applies to the latest software listed and higher versions. When a subsequent software version changes the information in this document, a new issue will be released. Initial Issue A16150-AA, 12/04 Software version 1.0 A16150-AB, 10/05 Software version 1.4 A16150-AC, 06/07 Software version 2.0 A16150-AD, 02/08 A16150-AE, 05/08 Software version 3.0 CHAPTER 1 Host Interface Specifications · Modified Connector Pin Assignments section · Added notes to Table 1.5 Serial Transmission Format CHAPTER 2 LX20/DxC Interface · Modified Note 5 and added Notes 10 and 11 for Table 2.4 Sample Cup Program · Added invalid characters to list in Table 2.1 ASCII Codes. CHAPTER 3 CX7 Compatible Interface · Modified Notes 3 and 5, added Notes 8 and 9 for Table 3.4 Sample/Cup Program · Added invalid characters to list in Table 3.1 ASCII Codes. CHAPTER 4 Tables/Codes · In Table 4.2 Sample Type Codes (CX and LX), some sample type codes were limited to specific analyzers. · Added chemistries to Table 4.6 Chemistry Codes and Table 4.7 Access Chemistry Codes. · Added instrument codes to Table 4.9 Instrument Codes with Remarks. · In Table 4.10 Result Error Codes, the IA Initial Absorbance Host Code was replaced by two codes: AH Initial absorbance high and AL Initial absorbance low. · Added rows to Table 4.14 Access/DxI Codes Converted to DxC Codes. CHAPTER 5 ASTM Interface Specifications · Added maximum values to Table 5.4 Patient Information Record · Added caution statement to Table 5.7 Sample Result Record · Changed Interpretation examples 8 through 12 for Field Number 4 in Table 5.7. · Deleted OR and CD flags from Table 5.8 Abnormal Result Flags.

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UniCel DxC Clinical Systems Host Interface Specifications A16150 May 2008

Contents

REVISION HISTORY CHAPTER 1 Host Interface Specifications, 1

Overview, 2 Hardware for Serial Interfaces, 6 Data Transmission, 7 Unidirectional Protocol, 9 Bidirectional, 12

CHAPTER 2

LX20/DxC Interface, 1

LX20/DxC Messages, 2 Stream 800 - Special Functions, 4 Stream 801 - Sample/Cup Program, 6 Stream 802 - Results, 15 Stream 803 - Instrument Status, 28 Stream 804 - Setup Status, 33

CHAPTER 3

CX7 Compatible Interface, 1

CX7 Compatible Messages, 2 Stream 700 - Special Functions, 4 Stream 701 - Sample/Cup Program, 6 Stream 702 - Results, 15 Stream 703 - Instrument Status, 30 Stream 704 - Setup Status, 35

CHAPTER 4

Tables/Codes, 1

Introduction, 2 Test Type Codes, 2 Sample Type Codes, 3 Chemistry Codes, 5 Unit Codes, 12 Instrument Codes, 14 Result Error Codes, 20 Special Calculation Status Codes, 26 Instrument Status Codes, 27 Access/DxI Codes Converted to DxC Codes for Reporting, 28 Key Code Conversion for Local Languages, 30

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Contents Page i of ii

CHAPTER 5 INDEX

ASTM Interface Specifications, 1

ASTM Interface, 2

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1

CHAPTER 1 Host Interface Specifications

Table of Contents

Host Interface Specifications ........................................................................... 1-2 Overview ....................................................................................................... 1-2 Introduction ................................................................................................ 1-2 LX20/DxC/CX7 Compatible ..................................................................... 1-2 Definitions ................................................................................................. 1-4 Interface Protocol Options ......................................................................... 1-5 Hardware for Serial Interfaces ...................................................................... 1-6 Introduction ................................................................................................ 1-6 Connector Pin Assignments ....................................................................... 1-6 Cable Length .............................................................................................. 1-6 Data Transmission ........................................................................................ 1-7 Introduction ................................................................................................ 1-7 Transmission Format ................................................................................. 1-7 TCP/IP Transmission ................................................................................. 1-8 Unidirectional Protocol ................................................................................. 1-9 Introduction ................................................................................................ 1-9 Transmitted Information ............................................................................ 1-9 Unidirectional Software Control (serial communication only) ............... 1-10 Protocol Control Characters (serial communication only) ...................... 1-10 Unidirectional Hardware Control (serial communication only) .............. 1-10 Unidirectional Transmission Example 1 .................................................. 1-11 Unidirectional Transmission Example 2 .................................................. 1-11 Bidirectional ................................................................................................ 1-12 Introduction .............................................................................................. 1-12 Bidirectional Protocol Control Characters - CX and LX20 Interfaces .... 1-12 Line Bidding (CX and LX20) .................................................................. 1-13 Data Transfer ........................................................................................... 1-14 Successful Data Transfer ......................................................................... 1-14 Unsolicited Messages .............................................................................. 1-16 Unsolicited Message Transmission Example .......................................... 1-18 Solicited Messages ................................................................................... 1-18 Solicited Message Transmission Example .............................................. 1-19 Downloading Sample Programming from Host to UniCel DxC ............. 1-19 Host Downloading Sample Program Example ........................................ 1-20

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Overview

Introduction

Host Interface Specifications

Overview

Introduction These instructions to the Host Interface Specification provide the necessary information to interface the UniCel DxC System to a Laboratory Information System (LIS). Use this computer communications specification with software version 2.0 or higher. This manual has five chapters: 1. 2. 3. 4. 5. Host Interface Specifications LX20/DxC Interface CX7 Compatible Interface Tables/Codes ASTM Interface

Host Interface Specifications and Tables/Codes are general sections. LX20/DxC Interface, CX7 Compatible Interface, and ASTM Interface are specific sections; refer to the section that describes the interface of your system. LX20/DxC/CX7 Compatible The following table describes the differences between the LX20/DxC Interface and the CX7 Compatible Interface on a UniCel DxC system. It also lists the results if you use the CX7 Compatible Interface. The ASTM interface is described in CHAPTER 5, ASTM Interface. Table 1.1 Feature Patient ID LX20/DxC/CX7 Compatible LX20/DxC Interface Specification 15 Alphanumeric CX7 Compatible Interface Specification 12 Alphanumeric The sample result is not transmitted if the Patient ID is more than 12 characters. Sex M, F, B Converts M/F to B Patient Comment 45 Alphanumeric M, F Converts M/F to M 25 Alphanumeric If more than 25 characters are used, only the first 25 are sent.

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LX20/DxC/CX7 Compatible

Overview

1

Table 1.1 Feature Sample ID

LX20/DxC/CX7 Compatible, continued LX20/DxC Interface Specification 15 Alphanumeric CX7 Compatible Interface Specification 11 Alphanumeric The Sample result is not transmitted if the Sample ID exceeds 11 characters.

Control Lot Numbers Sector/Rack Number

12 Characters 4 digits 0000 to 0999 can be accepted from the host (LIS). Up to 9999 can be sent from the instrument.

Not Supported 2 digits If the 3 digit check box is selected, 1 character field reserved for the cup data is used as a place to store the third digit of the rack number. E.g. rack 123, position 4 is represented as 23 in rack field and 14 in cup field. 2 Hexadecimal The cuvette number is reported in hexadecimal notation. For example, cuvette 100 is reported as 64; cuvette 109 is reported as 6D.

Cuvette Number

3 Numeric

Sample Comment 25 Alphanumeric Code 1 Sample Comment Not Supported Code 2 Dates 8 digits Long date. Format is LDATE (ddmmyyyy) Clear Rack/ Sample IDs

25 Alphanumeric 25 Alphanumeric Not Used 6 digits Format is DATE (ddmmyy)

Stream 801 - Function 3 Stream 701 - Function 3 Rack number field supports any rack to be cleared. Samples in racks above rack 99 must be cleared with Sample ID, or manually cleared.

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Overview

Definitions

Definitions The following terms and definitions are useful in understanding this interface specification. Table 1.2 A Access Access/DxI ALPHA AN ANS D DATE Download DT DxC DxC 600i DxC + DxI systems DxI Handshake Interface Specification Terms Term Alphanumeric (ASTM) Access Immunoassay System Abbreviated reference to the Access 2 and DxI Immunoassay analyzers. Alphanumeric Alphanumeric or numeric (ASTM) Alphanumeric or numeric or symbol (ASTM) Date. The format is yyyymmdd. (ASTM) Date. The format is ddmmyy. The process of the host sending sample/rack programming to the UniCel DxC System. (Bidirectional only) Date/time. The format is yyyymmddhhmmss. (ASTM) UniCel DxC 600 or UniCel DxC 800 UniCel DxC 600i (DxC 600 integrated with an Access 2) Abbreviated reference to systems such as the DxC 880i, where a DxC 800 is integrated with a DxI analyzer. Access DxI Immunoassay System The process of the UniCel DxC System and the host communicating with each other. Permission to transmit is requested, permission is granted, and receipt of transmission is acknowledged (ACK ­ NAK protocol). (Bidirectional only) Clinical laboratory computer system, Laboratory Information System (LIS) Long Date. The format is ddmmyyyy. A collection of related information, in the form of records, on a single patient, sent at one time. Numeric (ASTM) A message component that contains no data. Null components are represented by two component delimiters with no character in between.

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Definition

Host LDATE Message N Null Component

Interface Protocol Options

Overview

1

Table 1.2 Null Field

Interface Specification Terms, continued A message field that contains no data. Null fields are represented by two field delimiters with no character in between. The set of displayable characters, from ASCII characters decimal 32 to decimal 126.

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Text

Interface Protocol Options The UniCel DxC System provides four interface protocol options which are established using the Host Communications option in Setup. These protocol options are defined in the table below. Table 1.3 Interface Protocol Options Description Information is transmitted from the UniCel DxC System to the host computer. The host uses flow control to control incoming data. The three flow control options are: · Software Flow Control (XON/XOFF) · Hardware Flow Control (RTS/CTS) or · No Flow Bidirectional Information is transmitted from the UniCel DxC System to the host computer and from the host computer to the UniCel DxC System. The two systems use a software handshake to communicate with each other to request permission to send information and to acknowledge receipt of information (ACKNAK protocol). Follows the same protocol as bidirectional interface, with the added capability to request sample programs from the host. "Double host query" is not supported. (That is, the DxC queries the DL2000 and the DL2000 queries the LIS.) "Requery" allows the DxC to Query the Host when a sample is loaded and has a "Complete" status at the DxC. Off No information is sent or received by the UniCel DxC System.

Protocol Unidirectional (Not supported for ASTM)

Bidirectional with Query

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Hardware for Serial Interfaces

Introduction

Hardware for Serial Interfaces

Introduction The hardware interface to the UniCel DxC System external communication port uses a standard RS-232-C 9-pin connector (male). Communication is done with asynchronous byte transmission. Connector Pin Assignments Connector pin assignments are shown below. Table 1.4 9-Pin 1a 2 3 4a 5 6a 7b 8c 9

a b

Connector Pin Assignments Signal Data Carrier Detect (DCD) Receive data (RD) Transmit data (TD) Data terminal ready (DTR) Signal ground (SG) Data set ready (DSR) Request to send (RTS) Clear to send (CTS) Ring Indicator (RI) In Out In Direction In In Out Out

DTR, DSR and DCD are only needed when a modem is used. RTS is turned on when operational. c CTS is required before data will be transmitted.

Note: CTS and RTS are used only with hardware flow control. Note: For 3-wire connections (TD, RD and SG only), it is recommended that the CTS and RTS should be connected together. Also, DTR, DSR and DCD should be connected to each other. Do not use hardware flow control on 3-wire connections. Cable Length Use a cable length of 40 feet (12 m) or less with the RS-232-C interface.

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Data Transmission

Introduction

1

Data Transmission

Introduction For serial communications, the UniCel DxC System uses 7-bit ASCII (provides the 128 character ASCII set when 7 data bits are selected). For local languages, 8-bit ASCII must be used (provides the 256-character ASCII set). Transmission Format The serial transmission format is configured from the UniCel DxC System console using the Host Communications option as described in the Host Communications section of CHAPTER 3, Detailed System Setup in the UniCel DxC Synchron Clinical Systems Reference Manual. The following options are available. Table 1.5 Serial Transmission Format Options Unidirectionala, Bidirectional, Bidirectional with Query, Off 7c, 8d 1, 2 Even, Odd, None Software (XON/XOFF), Hardware (RTS/CTS), None 00-99 300, 1200, 2400, 4800, 9600, 19200 Selected, Not Selected Default Unidirectionala 8 1 None Software (XON/XOFF) 00 9600 Not Selected

Parameter Data Transmission Mode Data Bitsb Stop Flow Bitsb controlb Parityb

Device ID Baud Ratesb Re-query

a b

Unidirectional mode is not supported for ASTM. For serial transport only. c For use with non-English keyboards, select 8-bit ASCII for the host interface in order to send and receive special characters (for key code conversion information, refer to Figure 4.1 Key Code Conversion Chart). d 7 data bits are not recommended for the ASTM protocol because chemistry units include some special characters.

Note: Non-default settings for data bits, stop bits and parity are not supported for the serial expansion card.

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Data Transmission

TCP/IP Transmission

TCP/IP Transmission For TCP/IP communication, the computer system (LIS) is the server and the instrument is the client.

NOTICE Connecting the UniCel DxC System to the laboratory network can expose the instruments to computer viruses. A firewall is recommended between the instrument and the computer system (LIS).

Table 1.6 IP Address Port Number

TCP/IP Transmission Format Options XXX.XXX.XXX.XXX Any number greater than zero. Default None 12003

Parameter

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Unidirectional Protocol

Introduction

1

Unidirectional Protocol

Introduction In unidirectional transmission, information is transmitted in one direction only from the UniCel DxC System to the host computer. This information is transmitted as soon as it is available. Transmitted Information The information transmitted includes:

NOTICE The 800 stream below is referenced to the LX20/DxC Interface. The CX7 compatible interface is similar in data streams and should be interpreted as a 700 stream where an 800 stream is displayed.

Table 1.7 Cup Header

Transmitted Information Description The Cup Header information for each cup in the rack is transmitted when a cup has finished and results are ready to send to the host. (Stream 802 - Function 1) A Test Result message is transmitted as each test is completed. (Stream 802 - Functions 3, 11, 13, 81) An End-of-Cup message is transmitted when all tests programmed for a sample are completed. (Stream 802 - Function 5) An End-of-Run message is transmitted when all tests programmed have been completed and the DxC has gone into the Standby mode. (Stream 803 - Function 17) The Power Up message is transmitted when the DxC is booted. (Stream 803 - Function 1) The Host Setup message is transmitted when the DxC is booted and when there are changes in the Host Communications in System Setup. (Stream 800 - Function 2)

Information

Test Results End of Cup

End of Run

Power Up Host Setup

Output field width is dependent on the units and decimal precision selected. This should not exceed the fixed field width specified in this document.

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Unidirectional Protocol

Unidirectional Software Control (serial communication only)

Unidirectional Software Control (serial communication only) The flow of information from the UniCel DxC System can be controlled by the host through an XON/XOFF protocol. The sequence of events is: · The host transmits the character XOFF prior to its buffer overflowing. · The DxC immediately suspends transmission. · When the host's buffer is ready to accept information again, the character XON is transmitted. · The DxC then resumes transmission. · The host should transmit the XON character after power up to indicate it is ready to receive data. Protocol Control Characters (serial communication only) The software protocol control characters follow: Table 1.8 XON XOFF Protocol Control Characters Name Resume transmission Suspend transmission ASCII DL1 DL3 HEX 11 13

Character

Unidirectional Hardware Control (serial communication only) The flow of information from the UniCel DxC System can be controlled by the host through the CTS hardware signal. When the CTS signal is brought negative, the DxC will suspend transmission. The DxC will resume transmission when the CTS signal is brought positive. Examples of Unidirectional Transmission are cited below.

NOTICE Do not select the Hardware option for flow control if there is no wire for the CTS signal. With the Hardware option, ESD interference can affect the performance. NOTICE Unidirectional Transmission can be used with CX7 compatible and LX20/DxC only, not with ASTM.

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Unidirectional Transmission Example 1

Unidirectional Protocol

1

Unidirectional Transmission Example 1 Unidirectional mode is selected and the host is not using software control of transmission. The accession number is 168, the rack is 12, the position is 1, and the chemistries are Sodium (01A), Potassium (01B), and Chloride (04A). An operatordefined special calculation (SPC_CALC) is transmitted.

[-0,802,01,25091998,080534,--168,RE,--12,-1,RO,#########,SE,121------------,--------------------, -------------------------,Harris------------,Maria----------,J,100A10B100-----,Bond--------------, 25091998,0100,ER------------------,-47,5,26051951,B,Lipemic--------------------------------------, #######,####,####,######,--3,01A-,01B-,04A-]C2<CR><LF> [-0,802,03,25091998,080812,--168,------116,--12,-1,121------------,01A-,###,######,###,-1, ----104.7,#########,2,0,04,LO,NR,0,NA,104.65540,---------, NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,1.0000,#########################]0D <CR><LF> [-0,802,03,25091998,080811,--168,------116,--12,-1,121------------,01B-,###,######,###,-1, -----2.45,#########,2,0,04,LO,NR,0,NA,2.4467065,---------,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO, NO,NO,NO,1.0000,#########################]13<CR><LF> [-0,802,03,25091998,080812,--168,------116,--12,-1,121------------,04A-,###,######,###,-1, -----77.8,#########,2,0,04,LO,NR,0,NA,77.755951,---------,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO, NO,NO,NO,1.0000,#########################]FB<CR><LF> [-0,802,11,25091998,080534,--168,--12,-1,121------------,-1,SPC_CALC------------,OK,19.017143, --------]B9<CR><LF> [-0,802,05,25091998,082242,--168,121------------,--12,-1]D5<CR><LF>

(- Indicates space holder) Unidirectional Transmission Example 2 The same information is transmitted as in Example 1, but software flow control has been implemented by the host, selected by the DxC operator, and used by the Host where indicated. UniCel DxC HOST

<========================================================================== XON [-0,802,01,25091998,080534,--168,RE,--12,-1,RO,#########,SE,121------------, --------------------,-------------------------,Harris------------, Maria----------,J,100A10B100-----,Bond--------------,25091998,0100, ER------------------,-47,5,26051951,B,Lipemic--------------------------------------, #######,####,####,######,--3,01A-,01B-,04A-]C2<CR><LF> <========================================================================== XOFF <========================================================================== XON [-0,802,03,25091998,080812,--168,------116,--12,-1,121------------,01A-,###, ######,###,-1,----104.7,#########,2,0,04,LO,NR,0,NA,104.65540, ---------,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,1.0000, #########################]0D<CR><LF> [-0,802,03,25091998,080811,--168,------116,--12,-1,121------------,01B-,###, ######,###,-1,-----2.45,#########,2,0,04,LO,NR,0,NA,2.4467065,---------, NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,1.0000, #########################]13<CR><LF> [-0,802,03,25091998,080812,--168,------116,--12,-1,121------------,04A-,###, ######,###,-1,-----77.8,#########,2,0,04,LO,NR,0,NA,77.755951,---------, NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,1.0000, #########################]FB<CR><LF> [-0,802,11,25091998,080534,--168,--12,-1,121------------,-1, SPC_CALC------------,OK,19.017143,--------]B9<CR><LF> [-0,802,05,25091998,082242,--168,121------------,--12,-1]D5<CR><LF>

(- Indicates space holder)

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Bidirectional

Introduction

Bidirectional

Introduction In bidirectional transmission, information is transmitted from the UniCel DxC System to the host, and from the host to the DxC System. The two systems communicate with each other using a software handshake. Permission to send information is requested, permission is granted, and receipt of information is acknowledged (ACK - NAK protocol). Table 1.9 describes the bidirectional protocol control characters that are referred to throughout this section. Bidirectional Protocol Control Characters - CX and LX20 Interfaces Bidirectional protocol control characters are listed below. For the ASTM interface, refer to CHAPTER 5, ASTM Interface Specifications, Table 5.1 Bidirectional Protocol Control Characters (ASTM). Table 1.9 Acronym LB LBO LF ENQ EOT ACK-0 ACK-1 NAK Line Bid Line Bid Override Request Line Feed Enquiry (used to re-establish communications) End of Transmission Even Acknowledgment Odd Acknowledgment Negative Acknowledgment Bidirectional Protocol Control Characters (CX and LX20) Name ASCII SOH STX LF ENQ EOT ACK ETX NAK HEX 01 02 0A 05 04 06 03 15

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Line Bidding (CX and LX20)

Bidirectional

1

Line Bidding (CX and LX20) Before either the UniCel DxC System or the host transmits a message, they must bid for the communication line. Line bidding uses the LB, LBO, EOT, ACK-0, and NAK characters. For the ASTM interface, refer to CHAPTER 5, ASTM Interface Specifications, Line Bidding (ASTM). Stage 1 2 3 The EOT clears the line. The receiving system responds by transmitting ACK-0 to acknowledge the line bid and allow message transmission, or by transmitting NAK to deny the line bid. If the line bid is denied, the originator waits a short period of time (e.g., one second) then bids for the line again. Description To bid for the line, <EOT> <LB> is transmitted when the line is idle.

4

· LINE BID ­ When the DxC is very busy, the response to a LINE BID may take up to 15 seconds. 1. When the DxC has some messages in the output queue, it does a LINE BID. When the LINE BID is accepted by the host, the instrument sends one set of messages at a time. It then gives up the line and waits for 2 seconds before continuing with the other messages. 2. If the host has messages to transmit, it can do a LINE BID (EOT LB) even if the instrument is busy transmitting messages (after sending a message, the DxC looks for a NAK, ACK, or LB). When the DxC sends a message, the host can respond with a line bid <EOT><SOH>. The message in progress will be saved by the DxC. The line will be granted to the host by sending an <ACK>.

NOTICE Do not activate the LINE BID while the instrument is transmitting messages because it would stop the collation of results.

· LINE BID TIME OUT occurs if the receiving system does not respond to the EOT LB within 15 seconds, or responds with something other than an ACK-0 or LBO. After 7 consecutive time outs, or unrecognizable responses (i.e., not ACK-0 or NAK), the originator considers the line DOWN. The originator waits 20 seconds and tries the line bid again. · CONTENTION occurs when both systems bid for the line at the same time. The DxC will be considered the master and the host should respond with ACK-0. However, the host may override the DxC line bid by transmitting LBO in response. The DxC will respond by transmitting ACK-0 to acknowledge the line bid override and allow message transmission, or it will ignore the message if DxC was not bidding for the line when the message was sent.

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Bidirectional

Data Transfer

Data Transfer After successfully bidding for the line, the originator or sending system transmits its message. If the sending device does not transmit a message within 20 seconds, the receiving device times out. Further communication will require another line bid. Successful Data Transfer A successful data transfer consists of:[<MESSAGE>]<CS><CR><LF>. · CS ­ Check sum. It is two hexadecimal digits. 256 - ((Sum of ASCII value of all characters in <MESSAGE>, including spaces, commas, ' [ ' and ' ] ' ) MODULE 256) = CS · CR ­ Carriage return · LF ­ Line feed If the checksum is incorrect or if any element is missing, the data transfer is unsuccessful. After data transmission, the receiving system acknowledges transmission as follows: Stage 1 Description If data transfer was successful, the receiving system alternately returns ACK-1 and ACK-0 after each message. Since the receiving system responded ACK-0 to the line bid, ACK-1 is the correct acknowledgment to the first message, ACK-0 to the second message, ACK-1 to the next message, and so forth. When data transfer is complete, the sending system transmits EOT. If data transfer was unsuccessful due to a bad checksum or other problem, the receiving system responds NAK. The sending system re-transmits the message. If the sending system does not receive an acknowledgment within 15 seconds after data transfer, or if an incorrect acknowledgment is received, it transmits ENQ. The receiving system retransmits its last acknowledgment (e.g., ACK-0, ACK-1, or NAK). The sending system responds to that acknowledgment in one of the following manners: · If the correct acknowledgment is transmitted, the sending system transmits the next message or EOT. · If an incorrect acknowledgment or NAK is transmitted, the sending system retransmits the last message.

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2

3

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Successful Data Transfer

Bidirectional

1

Stage 4 TIME OUT occurs:

Description

· If the sending system does not transmit data in 20 seconds after successfully bidding for the line, the receiving system times out and returns to idle. · If the sending system does not receive an acknowledgment within 15 seconds after data transfer, or if an incorrect acknowledgment is received, it then transmits ENQ. If an acknowledgment is not received after seven consecutive ENQ transmissions, the DxC waits 20 seconds before it attempts a line bid and continues to do so until an acknowledgment is received.

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Examples of data transfer (These examples are also correct if the labels UniCel DxC and HOST are reversed): NAK Example UniCel DxC (Sending System)

EOT SOH Message 1 Message 2 Message 3 Message 3 EOT ------------------------------------------------------> <-----------------------------------------------------------------------------------------------------------> <-----------------------------------------------------------------------------------------------------------> <-----------------------------------------------------------------------------------------------------------> <-----------------------------------------------------------------------------------------------------------> <----------------------------------------------------------------------------------------------------------->

HOST (Receiving System)

ACK ETX ACK NAK ETX

No Response UniCel DxC (Sending System)

EOT SOH Message 1 Message 2 ENQ Message 2 EOT -------------------------------------------------------> <====================================================== =======================================================> <====================================================== =======================================================> =======================================================> <====================================================== =======================================================> <====================================================== =======================================================>

HOST (Receiving System)

ACK ETX No Response (15 secs) ETX ACK

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Bidirectional

Unsolicited Messages

No Response Return to Idle UniCel DxC (Sending System)

ACK IN IDLE STATE <======================================================= MESSAGE 1 IGNORED ACK ETX <======================================================= ========================================================> <======================================================= ========================================================> <======================================================= EOT SOH MESSAGE 1 EOT MESSAGE 1 <======================================================= ========================================================>

HOST (Receiving System)

EOT SOH No Response (>20 secs)

Request for Idle State UniCel DxC (Sending System)

EOT SOH Message 1 Message 2 EOT IN IDLE STATE ========================================================> <======================================================= ========================================================> <======================================================= ========================================================> <======================================================= ========================================================>

HOST (Receiving System)

ACK ETX ACK IN IDLE STATE

Unsolicited Messages Unsolicited messages are those messages which are automatically transmitted by the UniCel DxC System as the information becomes available. The following unsolicited messages are transmitted in the bidirectional mode.

NOTICE The 800 stream below is referenced to the LX20/DxC Interface. The CX7 compatible interface is similar in data streams and should be interpreted as a 700 stream where an 800 stream is displayed.

Table 1.10 Message Cup Header

Unsolicited Messages Description The Cup Header information for each cup in the rack is transmitted when a rack is loaded and accepted. (Stream 802 - Function 1) A Test Result message is transmitted as each test is completed. (Stream 802 - Functions 3, 11, 13, 81) An End-of-Cup message is transmitted when all tests programmed for a sample are completed. (Stream 802 - Function 5)

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Test Results End of Cup

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Unsolicited Messages

Bidirectional

1

Table 1.10 Message End of Run

Unsolicited Messages, continued Description An End-of-Run message is transmitted when all tests programmed have been completed and the DxC has gone into the Standby mode. (Stream 803 - Function 17) The Power Up message is transmitted when the DxC is booted. (Stream 803 - Function 1) Note: Undefined characters may be transmitted during system boot-up.

Power Up

Bidirectional Startup Host Setup

The Bidirectional message is transmitted when the bidirectional or bidirectional with query interface option is enabled. (Stream 803 - Function 2) The Host Setup message is transmitted when the DxC is booted and when the operator enters and exits Host Communications in System Setup. This is transmitted immediately after the interface is changed in the System Setup. (Stream 800 - Function 2)

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Host Interface Specifications Page 1-17

Bidirectional

Unsolicited Message Transmission Example

Unsolicited Message Transmission Example The following message is an example of an unsolicited message transmission. UniCel DxC

EOT SOH ======================================================================> <==========================================================================

HOST

ACK

[-0,802,01,25091998,080534,--168,RE,--12,-1,RO,#########,SE,121------------, --------------------,-------------------------,Harris------------,Maria----------, J,100A10B100-----,Bond--------------,25091998,0100,ER------------------,-47,5,26051951, B,Lipemic--------------------------------------,#######,####,####,######,--3,01A-,01B-, 04A-]C2<CR><LF> <========================================================================== ETX [-0,802,03,25091998,080812,--168,------116,--12,-1,121------------,01A-,###,######,###, -1,----104.7,#########,2,0,04,LO,NR,0,NA,104.65540,---------,NO,NO,NO,NO,NO,NO,NO,NO,NO, NO,NO,NO,NO,NO,NO,NO,1.0000,#########################]0D<CR><LF> <========================================================================== ACK [-0,802,03,25091998,080811,--168,------116,--12,-1,121------------,01B-,###,######,###, -1,-----2.45,#########,2,0,04,LO,NR,0,NA,2.4467065,---------,NO,NO,NO,NO,NO,NO,NO,NO,NO, NO,NO,NO,NO,NO,NO,NO,1.0000,#########################]15<CR><LF> <========================================================================== ETX [-0,802,03,25091998,080812,--168,------116,--12,-1,121------------,04A-,###,######,###, -1,-----77.8,#########,2,0,04,LO,NR,0,NA,77.755951,---------,NO,NO,NO,NO,NO,NO,NO,NO,NO, NO,NO,NO,NO,NO,NO,NO,1.0000,#########################]FB<CR><LF> <========================================================================== [-0,802,11,25091998,080534,--168,--12,-1,121------------,-1,SPC_CALC------------,OK, 19.017143,--------]B9<CR><LF> [-0,802,05,25091998,082242,--168,121------------,--12,-1]D5<CR><LF> <========================================================================== [ 0,803,17,06101998,100137]4C<CR><LF> <========================================================================== EOT ==========================================================================> ACK ETX ACK

(- Indicates space holder) Solicited Messages Solicited messages are transmitted by the host to request information from the UniCel DxC System. Solicited messages are used by the host to: · Confirm that a bidirectional system is attached to the host serial port. (Stream 800 - Function 1) · Obtain DxC instrument status information. (Stream 803 - Function 3) · Obtain a list of the DxC installed chemistries. (Stream 804 - Functions 7)

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Solicited Message Transmission Example

Bidirectional

1

Solicited Message Transmission Example The following message is an example of a solicited message transmission. UniCel DxC

<================================================== ACK ETX EOT SOH ==================================================> <================================================== ==================================================> <================================================== ==================================================> <================================================== [-0,803,04,07101998,111246,DxC-,02,15,#####]<CS><CR><LF>=> <================================================== EOT ==================================================> ETX ACK EOT [00,803,03]<CS><CR><LF>

HOST

EOT SOH

(<CS> Indicates checksum) (- Indicates space holder) Downloading Sample Programming from Host to UniCel DxC · Sample programming may be transmitted directly from the host to the UniCel DxC Systems. The information that can be programmed includes: - Rack and cup number - Sample ID - Test type - Fluid type - Demographics - Chemistry requests (Stream 801 - Function 1) · The host, after sending a single sample/cup must release the line by sending an EOT and then wait for the DxC to send the sample/cup return status. (Stream 801 Function 2) This response by the DxC is used to notify the host whether or not the program was accepted (e.g., a BUSY response may indicate programming is being done at the DxC console). There is an interlock prohibiting simultaneous programming of a single sample from the host and the UniCel DxC System console. · After the DxC releases the line (sends an EOT), the host may then repeat the process for as many sample/cups as necessary for completion of the download. If this protocol is not followed, improper chemistry requests may be downloaded to the DxC. · In addition, the host can clear previous rack programming before transmitting the new sample programming. (Stream 801 - Function 3)

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Host Interface Specifications Page 1-19

Bidirectional

Host Downloading Sample Program Example

· In response to the clear rack message transmitted by the host, the DxC transmits an OK, BUSY, or SYNTAX ERROR message. (Stream 801 - Function 4) This response by the DxC is used to notify the host as to whether the rack was cleared (e.g., A BUSY response may indicate programming is being done at the DxC console or the rack is on the sample carousel.) · There is an interlock prohibiting simultaneous clearing from the host and clearing or programming from the DxC System console. Host Downloading Sample Program Example The following is an example of a host downloading a sample program. UniCel DxC

<================================================== ACK ==================================================> <=========================== [00,801,01,0401,01,0,RO,TU,RSG0001--------,--------------------,------------, Sample-has-been-hemolyzed,Rosenthel---------,Robert---------,R,PID456789012345, Dr.-H.-Schwartz---,08041998,1134,Humana-Hospital-Brea,-35,5,12041963,M, Chronic-asmatic-activity-27293133353739414345,111.1--,22.2,33.3,03,4.4444,003, 01A-,0,01B-,0,02A-,0]<CS><CR><LF> ETX EOT SOH ==================================================> <================================================== ==================================================> <================================================== [-0,801,02,-0,--306,-401,-1,RSG0001--------]<CS><CR><LF>=> <================================================== EOT ==================================================> ETX ACK EOT

HOST

EOT SOH

(<CS> Indicates checksum) (- Indicates space holder)

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

2

CHAPTER 2 LX20/DxC Interface

Table of Contents

LX20/DxC Interface ........................................................................................ 2-2 LX20/DxC Messages .................................................................................... 2-2 Introduction ................................................................................................ 2-2 Message Format ......................................................................................... 2-2 Message Streams ........................................................................................ 2-3 Stream 800 - Special Functions .................................................................... 2-4 Stream 800 - Function 1: Are You There? ................................................ 2-4 Stream 800 - Function 2: Host Setup ......................................................... 2-4 Stream 801 - Sample/Cup Program .............................................................. 2-6 Stream 801 - Function 1: Sample/Cup Program ........................................ 2-6 Stream 801 - Function 2: Sample/Cup Return Status .............................. 2-10 Stream 801 - Function 3: Clear Rack/Sample IDs ................................... 2-11 Stream 801 - Function 4: Clear Rack/Sample IDs Status ........................ 2-12 Stream 801 - Function 6: Host Query Rack/Sample IDs ......................... 2-13 Stream 802 - Results ................................................................................... 2-15 Stream 802 - Function 1: Cup Header ..................................................... 2-15 Stream 802 - Function 3: Test Results ..................................................... 2-17 Stream 802 - Function 5: End of Cup ...................................................... 2-21 Stream 802 - Function 11: Special Calculations Results ......................... 2-21 Stream 802 - Function 13: Timed Urine Results ..................................... 2-23 Stream 802 - Function 81: Expanded Results .......................................... 2-24 Stream 803 - Instrument Status ................................................................... 2-28 Stream 803 - Function 1: Power Up ........................................................ 2-28 Stream 803 - Function 2: Bidirectional On .............................................. 2-30 Stream 803 - Function 3: Request Instrument State ................................ 2-31 Stream 803 - Function 4: Instrument State .............................................. 2-31 Stream 803 - Function 17: End of Run .................................................... 2-32 Stream 804 - Setup Status ........................................................................... 2-33 Stream 804 - Function 7: Request Installed Chemistries ......................... 2-33

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LX20/DxC Interface Page 2-1

LX20/DxC Messages

Introduction

LX20/DxC Interface

LX20/DxC Messages

Introduction The data record format for all messages transmitted to and from the UniCel DxC System is: `[`<MESSAGE>']'<CS><CR><LF> This section describes the information contained in the <MESSAGE> portion. Message Format The format of the <MESSAGE> is: <DEVICEID>,<STREAM>,<FUNCTION>,<FIELD1>, . , . . <FIELDN> where: · <DEVICE ID> is a number between 0 and 99. The default UniCel DxC ID is 0 but can be changed using the Host Communications Setup procedure. All messages which have a different Device ID than the Host Communications Screen will not be processed. · <STREAM> is a number between 800 and 899. · <FUNCTION> is a number between 1 and 99. · <FIELD1>,...,<FIELDN> are data fields associated with the <STREAM> and <FUNCTION>. · All data fields <FIELDN> are fixed lengths. · Numeric fields, excluding function numbers, are right justified and blank filled to the maximum length. · Character and string fields are left justified and right blank filled to the maximum length. · If numeric data exceeds the maximum field length, the field will be filled with asterisks (*). If a field does not apply in a record, it will be filled with pound signs (#). · Alphanumeric fields received from the host cannot contain commas (,). Commas received in an alphanumeric field will generate an HCP error. A comma entered in an alphanumeric field at the instrument is transmitted as a semicolon (;). A semicolon received from the host is converted to a comma. · Valid and Invalid characters for entries are listed in the table below:

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LX20/DxC Messages

Message Streams

2

Table 2.1

ASCII Codes THESE ARE VALID ASCII Character Codes... 33 thru 126 33 thru 126, % 32 thru 175 EXCEPT FOR THESE INVALID Characters and Character Codes... A space and $ , ; * ? [ ] \^ | & " % A space and $ , ; * ? [ ] \^ | & " ASCII Character Codes 34, 37, 44 and 127

Type of Entry Sample ID Patient IDa Other Entries

a

For Patient ID, % is allowed and for Japanese only, single byte Katakana is allowed.

· Alpha: Any printable ASCII string (Commas are translated into semicolons when sent to the host. Semicolons are translated into commas when received from the host.) · LDATE: Long Date. Format is ddmmyyyy. Message Streams Messages sent to and from the UniCel DxC System are divided into streams. · Each stream corresponds to one group of related operations within the interface. Within each stream are one or more functions. For each stream only one function can be active at a time. · Multiple streams can be active at the same time. Stream transmission options are described in the Host Communications section of CHAPTER 3, Detailed System Setup in the UniCel DxC Synchron Clinical Systems Reference Manual.

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LX20/DxC Interface Page 2-3

Stream 800 - Special Functions

Stream 800 - Function 1: Are You There?

Stream 800 - Special Functions

Stream 800 - Function 1: Are You There? Sent by: Host Purpose: To make sure that a bidirectional system is attached to the host port. Upon receipt of the message 800-01, the UniCel DxC responds with the message 800-02, Host Setup. Table 2.2 Field Device ID Stream Function Example:

[00,800,01]97<CR><LF>

Are You There Length 2 3 2 Format 0-99 800 01 Notes Operator assigned

Stream 800 - Function 2: Host Setup Sent by: UniCel DxC Purpose: Sent by the UniCel DxC in response to message 800-01. Also sent unsolicited upon power up and whenever there are changes to the Host Communications in System Setup. Table 2.3 Device ID Stream Function Date Time Software Revision Driver Mode Stream 800 Function 2 Stream 801 Function 6 Stream 802 Function 3 Host Setup Field Length 2 3 2 8 6 10 1 1 1 1 Format 0-99 800 02 LDate Time ALPHA B or U 0 or 1 0 or 1 0 or 1 Rev NNN.N B = Bidirectional U = Unidirectional 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON

(1 of 2)

LX20/DxC Interface Page 2-4 UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Notes Operator assigned

Stream 800 - Function 2: Host Setup

Stream 800 - Special Functions

2

Table 2.3

Host Setup, continued Field Length 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Format 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON

(2 of 2)

Notes

Stream 802 Function 7 Stream 802 Function 9 Stream 802 Function 11 Stream 802 Function 23 Stream 802 Function 25 Stream 802 Function 81 Stream 802 Function 83 Stream 803 Function 1 Stream 803 Function 2 Stream 803 Function 5 Stream 803 Function 7 Stream 803 Function 13 Stream 803 Function 17 Stream 802 Function 13

Example:

[-0,800,02,07101998,084523,1.05.48X--,U,1,0,1,0,0,1,0,0,1,0,1,1,0,0,0,1,1, 0,0,0,0,0,0,0]2A<CR><LF>

(- Indicates space holder)

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LX20/DxC Interface Page 2-5

Stream 801 - Sample/Cup Program

Stream 801 - Function 1: Sample/Cup Program

Stream 801 - Sample/Cup Program

Stream 801 - Function 1: Sample/Cup Program Sent by: Host Purpose: To inform UniCel DxC what tests to perform for a given sample. The DxC responds with an 801-02, Sample/Cup Return Status, which shows whether or not the program was accepted. Table 2.4 Field Device ID Stream Function Rack Number Sample/Cup Program Length 2 3 2 4 Format 00-99 801 01 0000-0999 0 = No rack number assigned (Cup Number must also be 0). Rack numbers greater than 999 will result in a Rack Number Too Large return code. Refer to Note 3 after this table. Cup Number 2 0-4 0 = No cup number assigned (Rack Number must also be 0). A cup number greater than 4 will result in a BAD MESSAGE return code. Refer to Note 3 after this table. Update Flag 1 FLAG 0 = Replace all programming and patient demographics 1 = Add to existing program Refer to Note 2 and Note 4 after this table. Test Type 2 TEST CODE Refer to Table 4.1 Test Type Codes (CX and LX20). Refer to Note 4 after this table. Sample Type 2 FLUID CODE Refer to Table 4.2 Sample Type Codes (CX and LX20).

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LX20/DxC Interface Page 2-6 UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Notes Operator assigned

Stream 801 - Function 1: Sample/Cup Program

Stream 801 - Sample/Cup Program

2

Table 2.4 Field Sample ID

Sample/Cup Program, continued Length 15 Format ALPHA Notes Must be present in all modes. All lower case letters are converted to upper case. Refer to Note 4, Note 10 and Note 11 after this table.

Control Name QC Lot Number Sample Comment Code 1 Name Last Name First Name Middle Initial Patient ID Doctor Draw Date Draw Time Location Age Age Units

20 12 25 18 15 1 15 18 8 4 20 3 1

ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA LDATE TIME ALPHA NUMERIC NUMERIC

Refer to Note 1 after this table. For future use.

Refer to Note 7 and Note 9 after this table.

Default = 0 Default = 5 Refer to Table 4.4 Age Unit Codes (CX and LX20).

Birth Date Sex Patient Comments Timed Urine Volume Timed Urine Period Timed Urine Creatinine

8 1 45 7 4 4

LDATE ALPHA ALPHA NUMERIC NUMERIC NUMERIC

Refer to Note 9 after this table. M, F, B 0-99999.0 Collection period 0-99.0 Serum creatinine 0-99.0

(2 of 3)

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LX20/DxC Interface Page 2-7

Stream 801 - Sample/Cup Program

Stream 801 - Function 1: Sample/Cup Program

Table 2.4 Field

Sample/Cup Program, continued Length 2 Format Notes UNIT CODE Blank is only valid if the Timed Urine Creatinine field is zero or blank. Refer to Note 8 after this table.

Timed Urine Creatinine Units

Timed Urine Area

6

NUMERIC

Surface area 0 ­ 9.9900 Blank is OK.

Number Tests Test-1 Chem Test-1 ORDAC Test-2 Chem Test-2 ORDAC Test-Na Chem Test-N ORDAC

a

3 4 1 4 1 4 1

NUMERIC

1-999

CHEM CODE Refer to Note 5 and Note 6 after this table. FLAG 1 = ORDAC CHEM CODE Refer to Note 5 and Note 6 after this table. FLAG 1 = ORDAC CHEM CODE Refer to Note 5 and Note 6 after this table. FLAG 1 = ORDAC

(3 of 3)

N = Value from Number Tests Field

Note 1: The Control Name uniquely identifies the control of this result. Only the selected fluid type for the control can be used. Any other fluid type is a syntax error. All lower case letters are converted to upper case. If a control name is included in the message, the system will address the sample program as a control sample program. Note 2: A new program will be entered if no program exists for the specified sample/ cup. Duplicate chemistries will not be added to an existing program. Updates consist of chemistry additions only and are allowed only under the following conditions: · Sample Type and Program Type of program to be updated match Fluid Type and Test Type (respectively) of sample program sent by the host. · Sample Status of the program to be updated is Sample Required, In-Progress, Removed, Manual Assign, or Rerun; and Control Name of the sample program sent by the host is blank for patient samples, or matches the Control Name of the existing control sample program. Overwrites are allowed under the following conditions:

LX20/DxC Interface Page 2-8 UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 801 - Function 1: Sample/Cup Program

Stream 801 - Sample/Cup Program

2

· Sample Status of the program to be overwritten is Sample Required, Incomplete, Complete, Manual Assign, or Rerun. Note 3: Rack numbers greater than 999 will result in a Rack Number too Large (15) return code in the 801:2 message. A cup number greater than 4 will result in a BAD MESSAGE return code in the 801:2 message. If the Rack Number is 0, the Cup Number must also be 0. If the Cup Number is 0, the Rack Number must also be 0. Note 4: If the Test Type is ST (STAT) or RO (Routine), the sample program will be rejected if the Sample ID matches a defined control ID on the system. Note 5: A control sample will be rejected when one or more chemistries sent by the LIS is not defined in the QC definition. The system will not accept control sample programs if they contain chemistries not defined for the control on the instrument. Note 6: If the host stream contains at least one of the Chem Codes used for serum index chemistries, the system will select to run all serum indices tests. The system will treat a serum index test selection as an exception to the requirement that chemistry selections in the host stream have to be configured on the instrument. Note 7: If the host stream contains a Draw Time but does not contain a Draw Date, the system will clear the Draw Time to zero and log an event, indicating it has done so. Note 8: In order for the Timed Urine Results Message to be sent back to the host, unit codes that are sent by the host must translate into one of the selectable CREm or CREA system (DxC) setup units. The Timed Urine Results Message is not sent back to the host if Timed Urine Creatinine units sent by the host · are blank · do not translate into one of the selectable CREm or CREA system setup units or · are not recognized by the instrument. For this case, an event is logged which indicates that the data in the Timed Urine Creatinine Field has been cleared and that the Timed Urine Results will not be run. Note 9: The DxC will reject a 2-digit year field. If the DxC receives a 2-digit field for the year, the DxC will log the event, indicating a problem was detected. The field will be cleared and process the sample with a blank date. Note 10: Refer to Table 2.1 for valid and invalid ASCII Codes.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008 LX20/DxC Interface Page 2-9

Stream 801 - Sample/Cup Program

Stream 801 - Function 2: Sample/Cup Return Status

Note 11: The Sample ID field must be present. Example:

[00,801,01,0401,01,0,RO,TU,RSG0001--------,--------------------, ------------,Sample-has-been-hemolyzed,Rosenthel---------, Robert---------,R,PID456789012345,Dr.-H.-Schwartz---,08041998, 1134,Humana-Hospital-Brea,-35,5,12041963,M,Chronic-asmatic-activity27293133353739414345,111.1--,22.2,33.3,03,4.4444,003,01A-,0,01B-,0, 02A-,0]<CS><CR><LF>

(- Indicates space holder) Stream 801 - Function 2: Sample/Cup Return Status Sent by: UniCel DxC Purpose: Sent in response to an 801-01 message from the host. 801-02 indicates whether the sample/cup program was accepted, or why it was not accepted. Table 2.5 Field Device ID Stream Function Return Code Sample/Cup Return Status Length 2 3 2 2 Format 0-99 801 02 00-99 0 = OK 1 = BAD MESSAGE ­ There is something wrong with the message syntax. 2 = BUSY ­ The cup is running or sample is being programmed. 3 = NOT CONFIGURED ­ Message contains at least one non ­configured chemistry. 4 = NON ORDAC ­ Message contains at least one non-ORDAC chemistry, required for ORDAC. 5 = DILUTION ERROR ­ Message contains chemistries with different dilution factors. 6 = CONTROL NOT CONFIGURED 7 = CALIBRATOR Rack ONLY

(1 of 2)

Notes Operator assigned

LX20/DxC Interface Page 2-10

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 801 - Function 3: Clear Rack/Sample IDs

Stream 801 - Sample/Cup Program

2

Table 2.5 Field Return Code, continued

Sample/Cup Return Status, continued Length 2 Format 0-99 Notes 8 = For future use. 9 = DxC ERROR ­ An internal logical error has occurred. 10 = Completed sample (Program update only) 11 = Incompatible fluid types. Used for program update or control sample program. 12 = Incompatible test types. (Program update only) 13 = Incompatible patient name. (Program update only) 14 = Sample ID matches existing Control ID. 15 = Rack Number too large. Rack Number must be between 0 and 99. 16 = Too many tests programmed for sample. 17-20 = For future use.

Accession Number Rack Number Cup Number Sample ID

5 4 2 15

NUMERIC 1-65535, supplied by DxC 0000-9999 00-4 ALPHA

(2 of 2)

0 = No rack number assigned

Example:

[-0,801,02,-0,--306,-401,-1,RSG0001--------]<CS><CR><LF>

(- Indicates space holder) Stream 801 - Function 3: Clear Rack/Sample IDs Sent by: Host Purpose: Sent by the host prior to programming samples to clear the program for a rack or a group of samples. It is not necessary for the host to send this message as each sample is cleared if the update flag is not set in the 801-01, Sample/Cup Program message. · Receipt of this message causes the DxC to clear the program(s) for the rack or Sample IDs specified in the message. · 801-03 messages that include both rack number and Sample IDs are rejected by sending an 801-04 message with a BAD MESSAGE status.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008 LX20/DxC Interface Page 2-11

Stream 801 - Sample/Cup Program

Stream 801 - Function 4: Clear Rack/Sample IDs Status

· DxC responds to the 801-03 message with an 801-04, Clear Rack/Sample IDs Status message indicating whether the clear command was accepted. · If the DxC aspirated reagent for a rack or Sample ID, an 801-03 request to clear that rack or Sample ID receives an 801-04 message indicating the rack or Sample ID is busy. Table 2.6 Field Device ID Stream Function Rack Number Sample ID 1 Sample ID 2 Sample ID 3 Sample ID 4 Clear Rack/Sample IDs Length 2 3 2 4 15 15 15 15 Format 0-99 801 03 0000-0999 ALPHA ALPHA ALPHA ALPHA 0 = No rack number assigned. Refer to Note 1 and Note 2 after this table. Sample ID for a cup Sample ID for a cup Sample ID for a cup Sample ID for a cup Notes Operator assigned

Note 1: If one or more Sample IDs are specified, rack number must be zero. Specification of a non-zero rack number with non-blank Sample IDs will result in a 801-04 being returned with a rack return code of BAD MESSAGE. Note 2: Rack numbers greater than 999 result in a rejected Clear Rack/Sample ID Message and cause the Clear Rack/Sample ID Status rack return code to be set to 5 Rack Number too large. Example:

[00,801,03,0000,SAMP1------,SAMP2------,SAMP3------,SAMP4------]6A<CR><LF>

(- Indicates space holder) Stream 801 - Function 4: Clear Rack/Sample IDs Status Sent by: UniCel DxC Purpose: Sent in response to the 801-03 message. The host is informed if the clear command was accepted. Table 2.7 Field Device ID Stream Function

LX20/DxC Interface Page 2-12

Clear Rack/Sample IDs Status Length 2 3 2 Format 0-99 801 04

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Notes Operator assigned

Stream 801 - Function 6: Host Query Rack/Sample IDs

Stream 801 - Sample/Cup Program

2

Table 2.7 Field Rack Number Rack Return Code

Clear Rack/Sample IDs Status, continued Length 4 2 Format 0000-0999 0-99 Notes 0 = No rack number assigned 0 = Complete rack or all Sample IDs cleared. 1 = BAD MESSAGE 2 = BUSY The rack or one of the Sample IDs was running. 3 = DxC error 4 = Non-existent error 5= Rack Number too large 0 = Cleared. 2 = BUSY - Not cleared 3 = DxC Error 4 = Non-existent error 0 = Cleared 2 = BUSY - Not cleared 3 = DxC Error 4 = Non-existent error 0 = Cleared 2 = BUSY - Not cleared 3 = DxC Error 4 = Non-existent error 0 = Cleared 2 = BUSY - Not cleared 3 = DxC Error 4 = Non-existent error

Sample ID 1 Return Code

2

0-99

Sample ID 2 Return Code

2

0-99

Sample ID 3 Return Code

2

0-99

Sample ID 4 Return Code

2

0-99

Example:

[-0,801,04,-0,-0,-4,-4,-4,-4]6B<CR><LF>

(- Indicates space holder) Stream 801 - Function 6: Host Query Rack/Sample IDs Sent by: UniCel DxC Purpose: To request the program for the Sample IDs, specified in the message from the host. This message is used in the bidirectional with query mode and finds samples for which it has no program. The host has 2.5 minutes to respond with first sample program.

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LX20/DxC Interface Page 2-13

Stream 801 - Sample/Cup Program

Stream 801 - Function 6: Host Query Rack/Sample IDs

Table 2.8 Field Device ID Stream Function Sample ID 1 Sample ID 2 Sample ID 3 Sample ID 4

Host Query Rack/Sample IDs Length 2 3 2 15 15 15 15 Format 0-99 801 06 ALPHA ALPHA ALPHA ALPHA Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Notes Operator assigned

Note 1: The message stream maintains the sample cup position of a rack. For example, if "samp 4" is in cup position 4, it will remain in the 7th field of the 801, 06 stream. Example:

[-0,801,06,samp1------,samp2------,samp3------,samp4 ------]EB<CR><LF>

(- Indicates space holder)

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 802 - Function 1: Cup Header

Stream 802 - Results

2

Stream 802 - Results

Stream 802 - Function 1: Cup Header Sent by: UniCel DxC Purpose: Sent before sending any test results because the header contains identification and demographic information about a sample. Table 2.9 Field Device ID Stream Function Start Date Start Time Accession Number Print Type Cup Header Length 2 3 2 8 6 5 2 Format 00-99 802 01 LDATE TIME NUMERIC 1-65535, supplied by DxC CODE RG = Regular RE = Recall IN = Incomplete The rack number in which the sample was run. 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). Cup Number 2 0-4 The cup number in which the sample was run. 0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only). Test Type Future Use Space Sample Type Sample ID Control Name 2 9 2 15 20 TEST CODE Refer to Table 4.1 Test Type Codes (CX and LX20). ALPHA FLUID CODE ALPHA ALPHA Refer to Note 1 after this table.

(1 of 3)

Notes Operator assigned

Rack Number

4

0-0999

For future use. Refer to Table 4.2 Sample Type Codes (CX and LX20).

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LX20/DxC Interface Page 2-15

Stream 802 - Results

Stream 802 - Function 1: Cup Header

Table 2.9 Field

Cup Header, continued Length 25 18 15 1 15 18 8 4 20 3 1 8 1 45 7 Format ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA LDATE TIME ALPHA NUMERIC Default = 0 NUMERIC Default = 5 LDATE ALPHA ALPHA REAL 0.0 - 99999.0 Blank is OK. Refer to Note 2 after this table. M, F, B Notes

Sample Comment Code 1 Name Last Name First Name Middle Initial Patient ID Doctor Draw Date Draw Time Location Age Age Units Birth Date Sex Patient Comments Timed Urine Volume

Timed Urine Period Timed Urine Creatinine Timed Urine Area

4

REAL

Collection period 0-99.0 Refer to Note 2 after this table.

4

REAL

Serum creatinine 0-99.0 Refer to Note 2 after this table.

6

REAL

Surface area 1-9.9900 Refer to Note 2 after this table.

Number Chems Programmed Com Chem ID 1

3 4

NUMERIC Does not include replicates 000-999 CHEM CODE

(2 of 3)

LX20/DxC Interface Page 2-16

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 802 - Function 3: Test Results

Stream 802 - Results

2

Table 2.9 Field

Cup Header, continued Length 4 4 Format CHEM CODE CHEM CODE N < 999

(3 of 3)

Notes

Com Chem ID 2 Com Chem ID N

Note 1: The Control Name uniquely identifies the control of this result. Note 2: The number of decimal places is adjusted so the number can fit in this field. Example:

[-0,802,01,25091998,080534,--168,RE,--12,-1,RO,#########,SE,121------------, --------------------,-------------------------,Harris------------, Maria----------,J,100A10B100-----,Bond--------------,25091998,0100, ER------------------,-47,5,26051951,B, Lipemic--------------------------------------,#######,####,####,######, --3,01A-,01B-,04A-]C2<CR><LF>

(- Indicates space holder) Stream 802 - Function 3: Test Results Sent by: UniCel DxC Purpose: Sent when all chemistry results for a cup have been completed and calculated. 802-03 can be turned off in the host setup option. Table 2.10 Field Device ID Stream Function Completion Date Completion Time Accession Number Result Record Number Rack Number Test Results Length 2 3 2 8 6 5 9 4 Format 00-99 802 03 LDATE TIME NUMERIC 1-65535, supplied by DxC NUMERIC 1-10000 0-0999 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). 0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only).

(1 of 4)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008 LX20/DxC Interface Page 2-17

Notes Operator assigned

Cup Number

2

0-4

Stream 802 - Results

Stream 802 - Function 3: Test Results

Table 2.10 Field Sample ID

Test Results, continued Length 15 4 3 6 3 2 9 9 1 Format ALPHA CHEM CODE ALPHA ALPHA NUMERIC NUMERIC ALPHA Refer to Note 2 and Note 3 after this NUMERIC table. REAL CODE Refer to Note 2 and Note 3 after this table. 0 = Negative 1 = Positive 2 = Not applicable 3 = Equivocal 4 = Non-reactive 5 = Reactive 6 = Not confirmed 7 = Confirmed 8 = Gray zone flag 9 = Access 2/DxI LOW flag Expanded Results 3 - 9 apply to the DxC 600i and the DxC + DxI systems only. Refer to Note 4 after this table. Refer to Table 4.6 and Table 4.7 for Chemistry (Chem) Codes. Notes

Com Chem ID Reagent Serial Number Reagent Lot Number Cuvette Number Replicate Number Results in Selected Units Calibration Rate Positive or Negative

Suppress Value Units Normal Range Critical Range ORDAC

1 2 2 2 1

FLAG CODE CODE CODE FLAG

1 = Suppress value Refer to Table 4.8 Unit Codes. Refer to range codes after this table. Refer to range codes after this table. 1 = ORDAC used

(2 of 4)

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 802 - Function 3: Test Results

Stream 802 - Results

2

Table 2.10 Field

Test Results, continued Length 2 Format FLAG Notes NA = Not applicable NR = Within 2 SD of mean H2 = 2 to 3 SD above mean H3 = Greater than 3 SD above mean H4 = Greater than 4 SD above mean L2 = 2 to 3 SD below mean L3 = Greater than 3 SD below mean L4 = Greater than 4 SD below mean IC = Incomplete CD = Control or chemistry deleted

Control Range

Calculated Result

9

ALPHA Refer to Note 1 and Note 3 after this NUMERIC table. Note: The Result field reporting the results for some assays (TDMs, for example) may contain a < (less than) or a > (greater than) sign.

Instrument Codes Result Error 1 Result Error 2 Result Error 3 Result Error 4 Result Error 5 Result Error 6 Result Error 7 Result Error 8 Result Error 9 Result Error 10 Result Error 11 Result Error 12 Result Error 13 Result Error 14 Result Error 15 Result Error 16

9 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2

ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA

Refer to Table 4.9 Instrument Codes with Remarks. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes.

(3 of 4)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

LX20/DxC Interface Page 2-19

Stream 802 - Results

Stream 802 - Function 3: Test Results

Table 2.10 Field

Test Results, continued Length 6 25 Format REAL ALPHA 0.0 ­ 1.0 For future use.

(4 of 4)

Notes

Dilution Factor Spare

RANGE CODES: HI = above normal range LO = below normal range NR = within normal range OR = out of range NA = not applicable Note 1: The number of decimal places is adjusted so the number can fit into this field. Note 2: The number of decimal places in this field is the number in the selected precision for the selected units field in the chemistry database. Note 3: If Suppress Value = 1, this field will be filled with #. Note 4: For DxC chemistries, 0 and 1 are used only for drugs of abuse (DAT). On DxC 600i and the DxC + DxI systems, values from the range 0, 1, 3-9, are used by some Access 2/DxI results, depending on the specific chemistry. Refer to the Access Immunoassay System Assay Manual for additional information. All other chemistries use 2. Example:

[-0,802,03,25091998,080812,--168,------116,--12,-1,121------------, 01A-,###,######,###,-1,----104.7,#########,2,0,04,LO,NR,0,NA,104.65540, ---------,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,1.0000, #########################]0D<CR><LF>

(- Indicates space holder)

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 802 - Function 5: End of Cup

Stream 802 - Results

2

Stream 802 - Function 5: End of Cup Sent by: UniCel DxC Purpose: To indicate the end of a stream of test result messages for a specific cup. Table 2.11 Field Device ID Stream Function Date Time Accession Number Sample ID Rack Number End of Cup Length 2 3 2 8 6 5 15 4 Format 00-99 802 05 LDATE TIME NUMERIC ALPHA 0-0999 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). 0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only). 1-65535, supplied by DxC Notes Operator assigned

Cup Number

2

0-4

Example:

[-0,802,05,25091998,082242,--168,121------------,--12,-1]D5<CR><LF>

(- Indicates space holder) Stream 802 - Function 11: Special Calculations Results Sent by: UniCel DxC Purpose: Contains the result of a special calculation. This message contains accession number, rack number, cup number, and Sample ID. This message can be turned OFF in the Host Communication parameters screen in system setup. Table 2.12 Field Device ID Stream Function Date Time Accession Number Special Calculations Results Length 2 3 2 8 6 5 Format 00-99 802 11 LDATE TIME NUMERIC 1-65535, supplied by DxC

(1 of 2)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008 LX20/DxC Interface Page 2-21

Notes Operator assigned

Stream 802 - Results

Stream 802 - Function 11: Special Calculations Results

Table 2.12 Field Rack Number

Special Calculations Results, continued Length 4 Format 0-0999 Notes 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). 0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only).

Cup Number

2

0-4

Sample ID Replicate Number Special Calc Name Special Calc Status

15 2 20 2

ALPHA NUMERIC ALPHA CODE Operator assigned OK = Result is valid AB = One of the involved chemistries was programmed but not run. ZD = Denominator of a Ratio is zero Refer to Note 1 after this table.

Special Calc Results Special Unit String

9 8

REAL ALPHA

(2 of 2)

Note 1: The number of decimal places is adjusted to fit the number into this field. Example:

[-0,802,11,25091998,080534,--168,--12,-1,121------------,-1, SPC_CALC------------,OK,50.367081,mmol----]34<CR><LF>

(- Indicates space holder)

LX20/DxC Interface Page 2-22

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 802 - Function 13: Timed Urine Results

Stream 802 - Results

2

Stream 802 - Function 13: Timed Urine Results Sent by: UniCel DxC Purpose: Contains the result of a timed urine test. This message can be turned off on the host setup option. Table 2.13 Field Device ID Stream Function Date Time Accession Number Rack Number Timed Urine Results Length 2 3 2 8 6 5 4 Format 0-99 802 13 LDATE TIME NUMERIC 0-0999 1-65535, supplied by DxC 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). 0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only). Notes Operator assigned

Cup Number

2

0-4

Sample ID Replicate Number TU Calc Name TU Calc Status

15 2 20 2

ALPHA NUMERIC ALPHA CODE Operator assigned OK = Result is valid AB = One of the involved chemistries was programmed but not run. ZD = Denominator of a Ratio is zero Refer to Note 1 after this table.

TU Calc results TU Unit String

9 8

REAL ALPHA

Note 1: The number of decimal places is adjusted to fit the number into this field. Example:

[-0,802,13,10041998,135429,---88,22,-1,S221-------,-1,NA------------------, OK,244.00033,mmol/24.]6B<CR><LF>

(- Indicates space holder)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

LX20/DxC Interface Page 2-23

Stream 802 - Results

Stream 802 - Function 81: Expanded Results

Stream 802 - Function 81: Expanded Results Sent by: UniCel DxC Purpose: Contains the expanded result of a test. This message can be turned off in the host setup option. Do not run the system with expanded results turned on unless directed by a Beckman Coulter representative. Table 2.14 Field Device ID Stream Function Date Time Accession Number Sample Record Number Result Record Number Sample ID Rack Number Expanded Results Length 2 3 2 8 6 5 9 9 15 4 Format 0-99 802 81 LDATE TIME NUMERIC NUMERIC NUMERIC ALPHA 0-0999 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). 0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only). 1-65535, supplied by DxC Notes Operator assigned

Cup Number

2

0-4

Reagent Record Number Replicate Number Com Chem ID Cuvette Number Cal Level Suppressed Answer ORDAC Result Noise Maximum Outlier Maximum

9 2 4 3 1 1 1 5 5

NUMERIC NUMERIC CHEM CODE Refer to Table 4.6 Chemistry (Chem) Codes. NUMERIC 0-6 FLAG FLAG NUMERIC NUMERIC

(1 of 4)

For future use. 1 = Answer suppressed 1 = ORDAC

LX20/DxC Interface Page 2-24

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 802 - Function 81: Expanded Results

Stream 802 - Results

2

Table 2.14 Field

Expanded Results, continued Length 3 3 9 9 9 9 9 9 Format NUMERIC NUMERIC REAL REAL REAL REAL REAL REAL Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Notes

Noise Threshold Total Outlier Threshold Total Initial Absorbance Final Absorbance Water Blank-Rate Water Blank-Abs Water Blank-Mean Deviation Water BlankMaximum Deviation Blank-Rate Blank-Abs Blank-Mean Deviation Blank-Maximum Deviation Reaction-Rate Reaction-Abs Reaction-Mean Deviation Reaction-Maximum Deviation Raw Result Calculated Result

9 9 9 9 9 9 9 9 9 9

REAL REAL REAL REAL REAL REAL REAL REAL ALPHA ALPHA

Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Note: The Result field reporting the results for some assays (TDMs, for example) may contain a < (less than) or > (greater than) sign.

Calibration Rate

9

REAL

Refer to Note 1 after this table.

(2 of 4)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

LX20/DxC Interface Page 2-25

Stream 802 - Results

Stream 802 - Function 81: Expanded Results

Table 2.14 Field

Expanded Results, continued Length 1 Format FLAG Notes 0 = Negative 1 = Positive 2 = Not applicable 3 = Equivocal 4 = Non-reactive 5 = Reactive 6 = Not confirmed 7 = Confirmed 8 = Gray zone flag 9 = Access 2/DxI LOW flag Expanded Results 3 - 9 apply to the DxC 600i and the DxC + DxI systems only. Refer to Note 2 after this table.

Positive or Negative

Units Instrument Codes Result Error 1 Result Error 2 Result Error 3 Result Error 4 Result Error 5 Result Error 6 Result Error 7 Result Error 8 Result Error 9 Result Error 10

2 9 2 2 2 2 2 2 2 2 2 2

CODE ALPHA CODE CODE CODE CODE CODE CODE CODE CODE CODE CODE

Refer to Table 4.8 Unit Codes. Refer to Table 4.9 Instrument Codes with Remarks. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes.

(3 of 4)

LX20/DxC Interface Page 2-26

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 802 - Function 81: Expanded Results

Stream 802 - Results

2

Table 2.14 Field

Expanded Results, continued Length 2 2 2 2 2 2 5 5 5 5 5 6 23 Format CODE CODE CODE CODE CODE CODE NUMERIC NUMERIC NUMERIC NUMERIC NUMERIC REAL ALPHA 0.0-1.0 For future use.

(4 of 4)

Notes Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes.

Result Error 11 Result Error 12 Result Error 13 Result Error 14 Result Error 15 Result Error 16 Intermediate ADC 1 Intermediate ADC 2 Intermediate ADC 3 Intermediate ADC 4 Intermediate ADC 5 Dilution Factor Future Use Space

Note 1: The number of decimal places is adjusted to fit the number into this field. Note 2: For DxC chemistries, 0 and 1 are used only for drugs of abuse (DAT). On UniCel DxC 600i and the DxC + DxI systems, values from the range 0, 1, 3-9, are used by some Access 2/DxI results, depending on the specific chemistry. Refer to the Access Immunoassay System Assay Manual for additional information. All other chemistries use 2. Example:

[-0,802,81,25091998,080812,--168,#########,------116,121------------,--12, -1,385875973,-1,01A-,###,#,0,0,#####,#####,###,###,#########,#########, #########,#########,#########,#########,#########,#########,#########, #########,#########,#########,#########,#########,-3882.800,104.65540, #########,2,04,---------,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO, --538,-3344,-3882,----6,----3,1.0000,#######################]71<CR><LF>

(- Indicates space holder)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008 LX20/DxC Interface Page 2-27

Stream 803 - Instrument Status

Stream 803 - Function 1: Power Up

Stream 803 - Instrument Status

Stream 803 - Function 1: Power Up Sent by: UniCel DxC Purpose: Sent upon DxC power up or reset. This message can be turned off in the host setup option. Table 2.15 Field Device ID Stream Function Date Time Software Set CV ICC BOOT CV ICC APP CV MSMC1 BOOT 1 CV MSMC1 BOOT 2 CV MSMC1 APP CV MSMC2 BOOT 1 CV MSMC2 BOOT 2 CV MSMC2 APP CV SM BOOT CV SM APP 21 CV SM APP 11 CV SM APP 12 CV SM APP 13 CV SM APP 14 CV SM APP 31 Power Up Length 2 3 2 8 6 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 Format 0-99 803 01 LDATE TIME ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA

(1 of 3)

Notes Operator assigned

Console Master Program Version Number

LX20/DxC Interface Page 2-28

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 803 - Function 1: Power Up

Stream 803 - Instrument Status

2

Table 2.15 Field

Power Up, continued Length 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 Format ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s

(2 of 3)

Notes

CV SM APP 41 CV SM APP 42 CV SM APP 43 CV SM APP 51 CV SM APP 52 CV SM APP 61 CV SM APP 62 CV SM APP 63 CV SM APP 71 CV SM APP 81 CV SM APP 82 CV SM APP 91 CV SM APP A1 CV SM APP A2 CV SM APP B1 CV SM APP B2 CV SM APP B3 CV SM APP C1 CV SM APP C2 CV SM APP C3 SPARE SPARE SPARE SPARE SPARE SPARE SPARE SPARE SPARE

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

LX20/DxC Interface Page 2-29

Stream 803 - Instrument Status

Stream 803 - Function 2: Bidirectional On

Table 2.15 Field SPARE SPARE SPARE

Power Up, continued Length 10 10 10 Format ALPHA ALPHA ALPHA All "#"s All "#"s All "#"s

(3 of 3)

Notes

Example:

[-0,803,01,10041998[-0,703,01,100497,164320, v01.00----,v00.00----, v00.00----,v00.00----,v00.00----,v00.00----,v00.00----,v00.00----, v00.00----,v01.06----,v00.13----,v04.54----,v04.54----,v04.54----, v04.54----,v01.30----,v00.89----,v00.89----,v00.89----,v00.89----, v00.89----,v04.54----,v04.54----,v04.54----,v00.89----,v00.1B----, ##########,v00.30----,v00.89----,v00.89----,v00.89----,v00.89----, v00.89----,v00.89----,v00.89----,v00.89----,##########,##########, ##########,##########,##########,##########,##########,##########, ##########,##########,##########,##########]5E<CR><LF>

(- Indicates space holder) Stream 803 - Function 2: Bidirectional On Sent by: UniCel DxC Purpose: This message is sent to the host when bidirectional communication is enabled. This message can be disabled in the host setup option. Table 2.16 Field Device ID Stream Function Date Time Software Set Example:

[-0,803,02,10041998,203332,A4.4.54---]F0<CR><LF>

Bidirectional On Length 2 3 2 8 6 10 Format 0-99 803 02 LDATE TIME ALPHA DxC Software Version Notes Operator assigned

(- Indicates space holder)

LX20/DxC Interface Page 2-30

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 803 - Function 3: Request Instrument State

Stream 803 - Instrument Status

2

Stream 803 - Function 3: Request Instrument State Sent by: Host Purpose: Sent to obtain the state of the UniCel DxC. Table 2.17 Field Device ID Stream Function Example:

[-0,803,03]92<CR><LF>

Request Instrument State Length 2 3 2 Format 0-99 803 03 Notes Operator assigned

(- Indicates space holder) Stream 803 - Function 4: Instrument State Sent by: UniCel DxC Purpose: Sent in response to a Request Instrument State, 803-03 message from the host. Table 2.18 Field Device ID Stream Function Date Time Configuration MC State CC State Future Use Space. Example:

[-0,803,04,11041998,105150,DxC-,02,15,##,-1]85<CR><LF>

Instrument State Length 2 3 2 8 6 5 2 2 5 Format 0-99 803 04 LDATE TIME ALPHA CODE CODE ALPHA DxC Refer to Table 4.13 Instrument Status Codes. Refer to Table 4.13 Instrument Status Codes. For future use. Notes Operator assigned

(- Indicates space holder)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

LX20/DxC Interface Page 2-31

Stream 803 - Instrument Status

Stream 803 - Function 17: End of Run

Stream 803 - Function 17: End of Run Sent by: UniCel DxC Purpose: Sent when the DxC completes all programmed tests. This message can be turned off in the host setup option. Table 2.19 Field Device ID Stream Function Date Queued Time Queued Example:

[-0,803,17,06101998,100137]4C<CR><LF>

End of Run Length 2 3 2 8 6 Format 0-99 803 17 LDATE TIME Notes Operator assigned

(- Indicates space holder)

LX20/DxC Interface Page 2-32

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 804 - Function 7: Request Installed Chemistries

Stream 804 - Setup Status

2

Stream 804 - Setup Status

Stream 804 - Function 7: Request Installed Chemistries Sent by: Host Purpose: Sent to obtain the list of installed chemistries from the DxC database. Table 2.20 Field Device ID Stream Function Example:

[00,804,07]8F<CR><LF>

Request Installed Chemistries Length 2 3 2 Format 0-99 804 07 Notes Operator assigned

Sent by: UniCel DxC Purpose: This message is sent in response to a Request Installed Chemistries, 804-07 message from the host. Table 2.21 Field Device ID Stream Function Date Time Com Chem ID 1 Com Chem ID N Installed Chemistries Length 2 3 2 8 6 4 4 Format 0-99 804 08 LDATE TIME CHEM CODE Refer to Table 4.6 and Table 4.7 for Chemistry (Chem) Codes. CHEM CODE Refer to Table 4.6 and Table 4.7 for Chemistry (Chem) Codes. N is incremented for each Com Chem ID that is configured. Notes Operator assigned

Note: Only chemistry codes of chemistries that are configured on the DxC will be included in the message. The last chemistry code transmitted will be 0000 to indicate that no more chemistry codes follow. If no chemistries are configured on the instrument, only 0000 chemistry code will be listed.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

LX20/DxC Interface Page 2-33

Stream 804 - Setup Status

Stream 804 - Function 7: Request Installed Chemistries

Example:

[-0,804,08,11041998,105518,01A-,01B-,04A-,02A-,09D-,08D-,05D-,03E-, 06D-,43D-,07D-,14B-,56B-,35A-,31A-,31B-,54A-,84A-,10A-,24C-,24B-,93B-, 30A-,30B-,85A-,86A-,05A-,98A-,59A-,44A-,32A-,32B-,40A-,87A-,89A-,12A-, 62A-,46B-,72C-,36A-,06A-,14A-,83A-,79B-,52B-,51B-,53B-,55A-,33A-,50A-, 50B-,07B-,64A-,63A-,48A-,92A-,66A-,67C-,68C-,65A-,93C-,94A-,91A-,11A-, 42B-,42C-,88A-,88B-,41A-,69C-,70C-,71B-,0000]BE<CR><LF>

(- Indicates space holder)

LX20/DxC Interface Page 2-34

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

3

CHAPTER 3 CX7 Compatible Interface

Table of Contents

CX7 Compatible Interface ............................................................................... 3-2 CX7 Compatible Messages ........................................................................... 3-2 Introduction ................................................................................................ 3-2 Message Format ......................................................................................... 3-2 Message Streams ........................................................................................ 3-3 Stream 700 - Special Functions .................................................................... 3-4 Stream 700 - Function 1: Are You There? ................................................ 3-4 Stream 700 - Function 2: Host Setup ......................................................... 3-4 Stream 701 - Sample/Cup Program .............................................................. 3-6 Stream 701 - Function 1: Sample/Cup Program ........................................ 3-6 Stream 701 - Function 2: Sample/Cup Return Status ................................ 3-9 Stream 701 - Function 3: Clear Rack/Sample IDs ................................... 3-11 Stream 701 - Function 4: Clear Rack/Sample IDs Status ........................ 3-13 Stream 701 - Function 6: Host Query Rack/Sample IDs ......................... 3-13 Stream 702 - Results ................................................................................... 3-15 Stream 702 - Function 1: Cup Header ..................................................... 3-15 Stream 702 - Function 3: Test Results ..................................................... 3-17 Stream 702 - Function 5: End of Cup ...................................................... 3-22 Stream 702 - Function 11: Special Calculations Results ......................... 3-23 Stream 702 - Function 13: Timed Urine Results ..................................... 3-24 Stream 702 - Function 81: Expanded Results .......................................... 3-25 Stream 703 - Instrument Status ................................................................... 3-30 Stream 703 - Function 1: Power Up ........................................................ 3-30 Stream 703 - Function 2: Bidirectional On .............................................. 3-32 Stream 703 - Function 3: Request Instrument State ................................ 3-32 Stream 703 - Function 4: Instrument State .............................................. 3-33 Stream 703 - Function 17: End of Run .................................................... 3-34 Stream 704 - Setup Status ........................................................................... 3-35 Stream 704 - Function 7: Request Installed Chemistries ......................... 3-35 Stream 704 - Function 8: Installed Chemistries ....................................... 3-35

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-1

CX7 Compatible Messages

Introduction

CX7 Compatible Interface

CX7 Compatible Messages

Introduction The data record format for all messages transmitted to and from the UniCel DxC System is: `[`<MESSAGE>']'<CS><CR><LF> This section describes the information contained in the <MESSAGE> portion. Message Format The format of the <MESSAGE> is: <DEVICEID>,<STREAM>,<FUNCTION>,<FIELD1>,...,<FIELDN> where: · <DEVICE ID> is a number between 0 and 99. The default UniCel DxC ID is 0 but can be changed using the Host Communications Setup procedure. All messages which have a different Device ID than the Host Communications Screen will not be processed. · <STREAM> is a number between 700 and 799. · <FUNCTION> is a number between 1 and 99. · <FIELD1>,...,<FIELDN> are data fields associated with the <STREAM> and <FUNCTION>. · All data fields <FIELDN> are fixed lengths. · Numeric fields, excluding function numbers, are right justified and blank filled to the maximum length. · Character and string fields are left justified and right blank filled to the maximum length. · If numeric data exceeds the maximum field length, the field will be filled with asterisks (*). If a field does not apply in a record, it will be filled with pound signs (#). · Alphanumeric fields received from the host cannot contain commas (,). Commas received in an alphanumeric field will generate an HCP error. A comma entered in an alphanumeric field at the instrument is transmitted as a semicolon (;). A semicolon received from the host is converted to a comma. · Valid and Invalid characters for entries are listed in the table below:

CX7 Compatible Interface Page 3-2

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Messages

Message Streams

3

Table 3.1

ASCII Codes THESE ARE VALID ASCII Character Codes... 33 thru 126 33 thru 126, % 32 thru 175 EXCEPT FOR THESE INVALID Characters and Character Codes... A space and $ , ; * ? [ ] \^ | & " % A space and $ , ; * ? [ ] \^ | & " ASCII Character Codes 34, 37, 44 and 127

Type of Entry Sample ID Patient IDa Other Entries

a

For Patient ID, % is allowed and for Japanese only, single byte Katakana is allowed.

· Alpha: Any printable ASCII string (Commas are translated into semicolons when sent to the host. Semicolons are translated into commas when received from the host.) Message Streams Messages sent to and from the UniCel DxC System are divided into streams. · Each stream corresponds to one group of related operations within the interface. Within each stream are one or more functions. For each stream only one function can be active at a time. · Multiple streams can be active at the same time. Stream transmission options are described in the Host Communications section of CHAPTER 3, Detailed System Setup in the UniCel DxC Synchron Clinical Systems Reference Manual.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-3

Stream 700 - Special Functions

Stream 700 - Function 1: Are You There?

Stream 700 - Special Functions

Stream 700 - Function 1: Are You There? Sent by: Host Purpose: To make sure that a bidirectional system is attached to the host port. Upon receipt of the message 700-01, the UniCel DxC responds with the message 700-02, Host Setup. Table 3.2 Field Device ID Stream Function Example:

[00,700,01]98<CR><LF>

Are You There Length 2 3 2 Format 0-99 800 01 Notes Operator assigned

Stream 700 - Function 2: Host Setup Sent by: UniCel DxC Purpose: Sent by the UniCel DxC in response to message 700-01. Also sent unsolicited upon power up and whenever there are changes to the Host Communications in System Setup. Table 3.3 Device ID Stream Function Date Time Software Revision Driver Mode Stream 700 Function 2 Stream 701 Function 6 Stream 702 Function 3 Host Setup Field Length 2 3 2 6 6 10 1 1 1 1 Format 0-99 700 02 Date Time ALPHA B or U 0 or 1 0 or 1 0 or 1 Rev NNN.N B = Bidirectional U = Unidirectional 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON

(1 of 2)

CX7 Compatible Interface Page 3-4 UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Notes Operator assigned

Stream 700 - Function 2: Host Setup

Stream 700 - Special Functions

3

Table 3.3

Host Setup, continued Field Length 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Format 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 or 1 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON 0 = OFF 1 = ON

(2 of 2)

Notes

Stream 702 Function 7 Stream 702 Function 9 Stream 702 Function 11 Stream 702 Function 23 Stream 702 Function 25 Stream 702 Function 81 Stream 702 Function 83 Stream 703 Function 1 Stream 703 Function 2 Stream 703 Function 5 Stream 703 Function 7 Stream 703 Function 13 Stream 703 Function 17 Stream 702 Function 13

Example:

[-0,700,02,100497,163322,v0.0.04.07,B,1,0,1,1,1,1,1,1,0,1,1,1,1,1,1,1,1,1, 1,1,1,1,1,1]6E<CR><LF>

(- Indicates space holder)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-5

Stream 701 - Sample/Cup Program

Stream 701 - Function 1: Sample/Cup Program

Stream 701 - Sample/Cup Program

Stream 701 - Function 1: Sample/Cup Program Sent by: Host Purpose: To inform UniCel DxC what tests to perform for a given sample. The DxC responds with a 701-02, Sample/Cup Return Status, that shows whether or not the program was accepted. Table 3.4 Field Device ID Stream Function Rack Number Sample/Cup Program Length 2 3 2 2 Format 00-99 701 01 0-999 0 = No rack number in bar code mode. (Cup Number must also be 0) Refer to Note 3 after this table. Cup Number 2 0-4 0 = No cup number in bar code mode. A cup number greater than 4 will result in a BAD MESSAGE return code in the 701-02 message. Refer to Note 3 after this table. Update Flag 1 FLAG 0 = Replace all programming and patient demographics. 1 = Add to existing program. Refer to Note 2 and Note 4 after this table. Test Type 2 TEST CODE Refer to Table 4.1 Test Type Codes (CX and LX20). Refer to Note 4 after this table. Sample Type 2 FLUID CODE Refer to Table 4.2 Sample Type Codes (CX and LX20).

(1 of 3)

Notes Operator assigned.

CX7 Compatible Interface Page 3-6

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 701 - Function 1: Sample/Cup Program

Stream 701 - Sample/Cup Program

3

Table 3.4 Field Sample ID

Sample/Cup Program, continued Length 11 Format ALPHA Notes Must be present in all modes. All lower case letters are converted to upper case. Refer to Note 4, Note 8 and Note 9 after this table.

Control Name Sample Comment Code 1 Sample Comment Code 2 Name Last Name First Name Middle Initial Patient ID Doctor Draw Date Draw Time Location Age Age Units

20 25 25 18 15 1 12 18 6 4 20 3 1

ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA DATE TIME ALPHA

Refer to Note 1 after this table.

Not Used by DxC

Refer to Note 7 after this table.

NUMERIC Default = 0 NUMERIC Default = 5 Refer to Table 4.4 Age Unit Codes (CX and LX20).

Birth Date Sex Patient Comments Timed Urine Volume Timed Urine Period

6 1 25 7 4

DATE ALPHA ALPHA NUMERIC 0-99999.0 NUMERIC Collection period 0-99.0

(2 of 3)

M, F, B

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-7

Stream 701 - Sample/Cup Program

Stream 701 - Function 1: Sample/Cup Program

Table 3.4 Field Timed Urine Creatinine

Sample/Cup Program, continued Length 4 6 3 4 1 4 1 4 1 Format Notes NUMERIC Serum creatinine 0-99.0 NUMERIC Surface area 1 ­ 9.9900 NUMERIC 1-999 CHEM CODE FLAG CHEM CODE FLAG CHEM CODE FLAG Refer to Note 5 and Note 6 after this table. 1 = ORDAC Refer to Note 5 and Note 6 after this table. 1 = ORDAC Refer to Note 5 and Note 6 after this table. 1 = ORDAC

(3 of 3)

Timed Urine Area Number Tests Test-1 Chem Test-1 ORDAC Test-2 Chem Test-2 ORDAC Test-Na Chem

Test-N ORDAC

a

N = Value from Number Tests Field

Note 1: The Control Name uniquely identifies the control of this result. Only the selected fluid type for the control can be used. Any other fluid type is a syntax error. All lower case letters are converted to upper case. If a control name is included in the message, the system will address the sample program as a control sample program. Note 2: A new program will be entered if no program exists for the specified sample/ cup. Duplicate chemistries will not be added to an existing program. Updates consist of chemistry additions only. Updates are allowed only under the following conditions: · Sample Type and Program Type of program to be updated match Fluid Type and Test Type (respectively) of sample program sent by the host. · Sample Status of the program to be updated is Sample Required, In-Progress, Removed, Manual Assign, or Rerun; and Control Name of the sample program sent by the host is blank for patient samples, or matches the Control Name of the existing control sample program. Overwrites are allowed under the following conditions: · Sample Status of the program to be overwritten is Sample Required, Incomplete, Complete, Manual Assign, or Rerun.

CX7 Compatible Interface Page 3-8

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 701 - Function 2: Sample/Cup Return Status

Stream 701 - Sample/Cup Program

3

Note 3: The most significant character of the range of the Rack Number field will be located in the most significant character position of the Cup Number field. To use this option, select the 3-Digit Rack Number button on the Host Communication Parameters screen, which is accessed through the Host Communication button on the System Setup screen. Example: Rack 345, Cup 1 would be 45, 31. Note 4: If the Test Type is ST (STAT) or RO (Routine), the sample program will be rejected if the Sample ID matches a defined control ID on the system. Note 5: A control sample will be rejected when one or more chemistries sent by the LIS is not defined in the QC definition. The system will not accept control sample programs if they contain chemistries not defined for the control on the instrument. Note 6: If the host stream contains at least one of the Chem Codes used for serum index chemistries, the system will select to run all serum indices tests. The system will treat a serum index test selection as an exception to the requirement that chemistry selections in the host stream have to be configured on the instrument. Note 7: If the host stream contains a Draw Time but does not contain a Draw Date, the system will clear the Draw Time to zero and log an event, indicating it has done so. Note 8: Refer to Table 3.1 for valid and invalid ASCII Codes. Note 9: The Sample ID field must be present. Example:

[00,701,01,01,03,1,CO,SE,samp3------,CONTROL_NAME________, -------------------------,SAMPLE_COMMENT_TWO_______,------------------, PATIENT_F_NAME_,M,------------,------------------,------,----, --------------------,000,4,------,M,-------------------------,-------, ----,----,------,001,01B-,0]2F<CR><LF>

(- Indicates space holder) Stream 701 - Function 2: Sample/Cup Return Status Sent by: UniCel DxC Purpose: Sent in response to a 701-01 message from the host. 701-02 indicates whether the sample/cup program was accepted, or why it was not accepted. Table 3.5 Field Device ID Stream7 Sample/Cup Return Status Length 2 3 Format 0-99 701

(1 of 3)

Notes Operator assigned

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-9

Stream 701 - Sample/Cup Program

Stream 701 - Function 2: Sample/Cup Return Status

Table 3.5 Field Function Return Code

Sample/Cup Return Status, continued Length 2 2 Format 02 00-99 0 = OK 1 = BAD MESSAGE ­ There is something wrong with the message syntax. 2 = BUSY ­ The cup is running or sample is being programmed. 3 = NOT CONFIGURED ­ Message contains at least one non ­ configured chemistry. 4 = NON ORDAC ­ Message contains at least one non-ORDAC chemistry, required for ORDAC. 5 = DILUTION ERROR ­ Message contains chemistries with different dilution factors. 6 = CONTROL NOT CONFIGURED 7 = CALIBRATOR Rack ONLY 8 = For future use. 9 = DxC ERROR ­ An internal logical error has occurred. 10 = Completed sample (Program update only) 11 = Incompatible fluid types. Used for program update or control sample program. 12 = Incompatible test types. (Program update only) 13 = Incompatible patient name. (Program update only) 14 = Patient Sample Program Sample ID matches existing DxC Control ID. 15 = Not used by CX7 I/F messages. 16 = Too many tests programmed for sample. 17-20 = For future use. Refer to Note 1 and Note 2 after this table. Notes

Accession Number

5

NUMERIC 1-65535, supplied by DxC

(2 of 3)

CX7 Compatible Interface Page 3-10

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 701 - Function 3: Clear Rack/Sample IDs

Stream 701 - Sample/Cup Program

3

Table 3.5 Field Rack Number

Sample/Cup Return Status, continued Length 2 Format 0-999 Notes 0 = No rack number assigned. Refer to Note 1 and Note 2 after this table. Refer to Note 1 and Note 2 after this table.

(3 of 3)

Cup Number Sample ID

2 11

0-4 ALPHA

Note 1: The cup number and rack number must be filled in when the instrument is in non-bar code mode. Note 2: The most significant character of the Rack Number field's range will be located in the most significant character position of the Cup Number field. To use this option, select the 3-Digit Rack Number button on the Host Communication Parameters screen, which is accessed through the Host Communication button on the System Setup screen. Example: Rack 345, Cup 1 would be 45, 31. Example:

[-0,701,02,-0,--230,-1,-3,samp3------]5D<CR><LF>

(- Indicates space holder) Stream 701 - Function 3: Clear Rack/Sample IDs Sent by: Host Purpose: Sent by the host prior to programming samples to clear the program for a rack or a group of samples. It is not necessary for the host to send this message as each sample is cleared if the update flag is not set in the 701-01, Sample/Cup Program message. · Receipt of this message causes the DxC to clear the program(s) for the rack or Sample IDs specified in the message. · 701-03 messages that include both rack number and Sample IDs are rejected by sending a 701-04 message with a BAD MESSAGE status. · DxC responds to the 701-03 message with a 701-04, Clear Rack/Sample IDs Status message indicating whether the clear command was accepted. · If the DxC aspirated reagent for a rack or Sample ID, a 701-03 request to clear that rack or Sample ID receives a 701-04 message indicating the rack or Sample ID is busy.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-11

Stream 701 - Sample/Cup Program

Stream 701 - Function 3: Clear Rack/Sample IDs

Table 3.6 Field Device ID Stream Function Rack Number

Clear Rack/Sample IDs Length 2 3 2 2 Format 0-99 701 03 0-99 0 = No rack number in bar code mode Refer to Note 3 after this table. Notes Operator assigned

Sample ID 1

11

ALPHA

Sample ID for a cup Refer to Note 2 after this table.

Sample ID 2

11

ALPHA

Sample ID for a cup Refer to Note 2 after this table.

Sample ID N

11

ALPHA

Sample ID for a cup. N = 3 thru 7.

Note 2: If one or more Sample IDs are specified, rack number must be zero. Specification of a non-zero rack number with non-blank Sample IDs will result in a 701-04 being returned with a rack return code of BAD MESSAGE. Note 3: Only rack numbers less than or equal to 99 may be cleared by rack number. All other racks must be cleared by Sample ID. Example:

[00,701,03,00,SAMP1------,SAMP2------,SAMP3------,SAMP4------,SAMP5------, SAMP6------,SAMP7------]D2<CR><LF>

(- Indicates space holder)

CX7 Compatible Interface Page 3-12

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 701 - Function 4: Clear Rack/Sample IDs Status

Stream 701 - Sample/Cup Program

3

Stream 701 - Function 4: Clear Rack/Sample IDs Status Sent by: UniCel DxC Purpose: Sent in response to the 701-03 message. The host is informed if the clear command was accepted. Table 3.7 Field Device ID Stream Function Rack Number Rack Return Code Clear Rack/Sample IDs Status Length 2 3 2 2 2 Format 0-99 701 04 0-99 0-99 0 = No rack number in bar code mode. 0 = Complete rack or all Sample IDs cleared. 1 = BAD MESSAGE 2 = BUSY The rack or one of the Sample IDs was running. 3 = DxC error 4 = Non-existent error 0 = Cleared. 2 = BUSY - Not cleared 3 = DxC Error 4 = Non-existent error 0 = Cleared 2 = BUSY - Not cleared 3 = DxC Error 4 = Non-existent error 0 = Cleared 2 = BUSY - Not cleared 3 = DxC Error 4 = Non-existent error N = 3 thru 7. Notes Operator assigned

Sample ID 1 Return Code

2

0-99

Sample ID 2 Return Code

2

0-99

Sample ID N Return Code

2

0-99

Example:

[-0,701,04,-0,-4,-4,-4,-4,-4,-4,-4,-4]28<CR><LF>

(- Indicates space holder) Stream 701 - Function 6: Host Query Rack/Sample IDs Sent by: UniCel DxC Purpose: To request the program for the Sample IDs, specified in the message from the host. This message is used in the bidirectional with query mode and finds samples for which it has no program. The host has 2.5 minutes to respond with first sample program.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008 CX7 Compatible Interface Page 3-13

Stream 701 - Sample/Cup Program

Stream 701 - Function 6: Host Query Rack/Sample IDs

Table 3.8 Field Device ID Stream Function Sample ID 1 Sample ID 2 Sample ID 3 Sample ID 4

Host Query Rack/Sample IDs Length 2 3 2 11 11 11 11 Format 0-99 701 06 ALPHA ALPHA ALPHA ALPHA Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Notes Operator assigned

Note 1: The message stream maintains the sample cup position of a rack. For example, if "samp 4" is in cup position 4, it will remain in the 7th field of the 701,06 stream. Example:

[-0,701,06,samp1------,samp2------,samp3------,samp4------,samp5------, samp6------,samp7------]EB<CR><LF>

(- Indicates space holder)

CX7 Compatible Interface Page 3-14

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 702 - Function 1: Cup Header

Stream 702 - Results

3

Stream 702 - Results

Stream 702 - Function 1: Cup Header Sent by: UniCel DxC Purpose: Sent before sending any test results because the header contains identification and demographic information about a sample. Table 3.9 Field Device ID Stream Function Start Date Start Time Accession Number Print Type Cup Header Length 2 3 2 6 6 5 2 Format 0-99 702 01 DATE TIME NUMERIC 1-65535, supplied by DxC CODE RG = Regular RE = Recall IN = Incomplete The rack number in which the sample was run. 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 1 after this table. Cup Number 2 0-4 The cup number in which the sample was run. 0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 1 after this table. Test Type Future Use Space Sample Type 2 9 2 TEST CODE Refer to Table 4.1 Test Type Codes (CX and LX20). ALPHA FLUID CODE For future use. Refer to Table 4.2 Sample Type Codes (CX and LX20).

(1 of 3)

Notes Operator assigned

Rack Number

2

0-999

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-15

Stream 702 - Results

Stream 702 - Function 1: Cup Header

Table 3.9 Field Sample ID Control Name

Cup Header, continued Length 11 20 25 25 18 15 1 12 18 6 4 20 3 1 6 1 25 7 Format ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA DATE TIME ALPHA NUMERIC Default = 0 NUMERIC Default = 5 DATE ALPHA ALPHA REAL 0.0 - 99999.0 mL Refer to Note 2 after this table. M, F Notes

Sample Comment Code 1 Sample Comment Code 2 Name Last Name First Name Middle Initial Patient ID Doctor Draw Date Draw Time Location Age Age Units Birth Date Sex Patient Comments Timed Urine Volume

Timed Urine Period

4

REAL

Collection period 0-99.0 Refer to Note 2 after this table.

Timed Urine Creatinine Timed Urine Area

4

REAL

Serum creatinine 0-99.0 Refer to Note 2 after this table.

6

REAL

Surface area 1-9.9900 Refer to Note 2 after this table.

Number Chems Programmed

3

NUMERIC 1-999 Does not include replicates. 001-999

(2 of 3)

CX7 Compatible Interface Page 3-16

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 702 - Function 3: Test Results

Stream 702 - Results

3

Table 3.9 Field

Cup Header, continued Length 4 4 4 Format CHEM CODE CHEM CODE CHEM CODE N 999

(3 of 3)

Notes

Com Chem ID 1 Com Chem ID 2 Com Chem ID N

Note 1: The most significant character of the Rack Number field will be located in the most significant character position of the Cup Number field. To use this option, select the 3-Digit Rack Number button on the Host Communication Parameters screen, which is accessed through the Host Communication button on the System Setup screen. Example: Rack 345, Cup 1 would be 45,31. Note 2: The number of decimal places is adjusted so the number can fit in this field. Example:

[-0,702,01,100497,135429,---88,RG,22,-1,RO,#########,TU,S221-------, --------------------,-------------------------,-------------------------, White-------------,Allen----------,B,S221-------,Nelson------------, 100497,1500,--------------------,-17,5,190280,M,-------------------------, 1400.00,24.0,2.30,1.7300,--3,01A-,01B-,04A-]3A<CR><LF>

(- Indicates space holder) Stream 702 - Function 3: Test Results Sent by: UniCel DxC Purpose: Sent when all chemistry results for a cup have been completed and calculated. 702-03 can be turned off in the host setup option. Table 3.10 Field Device ID Stream Function Completion Date Completion Time Accession Number Test Results Length 2 3 2 6 6 5 Format 00-99 702 03 DATE TIME NUMERIC 1-65535, supplied by DxC

(1 of 4)

Notes Operator assigned

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-17

Stream 702 - Results

Stream 702 - Function 3: Test Results

Table 3.10 Field Result Record Number Rack Number

Test Results, continued Length 9 2 Format NUMERIC 1-10000 0-999 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 5 after this table. Notes

Cup Number

2

0-4

0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 5 after this table.

Sample ID Com Chem ID Reagent Serial Number Reagent Lot Number Cuvette Number Replicate Number Results in Selected Units

11 4 3 6 2 2 9

ALPHA CHEM CODE ALPHA ALPHA HEX NUMERIC ALPHA Refer to Note 2 and Note 3 after this NUMERIC table. Note: The Result field reporting the results for some assays (TDMs, for example) may contain a < (less than) or a > (greater than) sign. Refer to Table 4.6 and Table 4.7 for Chemistry (Chem) Codes.

Calibration Rate

9

REAL

Refer to Note 2 and Note 3 after this table.

(2 of 4)

CX7 Compatible Interface Page 3-18

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 702 - Function 3: Test Results

Stream 702 - Results

3

Table 3.10 Field Positive or Negative

Test Results, continued Length 1 Format CODE Notes 0 = Negative 1 = Positive 2 = Not applicable 3 = Equivocal 4 = Non-reactive 5 = Reactive 6 = Not confirmed 7 = Confirmed 8 = Gray zone flag 9 = Access 2/DxI LOW flag Expanded Results 3 - 9 apply to the DxC 600i and DxC + DxI systems only. Refer to Note 4 after this table.

Suppress Value Units Normal Range Instrument Range Critical Range ORDAC Control Range

1 2 2 2 2 1 2

FLAG CODE CODE CODE CODE FLAG FLAG

1 = Suppress value Refer to Table 4.8 Unit Codes. Refer to range codes after this table. Refer to range codes after this table. Refer to range codes after this table. 1 = ORDAC used NA = Not applicable NR = Within 2 SD of mean H2 = 2 to 3 SD above mean H3 = Greater than 3 SD above mean H4 = Greater than 4 SD above mean L2 = 2 to 3 SD below mean L3 = Greater than 3 SD below mean L4 = Greater than 4 SD below mean IC = Incomplete CD = Control or chemistry deleted

Calculated Result

9

ALPHA Refer to Note 1 and Note 3 after this NUMERIC table. Note: The Result field reporting the results for some assays (TDMs, for example) may contain a < (less than) or a > (greater than) sign.

Instrument Codes

9

ALPHA

Refer to Table 4.9 Instrument Codes with Remarks.

(3 of 4)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-19

Stream 702 - Results

Stream 702 - Function 3: Test Results

Table 3.10 Field Result Error 1 Result Error 2 Result Error 3 Result Error 4 Result Error 5 Result Error 6 Result Error 7 Result Error 8 Result Error 9

Test Results, continued Length 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 6 2 20 Format ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA REAL CODE ALPHA Notes Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. 0.0 ­ 1.0 Refer to range codes after this table. For future use.

(4 of 4)

Result Error 10 Result Error 11 Result Error 12 Result Error 13 Result Error 14 Result Error 15 Result Error 16 Dilution Factor Reportable Range Spare

CX7 Compatible Interface Page 3-20

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 702 - Function 3: Test Results

Stream 702 - Results

3

RANGE CODES: HI = above normal range LO = below normal range NR = within normal range OR = out of range NA = not applicable Note 1: The number of decimal places is adjusted so the number can fit into this field. Note 2: The number of decimal places in this field is the number in the selected precision for the selected units field in the chemistry database. Note 3: If Suppress Value = 1, this field will be filled with #. Note 4: For DxC chemistries, 0 and 1 are used only for drugs of abuse (DAT). On UniCel DxC 600i and the DxC + DxI systems, values from the range 0, 1, 3-9, are used by some Access 2/DxI results, depending on the specific chemistry. Refer to the Access Immunoassay System Assay Manual for additional information. All other chemistries use 2. Note 5: The most significant character of the range of the Rack Number field is located in the most significant character position of the Cup Number field. To use this option, select the 3-Digit Rack Number button on the Host Communication Parameters screen, which is accessed through the Host Communication button on the System Setup screen. Example: Rack 345, Cup 1 would be 45, 31. Example:

[-0,702,03,100497,135610,---88,---916097,22,-1,S221-------,01A-,###, ######,##,-1,----174.3,#########,2,0,-4,NA,HI,NA,0,NA,136.20541, ---------,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,1.0000,NR, ####################]48<CR><LF>

(- Indicates space holder)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-21

Stream 702 - Results

Stream 702 - Function 5: End of Cup

Stream 702 - Function 5: End of Cup Sent by: UniCel DxC Purpose: To indicate the end of a stream of test result messages for a specific cup. Table 3.11 Field Device ID Stream Function Date Time Accession Number Sample ID Rack number End of Cup Length 2 3 2 6 6 5 11 2 Format 00-99 702 05 DATE TIME NUMERIC ALPHA 0-999 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 1 after this table. Cup number 2 0-4 0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 1 after this table. Note 1: The most significant character of the Rack Number field's range will be located in the most significant character position of the Cup Number field. To use this option, select the 3-Digit Rack Number button on the Host Communication Parameters screen, which is accessed through the Host Communication button on the System Setup screen. Example: Rack 345, Cup 1 would be 45, 31. Example:

[-0,702,05,100497,140240,---88,S221-------,22,-1]ED<CR><LF>

Notes Operator assigned

1-65535, supplied by DxC

(- Indicates space holder)

CX7 Compatible Interface Page 3-22

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 702 - Function 11: Special Calculations Results

Stream 702 - Results

3

Stream 702 - Function 11: Special Calculations Results Sent by: UniCel DxC Purpose: Contains the result of a special calculation. This message contains accession number, rack number, cup number, and Sample ID. This message can be turned OFF in the Host Communication parameters screen in system setup. Table 3.12 Field Device ID Stream Function Date Time Accession Number Rack Number Special Calculations Results Length 2 3 2 6 6 5 2 Format 00-99 702 11 DATE TIME NUMERIC 1-65535, supplied by DxC 0-999 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 2 after this table. Cup Number 2 0-4 0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 2 after this table. Sample ID Replicate Number Special Calc Name Special Calc Status 11 2 20 2 ALPHA NUMERIC ALPHA CODE Operator assigned OK = Result is valid AB = One of the involved chemistries was programmed but not run. ZD = Denominator of a Ratio is zero Refer to Note 1 after this table. Notes Operator assigned

Special Calc Results Special Unit String

9 8

REAL ALPHA

Note 1: The number of decimal places is adjusted to fit the number into this field.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-23

Stream 702 - Results

Stream 702 - Function 13: Timed Urine Results

Note 2: The most significant character of the range of the Rack Number field will be located in the most significant character position of the Cup Number field. To use this option, select the 3-Digit Rack Number button on the Host Communication Parameters screen, which is accessed through the Host Communication button on the System Setup screen. Example: Rack 345, Cup 1 would be 45, 31. Example:

[-0,702,11,100497,135429,---88,22,-1,S221-------,-1,SPC_CALC------------, OK,50.367081,mmol----]B5<CR><LF>

(- Indicates space holder) Stream 702 - Function 13: Timed Urine Results Sent by: UniCel DxC Purpose: Contains the result of a timed urine test. This message can be turned off on the host setup option. Table 3.13 Field Device ID Stream Function Date Time Accession Number Rack number Timed Urine Results Length 2 3 2 6 6 5 2 Format 00-99 702 13 DATE TIME NUMERIC 1-65535, supplied by DxC 0-999 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 2 after this table. Cup Number 2 0-4 0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 2 after this table. Sample ID Replicate Number TU Calc Name 11 2 20 ALPHA NUMERIC ALPHA Operator assigned Notes Operator assigned

CX7 Compatible Interface Page 3-24

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 702 - Function 81: Expanded Results

Stream 702 - Results

3

Table 3.13 Field

Timed Urine Results, continued Length 2 Format CODE Notes OK = Result is valid AB = One of the involved chemistries was programmed but not run. ZD = Denominator of a Ratio is zero Refer to Table 4.12. Refer to Note 1 after this table.

TU Calc Status

TU Calc results TU Unit String

9 8

REAL ALPHA

Note 1: The number of decimal places is adjusted to fit the number into this field. Note 2: The most significant character of the range of the Rack Number field will be located in the most significant character position of the Cup Number field. To use this option, select the 3-Digit Rack Number button on the Host Communication Parameters screen, which is accessed through the Host Communication button on the System Setup screen. Example: Rack 345, Cup 1 would be 45, 31 Example:

[-0,702,13,100497,135429,---88,22,-1,S221-------,-1,NA------------------, OK,244.00033,mmol/24.]0B<CR><LF>

(- Indicates space holder) Stream 702 - Function 81: Expanded Results Sent by: UniCel DxC Purpose: Contains the expanded result of a test. This message can be turned off in the host setup option. Do not run the system with expanded results turned on unless directed by a Beckman Coulter representative. Table 3.14 Field Device ID Stream Function Date Time Accession Number Expanded Results Length 2 3 2 6 6 5 Format 0-99 702 81 DATE TIME NUMERIC 1-65535, supplied by DxC

(1 of 5)

Notes Operator assigned

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-25

Stream 702 - Results

Stream 702 - Function 81: Expanded Results

Table 3.14 Field

Expanded Results, continued Length 9 9 11 2 Format NUMERIC NUMERIC ALPHA 0-999 0 = No rack number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 2 after this table. Notes

Sample Record Number Result Record Number Sample ID Rack Number

Cup Number

2

0-4

0 = No cup number when sample is directly loaded on Access 2 (DxC 600i only). Refer to Note 2 after this table.

Reagent Record Number Replicate Number Com Chem ID Cuvette Number Cal Level Suppressed Answer ORDAC Result Noise Maximum Outlier Maximum Noise Threshold Total Outlier Threshold Total Initial Absorbance Final Absorbance Water Blank-Rate Water Blank-Abs Water Blank-Mean Deviation

9 2 4 2 1 1 1 5 5 3 3 9 9 9 9 9

NUMERIC NUMERIC CHEM CODE Refer to Table 4.6 and Table 4.7 for Chemistry (Chem) Codes. HEX 0-6 FLAG FLAG NUMERIC NUMERIC NUMERIC NUMERIC REAL REAL REAL REAL REAL Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table.

(2 of 5)

For future use. 1 = Answer suppressed 1 = ORDAC

CX7 Compatible Interface Page 3-26

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 702 - Function 81: Expanded Results

Stream 702 - Results

3

Table 3.14 Field

Expanded Results, continued Length 9 9 9 9 9 9 9 9 9 9 9 Format REAL REAL REAL REAL REAL REAL REAL REAL REAL ALPHA ALPHA Notes Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Refer to Note 1 after this table. Note: The Result field reporting the results for some assays (TDMs, for example) may contain a < (less than) or > (greater than) sign.

Water BlankMaximum Deviation Blank-Rate Blank-Abs Blank-Mean Deviation Blank-Maximum Deviation Reaction-Rate Reaction-Abs Reaction-Mean Deviation Reaction-Maximum Deviation Raw Result Calculated Result

Calibration Rate Positive or Negative

9 1

REAL FLAG

Refer to Note 1 after this table. 0 = Negative 1 = Positive 2 = Not applicable 3 = Equivocal 4 = Non-reactive 5 = Reactive 6 = Not confirmed 7 = Confirmed 8 = Gray zone flag 9 = Access 2/DxI LOW flag Expanded Results 3 - 9 apply to the DxC 600i and DxC + DxI systems only. Refer to Note 3 after this table.

(3 of 5)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-27

Stream 702 - Results

Stream 702 - Function 81: Expanded Results

Table 3.14 Field Units

Expanded Results, continued Length 2 9 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 5 Format CODE ALPHA CODE CODE CODE CODE CODE CODE CODE CODE CODE CODE CODE CODE CODE CODE CODE CODE NUMERIC

(4 of 5)

Notes Refer to Table 4.8 Unit Codes. Refer to Table 4.9 Instrument Codes with Remarks. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes. Refer to Table 4.10 Result Error Codes.

Instrument Codes Result Error 1 Result Error 2 Result Error 3 Result Error 4 Result Error 5 Result Error 6 Result Error 7 Result Error 8 Result Error 9 Result Error 10 Result Error 11 Result Error 12 Result Error 13 Result Error 14 Result Error 15 Result Error 16 Intermediate ADC 1

CX7 Compatible Interface Page 3-28

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 702 - Function 81: Expanded Results

Stream 702 - Results

3

Table 3.14 Field

Expanded Results, continued Length 5 5 5 5 6 23 Format NUMERIC NUMERIC NUMERIC NUMERIC REAL ALPHA 0.0-1.0 For future use.

(5 of 5)

Notes

Intermediate ADC 2 Intermediate ADC 3 Intermediate ADC 4 Intermediate ADC 5 Dilution Factor Future Use Space

Note 1: The number of decimal places is adjusted to fit the number into this field. Note 2: The most significant character of the range of the Rack Number field will be located in the most significant character position of the Cup Number field. To use this option, select the 3-Digit Rack Number button on the Host Communication Parameters screen, which is accessed through the Host Communication button on the System Setup screen. Example: Rack 345, Cup 1 would be 45, 31. Note 3: For DxC chemistries, 0 and 1 are used only for drugs of abuse (DAT). On DxC 600i and the DxC + DxI systems, values from the range 0, 1, 3-9, are used by some Access 2/DxI results, depending on the specific chemistry. Refer to the Access Immunoassay System Assay Manual for additional information. All other chemistries use 2. Example:

[-0,702,81,100497,140128,---88,-50331669,---916097,S221-------,22,-1, 385875993,-1,05A-,-E,#,0,0,#####,#####,###,###,0.5623355,0.5538675, #########,-0.127546,#########,#########,-0.003311,0.5732892, 0.0002016,0.0003895,-0.012754,0.5577027,0.0001692,0.0002893,-0.012754, 46.466198,#########,2,-0,---------,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO,NO, NO,NO,NO,NO,#####,#####,#####,#####,#####,1.0000,#######################]AE<CR><LF>

(- Indicates space holder)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-29

Stream 703 - Instrument Status

Stream 703 - Function 1: Power Up

Stream 703 - Instrument Status

Stream 703 - Function 1: Power Up Sent by: UniCel DxC Purpose: Sent upon DxC power up or reset. This message can be turned off in the host setup option. Table 3.15 Device ID Stream Function Date Time Software Set CV ICC BOOT CV ICC APP CV MSMC1 BOOT 1 CV MSMC1 BOOT 2 CV MSMC1 APP CV MSMC2 BOOT 1 CV MSMC2 BOOT 2 CV MSMC2 APP CV SM BOOT CV SM APP 21 CV SM APP 11 CV SM APP 12 CV SM APP 13 CV SM APP 14 CV SM APP 31 CV SM APP 41 CV SM APP 42 CV SM APP 43 Power Up Length 2 3 2 6 6 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 Format 0-99 703 01 DATE TIME ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA

(1 of 2)

Field

Notes Operator assigned

Console Master Program Version Number

CX7 Compatible Interface Page 3-30

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 703 - Function 1: Power Up

Stream 703 - Instrument Status

3

Table 3.15

Power Up, continued Length 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 Format ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA ALPHA All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s All "#"s

(2 of 2)

Field CV SM APP 51 CV SM APP 52 CV SM APP 61 CV SM APP 62 CV SM APP 63 CV SM APP 71 CV SM APP 81 CV SM APP 82 CV SM APP 91 CV SM APP A1 CV SM APP A2 CV SM APP B1 CV SM APP B2 CV SM APP B3 CV SM APP C1 CV SM APP C2 CV SM APP C3 SPARE SPARE SPARE SPARE SPARE SPARE SPARE SPARE SPARE SPARE SPARE SPARE

Notes

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-31

Stream 703 - Instrument Status

Stream 703 - Function 2: Bidirectional On

Example:

[-0,703,01,100497,164320, v01.00----,v00.00----,v00.00----,v00.00----, v00.00----,v00.00----,v00.00----,v00.00----,v00.00----,v01.06----, v00.13----,v04.54----,v04.54----,v04.54----,v04.54----,v01.30----, v00.89----,v00.89----,v00.89----,v00.89----,v00.89----,v04.54----, v04.54----,v04.54----,v00.89----,v00.1B----,##########,v00.30----, v00.89----,v00.89----,v00.89----,v00.89----,v00.89----,v00.89----, v00.89----,v00.89----,##########,##########,##########,##########, ##########,##########,##########,##########,##########,##########, ##########,##########]5E<CR><LF>

(- Indicates space holder) Stream 703 - Function 2: Bidirectional On Sent by: UniCel DxC Purpose: This message is sent to the host when bidirectional communication is enabled. This message can be disabled in the host setup option. Table 3.16 Device ID Stream Function Date Time Software Set Example:

[-0,703,02,100497,203332,A4.4.54---]F0<CR><LF>

Bidirectional On Length 2 3 2 6 6 10 Format 0-99 703 02 DATE TIME ALPHA DxC Software Version Notes Operator assigned

Field

(- Indicates space holder) Stream 703 - Function 3: Request Instrument State Sent by: Host Purpose: Sent to obtain the state of the UniCel DxC. Table 3.17 Device ID Stream Function Example:

[-0,703,03]93<CR><LF>

Request Instrument State Length 2 3 2 Format 00-99 703 03 Notes Operator assigned

Field

(- Indicates space holder)

CX7 Compatible Interface Page 3-32 UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 703 - Function 4: Instrument State

Stream 703 - Instrument Status

3

Stream 703 - Function 4: Instrument State Sent by: UniCel DxC Purpose: Sent in response to a Request Instrument State, 703-03 message from the host. Table 3.18 Device ID Stream Function Date Time Configuration MC State CC State Future Use Space Instrument Mode Instrument State Length 2 3 2 6 6 5 2 2 2 2 Format 00-99 703 04 DATE TIME ALPHA CODE CODE ALPHA CODE DxC Refer to Table 4.13 Instrument Status Codes. Refer to Table 4.13 Instrument Status Codes. For future use. 0 = Rack/cup priority 1 = Bar code priority. Notes Operator assigned

Field

Example:

[-0,703,04,110497,105150,DxC-,02,15,##,-1]87<CR><LF>

(- Indicates space holder)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-33

Stream 703 - Instrument Status

Stream 703 - Function 17: End of Run

Stream 703 - Function 17: End of Run Sent by: UniCel DxC Purpose: Sent when the DxC completes all programmed tests. This message can be turned off in the host setup option. Table 3.19 Device ID Stream Function Date Queued Time Queued Example:

[-0,703,17,100497,140245]1F<CR><LF>

End of Run Length 2 3 2 6 6 Format 00-99 703 17 DATE TIME Notes Operator assigned

Field

(- Indicates space holder)

CX7 Compatible Interface Page 3-34

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Stream 704 - Function 7: Request Installed Chemistries

Stream 704 - Setup Status

3

Stream 704 - Setup Status

Stream 704 - Function 7: Request Installed Chemistries Sent by: Host Purpose: Sent to obtain the list of installed chemistries from the DxC database. Table 3.20 Device ID Stream Function Example:

[00,704,07]8E<CR><LF>

Request Installed Chemistries Length 2 3 2 Format 00-99 704 07 Notes Operator assigned

Field

Stream 704 - Function 8: Installed Chemistries Sent by: UniCel DxC Purpose: This message is sent in response to a Request Installed Chemistries, 704-07 message from the host. Table 3.21 Device ID Stream Function Date Time Com Chem ID 1 Installed Chemistries Length 2 3 2 6 6 4 Format 00-99 704 08 DATE TIME CHEM CODE CHEM CODE Refer to Table 4.6 and Table 4.7 for Chemistry (Chem) Codes. Refer to Table 4.6 and Table 4.7 for Chemistry (Chem) Codes. Notes Operator assigned

Field

Com Chem ID N

4

Note: Only chemistry codes of chemistries that are configured on the DxC will be included in the message. The last chemistry code transmitted will be "0000" to indicate that no more chemistry codes follow. If no chemistries are configured on the instrument, only "0000" chemistry code will be listed.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

CX7 Compatible Interface Page 3-35

Stream 704 - Setup Status

Stream 704 - Function 8: Installed Chemistries

Example:

[-0,704,08,110497,105518,01A-,01B-,04A-,02A-,09D-,08D-,05D-,03E-,06D-, 43D-,07D-,14B-,56B-,35A-,31A-,31B-,54A-,84A-,10A-,24C-,24B-,93B-,30A-, 30B-,85A-,86A-,05A-,98A-,59A-,44A-,32A-,32B-,40A-,87A-,89A-,12A-,62A-, 46B-,72C-,36A-,06A-,14A-,83A-,79B-,52B-,51B-,53B-,55A-,33A-,50A-,50B-, 07B-,64A-,63A-,48A-,92A-,66A-,67C-,68C-,65A-,93C-,94A-,91A-,11A-,42B-, 42C-,88A-,88B-,41A-,69C-,70C-,71B-,0000]BE<CR><LF>

(- Indicates space holder)

CX7 Compatible Interface Page 3-36

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

4

CHAPTER 4 Tables/Codes

Table of Contents

Tables/Codes 4-2 Introduction ............................................................................................................ 4-2 Test Type Codes .................................................................................................... 4-2 Sample Type Codes ............................................................................................... 4-3 Sample Type Codes ............................................................................................ 4-3 Age Unit Codes ................................................................................................... 4-4 Chemistry Codes .................................................................................................... 4-5 Chemistry Codes ................................................................................................. 4-5 Access Chemistry Codes .................................................................................... 4-9 Unit Codes ........................................................................................................... 4-12 Unit Codes ........................................................................................................ 4-12 Instrument Codes ................................................................................................. 4-14 Instrument Codes .............................................................................................. 4-14 Result Error Codes ............................................................................................... 4-20 Result Error Codes ............................................................................................ 4-20 Result Error Code Descriptions ........................................................................ 4-22 Special Calculation Status Codes ........................................................................ 4-26 Special Calculation Status Codes ..................................................................... 4-26 Instrument Status Codes ...................................................................................... 4-27 Instrument Status Codes ................................................................................... 4-27 Access Codes Converted to DxC Codes for DxC 600i Reporting ...................... 4-28 Access Codes Converted to DxC Codes (DxC 600i only) ............................... 4-28 Key Code Conversion for Local Languages ........................................................ 4-29 Key Code Conversion ....................................................................................... 4-29

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-1

Introduction

Tables/Codes

Introduction

This caution applies to all tables and codes in this chapter.

CAUTION Proper performance of the system requires that the Host system capture all pertinent flags and error messages.

Test Type Codes

Table 4.1 Code CAa CO EXa RO SC ST

a

Test Type Codes (CX and LX20) Description Calibrator Control Extinction Routine STAT control STAT

Not programmable by the Host.

Tables/Codes Page 4-2

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Sample Type Codes

Sample Type Codes

4

Sample Type Codes

Sample Type Codes Table 4.2 Code SE SF UR TU PL OT AM BL CE SA SY UT

a

Sample Type Codes (CX and LX20) Description Serum Spinal fluid Urine (Random) Timed urine (Cannot be used with control or STAT Control) Plasma Other Amniotic (DxC 600i and DxC + DxI systemsa only) Blood Cervical (DxC 600i and DxC + DxI systems only) Saliva (DxC 600i and DxC + DxI systems only) Synovial (DxC 600i and DxC + DxI systems only) Urethral (DxC 600i and DxC + DxI systems only)

In this manual, systems such as the DxC 880i, where a DxC 800 is integrated with a DxI, are described by the abbreviated term 'DxC + DxI systems'.

Table 4.3 Code Serum CSF Urine Timed Plasma Other

Sample Type Codes (ASTM) Description Serum Cerebrospinal fluid Urine (Random) Timed urine (Cannot be used with control or STAT Control) Plasma Other Amniotic (DxC 600i and DxC + DxI systems only) Blood Cervical (DxC 600i and DxC + DxI systems only) Saliva (DxC 600i and DxC + DxI systems only) Synovial (DxC 600i and DxC + DxI systems only) Urethral (DxC 600i and DxC + DxI systems only)

Amniotic Blood Cervical Saliva Synovial Urethral

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-3

Sample Type Codes

Age Unit Codes

Age Unit Codes Table 4.4 Code 1 2 3 4 5 Table 4.5 Code H D W M Y Hours Days Weeks Months Year (if empty = Year) Hours Days Weeks Months Years Age Unit Codes (ASTM) Description Age Unit Codes (CX and LX20) Description

Tables/Codes Page 4-4

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Chemistry Codes

Chemistry Codes

4

Chemistry Codes

Chemistry Codes Table 4.6 Code 01A 01B 02A 03A 03E 03F 04A 05A 05D 06A 06D 07A 07B 07D 08A 08D 08E 08M 09D 10A 10C 11A 12A 13B 14A 14B 14I Sodium (NA) Potassium (K) Carbon Dioxide (CO2) Creatinine (CREA) Creatinine (CREm) Creatinine (CR-S) Chloride (CL) Urea Nitrogen (BUN) Urea Nitrogen (BUNm) Glucose (GLU) Glucose (GLUCm) Total Protein (TP) Micro Protein (M-TP) Total Protein (TPm) Albumin (ALB) Albumin (ALBm) Prealbumin (PAB) Microalbumin (MA) ISE Calcium (CALC) Amylase (AMY) P-Amylase (PAM) Total Bilirubin (TBIL) Direct Bilirubin (DBIL) Infinity Lithium (LI) Hemoglobin, Total (Hb) Hemoglobin, A1c (A1c) Hemoglobin Total (Hb2)

(1 of 4)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008 Tables/Codes Page 4-5

Chemistry (Chem) Codes Chemistry

Chemistry Codes

Chemistry Codes

Table 4.6 Code 14J 15A 24B 24C 30A 30B 31A 31B 32A 32B 33A 34A 34B 35A 36A 40A 41A 42B 42C 43D 43E 44A 46B 48A 50Ba 50M 51B 52B 53B 54A

Chemistry (Chem) Codes, continued Chemistry Hemoglobin, A1c (A1c2) Homocysteine (HCY) Apolipoprotein B (ApoB) Apolipoprotein A (ApoA) Aspartate Aminotransferase (AST) Aspartate Aminotransferase (Pyridoxal-5-phosphate) (AST-) Alanine Aminotransferase (ALT) Alanine Aminotransferase (Pyridoxal-5-phosphate) (ALT-) Creatine Kinase (CK) Creatine Kinase (N-Acetyl-L-cysteine) (CK-) Lactate Dehydrogenase (LD) Lactate Dehydrogenase (LD-P) LDL Cholesterol (LDLD) Alkaline Phosphatase (ALP) Gamma Glutamyl Transferase (GGT) Creatine Kinase MB (CKMB) Uric Acid (URIC) Triglycerides GPO (TG) Triglycerides GPO Blanked (TG-B) Phosphorus (PHOSm) Phosphorus (PHS) Cholesterol (CHOL) Iron (FE) Magnesium (MG) Lipase Wash (LIWA) Haptoglobin (HPT) Immunoglobulin G (Ig-G) Immunoglobulin A (Ig-A) Immunoglobulin M (Ig-M) Ammonia (AMM)

(2 of 4)

Tables/Codes Page 4-6

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Chemistry Codes

Chemistry Codes

4

Table 4.6 Code 55A 56A 59A 60A 61M 61R 62B 63A 64A 65A 66A 67C 68C 69C 70C 71B 72C 72M 73A 73D 79B 83D 84A 85A 86A 86B 87A 88A 88B 88C

Chemistry (Chem) Codes, continued Chemistry Lactate (LAC) Ethanol Alcohol (ETOH) Cholinesterase (CHE) Lipase (LIP) Complement (C3) Complement (C4) Digoxin (DIGN) Methaqualone (METQ) Methadone (METD) Propoxyphene (PROX) Phencyclidine (PCP) Phenobarbital (PHE) Phenytoin (PHY) Theophylline (THE) Tobramycin (TOB) Transferrin (TRFN) Gentamicin (GEN) Vancomycin (VANC) Urea Nitrogen (UREA) Urea Nitrogen (UREAm) Iron Binding Capacity, Total (IBCT) HDL Cholesterol (HDLD) Amphetamines (AMPH) Barbiturates (BARB) Benzodiazepine (BENZ) Benzodiazepine (BNZG) Cocaine Metabolite (COCM) Cannabinoid 100 ng (THC) Cannabinoid 20 ng (THC2) Cannabinoid 50 ng (THC5)

(3 of 4)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-7

Chemistry Codes

Chemistry Codes

Table 4.6 Code 89A 89E 89G 90A 91A 92A 92B 93B 93C 94B 94M 95A 98A 99B 99C 99D 99Ea

a

Chemistry (Chem) Codes, continued Chemistry C-Reactive Protein (CRP) High Sensitivity C-Reactive Protein (CRPH) C-Reactive Protein (C-RP) T-Uptake (TU) Thyroxine (T4) Opiate 300 ng (OP) Opiate 2000 ng (OP2) Antistreptolysin-O (ASO-) Rheumatoid Factor (RF) Salicylate (SALY) Acetaminophen (ACTM) Valproic Acid (VPA) Carbamazepine (CAR) Icterus (ICTER) Lipemia (LIPEM) Hemolysis (HEMOL) Cartridge Chemistry Wash Solution (CCWA)

(4 of 4)

Do not use as a result.

Tables/Codes Page 4-8

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Chemistry Codes

Assay Codes

4

Assay Codes The following assay codes pertain to tests run on the Access Family of Immunoassay Systems, which includes the Access 2 and the DxI analyzer. In this manual, these instruments are referenced by the abbreviated term 'Access 2/DxI'. Systems such as the DxC 880i, where a DxC 800 is integrated with a DxI, are referenced by the abbreviated term 'DxC + DxI systems'. Table 4.7 Code A02 A03 A04 A05 A06 A07 A08 A10 A11 A12 A13 A14 A15 A16 A17 A18 A19 A22 A23 A25a A26a A27a A28a A30 A34a Alpha-fetoprotein (AFP) OV Monitor (OV125) BR Monitor (BR153) GI Monitor (GI199) Carcinoembryonic Antigen (CEA) Chlamydia (ChlAg) Chlamydia Block (ChlBk) Cortisol (Cort) Digoxin (Dig-) OSTASE (Ostas) Toxo IgM II (Tox-M) Estradiol (ESTRD) Unconjugated Estriol (uE3) Testosterone (Testo) Total BhCG (TBhCG) Diluted Total BhCG (DlhCG) Ferritin (Ferr) Ultrasensitive hGH (hGH) Thyroglobulin (TgAg) Hepatitis A IgM Antibody (HAV-M) Total Hepatitis A Antibody (HAVAb) Hepatitis B Core Antibody (HBcAb) Hepatitis B Core IgM Antibody (HBc-M) Myoglobin (MYO) Hepatitis C Antibody (HCVAb)

(1 of 3)

Assay Codes Chemistry

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-9

Chemistry Codes

Assay Codes

Table 4.7 Code A37a A36 A39 A40 A42 A43 A46 A49 A50 A51 A52 A53 A57 A59 A60 A61 A62 A63 A68 A72 A74 A75 A76 A77 A78 A79 A80 A81 A83 A84

Assay Codes, continued Chemistry HIV Antibody 1 & 2 "Version 2" (HIVAb) Human Follicle Stimulating Hormone (hFSH) Human Luteinizing Hormone (hLH) Insulin (Insul) Prolactin (PRL) Progesterone (Prog) Rubella IgG (Rub-G) Creatine Kinase-MB (CK-MB) Total T3 (TotT3) Total IgE (IgE) Total T4 (TotT4) Toxo IgG (Tox-G) HYPERsensitive hTSH (TSH) Uptake (TU-) Vitamin B12 (B12) Free T4 (FT4) Hybritech PSA (PSA) Hybritech free PSA (fPSA) Thyroglobulin Antibody (TgAb) Intrinsic Factor Antibody (IFAb) Triage BNP (BNP) Folate (FOL2) RBC Folate (RBC2) Diluted Alpha-fetoprotein (dAFP) Fast hTSH (FTSH) Thyroperoxidase Antibody (TPOAb) Free T3 (FT3) Erythropoietin (EPO) Diluted Ferritin (dFer) AccuTnI (aTnI)

(2 of 3)

Tables/Codes Page 4-10

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Chemistry Codes

Assay Codes

4

Table 4.7 Code A85 A86 A87 A88 A89 A90 A91 A92 A93 A94 A97a A98a A99a A100a A102a

a

Assay Codes, continued Chemistry Parathyroid Hormone Routine Mode (PTH) PTH Intra-Operative Mode (PTHIO) Interleukin 6 IVD (IL-6) Interleukin 6 RUO (IL6RU) Free PSA WHO Standardized (fPSAW) PSA WHO Standardized (PSA-W) Free T4 (FRT4) Ultrasensitive hGH WHO Standardized (hGH2) Thyroglobulin Antibody (ThgAb) Dehydroepiandrosterone Sulfate (DHE-S) Hepatitis B Surface Antibody (HBsAb) Hepatitis B Surface Antigen (HBsAg) Hepatitis B Surface Antigen Confirmatory - Block (HBsBk) Hepatitis B Surface Antigen Confirmatory - Control (HBsCt) Rubella IgM "Version 2" (MRub)

(3 of 3)

DxI analyzer only

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-11

Unit Codes

Unit Codes

Unit Codes

Unit Codes The CX and LX20 interfaces use the codes in the Codes column to represent the units. ASTM uses the units in the Units column directly, without using the codes. Table 4.8 Code 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 mg/dL mg/L g/dL g/L mmol/L µmol/L mEq/L nKat/L µKat/L IU/L µg/mL ng/mL µg/dL µg/L nmol/L Ku.u U/L Other % mA mA/min IU/mL U/mL Rate ng/dL µIU/mL

(1 of 2)

Tables/Codes Page 4-12 UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Unit Codes Unit

Unit Codes

Unit Codes

4

Table 4.8 Code 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53

Unit Codes, continued Unit mIU/mL KU/L nIU/dL mIU/L Positive Negative pg/mL pg/dL mg/mL ng/L pmol/L %Uptake %GHb %A1c GPL MPL APL RLU S/CO (sample to cutoff ratio) AU/mL (allergy units or arbitrary units) AU/L (arbitrary units) mAU/L (arbitrary units) mAU/mL (arbitrary units) (1) SI (T-uptake SI units) %Supp SGU SMU SAU

(2 of 2)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-13

Instrument Codes

Instrument Codes

Instrument Codes

Instrument Codes Table 4.9 Instrument Codes with Remarks Printed in Remark Area of Instrument Report CHECK RESULT Inst. Code Description

Instrument Report Printout

"a printed result" "a printed result"

Result was calculated DxC has processed the sample prior to Access 2/DxI. Results for specific Access 2/DxI tests should be checked for potential sample-to-sample carryover. This error code applies to Access 2/DxI assays where a small quantity of carryover could significantly increase the results. (DxC 600i and DxC + DxI systems only) Exceeds Critical range high Exceeds Critical range low Exceeds reference range high Exceeds reference range low Result is outside of reportable range ­ low (DxC 600i and DxC + DxI systems only) Access/DxI reagent storage temperature error (DxC 600i and DxC + DxI systems only) T T T T C D CC temperature Reagent temperature (DxC + DxI systems only) MC temperature ISE temperature Calibration overridden Reagent Days exceeded

(1 of 6)

"a printed result" "a printed result" "a printed result" "a printed result" "a printed result"

CRITICAL HIGH CRITICAL LOW HIGH LOW OIR LO

"a printed result"

TEMP ERR

"a printed result" "a printed result" "a printed result" "a printed result" "a printed result" "a printed result"

REAGENT ERR REAGENT TEMP TEMP ERR TEMP ERR

Tables/Codes Page 4-14

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Instrument Codes

Instrument Codes

4

Table 4.9

Instrument Codes with Remarks, continued Printed in Remark Area of Instrument Report Inst. Code Description

Instrument Report Printout

"a printed result"

E

Calibration time extended (DxC) Curve expired (Access 2/DxI results) Slope offset adjustment Set point modification ORDAC sample Default panel Reagent expired Rerun result Substrate expired (Access 2/DxI results) Less than X - OIR LO response from CAU but result is not suppressed Less than X - ORR LO response from console but result is not suppressed Greater than Y - ORR HI response from console but result is not suppressed Greater than Y - OIR HI response from CAU but result is not suppressed

"a printed result" "a printed result" "a printed result" "a printed result" "a printed result" "a printed result" "a printed result" < X (X = lower inst range) < X (X = lower reportable range) > Y (Y = upper reportable range) >Y (Y = upper inst range) BACK TO BACK CAL FAILED CAL TIMED OUT CHEM ABORTED CHEM BYPASSED CHEM DB ERROR CHEM NEEDS CAL Calibration failed Calibration failed

J M O P R V S

Back to back Calibration failed Calibration timed out Too many retries Channel bypassed Chemistry DB Error No curve ­ chemistry needs calibration

(2 of 6)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-15

Instrument Codes

Instrument Codes

Table 4.9

Instrument Codes with Remarks, continued Printed in Remark Area of Instrument Report Inst. Code Description

Instrument Report Printout

CHEM NOT RUN

Chemistry could not be run due to a system error condition at Access 2/DxI, CTA/UCTA or DxC. ISE DAC failure Mechanical device error detected Level sense error in diluent reagent Module Disabled 0 denominator High reagent level Insufficient diluent reagent Insufficient reagent Invalid chemistry Low reagent fluid Low reagent level Calibration required Math error Motion error No diluent reagent on the reagent carousel Reagent not on board Insufficient sample quantity at Access 2/DxI, or no sample detected - CTA/UCTA level sense (DxC 600i and DxI only) Sample not on board Cannot run Access 2/DxI test because sample ID is not programmed (DxC 600i and DxI only)

(3 of 6)

DAC ERROR DEVICE ERROR DIL1 LEV SENSE DISABLED DIVISION ERROR HI REAGENT INSUFF DIL1 INSUFF REAG INVALID CHEM LEV SENSE ERR LO REAGENT MATH ERR MOTION ERR NO DIL1 ON SYS NO REAG ON SYS NO SAMP DETECT

NO SAMP ON SYS NO SAMPLE ID

Tables/Codes Page 4-16

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Instrument Codes

Instrument Codes

4

Table 4.9

Instrument Codes with Remarks, continued Printed in Remark Area of Instrument Report Inst. Code Description

Instrument Report Printout

NOT ACCEPTED PENDING TEST PROBE OBSTRUCT RACK CONFLICT

Wrong state for sample program message Not ready Probe obstruction detected Test cancelled because sample is in a rack reserved for other tests (IBCT, HbA1c chemistries). A container type was assigned to a rack that was loaded at a location where the container type is not supported (DxC + DxI systems only) Calibration failed Calibration failed AG EXCESS BL ABS HI BL ABS LO BL MAX DEV BL MEAN DEV BL RATE HI BL RATE LO CAL REF DRIFT INDETERMINATE Range error Recovery error Result error Antigen Excess Blank absorbance high Blank absorbance low Blank outlier (maximum deviation) Blank noise (mean deviation) Blank rate high Blank rate low Excessive reference drift sample to calibration Unable to determine results near cutoff value (DxC 600i and DxI only) Initial Absorbance high Initial Absorbance too low Initial ADC error high

(4 of 6)

RANGE RECOVERY RESULT ERR Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed

Results Suppressed Results Suppressed Results Suppressed

INIT ABS HI INIT ABS LO INIT ADC HI

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-17

Instrument Codes

Instrument Codes

Table 4.9

Instrument Codes with Remarks, continued Printed in Remark Area of Instrument Report INIT ADC LO INIT COND HI INIT COND LO INIT RATE HI INIT RATE LO K REQ NA/K REQ OIR HI OIR LO ORDAC HI ORDAC LO URDAC HI URDAC LO ORR HI ORR LO ORR O HI OVERFLOW REF NOISE RLU RANGE Inst. Code Description

Instrument Report Printout

Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed

Initial ADC error low Initial conductance high Initial conductance low Initial rate high Initial rate low Bad K value Bad Na value Out of Instrument Range high Out of Instrument Range low Out of Instrument range ORDAC high Out of Instrument range ORDAC low URDAC high URDAC low Out of reportable range high Out of reportable range low Out of ORDAC reportable range high Number overflow error Reference signal noise Relative light units (RLUs) exceeds measuring range of Access/DxI luminometer (DxC 600i and DxC + DxI systems only) Reaction absorbance high Reaction absorbance low Reaction error Reaction outlier (maximum deviation)

(5 of 6)

Results Suppressed Results Suppressed Results Suppressed Results Suppressed

RX ABS HI RX ABS LO RX ERR RX MAX DEV

Tables/Codes Page 4-18

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Instrument Codes

Instrument Codes

4

Table 4.9

Instrument Codes with Remarks, continued Printed in Remark Area of Instrument Report RX MEAN DEV RX NOISE RX RATE HI RX RATE LO SAMP REF DRIFT SAMPLE NOISE SUB DEPL INCUBATOR TEMP A Inst. Code Description

Instrument Report Printout

Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed Results Suppressed

Reaction noise (mean deviation) Erratic ADC (cup) Reaction rate high Reaction rate low Excessive reference drift sample to sample Sample signal noise Substrate depleted Access/DxI incubator temperature error (DxC 600i and DxC + DxI systems only) Access/DxI substrate temperature error (DxC 600i and DxC + DxI systems only) Access carousel temperature error (DxC 600i only) Sensitivity error Severe recovery error Severe sensitivity error Span error Test was aborted by console recovery, cleanup, etc. Too many tests on CC

(6 of 6)

Results Suppressed

SUBSTRATE TEMP

Results Suppressed SENSITIVITY SEV RECOVERY SEV SENSITVITY SPAN TEST STOPPED TOO MANY TESTS

CAROUSEL TEMP Calibration failed Calibration required Calibration required Calibration failed

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-19

Result Error Codes

Result Error Codes

Result Error Codes

Result Error Codes Table 4.10 Host Code AB AH AL AX BH BL BN BO CH CL CR Initial absorbance high Initial absorbance low Antigen excess Blank absorbance high Blank absorbance low Blank noise (mean deviation) Blank outlier (maximum deviation) Initial conductance high Initial conductance low Check result Access result may have been contaminated by DxC processing of sample Out of instrument range high Out of instrument range low Reference signal noise Sample signal noise Erratic ADC Excessive reference drift - sample to calibration Excessive reference drift - sample to sample URDAC high URDAC low Greater than upper instrument or reportable range Initial ADC error high Reaction absorbance high Bad K value Initial rate too low Bad NA value

(1 of 2)

Tables/Codes Page 4-20 UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Result Error Codes Description Not all programmed tests have a valid result

DH DL DR DS EA EC ES GH GL GT HI HR IK IL IN

Result Error Codes

Result Error Codes

4

Table 4.10 IR LI LO LR LT OF OH OK OL OR RE RH RL RN RO SD SH SL TM UH UL UO ZD

Result Error Codes, continued Initial rate too high Initial ADC error low Result is lower than minimum reportable result value defined in APF (Access/DxI LOW flag) Reaction absorbance low Less than lower instrument or reportable range Number overflow error Out of instrument range ORDAC high Result was calculated Out of instrument range ORDAC low Relative light units (RLUs) are outside acceptable luminometer measuring range Reaction error Reaction rate high Reaction rate low Reaction noise (mean deviation) Reaction outlier (maximum deviation) Substrate depleted Blank rate high Blank rate low Temperature error Out of reportable range high Out of reportable range low Out of ORDAC reportable range high Zero denominator

(2 of 2)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-21

Result Error Codes

Result Error Code Descriptions

Result Error Code Descriptions The following table provides the DxC result error code descriptions. Table 4.11 Error Code Descriptions Description Failed antigen excess test for immunoglobulin reagents. The mean absorbance measured during the blank spin cycle (read window). The units are in absorbance and will characterize reagent quality. A single blank absorbance data point obtained during the blank read window deviates more than allowed from the line of regression. The Blank Deviation units are measured in delta absorbance. Blank Max Deviation will check for a constant rate during the blank spin cycles. The average difference between the absorbance readings and the line of regression is greater than allowed. This will check for a constant rate during the blank spin cycles. Occurs in rack mode when not all calibrator levels are in ascending order (low to high) and/or not all levels reside in the same rack. The difference between the high and low value of the four reference electrode readings (taken in milliseconds apart) has exceeded the limits allowed. Units are in ADCs and are a measurement of noise in the ISE system. An ISE reference electrode measurement for a sample drifted above the reference electrode measurement from the calibration and exceeded the limit. The units are in ADCs and are a measurement of ISE reference electrode drift. The reaction absorbance data taken from the first spin cycle after sample inject has exceeded specifications. This is a measure of sample integrity. The reaction absorbance data obtained between 2 and 17 seconds after sample inject exceeds specifications. GLUCm and BUNm reagent conductivity is below specifications. Too many iterations to fit nonlinear serum to multilevel calibration. During a particular spin cycle, the average difference between an absorbance reading and the line of regression exceeded specifications.

(1 of 4)

Error Antigen Excess Blank Absorbance (Hi/Lo) Blank Outlier Maximum Deviation

Blank Mean Deviation Calibrator Order Error Erratic ADCs

Excessive Reference Drift

Initial Absorbance (Hi/Lo) Initial Rate (Hi/Lo) Insufficient Reagent Strength Iteration Error Noise

Tables/Codes Page 4-22

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Result Error Code Descriptions

Result Error Codes

4

Table 4.11 Outlier

Error Code Descriptions, continued Description During a particular spin cycle, the deviation of a single absorbance reading with respect to the line of regression exceeded specifications. The recovered value exceeds the value that the instrument reports. Reaction exceeded the range of ORDAC value that the instrument reports.

Error

Out of Instrument Range (Hi/Lo) Out of ORDAC Range (Hi/Lo)

Reaction Absorbance The mean absorbance measured during the reaction spin (Hi/Lo) cycles. Reaction Maximum Deviation A single reaction absorbance data point obtained during the reaction read window deviates more than allowed from the line of regression. The units are in delta absorbance and will check for a constant rate during the reaction read window. The average difference between the reaction absorbance readings and the line of regression is greater than allowed. This will check for a constant rate during the reaction spin cycle. The rate calculated during the reaction read window. Units are in delta absorbance. The difference (delta) between the initial absorbance taken after sample inject and the final absorbance data point within the reaction read window exceeds specifications. Rate during blank timing period is not within specifications. The operating temperature of the system is beyond 0.1ºC from the set point value. All chemistries will be reported with a flag.

Reaction Mean Deviation

Reaction Rate (Hi/Lo) Substrate Depletion

Blank Rate (Hi/Lo) Temperature

Ig-A ORDAC (Hi/Lo) Result is outside the specifications for the special below normal range Ig-A ORDAC range. Back to Back (Linear cal) Difference between usable calibrator replicates. Units are dependent on the reagent. Measure of system precision during calibration.

(2 of 4)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-23

Result Error Codes

Result Error Code Descriptions

Table 4.11 Back to Back (ISE Cal)

Error Code Descriptions, continued Description Measure of system precision during calibration. The difference between the two middle Sample-Reference replicate values within a calibration level. If the back-toback limit is exceeded, the calibration fails. Only the two consecutive replicates that meet back-to-back are used; all other replicates are discarded. Select Calibrator Acceptance Limits under options in the Rgts/Cal screen to view current calibration limits. Verifies proper operation of electrodes. The Digital-toAnalog Conversion (DAC) check mimics expected ranges of electrode output. Failure to detect an output within a predetermined range for each channel will trigger a DAC INITIALIZATION ERROR HAS OCCURRED flag. The difference between the high and low value of the four electrode readings (taken milliseconds apart) must be within the delta limit. Measure of noise for modular chemistries. Multi-point calibration error. Algorithm produces curve parameters that are very large or small and/or rounding errors will give an invalid standard curve. Curve parameters are not reported and calibration may not be overridden. Computer is not able to calculate the parameters needed to determine the other math errors. Curve parameters are not reported and calibration may not be overridden. The range of data points is on a very small percent of the overall calculated curve. Curve is not sensitive enough to get valid results. Curve parameters are not reported and calibration may not be overridden. (For future use) Calculated curve has multiple inflection points within the dynamic range indicating more than one result is possible for the same data point. Curve parameters are not reportable and calibration may not be overridden. Data does not properly define the curve. Only one point is near the inflection point of the curve. Curve parameters are not reported and calibration may not be overridden. (For future use)

(3 of 4)

Error

DAC

Erratic ADCs

Math Error 1

Math Error 2

Math Error 3

Math Error 4 Math Error 5

Math Error 6

Math Error 7

Tables/Codes Page 4-24

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Result Error Code Descriptions

Result Error Codes

4

Table 4.11

Error Code Descriptions, continued Description Data does not properly define the curve. Only one point is near the inflection point of the curve. Results need to be evaluated by the user. Curve parameters are reported and calibration MAY be overridden. A less severe MATH ERROR 6. (For future use) Occurs when calibrations include division by 0. Measure of reagent and electrode performance. Determines if the calibrator set points fall within the acceptable range of ADC values. Absorbance or rate range that the usable calibrator replicates must fall between for a valid calibration. Determines if recovery errors of each calibration level are too large for a calibration to be useful. The difference between the recovered concentration and the actual concentration exceeds specifications. It is overrideable. Non-overrideable extreme recovery error. Refer to Recovery (Multi-point) above. A check of the calibration slope for each calibrator level and several intermediate levels to check if the response is too high or low. Is overrideable. Non-overrideable extreme sensitivity error. Refer to Sensitivity (Multi-point) above. Difference between the average ADC value of calibrator 1 and the average ADC value of calibrator 2. Measure of sensitivity. Difference between consecutive calibrator rates or absorbances. There can be up to 6 multi-point spans for level 0-1, 1-2, 2-3, 3-4, 4-5, 5-0. This is a measure of sensitivity over the entire standard curve. More than 1 second elapsed between the start and end of the ADC conversion process.

(4 of 4)

Error Math Error 8

Math Error 9-15 Math Error 16 Range (ISE cal)

Range (Linear cal) Recovery (Multi-point)

Recovery Severe (Multi-point) Sensitivity (Multi-point) Sensitivity Severe (Multi-point) Span (ISE cal)

Span (Multi-point)

ADC Electrolyte Error

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-25

Special Calculation Status Codes

Special Calculation Status Codes

Special Calculation Status Codes

Special Calculation Status Codes Table 4.12 Code AB OK UN ZD Valid result Units for the involved chemistries are not compatible (For future use) Denominator of a ratio is zero Special Calculation Status Codes Description One of the involved chemistries was programmed, but not run

Tables/Codes Page 4-26

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Instrument Status Codes

Instrument Status Codes

4

Instrument Status Codes

Instrument Status Codes Table 4.13 Code 01 02 Instrument Status Codes Cartridge Chemistry Instrument Status Stopped Pause initiated Code 01 02 03 04 05 06 07 08 09 10 11 12 Running Idle shutdown in progress (For future use) Idle (For future use) Initializing (For future use) Reagent load Homing Priming PVT 12 13 14 15 18 21 Standby Procedure in progress Waiting 15 Boot (For future use) Pause initiated Waiting System idle (For future use) 07 08 Running Maintenance 05 Modular Chemistry Instrument Status Stopped Standby System home Reagent load Prime

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-27

Access/DxI Codes Converted to DxC Codes for Reporting

Applies to DxC 600i and DxC + DxI systems only

Access/DxI Codes Converted to DxC Codes for Reporting

Applies to DxC 600i and DxC + DxI systems only Table 4.14 Access/DxI Codes Converted to DxC Codes

Access 2/DxI Description Normal result Indeterminate Out of range high Curve expired Substrate expired Lot expired Lower than reportable result No curve ­ cal required Pack expired Control outside QC limits (DxC 600i only) Control lot expired (DxC 600i only) Quantity not sufficient Air bubble detected in substrate (DxI only) Insufficient sample dispensed (DxI only) Insufficient sample aspirated (DxI only) Reflex test RLU is out of measuring range Instrument error Incubator temperature error Reagent temperature error (DxI only) Substrate temperature error Carousel temperature error (DxC 600i only)

Tables/Codes Page 4-28

DxC Flags none IND OVR CEX EXS LEX LOW none NCR PEX QCF QEX QNS QSB QSD QSS RFX RLU SYS TRI TRR TRS TRW Remarks none INDETERMINATE none none none none OIR LO none CHEM NEEDS CAL none NA NA NO SAMP DETECT SUBSTRATE BUBBLE INSUFF SAMP DISP INSUFF SAMP ASP NA RLU RANGE DEVICE ERROR INCUBATOR TEMP REAGENT TEMP SUBSTRATE TEMP CAROUSEL TEMP Inst Code none none none E S R none none NA D NA NA NA NA NA NA NA none NA none none none none

a

Value result "No value" >highest result result result result < lowest Raw RLUs result NA NA "No value" "No value" "No value" "No value" NA "No value" NA "No value" result "No value" "No value"

Result print result Suppressed print: >X print result print result print result print result print: < X incomplete print result NA NA incomplete incomplete incomplete incomplete NA Suppressed incomplete Suppressed print result Suppressed Suppressed

Host Code none RE GT none none none LO LT NA none NA NA NA NA NA NA NA OR NA TM TM TM TM

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Access/DxI Codes Converted to DxC Codes for Reporting

Applies to DxC 600i and DxC + DxI systems only

4

Table 4.14

Access/DxI Codes Converted to DxC Codes, continued

Access 2/DxI DxC Flags AVX Remarks AV EXPIRED Inst Code NA Result incomplete Host Code NA Value NA

Description More than 3 hours have elapsed since the sample was created at the CTA (DxC 600i only) More than 3 hours have elapsed since the sample was created at the UCTA (DxC + DxI systems only) Sample carousel cover open (DxC 600i only) User unloaded Access 2 sample (DxC 600i only) Cannot calculate result Cannot run test on Access 2 or DxI

a

NA

AEX

SV EXPIRED

NA

incomplete

NA

"No value" "No value"

AVC AVU

A2 DOOR OPEN SAMPLE REMOVED DEVICE ERROR CHEM NOT RUN

NA NA

incomplete incomplete

NA NA

"No value" NA

CCR other

NA NA

incomplete incomplete

NA NA

NA = Not applicable.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Tables/Codes Page 4-29

Key Code Conversion for Local Languages

Key Code Conversion

Key Code Conversion for Local Languages

Key Code Conversion For communications between the host computer and the UniCel DxC, local language character handling is accomplished using the extended ASCII character set as defined by IBM for the IBM PC and IBM compatible units. The correct interpretation of foreign language characters on the UniCel DxC will require the use of 8-bit communication between the system and the host computer. The defined foreign language characters and their extended ASCII character codes are shown below. No other extended ASCII characters are supported by the UniCel DxC system for display, printing and host communication.

Figure 4.1

Key Code Conversion Chart

Tables/Codes Page 4-30

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

5

CHAPTER 5 ASTM Interface Specifications

Table of Contents

ASTM Interface ..................................................................................................... 5-2 Bidirectional Protocol Control Characters - ASTM Interface ............................ 5-2 Line Bidding (ASTM) ........................................................................................ 5-3 ASTM Data Record Format ................................................................................ 5-4 ASTM Messages ................................................................................................. 5-5 Long Header Message ........................................................................................ 5-6 Short Header Message to LIS ............................................................................. 5-7 Patient Information Record ................................................................................. 5-8 Test Order Record ............................................................................................. 5-11 Sample Result Record ....................................................................................... 5-17 Host Query (Request Information Record) ....................................................... 5-22 Message Terminator Record ............................................................................. 5-24 Comment Record (Patient Comment) ............................................................... 5-25 Comment Record (Sample Comment) .............................................................. 5-26 Comment Record (Result Comment) ............................................................... 5-27 Manufacturer Record ........................................................................................ 5-28 Manufacturer Record - Special Calculations Message - M110 ........................ 5-29 Manufacturer Record - Timed Urine Calculations Message - M111 ............... 5-30 Manufacturer Record - Request Instrument State - M112 ................................ 5-31 Manufacturer Record - Instrument State Reply - M113 ................................... 5-32 Manufacturer Record - Test Availability Request - M114 ............................... 5-33 Manufacturer Record - Test Availability Reply- M115 ................................... 5-34 Scientific Record ............................................................................................... 5-34 ASTM Sample Order Reject Conditions .......................................................... 5-35 ASTM - LIS Message Flow Examples ............................................................. 5-36

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-1

ASTM Interface

Bidirectional Protocol Control Characters - ASTM Interface

ASTM Interface

The Low-level protocol transfers messages as specified by the Clinical and Laboratory Standards Institute (CLSI) LIS1-A Vol. 23 No.7 (formerly ASTM E1381-02) standard. The Message-level protocol transfers messages as specified by the Clinical and Laboratory Standards Institute (CLSI) LIS2-A Vol. 23 No. 8 (formerly ASTM E1394-97) standard.

Bidirectional Protocol Control Characters - ASTM Interface Bidirectional protocol control characters are listed below. Table 5.1

Acronym CR STX LF ENQ EOT ACK ETX ETB NAK Carriage Return Start of a frame Line Feed Line Bid End of Transmission Acknowledgment End of a frame End of an intermediate frame Negative Acknowledgment

Bidirectional Protocol Control Characters (ASTM)

Name CR STX LF ENQ EOT ACK ETX ETB NAK ASCII 02 0A 05 04 06 03 17 15 HEX (end of text)

ASTM Interface Specifications Page 5-2

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Line Bidding (ASTM)

ASTM Interface

5

Line Bidding (ASTM) Before either the DxC System or the host transmits a message, they must bid for the communication line. ASTM line bidding uses the ENQ, STX, EOT, ACK, and NAK characters. Stage 1 2 3 The EOT clears the line. The receiving system responds by transmitting ACK to acknowledge the line bid and allow message transmission, or by transmitting NAK to deny the line bid. If the line bid is denied, the originator waits a short period of time (for example, one second) then bids for the line again. Description To bid for the line, <EOT> <ENQ> is transmitted when the line is idle.

4

· LINE BID ­ When the DxC is very busy, the response to a LINE BID can take up to 15 seconds. 1. When the DxC has some messages in the output queue, it does a LINE BID. When the LINE BID is accepted by the host, the instrument sends one set of messages at a time. It then gives up the line and waits for 2 seconds before continuing with the other messages. 2. If the host has messages to transmit, it can do a LINE BID (EOT ENQ) even if the instrument is busy transmitting messages (after sending a message, the DxC looks for a NAK, ACK, or ENQ). When the DxC sends a message, the host can respond with a line bid <EOT><SOH>. The message in progress will be saved by the DxC. The line will be granted to the host by sending an <ACK>.

NOTICE Do not activate the LINE BID while the instrument is transmitting messages because it would stop the collation of results.

· LINE BID TIME OUT occurs if the receiving system does not respond to the EOT ENQ within 15 seconds, or responds with something other than an ACK or STX. After 7 consecutive time outs, or unrecognizable responses (i.e., not ACK or NAK), the originator considers the line DOWN. The originator waits 20 seconds and tries the line bid again. · CONTENTION occurs when both systems bid for the line at the same time. The DxC will be considered the master and the host should respond with ACK. However, the host may override the DxC line bid by transmitting STX in response. The DxC will respond by transmitting ACK to acknowledge the line bid override and allow message transmission, or it will ignore the message if DxC was not bidding for the line when the message was sent.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-3

ASTM Interface

ASTM Data Record Format

ASTM Data Record Format The data record format for all transmissions to and from the DxC is:

<STX> FN <FRAME> <CR> <ETB> or <ETX> <CS><CR><LF>

where:

<STX> FN <FRAME> <CR> <ETB> <ETX> <CS> The start of message character (02) Frame number (0-7) Data - the message (field delimiter is | and component delimiter is ^) Data always terminated by a carriage return (0D) End of frame - required when record is too big for a frame (17) End of frame (03) Checksum - sum of ASCII values in a frame start from the frame and ends with <ETB> or <ETX> (<STX> <CS> and trailing <CR><LF> are not included in the checksum calculation) ASCII carriage return. ASCII line feed.

<CR> <LF>

Valid Characters in ASTM Messages Within text data fields, only the ASCII characters 32 to 126 and the undefined characters 128 to 254 are permitted as usable characters (excluding those used as delimiter characters in a particular transmission). Furthermore, all characters used as delimiters in a particular transmission are excluded from the permitted range. The sender is responsible for screening all text data fields to ensure that the text does not contain those delimiters. Refer to Figure 4.1 Key Code Conversion Chart in CHAPTER 4, Tables/Codes in this manual.

ASTM Interface Specifications Page 5-4

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface

ASTM Messages

5

ASTM Message General Format Sending Sample program H - Header Record P - Patient Information (demographics) C - Patient Comment, if any O - Order (Sample Information) C - Sample Comment, if any R - Result C - Result Comment, if any L - Terminator Record ASTM Messages Note about null fields: In the CLSI LIS2-A2 specification, null fields may be used to indicate no change from the previous value in that position (so that fields like birthdate need not be resent). This functionality exists in the specification for backward compatibility with older versions of LIS2-A2, and is discouraged by CLSI, so it is not used by DxC.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-5

ASTM Interface

Long Header Message

Long Header Message This message is sent from both the DxC and the LIS. Every transmission of records has to start with a Header record. Sets of messages always start with a message header record "H". The second field of this record contains the delimiters used for the set of records. Table 5.2

Field Number 1 2

Long Header Record

Description Delimiter Example Max. Length 1 1 1 1 1 Format/ DxC Receive Required Required Required Required Required Ignored Ignored LIS or DxC ^ | | | | | | | | | <CR> 1394-97 20020417120501 12 14 1 123 40 3 AN/Yes N/Yes Ignored Ignored Ignored Ignored Ignored Ignored Ignored AN/Yes DT/Yes Required AN/Yes DT/Yes Required Format/ DxC Send Required Required Required Required Required No No AN/Yes N/Yes

Record Identifier Delimiters: Field Repeat Delimiter Component Delimiter Escape Delimiter

H | \ ^ & | |

3 4 5 6 7 8 9 10 11 12 13 14

Message Control ID Password Sender Name or ID Device ID Sender Street Address Reserved field Sender Telephone Number Characteristics of sender Receiver ID Comment or special instructions Processing ID Version Number Date and Time of Message End of Record Delimiter |

"|" Field delimiter "\" Repeat delimiter (repeats a field: SAMPLE123A\SAMPLE123B\SAMPLE123C) "^" Component delimiter (John^Doe^k). "&" Escape delimiter (can be used for 2-byte characters) LIS or DxC This can be used as instrument ID

Sender ID Device ID

ASTM Interface Specifications Page 5-6

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Short Header Message to LIS

ASTM Interface

5

Short Header Message to LIS The user can select a Short Header option on the DxC Host Communications Setup Screen for sending messages to the LIS. The DxC can still receive Long Header messages when it sends Short Header messages. Table 5.3

Field Number 1 2

Short Header Record

Description Record Identifier Delimiters: Field Repeat Delimiter Component Delimiter Escape Delimiter | \ ^ & | | LIS or DxC ^ | | | | | | | | | <CR> 1394-97 20020417120501 12 14 1 123 40 3 1 1 1 1 Required Required Required Required Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Required No No Required Required Required Required Required No No No No Delimiter H Example Max. Format/ DxC Format/ DxC Length Receive Send 1 Required Required

3 4 5 6 7 8 9 10 11 12 13 14

Message Control ID Password Sender Name or ID Device ID Sender Street Address Reserved field Sender Telephone Number Characteristics of sender Receiver ID Comment or special instructions Processing ID Version Number Date and Time of Message End of Record

Example: Sending Header and Terminator (short version)

H|\^&<CR> L|1|N<CR>

Sending Header and Terminator (long version)

H|\^&|||DxC^123||||||||1394-97|2002041720501<CR> L|1|N<CR>

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-7

ASTM Interface

Patient Information Record

Patient Information Record This Message is sent from the LIS and the DxC. A Patient record is required by ASTM protocol before a sample information message, even if there is no patient information. A patient message without a test order message will be ignored. When the DxC rejects a sample program, it sends an empty patient information record with a Patient ID, if it exists. When sending updates to existing sample programs, the LIS must send the patient demographics again for verification. The instrument receiving the sample program updates verifies whether the chemistry updates are put into the correct sample. Table 5.4

Field Number 1 2 3 4 5 6

Patient Information Record

Description Record Identifier Sequence Number Practice Assigned Patient ID Patient ID Patient ID #3 Patient Name Last Name First Name Middle Initial | ^ ^ | ^ ^ Doe John M 19501102 5 D (Refer to Table 4.5 Age Unit Codes (ASTM)) M = Male F = Female If "U" or anything other than "M" or "F" then this field is set to Unknown or 'Unspecified'. 18 15 1 8 3 1 AN/Yesa AN/Yesa AN/Yesa D/Yes N/Yes A/Yes AN/Yes AN/Yes AN/Yes D/Yes N/Yes A/Yes | | | | 15 Delimiter P Example Max. Length 1 3 Format/DxC Format/DxC Receive Send Required Required Ignored AN/Yesa Ignored Required Required No AN/Yes No

8

Birth Date Age Age Unit

9

Sex

|

1

Yes

No

10

Patient Race

|

Ignore

No (1 of 3)

ASTM Interface Specifications Page 5-8

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Patient Information Record

ASTM Interface

5

Table 5.4

Field Number 11 12 13 14

Patient Information Record, continued

Description Patient Address Reserved Field Patient Telephone Attending Physician Name Last Name First Name Middle Initial Smith 18 20 1 | | 3.69 (Unit is always m2) (Maximum is 9.99) 72 (Maximum is 999.99) cm or in 205 kg or lb (Maximum is 999.99) 8 AN/Yes No No Ignore N/Yes AN/Yes No No No No Delimiter | | | Example Max. Length Format/DxC Format/DxC Receive Send Ignore Ignore Ignore No No No

15 16

Special Field 1 Body Surface Area (m2) Patient Height

17

|

6

N/Yes

N/Yes

Patient Height Unit 18 Patient Weight Patient Weight Unit

^ | ^

5 6 5

A/Yes N/Yes A/Yes

A/Yes N/Yes A/Yes

19 20 21 22 23 24 25 26 27 28 29 30 31 32

Patient Diagnosis Patient Medications Patient Diet Practice Field #1 Practice Field #2 Admission and discharge dates Admission Status Location Nature of Alt. Diag. Code and Class Alt. Diag. Code and Class Patient Religion Marital Status Isolation Status Language

| | | | | | | | | | | | | | Room 201 20

Ignore Ignore Ignore Ignore Ignore Ignore Ignore AN/Yes Ignore Ignore Ignore Ignore Ignore Ignore

No No No No No No No AN/Yes No No No No No No (2 of 3)

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ASTM Interface Specifications Page 5-9

ASTM Interface

Patient Information Record

Table 5.4

Field Number 33 34 35

Patient Information Record, continued

Description Hospital Service Hospital Institution Dosage Category End of Record Delimiter | | | <CR> 1 Example Max. Length Format/DxC Format/DxC Receive Send Ignore Ignore Ignore Required No No No Required (3 of 3)

a

Used for verification in case chemistries are added to an existing sample. If previous information is Null or blank, new information can be added. Sample is rejected when previous information is not blank and it is different from the new information.

Example: Sending Patient Information Record

H|\^&<CR> P|1||PATIENT111||Smith^Tom^J||19600315^42^Y|M|||||Dr.Randall|||72^cm|205^lb||||||||Bre a<CR> L|1|N<CR>

ASTM Interface Specifications Page 5-10

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Test Order Record

ASTM Interface

5

Test Order Record The Test Order Record contains all specimen information, including test requests. When the DxC rejects a sample program, it sends an empty Patient Information Record with Patient ID and an empty Test Order Record with a Specimen ID and report type of "X". A repeat delimiter should be used for field 5 (Test ID), which contains all the tests for the sample program. If the LIS needs to clear a sample, an action code of C means "clear" the sample. This Message is sent from the LIS to the DxC. The DxC sends this message back only when it is rejecting the sample program because of a problem with the order or the patient record. When the DxC rejects a sample program, it does not use all the fields of an order record, only the Sample ID and Rejection Flag are sent. If the Sample ID contains invalid characters or if it is blank, a rejection message will not be sent, since this would violate the protocol. All messages with bad characters in required fields will be logged for debugging purposes. Table 5.5

Field Number 1 2 3

Test Order Record

Description Record Identifier Sequence Number Specimen (Sample ID/ Control ID) IDa | | SAMPLE001 "." (period) and " " (space) are invalid characters 0 = No rack number assigned. Any other number identifies the Rack. 0 = No position number assigned. Any other number identifies the rack position. Lot 1 (control sample only) Control 1 (control sample only) (All upper case assumed) Delimiter O Example Max. Format/DxC Format/DxC Length Receive Send 1 3 15 Required Required ANS/ Requireda (See Note 1) N/Yes 1-999 N/Yes 1-4 AN/Yes ANS/Yes (See Note 2) Ignored Required Required ANS/ Required

Rack Number

^

4

N/Yes 1-999 N/Yes 1-4 AN/Yes ANS/Yes

Position on the Rack

^

2

Control Lot Number Control Name

^ ^

12 20

4

Instrument Specimen ID

|

No (1 of 4)

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ASTM Interface

Test Order Record

Table 5.5

Field Number 5

Test Order Record, continued

Description Universal Test ID: Identifier Name Type Test ID or Name (UDR) Delimiter | ^ ^ ^ 01A (Refer to Table 4.4 Age Unit Codes (CX and LX20) and Table 4.5 Age Unit Codes (ASTM)) Use repeat delimiter for Field 5, if there is more than one chemistry. 1 P = Peak T = Trough A = Acute C = Convalescent (Refer to Table 4.3 Sample Type Codes (ASTM)) 20020215121532 4 Example Max. Format/DxC Format/DxC Length Receive Send Ignored Ignored Ignored AN/Yes No No No AN/Yes

Replicate Peak/Trough

^ ^

2 2

N/Yes No

N/Yes No

6 7

Priority Requested Date and Time (Sample program creation date) Specimen Collection Date and Time Specimen Collection End Date and Time (used for Timed Urine samples) Collection Volume (required for Timed Urine) Units for Collection Volume Timed Urine period (required for Timed Urine) Timed Urine Creatinine concentration

| |

1 14

A/Yes (See Note 3) Ignored

A/Yes DT/Yes

8 9

| |

20020215121532 20020215131539

14 14

DT/Yes DT/Yes

DT/Yes DT/No

10

|

1.5 0-99999.0 mL (Units are always mL) 0.0 ­ 99.0

7

N/Yes

N/Yes

^ ^

2 4

A/Yes N/Yes

A/Yes N/Yes

^

0.0 ­ 999999999.9

11

N/Yes

N/Yes

(2 of 4)

ASTM Interface Specifications Page 5-12

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Test Order Record

ASTM Interface

5

Table 5.5

Field Number

Test Order Record, continued

Description Timed Urine Creatinine unit Delimiter ^ | | Example Always mg/dL John N (Refer to Table 5.6 Field 12: Action Code Options) Max. Format/DxC Format/DxC Length Receive Send 8 18 1 A/Yes AN/Yes A/Yes A/Yes AN/Yes No

11 12

Collected By (ID or Name) Action Code

13 14 15 16

Danger Code Relevant Clinical Information Date/Time Specimen Received in the Lab Specimen Type

| | | | 20020215131539 Blood (Refer to Table 4.3 Sample Type Codes (ASTM)) LH = left hand RH = right hand LL = left lung 14 10

Ignored Ignored Ignored A/Yesa

No No No A/Yes

Specimen Source

^

2

No

No

17 18 19

Ordering Physician Physician Phone Number Offline Dilution Factor 1 Offline Dilution Factor 2

| | | ^ 1 Always one 16 2 2

Ignored Ignored N/Yes (See Note 4) N/Yesa (See Note 5) Ignored Ignored Ignored Ignored Ignored Ignored Y or Z = no information O, Q, or NULL = LIS provided order X = Sample rejected by DxC 1 A/Yes

No No N/Yes (See Note 4) N/No (See "R" record) No No No No No No A/Yes

20 21 22 23 24 25 26

User Field #2 Laboratory Field #1 Laboratory Field #2 Date/Time Results Reported/Mod. Instrument charge to computer system Instrument Section ID Report Type (Refer to Table 5.20 Sample Order Reject Conditions)

| | | | | | |

(3 of 4)

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ASTM Interface Specifications Page 5-13

ASTM Interface

Test Order Record

Table 5.5

Field Number 27 28 29 30 20

Test Order Record, continued

Description Reserved Field Location Speciment Collected Nosocomial Infection Flag Specimen Service Specimen Institution End of Record Delimiter | | | | | <CR> 1 Example Max. Format/DxC Format/DxC Length Receive Send Ignored Ignored Ignored Ignored Ignored Required No No No No No Required (4 of 4)

a

Used for verification in case chemistries are added to an existing sample.

Field 3: Specimen ID (Sample ID/Control ID) · The Specimen ID identifies the sample. The LIS cannot use rack and position only to order a sample. Rack and position are for information only, so they are ignored. · Recalled samples must have a Specimen ID, otherwise the recall is not sent to the LIS. The LIS cannot identify results without a Specimen ID. · Control samples are identified by their Control ID, control name and lot number. The LIS cannot use control name and lot number only to order controls. · If the LIS reuses a Specimen ID, then the operator needs to determine how often the LIS is allowed to reuse a Specimen ID and set the Sample Age accordingly in the System Setup screen. For example, if the LIS allows sample IDs to be reused every week, then the operator has to set the Sample Age to seven days. The DxC compares a sample's creation date with the Sample Age. If seven days have passed, then the sample is not runable. The ASTM protocol will reject the sample update if the sample is older than the Sample Age limit. Field 5: Universal Test ID · All components should be repeated when a repeat delimiter is used to order multiple chemistries. Name and type components are not used (any value is ignored). · Defined Chemistries: The LIS uses Beckman Coulter Chemistry codes (refer to Table 4.6 Chemistry (Chem) Codes in CHAPTER 4, Tables/Codes in this manual), or chemistry names for user-defined chemistries. · Replicates: If a replicates component has no content, then the system replicate number is assumed for each chemistry ordered. · The Peak/Trough field is not used by the DxC. · Field 5 Example:

|^^^01A^1\^^^73A^1\^^^63A^1\^^^75A^1\^^^11A^1\^^^95A^1|

ASTM Interface Specifications Page 5-14

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Test Order Record

ASTM Interface

5

Table 5.6

Test Order Type (Action Code) C - Clear Sample

Field 12: Action Code Options

No Matching Sample Program Matching Sample Program "No errors and not busy" Matching Sample Program "Sample in progress" or error condition Reject the clear request Reject the clear request

Accept and ignore

Accept and clear the sample Accept Clear the sample program Create a new program If Sample Age has expired, Reject. Otherwise, verify fields: Patient Name (First, Last, Middle Initial) Patient ID Specimen Type Dilution Factor If previous demographic fields are blank, assume verification. Accept Add chemistries If verification fails or any other sample errors occur, Reject.

N - New Accept and create a new Sample program Q - QC (same as N) A - Add Accept and create a new Chemistries chemistry

If Sample Age has expired, Reject. Otherwise, if sample is in progress, verify fields: Patient Name (First, Last, Middle Initial) Patient ID Specimen Type Dilution Factor If previous demographic foelds are blank, assume verification. Accept Add chemistries If verification fails or any other sample errors occur, Reject. If sample is completed, Reject (the sample has to be cleared, either by the operator or by the LIS.

Note: To avoid sample rejection and to avoid mixing samples, the LIS should send a "Clear" sample message if the same Specimen ID is reused for a different sample, or else the operator should manually clear (delete) the previous sample.

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-15

ASTM Interface

Test Order Record

Field 16: Specimen Type · DxC 600/800 options: Serum, Urine, CSF, Plasma, Timed, Blood, Other. · Specimen types that are not valid for the DxC 600/800 are converted to Other. · DxC 600i options: Amniotic, Urethral, Saliva, Cervical, Synovial. Field 26: Report Type The Report Type Field is only used by the DxC when a Sample Order is being rejected or when the DxC is waiting for a response to a Host Query. · Report Type = NULL, Q, or O (Sample Order is provided by LIS). If the LIS provides a Sample Order to the DxC, a NULL, Q, or O is placed in the Report Type field. The DxC processes the Sample Order, assuming that all fields are within appropriate ranges. · Report Type = Z, or Y (The LIS has no Order to Send the DxC in response to a Query). If the LIS has no record of the Sample ID being queried and cannot provide a Sample Order to the DxC, it places a Y or a Z in the Report Type field. The DxC assumes that a Sample Order is not forthcoming and queries the next sample. · Report Type = X (Sample Order is rejected by the DxC). If the Sample Order sent by the LIS to DxC cannot be accepted by the DxC, then the DxC sends an X in the Report Type field. · Report Type = All other values. If the Report Type Field contains any characters other than those described above, then the Report Type field is ignored by the DxC. Note 1: The Specimen/Sample ID is converted to upper case when it is received in lower case. Note 2: The Control name is a unique identifier indicating which control this result is related to. Only the selected fluid type for the control can be used. Any other fluid type is a syntax error. All lower case letters are converted to upper case. Note 3: A specimen priority change does not affect the sample run when the sample is already in progress. Note 4: Dilution Factor 1 is always 1 for the DxC. If this component is left blank, the DxC assumes that the factor is 1. If it is not 1 or blank, the DxC rejects the order. Note 5: Dilution Factor 2 must be a whole number. If the LIS sends a decimal number, the DxC rejects the order. Example: Sending Test Order Record

H|\^&<CR> P|1||PATIENT111||Smith^Tom^J||19600315^42^Y|M|||||Dr. Randall|||72^cm|205^lb||||||||Brea<CR> O|1|SAMPLE123^4^3^lot1^control 1||^^^01A^1\^^^73A^1\^^^63A^1\^^^75A^1\ ^^^11A^1\^^^95A^1|R|20060316135300||||John|N||||Urine|||1^1<CR> L|1|N<CR> ASTM Interface Specifications Page 5-16 UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Sample Result Record

ASTM Interface

5

Sample Result Record The Result Record contains the result of a single test run on the instrument. This message is sent from the DxC to the LIS. Table 5.7

Field Number 1 2 3

Sample Result Record

Description Record Identifier Sequence Number Universal Test ID Identifier Name Type Test ID or Name (UDR) | | ^ ^ ^ 01A (Refer to Table 4.6 Chemistry (Chem) Codes and Table 4.7 Assay Codes 2 Lot 1 123 TCDEJMOP (Refer to Table 4.9 Instrument Codes with Remarks) 1 (Always 1 for DxC) 16 4 Delimiter R Example Max. Format/DxC Format/DxC Length Receive Send 1 3 Required Required No No No No Required Required No No No AN/Yes

Replicate Number Reagent Lot Number Reagent Serial Number Instrument Code

^ ^ ^ ^

2 6 5 9

No No No No

N/Yes AN/Yes AN/Yes AN/Yes

Offline Dilution Factor 1 Offline Dilution Factor 2

^ ^

2 2

No No

N/Yes N/Yes (DxC sends whole number) (1 of 4)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-17

ASTM Interface

Sample Result Record

Table 5.7

Field Number 4

Sample Result Record, continued

Description Data Measurement/ Value (Offline dilution already applied) Delimiter | 199.03 For drugs of abuse, this value is either absorbance or rate, depending on the chemistry. Blank component when the result is suppressed or No Value. Caution: When this component is blank, it does not mean the value is zero. Interpretation component might have the value. (For example, |^1| means that the actual result should be displayed as "Negative") Caution: The Result field might contain "<" or ">" and a value. (For example, |< 4.9| or |> 4.9|. The actual result is NOT 4.9, so it should be displayed as "< 4.9" or "> 4.9".) If the option "Host does NOT accept either < or > symbols" is selected, then the system suppresses the result. This option is set during system setup using a checkbox in the Host Communications Parameters screen. (2 of 4) Example Max. Format/DxC Format/DxC Length Receive Send 10 No AN/Yes

ASTM Interface Specifications Page 5-18

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Sample Result Record

ASTM Interface

5

Table 5.7

Field Number

Sample Result Record, continued

Description Interpretation Delimiter ^ Example 1 = Negative 2 = Positive 3 = Equivocal 4 = Non-reactive 5 = Reactive 6 = Not confirmed 7 = Confirmed 10 = Reactive gray zone 11 = Non-reactive gray zone 13 = Suppressed (Blank means no interpretation) Max. Format/DxC Format/DxC Length Receive Send 2 No AN/Yes

5

Units

|

mg/mL (Refer to Table 4.8 Unit Codes) 5.6 to 99.0 1.12345678 to 9.12345678 NR = Normal Range CR = Critical Range RR = Reportable Range LO (Refer to Table 5.8 Field 7: Abnormal Result Flags for the flag definitions.)

8

No

A/Yes

6

Reference range (Repeat delimiter is used for multiple ranges) Reference Type

|

24

No

AN/Yes (10 to 10)

^

2

No

AN/Yes (DxC always sends NR if ranges exist) DT/Yes

7

Abnormal Result flag

|

14

No

8 9

Nature of Abnormality Testing Result Status

| | I = result is pending (for future use) R = request from result recall F = Final X = cannot be done (for future use) 1

No No

No A/Yes

10 11 12 13

Date of change Operator identification Date/time test started Date/time test completed

| | | | 2002031613500 14

No No No No

No No No DT/Yes (3 of 4)

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-19

ASTM Interface

Sample Result Record

Table 5.7

Field Number 14

Sample Result Record, continued

Description Instrument identification (Sender Name) Device ID End of Record Delimiter | Example LIS or DxC Max. Format/DxC Format/DxC Length Receive Send 40 No AN/Yes

^ <CR>

123

3 1

No Required

N/Yes End of Record (4 of 4)

ASTM Interface Specifications Page 5-20

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Sample Result Record

ASTM Interface

5

Table 5.8

Flag NA HI LO NR CL CH H2 H3 H4 L2 L3 L4 IC SU

Field 7: Abnormal Result Flags

Description Not applicable Above normal range Below normal range Within normal range or within 2 standard deviations (SD) of the mean Critical low Critical high 2 to 3 SD above mean More than 3 SD above mean More than 4 SD above mean 2 to 3 SD below mean More than 3 SD below mean More than 4 SD below mean Incomplete Suppressed result

Note 1: The Specimen/Sample ID is converted to upper case when it is received in lower case. Note 2: The Control name is a unique identifier indicating which control this result is related to. Only the selected fluid type for the control can be used. Any other fluid type is a syntax error. All lower case letters are converted to upper case. Example: Sending Sample Results

H|\^&<CR> P|1||PATIENT111||Smith^Tom^J||19600315^42^Y|M|||||Dr. Randall||||||||||||Brea<CR> O|1|SAMPLE123^4^3^lot1^control 1||^^^01A^1\^^^73A^1\^^^63A^1\^^^75A^1\ ^^^11A^1\^^^95A^1|R|20060316135300||||John|N||||Urine|||1^1<CR> R|1|^^^01A^1^lot1^123^TCD^1^1|14.5^2|Mg/ml||5.6 to 99.9^NR|NR||F||||20020316135300|DxC"123<CR> R|2|^^^73A^1^lot1^123^^1^1|15.5^1|Mg/ml||5.6 to 50.9^NR^<|NR||F||||20020316135301|DxC^123<CR> R|3|^^^63A^1^lot1^123^^1^1|16.5^|Mg/ml||1.1 to 20.9^NR|NR||F||||20020316135302|DxC^123<CR> R|4|^^^75A^1^lot1^123^JMOP^1^1|##########^|Mg/ml||3.8 to 9.9^HI|SU||F||||20020316135303|DxC^123<CR> R|5|^^^11A^1^lot1^123^^1^1|18.5^4|Mg/ml||26.6 to 99.9^LO|NR||F||||20020316135304|DxC^123<CR> R|6|^^^95A^1^lot1^123^^1^1|19.5^11|Mg/ml||5.6 to 99.9^NR|NR||F||||20020316135305|DxC^123<CR> L|1|N<CR>

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-21

ASTM Interface

Host Query (Request Information Record)

Host Query (Request Information Record) This record can be used by DxC to send a Host Query to LIS. When the DxC sees a sample tube and Host Query is enabled, DxC sends a Host Query (Q) message to the host. If the host does not respond within the configurable time, the DxC aborts the query and sends the next one. The DxC sends the Host Query and waits up to the maximum configured time. If the test order is received within time, the DxC continues to process the tube. If the test order is not received within the specified time, the DxC sends an abort host query message, if abort query is turned on. To avoid waiting the maximum time for a sample program, the host can send an empty Order record with report type of Z or O. An empty Patient Information record should also be sent, because P and O records should be used always together. This is recommended when the host has no test orders to send for a queried sample. Table 5.9

Field Number 1 2 3

Request Information Record

Description Delimiter Example Max. Format/ Length DxC Receive 1 3 20 Sample123 15 No No No No Format/ DxC Send Required Required No ANS/ Requiredb (DxC repeats Field 3 a maximum of 4 times, with 4 cups per rack) No No No No No No No No (1 of 2)

Record Identifier Sequence Number Patient ID Specimen IDa (Sample ID/ Control ID) | | ^

Q

4 5 6 7 8 9 10 11

Ending Range ID Universal Test ID Nature of Request Time Limits Beginning Request Results date/time Ending Request Results date/time Requesting Physician Name Requesting Physician Telephone User Field #1

| | | | | | | |

No No No No No No No No

ASTM Interface Specifications Page 5-22

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Host Query (Request Information Record)

ASTM Interface

5

Table 5.9

Field Number 12 13

Request Information Record, continued

Description Delimiter Example Max. Format/ Length DxC Receive No O = Request Sample Programming Information A= Abort Current Host Query Request 1 No Format/ DxC Send No A/Yes

User Field #2 Request Information Status Codes

| |

End of Record

a b

<CR>

1

Required

Required (2 of 2)

Used for verification in case chemistries are added to an existing sample. The repeat delimiter (\) can be used for Field 3, which has two components, Patient ID and Specimen ID. It should be repeated as follows: ^SampleID1\^SampleID2\^SampleID3\^SampleID4 The Patient ID is not used, but it holds the first component space.

The operator can set the following options for the Host Query Feature: · Query On/Off · Maximum wait before DxC timeout after sending a query · Host Query abort message after maximum time out Examples: Sending Query Record

H|\^&<CR> Q|1|^SAMPLE123||||||||||O<CR> L|1|N<CR>

Sending Query Cancellation (abort)

H|\^&<CR> Q|1|^SAMPLE123||||||||||A<CR> L|1|N<CR>

Sending Sample Order Record. Host Query Response -- No sample available.

H|\^&<CR> P|1||||||||||||||||||||||||<CR> O|1|SAMPLE123|||||||||||||||||||||||Z<CR> L|1|N<CR>

Sending Sample Terminator Record with "I" option to inform that there is no information for the previous query.

H|\^&<CR> L|1|I<CR>

Sending Sample Order Record. Host Query Response -- Sample available.

P|1||PATIENT111||Smith^Tom^J||19600315^42^Y|M|||||Dr.Randall||||||||||||Brea<CR> O|1|SAMPLE123^4^3^lot1^control 1||^^^01A^1\^^^73A^1\^^^63A^1\^^^75A^1\ ^^^11A^1\^^^95A^1|R|20060316135300||||John|N||||Urine|||1^1<CR> C|1||Comment for SAMPLE123 if any<CR> L|1|N<CR>

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-23

ASTM Interface

Message Terminator Record

Message Terminator Record This message is used both by LIS and the DxC. Each time a set of records is sent, this record is needed to terminate the set of messages. Any other Terminator code is ignored. The DxC only uses the contents of the Terminator code field when it is waiting for a response to a Host Query. When a Host Query is not in progress, the Terminator Code field is ignored by the DxC. · Terminator code = N Normal termination. This is the "normal" case for a terminator record. Normal Termination does not terminate the pending Host Query. · Query Termination codes = F, I or Q LIS does not have the information for the previous query. The DxC can start the next query. Table 5.10

Field Number 1 2 3

Message Terminator Record

Description Delimiter L | | N = Normal Termination F = Last request for information I = No information available from the last query Q = Error in last request for information (F,I,Q = Start the next query) Example Max. Length 1 3 1 Format/DxC Receive/Max Required Required A/Yes Format/DxC Send/Max Required Required A/Yes

Record Identifier Sequence Number Terminator Code

End of Record

<CR>

1

Required

Required

Example: Sending Message Terminator Record

H|\^&<CR> L|1|N<CR>

ASTM Interface Specifications Page 5-24

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Comment Record (Patient Comment)

ASTM Interface

5

Comment Record (Patient Comment) This record can be used by the LIS to send a Patient Comment to the DxC after a patient information record. Table 5.11

Field Number 1 2 3 4 5

Comment Record (Patient Comment)

Description Delimiter C | | | | 1 I = Clinical Instrument Sample Comment I = Instrument (result flags) G = Generic Comment Example Max. Length 1 3 1 45 1 Format/DxC Receive Required Required A/Yes ANS/Yes A/Yes Format/DxC Send No No A/Yes ANS/Yes A/Yes

Record Identifier Sequence Number Comment Source Patient Comment Comment Type

End of Record

<CR>

1

Required

Required

Example: Sending Patient Comment record

H|\^&<CR> P|1||PATIENT111||Smith^Tom^J||19600315^42^Y|M|||||Dr. Randall||||||||||||Brea<CR> O|1|SAMPLE123^4^3^lot1^control 1||^^^01A^1\^^^73A^1\^^^63A^1\^^^75A^1\ ^^^11A^1\^^^95A^1|R|20060316135300||||John|N||||Urine|||1^1<CR> C|1|I|patient comment|G<CR> L|1|N<CR>

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ASTM Interface Specifications Page 5-25

ASTM Interface

Comment Record (Sample Comment)

Comment Record (Sample Comment) This record can be used by LIS to send a sample comment to the DxC after a Test Order Record. The DxC uses the Comment Record to send the reason for an order rejection to the LIS. Table 5.12

Field Number 1 2 3 4 5

Comment Record (Sample Comment)

Description Delimiter C | | | | 1 I = Clinical Instrument Sample Comment I = Instrument (result flags) G = Generic Comment Example Max. Length 1 3 1 25 1 Format/DxC Format/DxC Receive Send Required Required A/Yes A/Yes A/Yes Required Required A/Yes ANS/Yes A/Yes

Record Identifier Sequence Number Comment Source Sample Comment Comment Type

End of Record

<CR>

1

Required

Required

Example: Sending Sample Comment record

H|\^&<CR> P|1||PATIENT111||Smith^Tom^J||19600315^42^Y|M|||||Dr. Randall||||||||||||Brea<CR> O|1|SAMPLE123^4^3^lot1^control 1||^^^01A^1\^^^73A^1\^^^63A^1\^^^75A^1\ ^^^11A^1\^^^95A^1|R|20060316135300||||John|N||||Urine|||1^1<CR> C|1|I|patient comment|G<CR> L|1|N<CR>

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Comment Record (Result Comment)

ASTM Interface

5

Comment Record (Result Comment) This record can be used by the DxC to send error conditions for a result after a Result Record. Table 5.13

Field Number 1 2 3 4

Comment Record (Result Comment)

Description Delimiter C | | | 1 I = Clinical Instrument IR\IL\DS Repeat delimiter is used for multiple error codes. (Refer to Table 4.10 Result Error Codes.) I = Instrument (result flags) G = Generic Comment Example Max. Length 1 3 1 160 Format/DxC Receive Required Required A/Yes A/Yes Format/DxC Send Required Required A/Yes ANS/Yes

Record Identifier Sequence Number Comment Source Result Error Codes

5

Comment Type

|

1

A/Yes

A/Yes

End of Record

<CR>

1

Required

Required

Example: Result error codes are separated by a repeat delimiter. Sending Result Comment record

H|\^&<CR> P|1||PATIENT111||Smith^Tom^J||19600315^42^Y|M|||||Dr. Randall||||||||||||Brea<CR> O|1|SAMPLE123^4^3^lot1^control 1||^^^01A^1\^^^73A^1\^^^63A^1\^^^75A^1\ ^^^11A^1\^^^95A^1|R|20060316135300||||John|N||||Urine|||1^1<CR> R|1|^^^01A^1^lot1^123^TCD^1^1|14.5^2|Mg/ml||5.6 to 99.9^NR|NR||F||||20020316135300|DxC"123<CR> C|1|I|IR\IL|I<CR> R|2|^^^73A^1^lot1^123^^1^1|15.5^1|Mg/ml||5.6 to 50.9^NR^<|NR||F||||20020316135301|DxC^123<CR> C|1|I|IR\IL|I<CR> L|1|N<CR>

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ASTM Interface

Manufacturer Record

Manufacturer Record The manufacturer can define this message. The format of the M record changes according to its purpose. Field 3 indicates the record's purpose. The following Manufacturer Records are not used for the DxC: · Sample Arrival Message - M101 · Sample/Primary Aliquot Message - M102 · Sample Tracking Message - M103 · Sample Complete Message - M104 · PrepLink Error Message - M105 · Test Communication - M106

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Manufacturer Record - Special Calculations Message - M110

ASTM Interface

5

Manufacturer Record - Special Calculations Message - M110 This is sent from the DxC to the LIS if special calculations are enabled. Several of these messages can be transmitted with each sample program. Table 5.14

Field Number 1 2 3 4 5 6

Manufacturer Record - Special Calculations

Description Record Identifier Sequence Number Record Identifier Date and Time Special Calc Name Special Calc Code | | | | | 110 20060215121532 Creatinine clear OK (Refer to Table 4.12 Special Calculation Status Codes) 19.99 mmoL 1 1 = LIS downloaded parameters (for future use) 2 = User entered parameters (for future use) 3 = None 1 = system result 2 = manual entry of result (for future use) 3 = user edited results (for future use) 1 = user defined 2 = built in Delimiter M Example Max. Format/DxC Format/DxC Length Receive Send 1 3 3 14 30 2 No No No No No No Required Required Required DT/Yes A/Yes A/Yes

7 8 9 10

Special Calc Value Special Calc Unit Replicate Calculations Parameters

| | | |

14 10 2 2

No No No No

N/Yes A/Yes N/Yes N/Yes

11

Result Origin

|

2

No

N/Yes

12

Calculation Formula End of Record

| <CR>

2 1

No No

N/Yes Required

Example: DxC sending results with special calculations. Sending Manufacturer Record M110

H|\^&<CR> P|1||PATIENT111||Smith^Tom^J||19600315^42^Y|M|||||Dr. Randall||||||||||||Brea<CR> O|1|SAMPLE123^4^3^lot1^control 1||^^^01A^1\^^^73A^1\^^^63A^1\^^^75A^1\ ^^^11A^1\^^^95A^1|R|20060316135300||||John|N||||Urine|||1^1<CR> R|1|^^^01A^1^lot1^123^TCD^1^1|14.5^2|Mg/ml||5.6 to 99.9^NR|NR||F||||20020316135300 |DxC"123<CR> R|2|^^^73A^1^lot1^123^^1^1|15.5^1|Mg/ml||5.6 to 50.9^NR^<|NR||F||||20020316135301 |DxC^123<CR> M|1|110|20060423125522|Creatinine clear|OK|19.99|mmol|1|3|1|2<CR> L|1|N<CR>

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ASTM Interface

Manufacturer Record - Timed Urine Calculations Message - M111

Manufacturer Record - Timed Urine Calculations Message - M111 This is sent from the DxC to the LIS for timed urine calculations. If the Specimen Type is Timed Urine, several of these messages can be transmitted with each sample program. Table 5.15

Field Number 1 2 3 4 5 6

Manufacturer Record - Timed Urine Calculations

Description Record Identifier Sequence Number Record Identifier Date and Time TU Name TU Code | | | | | 111 20040215121532 Chem 1 OK (Refer to Table 4.12 Special Calculation Status Codes) 19.99 mmoL 1 1 = LIS downloaded parameters (for future use) 2 = User entered parameters (for future use) 3 = None 1 = system result 2 = manual entry of result (for future use) 3 = user edited results (for future use) 1 = user defined 2 = built in Delimiter M Example Max. Format/DxC Format/DxC Length Receive Send 1 3 3 14 30 2 No No No No No No Required Required Required DT/Yes A/Yes A/Yes

7 8 9 10

TU Value TU Unit Replicate Calculations Parameters

| | | |

14 10 2 2

No No No No

N/Yes A/Yes N/Yes N/Yes

11

Result Origin

|

2

No

N/Yes

12

Calculation Furmula End of Record

| <CR>

2 1

No No

N/Yes Required

Example: DxC sending results with timed urine calculations. Sending Manufacturer Record M111

H|\^&<CR> P|1||PATIENT111||Smith^Tom^J||19600315^42^Y|M|||||Dr. Randall||||||||||||Brea<CR> O|1|SAMPLE123^4^3^lot1^control 1||^^^01A^1\^^^73A^1\^^^63A^1\^^^75A^1\ ^^^11A^1\^^^95A^1|R|20060316135300||||John|N||||Urine|||1^1<CR> R|1|^^^01A^1^lot1^123^TCD^1^1|14.5^2|Mg/ml||5.6 to 99.9^NR|NR||F||||20060316135300 |DxC"123<CR> R|2|^^^73A^1^lot1^123^^1^1|15.5^1|Mg/ml||5.6 to 50.9^NR^<|NR||F||||20060316135301 |DxC^123<CR> M|1|111|20060423125522|Chem1|OK|19.99|mmol|1|3|1|2<CR> M|1|111|20060423125522|Chem2|OK|14.01|mmol|1|3|1|2<CR> M|1|111|20060423125522|Chem3|OK|63.20|mmol|1|3|1|2<CR> L|1|N<CR> ASTM Interface Specifications Page 5-30 UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Manufacturer Record - Request Instrument State - M112

ASTM Interface

5

Manufacturer Record - Request Instrument State - M112 This message is sent from the LIS to the DxC to request an instrument's state. Table 5.16

Field Number 1 2 3 4

Manufacturer Record - Request Instrument State

Description Record Identifier Sequence Number Record Identifier Date and Time End of Record | | | <CR> 112 20030415121532 Delimiter M Example Max. Length 1 3 3 14 1 Format/DxC Receive Required Required Required DT/Yes Required Format/DxC Send No No No No No

Example: LIS sending a request for the DxC instrument state. Sending Manufacturer Record M112

H|\^&<CR> M|1|112|20030423125522<CR> L|1|N<CR>

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ASTM Interface

Manufacturer Record - Instrument State Reply - M113

Manufacturer Record - Instrument State Reply - M113 This message is sent from the DxC to the LIS in reply to an instrument state request. Table 5.17

Field Number 1 2 3 4 5

Manufacturer Record - Instrument State Reply

Description Delimiter M | | | | 113 20030423125522 0 = cannot run tests 1 = ready to run 2 = running Example Max. Length 1 3 3 14 1 Format/DxC Receive No No No No No Format/DxC Send Required Required Required DT/Yes N/Yes

Record Identifier Sequence Number Record Identifier Date and Time Instrument State

End of Record

<CR>

1

No

Required

Example: LIS sending a request for the DxC instrument state. Sending Manufacturer Record M113

H|\^&<CR> M|1|113|20030423125522|2<CR> L|1|N<CR>

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Manufacturer Record - Test Availability Request - M114

ASTM Interface

5

Manufacturer Record - Test Availability Request - M114 This message is sent from the LIS to the DxC to check for available tests. Table 5.18

Field Number 1 2 3 4

Manufacturer Record - Test Availability Request

Description Delimiter M | | | <CR> 114 20030415121532 Example Max. Length 1 3 3 14 1 Format/DxC Receive Required Required Required DT/Yes Required Format/DxC Send No No No No No

Record Identifier Sequence Number Record Identifier Date and Time End of Record

Example: LIS sending a request for test availability. Sending Manufacturer Record M114

H|\^&<CR> M|1|114|20030423125522|2<CR> L|1|N<CR>

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ASTM Interface

Manufacturer Record - Test Availability Reply- M115

Manufacturer Record - Test Availability Reply- M115 This message is sent from the DxC to the LIS in reply to a test availability request. Table 5.19

Field Number 1 2 3 4 5 6

Manufacturer Record - Test Availability Reply

Description Delimiter M | | | | | ^ 115 20030415121532 1-999 01A 0 = test cannot run 1 = limited run only (low on reagent or calibration may expire) 2 = test can run Example Max. Format/DxC Format/DxC Length Receive Send 1 3 3 14 3 4 1 No No No No No No No Required Required Required DT/Yes N/Yes AN/Yes N/Yes

Record Identifier Sequence Number Record Identifier Date and Time Number of tests Test ID or Name (UDR) Test State

End of Record

<CR>

1

No

Required

Example: DxC sending test availability reply. Sending Manufacturer Record M115

H|\^&<CR> M|1|115|20030423125522|3|01A^1\04B^1\05A^0<CR> L|1|N<CR>

Field 6: A repeat delimiter can be used to send the status of all the chemistries on board. Scientific Record The Scientific Record exchanges the test data on clinical laboratory/instrument performance, quality assurance, or method development. The Scientific Record is not used for the DxC.

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Sample Order Reject Conditions

ASTM Interface

5

ASTM Sample Order Reject Conditions After a Sample Order is rejected, the ASTM Sample Order conditions are logged and the DxC sends a sample comment record to the LIS explaining the reason for the rejection. The rejection message is the same for all errors. The operator has to check the Event Log to identify the reason for the rejection. A Sample Order can be rejected for the following conditions. Table 5.20 Bad Message Busy Not Configured Dilution Error Calibrator Sample ID Internal Completed Sample Sample Order Reject Conditions Description Something is wrong with the message syntax. Sample is running or being programmed (cannot be cleared or overwritten). Message contains at least one non-configured chemistry. Message contains chemistries with different dilution factors. The Specimen ID is being used for the Calibrator. The instrument has an internal logical error. The sample cannot be updated when the status of the sample is Completed.

Message

Incompatible Fluid Types The sample fluid type does not match with the previous sample (when adding to a previous sample). Incompatible Test Types Incompatible Patient ID Incompatible Patient First Name Incompatible Patient Last Name Incompatible Patient Middle Name Too Many Tests Programmed The sample test type does not match with the previous sample (when adding to a previous sample). The Patient ID does not match with the previous sample (when adding to a previous sample). The patient's first name does not match with the previous sample (when adding to a previous sample). The patient's last name does not match with the previous sample (when adding to a previous sample). The patient's middle initial does not match with the previous sample (when adding to a previous sample). The number of chemistries in the order is over the limit.

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ASTM Interface

ASTM - LIS Message Flow Examples

ASTM - LIS Message Flow Examples Example of a Sample Download:

SD = LIS sends RC = LIS receives

SD:<EOT><ENQ> RC:<ACK> SD:<STX>1H|\^&<CR><ETX>E5<CR><LF> RC:<ACK> SD:<STX>2P|1||MM0001||Smith^Mark^||19540209^99^|U|||||||||||||||||<CR><ETX>A7<CR><LF> RC:<ACK> SD:<STX>3C|1||123456789<CR><ETX>08<CR><LF> RC:<ACK> SD:<STX>4O|1|MM0001||^^^A64^1\^^^A65^1\^^^A66^1|R||||^||N||||Serum|||1^|||||||<CR><ETX >8B<CR><LF> RC:<ACK> SD:<STX>5L|1|N<CR><ETX>08<CR><LF> RC:<ACK> SD:<EOT>

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM - LIS Message Flow Examples

ASTM Interface

5

Host Query and LIS sample download. The LIS has the samples and downloads them to the DxC.

SD = LIS sends RC = LIS receives

RC:<ENQ> SD:<ACK> RC:<STX>1H|\^&<CR><ETX>E5<CR><LF> SD:<ACK> RC:<STX>2Q|1|^SAMPLE1\^SAMPLE2\^SAMPLE3\^SAMPLE4||||||||||O<CR><ETX>41<CR><LF> SD:<ACK> RC:<STX>3L|1|N<CR><ETX>06<CR><LF> SD:<ACK> RC:<EOT> SD:<EOT><ENQ> RC:<ACK> SD:<STX>1H|\^&<CR><ETX>E5<CR><LF> SD:<STX>2P|1||PatientID1||Flinstone^Fred^F||^99^Y|M|||||||||||||||||<CR><ETX>7B<CR><LF> RC:<ACK> SD:<STX>3O|1|SAMPLE1||^^^30A^1\^^^05A^1\^^^61M^1\^^^61R^1|R||||^||N||||Serum|||1^|||||||<CR><ETX>DA<CR><LF> RC:<ACK> SD:<STX>4C|1||Sample is OK<CR><ETX>44<CR><LF> RC:<ACK> SD:<STX>5L|1|N<CR><ETX>08<CR><LF> RC:<ACK> SD:<EOT> SD:<EOT><ENQ> RC:<ACK> SD:<STX>1H|\^&<CR><ETX>E5<CR><LF> RC:<ACK> SD:<STX>2P|1||PATIENTID2||^^||^0^|U|||||||||||||||||<CR><ETX>B0<CR><LF> RC:<ACK> SD:<STX>3O|1|SAMPLE2||^^^08D^1\^^^10A^1|R||||^||N||||Serum|||1^|||||||<CR><ETX>68<CR><LF> RC:<ACK> SD:<STX>4L|1|N<CR><ETX>07<CR><LF> RC:<ACK> SD:<EOT> SD:<EOT><ENQ> RC:<ACK> SD:<STX>1H|\^&<CR><ETX>E5<CR><LF> RC:<ACK> SD:<STX>2P|1||PATIENTID3||^^||^0^|U|||||||||||||||||<CR><ETX>B1<CR><LF> RC:<ACK> SD:<STX>3O|1|SAMPLE3||^^^35A^1\^^^30A^1|R||||^||||||Serum|||1^|||||||<CR><ETX>1A<CR><LF> RC:<ACK> SD:<STX>4L|1|N<CR><ETX>07<CR><LF> RC:<ACK> SD:<EOT> SD:<EOT><ENQ> RC:<ACK> SD:<STX>1H|\^&<CR><ETX>E5<CR><LF> RC:<ACK> SD:<STX>2P|1||PATIENTID4||^^||^0^|U|||||||||||||||||<CR><ETX>B2<CR><LF> RC:<ACK> SD:<STX>3O|1|SAMPLE4||^^^35A^1\^^^31A^1\^^^10A^1|R||||^||||||Serum|||1^|||||||<CR><ETX>C3<CR><LF> RC:<ACK> SD:<STX>4L|1|N<CR><ETX>07<CR><LF> RC:<ACK> SD:<EOT>

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

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ASTM Interface

ASTM - LIS Message Flow Examples

DxC sends results to the LIS.

SD = LIS sends RC = LIS receives

RC:<ENQ> SD:<ACK> RC:<STX>1H|\^&<CR><ETX>E5<CR><LF> SD:<ACK> RC:<STX>2P|1||||||^0|U|||||||||||||||||<CR><ETX>C2<CR><LF> SD:<ACK> RC:<STX>3O|1|23^6^3||^^^53B^3\^^^67C^3\^^^72M^3|R|20070308161217|||0.0^^^0.0||||||Serum|||1^1|||||||<CR><ETX>4C <CR><LF> SD:<ACK> RC:<STX>4R|1|^^^53B^1^LOTIGM^013^^1^1|78|mg/dL||NR||R||||20070308161217|DXC^0<CR><ETX>45<CR><LF> SD:<ACK> RC:<STX>5R|2|^^^53B^2^LOTIGM^013^^1^1|80|mg/dL||NR||R||||20070308161217|DXC^0<CR><ETX>41<CR><LF> SD:<ACK> RC:<STX>6R|3|^^^53B^3^LOTIGM^013^^1^1|81|mg/dL||NR||R||||20070308161217|DXC^0<CR><ETX>45<CR><LF> SD:<ACK> RC:<STX>7R|4|^^^67C^1^LOTPHE^014^^1^1|37.2|µg/mL||NR||R||||20070308161217|DXC^0<CR><ETX>C0<CR><LF> SD:<ACK> RC:<STX>0R|5|^^^67C^2^LOTPHE^014^^1^1|38.1|µg/mL||NR||R||||20070308161217|DXC^0<CR><ETX>BB<CR><LF> SD:<ACK> RC:<STX>1R|6|^^^67C^3^LOTPHE^014^^1^1|39.0|µg/mL||NR||R||||20070308161217|DXC^0<CR><ETX>BE<CR><LF> SD:<ACK> RC:<STX>2R|7|^^^72M^1^LOTVANC^015^^1^1|10.9|µg/mL||NR||R||||20070308161217|DXC^0<CR><ETX>0E<CR><LF> SD:<ACK> RC:<STX>3R|8|^^^72M^2^LOTVANC^015^^1^1|11.2|µg/mL||NR||R||||20070308161217|DXC^0<CR><ETX>0B<CR><LF> SD:<ACK> RC:<STX>4R|9|^^^72M^3^LOTVANC^015^^1^1|11.6|µg/mL||NR||R||||20070308161217|DXC^0<CR><ETX>12<CR><LF> SD:<ACK> RC:<STX>5L|1|N<CR><ETX>08<CR><LF> SD:<ACK> RC:<EOT>

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UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM - LIS Message Flow Examples

ASTM Interface

5

DxC sends results to the LIS. This example includes suppressed results with interpretation of positive and negative.

SD = LIS sends RC = LIS receives

RC:<ENQ> SD:<ACK> RC:<STX>1H|\^&<CR><ETX>E5<CR><LF> SD:<ACK> RC:<STX>2P|1||||||^0|U|||||||10.00|60.00^cm|120.00^Kg||||||||<CR><ETX>04<CR><LF> SD:<ACK> RC:<STX>3O|1|9^3^1||^^^84A^4\^^^85A^4\^^^86A^4\^^^87A^4\^^^64A^4|R|20070308161216|||1200.0^^^100.0|||||| Urine|||1^1|||||||<CR><ETX>6D<CR><LF> SD:<ACK> RC:<STX>4R|1|^^^84A^1^LOTAMPH^027^^1^1|0.44^2|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>EA<CR><LF> SD:<ACK> RC:<STX>5R|2|^^^84A^2^LOTAMPH^027^^1^1|0.36^1|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>ED<CR><LF> SD:<ACK> RC:<STX>6R|3|^^^84A^3^LOTAMPH^027^^1^1|0.44^2|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>F0<CR><LF> SD:<ACK> RC:<STX>7R|4|^^^84A^4^LOTAMPH^027^^1^1|0.36^1|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>F3<CR><LF> SD:<ACK> RC:<STX>0R|5|^^^85A^1^LOTBARB^028^^1^1|0.29^2|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>E0<CR><LF> SD:<ACK> RC:<STX>1R|6|^^^85A^2^LOTBARB^028^^1^1|0.23^1|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>DC<CR><LF> SD:<ACK> RC:<STX>2R|7|^^^85A^3^LOTBARB^028^^1^1|0.29^2|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>E6<CR><LF> SD:<ACK> RC:<STX>3R|8|^^^85A^4^LOTBARB^028^^1^1|0.23^1|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>E2<CR><LF> SD:<ACK> RC:<STX>4R|9|^^^86A^1^BENZ^029^^1^1|^13|mA/min||SU||R||||20070308161216|DXC^0<CR><ETX>84<CR><LF> SD:<ACK> RC:<STX>5C|1|I|SH|I<CR><ETX>D6<CR><LF> SD:<ACK> RC:<STX>6R|10|^^^86A^2^BENZ^029^^1^1|0.45^1|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>3B<CR><LF> SD:<ACK> RC:<STX>7R|11|^^^86A^3^BENZ^029^^1^1|0.55^2|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>40<CR><LF> SD:<ACK> RC:<STX>0R|12|^^^86A^4^BENZ^029^^1^1|0.45^1|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>39<CR><LF> SD:<ACK> RC:<STX>1R|13|^^^87A^1^LOTCOCM^030^^1^1|0.55^2|mA/min||NR||R||||20070308161216|DXC^0<CR><ETX>15<CR><LF> SD:<ACK> RC:<STX>2R|14|^^^87A^2^LOTCOCM^030^^1^1|0.45^1|mA/ min||NR||R||||20070308161216|DXC^0<CR><ETX>16<CR><LF> SD:<ACK> RC:<STX>3R|15|^^^87A^3^LOTCOCM^030^^1^1|0.55^2|mA/ min||NR||R||||20070308161216|DXC^0<CR><ETX>1B<CR><LF> SD:<ACK> RC:<STX>4R|16|^^^87A^4^LOTCOCM^030^^1^1|0.45^1|mA/ min||NR||R||||20070308161216|DXC^0<CR><ETX>1C<CR><LF> SD:<ACK> RC:<STX>5R|17|^^^64A^1^LOTMETD^031^^1^1|0.44^2|mA/ min||NR||R||||20070308161216|DXC^0<CR><ETX>1F<CR><LF> SD:<ACK> RC:<STX>6R|18|^^^64A^2^LOTMETD^031^^1^1|0.36^1|mA/ min||NR||R||||20070308161216|DXC^0<CR><ETX>22<CR><LF> SD:<ACK> RC:<STX>7R|19|^^^64A^3^LOTMETD^031^^1^1|0.44^2|mA/ min||NR||R||||20070308161216|DXC^0<CR><ETX>25<CR><LF> SD:<ACK> RC:<STX>0R|20|^^^64A^4^LOTMETD^031^^1^1|0.36^1|mA/ min||NR||R||||20070308161216|DXC^0<CR><ETX>17<CR><LF> SD:<ACK> RC:<STX>1L|1|N<CR><ETX>04<CR><LF> SD:<ACK> RC:<EOT>

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-39

ASTM Interface

ASTM - LIS Message Flow Examples

DxC queries the host, the LIS does not reply, the DxC times out and sends a query abort message. It is not recommended to allow the DxC to timeout post query. The LIS does not respond when the DxC is querying the host.

SD = LIS sends RC = LIS receives

RC:<ENQ> SD:<ACK> RC:<STX>1H|\^&<CR><ETX>E5<CR><LF> SD:<ACK> RC:<STX>2Q|1|^SAMPLE1\^SAMPLE2\^SAMPLE3\^SAMPLE4||||||||||O<CR><ETX>41<CR><LF> SD:<ACK> RC:<STX>3L|1|N<CR><ETX>06<CR><LF> SD:<ACK> RC:<EOT> RC:<ENQ> SD:<ACK> RC:<STX>1H|\^&<CR><ETX>E5<CR><LF> SD:<ACK> RC:<STX>2Q|1|^SAMPLE1\^SAMPLE2\^SAMPLE3\^SAMPLE4||||||||||A<CR><ETX>33<CR><LF> SD:<ACK> RC:<STX>3L|1|N<CR><ETX>06<CR><LF> SD:<ACK> RC:<EOT>

ASTM Interface Specifications Page 5-40

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM - LIS Message Flow Examples

ASTM Interface

5

Results sent from DxC to LIS. (Results with special calculations):

SD = LIS sends RC = LIS receives

RC:<ENQ> SD:<ACK> RC:<STX>1H|\^&<CR><ETX>E5<CR><LF> SD:<ACK> RC:<STX>2P|1||||||^0|U|||||||||||||||||<CR><ETX>C2<CR><LF> SD:<ACK> RC:<STX>3O|1|27^7^3||^^^08A^2\^^^06A^2\^^^03A^2\^^^48A^2|R|20070308161217|||0.0^^^0.0||||||Other|||1^1 |||||||<CR><ETX>DB<CR><LF> SD:<ACK> RC:<STX>4R|1|^^^08A^1^LOTALB^001^^1^1|^13|g/dL||SU||R||||20070308161217|DXC^0<CR><ETX>21<CR><LF> SD:<ACK> RC:<STX>5C|1|I|SD|I<CR><ETX>D2<CR><LF> SD:<ACK> RC:<STX>6R|2|^^^08A^2^LOTALB^001^^1^1|3.8|g/dL||NR||R||||20070308161217|DXC^0<CR><ETX>F4<CR><LF> SD:<ACK> RC:<STX>7R|3|^^^06A^1^LOTGLU^002^^1^1|430|mg/dL||NR||R||||20070308161217|DXC^0<CR><ETX>78<CR><LF> SD:<ACK> RC:<STX>0R|4|^^^06A^2^LOTGLU^002^^1^1|412|mg/dL||NR||R||||20070308161217|DXC^0<CR><ETX>73<CR><LF> SD:<ACK> RC:<STX>1R|5|^^^03A^1^LOTCRE^003^^1^1|4.55|mg/dL||NR||R||||20070308161217|DXC^0<CR><ETX>99<CR><LF> SD:<ACK> RC:<STX>2R|6|^^^03A^2^LOTCRE^003^^1^1|4.11|mg/dL||NR||R||||20070308161217|DXC^0<CR><ETX>94<CR><LF> SD:<ACK> RC:<STX>3R|7|^^^48A^1^LOTMG^017^^1^1|1.24|mg/dL||NR||R||||20070308161217|DXC^0<CR><ETX>5E<CR><LF> SD:<ACK> RC:<STX>4R|8|^^^48A^2^LOTMG^017^^1^1|1.26|mg/dL||NR||R||||20070308161217|DXC^0<CR><ETX>63<CR><LF> SD:<ACK> RC:<STX>5M|1|110|20070309090236|SPECIAL CALC 1|OK|434.55|Unit 1|1|3|1|1<CR><ETX>7B<CR><LF> SD:<ACK> RC:<STX>6M|1|110|20070309090236|SPECIAL CALC 2|OK|5.79|Unit 2|1|3|1|1<CR><ETX>1E<CR><LF> SD:<ACK> RC:<STX>7L|1|N<CR><ETX>0A<CR><LF> SD:<ACK> RC:<EOT>

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

ASTM Interface Specifications Page 5-41

ASTM Interface

ASTM - LIS Message Flow Examples

DxC queries the host, but the LIS returns no information. In case the LIS does not have samples requested by the DxC, it is recommended that the LIS send a 'No Sample' reply message, to avoid long waiting periods.

SD = LIS sends RC = LIS receives

RC:<ENQ> SD:<ACK> RC:<STX>1H|\^&<CR><ETX>E5<CR><LF> SD:<ACK> RC:<STX>2Q|1|^SAMPLE1\^SAMPLE2\^SAMPLE3\^SAMPLE4||||||||||O<CR><ETX>41<CR><LF> SD:<ACK> RC:<STX>3L|1|N<CR><ETX>06<CR><LF> SD:<ACK> RC:<EOT> SD:<EOT><ENQ> RC:<ACK> SD:<STX>1H|\^&<CR><ETX>E5<CR><LF> RC:<ACK> SD:<STX>2P|1||||||||||U<CR><ETX>6C<CR><LF> RC:<ACK> SD:<STX>3O|1|SAMPLE1^|||||||||||||||1^1.00||||||||Y<CR><ETX>D7<CR><LF> RC:<ACK> SD:<STX>4L|1|N<CR><ETX>07<CR><LF> RC:<ACK> SD:<EOT> SD:<EOT><ENQ> RC:<ACK> SD:<STX>1H|\^&<CR><ETX>E5<CR><LF> RC:<ACK> SD:<STX>2P|1||||||||||U<CR><ETX>6C<CR><LF> RC:<ACK> SD:<STX>3O|1|SAMPLE2^|||||||||||||||1^1.00||||||||Y<CR><ETX>D8<CR><LF> RC:<ACK> SD:<STX>4L|1|N<CR><ETX>07<CR><LF> RC:<ACK> SD:<EOT> SD:<EOT><ENQ> RC:<ACK> SD:<STX>1H|\^&<CR><ETX>E5<CR><LF> RC:<ACK> SD:<STX>2P|1||||||||||U<CR><ETX>6C<CR><LF> RC:<ACK> SD:<STX>3O|1|SAMPLE3^|||||||||||||||1^1.00||||||||Y<CR><ETX>D9<CR><LF> RC:<ACK> SD:<STX>4L|1|N<CR><ETX>07<CR><LF> RC:<ACK> SD:<EOT> SD:<EOT><ENQ> RC:<ACK> SD:<STX>1H|\^&<CR><ETX>E5<CR><LF> RC:<ACK> SD:<STX>2P|1||||||||||U<CR><ETX>6C<CR><LF> RC:<ACK> SD:<STX>3O|1|SAMPLE4^|||||||||||||||1^1.00||||||||Y<CR><ETX>DA<CR><LF> RC:<ACK> SD:<STX>4L|1|N<CR><ETX>07<CR><LF> RC:<ACK> SD:<EOT>

ASTM Interface Specifications Page 5-42

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Index

A

Access codes converted to DxC codes for DxC 600i reporting, 4-28 Action Code Options, 5-15 ASTM - LIS Message Flow Examples, 5-36 ASTM Data Record Format, 5-4 ASTM Interface, 5-2 ASTM Messages, 5-5 ASTM Sample Order Reject Conditions, 5-35

L

Line Bidding (ASTM), 5-3 Long Header Message, 5-6

M

M112 Request Instrument State, 5-31 M113 Instrument State Reply, 5-32 M114 Test Availability Request, 5-33 M115 Test Availability Reply, 5-34 Manufacturer Records, 5-28 Message format, 2-2, 3-2 Message streams, 2-3, 3-3 Stream 700-Special functions Function 1: Are you there?, 3-4 Function 2: Host setup, 3-4 Stream 701-Sample/cup program Function 1: Sample/cup program, 3-6 Function 2: Sample/cup return status, 3-9 Function 3: Clear rack/sample IDs, 3-11 Function 4: Clear rack/sample IDs status, 3-13 Function 6: Host query rack/sample IDs, 3-13 Stream 702-Results Function 1: Cup header, 3-15 Function 3: Test results, 3-17 Function 5: End of cup, 3-22 Function 11: Special calculations results, 3-23 Function 13: Timed urine results, 3-24 Function 81: Expanded results, 3-25 Stream 703-Instrument status Function 1: Power up, 3-30 Function 2: Bidirectional on, 3-32 Function 3: Request instrument state, 3-32 Function 4: Instrument state, 3-33 Function 17: End of run, 3-34 Stream 704-Setup status Function 7: Request installed chemistries, 3-35 Function 8: Installed chemistries, 3-35 Stream 800-Special functions Function 1: Are you there?, 2-4 Function 2: Host setup, 2-4 Stream 801-Sample/cup program Function 1: Sample/cup program, 2-6 Function 2: Sample/cup return status, 2-10 Function 3: Clear rack/sample IDs, 2-11 Function 4: Clear rack/sample IDs status, 2-12 Function 6: Host query rack/sample IDs, 2-13 Stream 802-Results Function 1: Cup header, 2-15 Function 3: Test results, 2-17 Function 5: End of cup, 2-21

B

Bidirectional protocol, 1-12 Control characters, 1-12 Data transfer, 1-14 Downloading sample programming, 1-19 Line bidding, 1-13 Solicited messages, 1-18 Unsolicited messages, 1-16

C

Cable length, 1-6 Chemistry codes, 4-5 Comment Record (Patient Comment), 5-25 Comment Record (Result Comment), 5-27 Comment Record (Sample Comment), 5-26 Connector pin assignments, 1-6

D

Definitions, 1-4

H

Host Query, 5-22 Host Query (Request Information Record), 5-22

I

Instrument codes, 4-14 Instrument State Reply, 5-32 Instrument status codes, 4-27 Interface protocol options, 1-5 Invalid/valid characters, 2-2, 3-2

K

Key code conversion for local languages, 4-30

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

Index Page i of ii

Function 11: Special calculations results, 2-21 Function 13: Timed urine results, 2-23 Function 81: Expanded results, 2-24 Stream 803-Instrument status Function 1: Power up, 2-28 Function 2: Bidirectional on, 2-30 Function 3: Request instrument state, 2-31 Function 4: Instrument state, 2-31 Function 17: End of run, 2-32 Stream 804-Setup status Function 7: Request installed chemistries, 2-33 Message Terminator Record, 5-24

Sample Result Record, 5-17 Sample type codes, 4-3 Short Header Message, 5-7 Special calculation status codes, 4-26 Special Calculations, 5-29 Stream 700-Special functions, 3-4 Stream 800-Special functions, 2-4

T

Test Availability Reply, 5-34 Test Availability Request, 5-33 Test Order Record, 5-11 Test type codes, 4-2 Timed Urine Calculations, 5-30 Transmission format defaults, 1-7 Transmission format options, 1-7

P

Patient Comment, 5-25 Patient Information Record, 5-8

R

Request Information Record, 5-22 Request Instrument State, 5-31 Result Comment, 5-27 Result error codes, 4-20 Descriptions, 4-22

U

Unidirectional protocol, 1-9 Hardware control, 1-10 Protocol control characters, 1-10 Software control, 1-10 Transmitted information, 1-9 Unit codes, 4-12

S

Sample Comment, 5-26

V

Valid/invalid characters, 2-2, 3-2

Index Page ii of ii

UniCel DxC Synchron Clinical Systems Host Interface Specifications A16150 May 2008

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