Interf Architect
Interf Architect
Interf Architect
1998, 2002 Abbott Laboratories ARCHITECT is a registered trademark of Abbott Laboratories Patents Pending
Foreword
This manual has been designed to help you familiarize yourself with all aspects of the Abbott Standard Interface for the ARCHITECT System. If you have any questions, do not hesitate to contact your local Abbott Laboratories Diagnostics Division Customer Support Representative to obtain prompt answers to your inquiries.
Customer Support
United States: 1-800-527-1869 Canada: 1-800-387-8378 (English speaking customers) 1-800-465-2675 (French speaking customers)
Proprietary Statement
The ARCHITECT System software programs and system documentation are protected by copyright. All rights are reserved. The software and manual were developed solely for use with the ARCHITECT System and for in vitro diagnostic applications as specified in the operating instructions. The information, documents and related graphics published herein (the Information) are the sole property of Abbott Laboratories. Permission to use the Information is granted, provided that the copyright notice appears on all copies; use of the Information is for operation of ABBOTT products by Abbott trained personnel or informational use only; the Information is not modified in any way; and no graphics are used separate from accompanying text. Each person assumes full responsibility and all risks arising from use of the Information. The Information is presented AS IS and may include technical inaccuracies or typographical errors. Abbott Laboratories reserves the right to make additions, deletions, or modifications to the Information at any time without any prior notification.
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Disclaimers
All samples (printouts, graphics, displays, screens, etc.) are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample printouts and screens do not reflect actual patient names or test results. Abbott Laboratories makes no representations or warranties about the accuracy and reliability of the information contained in or printed from the ARCHITECT System Operations Manual CD-ROM. The Information was developed to be used by Abbott Laboratories trained personnel, by other persons knowledgeable or experienced with the operation and service of the product identified, or under the direct supervision and with cooperation from Abbott Laboratories technical sales or service representatives. In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred in connection with or arising from the use of the Information by persons not fully trained by Abbott Laboratories. This limitation shall not apply to those persons knowledgeable or experienced with the operation and service of the product identified, or under the direct supervision and with cooperation from Abbott Laboratories technical sales or service representatives. No confidential relationship shall be established in the event that any user of the Information should make any oral, written or electronic response to Abbott Laboratories (such as feedback, questions, comments, suggestions, ideas, etc.). Such response and any information submitted therewith shall be considered non-confidential, and Abbott shall be free to reproduce, publish or otherwise use such information for any purposes whatsoever including, without limitation, the research, development, manufacture, service, use, or sale of products incorporating such information. The sender of any information to Abbott is fully responsible for its content, including its truthfulness and accuracy and its non-infringement of any other persons proprietary rights. Abbott Laboratories is not engaged in rendering medical advice or services.
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Updates to the Information may be provided in either paper or electronic format. Always refer to the latest documents for the most current information. Incremental manual updates may cause the master Table of contents or master Index page numbering to change.
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Abbotts liability for all matters arising from the supply, installation, use, repair, and maintenance of the instrument, whether arising under this Warranty or otherwise, shall be limited solely to the repair or (at Abbotts sole discretion) replacement of the instrument or of components thereof. Replaced parts shall become the property of Abbott Laboratories. In no event shall Abbott be liable for injuries sustained by third parties, consequential damages, and/or lost profits. The ICT module Warranty is 15,000 samples or two months post-installation, whichever occurs first. The cuvette warranty is one year post-installation. THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTT LABORATORIES REGARDING THE INSTRUMENT, AND ABBOTT SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS IMPLIED FOR A PARTICULAR PURPOSE.
Abbott warranty
ABBOTT LABORATORIES MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE WITH RESPECT TO THE INFORMATION. ABBOTT LABORATORIES HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NONINFRINGEMENT. IN NO EVENT SHALL ABBOTT LABORATORIES BE LIABLE FOR ANY DAMAGES OF ANY KIND OR NATURE, INCLUDING, WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL (INCLUDING LOSS OF PROFIT) CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE EXISTENCE OR USE OF THE INFORMATION, REGARDLESS OF WHETHER ABBOTT LABORATORIES HAS BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES. ABBOTT MAKES NO WARRANTIES FOR THE INTERFACE, THE ARCHITECT HOST/INSTRUMENT DATA DISK, ASIST, OR THE ARCHITECT SCC SIMULATOR (FOR LIS VENDORS) BEYOND THOSE SET FORTH IN THE OPERATIONS MANUAL FOR THE ABBOTT SYSTEM/INSTRUMENT.
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Agency approvals
The ARCHITECT System has been tested and found to comply with the following agency standards: Underwriters Laboratories: UL 3101-1 or UL61010A-1 Electrical Equipment for Laboratory Use Part 1: General Requirements cUL: CSA c22.2 No. 1010 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General Requirements 21CFR Part 1040.10: Performance Standards for Light Emitting Products IEC 60825-1: Safety of Laser Products (Class I Laser Products) CE Marking
In Vitro Diagnostic Directive Legal Manufacturer Authorized Representative 98/79/EC Abbott Laboratories Abbott Park, IL 60064 USA Abbott Max-Planck-Ring 2 65205 Wiesbaden Germany +49-6122-580
Trademark statement
ARCHITECT, i 2000, Chemiflex, and AxSYM are registered trademarks of Abbott Laboratories. i 2000SR, i 4000, i 6000, i 8000, ci 8200, ARCHITECT ARMTM, c 8000, and SmartWash are trademarks of Abbott Laboratories. INTEL and PENTIUM are registered trademarks of Intel Corporation. ASTM is a registered trademark of the American Society for Testing and Materials. Windows and MS-DOS are registered trademarks of Microsoft Corporation. The following references are used throughout this manual to represent trademarks of Abbott Laboratories.
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Reference
ARM c 8000 i 2000 i 2000SR ci 8200
Trademark
ARCHITECT ARMTM c 8000 i 2000 i 2000SR ci 8200
All Abbott Laboratories product names and trademarks are owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, trade dress, or product name may be made without the prior written authorization of Abbott Laboratories, except to identify the product or services of Abbott Laboratories. All other trademarks, brands, product names, and trade names are the property of their respective companies. All rights reserved. Except as permitted above, no license or right, express or implied, is granted to any person under any patent, trademark, or other proprietary right of Abbott Laboratories. The following U.S. Patents are relevant to the ARCHITECT c System or its components.
4,533,457 4,797,192 4,619,739 5,025,389 4,647,362 5,413,770 4,678,755
The following U.S. Patents are relevant to the ARCHITECT i System or its components.
5,468,646 5,565,570 5,795,784 Des. 401,700 Des. 404,829 Des. 413,539 6,150,113 5,536,049 5,669,819 Des. 397,938 5,783,699 Des. 406,901 5,965,828 6,153,377 5,543,524 5,682,662 Des. 401,699 5,856,194 5,915,583 6,022,746 6,162,645 5,545,739 5,723,795 Des. 401,697 5,859,429 5,938,120 6,063,634
There are other such patents and patent applications in the United States and worldwide.
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System labeling
The symbols in the following table are used on ARCHITECT System labeling. Key to symbols used on labeling
Label Description
Authorized representatitve
Legal manufacturer
Date of manufacture
Electrical shock
Sample Cups
ICT Cleaning Fluid ICT Lyophilized Cleaning Solution Water Bath Additive
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Pre-Trigger Solution
Septum
Replacement Caps
List number
Temperature limitation
Lot number
Quantity
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Table of Contents
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Disclaimers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv ARCHITECT i System warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .v ARCHITECT c System warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .v Abbott warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Agency approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Trademark statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii System labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
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ASTM E 1381-91 Sender/ Receiver State Diagram. . . . . . . . . . . 1-24 Presentation Layer Message Content. . . . . . . . . . . . . . . . . . . . . . . . 1-27 Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27 Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28 Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31 Delimiters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31 ASI Defined Fields. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35 Sender Name or ID (ASTM E 1394-91 Field 7.1.5) . . . . . . . 1-35 Universal Test ID (ASTM E 1394-91 Field 6.6.1) . . . . . . . . 1-36 Specimen IDs (ASTM E 1394-91 Field 9.4.3, 9.4.4) . . . . . . 1-39 Patient IDs (ASTM E 1394-91 Fields 8.1.3, 8.1.4, and 8.1.5) 1-39 Action Codes (ASTM E 1394-91 Field 9.4.12). . . . . . . . . . . 1-41 Report Type (ASTM E 1394-91 Field 9.4.26). . . . . . . . . . . . 1-42 Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42 Record Sequence Number . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43 Records and Fields. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-44 Request Information Record . . . . . . . . . . . . . . . . . . . . . . . . . 1-56 Application Layer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-65 Category I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-65 Category II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-66 Category III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-67 Category IV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-68
ARCHITECT i 2000SR System . . . . . . . . . . . . . . . . . . . . . . . . 2-6 System control center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 SCC standard components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 Network hub . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11 SCC optional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 ARCHITECT System software. . . . . . . . . . . . . . . . . . . . . . . . . 2-13 Software interface description . . . . . . . . . . . . . . . . . . . . . . . . 2-13 Screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17 Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18 Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19 Software navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
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Snapshot screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20 User logon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22 Processing modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27 Processing module (c 8000) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27 Processing module keypad (c System) . . . . . . . . . . . . . . . . . . 2-29 Processing center (c System) . . . . . . . . . . . . . . . . . . . . . . . . . 2-30 Supply and pump center (c System) . . . . . . . . . . . . . . . . . . . . 2-44 Optional components (c 8000 processing module) . . . . . . 2-47 Processing modules (ARCHITECT i System). . . . . . . . . . . . . . 2-48 i 2000 processing module . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48 i 2000SR processing module . . . . . . . . . . . . . . . . . . . . . . . . 2-53 Processing module keypad (i System) . . . . . . . . . . . . . . . . . . 2-55 Processing center (i System). . . . . . . . . . . . . . . . . . . . . . . . . . 2-56 Supply and waste center (i System) . . . . . . . . . . . . . . . . . . . . 2-75 Optional components (i System) . . . . . . . . . . . . . . . . . . . . . . 2-85 Sample handlers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-92 RSH retest sample handler (c 8000 or i 2000SR) . . . . . . . . . . . . 2-92 Priority bay (RSH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-93 Routine bay (RSH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-95 RSH keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-97 SSH standard sample handler (i 2000). . . . . . . . . . . . . . . . . . . . 2-97 SSH keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-100 LAS carousel sample handler (i 2000) . . . . . . . . . . . . . . . . . . . . 2-101 LAS carousel sample handler keypad. . . . . . . . . . . . . . . . . . 2-102 System statuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-103 Sample handler status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-103 RSH status types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-104 SSH status types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-105 LAS carousel sample handler status types . . . . . . . . . . . . . . 2-106 Processing module status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-107 Processing module status types (c 8000) . . . . . . . . . . . . . . . 2-108 Processing module status types (i 2000 and i 2000SR). . . . . 2-109
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Power on the processing module and/or sample handler. . . . . 3-7 Power off the processing module and/or sample handler . . . . 3-7 Cycle power to the processing module and/or sample handler 3-8 Start up the processing module and/or sample handler . . . . . . 3-9 Pause the processing module . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 Pause the RSH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11 Pause the sample carousel (c System) . . . . . . . . . . . . . . . . . . 3-12 Pause the sample load queue (SSH) . . . . . . . . . . . . . . . . . . . 3-12 Pause the LAS carousel sample handler . . . . . . . . . . . . . . . . 3-13 Setting Communications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15 Host Release Mode Configuration Windows . . . . . . . . . . . . . . 3-17 Configuration screen System settings view. . . . . . . . . . . . . . . . 3-20 Access the Configuration screen System settings view . . . 3-21 System Control Center Configuration Windows . . . . . . . . . . . . . 3-24 Serial Ports Configuration Windows . . . . . . . . . . . . . . . . . . . . . . 3-28
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Message Header Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6 Patient Information Record . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6 Test Order Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8 Comment Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11 Negative Query Response Record . . . . . . . . . . . . . . . . . . . . . 5-12 Message Terminator Record . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Section 7 Troubleshooting
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Error codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Error Messages Specific to the RS-232 Interface . . . . . . . . . . . . . . 7-3 Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-31
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Viewing item details from the database. . . . . . . . . . . . . . . . . 8-38 Disconnecting from the communication port . . . . . . . . . . . . 8-43 Sending results or queries to a host . . . . . . . . . . . . . . . . . . . . 8-45
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ARCHITECT ONLY: Comment Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-35 Negative Query Response Record, ARCHITECT . . . . . . . . . 9-36 Request Information Record, AxSYM . . . . . . . . . . . . . . . . . . 9-36 Message Terminator Record . . . . . . . . . . . . . . . . . . . . . . . . . . 9-38
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Table of Contents-8
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Section 0Introduction
The Abbott Standard Interface RS-232 Manual/ ARCHITECT System Edition provides the necessary information for interfacing the ARCHITECT System to hospital or laboratory information systems across the serial RS-232 communications port. Topics in this section include: Overview of the Manual Alternative Reference Materials
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Introduction
NOTES
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This manual assumes the reader is familiar with programming techniques and is capable of programming using a high level language. This manual also assumes the reader has a good working knowledge of serial communications as they relate to the computer system that interfaces with the Abbott instrument or system. For readers not familiar with the ASTM E 1381-91 and E 1394-91 communications standards, we highly recommend ordering these standards by calling or writing ASTM using the information provided in "Alternative Reference Materials" on page 5: All readers should carefully study the Overview of the Abbott Standard Interface section and all subsequent sections to understand how Abbott instruments implement the ASTM standards. The reader should then be able to develop and program the logic required to effectively communicate with the ARCHITECT System as well as setup and diagnose communications. Included with this manual is a data diskette containing the Instrument Specification File (ISF) for the ARCHITECT System. When this file is loaded as the current instrument in the ASIST environment, the user can perform comprehensive testing and validation of communication protocols. Instrument developers can use ASIST to emulate a Host computer. ASIST sends requests in user-generated test protocols to ensure that the equipment accepts and interprets these communications correctly. Host computer software developers can use ASIST to emulate Abbott instruments to test communications without having to invest in the instruments themselves. Test transmissions of report data, using established record layouts and communications protocols, ensure that host software properly interfaces with actual instruments after installation. The data diskette is provided with the understanding that modifying originals or copies of the data files invalidates the data files. Do not use invalid data files to represent instrument output. Abbott provides this software as a tool to assist the development of interface software to Abbott instruments and systems. Developers should not rely solely on the use of this product for verification and validation of their interface software. ASIST software is provided with the understanding that Abbott does not guarantee its support or future availability.
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NOTES
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Section 1
Section 1Introduction
This section explains the Abbott implementation of the ASTM E 1381-91 and E 1394-91 communications standards. Topics include: Overview of the Abbott Standard Interface (ASI) Layered Protocols Physical Layer Electrical, Mechanical, and Signaling Characteristics Data Link Layer Establishment, Transfer, and Termination Presentation Layer Message Content Application Layer
Section 1-1
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Section 1
NOTES
Section 1-2
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Section 1
Section 1-3
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Section 1
Definition
Abbott Standard Interface: Abbotts implementation of the American Society for Testing and Materials (ASTM) Standard. E 1394-91, A Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems. E 1381-91, Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems. All data is represented in ASCII format within the range 0 255. Values 0 127 are defined by ANSI X3.4-1986 Standard. Values 128 255 are defined as needed by specific instruments. Values 0 31 cannot be used, with the exception of 13 (<CR>). The value 13 is reserved as a record terminator. Values 32 255 can be used, with the exception of 127 and 255. Within a data text field, only the ASCII characters 32 126 and 128 254 are permitted as usable characters. Characters used as delimiters in the transmission are excluded from the above permitted range. The sender is responsible for checking that a data text field does not contain any delimiters. The record identifier fields (H,P, O, R, L, C, M, and Q) are always uppercase when output from the Abbott instrument. On input, both upper- and lowercase record identifiers are accepted. Fields and records are variable in length with no restriction placed on the maximum length of a field or record. The high-level protocol depends on the receivers buffering capability and the low-level communication ability to divide the information into workable lengths for transmission and processing purposes. All Abbott Standard Interface RS-232 manuals provide the maximum allowable length of each field transmitted and received. A block of data that is transmitted in a format consistent with the ASTM E 1394-91 Standard. Data is transmitted in a series of records starting with a Header Record (H) and ending with a Terminator Record (L). When a transmission is lost, the Abbott instrument retransmits or accepts only complete messages. An E 1394 Record is a string of characters starting with a capital ASCII alphabet character and ending with a carriage return (ASCII 13), as defined by the ASTM E 1394-91 Standard. The following characters have special uses and should not be used for data: Vertical Bar (|) Backslash (\) Ampersand (&) Carriage Return (<CR>) Caret (^) A block of data that is transmitted in a format consistent with the ASTM E 1381-91 Standard. Abbott ASI instruments use an E 1394-91 Record as the E 1381-91 Message. Thus, an E 1381-91 Message may be transmitted using multiple (one or more) frames, based on the length of the message. A frame is a subdivision of a message and allows transmission of up to 247 characters (240 data characters and 7 control characters). The Abbott instrument transmits one record per frame. Messages more than 247 characters long can be divided into multiple frames, as long as each frame contains only information from one record at a time.
E 1394-91 Message
E 1381-91 Message
E 1381-91 Frame
Section 1-4
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Section 1
Host System
Layer 4 (OSI Layer 7) Layer 3 (OSI Layer 6) Layer 2 (OSI Layer 2)
Figure 1.1:
The OSI layer designators are used as reference and do not imply compliance with actual ISO/OSI Standards. Based on this architecture, ASI defines the following layers for implementation of communications software:
Section 1-5
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Section 1
Physical Layer (Layer 1) Directs transmission of serial binary data bits between the Abbott instruments and systems and external host computers across a mechanical and electrical connection, as defined by this document and ASTM E 1381-91 section 5. Data Link Layer (Layer 2) Provides services for establishing a link connection, transferring data, and releasing the connection. Also provides services for delimiting, synchronism, sequence control, error detecting and recovering of the link, as defined by this document and ASTM E 1381-91 section 6. Presentation Layer (Layer 3) Provides services for building message content into a standard and interpretable form, as defined by this document and ASTM E 1394-91. Application Layer (Layer 4) Provides services for processing test requests, running assays, reporting results, etc., as defined by this document and the instrument specific operations manual. The following figure depicts the general implementation of these layers on new Abbott instruments and systems that support the ASTM Standards.
ASI Implementations
Host System
Application Layer Software to request tests, process, store, report, and manage patient data Message Content Layer Software to convert above data into a standard and interpretable form Data Link Layer Software for link connection and release, delimiting and synchronism, sequence control, error detection and recovery
Physical Layer Mechanical and electrical connection for serial binary data bit transmission between the instrument and the host
Figure 1.2:
ASI Implementations
Section 1-6
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Section 1
Host System
Application Layer Presentation Layer Data Link Layer
Figure 1.3:
Physical Layer
Abbott instruments and systems supporting the Abbott Standard Interface (ASI) implement the physical layer of the interface as specified by the ASTM E 1381-91 standard. This interface is based on the EIA RS-232D -1986 standards, for the mechanical and electrical characteristics and the ANSI X3.15-1976 and ANSI X3.16-1976 for the signaling characteristics, such as the structure of the characters being transmitted.
Electrical Characteristics
Abbott instruments use a voltage more negative than minus three volts (with respect to signal ground) to indicate a marking condition (binary one). A voltage more positive than plus three volts (with respect to signal ground) indicates a spacing condition (binary zero). The relevant voltage and impedance levels of the signal generator and the signal receiver circuits of ASI instruments meet the requirements set forth in the RS-232D-1986 standard.
Mechanical Characteristics
ASI instruments use a 25-pin connector to facilitate connection to an external computer system. The connection provided conforms to the requirements of the EIA RS-232D Standard. The Communication Setup section of each Abbott Standard Interface RS-232 manual covers the specifics for that instrument. The cabling and pin-out requirements of Abbott instruments and systems conform to the specifications defined in the ASTM E 1381-91 standard. Only pins 1, 2, 3, and 7 of the connector are used. Refer to the following table and figure for pin assignment information. The ASTM E 1381-91 standard requires that the external Host computer is configured as a DCE device.
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Table 1.2: Pin Assignments for the 25-Pin Connector Pin No. EIA Circuit
BA BB AB
Abbott Instrument (DTE) 1 Shield 2 Output 3 Input
Description
1 2 3 7
Pin-to-Pin Connections (Wiring Diagram)
Output Input
Signal Ground
Figure 1.4:
NOTE: If a computer is configured as a DTE Device (i.e., pin 2 is the output and pin 3 is the input), then the cable connecting the ASI instrument to the computer must have lines 2 and 3 crossed.
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For Host computer systems that do not conform to the ASTM standard for the physical connection, other cabling schemes may be required as shown below. Many personal computers may have a 9-pin connector instead of the 25-pin required by the ASTM specifications.
Host computer (PC with 9-pin connector) with Non-ASTM compliant connector
1 2 3 7
1 2 3 5
9-Pin Connector
Figure 1.5:
Host computer (PC with 9-pin connector) with Non-ASTM compliant connector
NOTE: Pin 1 is the shield connection and connects to the instruments (DTE) frame. Leave the shield connection open at the computer (DCE) to avoid ground loops.
Host Computer with 9-Pin PC-AT style connector
1 2 3 7
1
Output Input Ground
2 3 5
9-Pin Connector
Figure 1.6:
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Section 1
If the same computer used a 25-pin connector configured as a DTE, the cabling requirements are as follows:
Host computer (PC with 25-pin connector) with Non-ASTM compliant connector
1 2 3 7
1 2 3 7
25 Pin Connector
Figure 1.7:
Host computer (PC with 25-pin connector) with NonASTM compliant connector.
ASI instruments and systems may optionally provide fixed length cables for connecting to external systems. When cable lengths greater than 50 feet are required, then Low Capacitance shielded cables are recommended. Local Building Fire Code standards may require the use of Plenum rated cables for connecting systems. Please check with your building personnel for specific requirements that apply to wiring and cabling in your specific environment.
Signaling Characteristics
Character Structure
Character bit patterns and bit rates determine how Abbott instruments communicate with computer systems. The character bit sequencing, structure, and parity sense definitions conform to ANSI standards X3.15-1976 and X3.16-1976. The default structure for Abbott instruments character bit sequencing is: 1. A start bit with a value of zero. 2. The start bit is followed by eight bits that represent character data.
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8 Data Bits
Start Bit
Stop Bit
Figure 1.8:
Default Abbott Instruments Character Structure. The start and stop bits separate ASCII characters which are eight bits long.
All ASI instruments support the ASTM required combinations of: Start bits Data bits Parity bits Stop bits
Speed
Abbott instruments that implement ASI provide multiple baud rates for transmitting data to external systems. As a minimum, all ASI instruments support the ASTM preferred communications speed of 9600 baud, and may also support one or more of the following [1200, 2400, 4800, 14400, 19200, 28800, 38400, 57600, 115200]. The default setting of all ASI instruments for host communications is 9600 baud. For information on the exact baud rates supported by each instrument, refer to Communication Setup. Abbott data management systems that are used as hosts support all four of the ASTM E 1381-91 required baud rates [1200, 2400, 4800, 9600]. Optionally, they may also support other baud rates [e.g., 19200, etc.] as required.
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NOTES
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Host System
Application Layer Presentation Layer Data Link Layer
Figure 1.9:
The data link layer covers methods for the following: Establishing communication connections with an external system Providing error detection and error recovery of communications Delimiting and synchronism Controlling sequence Sending and receiving messages Terminating the communications connections In addition, the data link layer performs the following inter-layer functions: Interacts with higher layers in transferring data Handles requests for establishing and terminating connections Reports the data link layer status The data link layer uses a character-oriented protocol to send messages between two systems that are directly connected. One system transmits while the other system monitors the communications link. Thus, information flows in only one direction at a time. Replies occur after information is sent, never at the same time. Abbott instruments implement the data link layer as specified in the ASTM E 1381-91 standard. This standard defines conditions that apply to a device if the device is an instrument, and other conditions if the device is a host computer system. Because Abbott Data Management systems are sometimes used as hosts for other Abbott instruments and other times as a link communicating to Laboratory Information Systems, these systems implement both the ASTM host and the instrument logic of the data link protocol. The configuration of these systems allows them to communicate appropriately based on the role that they are serving.
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The data link layer consists of the three following communications phases: Establishment phase Transfer phase Termination phase Each phase is discussed in detail.
Establishment Phase
The establishment phase determines the direction of information flow and prepares the receiver to accept information. The system with data available for transmission initiates the establishment phase. When Abbott ASI instruments and systems have data to send, they go into the establishment phase by transmitting the [ENQ] character. If a valid reply ([ACK], [NAK], or [ENQ]) is not received within the 15 second time period specified by ASTM E 1381-91, the Abbott instruments and systems enter the termination phase. The instrument returns to the establishment phase after waiting a certain amount of time (e.g., 30 seconds, 60 seconds, etc.) specific to that instrument. If after a certain number of attempts the instrument is unable to establish communications with the external system, the operator is informed via a dialog box (or error message) and an error message is posted to the error log file.
Receiver
Figure 1.10:
Sender Initiating Establishment Phase. The receiver returns a signal to the sender acknowledging that it is ready to receive.
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Receiver
[ENQ]
Figure 1.11:
Sender Receives a [NAK] Signal. If the sender receives a [NAK], the sender waits ten seconds before re-initiating the establishment phase.
Abbott Instrument
Prepare to Receive
2 [ENQ] 4 [ACK] 3
Figure 1.12:
Sender Receives an [ENQ] after Sending an [ENQ]. The sender prepares to receive.
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In the example shown in the following figure, the instrument sends an [ENQ] and receives an [ENQ]. The instrument waits at least one second before re-sending another [ENQ]. The computer system must wait at least twenty seconds before trying to initiate the communications by sending another [ENQ].
Instrument Receives an [ENQ] after Sending an [ENQ]. The instrument waits one second before re-sending another [ENQ].
Abbott Instrument 1
3 1 Second
[ENQ]
Figure 1.13:
Instrument Receives an [ENQ] after Sending an [ENQ]. The instrument waits one second before re-sending another [ENQ].
Transfer Phase
During the transfer phase, the sender transmits messages to the receiver until all messages are sent. Messages are sent in frames which contain a maximum of 247 characters. Special control characters identify the frame type, the beginning and end of a frame, and provide for error detection. The following table lists the special control characters.
.
Character
Description
Start of Text transmission control First character transmitted at the beginning of a frame. character Frame Number The frame number is an ASCII digit from 0 to 7. Its purpose is to permit the receiver to distinguish between new and re-transmitted frames. This single digit is sent immediately after the STX character. The frame number begins with 1 when the transfer phase is initialized and increments by 1 each time a new frame is transmitted and acknowledged. After 7, the frame number returns to 0 and repeats the above sequence. Character used to indicate end of an intermediate frame.
[ETB] [ETX]
End of Text transmission control Character used to indicate the end of an end frame. character
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Character
Most significant character of checksum 0 9 and A F Least significant character of checksum 0 9 and A F
Description
The checksum determines if a frame is defective. The checksum is encoded as two characters and is sent after the ETB or ETX character. The checksum is computed by adding the binary values of the characters (modulo 256), keeping the least significant 8 bits of the result. The 8 bits can be considered as two groups of 4 bits which are converted to ASCII and represented in hexadecimal format. The two ASCII characters are transmitted as the checksum with the most significant character first. The STX character initializes the checksum to zero. The first character used in computing the checksum is the frame number. The last character used is the ETB or ETX. The STX, CR, or LF are not included. Using the following Frame as an example, the checksum for this frame is calculated.
<STX> 1
<STX> 1 A B C D E F G H I <ETX> Total=
ABCDEFGHI
002 049 065 066 067 068 069 070 071 072 073 003 673
<ETX>
A1 <CR> <LF>
Not included in calculation 1st character for calculation 2nd etc. etc. etc. etc. etc. etc. etc. etc. Last character for calculation Total sum value
Then 673 (decimal) = 2A1 (HEX) The most significant byte (2) is discarded and the remainder is then transmitted as two characters, A (ASCII 65) and 1 (ASCII 49) to form the checksum. [CR] [LF] ASCII character for carriage return ASCII character for line feed Character used to end an E 1394-91 record (i.e., E1381-91 message) and the second to last character transmitted in a frame. The LF character is used as the last character of a frame. The LF character may not display in the message text.
Frames
Abbott instruments and systems supporting ASI handle an ASTM E 1394-91 record as an ASTM E 1381-91 message. If the E 1394-91 record is longer than 240 characters, the message is transmitted in multiple frames consisting of end frames and intermediate frames. If the message (i.e., E 1394-91 record) is less than or equal to 240 characters, the single frame transmitted is an end frame.
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
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Each new message begins in a new frame. A frame never contains more than one message or parts of more than one message. Two types of frames are used: End frames. A message with 240 characters or less is sent in a single end frame.
[STX] [F#] Message [ETX] [CS1] [CS2] [CR] [LF]
Intermediate frames. Messages that are longer than 240 characters are broken into pieces that are 240 characters or less in length and sent in multiple or intermediate frames with the last part of the message sent in an end frame
.
The following figure shows how a message with more than 240 characters is sent.
[ETB] indicates an intermediate frame. Message 1 is longer than 240 characters so it is divided into sections. Frame numbers reset after count reaches 7. Message 2 is not added to the frame containing the second part of Message 1, but begins in a new frame. [STX][1] [STX][2] Message 1 Message 1 continued [ETB] [CS1] [CS2] [CR] [LF] [ETB] [CS1] [CS2] [CR] [LF]
[STX][3], etc. [STX] [7] [STX] [0] [STX] [1] Message 1 continued Message 2 Message 2 continued [ETX] [CS1] [CS2] [CR] [LF] [ETB] [CS1] [CS2] [CR] [LF] [ETX] [CS1] [CS2] [CR] [LF]
Figure 1.14:
Intermediate and End Frames. Multiple frame messages start with intermediate frames and end with end frames containing only the end of one message.
After a frame is sent, the sender stops transmitting and waits for an acknowledgment [ACK] from the receiver. The receiver responds to every frame and when it is ready to receive another frame, it sends one of the following replies: Message Acknowledged [ACK] Message Not Acknowledged [NAK] End of Transmission [EOT]
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Receiver
Figure 1.15:
Sender Transmitting After Receiving [ACK]. The sender sends another frame after successfully transferring a frame.
A reply of [NAK] means that the last frame was not received successfully and that the receiver is ready to receive the frame again. The sender may re-transmit the frame or proceed to the termination phase.
Sender Retransmitting a Frame After Transmission Failure. The receiver indicates transmission failure with [NAK].
Receiver
Frame 1
Figure 1.16:
Sender Retransmitting a Frame After Transmission Failure. The receiver indicates transmission failure with [NAK].
Abbott ASI instruments and systems [NAK] a frame for the following reasons: Improperly framed transmission received after [STX]. Certain situations cause a time-out condition to occur if insufficient information is received to properly process the frame. Under these conditions, ASI instruments return to idle state without transmitting a [NAK] or any other characters. Invalid frame number or frame number out of sequence. Restricted character received in message text. Invalid checksum received.
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
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Characters received before [STX] are ignored. Once [STX] is received, the ASI instrument expects a complete frame. A reply of [EOT] acknowledges that the last frame was received successfully and that the receiver is ready for another frame, but the receiver is requesting that the sender stop transmitting. The sender must send a reply within the time-out period.
End of Transmission. The receiver indicates successful receipt of the complete message with an [EOT], but requires an interrupt.
Receiver
Figure 1.17:
End of Transmission. The receiver indicates successful receipt of the complete message with an [EOT], but requires an interrupt.
The sender can ignore the request and continue transmitting. In this case, the receiver must re-request the interrupt for the request to remain valid. Abbott ASI instruments and systems (acting as senders) do not honor the interrupt requests originating from the receiver. Receiving the [EOT] character in place of an [ACK] character is treated equivalent to receiving the [ACK] character. Abbott ASI instruments transmit all available data before entering the termination phase and relinquishing control of the data link (return to neutral state).
Error Handling
When errors in the data transmission occur, both the receiver and sender must have orderly recovery procedures. The receiver checks every frame for defects. The receiver sends a [NAK] reply if it receives a defective frame. When the sender receives a [NAK], it re-transmits the last frame using the same frame number.
Re-sending a Frame after a Transmission Failure. The receiver indicates a transmission failure with a [NAK].
Receiver
Frame 1
Figure 1.18:
Re-sending a Frame After a Transmission Failure. The receiver indicates a transmission failure with a [NAK].
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ASI instrument communication software depends on properly framed transmissions being received. If an [STX] is received, it is an indication that a frame is being transmitted. If all of the components of a frame are not received in proper relationship to one another, the frame is rejected. A frame is rejected by the receiver for several reasons, including: Character structure errors are detected in parity, baud rate, etc., or transmission is improperly framed. The frame checksum from the sender does not match the checksum on the receiving end. The frame number is incorrect. The number must be the same as the last one rejected or one number higher than the last one accepted by the receiver. When the sender receives anything other than an [ACK] or an [EOT], it updates a re-transmit counter by one and re-sends the frame. A frame can be re-transmitted a maximum of six times. After that, the sender must abort the message and proceed to the termination phase. If an [EOT] is encountered by the ASI instruments during the processing of a frame, the instruments return to idle state assuming that the sender terminated transmission prematurely. The sender must re-establish the connection in order to continue. NOTE: If the [ACK] is corrupted during transmission, the sender of data retransmits the last frame, since any character received other than an [EOT] or [ACK] is treated as a [NAK]. However, since the [ACK] was already transmitted for that frame, the receiver [NAK] duplicates frames to avoid any possibility of infinite loops. This leads to Termination Phase after six attempts.
Incrementing the Frame Counter. The sender keeps track of retransmissions with a frame counter.
Receiver
Figure 1.19:
Incrementing the Frame Counter. The sender keeps track of retransmissions with a frame counter.
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Time-outs
The sender and receiver have timers to control the coordination between them and to allow a recovery method in the event a communication line fails to respond.
Termination Phase
During the termination phase, the sender transmits the [EOT] transmission control character, notifying the receiver that all of the information has been sent. The sender regards the link to be in a neutral state. After receiving the [EOT], the receiver regards the link to be in a neutral state.
Definition
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Definition
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ASTM E 1381
A1 STATE DIAGRAM
Receiving Device
Idle
Busy Send <NAK> Receive <ENQ>
Sending Device
Send <EOT>
Waiting
Waiting
Get Frame
Increment %8 Count
Frame Received
Bad Frame Send <NAK> Timer = 30 Send <EOT> Timer = 30 New Frame Increment %8 Count
Done
Time Out
Accept
Frame Ready
Repeat Frame Send Frame Timer = 15
Interrupt Requested
Waiting
Receive <NAK> Increment Retries Receiving any character except <ACK> or <EOT> Receive <EOT>
NOTE 1 %8 represents modulo 8. NOTE 2 = represents assignment of a value. Timer: = 15 resets the timer to 15 s as used here. NOTE 3 Arrow associated normal text denotes a condition; arrow associated italicized text denotes action taken.
Figure 1.20:
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Condition
Have data to send (periodic check) ContentTimer <=0 BusyTimer <=0 Received ENQ Have Data to Send ContentTimer <=0 BusyTimer <=0 Received ENQ ContentTimer <=0 BusyTimer <=0 Received ENQ ContentTimer > 0 or BusyTimer > 0
Action
send ENQ transTimer = 15
Final State
transENQ
send NAK
Idle
send ACK
rcvWait
Protocol error
Idle
transENQ
ContentTimer = 1 BusyTimer = 10 Send Frame numNAK = 0 transTimer = 15 Ignore Ignore Send EOT Send next Frame numNAK = 0 transTimer = 15 Send old frame numNAK = numNAK + 1 Send next Frame numNAK = 0 transTimer = 15 Send EOT Send EOT send ACK rcvTimer = 30 increment frame # send NAK rcvTimer = 30 discard last incomplete message discard last incomplete message
Received other characters Received EOT transTimer <=0 transWait Received ACK
transWait transWait
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NOTES
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Host System
Application Layer Presentation Layer Data Link Layer
Figure 1.21:
Presentation Layer
The Abbott Standard Interface (ASI) uses the protocol defined by ASTM E 1394-91 standard as the basis for the message content layer of instrument communications software. This layer specifies the conventions used in structuring information (messages) for transmission to external host systems and for receiving information from these host systems.
Messages
The Presentation Layer requires that transmission and reception of all data must be performed using messages. A message consists of complete study files on one or more patients. Each message is a string of records which in turn are made up of fields. The following figure shows the basic structure of a message.
Message Logical Structure. Messages are subdivided into records which are made up of fields.
Message Record
Field
Figure 1.22:
Message Logical Structure. Messages are subdivided into records which are made up of fields.
The high-level protocol follows two general conventions: A hierarchical convention is implemented where records higher in the hierarchy contain information that is common to all records lower in the hierarchy. A positional convention is used to define the structure of the records.
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These conventions allow the fields, and thus the records, to vary in length. The ASTM E 1394-91 standard allows manufacturers the flexibility to: Create new record types through the use of the Manufacturer Record. Define the structure of certain existing fields. Define the structure of new manufacturer records. This manual describes how Abbott instruments use this flexibility.
Records
Records are collections of related information within a message. For example, one record may contain information about the system sending the message and the system receiving the message while another record may contain personal information about a patient who is to undergo tests. Records begin with an ASCII alphabetical character, called a record identifier, and end with a carriage return. In the following example, the record identifier is H, which is used to identify the Header Record.
H [CR]
ASI instruments use uppercase letters for all record identifiers transmitted. ASI instruments can receive upper or lowercase letters for record identifiers. The following table describes the records that Abbott instruments use and their associated record identifier fields.
Table 1.6: Record Types Record Type Record ID Field Level Description For Field Contents Refer to ASTM E 1394-91, Section
Header
7 Identifies the message. Contains information about the sender and receiver of the message, such as location and type of equipment used to send and receive the message. Contains information about a patient. Used to request information on a range of test results or test orders from another system. Contains information defining tests performed or requested. Contains information about test results. Contains comment text on the preceding record. 8 12
Patient Information
1 1
2 3 14
9 10 11
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M S L
14 N/A 0
Provided for custom use by the instrument or computer system manufacturer. Not used. Terminates the message.
The records within a message are arranged in a hierarchy of levels. The records higher in the hierarchy contain information that is common to all records that are lower in the hierarchy. The lowest number is the highest in the hierarchy. For example a Level 2 record is higher than a Level 3 record. Manufacturers Records and Comment Records may be used within any level except Level 0. Each level, other than Level 0, must be preceded by a higher level. The Manufacturer and Comment Records can be inserted at any level in the hierarchy and are considered to be one level below the preceding record. For example, a Comment Record below a Patient Record at Level 1 is considered a Level 2 record and contains comments about the patient in the Patient Record. A Comment Record below a Test Order Record (O) is considered a Level 3 record and contains comments about tests described in the Test Order Record.
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The following figure shows how the Comment and Manufacturer Records fit into a message hierarchy.
Comment and Manufacturer Records always refer to the preceding record and are one level below the record they are referring to.
No records are allowed below a Message Terminator Record except a Header Record.
Message 1 Level 0 Header Record (H) Level 1 Comment Record (C) - Comments about the message sender and/or receiver Manufacturer Record (M) - Custom information about the message sender and/or receiver Patient Record (P) Level 2 Comment Record (C) - Comments about the patient Manufacturer Record (M) - Custom information about the patient Test Order Records (O) Level 3 Comment Record (C) - Comments about the tests ordered Manufacturer Record (M) - Custom information about the tests ordered Result Records (R) Level 4 Comment Record (C) - Comments about the test results Manufacturer Record (M) - Custom information about the test results Level 0 Message Terminator Record (L) Message 2 Level 0 Header Record (H) Level 1 Request Information Record (Q) Level 2 Comment Record (C) Level 0 Message Terminator Record (L)
Figure 1.23:
Comment and Manufacturer Records. These records can be placed anywhere in a message between the Header and Message Terminator Records.
ASI instruments may optionally support the use of the Request Information Record (Q). Refer to the instrument specific section of each Abbott Standard Interface RS-232 manual for details on that instruments support of the Request Information Record. ASI instruments do not accept the Request Information Record as part of a message containing Patient (P) and Order (O) Records. Also, ASI instruments do not transmit the Request Information Record as part of a message containing Patient (P), Order (O), and Result (R) Records. When used, the message only includes the following: Header Record (H) Request Information Record (Q) Terminator Record (L) Manufacturer and Comment records may be used in conjunction with the Request Information Records, as needed by specific instruments.
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ASI instruments and systems may be batch as well as real time. Batch instruments and systems communicate the results of a run all at one time, usually at the end of that run. The results message consists of information on multiple samples. Real time systems, however, communicate the information as it becomes available. These systems normally communicate a shorter results message consisting of information on the results of only one sample test (the one that was just completed).
Fields
Fields are groups of characters that define a specific piece of information within a record, such as a patients name, telephone number, or street address. For example, the Patients Name field in the Patient Record is shown below:
P Field 2 Field 3 Field 6 Field 34 [CR]
Fields are position dependent. That is, fields are identified by their relative position in the record. For example, the field representing a patients name is always the sixth field in the Patient Record. Fields are all variable length. The Instrument Specific section of the Abbott Standard Interface RS-232 manual provides the maximum allowed length of each field transmitted or received by that instrument.
Delimiters
The ASTM E 1394-91 standard allows for the use of special characters to be used to separate: Adjacent fields Repeating information within a field Components of a field
Table 1.7: Delimiter Summary Delimiter Type
Field Repeat Component Escape | \ ^ &
Character
Description
Separates fields within records. Separates multiple occurrences for the same type of information within a field. Separates a field into smaller groups of characters. Allows imbedding of special characters within the data.
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The standard also indicates the use of special characters, such as delimiters, carriage returns, line feeds, etc. imbedded within text fields. The Abbott Standard Interface defines the delimiters used by Abbott Instruments for transmission to be as follows: Field DelimiterVertical Bar (|) Repeat DelimiterBackslash (\) Component DelimiterCaret (^) Escape DelimiterAmpersand (&) ASI instruments accept any characters defined in the header record and transmitted by the external system as the delimiters for that message. If a received data field contains a character that conflicts with the ASI defined delimiters (| \ ^ &), ASI instruments and systems may optionally use the Escape Delimiter to return the original data (i.e., conflicting character) back to the external system. Refer to the instrument specific sections to determine if this feature is supported by the instrument or the system. ASI instruments and systems may optionally support the ability to delete contents of specific fields that were previously transmitted by using the ASCII 34 quote character () as specified by ASTM E 1394-91 standard. Refer to the instrument specific sections to determine if this feature is supported by the instrument or the system. Following is a description of how delimiters work.
Field Delimiters
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Empty fields
R|1||0295||||||||198327132247[CR]
If a carriage return is introduced, this indicates that all the remaining fields in the record are empty. A carriage return can also indicate the end of the last field in a record.
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Component Delimiters
For example, the Patient Name field uses component delimiters to differentiate between first name, last name, middle name, suffix, and title: |BLAKE^LINDSEY^ANN^MISS|
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The following figure summarizes the delimiters used by the Abbott instrument.
Records
[CR]
| [CR]
^ ^
| [CR]
Figure 1.24:
Delimiter Summary. Field delimiters separate fields within records, repeat delimiters separate multiple occurrences of the same type of data within a field, component delimiters separate components within fields.
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Instrument/System Serial Number Interface Version Control The Interface Version Control is of the form XnXn... (without quotes). The X is used to indicate the record types the instrument supports. The n is used to indicate the implemented version of that record, and n can be any number. The valid characters for X are (H, P, O, R, L, C, M, and Q). The S (Scientific) record is not supported by ASI instruments. Thus, the Interface Version Control string H1P1O1R1L1 indicates an instrument that supports the header, patient, order, result, and terminator records. Any changes to the interface that would affect a particular record, would increment the version number of that record. An interface version of H1P1O2R2Q1L1 would indicate that the interface has changes to the order record, the result record, and the instrument/system is now supporting the query record. This allows host systems to compare the interface version control strings and focus their attention on the records that have changed. The component is optional and may not be supported by all instruments. Refer to the instrument specific section for details. When all components are supported, this field is transmitted as follows: |Instrument_name^Software_version^Serial_number^Interfac e_version_control| This field can be used to assist with field upgrades of interfaced instruments. If host systems support E-mail links to the developers, then this field can be used to inform the interface development team of a potential problem due to a mismatch of interface software between a host and an instrument.
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The Universal Test ID is composed of four major parts. The first three parts are reserved for future ASTM usage and are not used by ASI instruments and systems. As specified by the ASTM Standard E 1394-91 (section 6.6.1.4), the fourth part of the Universal Test ID is defined by each manufacturer. ASI instruments use the following components for the manufacturers code: Test or Assay Code Test or Assay Name Dilution or Neutralization Protocol Test Qualifier Result Qualifier When all components of the manufacturers code are used, the Universal Test ID is transmitted as follows: |^^^Test_Code^Test_Name^Dilution^Test_Qualifier^ Result_Qualifier| For downloading orders to instruments or systems, the Test_Code is the only required component of the Universal Test ID. Other components are optional and may be used as needed. The Result_Qualifier component is never downloaded from Host (LIS) systems. The first three parts are reserved for future use and are not currently used by the Abbott instrument. The valid Test_Code and Test_Name components for each instrument and system may be obtained by reviewing the Test or Assay Parameter screens on each instrument. Valid assay protocols such as Dilutions or neutralization protocols are also defined per test or assay code. Two continuous component delimiters indicate default dilution for that assay. When the Universal Test ID is used in a Result Record, the last component contains a result type code.
Test_Qualifier
This component may be optionally used to provide a modifier for the test_code. Hematology instruments may use this component to allow an LIS vendor to selectively request only results associated with predefined parameter sets to be returned.
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Section 1
Result_Qualifier
The result qualifier is used as the last component of the Universal Test ID field when transmitting results. ASI instruments and systems use the Result_Qualifier to identify the nature of the result data being communicated. Several codes are defined for use to describe the most common result types returned by Abbott instruments and systems. They are: Final (F) Used to identify the calculated values for primary results such as concentrations. The data field contains the actual value of the result. The Units field identifies the units (i.e., type) of the result. Preliminary (P) Used to identify the raw instrument readings such as RATES, or POLARIZATIONS, etc. The data field contains the actual value of the result. The units field contains the type of preliminary result. Interpreted (I) Used to identify an interpretation such as POSITIVE or NEGATIVE that is based on the ranges defined on the instrument for those interpretations. The data field contains the actual interpretation. Final Avg. (Favg) Identifies the average of a set of final results. Returned in cases where multiple repetitions of a test are run for a specific specimen. The data field contains the actual calculated average of the result. The Units field identifies the units of the final result average (e.g., g/ml, etc.). Preliminary Avg (Pavg) Identifies the average of a set of preliminary results. Returned in cases where multiple repetitions of a test are run for a specific specimen. The data field contains the actual calculated average of the preliminary result. The Units field identifies the type of preliminary result average (e.g., RATES, Net Polarization, etc.). Interpreted Average (Iavg) Identifies the interpretation associated with the average final result (Favg). The data field contains the actual interpretation such as POSITIVE, NEGATIVE, REACTIVE, etc. Abbott instruments and systems also communicate other calculated information based on the above result types. For example, it is common for instruments and systems to calculate coefficient of variances, standard deviations, root mean square errors, or curve fit information on final and preliminary results when tests are performed in replicates. In these cases, the result type flag identifies the group of
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data used (i.e., Final or Preliminary results), the data field contains the actual calculated data, and the units field identifies the type of calculation (i.e., %CV, RMSE, STD, etc.). Refer to instrument specific sections for the complete set of results (i.e., result types) handled by that particular system.
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Section 1
1. ASI recommends that an external host computer provide the Patient ID in the Laboratory Patient ID field (8.1.4). This field is displayed on the instrument screen as the Patient ID. This ID is returned unchanged in the same field to the external host computer when the instrument returns results. 2. If the Patient ID is entered at the instrument or changed at the instrument, the new information is returned to the external host computer in the Instrument Patient ID field (8.1.5). Changes or edits done by an instrument operator to the Patient ID field do not overwrite the previously downloaded Laboratory Patient ID. 3. Other Patient IDs such as Admission IDs may be communicated in the Practice Patient ID field (8.1.3). These fields may be optionally supported by ASI instruments. Also instruments may optionally allow this ID to be mapped to the Patient ID if no Laboratory Patient ID (8.1.4) is defined. For example, if an institution uses the social security numbers as patient IDs, but also uses unique admission IDs that are specific to each time the patient receives medical services, then the following would need to be communicated.
Institution Using Laboratory and Practice Patient IDs.
Figure 1.25:
If the instrument supports patient IDs as well as admission IDs then it assigns the following: Patient ID = SSN123456789 {admission id = ADMIT1111} Patient name = John Doe Specimen 1 ID = SID101 Tests Ordered = Test1 Specimen 2 ID = SID102 Tests Ordered = Test2 The admission ID is only captured if supported by the instrument. If the institution wanted to track laboratory results by the admission ID, the host computer would need to communicate the patient IDs as follows:
Institution Using Laboratory Patient ID only.
Figure 1.26:
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ASI instruments then use the following: Patient ID = ADMIT1111 Patient name = John Doe Specimen 1 ID = SID101 Tests Ordered = Test1 Specimen 2 ID = SID102 Tests Ordered = Test2 These rules are followed by ASI instruments in order to simplify the interfacing concerns associated with patient IDs.
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Section 1
Quality Control (Q) This code is used to indicate that this specimen should be treated as a control for the specified test code. The instrument checks the predefined controls of that test code for a matching ID. If a match is found, the order is scheduled for processing. If a match is not found, the order is canceled. A Test Order Canceled message may optionally be returned to the Host with the comment record containing the reason for cancellation.
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Section 1
Header Record C|1|[CR] P|1|[CR] O|1|[CR] R|1|[CR] R|2|[CR] R|3|[CR] O|2|[CR] R|1|CR] R|2|CR] P|2|[CR] O|1|CR] R|1|[CR] Message Terminator Record
Figure 1.27:
Record Sequence Numbers. Record Sequence Numbers keep track of the number of records of the same type and at the same hierarchical level.
NOTE: When the high level messages are parsed, ASI instruments check for proper sequencing as defined by the ASTM standards. If a record is encountered with an invalid sequence, an error is logged locally and the remainder of the message is ignored. Records that were parsed prior to the sequencing error are accepted and processed further. An error code is not transmitted to the external system, indicating that the sequencing error occurred.
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Certain key fields are identified as required fields if supported by an instrument. These fields are: Specimen ID field Test Code component of Universal Test ID Action Code field The following tables define the location and contents of each field in a specific type of record. The records and corresponding tables are as follows: Table 1.8 Message Header Record Table 1.9 Patient Record Table 1.10 Order Record Table 1.11 Result Records Table 1.12 Comment Record Table 1.13 Request Information Record Table 1.14 Terminator Record Table 1.15 Manufacturers Record
Field Name
Record Type Delimiters Field Repeat Component Escape
Description
ASI instruments transmit upper case characters, receive upper or lower case. ASI instruments accept any valid delimiters specified in the header record.
7.1.3 7.1.4
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Section 1
Field Name
Sender Name or ID
Description
This field is made up of the following four (4) components. When transmitting, ASI instruments send their name, software version, and serial number and may also send the interface version control string specified in the fourth component of the field. Name of instrument. Version of system software. Serial number of instrument or system. ASI instruments may use this field to implement an interface version control scheme that indicates the record type and version of the record supported by the instrument. X is the record type and n is the version number. The possible characters for X are (H, P, O, R, L, Q, C, M). See the instrument specific section for handling this field. Not supported Not supported Not supported Not supported Not supported for serial (point-to-point) connections.
* * * (XnXn.....)
Sender Address Reserved Sender Telephone Characteristics of Sender Receiver ID Host_Name ^IP_Address * *
Network implementations use this field to contain the name and network address (TCP/IP address) of the Host (LIS) system. The structure of this field is Host_ name^IP_ address. Not supported
7.1.11
Comment
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Field Name
Processing ID
Description
(P)roduction Treat message as an active message to be completed according to standard processing. If the field is blank, this is the default. (D)ebugging Message is initiated for the purpose of testing the interface. ASI instruments may use this flag to provide transfer of messages for diagnostic purposes. The diagnostic message consists of at least one record of each type transmitted by the instrument or system. The transmission of this type of message is under operator control and is part of the diagnostics of the instrument/system. Instruments may optionally receive (D)iagnostic messages consisting of header, patient, and order records. (Q)uality Control. Message contains only quality control information. See Instrument specific section for information on how this field is handled.
7.1.13 7.1.14
YYYYMMDDH YYYYMMDDH See the instrument specific section for handling HMMSS HMMSS this field. This field contains the message transmission time and date.
* Indicates supported field. Refer to instrument sections for size of supported fields.
Field Name
Record Type Sequence Number
Description
ASI instruments receive upper or lower case characters. Sequential number starting with one (1) and continuing until the last patient in the message. (This field follows the sequence number rules set forth by ASTM E 1394-91 Standard Section 6.6.7.) ASI instruments accept the Practice PID if it is transmitted by the Host and return it, unchanged, to the Host. Otherwise this field is not used. ASI instruments accept the Laboratory PID transmitted by the Host and return it unchanged to the Host. This field is the recommended field for an LIS to communicate Patient IDs to an instrument.
8.1.3
Practice PID
8.1.4
Laboratory PID
* Indicates supported field. Refer to instrument sections for size of supported fields.
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
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Section 1
Field Name
Instrument PID
Description
ASI instruments may ignore any PID downloaded in this field. This field is used by the instrument or system to communicate a patient ID entered by the Lab operator or read by the instrument, to a Host (LIS). ASI instruments may optionally handle this field. When used, this field has the following components: Last_name, First_name, Middle_initial, suffix (Jr.,Sr., etc.), and title (Mr., Mrs., Ms., etc.). See the instrument specific section for handling this field. ASI instruments may optionally handle this field. See the instrument specific section for handling this field. ASI instruments may optionally handle this field. See the instrument specific section for handling this field. ASI instruments may optionally handle this field. When used, this field has the following flags: (M)ale (F)emale (U)nknown See the instrument specific section for handling this field. ASI instruments may optionally handle this field. See the instrument specific section for handling this field. ASI instruments may optionally handle this field. See the instrument specific section for handling this field. Not supported ASI instruments may optionally handle this field. See the instrument specific section for handling this field. ASI instruments may optionally handle this field. See the instrument specific section for handling this field. Not supported Not supported
8.1.6
Patient Name
8.1.7
8.1.8
8.1.9
Patient Sex M F U M F U
8.1.10
8.1.11
8.1.12 8.1.13
8.1.14
Attending Physician
ASI instruments may optionally handle this field. See the instrument specific section for handling this field. ASI instruments may optionally handle this field. See the instrument specific section for handling this field.
8.1.18
Patient Weight
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Field Name
Patient Diagnosis Code ^Description
Description
Identifies the ICD-9 code for the diagnosis. Text description for the code. Both components are optional and are provided as known. Multiple diagnosis may be communicated via the use of repeat delimiters. Refer to instrument specific section for support of this field and support of repeat delimiters within this field.
8.1.20
Patient Medications Name ^Level * * * * Identifies the therapy name or generic drug name (e.g., Aspirin). Identifies the amount or dosage of drug or therapy as well as the frequency (e.g., 2 tablets every 4 hours). Refers to the beginning date of the therapy or medication. Refers to the stop date of the therapy or medication. Multiple Medications may be communicated via the use of repeat delimiters. Refer to instrument specific section for support of this field and support of repeat delimiters within this field.
^Start_Date ^End_Date
* *
* *
8.1.21
Patient Diet
ASI instruments may optionally handle this field. See the instrument specific section for handling this field. Not supported Not supported
ASI instruments may optionally handle this field. See the instrument specific section for handling this field. ASI instruments may optionally handle this field. See the instrument specific section for handling this field. ASI instruments may optionally handle this field. See the instrument specific section for handling this field. Not supported Not supported Not supported Not supported
8.1.25
8.1.26
Location
Nature of Diagnostic Codes Alternative Diagnostic Codes Patient Religion Marital Status
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Section 1
Field Name
Isolation Status
Description
ASI instruments may optionally handle this field. See the instrument specific section for handling this field. Not supported Not supported
Name of hospital or lab. Hematology instruments may use this field to communicate Limit Set Information relating to the category the patient/sample should be analyzed against. See instrument specific section for the structure of this field. ASI instruments may optionally handle this field. See the instrument specific section for handling this field.
* Indicates supported field. Refer to instrument sections for size of supported fields.
Field Name
Record Type Sequence Number
Description
ASI instruments receive upper- or lowercase characters. Sequential number starting with one (1) and continuing until the last order for a given patient in the message. (This field follows the sequence number rules set forth by ASTM E 1394-91 Standard Section 6.6.7.) ASI Instruments accept the Specimen ID received in this field and return it unchanged to the Host (LIS) when transmitting.
9.4.3
Specimen ID field
Specimen ID ^location ID
* *
* * The Location Information (location_ID^position) components may be used to uniquely identify replicates of a single sample. This component is optional when downloading orders to ASI instruments and systems. ASI instruments may optionally accept the location ID and position information. (Recommended for batch systems.)
^position
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Field Name
Instrument SID field
Description
ASI Instruments ignore the contents in this field when receiving information. This field is used by the instrument or system to communicate a specimen ID entered by the lab operator, or read by the instrument to a Host (LIS).
Specimen_ID ^location_ID
* * The Location Information (location_ID^position) components may be used to uniquely identify replicates of a single sample.
* As defined by ASTM 1394-91 section 6.6.1.4. The manufacturers local code is made up of five (5) component fields as defined below. ASI instruments handle repeat delimiters in this field. * * The Test Information (Assay_code^Assay_name) is used to uniquely identify the test or tests to be done on the specimen. Dilution or neutralization protocols defined per assay code. See the instrument specific section for applicable assay protocols. Optional qualifier for test code. See the instrument specific section for handling this field. Not applicable on Order Records. (S)tat (R)outine default value See the instrument specific section for handling this field. See the instrument specific section for handling this field. Date and time of sample collection. See the instrument specific section for handling this field. Not supported Not supported * * See the instrument specific section for handling this field.
^^^Assay_code ^Assay_name
^Assay protocol
* * S R
* * S R
9.4.7 9.4.8
Requested Date and Time Collection Date and Time Collection End Time Collection Volume Collector ID
* *
* *
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Section 1
Field Name
Action Code
Description
(C)ancel Used to cancel a previously downloaded Test Order. (A)dd Used to add a test to a known specimen. (N)ew Used to identify new Test Orders for an unknown specimen. If the specimen is known by the instrument/system, this message is ignored as a duplicate transmission. (Q)uality Control Specimen See the instrument specific section for handling this field. See the instrument specific section for handling this field. See the instrument specific section for handling this field. Date and Time specimen received in the Lab. See the instrument specific section for handling this field. See the instrument specific section for handling this field. See the instrument specific section for handling this field. See the instrument specific section for handling this field. See the instrument specific section for handling this field. See the instrument specific section for handling this field. Not supported Not supported Not supported Not supported
Danger Code Relevant Clinical Info Date/Time Specimen Received Specimen Descriptor Specimen Type ^Specimen Source Ordering Physician Physicians Phone User Field No. 1 User Field No. 2 Lab Field No. 1 Lab Field No. 2 Date/Time Reported Instrument Charge Instrument Section Report Type Reserved Field
* * *
* * *
9.4.16
* * * * * *
* * * * * *
9.4.17 9.4.18 9.4.19 9.4.20 9.4.21 9.4.22 9.4.23 9.4.24 9.4.25 9.4.26 9.4.27
* *
* *
Abbott Data Management systems use this field to assign test instruments. See the instrument specific section for handling this field. Not supported
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Field Name
Location or Ward for Collection Nosocomial Infection Flag Specimen Service Specimen Institution
Description
See the instrument specific section for handling this field. Not supported Not supported Not supported
* Indicates supported field. Refer to instrument sections for size of supported fields.
Field Name
Record Type
Description
Result records are never accepted from an LIS or Host system. ASI instruments and systems use separate result records for replicates, averages of replicates, intermediate, final, and interpreted results. Sequential number starting with one and continuing until the last result record for a given order in the message. (This field follows the sequence number rules set forth by ASTM E 1394-91 Standard Section 6.6.7.)
10.1.2
Sequence Number
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Section 1
Field Name
Universal Test ID
Description
The manufacturers local code is made up of five (5) component fields as defined below. ASI instruments do not use repeat delimiters in this field.
^^^Assay_code ^Assay_name
The Test Information (Assay_code^Assay_name) component is used to uniquely identify the test or tests done on the specimen. Dilution or neutralization protocols defined per assay code. See the instrument specific section for applicable assay protocols. Further qualification of the test or assay code. (F)inal Indicates final calculated values of concentrations, etc. (I)nterpreted Indicates interpretations of final results based on user-defined criteria. (P)reliminary Indicates raw instrument readings such as the RATE. Identifies the average of a set of final results. Identifies the average of a set of preliminary results. Identifies the interpretation associated with the average final result. See the instrument specific section for handling this field. See the instrument specific section for handling this field. See the instrument specific section for handling this field. This field is used to communicate the laboratorydefined ranges for this assay. It is composed of two components separated by the component delimiter (^).
^Assay_protocol
* *
Range
Multiple ranges may be communicated using repeat delimiters. The range is of the form, value to value. See the instrument specific section for specific ranges communicated. Label assigned by the laboratory to the preceding range. See the instrument specific section for handling this field.
^Description
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Field Name
Description
(L)ess than normal range (H)igher than normal range (LL) Less than extreme range (HH) Higher than extreme range (QC) Result based on a QC out of range (>) Above dynamic range of assay (<) Below dynamic range of assay (EXP) - Result based on expired reagent. Additional abnormal flags may be defined as needed by instruments. See the instrument specific section for handling this field. (F)inal Results Used to indicate initial transmission of results. (R)epeat Used to indicate previously transmitted results. (X) Test cannot be completed. Used to indicate error during processing. This field may be used to indicate the date of the last calibration of an instrument. (operator) When used, this field contains the ID or name of the operator who performed the test. (approver) When used, this field contains the ID or name of the operator who approved the test results. See the instrument specific section for handling this field. See the instrument specific section for handling this field. See the instrument specific section for handling this field. Used by Abbott Data Management Systems to indicate the source of results. When used, this field contains the serial number or a unique identifier for each instrument returning results. If results are manually entered, this field contains the string MANUALLY ENTERED, and the Operator Id (10.1.11) contains the ID or name of the person entering the results.
10.1.8 10.1.9
* F R X
10.1.10 10.1.11
^approver
* * *
MANUALLY ENTERED
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Section 1
Field Name
Record Type Sequence Number
Description
Comment records. Sequential number starting with one. (This field follows the sequence number rules set forth by ASTM E 1394-91 Standard Section 6.6.7.) (I)nstrument (L)IS (Computer System) (D)ata Management Systems As described by each instrument. (G)eneric free form comments entered by the lab operator. (I)nstrument generated exception string.
11.1.3
Comment Source
I L D
11.1.4 11.1.5
* G I
* G
* Indicates supported field. Refer to instrument sections for size of supported fields.
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of specimen IDs may be requested by providing the starting specimen ID (12.1.3) and the ending specimen ID (12.1.4). The specimen ID is the second component in these fields. If the request is made based on the specimen ID only, it would be transmitted as |^specimen_ID|. If the request is made based on patient ID and Specimen ID, it would be transmitted as |patient_ID^Specimen_ID|. Repeat delimiters may not be used to indicate multiple specimen IDs or ranges. Test Code Requests can be made based on the test code. Date/Time Requests can be made based on a specific date and/or time, or a range of date/time. For a single date/time, only field 12.1.7 should be used. If a time is not specified, the entire day is assumed for that date. Field 12.1.6 specifies what type of time and date is being requested. Ranges A range may be specified by utilizing the Starting Range (12.1.3) and Ending Range (12.1.4) fields for patient IDs or specimen IDs. The range is interpreted using ASCII byte ordering (numbers before all alphabetic letters and upper case letters before lower case letters) to identify the matched IDs that fall between the starting and ending values. For example, using the following data set: {Abcd, abcd, ABcd, AB123, aBcd, 12ab, 12bb} The sort of this data (in ascending order) generates the following order: {12ab, 12bb, AB123, ABcd, Abcd, aBcd, abcd} Therefore, if the range had been specified as 12ab and abcd the data associated with all the IDs above would be returned. Some systems may support only upper case letters (or assign equivalent values to upper and lower case letters). A system that treats upper and lower case as equivalent would treat {ABcd, Abcd, aBcd, abcd} as equivalent IDs. NOTE: Each condition specified in the Request Information Record narrows the request further. The request returns records with information matching all the conditions specified (logical AND operation). NOTE: ASI instruments and systems may not honor the request that uses only the ALL qualifiers for patient and sample IDs together. ASI instruments and systems do not generate queries using the ALL qualifier for patient and sample IDs together (i.e., no queries for information on ALL samples of ALL patients).
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
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Section 1
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Patient Demographics (D) This indicates a request for patient demographics only. This request returns all patient records meeting the request criteria. This request may be made based on single or ranges of patient(s). Canceled Cannot be Done (X) This indicates that the request previously made cannot be performed with the information provided. ASI instruments and systems may return a Comment record following the Request Information Record (Q) with the reason for not completing the request. Abort Last Request (A) This indicates that the requesting system would like to cancel the previously transmitted request.
Table 1.13: Request Information Record ASTM Field
12.1.1
Field Name
Record Type
Description
Request Information Records may be used to request information on patients, samples, and tests. These requests may be specific to a date and time or may apply to a time period with a start date and time and an end date and time. Patient IDs, Sample IDs, Test IDs, and Date/ Times are AND conditions to make the request more specific. Sequence number is always one (1). Only one Request Information Record is sent at any one time. From Host: (ALL) indicates return all information associated with all known Patient IDs and/or Specimen IDs. From Instrument: (ALL) indicates return all requested information associated with known Patient IDs and/or Specimen IDs assigned to this instrument.
12.1.2
Sequence Number
12.1.3
* ALL * *
* ALL * * Used when Patient and/or Specimen IDs are sequential. Standard string comparison rules apply to determine if a Patient ID Specimen ID falls within the range provided by fields 12.1.3 and 12.1.4.
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Section 1
Field Name
Universal Test ID
Description
Used to request test results for the specified test (assay code) on a specific sample or patient ID. Also used to request test orders on a specific sample ID. This field becomes an AND condition to the previous fields. (ALL) indicates all test codes and result types. The Test Information (Assay_code ^ Assay_name) component is used to uniquely identify the test or tests to be done on the specimens. (S) Specimen order dates. (R) Result test dates. Instruments Date and Time. When a time is not specified, the 24-hour range for that date is assumed. Instruments Date and Time. When used, the date and time specified is the end of the time range of interest. When a beginning Date and Time is not specified (field 12.1.7), this field is interpreted as known information up to and including this date and time. If a time is not specified, 12:00 p.m. is used as the default. See the instrument specific section for handling this field. Not supported Not supported Not supported
^^^Assay_code ^Assay_name
12.1.6 12.1.7
Request Time Limits Beginning Request Date and Time Ending Request Date and Time
S R *
S R *
12.1.8
Requesting Physician Name Requesting Physician Phone # User Field No. 1 User Field No. 2
A F N O D X
(A)bort Cancel last request. (F)inal Report (N)ew or Edited Results (O)rders and Demographics (D)emographics only (X) Request cannot be done.
* Indicates supported field. Refer to instrument sections for size of supported fields.
Field Name
Record Type Sequence Number
Description
Terminator records indicate the end of a message. Sequential number always equal to one (1).
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Field Name
Termination Code
Description
(N)ormal termination. If this field is not transmitted, (N) is assumed. (I)nformation not available on last request. (F)inished processing last request.
Field Name
Record Type
Description
(M)anufacturer Defined Records Refer to instrument specific sections on support and structure of manufacturer Instrument record types. These records are used to supplement the information provided in the PATIENT/ORDER/ RESULT records. They are used specifically to provide a mechanism for communicating information that does not fit within the PATIENT/ORDER/ RESULT structure. Any sequential number within a level. Defines the usage of the Abbott Manufacturer record. It contains two components.
15.1.2 15.1.3
Record Class
Identifies the information content of the record. Valid Classes of manufacturer records are as follows: (I)nstrument Information Records. Examples of instrument information record types are as follows:
^Instrument_Record_ Type
(DM) Destination Maps for pipetting information (SM) Source Maps for pipetting information (GR) Graphics Record (CL) Instrument Calibration information (P)atient class Contains information relevant to patient demographics.
* Indicates supported field. Refer to instrument sections for size of supported fields.
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Section 1
Table 1.15: Manufacturers Record (continued) ASTM Field Field Name Transmitted Received (To Host) (From Host)
O
Description
(O)rder Class Contains information relevant to order information. (R)esult Class Contains information relevant to result information.
* Indicates supported field. Refer to instrument sections for size of supported fields.
Refer to instrument specific sections for information on supported Manufacturer Records. Additional Abbott Record Types may be created by ASI instruments and systems as needed, to communicate information not covered by the ASTM standards and this document.
Example Messages
Below are examples of messages which conform to the requirements defined for instruments implementing the Abbott Standard Interface as described in the preceding section. Specimen Query from an ASI Instrument The following example shows a simple request for test information and patient demographics for a range of specimens (SID1000 through SID1008).
H|\^&|||ASI^1.0^s/n^H1P1O1R1Q1L1C1|||||My^Host^System||P|1|19930631[CR] Q|1|^SID1000|^SID1008|^^^ALL||||||||O[CR] L|1|N[CR]
Figure 1.28:
Test Ordering by an External Host Computer The following figure shows the partial Test Request message from an external host system to an ASI instrument. It contains patient demographics and test orders associated with each patient. The download of the Test Request message may be initiated by the external system or may be in reply to a query from the ASI instrument as indicated above.
H|\^&|||My^Host^Computer|||||ASI^1.0^s/n||P|1|19930631[CR] P|1||PID1234||Doe^John|Smith|19500522|M|||||Jones^Bob^^^Dr|||||300.0^Anxiety\311.0^Depression|[CR} O|1|SID1000||^^^10^Test10^protocol1|S|19930631|19930629||||N||||SERUM|Miller^John^^^Dr|||||||||Q|[CR} O|2|SID1000||^^^22^Test22|S|19930631|19930629||||A||||SERUM|Miller^John^^^Dr|||||||||Q|[CR} P|2||PID2222||Small^Jane|Smith|19400820|M|||||Jones^John^^^Dr||||||[CR} O|1|SID1001||^^^20^Test20^protocol4|R|19930631|19930629||||N||||SERUM|Ahmad^Joe^^^Dr|||||||||Q|[CR} P|3|....... .......... L|1|F [CR]
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The Report Type field of the Order record as well as the Terminator record (L|1|F [CR]) indicate that the Test Request message was in response to a query (Report Type = Q, Termination Code = F). Also, the two test orders for patient John Doe (PID1234, SID1000) could be communicated in one order record with the use of the repeat delimiters in the Universal Test ID field. The Test Request message would have been transmitted as follows:
Example of Test Ordering With Repeat Delimiters
Figure 1.30:
The above message was not a response to a query (Report Type = O, Termination Code = N). Results from an ASI Instrument to a Computer System The following figure shows a partial Test Results message from an ASI instrument to an external host computer. This message may contain the results for multiple patients and tests if they have been completed and approved. One or more result records associated with a test follows each order record. All result records for that test (per specimen) are communicated together.
H|\^&|||ASI^1.0^s/n^H1P1O1R1Q1L1C1|||||My^Host^System||P|1|19930631[CR] P|1||PID1234||Doe^John|Smith|19500522|M|||||Jones^Bob^^^Dr|||||300.0^Anxiety\311.0^Depression|[CR} O|1|SID1000||^^^10^Test10^protocol1|S|19930631|19930629||||||||SERUM|Miller^John^^^Dr|||||||||O|[CR} R|1|^^^10^Test10^protocol1^^P|500.56|RATE|||F||OPERATOR12^SUPER12|| 199306310930|MANUALLY ENTERED[CR} C|1|I|Accidently deleted result and had to reenter|G [CR] R|2|^^^10^Test10^protocol1^^F|56.33|ng/ml|25 to 60^normal||F||OPERATOR12 ^SUPER12|| 199306310930|[CR} O|2|SID1000||^^^22^Test22|S|19930631|19930629||||||||SERUM|Miller^John^^^Dr|||||||||O|[CR} R|1|^^^22^Test22^^^I|REACTIVE||||F||OPERATOR#5^SUPER12||199306310930|[CR} P|2|........ .......... .......... L|1|N [CR]
Figure 1.31:
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Section 1
Query for Final Results The following example shows a simple request for final results associated with previously run samples and tests for a patient (PID1234). This query may be used to provide a lab operator with a temporary view of patient history to facilitate approval of current results.
H|\^&|||ASI^1.0^s/n^H1P1O1R1Q1L1C1|||||My^Host^System||P|1|19930631[CR] Q|1|PID1234^ALL||^^^ALL||||||||F[CR] L|1|N[CR]
Figure 1.32:
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Section 1
Host System
Application Layer Presentation Layer Data Link Layer
Figure 1.33:
Application Layer
Generally, the Application Layer of ASI instruments and systems provides services for user interaction, instrument operation, maintenance, communication, etc. These services vary considerably from instrument to instrument and system to system, based on instrument capability, target market, and other design considerations. In terms of communications, the Application Layer of each ASI instrument and system defines the type of messages that an instrument or system can support. In order to clarify this point, ASI instruments are grouped in the following four categories. All ASI instruments and systems, regardless of the category, implement the Data Link layer in a similar fashion. Also, ASI instruments and systems, regardless of category, assay implement Comment and Manufacturer records as part of their supported messages in order to pass back information that does not fit within the ASTM defined records.
Category I
Category I Instruments and Systems
Host
ASI Instrument/System
Figure 1.34:
Category I instruments and systems have the ability to return test result messages to a host system in accordance with ASTM E 1394-91 standard and as described in this document. The Test Result messages consist of Header, Patient, Order, Result, and Terminator Records. Because of the minimal data management capabilities of these instruments and systems, patient demographics is unlikely to be supported (with the possible exception of patient IDs).
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Section 1
Category II
Category II Instruments and Systems
Test Orders Host Data Link Layer (ACK/NAK) Test Results Test Orders Canceled Figure 1.35: Category II Instruments and Systems ASI Instrument/System
Category II instruments and systems have the ability to accept Test Order messages from an external host and return Test Result messages to that host system in accordance with ASTM E 1394-91 standard and as described in this document. In addition, these instruments and systems also return Test Order Canceled messages if an invalid order is received. Test Order messages minimally consist of Header, Patient, Order, and Terminator records. Test Result messages minimally consist of Header, Patient, Order, Result, and Terminator records. Test Orders Canceled messages consist of Header, Patient, Order, and Terminator records. The Report Type field of the Order record contains an X (without quotes). The Test Order Canceled message may also contain a Comment record with the specific reason why the test was canceled. The extent that patient demographics are supported (with the exception of patient IDs) by these instruments and systems varies based on their data management capabilities.
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Category III
Category III Instruments and Systems
Query Canceled Result Queries Test Orders/Test Order Canceled Host Data Link Layer (ACK/NAK) Test Results Test Orders Canceled Query Canceled Test Order Query Figure 1.36: Category III Instruments and Systems ASI Instrument/System
In addition to the capabilities described for Category II instruments and systems, Category III instruments accept the Result Query message and return a Query Canceled message whenever they are unable to perform the requested query. Also, they may submit a Test Order Query message requesting test orders assigned to this instrument. Instruments also accept the Query Canceled message if the host is unable to satisfy the request. Result Query messages consist of Header, Request Information, and Terminator records. The Request Status Code field in the Request Information record contains an F to indicate final results or an N to indicate new or updated results from a certain start date. The Test Order Query message is similar. The Request Status Code field contains an O. Query Canceled messages consist of Header, Request Information, and Terminator records. The Request Information record contains an X in the Request Status Code field to indicate that the request cannot be done. A variation of the Query Canceled message is used to abort a previously made query. The extent that patient demographics are supported (with the exception of patient IDs) by these instruments and systems varies based on their data management capabilities. A variation of the Test Order Canceled message is used to abort a previously made test order.
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Category IV
Category IV Instruments and Systems
Patient/Order Queries Query Canceled Result Queries Test Orders/Test Order Canceled Host Data Link Layer (ACK/NAK) Test Results Test Orders Canceled Query Canceled Test Order Query Patient/Orders Figure 1.37: Category IV Instruments and Systems ASI Instrument/System
In addition to the abilities described for Category III instruments and systems, Category IV instruments and systems can accept Patient Demographics Query and Test Order Query messages from an external host and return Patient and Order messages to that host system, in accordance with ASTM E 1394-91 standard and as described in this document. In addition, these systems may generate Patient Demographics Queries and Test Order Queries. The Patient Demographics Query messages and the Test Order Query messages consist of Header, Request Information, and Terminator records. When requesting patient demographics only, the Request Status Code field in the Request Information record contains a D. When requesting orders also, the field contains an O. The Patient messages minimally consist of Header, Patient, and Terminator records while the Test Order messages consist of Header, Patient, Order, and Terminator records. All instruments and systems in Category IV support complete demographic and order information as described in the ASTM E 1394-91 standard and this document. The instruments and systems provide maximum flexibility for a lab environment. They allow the generation and input of patient demographics and test orders on any interconnected system. Through the use of the Query messages, the systems are able to synchronize the data bases on all relevant patients and orders without requiring redundant manual input of information.
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Section 2
Use or function
Section 2Introduction
The modular design and integration capabilities of the ARCHITECT family of analyzers provide a single workstation capable of processing a variety of assays. With an intuitive software interface, real-time display of system statuses, and a to do list of scheduled maintenance activities, you can minimize system interaction and optimize your productivity. Use or function topics include: ARCHITECT System overview, page 3 Provides a general description of the available ARCHITECT System configurations. System control center, page 9 Provides a detailed description of the computer system, both hardware and software, that provides the interface to your ARCHITECT System. Processing modules, page 27 Provides a detailed description of each processing module including all related hardware components. Sample handlers, page 92 Provides a detailed description of each sample transport system including all related hardware components. System statuses, page 103 Lists and describes the various statuses of each system.
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Introduction
Section 2
NOTES
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Use or function
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ARCHITECT System overview
Section 2
1. SCC (system control center): 2. c 8000 processing module: Computer system that provides user Diagnostic module that performs control of the processing module(s) sample processing using and related components through a potentiometric and photometric centralized interface. methods. 3. i 2000SR processing module: Diagnostic module with priority processing capability that performs sample processing using the CMIA (chemiluminescent microparticle immunoassay) method. 4. RSH retest sample handler: Transport module that presents samples to the processing module(s) for analysis and retesting.
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1. c 8000 processing module: Diagnostic module that performs sample processing using potentiometric and photometric methods. 3. SCC (system control center): Computer system that provides user control of the processing module(s) and related components through a centralized interface.
2. RSH retest sample handler: Transport module that presents samples to the processing module(s) for analysis and retesting.
i 2000 System
The i 2000 System is a fully-automated immunoassay system allowing random and continuous access, and priority processing. Up to four processing modules can be joined to form a single workstation.
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ARCHITECT System overview
Section 2
1. i 2000 processing module: Diagnostic module that performs sample processing using the CMIA (chemiluminescent microparticle immunoassay) method. 3. SCC (system control center): Computer system that provides user control of the processing module(s) and related components through a centralized interface.
2. SSH standard sample handler: Transport module that presents samples to the processing module(s) for analysis.
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1. i 2000SR processing module: Diagnostic module with priority processing capability that performs sample processing using the CMIA (chemiluminescent microparticle immunoassay) method. 3. SCC (system control center): Computer system that provides user control of the processing module(s) and related components through a centralized interface.
2. RSH retest sample handler: Transport module that presents samples to the processing module(s) for analysis and retesting.
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ARCHITECT System overview
Section 2
NOTES
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Use or function
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System control center
Section 2
1. Touch-screen monitor: Allows you to 2. CPU (central processing unit): make on-screen selections by Houses the microprocessor and touching text areas and graphics, other computer components. icons and menu items, and function NOTE: Upgrades to the computer bar buttons. hardware may change the location of CPU components. 3. Floppy drive: Used to: Collect system logs for troubleshooting purposes. Import and export assay files (c System). 4. CD-RW drive: Used to: Install assay, maintenance, and diagnostic files Upgrade system software Archive patient and quality control results Collect system logs for troubleshooting purposes
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5. Keyboard: Used with the mouse 6. Mouse (pointing device): Used with and/or touch-screen monitor to enter the touch-screen monitor and/or information. You can use the keyboard to make onscreen keyboard as an alternate means of selections. performing most functions. 7. Network hub and CPU back panel (not shown): Provides the connection between the SCC and modules for information exchange.
Network hub
The network hub is an external device that joins communication lines and enables the electronic transfer of information between the SCC (system control center) and processing modules(s). Cables run from the hub to ethernet connectors on the back of the SCC and processing module(s). Additional I/O (input/output) ports and connectors on the back panel of the CPU (central processing unit) provide connections to other external devices, such as a keyboard, mouse, printer, and monitor.
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System control center
Section 2
1. CPU (central processing unit rear 2. Ethernet connector: Provides the view): Provides the I/O (input/output) physical connection between the ports and connectors for external network hub and the SCC and allows devices. communication between the SCC and the processing module(s). NOTE: Upgrades to the computer hardware may change the location of CPU components. 3. Ethernet connectors: Provides the 4. Scanner and keyboard connector: physical connection between the Provides the connection for the bar network hub and each module, and code scanner and keyboard. allows communication between the processing module(s) and the SCC. 5. Mouse connector: Provides the connection for the mouse. 6. Com1 port: Provides the connection for the touch-screen interface
7. Printer port: Provides the connection 8. Video connector: Provides the for the printer. connection for the monitor.
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External modem connects the ARCHITECT System to a telephone line, which allows communication with Abbott personnel for training and troubleshooting purposes. Cart supports the SCC components. Speakers provide audio output.
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System control center
Section 2
1. Icons: Represent a category of 2. Menu: Lists the available screens for screens. When you select an icon, the selected category (icon). When its color changes from green to blue you select a menu item, the and a menu displays below the icon. associated screen displays. 3. Screen: Provides access to all related system information and functions. 4. Function bar buttons: Allow you to perform actions associated with the active screen and correspond to the function keys on the keyboard. Some may be unavailable until you make a selection on the screen.
5. Window: Provides additional details 6. Message or prompt: Provides or functions related to the active informational or error messages that screen. allow you to complete a procedure or address the current situation. 7. Help button: Provides access to context-sensitive Help for the active screen, window, or error message.
Screens
When you select an icon, and then a menu item, the associated screen displays. This screen is considered the active screen and provides access to all related system information and functions. A screen can have different views (information displays) based on module type and your onscreen selections.
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3. Information area: Displays data and 4. Function bar buttons: Allow you to allows you to make selections and/ perform actions associated with the or enter information to perform active screen and correspond to the various functions. function keys on the keyboard. Some may be unavailable until you 5. Help button: Provides access to make a selection on the screen. context-sensitive Help for the active screen, window, or error message.
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System control center
Section 2
1. Icons: Represent a category of 2. Menu: Lists the available items for screens. When you select an icon, the selected category (icon). When its color changes from green to blue you select a menu item, the and a menu displays below the icon. associated screen displays.
NOTE: The SCC (system control center) keyboard is labeled to show the key equivalents for the icons. Figure 2.10: Keyboard label
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1. Screen available function bar 2. Unavailable context function bar buttons: Are always available for the buttons: Are available after you active screen. make a selection on the screen.
Windows
Windows provide additional information or functions related to the active screen. You access windows by selecting a button on the screen. The window displays on top of, or in front of, the screen.
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System control center
Section 2
2. Information area: Displays data and allows you to make selections and/ or enter information to perform 3. Help button: Provides access to various functions. context-sensitive Help for the active screen, window, or error message.
Messages
Messages provide important information during the course of normal system operation. They display in front of the currently displayed screen or window and require an acknowledgement. All interaction with the user interface is suspended as long as the message displays. Figure 2.13: Example of a message
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The type of message is indicated by one of two symbols at the left of the window.
Caution: Indicates a condition that requires you to take corrective action as described in the text of the message.
Prompts
Prompts allow you to continue or cancel the requested operation. They display in front of the currently displayed screen or window and require a response. All interaction with the user interface is suspended as long as the prompt displays. Figure 2.14: Example of a prompt
Software navigation
The ARCHITECT System software interface is designed to provide consistent and easy access to system information, software functions, and context-sensitive Help. You can navigate through the screens and windows by using the mouse (pointing device), touch-screen monitor, and/or keyboard.
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System control center
Section 2
1. Select an icon to display a menu that 2. Select a menu item from the menu to lists related screens. display that screen. 3. Select a function bar button to 4. Select the help button to access perform an action or access a context-sensitive help for the window associated with the screen. screen, window, or error message. NOTE: Some function bar buttons may be unavailable until you make a selection on the screen.
Snapshot screen
From the Snapshot screen you can view key system information such as: Sample handler status displays on the sample handler graphic. Processing module status displays on the processing module graphic(s). Test processing status displays on the order status button. You can select this button to display the Order status screen. Reagent status displays on the reagent status button. You can select this button to display the Reagent status screen. Calibration curve status (c System) displays on the calibration status button. You can select this button to display the Calibration status screen. Supply and waste status displays on the supply status button (c System) or the supply status button (i System). You can select this button to display the Supply status screen. Number of orders pending rerun displays on the Reruns status button. You can select this button to display the Rerun status screen.
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Number of exceptions pending review displays on the Exceptions status button. You can select this button to display the Exception status screen. Additionally, the Printer, LIS, ARM, and LAS status buttons display if your system is configured with these optional components. A caution symbol indicates a condition that requires attention. Figure 2.16: Snapshot screen
To display this screen, see Access the Snapshot screen, page 21. Related procedures... Log on (general operator), page 23 Log on (system administrator), page 23 Log off, page 25
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Use or function
System control center
Section 2
Select Overview from the menu bar, and then select Snapshot. The Snapshot screen displays. The information is dependent on your system configuration and test processing status. Related information... Snapshot screen, page 20 Sample handler status, page 103 Processing module status, page 107
Related procedures... Log on (general operator), page 23 Log on (system administrator), page 23 Log off, page 25
User logon
Logon is the process of signing in or gaining access to certain SCC (system control center) functionality. There are two types of logon: General operator used to log on to the system so that your operator ID displays on printouts and reports
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Administrator required to perform administrator functions such as configuring settings, performing specific diagnostic procedures, and approving the maintenance log Additionally, Abbott area customer support may provide a user name and temporary password to operators who call for troubleshooting assistance. This logon authorizes selected functions in addition to those allowed by the system administrator logon.
To log on (general operator): 1. Select F2 - Log on on the Snapshot screen. The Log on window displays. 2. Type your operator ID in the User name data entry box (maximum of 12 alphanumeric characters). 3. Select Done to log on. Your operator ID displays in the upper left-hand corner of the Snapshot screen. Related information... User logon, page 22 Snapshot screen, page 20 Log on window, page 22
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System control center
Section 2
To log on as a general operator, see Log on (general operator), page 23. To change the system administrator password, see Change the system administrator password, page 24.
Prerequisite Module status Supplies Access the Snapshot screen, page 2-21 Any NA
To log on (system administrator): 1. Select F2 - Log on on the Snapshot screen. The Log on window displays. 2. Type ADMIN (all capital letters) in the User name data entry box. 3. Type the system administrator password in the Password field. 4. Select Done to log on. ADMIN displays in the upper left-hand corner of the Snapshot screen. Related information... User logon, page 22 Snapshot screen, page 20 Log on window, page 22
To change the system administrator password: 1. Select Password from the System categories list on the Configuration screen. 2. Select F6 - Configure. The Configure password window displays. 3. Enter the new password in the System administrator password data entry box.
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4. Enter the new password in the System administrator password confirm data entry box to confirm the new password. 5. Select Done to save your changes. Log off Perform this procedure to log off if you are currently logged on to the system.
Prerequisite Module status Supplies Access the Snapshot screen, page 2-21 Any NA
To log off: 1. Select F2 - Log on on the Snapshot screen. The Log on window displays. 2. Press the Delete key on the keyboard to delete the user name. 3. Select Done to log off. 4. Verify that a logon identifier does not display in the upper lefthand corner of the Snapshot screen. Related information... User logon, page 22 Snapshot screen, page 20 Log on window, page 22
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System control center
Section 2
NOTES
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Use or function
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Processing modules
Section 2
Figure 2.18: c 8000 processing module (front view)
1. Front processing center cover: 2. Processing module keypad: Provides access to the components Provides a local user interface for that perform assay processing controlling the processing center. activities. 3. Supply center door: Provides access 4. Pump center door: Provides access to the bulk storage supply center. to the pump center. 5. Card cage door: Provides access to the card cage.
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1. Rear processing center cover: 2. Main power supply: Provides power Provides access to the components to the processing module. that perform assay processing activities. 3. Water management unit: Provides the water supply connection.
Related information... Processing center (c System), page 30 Bulk solution supply center (c System), page 46 Optional components (c 8000 processing module), page 47 ARCHITECT ci 8200 integrated system, page 3 ARCHITECT c 8000 System, page 4
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Processing modules
Section 2
Figure 2.20: Components of the c 8000 processing module keypad
1. Run key: Places the processing module into a Running status and prepares the module to accept samples. Restarts the processing center after a Scheduled Pause.
2. Carousel advance key (2): Aligns, if necessary, and then advances reagent supply center 2 by 1/3 turn to aid in loading and unloading reagents. The LED illuminates when access to the reagent supply center is allowed.
3. Carousel advance key (1): Aligns, if 4. Pause key: Places the processing necessary, and then advances module into a Scheduled Pause reagent supply center 1 by 1/3 turn status and stops aspiration of new to aid in loading and unloading tests. Tests already in progress reagents. The LED illuminates when continue to completion. access to the reagent supply center is allowed. 5. Stop key: Stops all processing module activity, but does not shut down power to the processing module. 7. Display area: Displays text during some maintenance and diagnostic procedures. 6. L1, L2, L3, L4 keys: Used when performing some diagnostic and maintenance procedures.
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1. Sample hardware components: 2. Reagent hardware components: Provide sample aspiration, Provide reagent aspiration, dispense, and positive identification. dispense, and positive identification. 3. Reaction carousel hardware components: Position the cuvettes for sample and reagent aspiration, mixing, photometric or potentiometric analysis, and cuvette cell washing.
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Processing modules
Section 2
Figure 2.22: Sample hardware components
1. Sample carousel: Used for loading patient samples, calibrators and controls.
3. Sample bar code reader: Reads the 4. Sample pipettor: Aspirates and carousel ID and sample ID. dispenses samples into cuvettes. 5. Sample probe wash cup: Used to wash remaining fluid from the probe exterior, interior, and tip.
Sample carousel (c System) The sample carousel is a local sample handler with 32 refrigerated positions used for loading clinical chemistry patient samples, calibrators, and controls. Positions 31 and 32 are reserved for onboard solutions that are used in maintenance procedures. Samples can be loaded in tubes and sample cups. Patient samples and controls in tubes can be bar code labeled to provide positive identification. Bar codes cannot be used for calibrator samples. In the event of RSH (retest sample handler) failure, the sample carousel can be used as the primary area for loading clinical chemistry samples. Under normal operating conditions when both the sample carousel and the RSH are functional, samples on the carousel take priority over those on the RSH.
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1. Sample carousel: Used for loading patient samples, calibrators and controls. 3. Sample carousel access indicator (square): Indicates when you can access the sample carousel and provides a method to pause. When the access indicator light is: Off the sample carousel is moving and cannot be accessed Blinking the access indicator has been pressed and the sample carousel is in the process of pausing On the sample carousel can be accessed
2. Sample bar code reader: Reads the carousel ID and bar coded labels on samples. 4. Sample carousel advance indicator (round): Indicates when you can advance the sample carousel. When the advance indicator light is: On the sample carousel can be advanced Off the advance indicator button has been pressed and the sample carousel is in the process of advancing a 1/3 rotation or the sample carousel is closed
Sample pipettor and sample probe wash cup (c System) The sample pipettor is a device that detects, aspirates, transfers, and dispenses samples into the cuvettes. It also transfers diluted samples from the cuvette used to make the dilution into the cuvette used for the reaction. This pipettor assembly includes a fluid sense/pressure monitoring system that helps to identify errors in aspiration.
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Section 2
The sample probe wash cup is a passive wash station used to wash any remaining fluid from the probe exterior, interior, and tip. The sample probe is washed between samples to eliminate carryover. Figure 2.24: Sample pipettor and sample probe wash cup
2. Sample probe wash cup: Washes remaining fluid from the probe exterior, interior, and tip.
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1. Reagent supply center 1 (R1): Provides refrigerated storage for reagent kits and diluents. 3. Reagent pipettor 1 and wash cup: Pipettor aspirates and dispenses reagents into cuvettes. Wash cup washes the probe exterior, interior, and tip. 5. R1 onboard solution area: Holds probe wash solutions for the SmartWash function and maintenance procedures.
2. Reagent supply center 2 (R2): Provides refrigerated storage for reagent kits and onboard solutions. 4. Reagent pipettor 2 and wash cup: Pipettor aspirates and dispenses reagents into cuvettes. Wash cup washes the probe exterior, interior, and tip. 6. R2 onboard solution area: Holds probe wash solutions for the SmartWash function and maintenance procedures.
7. R1 bar code reader: Reads 2D 8. R2 bar code reader: Reads 2D (two-dimensional) bar code labels on (two-dimensional) bar code labels on reagent cartridges. reagent cartridges.
Reagent supply centers (c System) Reagent supply centers (R1 and R2) are refrigerated reagent carousels for onboard storage of reagent kits and sample diluents. These reagent supply centers and their associated reagent pipettors are separately controlled to allow reagents to be independently aspirated and dispensed by each reagent pipettor. Reagent supply center 1 consists of an inner and outer carousel that is segmented to store a maximum of 56 - 65 reagent cartridges depending on the configuration of the segments. Reagent supply center 2 consists of one carousel that is segmented to store a maximum of 36 - 56 reagent cartridges depending on the configuration of the segments. Reagents can be bar code labeled to provide positive identification.
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Section 2
Figure 2.26: Temperature-controlled reagent supply centers
1. Reagent supply center 1 (R1): Provides onboard storage for reagent kits and diluents.
2. Reagent supply center 2 (R2): Provides onboard storage for reagent kits.
Reagent pipettors and wash cups (c System) Reagent pipettors 1 and 2 are devices that detect, aspirate, transfer, and dispense reagents into the cuvette. Reagent pipettor 1 also transfers sample diluents from reagent supply center 1 into a cuvette to be used for onboard sample dilution. Reagent pipettor wash cups are active wash stations that wash any remaining fluid from the probe exterior, interior, and tip.
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1. Reagent pipettor 1: Aspirates and dispenses reagents into cuvettes. 3. Reagent pipettor 2: Aspirates and dispenses reagents into cuvettes.
2. Reagent pipettor 1 wash cup: Washes the probe exterior, interior, and tip. 4. Reagent pipettor 2 wash cup: Washes the probe exterior, interior, and tip.
Onboard solution areas (c System) Reagent onboard solution areas are storage locations for probe wash solutions, which are used for the SmartWash function and maintenance procedures. A rack within each area holds two 90 mL cartridges in positions E1 and E2.
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Section 2
Figure 2.28: Onboard solution areas
1. Reagent supply center 1 (R1) 2. Reagent supply center 2 (R2) onboard solution area: Holds probe onboard solution area: Holds probe wash solutions for the SmartWash wash solutions for the SmartWash function and maintenance function and maintenance procedures. procedures.
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1. Reaction carousel: Positions the cuvettes for sample processing. 3. Lamp: Measures the intensity of a photometric reaction. 5. Cuvette washer: Washes and dries the cuvettes.
2. Cuvette segments: Hold cuvettes in the reaction carousel. 4. Mixer unit: Houses the mixers that mix sample with reagent. 6. ICT unit: Measures potentiometric assays (electrolytes) using ICT (integrated chip technology).
Reaction carousel (c System) The reaction carousel is a device that: Accommodates a variety of assay protocols Consists of 11 cuvette segments Is surrounded by a 37C water bath Rotates counter-clockwise to position the cuvettes at the following locations: Sample dispense R1 reagent dispense R2 reagent dispense ICT electrolyte aspiration Mixing positions (2) Photometric read position Diluted sample aspiration
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Section 2
Figure 2.30: Reaction carousel
Cuvette segments (c System) Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 15 cuvettes. With 11 segments, the reaction carousel can hold 165 cuvettes. Figure 2.31: Cuvette segment
Lamp (c System) The lamp is an optical device used to provide the light source for photometric measurement.
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Mixer unit (c System) The mixer unit is a device that houses two mixers (1 and 2) that mix the sample and reagent together. Mixer 1 (left side) mixes the sample (undiluted or diluted) with reagent 1. Mixer 2 (right side) mixes the sample/reagent 1 mixture with reagent 2. The exterior of each mixer is washed after each mixing operation. Figure 2.33: Mixer unit and mixers
Section 2-41
91407-104November, 2002
Use or function
Processing modules
Section 2
Cuvette washer (c System) The cuvette washer is a device with eight nozzles that, from left to right, perform the following functions before and after each cuvette is used: Nozzle 1 aspirates sample and reagent mixture to waste Nozzle 2 dispenses Alkaline Wash to clean the cuvette, and then aspirates it to waste Nozzle 3 dispenses Acid Wash to clean the cuvette, and then aspirates it to waste Nozzles 4 and 5 dispense water to rinse the cuvette, and then aspirate it to waste Nozzle 6 dispenses water into the cuvette for the water blank measurement, which ensures cuvette integrity Nozzle 7 aspirates the remaining water in the cuvette to waste Nozzle 8 dries the cuvette Figure 2.34: Cuvette washer
Section 2-42
91407-104November, 2002
ICT unit (c System) The ICT unit is a device that consists of the ICT probe and ICT module and is used to perform indirect potentiometric analysis. The ICT probe aspirates the sample. The ICT module simultaneously measures Na+, K+, and Cl- using integrated chip technology. Figure 2.35: ICT unit
1. ICT probe: Aspirates the sample or ICT reference solution into the ICT module.
2. ICT module: Measures potentiometric assays (electrolytes) using ICT (integrated chip technology).
Section 2-43
91407-104November, 2002
Use or function
Processing modules
Section 2
1. Pump center: Houses the processing module pumps. 3. Sample and reagent syringes area: Houses the sample and reagent syringes and drives.
2. Bulk solution supply center: Provides onboard storage for ICT Reference Solution, Alkaline Wash, and Acid Wash.
Section 2-44
91407-104November, 2002
1. ICT reference solution pump: 2. Wash solution pump: Delivers Aspirates ICT Reference Solution diluted alkaline and acid wash through the ICT reference solution solutions to the cuvette washer to pre-heater into the ICT reference wash cuvettes during daily operation solution cup, and then drains the cup and maintenance procedures. when completed. 3. ICT aspiration pump: Aspirates samples or ICT reference solution into the ICT module for measurement, and then moves the waste into the water bath/waste overflow area. 5. Probe wash pump: Uses Reagent Grade Type ll water to flush the sample and reagent probes. 4. Cuvette wash pump: Delivers Reagent Grade Type ll water to the cuvette washer.
6. High-concentration waste pump: Works with the cuvette washer to aspirate waste from the cuvettes to the optional high concentration waste container or the drain.
Section 2-45
91407-104November, 2002
Use or function
Processing modules
1. ICT Reference Solution: Aspirated and analyzed by the ICT module before and after each sample, to provide a reference concentration used to calculate results. 3. Acid Wash: Used by the cuvette washer to clean the cuvettes after sample analysis.
2. Alkaline Wash: Used by the cuvette washer to clean the cuvettes after sample analysis.
Section 2-46
91407-104November, 2002
Section 2-47
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Use or function
Processing modules
Section 2
Section 2-48
91407-104November, 2002
1. Front processing center cover: 2. Processing module keypad: Provides access to the components Provides a local user interface for controlling the processing center. that perform assay processing activities. 3. Supply and waste center door: 4. Card cage door: Provides access to Provides access to the bulk storage the pump center. and solid waste storage area.
Section 2-49
91407-104November, 2002
Use or function
Processing modules
Section 2
Figure 2.41: i 2000 processing module (rear view SSH)
1. Rear processing center cover: 2. Rear processing center access Provides access to the components panel: Provides access to the that perform assay processing processing center components. activities. 3. Power supply panel: Provides access to the power supply components. 4. Pump bay panel: Provides access to the pumps and vacuum center.
Section 2-50
91407-104November, 2002
Figure 2.42: i 2000 processing module (front view LAS carousel sample handler)
1. Front processing center cover: 2. Processing module keypad: Provides access to the components Provides a local user interface for controlling the processing center. that perform assay processing activities. 3. Sample pipettor cover: Covers the sample pipettor as it accesses samples on the LAS track. 5. Card cage door: Provides access to the card cage. 4. Supply and waste center door: Provides access to the bulk storage and solid waste storage area.
Section 2-51
91407-104November, 2002
Use or function
Processing modules
Section 2
Figure 2.43: i 2000 processing module (rear view LAS carousel sample handler)
1. Rear processing center cover: 2. Rear processing center access Provides access to the components panel: Provides access to the that perform assay processing processing center components. activities. 3. Power supply panel: Provides access to the power supply components. 4. Pump bay panel: Provides access to the pumps and vacuum system.
Related information... Processing module keypad (i System), page 55 Processing center (i System), page 56 Supply and waste center (i System), page 75 Optional components (i System), page 85 i 2000 System, page 5
Section 2-52
91407-104November, 2002
1. Front processing center cover: 2. Processing module keypad: Provides access to the components Provides a local user interface for that perform assay processing controlling the processing center. activities. 3. Supply and waste center door: 4. Card cage door: Provides access to Provides access to the bulk storage the card cage. and solid waste storage area.
Section 2-53
91407-104November, 2002
Use or function
Processing modules
Section 2
Figure 2.45: i 2000SR processing module (rear view RSH)
1. Rear processing center cover: 2. Rear processing center access Provides access to the components panel: Provides access to the that perform assay processing processing center components. activities. 3. Power supply panel: Provides access to the power supply components. 4. Pump bay panel: Provides access to the pumps and vacuum system.
Related information... Processing center (i System), page 56 Supply and waste center (i System), page 75 Optional components (i System), page 85 ARCHITECT ci 8200 integrated system, page 3 ARCHITECT i 2000SR System, page 6
Section 2-54
91407-104November, 2002
1. Run key: Places the processing module into Running status and prepares the module to accept samples. Restarts the processing center after a Scheduled Pause.
2. Carousel advance key: Aligns the reagent carousel and advances the reagent carousel five positions to aid in loading reagents.
3. Access indicator light: Illuminates to 4. Stop key: Stops all processing indicate that the processing module module activity, but does not shut is in the Warming or Ready status down power to the processing and you can access the reagent module. carousel. 5. L1, L2, L3, L4 keys: Used when performing some diagnostic and maintenance procedures.
Section 2-55
91407-104November, 2002
Use or function
Processing modules
Section 2
1. Sample hardware components: Provide sample aspiration and dispense. 3. Process path hardware components: Position the RVs for sample and reagent aspiration, mixing, washing, and CMIA processing.
Section 2-56
91407-104November, 2002
Processing modules
Figure 2.50:
Section 2-57
91407-104November, 2002
Use or function
Processing modules
1. Sample and STAT pipettors (S and 2. Sample and STAT syringes (SS and ST): Aspirate and dispense samples STS): Control the aspiration and into the RVs (reaction vessels). dispense of samples. 3. Sample and STAT wash stations (SW and STW): Used to wash remaining fluid from the probe interior and tip.
Sample and STAT pipettors (i System) The sample and STAT pipettors (S and ST, respectively, on the processing center map) are devices that detect, aspirate, transfer, and dispense samples into the reaction vessel. The sample pipettor also transfers pretreated samples into a new reaction vessel after the appropriate incubation period. These pipettor assemblies include a fluid sense/pressure monitoring system that helps to identify errors in aspiration.
Section 2-58
91407-104November, 2002
1. Sample pipettor
2. STAT pipettor
Sample and STAT syringes (i System) The sample and STAT syringes (SS and STS, respectively, on the processing center map) are devices that control the aspiration and dispense of samples. Figure 2.53: Example of a sample or STAT syringe
Section 2-59
91407-104November, 2002
Use or function
Processing modules
Section 2
Sample and STAT wash stations (i System) The sample and STAT wash stations (SW and STW, respectively, on the processing center map) are passive wash stations that dispense excess sample and wash any remaining fluid from the probe interior and tip. Figure 2.54: Example of a sample or STAT wash station
Section 2-60
91407-104November, 2002
1. Reagent carousel: Provides cooled, 2. Reagent bar code reader: Reads temperature-controlled storage for two dimensional (2D) bar code reagent kits. labels on reagent bottles. 3. Reagent pipettors (R1 and R2): 4. Reagent syringes (R1S and R2S): Aspirate and dispense reagents into Aspirate and dispense reagents. RVs (reaction vessels). 5. Reagent wash stations (R1W and R2W): Washes any remaining fluid from the probe interior and exterior surfaces.
Section 2-61
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Use or function
Processing modules
Section 2
Reagent carousel (i System) The reagent carousel is a rotating circular device that: Holds up to 25 bar coded, reagent kits (75 individual bottles) in a cooled, temperature-controlled environment Consists of three rings that are color coded to match the color stripe at the top of the reagent bottle labels Provides microparticle dispersion by continuously rotating the microparticle reagent bottles Rotates to position bottles for reagent aspiration and dispense Figure 2.56: Reagent carousel
Section 2-62
91407-104November, 2002
Reagent pipettors (i System) Reagent pipettors (R1 and R2 on the processing center map) are devices that detect, aspirate, transfer, and dispense reagents into the RV (reaction vessel). Each pipettor assembly includes a fluid sense/ pressure monitoring system that helps to identify errors in aspiration. Figure 2.57: Reagent pipettor (R1)
Section 2-63
91407-104November, 2002
Use or function
Processing modules
Section 2
Reagent syringes (i System) The reagent syringes (R1S and R2S on the processing center map) are devices that control the aspiration and dispense of reagents. Figure 2.59: Example of a reagent syringe (R1 or R2)
Section 2-64
91407-104November, 2002
Reagent wash stations (i System) The reagent wash stations (R1W and R2W on the processing center map) are active wash stations that are used to wash any remaining fluid from the probe interior and exterior surfaces. In addition, a vacuum source dries the exterior of the probe. The portion of the probe that enters the reagent bottle is washed and dried in this wash station. Figure 2.60: Example of a reagent wash station (R1 or R2)
Section 2-65
91407-104November, 2002
Use or function
Processing modules
1. Load diverter (LD): Moves RVs from 2. RV access door (RVA): Used for the inner track to the outer track of diagnostic purposes only. This door the process path when reaction allows access to one position on the vessels are needed for processing. outer track. 3. RV loader and hopper assembly 4. STAT diverter (STD): Moves (RVL): Provides onboard storage for reaction vessels on an i 2000SR processing module from the inner RVs and transports RVs into the track to the outer track of the process path. process path when RVs are needed for STAT processing. 5. Vortexers (VTX1, VTX2, VTX3, 6. Wash zone diverter (WZD): Directs VTXST): Mix the reaction mixture to RVs to one of two paths. One path suspend microparticles. moves RVs through the wash zone where a wash occurs. The other path moves RVs around the wash zone.
Section 2-66
91407-104November, 2002
7. Wash zone manifolds (WZ1, WZ2): 8. Process path drive motor (PPM): Dispenses wash buffer, and Rotates the process path disk, which removes and discards unbound holds RVs in place, and advances analyte from the reaction mixture in the RVs from position to position. the RV. 9. Pre-trigger/trigger manifold (PT/T): 10.CMIA reader (CMIA): Measures the Dispenses Pre-Trigger Solution, and chemiluminescent emission from then Trigger Solution into the RVs. RVs and outputs data corresponding to the quantity of emission detected. 11.Liquid waste arm (A): Removes liquid from RVs prior to unloading it to the solid waste container. 12.RV unloader (UL): Removes used RVs from the process path and discards them into the solid waste container after assay processing.
Load diverter (i System) The load diverter (LD on the processing center map) is a device that moves RVs (reaction vessels) from the inner track to the outer track of the process path when RVs are needed for routine processing. Figure 2.62: Load diverter
Section 2-67
91407-104November, 2002
Use or function
Processing modules
Section 2
RV access door (i System) The RV access door (RVA on the processing center map) is an opening that allows access to one position on the outer track. You use this door for diagnostic purposes only and should always make sure it is closed during system operation. Figure 2.63: RV access door
RV loader and hopper assembly (i System) The RV loader and hopper assembly (RVL on the processing center map) is a device that provides onboard storage for RVs (reaction vessels) and transports the RVs into the process path. Figure 2.64: RV loader and hopper assembly
Section 2-68
91407-104November, 2002
STAT diverter (i 2000SR) The STAT diverter (STAT on the processing center map) is a device that moves RVs (reaction vessels) from the inner track to the outer track of the process path when the RVs are needed for STAT processing. Figure 2.65: STAT diverter
Section 2-69
91407-104November, 2002
Use or function
Processing modules
Section 2
Vortexers (i System) The vortexers (VTX1, VTX2, VTX3, and VTXST on the processing center map) are devices that mix the reaction mixture to suspend microparticles. The RVs are vortexed in the process path. Figure 2.66: Vortexers
Wash zone diverter (i System) The wash zone diverter is a device that directs RVs (reaction vessels) to one of two paths. One path moves RVs through the wash zone where a wash occurs. The other path moves RVs around the wash zone. Figure 2.67: Wash zone diverter
Section 2-70
91407-104November, 2002
Wash zone manifolds (i System) The wash zone manifolds (WZ1 and WZ2 on the processing center map) are devices that remove and discard unbound analyte from the reaction mixture in an RV (reaction vessel). Each wash zone has four positions where the following actions occur: Position 1 A magnet attracts paramagnetic microparticles to the wall of the RV and a dispense nozzle dispenses wash buffer into the RV. Positions 2 and 3 A vacuum is applied to the aspiration probes as they move to the bottom of the RV. In addition, nozzles dispense wash buffer into the RV. Additional wash/aspiration cycles occur at these positions. Position 4 An aspiration probe aspirates liquid waste from the RV. Figure 2.68: Wash zone manifold (WZ1)
Section 2-71
91407-104November, 2002
Use or function
Processing modules
Section 2
Process path drive motor (i System) The process path drive motor (PPM on the processing center map) is a device that rotates the process path disk, which holds the RVs in place, and advances the RVs from position to position. Figure 2.69: Process path drive motor (PPM)
Pre-trigger/trigger manifold (i System) The pre-trigger/trigger manifold (PT/T on the processing center map) is a device that dispenses Pre-Trigger Solution, and then Trigger Solution into RVs (reaction vessels). Figure 2.70: Pre-trigger/trigger manifold (PT/T)
Section 2-72
91407-104November, 2002
CMIA reader (i System) The CMIA reader (CMIA on the processing center map) is a device that measures the chemiluminescent emission from RVs (reaction vessels) and reports the quantity of emission detected. Figure 2.71: CMIA reader (CMIA)
Section 2-73
91407-104November, 2002
Use or function
Processing modules
Section 2
Liquid waste arm (i System) The liquid waste arm (A on the processing center map) is a device that removes liquid from RVs (reaction vessels) prior to unloading them to the solid waste container. Figure 2.72: Liquid waste arm (A)
RV unloader (i System) The RV unloader (UL on the processing center map) is a device that removes used RVs (reaction vessels) from the process path and discards them into the solid waste container after assay processing. Figure 2.73: RV unloader (UL)
Section 2-74
91407-104November, 2002
1. Pre-trigger and trigger storage area: 2. Wash buffer storage area: Provides Provides onboard storage for Preonboard storage for the wash buffer. Trigger and Trigger Solution. 3. Solid waste storage area: Provides storage for the used RVs (reaction vessels).
Section 2-75
91407-104November, 2002
Use or function
Processing modules
1. Pre-trigger/trigger tray: Holds the pre-trigger and trigger bottles. 3. Pre-trigger level sensor: Detects the volume of remaining pre-trigger solution.
Section 2-76
91407-104November, 2002
Pre-trigger/trigger tray (i System) The pre-trigger/trigger tray is a platform in the supply and waste center that holds the Pre-Trigger Solution and Trigger Solution bottles. Figure 2.76: Pre-trigger/trigger tray
1. Trigger solution: Used to produce the chemiluminescent reaction that provides the final read.
2. Pre-trigger solution: Used to split the acridinium dye off the conjugate bound to the microparticle complex. This process prepares the acridinium dye for the addition of trigger solution.
Section 2-77
91407-104November, 2002
Use or function
Processing modules
Section 2
Pre-trigger level sensor (i System) The pre-trigger level sensor is an assembly with a magnetic float sensor located in the pre-trigger bottle that indicates when the liquid level is low. When the sensor trips, approximately 70 mL of usable solution remains. Figure 2.77: Pre-trigger level sensor
Section 2-78
91407-104November, 2002
Trigger level sensor (i System) The trigger level sensor is an assembly with a magnetic float sensor located in the trigger bottle that indicates when the liquid level is low. When the sensor trips, approximately 70 mL of usable solution remains. Figure 2.78: Trigger level sensor
Section 2-79
91407-104November, 2002
Use or function
Processing modules
1. Wash buffer reservoir: Provides 2. Wash buffer level sensor: Draws onboard storage for up to 25 liters of wash buffer from the reservoir and wash buffer. measures the remaining volume of wash buffer. 3. Wash buffer inlet assembly: Dispenses wash buffer into the reservoir from the wash buffer preparation container or ARCHITECT ARMTM (Automatic Reconstitution Module). 4. Wash buffer filter: Protects the fluidics components by eliminating particulates.
Section 2-80
91407-104November, 2002
Wash buffer reservoir (i System) The wash buffer reservoir is an onboard container in the supply and waste center that holds up to 25 liters of wash buffer. Figure 2.80: Wash buffer reservoir
Section 2-81
91407-104November, 2002
Use or function
Processing modules
Section 2
Wash buffer level sensor (i System) The wash buffer level sensor, located in the wash buffer reservoir, is an assembly containing a tube with three magnetic float sensors that indicate when the wash buffer reservoir is full (top sensor), needs to be filled by the ARCHITECT ARMTM (Automatic Reconstitution Module) accessory (middle sensor), or is empty (lower sensor). The tube draws wash buffer from the reservoir during test processing. The inlet assembly dispenses wash buffer into the reservoir from the wash buffer preparation container or ARM. Figure 2.81: Wash buffer level sensor
Section 2-82
91407-104November, 2002
Wash buffer filter (i System) The wash buffer filter, located in the wash buffer storage area, is an assembly containing material used to eliminate particulates that might damage the fluidics components of the system. Figure 2.82: Wash buffer filter
Section 2-83
91407-104November, 2002
Use or function
Processing modules
Section 2-84
91407-104November, 2002
Waste chute and trap door (i System) The waste chute is a device in the supply and waste center that receives used RVs (reaction vessels) by gravity and directs them into the solid waste container. The trap door holds up to 50 RVs when you remove the solid waste container during processing. Figure 2.84: Waste chute and trap door
Section 2-85
91407-104November, 2002
Use or function
Processing modules
Section 2
The ARM is connected to a water supply and is loaded with a 10 L container of concentrated wash buffer. A single motor operating at a constant speed is geared to drive two pumps at a 9:1 ratio to each other, pumping the necessary proportions of water and concentrated wash buffer into a mixing chamber. Sensors verify that incoming water and outgoing wash buffer meet predetermined specifications for ion content and temperature. If the standards are not met, the ARM motor stops automatically. Figure 2.85: ARM (front view)
1. ARM keypad: Provides a local user interface for controlling the ARM.
2. Tubing assembly: Detects the level of concentrated wash buffer in the 10 liter container and transfers the concentrated wash buffer to the mixing chamber inside the ARM. 4. Concentrated Wash Buffer (10 L container): Concentrated buffer diluted by the ARM and delivered to the processing modules.
3. Fluidics and electronics bay: Provides access to the pump and circuit boards.
Section 2-86
91407-104November, 2002
Section 2-87
91407-104November, 2002
Use or function
Processing modules
Section 2
ARCHITECT ARMTM keypad (i System) The ARM keypad is an input device used by the operator to operate the ARCHITECT ARMTM (Automatic Reconstitution Module) accessory. Figure 2.87: Components of the ARM keypad
1. Start key: Initiates operation. The 2. Decontamination key (used by green indicator below the key Abbott service representatives): Initiates the decontamination illuminates during operation and procedures. flashes when wash buffer is being pumped to the wash buffer reservoir in the processing module. 3. Flush to drain key: Initiates a flush. 4. Replace buffer key: Initiates loading This key is not functional when your of the 10 L container of wash buffer transfer option is set to Concentrated Wash Buffer. The Automatic. amber indicator illuminates during this procedure. 5. Stop key: Stops the procedure currently in progress and/or interrupts communication to the SCC (system control center). The red indicator illuminates when you press the stop key. 6. Water quality error indicator: Illuminates red if the incoming water does not meet the NCCLS Type II resistivity standard. When this occurs, transfer of buffer stops.
7. Buffer quality error indicator: 8. Flood indicator: Illuminates red if Illuminates red if the diluted buffer liquid is detected in the flood pan. mixture is outside acceptable limits. When this occurs, transfer of buffer The up arrow indicates too much stops. water. The down arrow indicates too little water. When either occurs, the system stops transfer of buffer.
Section 2-88
91407-104November, 2002
9. Water temperature indicator: 10.Low inlet pressure indicator: Illuminates red if incoming water Illuminates red if incoming water temperature is outside the range of pressure or the flow rate is too low. 15-37C. When this occurs, transfer When this occurs, transfer of buffer of buffer stops. stops. 11.High outlet pressure indicator: 12.Inventory level indicator: Indicates Illuminates red if the outgoing wash the volume of buffer remaining in the buffer pressure exceeds the container. pressure limit of the inlet valves. 3 bars illuminated = full When this occurs, transfer of buffer 2 bars illuminated = mid (50%) stops. 1 bar illuminated = low (20%) No bar illuminated = empty (<2%) The red indicator illuminates and the ARM stops.
ARM connectors (i System) Connectors on the ARCHITECT ARMTM (Automatic Reconstitution Module) accessory are ports that provide the connections for transporting fluids to and from the ARM and communicating with the SCC (system control center).
Section 2-89
91407-104November, 2002
Use or function
Processing modules
Section 2
Figure 2.88: Connectors on rear of ARM
1. Diluted wash buffer outlet: Provides the connection that allows diluted wash buffer to be transferred to the wash buffer reservoir in the processing module. 3. Water inlet: Provides the connection from the deionized water system to the ARM.
2. Decontamination port 1: Provides the connection that allows a 0.5% sodium hypochlorite solution to be flushed through the ARM for decontamination. 4. Waste 1 (pressurized) port: Provides pressurized waste from the internal drip pan located inside the ARM to the external waste pump or floor drain. 6. RS232 port: Provides communication between the ARM and the SCC.
5. Waste 2 (gravity) port: Provides gravity waste from the internal drip pan, located inside the ARM, to the external waste pump or floor drain. 7. Power switch: Used to cycle the power.
Section 2-90
91407-104November, 2002
1. Sensor cable: Provides the connection from the tubing assembly to the ARM. 3. Decontamination port 2: Provides the connection that allows the ARM system to be flushed with water to remove the 0.5% sodium hypochlorite solution.
2. Concentrated wash buffer inlet: Provides the connection that allows the concentrated wash buffer to be transferred to the mixing chamber of the ARM.
Section 2-91
91407-104November, 2002
Section 2
Use or function
Section 2-92
91407-104November, 2002
1. RSH cover: Provides access to the RSH components. 3. RSH bar code reader: Reads the sample and sample carrier ID.
2. RSH keypad: Provides a local user interface for controlling the sample handler. 4. Priority bay: Positions samples for priority processing.
5. Routine bays: Positions samples for 6. Carrier positioner: Positions carriers routine processing. for sample aspiration. 7. Carrier transport: Transfers sample carriers from the bays to the carrier positioner and back.
Section 2-93
91407-104November, 2002
Use or function
Sample handlers
Section 2
Figure 2.91: Priority bay
1. Priority bay: Holds carriers and positions samples for priority processing. 3. Sample carrier: Holds five primary tubes, aliquot tubes, or sample cups. You may mix different types of sample vessels in a sample carrier.
2. Status indicator: Indicates the status of sample processing and when you can access samples: Indicators off no samples are loaded in the position. Green (steady) samples are loaded, but processing has not begun. You can access the samples. Amber (steady) samples are processing and you cannot access them. Green (blinking) processing is complete and you can access the samples. Amber and green (alternating) bar code scan or other error occurred. You can access the samples.
Section 2-94
91407-104November, 2002
Section 2-95
91407-104November, 2002
Use or function
Sample handlers
Section 2
Figure 2.92: Routine bay
1. Status indicator: Indicates the status 2. Carrier tray: Holds up to five sample of sample processing and when you carriers. can access samples: Indicators off no samples are loaded in the position. Green (steady) samples are loaded, but processing has not begun. You can access the samples. Amber (steady) samples are processing and you cannot access them. Green (blinking) processing is complete and you can access the samples. Amber and green (alternating) bar code scan or other error occurred. You can access the samples. 3. Bay door: Provides access to the routine bay.
Section 2-96
91407-104November, 2002
1. Run key: Resumes or begins the 2. Pause key: Pauses the sample transport of samples that are located handler. in the bays. 3. Stop key: Stops the sample handler, but does not shut down power to the sample handler.
Section 2-97
91407-104November, 2002
Use or function
Sample handlers
Section 2
Depending on the number of processing modules, there are two SSH configurations: Single lane provides sample handling for a single processing module. The maximum capacity is 125 samples (25 sample carriers, 5 samples per carrier). Double lane provides sample handling for multi-module (up to four processing modules) systems. The maximum capacity is 250 samples (50 sample carriers, 5 samples per carrier). Figure 2.94: SSH components (single lane)
1. Sample load queue (single lane): 2. Sample carriers: Hold five primary Transfers the sample carriers to the tubes, aliquot tubes, or sample cups. sample processing queue. Different types of sample vessels may be mixed on each carrier. 3. Sample handler keypad: Provides a 4. Sample load queue bar code reader: local user interface for controlling Reads the sample carrier ID, the sample handler. position, and sample ID. 5. Sample processing queue bar code 6. Left processing queue access door: reader: Reads the sample carrier ID Provides access to the sample and position. Does not read the processing queue. sample ID. 7. Right processing queue access 8. Sample processing queue: door: Provides access to the sample Transfers the sample carrier to the processing queue. sample pipettor. Once samples are aspirated, the sample carrier is 9. Sample unload queue (single lane): transferred to another processing Provides the location where sample module or to the sample unload carriers are unloaded. queue.
Section 2-98
91407-104November, 2002
1. Sample load queue (double lane): 2. Sample unload queue (double lane): Transfers the sample carriers to the Provides the location where sample sample processing queue. carriers are unloaded.
Section 2-99
91407-104November, 2002
Use or function
Sample handlers
Section 2
SSH keypad
The SSH (standard sample handler) keypad is an input device used by the operator to control the sample handler. Figure 2.96: Components of the SSH keypad
1. Run key: Resumes or begins the 2. Pause key: Pauses the sample load transport of samples that are located queue so you can load sample on the sample load queue. carriers or perform priority loading. 3. Pause indicator (yellow): Illuminates 4. Reverse key: Reverses the sample to indicate that the sample load load queue direction for ease of queue is paused and ready for loading priority sample carriers. loading of sample carriers. Functional only when the pause indicator is illuminated. 5. Stop key: Stops the sample handler, 6. Active lane indicators (green; active but does not shut down power to the on double load queues only): sample handler. Indicate the currently active lane. The lane indicator is used to facilitate priority loading on multimodule systems.
Section 2-100
91407-104November, 2002
1. LAS carousel cover: Provides 2. LAS sample carousel: Holds 20 access to the LAS sample carousel. primary tubes, aliquot tubes, or sample cups. Different types of 3. LAS carousel sample handler sample vessels may be mixed on keypad: Provides a local user the carousel. interface for the control of the LAS carousel.
Section 2-101
91407-104November, 2002
Use or function
Sample handlers
Section 2
1. Run key: Resumes or begins the processing of samples located on the LAS carousel.
2. Pause key: Pauses the LAS carousel after completing aspiration of the current sample or current group of calibrators.
3. Pause indicator (yellow): Illuminates 4. Carousel advance key: Moves the to indicate that the LAS carousel is LAS carousel clockwise 5 positions. paused and ready for loading or Functional only when the pause unloading samples. indicator is illuminated. 5. Stop key: Stops the LAS carousel, but does not shut down the power to the carousel.
Section 2-102
91407-104November, 2002
Section 2
Use or function
*The Scheduled pause status applies to all processing modules, the RSH (retest sample handler) and the LAS (laboratory automation system) carousel sample handler. For the SSH (standard sample handler) this status is Load queue paused. System status topics include: Sample handler status, page 103 Processing module status, page 107
Section 2-103
91407-104November, 2002
Use or function
System statuses
Section 2
Stopped
Ready
Running
Scheduled Pause
Initializing
Section 2-104
91407-104November, 2002
System statuses
Stopped
Ready Running
Initializing
Section 2-105
91407-104November, 2002
Use or function
System statuses
Section 2
Stopped
Ready
Running
Scheduled pause
Initializing
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Processing module status types depend upon the configuration of your system. For a description of the various statuses, see: Processing module status types (c 8000), page 108 Processing module status types (i 2000 and i 2000SR), page 109
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Use or function
System statuses
Section 2
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Table 2.4: c 8000 processing module status types (continued) Status Initializing Indicates A temporary status that occurs when the run key, F8 - Run, or F5 - Startup is selected. The following initialization functions are performed by the system: Initialization after F5 - Startup is selected: Homes motors Initializes the reagent bar code reader Initialization after the run key or F8 - Run is selected: Checks cover sensors Scans reagents Washes probes Checks inventory Once initialization is complete, the status changes to Running or Ready depending on whether run or startup was selected. Scanning A temporary status that occurs when F4 - Scan on the Reagent status screen is selected. Once the scan is complete, the status changes to Ready. A temporary status that occurs when certain maintenance procedures are performed. You cannot open the processing center covers. Prohibited activities You cannot run samples on the module. You cannot load or unload reagents because the reagent supply center is not aligned correctly.
Maintenance
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Use or function
System statuses
Section 2
Table 2.5: i 2000 and i 2000SR processing module status types (continued) Status Stopped Indicates One of the following exists: Power to the processing module is on but F5 Startup on the Snapshot screen has not been selected. F6 - Stop on the Snapshot screen was selected. Stop key on the processing module keypad was selected. Processing module diagnostic procedure has completed. Processing module detected a fatal error while processing. Warming Ready Startup is complete but temperature initialization is not. One of the following exists: Startup is complete (including temperature initialization). Scheduled Pause status is complete. Scheduled Pause One of the following exists: F7 - Pause on the Snapshot screen was selected. Supplies ran out. Processing module detected an error while processing. Running One of the following exists: F8 - Run on the Snapshot screen was selected. Run key on the processing module keypad was selected. You cannot open the processing center covers. You cannot open the processing center covers. You cannot run samples on the module. You cannot load or unload reagents because the reagent supply center is not aligned correctly. Prohibited activities
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System statuses
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Use or function
System statuses
Section 2
NOTES
Section 2-112
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Section 3
Communication Setup
Section 3Introduction
This section describes powering the ARCHITECT System and configuring communications to a host computer to meet your sites specific requirements. Configuration is performed at time of installation and may be changed at a later time if necessary. The following topics are included in this section: System startup, pause, and shutdown, page 3 Setting Communications, page 15
Section 3-1
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Communication Setup
Introduction
Section 3
NOTES
Section 3-2
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Section 3
Communication Setup
Section 3-3
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Communication Setup
System startup, pause, and shutdown
Section 3
1. Verify the processing module power is off before applying power to the SCC. NOTE: If the processing module(s) power is on when you power on the SCC, communication is not properly initialized between the system components. 2. Press the power switch on the CPU (central processing unit) to turn on the SCC.
To power off the SCC: 1. Select F3 - Shutdown on the Snapshot screen. NOTE: The sample handler and processing module(s) are not functional when the system control center is off. To prevent flooding when your system is connected to an ARCHITECT ARMTM (Automatic Reconstitution Module) accessory, do not shut down the SCC if the ARM is in the process of filling the wash buffer reservoir. A confirmation message displays. 2. Select OK to initiate shutdown. 3. Wait for the information window to display, and then simultaneously press the CTRL+ALT+DELETE keys on the keyboard. The Confirm Exit window displays. 4. Leave the Shutdown Computer option selected, and then select OK. 5. Wait for the information window to display, and then press and hold the power switch on the front of the CPU (central processing unit) to turn off power to the SCC.
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To cycle power to the SCC: 1. Select F3 - Shutdown on the Snapshot screen. NOTE: The sample handler and processing module(s) are not functional when the system control center is off. To prevent flooding when your system is connected to an ARCHITECT ARMTM (Automatic Reconstitution Module) accessory, do not shut down the SCC if the ARM is in the process of filling the wash buffer reservoir. A confirmation message displays. 2. Select OK to confirm the shutdown. 3. Wait for the information window to display, and then simultaneously press the CTRL+ALT+DELETE keys on the keyboard. The Confirm Exit window displays. 4. Leave the Shutdown Computer option selected, and then select OK. 5. Wait for the information window to display, and then press and hold the power switch on the front of the CPU (central processing unit) to turn off power to the SCC. NOTE: The SCC may power off immediately, or it may take up to 10 seconds depending on the type of SCC you have.
Section 3-5
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Communication Setup
System startup, pause, and shutdown
Section 3
6. Move the power switch on the lower left rear of the processing module(s) down to turn off the power. 7. Press the power switch on the front of the CPU to turn on power to the SCC. 8. Wait for the Snapshot screen to display. It may take several minutes to display. 9. Ensure the processing module(s) has been powered off for five minutes, and then move the power switch up to turn on power. To change the status of the processing module from Stopped to Ready, see Start up the processing module and/or sample handler, page 9. Related information... Snapshot screen, page 2-20 System control center, page 2-9
Processing module and sample handler cycle power, startup, and pause
It may be necessary for you to remove power to the processing module(s) and sample handler to perform certain procedures. Cycling power involves powering off the processing module and sample handler followed by applying power. Once the power is on, you must perform a startup to attain a Ready status. You are required to pause the sample load queue to load samples on the SSH (standard sample handler), and you must pause the sample carousel (c System) to load samples in the carousel. You are required to pause the processing module and sample handler to load reagents, and solutions and to perform maintenance or diagnostic procedures. Processing module and sample handler cycle power, startup, and pause procedures include: Power on the processing module and/or sample handler, page 7 Power off the processing module and/or sample handler, page 7 Cycle power to the processing module and/or sample handler, page 8 Start up the processing module and/or sample handler, page 9 Pause the processing module, page 10 Pause the RSH, page 11 Pause the sample carousel (c System), page 12 Pause the sample load queue (SSH), page 12 Pause the LAS carousel sample handler, page 13
Section 3-6
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To power on the processing module and/or sample handler: 1. Ensure that the SCC (system control center) power is on and that the Snapshot screen displays. 2. Move the power switch on the lower left rear of the processing module up to turn on the power. NOTE: In a single module system, powering off the processing module also turns off power to the sample handler. In a multi-module system, powering off the processing module furthest to the right (when facing the front of the system) also powers off the sample handler. To change the status of the processing module and sample handler from Stopped to Ready, see Start up the processing module and/or sample handler, page 9. Related information... Snapshot screen, page 2-20 Processing module (c 8000), page 2-27 Processing modules (ARCHITECT i System), page 2-48
Section 3-7
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Communication Setup
System startup, pause, and shutdown
Section 3
To power off the processing module and/or sample handler: 1. Determine the module to power off. 2. Verify the processing module and/or sample handler are in Offline, Stopped, Warming, or Ready status. The processing module MUST be in one of these statuses to ensure that test processing is not interrupted. 3. Move the power switch on the lower left rear of the processing module down to turn off the power. NOTE: In a single module system, powering off the processing module also turns off power to the sample handler. In a multi-module system, powering off the processing module furthest to the right (when facing the front of the system) also powers off the sample handler. Related information... Snapshot screen, page 2-20 Processing module (c 8000), page 2-27 Processing modules (ARCHITECT i System), page 2-48
To cycle power to the processing module and/or sample handler: 1. Determine the module to power off. 2. Verify the processing module and/or sample handler are in Offline, Stopped, Warming, or Ready status. The processing module MUST be in one of these statuses to ensure that test processing is not interrupted.
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3. Move the power switch on the lower left rear of the processing module down to turn off the power. NOTE: In a single module system, powering off the processing module also turns off power to the sample handler. In a multi-module system, powering off the processing module furthest to the right (when facing the front of the system) also powers off the sample handler. 4. Ensure that the SCC (system control center) power is on and that the Snapshot screen displays. 5. Ensure the processing module has been powered off for five minutes, and then move the power switch up to turn on the processing module and/or sample handler. To change the status of the processing module and sample handler from Stopped to Ready, see Start up the processing module and/or sample handler, page 9. Related information... Snapshot screen, page 2-20 Processing module (c 8000), page 2-27 Processing modules (ARCHITECT i System), page 2-48
To start up the processing module and/or sample handler: 1. Select the processing module graphic and/or sample handler graphic on the Snapshot screen, and then select F5 - Start-up. 2. Verify the status(es) when startup is complete:
Section 3-9
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Communication Setup
System startup, pause, and shutdown
Section 3
Ready or Warming (processing module) Ready (sample handler) Related information... Snapshot screen, page 2-20 Processing modules, page 2-27
Prerequisite
To pause the processing module: 1. Verify the sample handler is not in the Running status. NOTE: If you do not pause the sample handler and wait for all scheduled tests to aspirate before you pause the processing module, all tests with a status of Scheduled become exceptions and are not processed. 2. Verify all tests have a status of Pending or Running. 3. Select the desired processing module graphic on the Snapshot screen, and then select F7 - Pause. A confirmation message displays.
Section 3-10
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4. Select OK to pause the processing module. NOTE: If you are pausing a c System processing module, do not open the R1 and R2 reagent supply center covers until the access indicators on the processing module keypad illuminate. NOTE: If you are pausing an i System processing module, do not open the module covers until the access indicator on the processing module keypad illuminates, indicating the status is Ready. Related information... Snapshot screen, page 2-20 Processing module (c 8000), page 2-27 Processing modules (ARCHITECT i System), page 2-48
Section 3-11
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Communication Setup
System startup, pause, and shutdown
Section 3
To pause the RSH: 1. Select the sample handler graphic on the Snapshot screen, and then select F7 - Pause. A confirmation message displays. 2. Select OK to pause the RSH. The pause indicator illuminates on the sample handler keypad. Related information... Snapshot screen, page 2-20
To pause the sample carousel: 1. Press the sample carousel access indicator button (square) next to the sample carousel. The sample carousel access indicator blinks to indicate the sample carousel is in the process of pausing. 2. Verify the illuminated sample carousel access indicator is no longer blinking.
Section 3-12
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You may also perform this procedure to pause the SSH prior to pausing a processing module(s) so that samples are not transported to the module(s). NOTE: When you pause the sample load queue, the sample handler status transitions from Running to Load queue paused. The sample load queue stops routing any new carriers, but the processing queue and unload queue remain active for approximately 20 minutes after the last carrier is unloaded. If you do not initiate a run on the sample handler during that time, the sample handler status changes to Ready. To pause the processing module see, Pause the processing module, page 10.
Prerequisite Module status User access level Supplies Access the Snapshot screen, page 2-21 Running General operator NA
To pause the sample load queue: 1. Select the sample handler graphic on the Snapshot screen, and then select F7 - Pause. A confirmation message displays. 2. Select OK to pause the SSH. The pause indicator illuminates on the sample handler keypad. Related information... Snapshot screen, page 2-20
Section 3-13
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Communication Setup
System startup, pause, and shutdown
Section 3
You may also perform this procedure to pause the LAS carousel sample handler prior to pausing the processing module. NOTE: When you pause the LAS carousel sample handler, the sample handler status transitions from Running to Scheduled pause. The processing module completes aspirations for the current sample or for all scheduled calibrators. If you do not initiate a run on the sample handler during that time, the sample handler status changes to Ready. To pause the processing module see, Pause the processing module, page 10.
Prerequisite Module status User access level Supplies Access the Snapshot screen, page 2-21 Running General operator NA
To pause the LAS carousel sample handler: 1. Select the sample handler graphic on the Snapshot screen, and then select F7 - Pause. A confirmation message displays. 2. Select OK to pause the LAS carousel sample handler. The pause indicator illuminates on the sample handler keypad. NOTE: If you open the LAS carousel cover before the indicator illuminates, all tests in process on the carousel become exceptions and do not complete. Related information... Snapshot screen, page 2-20
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Section 3
Communication Setup
Section 3-15
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Communication Setup
Setting Communications
Section 3
To access the Configuration screen, select the System icon, then select Configuration from the drop-down menu (Figure 3.1). The Configuration screen for System settings is displayed (Figure 3.2).
Figure 3.1: Accessing the System Configuration Screen
Figure 3.2:
Section 3-16
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1. Configure: Allows you to select one of the following categories for configuration: System settings Assay settings QC-Cal settings
2. System categories: Allows you to select the following system configuration items: Sample ordering Host-Release mode Reports - Printing Reagents - Supplies Password System control center Modules Sample handler Sample bar code readers Serial ports
3. F1 - Exit: Displays the Snapshot screen. 4. F5 - Details: Displays the details window allowing you to view detailed information 5. F6 - Configure: Displays the for the item(s) you selected. configuration window allowing you to configure the information for the selected item(s).
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Communication Setup
Setting Communications
Section 3
1. Release mode: Allows the general operator to select the release mode for results. Options are: Manual - All results must be manually released. (Default) Hold - All results with flags must be manually released. Automatic - Results are released automatically. Automatic with exceptions - Results and exceptions are automatically released.
2. Host query timeout: Allows the general operator to enter the maximum time period (in seconds) that the system waits for the host computer to respond to a query. Range: 5 60 seconds (Default: 10 seconds) NOTE: System throughput may degrade if this timeout period is greater than ten seconds.
3. Communications: Allows the general 4. Transmit to host: Allows the general operator to enable the bidirectional host operator to define the method for mode, so the system can receive orders transmitting patient and quality control from and transmit results to a host results to the host computer. computer. Options are: On On with query Off (Default) NOTE: Turning bidirectional host off allows you to clear all results waiting to be sent to the host. 5. Done: Accepts your selection(s) and returns to the Configuration screen. 6. Cancel: Cancels your selection(s) and returns to the Configuration screen.
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1. Release mode: Displays the current setting for result release mode.
2. Host query timeout: Displays the maximum time period (in seconds) that the system waits for the host computer to respond to a query. 4. Transmit to host: Displays the method for transmitting patient and quality control results to the host computer.
3. Communications: Displays the current setting for bidirectional host transmissions. 5. Done: Returns to the Configuration screen.
Section 3-19
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Communication Setup
Setting Communications
Section 3
Off
Off
Sample ordering Host - Release mode Reports - Printing Reagents - Supplies Password
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
91407-104November, 2002
To access the Configuration screen System settings view: Select System from the menu bar, and then select Configuration. The Configuration screen System settings view displays. Related information... Configuration screen System settings view, page 20
To view the host communication settings: 1. Select Host - Release mode from the System categories list on the Configuration screen. 2. Select F5 - Details. The Details for host - release mode window displays. Related information... Configuration screen System settings view, page 20
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
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Communication Setup
Setting Communications
Section 3
To configure host interface settings: 1. Select Host - Release mode from the System categories list on the Configuration screen. 2. Select F6 - Configure. The Configure host-release mode window displays. 3. Select the desired Release mode option. Manual - All results must be released manually. Hold - All results with flags and interpretations that are configured for results review must be released manually. Automatic - All results are released automatically. Automatic with exceptions - All results and exceptions are released automatically. 4. Enter the timeout interval (in seconds) in the Host query timeout data entry box. (optional) NOTE: You can configure this value in any system status. System throughput may be degraded if the time interval is greater than 10 seconds. 5. Select the desired Bidirectional host option. NOTE: You can configure this value in any system status. NOTE: Turning Bidirectional host off allows you to clear all results waiting to be sent to the host. 6. Select the desired Transmit to host option:
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Approved patient results - transmits collated or single patient results to the host after release NOTE: Results are collated by sample ID when you select the collated option. If the release mode is configured for automatic release, results are held in Pending collation status until all results for a sample ID are released. Approved QC results - transmits control results to the host after release Doctor, location, and draw date / time - transmits doctor, location, and draw date and time information to the host after release 7. Select Done to save your changes. Related information... Configuration screen - System settings view, page 16 Configure host - release mode window, page 18
To cancel result transmission: 1. Select Host-Release mode from the System categories list on the Configuration screen. 2. Select F6 - Configure. The Configure host - release mode window displays. 3. Select the Bidirectional host: Off option, and then select Done. A message displays when you have results that are pending transmission to the host. 4. Select OK to cancel result transmission. NOTE: If you select Cancel to leave the Bidirectional host on, the results pending transmission remain until transmission is successful.
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
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Communication Setup
Setting Communications
Section 3
Results with a status of Pending Transmission go to a status of complete. Error message 8465, Host transmission canceled by the user, is logged in the Message History log. NOTE: To resume host communication, you must reset the bidirectional host option.
Related information... Configuration screen System settings view, page 20 Details for host - release mode window, page 19 Configure host - release mode window, page 18
Section 3-24
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Setting Communications
3. Date format: Allows you to edit the date 4. Time zone (list): Allows you to select the format setting. area-specific time zone used to automatically adjust for daylight savings Options are: time. MM.DD.YYYY (Default) DD.MM.YYYY YYYY.MM.DD 5. Automatically adjust for daylight savings 6. Thousands separator: Allows you to time: Allows you to select the check box select the number format for the to automatically adjust the clock for thousands separator. daylight savings. Options are: Default: checked. Comma None (Default) NOTE: Previously generated results are not updated to the new format. 7. Architect system no.: Allows the Abbott service representative to enter the ARCHITECT serial number. 9. System language (list): Allows the general operator to select the system language. Option is: English 8. SCC serial no.: Allows the Abbott service representative to enter the SCC serial number. 10. Screen timeout: Allows you to edit the setting for screen timeout. Range: 0 60 minutes Default: 0 NOTE: System generated information or information messages do not remove the screen saver. To restore the screen, press Enter on the keyboard
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Communication Setup
Setting Communications
Section 3
11. QC run definition - Start time: Allows you 12. QC run definition - No. of hours per run: to enter the run definition start time. This Allows you to enter the run definition information is used during Westgard rule number of hours per run. This analysis. information is used during Westgard rule analysis. Default: Start time - 6:00 Default: Hours per run - 12 13. Beep volume: Allows you to enter a value for the beep volume for the following audible tones: Alert (occurs when an information message displays) Invalid key (occurs when you press an invalid keyboard key) Range: 0 10 Default: 5 NOTE: This setting is only available if your system is configured with speakers. 15. Cancel: Cancels your selection(s) and returns to the Configuration screen. 14. Done: Accepts your selection(s) and returns to the Configuration screen.
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Setting Communications
1. System date: Displays the current system date. 3. Date format: DIsplays the current date format setting. 5. Automatically adjust for daylight savings: If selected, indicates the system automatically adjusts the clock for daylight savings.
2. System time: Displays the current system time. 4. Time zone: Displays the area-specific time zone used to automatically adjust for daylight savings time. 6. Number format - Thousands separator: Displays the current number format for the thousands separator. NOTE: Previously generated results are not updated to the new format.
7. Architect system no.: Displays the ARCHITECT System number. NOTE: Only an Abbott service representative can edit this setting. 9. System language: Displays the current setting for system language.
8. SCC serial no.: Displays the SCC serial number. NOTE: Only an Abbott service representative can edit this setting. 10. Screen timeout: Displays the current setting for screen timeout.
11. QC run definition Start time: Displays the 12. QC run definition No. of hours per run: run definition start time. This information Displays the run definition number of is used during Westgard rule analysis. hours per run. This information is used during Westgard rule analysis. 13. Beep volume: Displays the beep volume 14. Done: Returns to the Configuration settings for the Alert and Invalid key screen. audible tones. NOTE: Displays only if your system is configured with speakers.
NOTE: If a date is entered when you change the date format, the new format does not display in the system date field until you select Done and the dialog window is accessed again.
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
Section 3-27
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Communication Setup
Setting Communications
Section 3
1. Port type: Allows you to select the list button to view the port types supported by the system, and then select the desired port type(s). Options are: LIS (Default) ARM LAS
2. Port ID: Displays the unique ID for the port. Options are: COM5 (LIS) Connector P3 (Default) COM6 (LAS) Connector P4 COM7 (ARM) Connector P5
3. Baud rate: Allows you to select the baud 4. Parity: Allows you to select from the rate for the selected port. following parity options: None (Default) Options are: Even 1200 Odd 2400 4800 NOTE: You cannot edit the parity option 9600 (Default) for the ARCHITECT ARM serial port. 14400 19200 28800 38400 57600 115200 NOTE: You cannot edit the baud rate for the ARCHITECT ARM serial port.
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5. Data bits: Allows you to select from the following options: 7 8 (Default) NOTE: You cannot edit data bits for the ARCHITECT ARM serial port. 7. Done: Accepts your selection(s) and returns to the Configuration screen.
6. Stop bits: Allows you to select from the following options: 1 (Default) 2 NOTE: You cannot edit stop bits for the ARCHITECT ARM serial port. 8. Cancel: Cancels your selection(s) and returns to the Configuration screen.
1. Port type (list): Displays the selected port 2. Port ID: Displays the unique ID and the type supported by the system. Select the communication connector number for list button to view all port types. the port. 3. Baud rate: Displays the selected baud rate. 5. Data bits: Displays the selected data bits. 7. Done: Returns to the Configuration screen. 4. Parity: Displays the selected parity. 6. Stop bits: Displays the selected stop bits.
Change the LIS serial port settings Perform this procedure to change the LIS (laboratory information system) serial port settings.
Prerequisite Module status User access level Access the Configuration screen System settings view, page 3-21 Stopped, Warming, or Ready System administrator Section 3-29
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Communication Setup
Setting Communications
Section 3
Supplies
NA
To change the LIS serial port settings: 1. Select Serial ports from the System categories list on the Configuration screen. 2. Select F6 - Configure. The Configure serial ports window displays. 3. Select the Port type list button, and then select LIS. 4. Select the Baud rate list button, and then select the desired value. 5. Select the desired Parity option. 6. Select the desired Data bits option. 7. Select the desired Stop bits option. 8. Select Done. A confirmation message displays. 9. Select OK to save your changes. The serial port changes take effect the next time the system control center power is cycled. To cycle power to the system control center, see Cycle power to the SCC, page 3-5. Related information... Configuration screen - System settings view, page 16 Configure serial ports window, page 28
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Section 4
Section 4Introduction
This section outlines the ASTM records and field contents needed to establish communication from the ARCHITECT System to a host computer. Topics include: Communication: ARCHITECT System to Host Unicode Support For information on communicating from the host to the ARCHITECT System, refer to ARCHITECT System-specific Incoming Messages on page 5-1.
Section 4-1
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Section 4
NOTES
Section 4-2
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Section 4
QC Results Transmission
A Control test result is queued for transmission to the host (and considered pending transmission) if the following conditions are satisfied: (1) it is released, (2) if, at the time of its release, the Approved QC results transmission option is On and (3) if, at the time of its release, the Host Bidirectional Mode is On or On with query. The record hierarchy is in the same format as Single Approved Patient results, see Patient Results Transmission.
Section 4-3
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Section 4
A Control test exception is queued for transmission to the host (and considered pending transmission) if the following conditions are satisfied: (1) if the control test exception is manually selected for Release or the Release Mode is Automatic with Exceptions, (2) if, at the time of its release, the Approved QC results transmission Option is On, and (3) if, at the time of its release, the Bidirectional Host Mode is On or On with query
Single
When the Approved Patient results transmission option is Single, a Patient test result or exception is queued for transmission to the host (and considered pending transmission), if the result is released (available for transmission), and if, at the time of its release, the Bidirectional Host Mode is On or On with query. The record hierarchy of outgoing messages for Patient results and exceptions is as follows: Message Header Record Patient Information Record Test Order Record Result Record (Final) Comment Record (optional) Result Record (Interpretation- optional) Result Record (Preliminary- optional) Message Terminator Record
Collated
When the Approved Patient results transmission option is Collated, the system waits until the outcome (results or exceptions) of all Patient test orders and reruns for a sample are reported, before queuing any outcomes for transmission to the host.
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All test results for a given sample are queued for transmission to the host (and be considered pending transmission) if the following conditions are satisfied: (1) all test results for the sample in question are released (available for transmission), (2) all test exceptions for the sample are reported (result or exception), and (3) the Bidirectional Host Mode is On or On with query. The system assigns the Pending collation status to any released test outcomes for a sample while it waits for all other patient test orders and reruns to be completed for the sample. The record hierarchy of outgoing messages is as follows: Message Header Record Patient Information Record Test Order Record (Result) Result Record (Final) Comment Record (optional) Result Record (Interpretation - optional) Result Record (Preliminary - optional) Test Order Record (Exception) Comment Record Test Order Record (Result) Result Record (Final) Comment Record (optional) Result Record (Interpretation - optional) Result Record (Preliminary - optional) Message Terminator Record
Section 4-5
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Section 4
The system only accepts a Negative Query Response or a Test Order Request(s) from the host in response to a Test Order Query Request. A Test Order Query Request is considered complete under any of the following conditions: The system receives a Negative Query Response for the sample ID in the query The system receives a Test Order Request(s) for the sample ID in the query The system does not receive a response of a Negative Query Response or a Test Order Request for the sample ID in the query within the configured host query time out period A connection has been established with the host, but the system is unable to successfully transmit the Test Order Query Request to the host on its first attempt, due to a communication failure A connection cannot be successfully established with the host and the Bidirectional Host Mode is transitioned to Off The system notifies the user if no Test Order Request(s) is received for the Sample ID. The system does not retry transmission of the Test Order Query Request message in the event of a communication failure. After three consecutive query time out errors, the system disables the query mode, pause the sample handler and notify the user. If the system receives a Negative Query Response for a sample ID other than the sample ID in the issued Test Order Query Request, the system notifies the user and the Negative Query Response is ignored. If the system receives a Negative Query Response and there are no outstanding Test Order Query Requests, the system notifies the user and the Negative Query Response is ignored. If the system receives a Test Order Request, which is indicated as a query response for a sample ID other than the sample ID in the issued Test Order Query Request, the system notifies the user and the Test Order Request is handled as an unsolicited Test Order Request. If the system receives a Test Order Request which is indicated as a query response and there are no outstanding Test Order Query Requests, the system notifies the user and the Test Order Request is handled as a an unsolicited Test Order Request. The record hierarchy for a Test Order Query Request is as follows:
Section 4-6
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Section 4-7
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Section 4
If the record fails due to rejection of data content by the Host, the message is re-sequenced based upon the failed record. Transmission of the re-sequenced message is only retried if a complete message with at least one Result can be constructed. The re-sequencing must use the following rules: If failure occurs on a record, which is part of a Result, all records comprising the Result are skipped (not included in the resequenced message), and the rest of the message is re-sequenced. If failure occurs on a record, which is not part of a Result, that record (and all records at a lower level in the hierarchical record structure) is skipped, and the rest of the message is re-sequenced. If the record fails due to other communication errors (i.e. timeout waiting for acknowledgement from the Host), then the Test Result/Exception Message is re-sequenced and transmission retried. The example below illustrates the decremental change in the hierarchical level that defines the point where the data is presumed to be saved at the host. At these level changes, all the data received, not including the record at which the decremental change occurred, is saved. In the example below at the left, storage would occur at points E, G, I, M, O, Q and T. (Refer to ASTM E 394-91 standard, section 5.2). In order to fulfill hierarchical record level requirements, all logical records necessary to reach the restart record point are sent prior to transmitting the record where the line failure originally occurred. A list of which records would be resent in case of a transmission failure is shown at the right.
Section 4-8
91407-104November, 2002
Line # Record Type A B C D E F G H I J K L M N O P Q R S T Header Patient1 Order1 Result1 Order2 Comment1 Order3 Comment1 Patient2 Order1 Result1 Comment1 Result2 Result3 Order2 Comment1 Patient3 Order1 Result1 Terminator
(Level)
Increment +0 +1 +1 +1
Action of Host:
ARCHITECT would retransmit: A AB ABC ABCD ABCDE ABEF ABEFG ABGH ABGHI AIJ AIJK AIJKL AIJKLM AIJMN AIJMNO AIOP AIOPQ AQR AQRS AQRST
at this point, saves A thru D at this point, saves E thru F at this point, saves G thru H
at this point, saves I thru L at this point, saves M thru N at this point, saves O thru P
Figure 4.1:
Format Detail
The following sections detail the exact formats for these ASTM records: Message Header Record Patient Information Record Request Information Record Result Record Test Order Record Comment Record Message Terminator Record ASTM records that are not used: Scientific Record Manufacturer Information Record
Section 4-9
91407-104November, 2002
Section 4
Field Name
Record Type ID
Maximum Characters
1
Field Contents
H | \ Header
Field Description
Field delimiter: vertical bar Repeat delimiter: backslash Component delimiter: caret Escape delimiter: ampersand Instrument Name Version number in the format 1.23 SCC Serial Number Record types the system supports Production: Treat message as an active message to be completed according to standard processing Mandatory Field
7.1.2
Delimiter Definition
^ &
9 4 25 16
ARCHITECT ^Version Number (numeric) ^Serial Number (alphanumeric) ^Interface Version (alphanumeric) P 1
1 1 14
H|\^&|||ARCHITECT^1.00^123456789^H1P1O1R1C1Q1L1|||||||P|1|19930330133346[CR]
Figure 4.2:
Field Name
Record Type Sequence Number PracticeAssigned Patient ID
Maximum Characters
1 5 20
Field Contents
P 1 to 65535 Printable string Patient
Field Description
Must be consistent with sequence number rules, described in ASTM E 1394-91. Returned unchanged during transmission to the host for patient test orders placed from the host. Returned empty for test orders placed on the system. Field returned empty for Control orders.
Section 4-10
91407-104November, 2002
Table 4.2: Patient Information Record: ARCHITECT System to Host (continued) ASTM Field
8.1.4
Field Name
LaboratoryAssigned Patient ID
Maximum Characters
20
Field Contents
Printable string
Field Description
Returned unchanged during transmission to the host for patient test orders placed from the host. Returned empty for test orders placed on the system. Field returned empty for Control orders. Optional for Patient test orders. Field contains the data displayed in the optional PID attribute on the system for patient test orders Empty for Control orders Last, first and middle patient name Optional for Patient test orders. Empty for Control orders
8.1.5
Patient ID No. 3
20
Printable string
8.1.6
Patient Name
20 20 12
Last (printable string) ^First (printable string) ^Middle (printable string) YYYYMMDD date18000101 datecurrent system date M, F, U
8.1.8
Birth Date
Patient birth date Optional for Patient test orders. Empty for Control orders Patient's gender (Male, Female or Unknown) Optional for Patient test orders. Empty for Control orders Field is returned unchanged in transmission to the host for patient test orders placed from the host.
8.1.9
Patient Gender
8.1.14
Doctor
20
Printable String Patient Doctor's name Field contains the data displayed in the optional Doctor attribute on the UI for Patient Test Orders if Transmit to host: Doctor, location and draw date/time configuration option is On. Field is empty for patient test orders if Transmit to host: Doctor, location and draw date/time configuration option is Off. Field is empty for Control test orders
Section 4-11
91407-104November, 2002
Section 4
Table 4.2: Patient Information Record: ARCHITECT System to Host (continued) ASTM Field
8.1.26
Field Name
Location
Maximum Characters
20
Field Contents
Field Description
Printable String The general clinic location or nursing unit, or ward or bed or both of the patient. Field contains the data displayed in the optional Location attribute on the UI for Patient Test Orders if Transmit to host: Doctor, location and draw date/time configuration option is ON. Field is empty for patient test orders if Transmit to host: Doctor, location and draw date/time configuration option is Off. Field is empty for Control test orders
P|1|||PIDSID13|Patient^Im^A||19320122|F|||||Dr.Amesbury||||||||||||ParkClinic[CR]
Figure 4.3:
Example of Patient Information Record for Patient order: ARCHITECT System to Host
P|1<CR>
Figure 4.4:
Example of Patient Information Record for Control order: ARCHITECT System to Host
Contents of fields 8.1.14 and 8.1.26 are not transmitted to the host if the system configuration of Transmit to host: Doctor, location, draw date and time is configured to Off.
Field Name
Record Type Sequence Number
Maximum Characters
1 5
Field Contents
O 1 to 65535 Order
Field Description
Must be consistent with sequence number rules (described in ASTM E 1394-91). Sample ID downloaded from Host, for Host-originated orders, or entered on the system, for user-originated orders.
9.4.3
Specimen ID
20
Printable String
Section 4-12
91407-104November, 2002
Table 4.3: Test Order Record: ARCHITECT System to Host (continued) ASTM Field Field Name
Instrument specimen ID 9.4.4 Carrier/Carousel ID Position Universal Test ID Code Name Assay Protocol
Maximum Characters
20 4 2 4 10 10
Field Contents
Printable String ^alphanumeric ^numeric ^^^Assay Number (numeric) ^Assay Name (printable string) ^Dilution (printable string)
Field Description
Instrument Specimen ID, Carrier/Crsl ID and Position are returned for all specimens tested. The position is blank for LAS orders.
Specific number that identifies the test Assay test name Dilution protocol name Empty for calculated results Assay status: P if assay is installed as the primary version C if the assay is installed as the correlation version Test specified as STAT.
9.4.5
Assay Status
^Status (P or C)
S 9.4.6 Priority 1 R
or
Routine
9.4.8
14
Date and time of sample collection Field contains the data displayed in the optional Draw date/time attribute on the YYYYMMDDHHMM UI for Patient Test Orders if Transmit to SS host: Doctor, location and draw date/ time configuration option is ON. 19700101000000 Field is empty for Patient Test Orders if and Transmit to host: Doctor, location and current system draw date/time configuration option is date OFF. Field is Empty for Control Test Orders Q Quality Control Result
or
9.4.12
Action Code
1 F
Empty for Patient result Final Result Test could not be performed
O|1|SID13|SID3^A123^5|^^^123^Assay1^UNDILUTED^P|R||20010223081223||||||||||||||||||F[CR]
Figure 4.5:
Figure 4.6:
Section 4-13
91407-104November, 2002
Section 4
The Report Type field (9.4.26) of the Test Order Record contains an X, when the test request cannot be processed. A comment record follows the order record and specifies the reason why the test could not be done. The content of field 9.4.8 is not transmitted to the host if the system configuration of Transmit to host: Doctor, location, draw date and time is configured to Off.
Result Record
The following table details the exact format of the Result Record which shall be sent by the ARCHITECT System to the Host. The system shall be capable of transmitting Patient and Control test results to Host systems. Separate Result Records identifiable by Universal Test ID shall be sent for each of the following (since multiple result records may be sent for a single test result): The final result (concentration) Result type F in field 10.1.3 An optional interpretation Result type I in field 10.1.3 The instrument response used to calculate a concentration/result. (This Record is not sent for calculated results.) Result type P in field 10.1.3 A Comment record shall follow a Result Record type F if information is entered into the comment section of the Order or Results Review screen, or downloaded from the Host with a Host-originated order.
Table 4.4: Result Record: ARCHITECT System to Host ASTM Field
10.1.1 10.1.2
Field Name
Record Type Sequence Number
Maximum Characters
1 5
Field Contents
R 1 to 65535 Result
Field Description
Section 4-14
91407-104November, 2002
Table 4.4: Result Record: ARCHITECT System to Host (continued) ASTM Field Field Name
Universal Test ID Code Name Assay Protocol
Maximum Characters
4 10 10
Field Contents
^^^Assay Number (numeric) ^Assay Name (printable string) ^Dilution (printable string)
Field Description
Specific number that identified the test Test name Dilution protocol name (empty for calculated test results) Assay Status: P if assay is installed as primary version C if assay is installed as correlation version Reagent Master Lot # (empty for calculated results) Serial number of reagent kit used to process the test result (empty for calculated results) Lot number of the control material (empty for patient results and calculated results) Final result concentration patient, or control result Preliminary instrument result Interpretation of final result for patient test results For Result Type F (concentration value if within dynamic range -- may include > or <)
Assay Status
^Status (P or C)
10.1.3
15
^alphanumeric
^alphanumeric
20
Printable String
^F
or
Result Type
or
P I
10.1.4
Data Value
15
Printable String
For Result Type P (numeric instrument response) For Result Type I (interpretation)
Result Units (printable string) 10.1.5 Units 7 RLU, Abs, or mV (printable string) Empty
or or
Section 4-15
91407-104November, 2002
Section 4
Table 4.4: Result Record: ARCHITECT System to Host (continued) ASTM Field Field Name Maximum Characters Field Contents Field Description
Normal/Therapeutic Ranges (printable string For Result Type F for Patient Result formatted as minimum value to maximum value)
or
10.1.6
Reference Ranges
At least 35
Empty IUO EDIT 1-2S 1-3S 2-2s1R1M 2-2s1RxM 2-2sxR1M R-4s 4-1s1M 4-1sxM 10-x1M 10-xxM EXP EXPC A#1 A#2 CNTL < or > INDX FLEX LL or HH PSHH LOW or HIGH CORR F 10.1.9 Result Status 1
or
For Result Type I or P and for Result Type F, if range undefined. For Result Type F: This field can be blank or contain one of the following flags: LOW, HIGH, LL, HH, <, >, or EDIT, EXP, EXPC, CNTL, Westgard Flags, A#1, A#2, CORR, FLEX, PSHH, IUO, INDX (post launch). For Result Type P and I: This field is blank. NOTE: Multiple flags can be sent when the Result Type in field 10.1.3 is F. Multiple flags are sent separated by component delimiters (which are used as a repeat delimiter). The following flags are Westgard analysis flags and only display if the result is a control: 1-2S, 1-3S, 22s1R1M, 2-2s1RxM, 2-2sxR1M, R-4s, 4-1s1M, 4-1sxM, 10-x1M, 10-xxM
10.1.7
25
Final Results Previously Transmitted Results ID of Operator logged into system at time of order ID of Operator logged in at time of result release Date and time the test processing completed. Serial # of the module which performed the test. Module serial number for all tests except calculated test results, which returns the system serial number.
R 12 10.1.11 Operator Identification 12 10.1.13 Date/Time Test Complete 14 Order Operator ID (printable string) ^Release Operator ID (printable string) YYYYMMDDHHMMSS
10.1.14
Instrument Identification
25
Alphanumeric
Section 4-16
91407-104November, 2002
R|1|^^^0021^B-hCG^UNDILUTED^P^47331M100^00788^^F|<1.20|mIU/mL|0.35 TO 4.94|EXP^<||F||||19990715081030|I20100[CR]
Figure 4.7:
Example of Result Record (Result Type F) for a Patient Result: System to Host
R|2|^^^0021^B-hCG^UNDILUTED^P^47331M100^00788^^I|NEGATIVE|||||F|||| 19990715081030|I20100[CR]
Figure 4.8:
Example of Result Record (Result Type I) for a Patient Result: System to Host
R|3|^^^0021^B-hCG^UNDILUTED^P^47331M100^00788^^P|9245|RLU||||F|||| 19990715081030|I20100[CR]
Figure 4.9:
Example of Result Record (Result Type P) for a Patient Result: System to Host
R|1|^^^0241^TSH^UNDILUTED^P^0607M200^01824^40080^F|4.6011|mIU/mL|4.292500 TO 5.397300|||F||ECB^RY||19990715081030|I20100[CR]
Figure 4.10:
Example of Result Record (result type F) for a Control Result: System to Host
The following list of field contents of 10.1.7 (Result Abnormal Flags) are not part of the ASTM standard: EXP, CORR, the Westgard Analysis flags (Example: 1-2S, 1-3S, 2-2S, R-4S, 4-1S, 10X), IUO, EXPC, A#1, A#2, PSHH, FLEX, EDIT, CNTL and INDX. NOTE: The number format for the P value is transmitted as configured by the user. Options are: Comma None
Comment Record
The following table details the exact format of the Comment Record which shall be sent by the ARCHITECT System to the Host.
Table 4.5: Comment Record: ARCHITECT System to Host ASTM Field
11.1.1 11.1.2 11.1.3 11.1.4
Field Name
Record Type Sequence Number Comment Source Comment Text
Maximum Characters
1 5 1 At least 260
Field Contents
C 1 to 65535 I Printable String
Field Description
Comment Must be consistent with sequence number rules, described in ASTM E 1394-91. Instrument Result Comment or Exception String
Section 4-17
91407-104November, 2002
Section 4
Table 4.5: Comment Record: ARCHITECT System to Host (continued) ASTM Field
11.1.5
Field Name
Maximum Characters
1
Field Contents
G
Field Description
Result Comment Exception String
Comment Type
or
Figure 4.11:
For test results, a comment record follows the final result record if information is entered in the comment field of the patient or QC order or result, or downloaded from the Host. For test exceptions, a comment record follows the order record and contain the reason for the test exception.
Field Name
Record Type ID Sequence Number ID Number Universal Test ID Status Code
Maximum Characters
1 1 20 3 1
Field Contents
Q 1 ^Specimen ID ^^^ALL O Query
Field Description
Always contains 1 Sample ID read from the bar code label on the sample tube System always requests that ALL outstanding orders are sent System only requests Orders
Q|1|^SID12345||^^^ALL||||||||O[CR]
Section 4-18
91407-104November, 2002
Field Name
Record Type Sequence Number
Maximum Characters
1 1
Field Contents
L 1 Last
Field Description
Always set as 1
L|1[CR]
Figure 4.13:
Section 4-19
91407-104November, 2002
Section 4
NOTES
Section 4-20
91407-104November, 2002
Section 4
NOTE: The following information does not apply to the ARCHITECT System as supplied at market launch. Unicode support is planned for a future version of ARCHITECT System software. The ARCHITECT System host interface port can be configured to transmit and receive 8 or 16 bit characters. Sixteen bit characters are encoded using Unicode. All eight bit characters assume use of the Code Page 850 (same as AxSYM).
Control Characters
When the ARCHITECT System host interface port is configured to support UNICODE, all control characters ([ENQ], [ACK], [NAK], [STX], [ETB], [ETX], [EOT]) are represented using sixteen bits.
Checksum
When the ARCHITECT System host interface port is configured to support UNICODE, the checksum is encoded as four characters sent after the ETB or ETX character. The checksum is computed by adding the binary values of the characters (modulo 65536), keeping the least significant 16 bits of the result. The 16 bits are considered as 4 groups of 4 bits. Each group is converted to a character representing a hexadecimal number. The four characters are transmitted as the checksum in order of numeric significance. Each of the checksum characters is represented using 16 bits.
Section 4-21
91407-104November, 2002
Section 4
NOTES
Section 4-22
91407-104November, 2002
Section 5
Section 5Introduction
This section outlines the ARCHITECT System records and field contents needed to establish communications from a host computer to the ARCHITECT System. For information on communicating from the ARCHITECT System to a host computer refer to ARCHITECT System-specific Outgoing Messages on page 4-1.
Section 5-1
91407-104November, 2002
Section 5
NOTES
Section 5-2
91407-104November, 2002
Section 5
Section 5-3
91407-104November, 2002
Section 5
The system accepts Negative Query Responses within the same communication session as Test Order Requests. Each message is validated to application level requirements. The data extracted from all valid records of a given message adheres to the application level requirement portion of the record that is denoted with an asterisk. If a given application level requirement is violated, the user is notified and the data set which contains the error is considered invalid. Transmission of patient orders to the ARCHITECT System from the host takes place according to the following logical record hierarchy as a single or multiple request(s). Message Header Record Patient Information Record Test Order Record Patient Information Record Test Order Record Test Order Record Comment Record (optional) Patient Information Record Comment Record (optional) Test Order Record Test Order Record Message Terminator Record Transmission of a Negative Query Response (those responses that indicate that the Query Request SID is unknown, or has no outstanding orders) utilizes the following logical record hierarchy. Message Header Record Request Information Record Message Terminator Record NOTE: In the case of a negative Query Response, the Request Information Record is a copy of the original record sent from ARCHITECT System, with the Status Code field set to X.
Section 5-4
91407-104November, 2002
At decremental changes in the hierarchical level. Any unsaved data is saved prior to this record. At receipt of a test order. Any unsaved test order record and associated comment record(s) received prior to this record are saved. According to the hierarchical record level requirements, all logical records necessary to reach the point [record] where transmission failure occurred must be retransmitted. An example message, showing save points, is provided below at left. A list of which records would need resending in case of transmission failure is shown at right.
Line # Record Type A B C D E F G H I J K L M N O P Header Patient1 Order1 Order2 Comment1 Order3 Comment1 Patient2 Order1 Order2 Comment1 Patient3 Comment1 Order1 Comment1 Terminator
(Level) Increment Action by ARCHITECT: (Level 0) +0 (Level 1) +1 (Level 2) +1 (Level 2) +0 (Level 3) +1 (Level 2) 1 (Level 3) +1 (Level 1) 2 (Level 2) +1 (Level 2) +0 (Level 3) +1 (Level 1) (Level 2) (Level 2) (Level 3) 2 +1 +0 +1
at this point, saves A thru C at this point, saves D thru E at this point, saves F thru G at this point, saves H thru I at this point, saves J thru K
ARCHITECT would require retransmission of: A AB ABC ABCD ABDE ABDEF ABFG ABFGH AHI AHIJ AHJK AHJKL ALM ALMN ALMNO ALMNOP
(Level 0) 3
Figure 5.1:
Format Detail
The ARCHITECT System recognizes only fields associated with the following records: Message Header Record Patient Information Record Request Information Record Test Order Record Comment Record Message Terminator Record The following records are not used by the ARCHITECT System:
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
Section 5-5
91407-104November, 2002
Section 5
Field Name
Record Type Delimiter Definition
Maximum Characters
1 4
Field Contents
H or h Header
Field Description
Bytes 2 and 6 of the record must be the same and bytes 2, 3, 4, and 5 must be different. P or p 1 Production: Treat message as an active message to be completed according to standard processing Must be 1
7.1.12 7.1.13
1 1
H|\^&||||||||||P|1[CR]
Figure 5.2:
Processing ID must be P and Version Number must be 1 or the message Message Header Record to Terminator Record is ignored.
Field Name
Record Type Sequence Number
Maximum Characters
1 5
Field Contents
P or p 1 to 65535 Patient
Field Description
Must be consistent with sequence number rules, described in ASTM E 1394-91. Returned unchanged during transmission to the host Optional for Patient test orders Default = empty field The system does not use contents of this field for Control test orders
8.1.3
PracticeAssigned Patient ID
20*
Printable String
*The data extracted from all valid records of a given message adhere to the application level requirement portion of the record that is denoted with an asterisk.
Section 5-6
91407-104November, 2002
Table 5.2: Patient Information Record: Host to ARCHITECT System (continued) ASTM Field Field Name Maximum Characters Field Contents Field Description
Returned unchanged during transmission to the host Optional for Patient test orders The system does not use contents of this field for Control test orders Optional for Patient test orders Empty for Control test orders
8.1.4
LaboratoryAssigned Patient ID
20*
Printable String
8.1.5
Patient ID No. 3
20* 20*
Printable String Last (printable string) ^First (printable string) ^Middle (printable string) YYYYMMDD date 18000101* date Current System Date*
8.1.6
Patient Name
20* 12*
Last, first, and middle patient name for Patient test orders The system does not use contents of this field for Control test orders
8.1.8
Birth Date
Patient birth date Optional for Patient test orders The system does not use contents of this field for Control test orders. Patient sex (Male, Female, Unknown) Optional for Patient test orders The system does not use contents of this field for Control test orders. Patient Doctor's name Optional for Patient test orders The system does not use contents of this field for Control test orders The general clinic location or nursing unit, or ward or bed or both of the patient Optional for Patient test orders The system does not use contents of this field for Control test orders
8.1.9
Patient Sex
M, F, U
8.1.14
Doctor
20*
Printable string
8.1.26
Location
20*
Printable string
*The data extracted from all valid records of a given message adhere to the application level requirement portion of the record that is denoted with an asterisk.
Examples:
Patient Test Order
Figure 5.3:
Section 5-7
91407-104November, 2002
Section 5
P|1[CR]
Figure 5.4:
NOTE: If the Date of birth field is left empty, the age on the system (for result flagging purposes) is considered to be 0 (zero) years. The field contents of Practice Assigned Patient ID (8.1.3) shall be copied into the Patient ID No. 3 field upon transmission back to the host (8.1.5) if the field contents of both the Laboratory Assigned Patient ID (8.1.4) and the Patient ID No. 3 (8.1.5) are blank. The field contents of Laboratory Assigned Patient ID (8.1.4) shall be copied into Patient ID No. 3 field upon transmission back to the host (8.1.5), if the field of the Patient ID No. 3 (8.1.5) is blank.
Section 5-8
91407-104November, 2002
Table 5.3: Test Order Record: Host to ARCHITECT System ASTM Field
9.4.1 9.4.2
Field Name
Record Type Sequence Number Specimen ID
Maximum Characters
1 5 20* 4 2
Field Contents
O or o 1 to 65535 Printable String ^alphanumeric ^numeric Order
Field Description
Must be consistent with sequence number rules, described in ASTM E 1394-91. Sample ID downloaded from Host Carrier ID and position are ignored on input
9.4.3
9.4.4
Carrier ID Position
N/A
N/A
4*
^^^(numeric)*
Specific number that identifies the test Assay test name -- optional for all test orders. The system ignores the assay name sent by the Host and place the test order according to the assay number. Dilution protocol name -- optional for all test orders. If left blank, the system places the test order for the default dilution. Assay status P or p if assay is installed as the primary version C or c if the assay is installed as the correlation version (optional for all test orders. If left blank, the system places the test order for the primary version of the assay) STAT (any other printable character or blank for Routine) Date and time of sample collection Optional for Patient test orders The system does not use contents of this field for Control test orders New order for a patient sample Unconditional Add order for a patient sample Cancel or Delete the existing order Control Sample
10*
^(printable string)
Universal Test ID 9.4.5 (The only required component of this field is the assay number)
10*
^(printable string)
^(P, p, C, or c)
9.4.6
Priority
S or s YYYYMMDDHHMMSS
9.4.8
14
19700101000000*
and
current system date*
N
or
C
or
*The data extracted from all valid records of a given message adhere to the application level requirement portion of the record that is denoted with an asterisk.
Section 5-9
91407-104November, 2002
Section 5
Table 5.3: Test Order Record: Host to ARCHITECT System (continued) ASTM Field
9.4.13 9.4.14
Field Name
Danger Code Clinical Information Specimen Type
Maximum Characters
15 15 5 15 1
Field Contents
Printable String Printable String Printable String ^(printable string) O or o
or
Field Description
Part of the Test Order Comment Field (optional) Part of the Test Order Comment Field (optional) Part of the Test Order Comment Field (optional) Order Order in response to a Query Request.
Q or q
*The data extracted from all valid records of a given message adhere to the application level requirement portion of the record that is denoted with an asterisk.
O|1|MCC1||^^^16\^^^606|||20010223081223||||A|Hep|lipemic||serum||||||||||Q[CR]
Figure 5.5:
Refer to the ARCHITECT System configuration details for assay parameters to determine assay numbers and dilution protocol names to be used for Universal Test IDs. Before a test order is created on the system, the system validates the Test Order Request received from the LIS. The system validates the assay information in each Test Order Request as follows: If a Test Order Request received from the host specifies an assay (defined by Assay Number and Assay Status) that is not defined (or is disabled) by the system, the system considers this request invalid and notifies the user. If a Test Order Request received from the host does not specify the Assay Protocol (Dilution), the system requests the test order for the default dilution of the assay. If a Test Order Request received from the host does specify the dilution, the system considers the specified dilution as valid and requests the test order for the specified dilution of the assay if all of the following conditions are met: the dilution protocol exists for that assay (dilution names are case sensitive) and the specified sample (SID) does not have a manual (offline) dilution factor specified. If the specified dilution is not valid, the system notifies the user and the Test Order Request is considered invalid. If a Test Order Request received from the host does not specify the Assay Status, the system requests the test order for the primary version of the assay.
Section 5-10
91407-104November, 2002
If the field content of 9.4.12 (Action Code) is N for Patient test orders, the test order is considered a new test. However, if the same test order for this sample ID already exists (Pending, Scheduled, or Running), the system considers this an invalid request and error message is generated. If the field content of 9.4.12 (Action Code) is A, the test order shall be processed as a mandatory added test order. It shall be added to the test order list regardless of whether or not the same test order exists (Pending, Scheduled, or Running) in the instruments database. If the field content of 9.4.12 (Action Code) is C, the test order shall be processed as a request to cancel the specified test order. The instrument shall cancel the first pending test order found, from its pending test order list which has the same SID, Assay Number, Dilution Name, and Assay Status. If no such order is found, the system ignores this request. If the field content of 9.5.12 (Action Code) is Q, the sample is established and verified as a control for the requested analytes. If verified, the QC tests are created.
Comment Record
The following table details the exact format of the Comment Record which shall be sent by the Host to the system following the patient record, or the test order record.
Table 5.4: Comment Record: Host to ARCHITECT System ASTM Field
11.1.1 11.1.2 11.1.3 11.1.4 11.1.5
Field Name
Record Type Sequence Number Comment Source Comment Text Comment Type
Maximum Characters
1 5 1 at least 50 1
Field Contents
C or c 1 to 65535 L Comment
Field Description
Must be consistent with sequence number rules, described in ASTM E 1394-91. Computer system
C|1|L|Example Comment|G[CR]
Figure 5.6: Example of Comment Record: Host to ARCHITECT System
When the Comment Record follows a patient record, the comment in 11.1.4 refers to that patient sample and is duplicated in the comment field for each test order for that patient sample.
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
Section 5-11
91407-104November, 2002
Section 5
When the Comment Record follows a test order, it refers only to that test order. The following comment textlimited to a maximum of 50 characters in lengthis placed in the comment field of an ARCHITECT System test order in the following sequence: 1. Text in field 11.1.4 (refer to table 5.4 Comment Record) of one or more comment records associated with the patient record. then 2. Text in fields 9.4.13, 9.4.14 and two components of 9.4.16 (refer to table 5.3 Test Order Record). then 3. Text in field 11.1.4 of one or more comment records associated with the test order.
Field Name
Record Type ID Sequence Number ID Number Universal Test ID Status Code
Maximum Characters
1 1 20* 3 1
Field Contents
Q or q 1 ^Specimen ID (printable string) ^^^ALL X Query
Field Description
Always contains 1 Sample ID that was originally sent by the system Field contents originally sent by the system Indicates that either the Sample ID is unknown to the Host, or there are no outstanding orders for the specified Sample ID
*The data extracted from all valid records of a given message adhere to the application level requirement portion of the record that is denoted with an asterisk.
Section 5-12
91407-104November, 2002
Q|1|^SID1234||^^^ALL||||||||X[CR]
Figure 5.7:
The system shall discontinue waiting for either Test Orders or a Negative Query Response in response to an earlier issued Query Request, as defined in the user-configurable option Host timeout. After a predefined number of allowed consecutive host time-out errors (currently set to 3), the software shall: Log an error Disable the query mode
Field Name
Record Type Sequence Number
Maximum Characters
1 1
Field Contents
L or l 1 Last
Field Description
Must be 1
L|1[CR]
Figure 5.8:
Section 5-13
91407-104November, 2002
Section 5
NOTES
Section 5-14
91407-104November, 2002
Section 6
Section 6Introduction
This section describes ARCHITECT System Support of ASI Options. The following items are defined as optional by the Abbott Standard Interface. The ARCHITECT System supports these items as defined in this section. The following topics are included in this section: Establishment Phase ASI Code Page for the ARCHITECT System
Section 6-1
91407-104November, 2002
Section 6
NOTES
Section 6-2
91407-104November, 2002
Section 6
Section 6-3
91407-104November, 2002
Section 6
Contention still exists after a predefined number of consecutive attempts (3) to resolve the contention per ASTM E 1381-91 Section 6.2.7.1, or The prospective receiver does not respond within the required time period (per ASTM E 1381-91 Section 6.5.2.1).
16 1
DLE DC1 DC2 DC3 DC4 NA K SYN ETB CA N EM SUB ESC FS GS RS US
32 2
SP ! " # $ %
48 3
0 1 2 3 4 5
64 4
@ A B C D E
80 5
P Q R S T U
96 6
` a b c d e
112 7
p q r s t u
128 8
144 9
160 A
176 B
* * * * *
192 C
* * * * * *
208 D
* * *
224 E
p P y Y * *
240 F
* * * * * *
& ' ( ) * + , . /
6 7 8 9 : ; < = > ?
F G H I J K L M N O
V W X Y Z [ \ ] ^ _
f g h i j k l m n o
v w x y z { | } ~ *
* * * * *
* * * * * * * *
* * * * * * * *
* * * * * * * *
* * * * * *
* * * * * * * * * *
* Unsupported characters.
Section 6-4
91407-104November, 2002
Section 7
Troubleshooting
Section 7Introduction
This section describes error codes and observed problems that are specific to the host interface of the ARCHITECT System. In addition, it describes the probable causes and corrective actions. If the corrective actions do not solve the problem, call the ARCHITECT System Customer Support Center. United States: Canada: International: Topics include: Error codes Observed Problems 1-800-527-1869 1-800-387-8378 (English speaking customers) 1-800-465-2675 (French speaking customers) Call your local Abbott Customer Support representative.
Section 7-1
91407-104November, 2002
Troubleshooting
Introduction
Section 7
NOTES
Section 7-2
91407-104November, 2002
Section 7
Troubleshooting
2000-2999 Maintenance 3000-3999 Level Sense 4000-4999 Bar Code Reader 5000-5999 Robotic and Sensor
9000-9999 Software
Section 7-3
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Hardware failure: Contact your Area Customer Support to resolve any Cable from LIS to SCC (COM5, Connector 3) hardware failure. has a poor connection or failed Digiboard
Section 7-4
91407-104November, 2002
Error codes
Hardware failure: Contact your Area Customer Support to resolve any Cable from LIS to SCC (COM5, Connector 3) hardware failure. has a poor connection or failed Digiboard failure
The system received an order from the host and the If this error occurs frequently without obvious order already exists. The new order from the host is explanation check the function of the host interface. ignored by the system.
The system received a cancellation request from If this error occurs frequently without obvious the host on a test order and the order does not exist explanation check the function of the host interface. in the database. The cancellation request from the host is ignored by the system.
Section 7-5
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Section 7-6
91407-104November, 2002
Error codes
Section 7-7
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Section 7-8
91407-104November, 2002
Error codes
Section 7-9
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Test order message received from the host contains Refer to Section 5: ARCHITECT System-specific an unacceptable ASTM record. Acceptable records Incoming Messages. in a test order message: Header, Patient, Test Order, Comment and Terminator records.
Section 7-10
91407-104November, 2002
Error codes
A query message was never issued to the Host. Refer to Section 4: ARCHITECT System-specific Outgoing Messages.
The host did not respond to the query message Increase the host query timeout value. within the time period specified in the configuration. Refer to Section 3: Communication Setup.
Section 7-11
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Section 7-12
91407-104November, 2002
Error codes
Section 7-13
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Section 7-14
91407-104November, 2002
Error codes
The system received an order from the host and the Correct birth date in the host, then resend the order order contained a birth date that is later than the from the host. current date.
Section 7-15
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Record sent to the host contained a character that Refer to Section 6: ARCHITECT System Support of is not supported in the ASI Code page. This ASI Options. character is translated as the registered mark ( or code 0174).
Section 7-16
91407-104November, 2002
Error codes
Section 7-17
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Section 7-18
91407-104November, 2002
Error codes
Section 7-19
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Section 7-20
91407-104November, 2002
Error codes
There are no ARCHITECT System test orders Enter the test order(s) for the sample ID into the for the specified sample ID. host computer. Host computer is not functioning properly. If unable to place test order in the host, manually order the required tests on the SCC.
Section 7-21
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Hardware failure: Cable from LIS to SCC (COM5, Connector P3) has a poor connection or failed
Section 7-22
91407-104November, 2002
Error codes
Message response is incorrectly defined for the Refer to Section 1: Abbott Standard Interface for host. information about the ASTM protocol. Hardware failure: Cable from LIS to SCC (COM5, Connector P3) has a poor connection or failed ARM: Communication failure. Condition may be temporary, if so, no corrective action is required. If condition is not temporary, a 3901 error code displays as an alert popup. Follow the corrective action for this specific error code in the ARCHITECT System Operations Manual. Contact your Area Customer Support to resolve any hardware failure.
Section 7-23
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Host query option was turned off due to a Re-enable the Bidirectional host option in system previous communication error or was turned off settings. by the user. Refer to Section 3: Communication Setup. Incorrect baud rate on host port. Reconfigure the host baud rate. Refer to Section 3: Communication Setup.
Message response is incorrectly defined for the Refer to Section 1: Abbott Standard Interface for host. information about the ASTM protocol. Hardware failure: Cable from LIS to SCC (COM5, Connector P3) has a poor connection or failed Contact your Area Customer Support to resolve any hardware failure.
Section 7-24
91407-104November, 2002
Error codes
Section 7-25
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Message response is incorrectly defined for the Refer to Section 1: Abbott Standard Interface for host. information about the ASTM protocol. Hardware failure: Cable from LIS to SCC (COM5, Connector P3) has a poor connection or failed ARM: Communication failure. Condition may be temporary, if so, no corrective action is required. If condition is not temporary, a 3901 error code displays as an alert popup. Follow the corrective action for this specific error code in the ARCHITECT System Operations Manual. Contact your Area Customer Support to resolve any hardware failure.
Section 7-26
91407-104November, 2002
Error codes
Hardware failure: Contact your Area Customer Support to resolve any Cable from ARM to SCC (COM7, Connector hardware failure. P5) has a poor connection or failed
Section 7-27
91407-104November, 2002
Troubleshooting
Error codes
Section 7
Section 7-28
91407-104November, 2002
Error codes
Section 7-29
91407-104November, 2002
Troubleshooting
Error codes
Section 7
NOTES
Section 7-30
91407-104November, 2002
Section 7
Troubleshooting
Results were sent to the host twice. Test results are resent to the host as initial results if the SCC is shutdown in the middle of a transmission. Unable to delete results.
1. Results are being transmitted 1. Wait until transmission is to the host. complete, then delete the required results. 2. Transmission requested when System is configured for host 2. Reconfigure the host and there is no host communication to Off. A connected. Result status is popup displays. Select OK pending transmission. to clear results waiting to 3. The host mode is set to collate be sent to the host, then and not all of the results for the delete results. Refer to SID have been released. Refer to Section 3: Setting Result status is pending Communications, collation. Host-Release Mode. 3. Release or delete associated SIDs, then delete the result.
Section 7-31
91407-104November, 2002
Troubleshooting
Observed Problems
Section 7
NOTES
Section 7-32
91407-104November, 2002
Section 8
Section 8Introduction
This section provides information about the Abbott ARCHITECT Host/ Instrument Interface tools. Tools include: ASIST (Abbott Standard Interface Simulator Tool) Abbott ARCHITECT Host/Instrument Interface Data Disk ARCHITECT SCC Simulator (for LIS Vendors)
Section 8-1
91407-104November, 2002
Section 8
NOTES
Section 8-2
91407-104November, 2002
Section 8
Section 8-3
91407-104November, 2002
Section 8
10.Select Finish to start the software installation. NOTE: If a window displays asking whether or not a file should be overwritten, respond by selecting No. 11.Insert disk 2 - 5 when prompted, and then select Finish to complete the installation. 12.Remove the floppy disk from the drive. Setup Before you begin testing using ASIST the following setup functions are required: Setting Up Files and Paths Set Communication Port Settings Use the ASIST HELP 2.1 for instructions on performing the setup. To access the ASIST HELP 2.1: 1. Select Start from the Windows desktop. 2. Select Programs, and then Asist V 2.1. 3. Double-click on ASIST HELP 2.1. 4. Select How do I ?, and then select the appropriate item under the Getting started with ASIST section. Refer to the ASIST Version 2.0/2.1 Installation/Quick Reference Guide (List No. 6D02-01) for more information.
Section 8-4
91407-104November, 2002
Section 8
Section 8-5
91407-104November, 2002
Section 8
NOTES
Section 8-6
91407-104November, 2002
Section 8
Installation
The SCC Simulator can run on a Windows 2000 System with a COM port connected to an LIS. The connection requires a three wire RS-232 interface with configurable settings for baud rate, data bits, parity, and stop bits. Prior to running the SCC Simulator, you must set up your system or systems with an RS-232 cable and null modem. Minimum System Requirements for installation: Windows 2000 PENTIUM 350 MHz processor 640 MB RAM NOTE: Do not load the ARCHITECT SCC Simulator software on the SCC that is part of the ARCHITECT System. To install the ARCHITECT SCC Simulator (for LIS vendors): 1. Close all applications and place floppy disk 1 into the floppy drive. 2. Select Start from the Windows 2000 desktop, and then select Run. 3. Type A:\setup.exe (where A: is the location of the floppy drive on your computer), and then select OK. 4. Select Next at each screen prompt, and then when prompted insert disk 2. 5. Select Finish when prompted to complete the installation. 6. Remove the floppy disk from the drive.
Section 8-7
91407-104November, 2002
Section 8
Section 8-8
91407-104November, 2002
Figure 8.1:
Figure 8.2:
Section 8-9
91407-104November, 2002
Section 8
Figure 8.3:
Section 8-10
91407-104November, 2002
Figure 8.4:
Figure 8.5:
Section 8-11
91407-104November, 2002
Section 8
(Figure 8.7), or by selecting File, Connect (Figure 8.8). After the connection is established, the main application status window connection status field displays ON LINE, the communication port status field displays COM# (# is 1-10), and the baud rate status field displays one of the following baud rate values (1200, 2400, 4800, 9600, 14400, 19200, 28800, 38400, 57600, 115200) (Figure 8.9).
Figure 8.6:
Section 8-12
91407-104November, 2002
Figure 8.7:
Figure 8.8:
Section 8-13
91407-104November, 2002
Section 8
Figure 8.9:
Section 8-14
91407-104November, 2002
Figure 8.10:
Figure 8.11:
Section 8-15
91407-104November, 2002
Section 8
Figure 8.12:
Collate results
The SCC Simulator provides the ability for the user to collate results that are sent to the LIS. The SCC Simulator defaults to not collating results when the application is started (Figure 8.13). Results are only collated if Collate Results is checked. The user can change this by selecting Edit, Collate (Figure 8.14). Selecting this menu item toggles the selection of the Collate Results menu item (Figure 8.15).
Section 8-16
91407-104November, 2002
Figure 8.13:
Collated Results
Figure 8.14:
Section 8-17
91407-104November, 2002
Section 8
Figure 8.15:
Selecting views
The SCC Simulator supports multiple views [RESULTS VIEW, QUERIES VIEW, and ORDERS VIEW] that can be displayed based on user input through the user interface. The default view [RESULTS VIEW] is displayed immediately after the user has selected a database (Figure 8.3). The user can change the displayed view by selecting View, Queries (Figure 8.16). The QUERIES VIEW displays in the main application window (Figure 8.17). The user can change to the ORDERS VIEW by selecting View, Order From DB (Figure 8.18). The ORDERS VIEW displays in the main application window (Figure 8.19). The display can be changed back to the RESULTS VIEW by selecting View, Results.
Section 8-18
91407-104November, 2002
Figure 8.16:
Figure 8.17:
Queries View
Section 8-19
91407-104November, 2002
Section 8
Figure 8.18:
Figure 8.19:
Orders View
Section 8-20
91407-104November, 2002
Figure 8.20:
Refresh Notification
Section 8-21
91407-104November, 2002
Section 8
Figure 8.21:
Figure 8.22:
Section 8-22
91407-104November, 2002
Figure 8.23:
Refreshed View
Installing assays
The SCC Simulator provides a user interface to install Immunoassay and Clinical Chemistry assays in order to create control and patient results. The user can request to install a Clinical Chemistry assay or Immunoassay assay by selecting Edit, Install CC Assay or Install IA Assay (Figure 8.24). The simulator displays the Install Assay window allowing the user to install an assay name and assay number (Figure 8.25). After the user installs the assay, the assay name displays in the Available Assays/Tests list in the Create Results window. For more information, see Creating results, page 8-27.
Section 8-23
91407-104November, 2002
Section 8
Figure 8.24:
Install Assay
Figure 8.25:
Section 8-24
91407-104November, 2002
Figure 8.26:
Install Dilution
Figure 8.27:
Deleting assays
The SCC Simulator provides a user interface to delete Immunoassay and Clinical Chemistry assays. The user can request to delete a Clinical Chemistry assay or Immunoassay by selecting Edit, Delete CC Assay or Delete IA Assay (Figure 8.28). The simulator displays the Delete Assay window and allows the user to delete an Assay Name (Figure 8.29). After the user deletes the assay, the assay name no longer displays in the Available Assays/Tests list in the Create Results window. For more information, see Creating results, page 8-27.
Section 8-25
91407-104November, 2002
Section 8
Figure 8.28:
Delete Assay
Figure 8.29:
Section 8-26
91407-104November, 2002
Figure 8.30:
Figure 8.31:
Creating results
The SCC Simulator provides the user the capability to create control and patient results against installed assays and dilution names and store created results in the user-selected database. The user navigates to the Create Results window through the Edit menu and selecting the Create Results menu item (Figure 8.32). Once the Create Results window is displayed (Figure 8.33), the user has the ability to create control or patient results against the displayed assays and dilution names. The Create Results window allows the user to create results to be stored in the database (Figure 8.33). The form allows the user to specify information for results on a particular instrument and
Section 8-27
91407-104November, 2002
Section 8
demographic information related to the patient. Once the information has been specified, the user can select Create Result to add the result or results to the database. The results stored in the database are used to send to the LIS in response to orders that have been received. Note that the results sent to the LIS are not automatically sent in response to an order.
Figure 8.32:
Section 8-28
91407-104November, 2002
Figure 8.33:
Creating queries
The SCC Simulator provides the user the capability to create queries to be stored in the user-selected database and sent to the LIS for solicitation of orders against a SID. The user navigates to the Create Query window through the Edit menu and selecting the Create Query menu item (Figure 8.34). Once the Create Query window is displayed (Figure 8.35), the user has the ability to create a query for a particular SID. The Create Query window allows the user to create a query to be stored in the database (Figure 8.35). The form allows the user to specify information for a query on a particular instrument with version information. Once the information has been specified, the user can select Create Query to add the query to the database. The queries stored in the database are used to send to the LIS in order to solicit orders for a particular SID.
Section 8-29
91407-104November, 2002
Section 8
Figure 8.34:
Figure 8.35:
Order filtering
The SCC Simulator allows the user to select different filter options in the ORDERS view. In order to change filter options, the user needs to navigate to the ORDERS view. For more information, see Selecting views, page 8-18. The filter options allow for easier selection of orders to view. The filter options display with a right mouse click in the
Section 8-30
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
91407-104November, 2002
ORDERS view. Select the Filter Options menu item (Figure 8.36). This displays the Order View Filter Options Window (Figure 8.37). The filter options window allows the user to filter options based on Creation Order (Figure 8.37), Assay Name (Figure 8.39), or SID (Figure 8.41). Figure 8.38 shows the Order View with a filter option that is based on Creation Order. Figure 8.40 shows the Order View with a filter option that is based on Assay Name TT4. Figure 8.42 shows the Order View with a filter option based on SID002. Note that if a SID is not given with the filter option based on SID, the Order View is sorted alphabetically by SID name (Figure 8.43). The same is true for a filter option based on Assay Name and no Assay Name is given. The Order View is sorted alphabetically by Assay Name (Figure 8.44). The default filter option on application startup is Creation Order (Figure 8.38).
Figure 8.36:
Section 8-31
91407-104November, 2002
Section 8
Figure 8.37:
Figure 8.38:
Section 8-32
91407-104November, 2002
Figure 8.39:
Figure 8.40:
Section 8-33
91407-104November, 2002
Section 8
Figure 8.41:
Figure 8.42:
Section 8-34
91407-104November, 2002
Figure 8.43:
Figure 8.44:
Section 8-35
91407-104November, 2002
Section 8
Figure 8.45:
Section 8-36
91407-104November, 2002
Figure 8.46:
Figure 8.47:
Section 8-37
91407-104November, 2002
Section 8
Figure 8.48:
Section 8-38
91407-104November, 2002
Figure 8.49:
Figure 8.50:
Section 8-39
91407-104November, 2002
Section 8
Figure 8.51:
Figure 8.52:
Section 8-40
91407-104November, 2002
Figure 8.53:
Figure 8.54:
Section 8-41
91407-104November, 2002
Section 8
Figure 8.55:
Section 8-42
91407-104November, 2002
Figure 8.56:
Section 8-43
91407-104November, 2002
Section 8
Figure 8.57:
Figure 8.58:
Section 8-44
91407-104November, 2002
Figure 8.59:
Section 8-45
91407-104November, 2002
Section 8
Figure 8.60:
Figure 8.61:
Section 8-46
91407-104November, 2002
Section 9
Section 9Introduction
This section provides a comparison of RS-232 interface specifications between the ARCHITECT System and the AxSYM System including: A functional comparison between the two systems. A document comparison between the Abbott Standard Interface RS-232 Manuals of the two systems covering Section 4: Systemspecific Outgoing Messages and Section 5: System-specific Incoming Messages. This document comparison is based on the: Abbott Standard Interface RS-232 Manual/ ARCHITECT System Edition (91407-104November, 2002) Abbott Standard Interface RS-232 Manual/AxSYM Edition (66-6837/R3February 1996)
Section 9-1
91407-104November, 2002
Section 9
NOTES
Section 9-2
91407-104November, 2002
Section 9
Physical Layer
Speed AxSYM System
Supported baud rates are: 1200, 2400, 4800, 9600, 19200
ARCHITECT System
Supported baud rates are: 1200, 2400, 4800, 9600, 14400, 19200, 28800, 38400, 57600, 115200
ARCHITECT System
The COM5 Port (Connector P3) is used as the Host Interface Port and is located at the back of the System Control Center (SCC).
Section 9-3
91407-104November, 2002
Section 9
ARCHITECT System During the Establishment Phase, if the ARCHITECT System has information to transmit, it attempts to establish a connection with a host every 30 seconds. If, after ten unsuccessful attempts to establish the connection with the host system (e.g., the host system is down), the ARCHITECT System displays an alert message, and discontinues attempts to establish a connection with the host system. In the case of discontinuation of attempts, the Host Interface Port is disabled and the user must re-enable Host Communication via the Configure host-release mode dialog window. Refer to Section 5: ARCHITECT System-specific Incoming Messages.
ARCHITECT System
ARCHITECT currently supports the ability for a host to cancel a previously down-loaded test order through the use of the Action Code field. Refer to Section 5: ARCHITECT System-specific Incoming Messages, Test Order Records.
91407-104November, 2002
Functional Comparison
Off
Off
Section 9-5
91407-104November, 2002
Section 9
ARCHITECT System
Automatically sends result related flags in the Result Record Type F. All flags are transmitted to the host separated by Component Delimiters (^).
Section 9-6
91407-104November, 2002
ARCHITECT System
Incoming messages: stores segments of the message as received, according to the following criteria: At decremental changes in the hierarchical level. Any unsaved data is saved prior to this record. At receipt of a test order. Any unsaved test order record and associated comment record(s) received prior to this record are saved. According to the hierarchical record level requirements, all logical records necessary to reach the point [record] where transmission failure occurred must be retransmitted. An example message, showing save points, is provided below at left. A list of which records would need resending in case of transmission failure is shown at right.
Section 9-7
91407-104November, 2002
Section 9
Line # Record Type(Level) IncrementAction of Host: A B C D E F G H I J K L M N O P Header Patient1 Order 1 Order 2 Comment1 Order 3 Comment1 Patient2 Order 1 Order 2 Comment1 Patient3 Comment1 Order1 Comment1 Terminator (Level 0)+0 (Level 1)+1 (Level 2)+1 (Level 2)+0 (Level 3)+1 (Level 2)-1 (Level 3)+1 (Level 2)-2 (Level 2)+1 (Level 2)+0 (Level 3)+1 (Level 1)-2 (Level 2)+1 (Level 2)+0 (Level 3)+1 (Level 0)-3
ARCHITECT would require retransmission of: A AB ABC ABCD ABDE ABDEF ABFG ABFGH AHI AHIJ AHJK AHJKL ALM ALMN ALMNO ALMNOP
at this at this point, at this point, at this point, at this point, at this point,
Figure 9.1:
Outgoing messages: Data is presumed to be saved at the host whenever any decremental change in the hierarchical level is observed. The example below illustrates the decremental change in the hierarchical level that defines the point where the data is presumed to be saved at the host. At these level changes, all the data received, not including the record at which the decremental change occurred, is saved. In the example below at the left, storage would occur at points E, G, I, M, O, Q, and T. In order to fulfill hierarchical record level requirements, all logical records necessary to reach the restart record point are sent prior to transmitting the record where line failure originally occurred. A list of which records would be resent in case of a transmission failure is shown at the right.
Section 9-8
91407-104November, 2002
Line # Record Type(Level) IncrementAction of Host: A B C D E F G H I J K L M N O P Q R S T Header Patient1 Order 1 Result1 Order 2 Comment1 Order 3 Comment1 Patient2 Order 1 Result1 Result2 Result3 Order2 Comment1 Patient3 Order1 Result1 Terminator (Level 0)+0 (Level 1)+1 (Level 2)+1 (Level 3)+1 (Level 2)-1 (Level 3)+1 (Level 2)-1 (Level 3)+1 (Level 2)-2 (Level 2)+1 (Level 3)+1 (Level 3)-1 (Level 3)+0 (Level 2)-1 (Level 3)+1 (Level 1)-2 Comment1(Level 4)+1
ARCHITECT would require retransmission of: A AB ABC ABCD ABCDE ABEF ABEFG ABGH ABGHI AIJ AIJK AIJKL AIJKLM AIJMN AIJMNO AIOP AIOPQ AQR AQRS AQRST
at this at this
at this point, saves G thru H
Figure 9.2:
Section 9-9
91407-104November, 2002
Section 9
NOTES
Section 9-10
91407-104November, 2002
Section 9
Overview
The following section outlines the ASTM records and field contents needed to establish communication from the ARCHITECT / AxSYM System to a host computer. For information on communicating from the host to the ARCHITECT / AxSYM System, refer to Section 5: System-Specific Incoming Messages in the respective Abbott Standard Interface RS-232 Manuals.
Section 9-11
91407-104November, 2002
Section 9
Message Header Record Patient Information Record Test Order Record (Result) Result Record (Final) Comment Record (optional) Result Record (Interpretation - optional) Result Record (Preliminary - optional) Test Order Record (Exception) Comment Record Test Order Record (Result) Result Record (Final) Comment Record (optional) Result Record (Interpretation - optional) Result Record (Preliminary - optional) Message Terminator Record The ARCHITECT System collates all the results for a sample and transmits to the host only after the last test for that sample has been completed and released, including reruns. The ARCHITECT System sends one patient information record per session. AxSYM System: The AxSYM System collates all the results for a sample and transmits to the host only after the last test for that sample has been completed and released. The AxSYM System collates multiple patient information records within one session.
91407-104November, 2002
Field Name
Record Type ID (Same for both)
Maximum Characters
1
Field Contents
H | Header
Field Description
Field delimiter: vertical bar Repeat delimiter: backslash Component delimiter: caret Escape delimiter: ampersand
7.1.2
Sender Name or ID AxSYM 5 Software Version (Same for both) 7.1.5 ARCHITECT: 25 Serial Number AxSYM: 10 Interface Version (Same for both) 16 ^Interface Version (alphanumeric) ^Serial Number (alphanumeric) 4 AxSYM ^Version Number (numeric)
Instrument Name
Version number in the format 1.23 ARCHITECT: SCC Serial Number AxSYM: Instrument Serial Number Record types the system supports ARCHITECT: Production: Treat message as an active message to be completed according to standard processing AxSYM: Patient results
7.1.12
Processing ID
AxSYM: Q 7.1.13 Version No. (Same for both) Date and Time (Same for both) 1 1
AxSYM: Quality Control results Mandatory Field Date and Time of transmission in ASTM format.
7.1.14
14
YYYYMMDDHHMMSS
Section 9-13
91407-104November, 2002
Section 9
H|\^&|||ARCHITECT^1.00^123456789^H1P1O1R1C1Q1L1|||||||P|1|19930330133346[CR]
Figure 9.3:
H|\^&|||AxSYM^1.00^1234567-89^H1P1O1R1C1Q1L1|||||||P|1|19930330133346[CR]
Figure 9.4:
Field Name
Record Type
Maximum Characters
1 ARCHITECT: 5
Field Contents
P ARCHITECT: 1 to 65535 AxSYM: 1 to n Printable String Patient
Field Description
Must be consistent with sequence number rules. n represents any number. Returned unchanged during transmission to the host Always returned unchanged to the host. Returned unchanged during transmission to the host Always returned unchanged to the host. Optional for Patient test orders Instrument PID assigned by operator.
8.1.2
8.1.3
Practice-Assigned Patient ID
20 AxSYM: 15 ARCHITECT:
(Any character)
8.1.4
Laboratory-Assigned Patient ID
20 AxSYM: 15 ARCHITECT: 20
Printable String
(Any character)
Printable String
8.1.5
Section 9-14
91407-104November, 2002
Table 9.3: Patient Information Record: ARCHITECT / AxSYM System to Host (continued) ASTM Field Field Name Maximum Characters
ARCHITECT: 20 AxSYM: 15 ARCHITECT: 20 8.1.6 Patient Name AxSYM: 20 ARCHITECT: 12 AxSYM: 1 ARCHITECT: 8.1.8 ^First (any character) ^Middle (printable string) ^Middle Initial (any character) YYYYMMDD 18000101 datecurrent system date Patient birth date Optional for Patient test orders Empty for Control test orders. Patient's gender (Male, Female, or Unknown) Optional for Patient test orders. Empty for Control orders Field is returned unchanged in transmission to the host for patient test orders placed from the host. Patient Doctor's name Field contains the data displayed in the optional Doctor attribute on the UI for Patient Test Orders if Transmit to host: Doctor, location and draw date/time configuration option is On. Field is empty for patient test orders if Transmit to host: Doctor, location and draw date/time configuration option is Off. Field is empty for Control test orders
Field Contents
Last (printable string) Last (any character) ^First (printable string)
Field Description
Last, first, and middle patient name ARCHITECT ONLY: Optional for Patient test orders Empty for Control test orders
Birth date
ARCHITECT: 8.1.9
Patient Gender
M, F, U
ARCHITECT: 8.1.14
Doctor
20
Printable String
Section 9-15
91407-104November, 2002
Section 9
Table 9.3: Patient Information Record: ARCHITECT / AxSYM System to Host (continued) ASTM Field Field Name Maximum Characters Field Contents Field Description
The general clinic location or nursing unit, or ward or bed or both of the patient. Field contains the data displayed in the optional Location attribute on the UI for Patient Test Orders if Transmit to host: Doctor, location and draw date/time configuration option is ON. Field is empty for patient test orders if Transmit to host: Doctor, location and draw date/time configuration option is Off. Field is empty for Control test orders
ARCHITECT: 8.1.26
Location
20
Printable String
P|1|||PID13|Patient^Im^A||19320122|F|||||Dr.Amesbury||||||||||||ParkClinic[CR]
Figure 9.5:
P|1|||PID13|PATIENT^IM^A[CR]
Figure 9.6:
Field Name
Record Type
Maximum Characters
1 ARCHITECT: 5
Field Contents
O 1 to 65535
Field Description
Order Must be consistent with sequence number rules. n represents any number
9.4.2
Section 9-16
91407-104November, 2002
Table 9.4: Test Order Record: ARCHITECT / AxSYM System to Host (continued) ASTM Field Field Name Maximum Characters
ARCHITECT: 20 9.4.3 Specimen ID AxSYM: 15 ARCHITECT: Instrument specimen ID Carrier ID Position 9.4.4 AxSYM: Instrument specimen ID ^location_ID ^position 15 any character ^segment (Alphanumeric) ^position (Numeric) 20 4 2 Printable String ^alphanumeric ^numeric AxSYM: any character Instrument Specimen ID, Carrier_ID, and Position are returned for all specimens tested, although Instrument Specimen ID may be different than Specimen ID in 9.4.3 if changed by operator or scanned by the instrument Instrument Sample ID, segment, and position are returned for all specimens tested, although Instrument Sample ID may be different than Sample ID in 9.4.3 if changed by the operator. NOTE: The information in the Segment/Position portion of the field is invalid for Control Orders.
Field Contents
ARCHITECT: Printable String
Field Description
1 2 ARCHITECT:
4 AxSYM: 3 ARCHITECT: 10
^Assay Name (printable string) Test name ^Assay Name (alphanumeric) ARCHITECT: ^Dilution (printable string)
Name AxSYM: 9 9.4.5 Assay Protocol 10 AxSYM: ^Dilution (Alphanumeric) Assay status: ARCHITECT: Assay Status 1 ^Status (P or C)
P or p if assay is installed as the primary version C or c if the assay is installed as the correlation version STAT ARCHITECT: R or any other character
S or s
or
Section 9-17
91407-104November, 2002
Section 9
Table 9.4: Test Order Record: ARCHITECT / AxSYM System to Host (continued) ASTM Field
ARCHITEC T:
Field Name
Maximum Characters
Field Contents
Field Description
9.4.8
14
Date and time of sample collection Field contains the data displayed in the optional Draw date/time attribute on the UI for Patient Test Orders if Transmit to host: Doctor, location YYYYMMDDHHMMSS and draw date/time configuration option is ON. 19700101000000 Field is empty for Patient Test and Orders if Transmit to host: Doctor, current system date location and draw date/time configuration option is OFF. Field is Empty for Control Test Orders Q F
or
9.4.12
Action Code (Same for both) Report Types (Same for both)
Quality Control Result Empty for Patient result Final Result Test could not be performed
9.4.26
O|1|SID13|SID3^A123^5|^^^123^Assay1^UNDILUTED^P|R||20010223081223||||||||||||||||||F[CR]
Figure 9.7:
O|1|SID13|SID13^A^1|^^^16^Assay1^NEAT|R||||||||||||||||||||F[CR]
Figure 9.8:
Result Record
The following table details the format of the Result Record sent by the ARCHITECT System or AxSYM System to the Host.
Table 9.5: Result Record: ARCHITECT / AxSYM System to Host ASTM Field
10.1.1
Field Name
Record Type (Same for both)
Maximum Characters
1 ARCHITECT: 5
Field Contents
R 1 to 65535 1 to n Result
Field Description
10.1.2
Sequence Number
AxSYM: 1
Section 9-18
91407-104November, 2002
Table 9.5: Result Record: ARCHITECT / AxSYM System to Host (continued) ASTM Field
10.1.3
Field Name
Maximum Characters
ARCHITECT: 4 AxSYM: 3 ARCHITECT: 10
Field Contents
Field Description
^Assay Name (printable string) ^Assay Name (alphanumeric) ARCHITECT: ^Dilution (printable string) AxSYM: ^Dilution (alphanumeric)
Name
AxSYM: 9
Test name
Assay Protocol
10
^ Status (P or C)
Assay Status: P if assay is installed as primary version C if assay is installed as correlation version Reagent Master Lot # (empty for calculated results) Serial number of reagent kit used to process the test result (empty for calculated results) Lot number of the control material (empty for patient results and calculated results) Always null ARCHITECT: Final result concentration or result value AxSYM: Final result concentration ARCHITECT: Preliminary instrument result (RLU, mV, Abs) AxSYM: Preliminary instrument result (rate or mP) Interpreted result
ARCHITECT: Reagent Lot ARCHITECT: Reagent Serial Number ARCHITECT: Control Lot Number AxSYM: Test_Qualifier
15
^ alphanumeric
^ alphanumeric
20
printable string
^^ ARCHITECT: ^F AxSYM: F
or
Result Type
1 P
or
Section 9-19
91407-104November, 2002
Section 9
Table 9.5: Result Record: ARCHITECT / AxSYM System to Host (continued) ASTM Field Field Name Maximum Characters Field Contents Field Description
For Result Type F (concentration value if within dynamic range) including < or > For Result Type P (numeric response) For Result Type I (interpretation) 10.1.4 Data Value 15 AxSYM: Numeric AxSYM: Numeric Response AxSYM: Interpretation String ARCHITECT: Result Units (printable string) AxSYM: Concentration Units 10.1.5 Units 7
or
For Result Type F For Result Type P (Float decimal position or comma for both Result Type F and P.) For Result Type I
Result Type F
ARCHITECT: RLU or mV or Abs AxSYM: Rate or mP or Percent Empty Normal/Therapeutic Ranges ARCHITECT: at least 35
or
Result Type P
Result Type I
ARCHITECT ONLY: For Result Type F for Patient Result (Printable string formatted as minimum value to maximum value) AxSYM: Control Range
or
10.1.6
Reference Ranges
AxSYM: 25
ARCHITECT ONLY: Control Range (Printable string For Result Type F for Control Result formatted as minimum value to maximum value)
or
Empty
Section 9-20
91407-104November, 2002
Table 9.5: Result Record: ARCHITECT / AxSYM System to Host (continued) ASTM Field Field Name Maximum Characters Field Contents
IUO EDIT 1-2S 1-3S 2-2s1R1M 2-2s1RxM 2-2sxR1M R-4s 4-1s1M 4-1sxM 10-x1M 10-xxM EXP EXPC A#1 A#2 CNTL < or > INDX FLEX LL or HH PSHH LOW or HIGH CORR EX QC < or > LL or HH L or H
Field Description
For Result Type F: This field can be blank or can contain one or more result flags. Multiple flags are sent separated by component delimiters (which are used as a repeat delimiter). For Result Type P and I: This field is blank. The following flags are Westgard analysis flags and only display if the result is a control: 1-2S, 1-3S, 22s1R1M, 2-2s1RxM, 2-2sxR1M, R-4s, 4-1s1M, 4-1sxM, 10-x1M, 10-xxM
10.1.7
ARCHITECT: 25
AxSYM: 12
For Result Type F: If configured for multiple result flags, this field can be blank or can contain one or more result flags (separated by a component delimiter). For Result Type P and I: This field is blank.
10.1.9
F R
or
Final Results Previously Transmitted Results ID of Operator logged into system at time of order
10.1.11
Operator Identification
ARCHITECT: 12 AxSYM: 6
^Release Operator ID ID of Operator logged in at time of result release (printable string) printable string
14
25
Alphanumeric
Section 9-21
91407-104November, 2002
Section 9
R|1|^^^16^TSH^DIL1^P^12345AB89^12345^^F|28.275|mIU/mL|30.000TO500.000|EXP^LOW| |F||OP345^OP346||19930330132949|IA200A345[CR]
Figure 9.9:
R|1|^^^16^Assay1^UNDILUTED^^F|28.275|mIU/mL|30.000 TO 500.000|EX^L||F||||19930330132949[CR]
Figure 9.10:
ARCHITECT: The following list of field contents of 10.1.7 (Result Abnormal Flags) are not part of the ASTM standard: EXP, CNTL, CORR, the Westgard Analysis flags (1-2S, 1-3S, 2-2S 1R 1M, 2-2S 1R xM, 2-2S xR 1M, R-4S, 41S 1M, 4-1S xM, 10x 1M, 10x xM), IUO, EXPC, A#1, A#2, FLEX, EDIT, and PSHH.
Field Name
Record Type (Same for both)
Maximum Characters
1 ARCHITECT: 5
Field Contents
C 1 to 65535 1 to n I
Field Description
Comment Must be consistent with sequence number rules n represents any number Instrument
11.1.2
Sequence Number
11.1.3
11.1.4
Comment Text
AxSYM: 100
Printable String
Section 9-22
91407-104November, 2002
Document Comparison
Field Name
Comment Type (Same for both)
Maximum Characters
1
Field Contents
G
or
Field Description
Result Comment Exception String
Figure 9.11:
ARCHITECT
The following table details the exact format of the Request Information Record which shall be sent by the ARCHITECT System to the Host.
Table 9.7: Request Information Record: ARCHITECT / AxSYM System to Host ASTM Field
12.1.1
Field Name
Record Type ID (Same for both) Sequence Number (Same for both) ARCHITECT: ID Number
Maximum Characters
1
Field Contents
Q
Field Description
12.1.2
1 20
Always contains 1
12.1.3
^Specimen ID 15 ARCHITECT: 3
Sample ID read from the bar code label on the sample tube
12.1.5
Universal Test ID
AxSYM: [blank] 1
^^^ALL
12.1.13
Q|1|^SID12345||^^^ALL||||||||O[CR]
Figure 9.12:
Section 9-23
91407-104November, 2002
Section 9
Field Name
Record Type (Same for both) Sequence Number (Same for both)
Maximum Characters
1
Field Contents
L Last
Field Description
13.1.2
L|1[CR]
Figure 9.13:
Overview
The following section outlines the ARCHITECT / AxSYM System records and field contents needed to establish communication from a host computer to the ARCHITECT / AxSYM System. For information on communicating from the ARCHITECT / AxSYM System to a host computer, refer to Section 4: System-Specific Outgoing Messages in the respective Abbott Standard Interface RS-232 Manuals.
ARCHITECT:
Message Header Record
Section 9-24
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
91407-104November, 2002
AxSYM:
Message Header Record Patient Information Record Test Order Record Message Terminator Record Both Transmission of a negative Query Response (those responses that indicate that the Query Request SID is unknown, or has no outstanding orders) utilize the following logical record hierarchy. Message Header Record Request Information Record Message Terminator Record NOTE: In the case of a negative Query Response, the Request Information Record is a copy of the original record sent from ARCHITECT / AxSYM System, with the Status Code field set to X.
ARCHITECT:
An error is logged and the remainder of the messageup to the message terminator recordis ignored if the ARCHITECT System receives a record that: Is missing a required field as defined in this section Is not defined for ARCHITECT System incoming messages Has an invalid sequence number
Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
Section 9-25
91407-104November, 2002
Section 9
Has one or more fields or components that do not conform to requirements as defined further in this section Records that were received prior to this record are accepted and processed further.
Format Detail
The ARCHITECT / AxSYM System recognizes fields when parsing for the following records: Message Header Record Patient Information Record Request Information Record Test Order Record Comment Record [ARCHITECT System ONLY] Message Terminator Record
ARCHITECT:
The following records are not used by the ARCHITECT System: Scientific Record Manufacturer Information Record
AxSYM:
All other fields are ignored regardless of content. The following records are ignored by the AxSYM System: Comment Record Scientific Record Manufacturer Information Record
Field Name
Record Type (Same for both)
Maximum Characters
1 ARCHITECT: 4
Field Contents
H or h Header
Field Description
7.1.2
Delimiter Definition
AxSYM: [blank]
Section 9-26
91407-104November, 2002
Table 9.9: Message Header: Host to ARCHITECT / AxSYM System (continued) ASTM Field Field Name Maximum Characters Field Contents Field Description
ARCHITECT: Production: Treat message as an active message to be completed according to standard processing AxSYM: Processing ID 7.1.13 Version Number (Same for both) 1 1 Must be 1
7.1.12
Processing ID
P or p
H|\^&||||||||||P|1[CR]
Figure 9.14:
Processing ID must be P and Version Number must be 1 or the message Message Header Record to Terminator Record is ignored. ASTM Fields 7.1.1, 7.1.2, 7.1.12, and 7.1.13 of the Message Header Record are all required by the ARCHITECT / AxSYM System.
Field Name
Record Type (Same for both) Sequence Number (Same for both)
Maximum Characters
1
Field Contents
Field Description
P or p
Patient Must be consistent with sequence number rules Returned unchanged during transmission to the host Optional for Patient test orders Empty for Control test orders Returned unchanged during transmission to the host.
8.1.2
1 to 65535
8.1.3
Printable String
Any character
Section 9-27
91407-104November, 2002
Section 9
Table 9.10: Patient Information Record: Host to ARCHITECT / AxSYM System (continued) ASTM Field Field Name Maximum Characters
ARCHITECT: 20 AxSYM: 15 ARCHITECT: 20 8.1.5 Patient ID No. 3 AxSYM: 15 ARCHITECT: 20 AxSYM: 15 Any character ARCHITECT: Last (printible string) AxSYM: Last (any character) ARCHITECT: ^First (printible string) 8.1.6 Patient Name 20 AxSYM: First (any character) ARCHITECT: 12 AxSYM: 1 ARCHITECT: 8.1.8 ARCHITECT: ^Middle (printible string) AxSYM: Middle initial (any character) YYYYMMDD 18000101 current system date Patient birth date Optional for Patient test orders Empty for Control test orders. Patient sex (Male, Female, Unknown) Optional for Patient test orders Empty for Control test orders. ARCHITECT: Last, first, and middle patient name for Patient test orders Empty for Control test orders AxSYM: Last, first, and middle initial of the patient name. See note below.
Field Contents
Field Description
Returned unchanged during transmission to the host Optional for Patient test orders Empty for Control test orders Returned unchanged during transmission to the host. Optional for Patient test orders Empty for Control test orders
8.1.4
LaboratoryAssigned Patient ID
Printable String
Birth Date
ARCHITECT: 8.1.9
Patient Sex
M, F, U
Section 9-28
91407-104November, 2002
Table 9.10: Patient Information Record: Host to ARCHITECT / AxSYM System (continued) ASTM Field Field Name Maximum Characters
ARCHITECT: 20 AxSYM: 15 ARCHITECT: 20 8.1.5 Patient ID No. 3 AxSYM: 15 ARCHITECT: 20 AxSYM: 15 Any character ARCHITECT: Last (printible string) AxSYM: Last (any character) ARCHITECT: ^First (printible string) 8.1.6 Patient Name 20 AxSYM: First (any character) ARCHITECT: 12 AxSYM: 1 ARCHITECT: 8.1.8 ARCHITECT: ^Middle (printible string) AxSYM: Middle initial (any character) YYYYMMDD 18000101 current system date Patient birth date Optional for Patient test orders Empty for Control test orders. Patient sex (Male, Female, Unknown) Optional for Patient test orders Empty for Control test orders. ARCHITECT: Last, first, and middle patient name for Patient test orders Empty for Control test orders AxSYM: Last, first, and middle initial of the patient name. See note below.
Field Contents
Field Description
Returned unchanged during transmission to the host Optional for Patient test orders Empty for Control test orders Returned unchanged during transmission to the host. Optional for Patient test orders Empty for Control test orders
8.1.4
LaboratoryAssigned Patient ID
Printable String
Birth Date
ARCHITECT: 8.1.9
Patient Sex
M, F, U
Section 9-29
91407-104November, 2002
Section 9
Table 9.10: Patient Information Record: Host to ARCHITECT / AxSYM System (continued) ASTM Field Field Name Maximum Characters Field Contents Field Description
Patient Doctors name Field contains the data displayed in the optional Doctor attribute on the UI for Patient Test Orders if Transmit to host: Doctor, location, and draw date/time configuration option is On. Field is empty for patient test orders if Transmit to host: Doctor, location, and draw date/time configuration option is Off. Field is empty for Control test orders. The general clinic location or nursing unit, or ward or bed or both, of the patient. Field contains the data displayed in the optional Location attribute on the UI for Patient Test Orders if Transmit to host: Doctor, location, and draw date/time configuration option is On. Field is empty for patient test orders if Transmit to host: Doctor, location and draw date/ time configuration option is Off. Field is empty for Control test orders.
ARCHITECT: 8.1.14
Doctor
20
Printable String
ARCHITECT: 8.1.26
Location
20
Printable String
Examples:
Patient Test Order
Figure 9.15:
Example of Patient Information Record: (Patient Test Ordering): Host to ARCHITECT System
Figure 9.16:
Example of Patient Information Record: (Patient Test Ordering): Host to AxSYM System
Section 9-30
91407-104November, 2002
Document Comparison
Figure 9.17:
Example of Patient Information Record (Control Test Ordering): Host to ARCHITECT System
NOTE: The field contents of Practice Assigned Patient ID (8.1.3) shall be copied into the Patient ID No. 3 field upon transmission back to the host (8.1.5) if the field contents of both the Laboratory Assigned Patient ID (8.1.4) and the Patient ID No. 3 (8.1.5) are blank. The field contents of Laboratory Assigned Patient ID (8.1.4) shall be copied into Patient ID No. 3 field upon transmission back to the host (8.1.5), if the field contents of the Patient ID No. 3 (8.1.5) are blank.
AxSYM:
A host-defined panel is not recognized by the AxSYM System. Panels must be converted into individual tests and then regrouped into predefined panels by the host computer. Replicates for an assay may be ordered using one of two methods: 1. Use of Repeat Delimiter in Universal Test ID (Field 12). 2. Multiple Order Records containing Action Code A. NOTE: The only field in which the AxSYM System supports the repeat delimiter, within Incoming Messages, is the Universal Test ID of the Test Order Record.
Section 9-31
91407-104November, 2002
Section 9
The following table details the format of the Test Order Record sent by the Host to the ARCHITECT System or AxSYM System.
Table 9.11: Test Order Record: Host to ARCHITECT / AxSYM System ASTM Field
9.4.1
Field Name
Record Type (Same for both) Sequence Number (Same for both) ARCHITECT: Specimen ID Carrier ID
Maximum Characters
1
Field Contents
O or o Order
Field Description
9.4.2
5 20 4 2
Must be consistent with sequence number rules Sample ID downloaded from Host Carrier ID and position are ignored on input Sample ID downloaded from Host. Location and position are ignored on input.
9.4.3
15
Specimen
9.4.4
N/A
N/A
4 ARCHITECT: Universal Test ID (The only required component of this field is the assay number) 10 10
Specific number that identifies the test Test name Dilution protocol name Assay status: P or p if the assay is installed as the primary version C or c if the assay is installed as the correlation version Specific number that identifies the test Test Name Dilution Protocol (The only required component of this field is the assay number.) STAT (otherwise blank for Routine)
9.4.5
^(P, p, C, or c)
N/A
9.4.6
Section 9-32
91407-104November, 2002
Table 9.11: Test Order Record: Host to ARCHITECT / AxSYM System (continued) ASTM Field
ARCHIT ECT:
Field Name
Maximum Characters
Field Contents
Field Description
9.4.8
14
Date and time of sample collection Field contains the data displayed in the optional Draw date/time attribute on the UI for Patient Test Orders if Transmit to YYYYMMDDHHMMSS host: Doctor, location and draw date/ time configuration option is ON. 19700101000000 Field is empty for Patient Test Orders if and Transmit to host: Doctor, location, and current system date draw date/time configuration option is OFF. Field is Empty for Control Test Orders ARCHITECT: New order for a patient sample AxSYM: New Patient or New Order for an existing Sample ARCHITECT: A Unconditional Add order for a patient sample. AxSYM: Add order for Patient
or
N
or
9.4.12
Action Code
ARCHITECT: Q
or
ARCHITECT ONLY: C ARCHITECT: 15 9.4.13 Danger Code AxSYM: [blank] ARCHITECT: 15 9.4.14 Clinical Information AxSYM: [blank] 5 15 Printable String Alphanumeric Printable String Alphanumeric Printable String ^Printable String ^Alphanumeric [blank] ^Alphanumeric ^Alphanumeric
Cancel or Delete the existing order Part of the Test Order Comment Field (optional) Part of the Sample Comment Field Part of the Test Order Comment Field (optional) Part of the Sample Comment Field
ARCHITECT: Specimen Type Specimen Source 9.4.16 AxSYM: Specimen Descriptor Specimen Type Specimen Source
Section 9-33
91407-104November, 2002
Section 9
Table 9.11: Test Order Record: Host to ARCHITECT / AxSYM System (continued) ASTM Field
9.4.26
Field Name
Report Types (Same for both)
Maximum Characters
1
Field Contents
O or o
or
Field Description
Order Order in response to a Query Request.
Q or q
O|1|MCC1||^^^16\^^^606|||20010223081223||||A|Hep|lipemic||serum||||||||||Q[CR]
Figure 9.18:
O|1|OMEGA_1||^^^16\^^^606|||||||Q||||||||||||||O[CR]
Figure 9.19:
AxSYM only:
ASTM Fields 9.4.1, 9.4.2, 9.4.3, 9.4.5, 9.4.12, and 9.4.26 of the Test Order Record are required by the AxSYM System. Text in fields 9.4.13, 9.4.14 and two components of field 9.4.16 (Refer to Table 5.3), limited to a maximum of 50 characters in length, is placed sequentially in the Comment field of an AxSYM System order. If a dilution is specified for supported assays, the dilution is run. If a dilution is not specified, default dilution is ordered for that assay. If the field content of 9.4.12 (Action Code) is N, the test order is considered a new patient. However, if the sample and test already exists in the host input spool, an error message is generated on the instrument and the test order record is ignored. If the field content of 9.5.12 (Action Code) is A, the test order is processed as a patient request. If the sample exists, the test requests is added to the sample. If the sample does not exist, a patient request is created. If the field content of 9.5.12 (Action Code) is Q the sample is created and verified as a control for the requested analytes. If verified, the QC tests is created.
ARCHITECT:
If a dilution is specified for supported assays, the dilution is run. If a dilution is not specified, default dilution is ordered for that assay.
Section 9-34
91407-104November, 2002
If the field content of 9.4.12 (Action Code) is N for Patient test orders, the test order is considered a new test. However, if the same test order for this sample ID already exists (Pending, Scheduled, or Running), the system considers this an invalid request and error message is generated. If the field content of 9.4.12 (Action Code) is A, the test order shall be processed as a mandatory added test order. It shall be added to the test order list regardless of whether or not the same test order exists (Pending, Scheduled, or Running) in the instruments database. If the field content of 9.4.12 (Action Code) is C, the test order shall be processed as a request to cancel the specified test order. The instrument shall cancel the first pending test order found, from its pending test order list which has the same SID, Assay Number, Dilution Name, and Assay Status. If no such order is found, the system ignores this request. If the field content of 9.5.12 (Action Code) is Q, the sample is established and verified as a control for the requested analytes. If verified, the QC tests are created.
Field Name
Record Type Sequence Number Comment Source Comment Text Comment Type
Maximum Characters
1 5 1 50 1
Field Contents
C or c 1 to 65535 L Printable characters G
Field Description
Comment Must be consistent with sequence number rules Computer system Comment text Generic comment
Q|1|^SID1234||^^^ALL||||||||X[CR]
C|1|L|Example Comment|G[CR]
Figure 9.20:
Section 9-35
91407-104November, 2002
Section 9
When the Comment Record follows a patient record, the comment in 11.1.4 refers to that patient sample and is duplicated in the comment field for each test order for that patient sample. When the Comment Record follows a test order, it refers only to that test order. The following comment textlimited to a maximum of 50 characters in lengthis placed in the comment field of an ARCHITECT System test order in the following sequence: 1. Text in field 11.1.4 (refer to table 5.9 Comment Record) of one or more comment records associated with the patient record. then 2. Text in fields 9.4.13, 9.4.14 and two components of 9.4.16 (refer to table 5.3 Test Order Record). then 3. Text in field 11.1.4 of one or more comment records associated with the test order.
Negative Query Response Record, ARCHITECT Request Information Record, AxSYM ARCHITECT:
The system shall accept a Negative Query Response from the Host system. The Negative Query Response is used to indicate that an earlier Query Request from the system resulted in no orders being sent, either due to: The sample ID specified in the original Query Request was unknown to the Host system or The sample ID specified had no outstanding orders at the time the Query Request was received. The following table details the exact format of the Negative Query Response Record which shall be sent by the Host to the system
Table 9.13: Request Information Record: Host to AxSYM System Negative Query Response Record: Host to ARCHITECT System ASTM Field
12.1.1
Field Name
Record Type ID (Same for both)
Maximum Characters
1
Field Contents
Q or q
Field Description
Section 9-36
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Table 9.13: Request Information Record: Host to AxSYM System Negative Query Response Record: Host to ARCHITECT System (continued) ASTM Field
12.1.2
Field Name
Sequence Number (Same for both) ARCHITECT: ID Number
Maximum Characters
1 20
Field Contents
1 ^Specimen ID (printable string) ^Specimen ID
Field Description
Always contains 1
12.1.3
15 ARCHITECT: 3
12.1.5
Universal Test ID
AxSYM: [blank]
^^^ALL
12.1.13
Indicates that either the Sample ID is unknown to the Host, or there are no outstanding orders for the specified Sample ID
ARCHITECT
Q|1|^SID1234||^^^ALL||||||||X[CR]
Figure 9.21:
AxSYM
Q|1|^SID12345||^^^ALL||||||||X[CR]
Figure 9.22:
The system shall discontinue waiting for either Test Orders or a Negative Query Response in response to an earlier issued Query Request, as defined in the user-configurable option Host timeout. After a predefined number of allowed consecutive host time-out errors, the software shall: Log an error Disable the query mode
Section 9-37
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Section 9
AxSYM:
The only form of the Request Information Record that is supported by AxSYM as an incoming transmission, is that of the Negative Query Response. The Negative Query Response is used to indicate that an earlier Query Request from the AxSYM System results in no orders being sent. This can be due to (1) the Sample ID specified in the original Query Request was unknown to the Host system, or (2) the Sample ID specified has no outstanding orders at the time the Query Request was received. The Negative Query Response is essentially a copy of the original Query Request with the Status Code set to X.
Field Name
Record Type Sequence Number
Maximum Characters
1 1
Field Contents
L 1 Last
Field Description
Must be 1
L|1[CR]
Figure 9.23:
Section 9-38
91407-104November, 2002
Section 9Bibliography
American National Standards Institute. 1976. X3.15-1976 American National Standard for Bit Sequencing of the American National Standard Code for Information Interchange in Serial-by-Bit Data Transmission. X3.16-1976 American National Standard Character Structure and Character Parity Sense for Serial-by-Bit Data Communication in the American National Standard Code for Information Interchange. American National Standards Institute. 1984. International Standard ISO 7498-1984(E). American National Standards Institute. 1986. ANSI Standards - X3.41986 American National Standard Code for Information Systems. American National Standards Institute. 1989. X3.30 ANSI Information System Codes. X3.43 ANSI Information System Codes. American National Standards Institute. 1993. ISO 2955-93 Information Processing-Representation of SI and Other Units in Systems with Limited Character Sets. American Society of Testing and Materials. 1991. ASTM Designation: E 1381-91 Specification for Low-level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems. ASTM Designation: E 1394-91 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems. Electronics Industries Association. 1986. EIA-232-D-1986 Interface Between Data Terminal Equipment and Data Circuit-Terminating Equipment Employing Serial Binary Data Interchange.
Bibliography-1
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NOTES
Bibliography-2
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Glossary
Glossary
Allowed Data Formats
All data is represented in ASCII format within the range 0 - 255. Values 0 - 127 are defined by ANSI X3.4-196 Standard. Values 128 - 255 are defined as needed by specific instruments. Values 0 - 31 cannot be used, with the exception of 13 (<CR>). The value 13 is reserved as a record terminator. Values 32 - 255 can be used, with the exception of 127 and 255. Within a data text field, only the ASCII characters 32 - 126 and 128 - 254 are permitted as usable characters. Characters used as delimiters in the transmission are excluded from the above permitted range. The sender is responsible for checking that a data text field does not contain any delimiters. The record identified fields (H, P, O, R, L, C, M, and Q) are always uppercase when output from the Abbott instrument. On input, both upper- and lowercase record identifiers are accepted. Fields and records are variable in length with no restriction placed on the maximum length of a field or record. The high-level protocol depends on the receivers buffering capability and the low-level communication ability to divide the information into workable lengths for transmission and processing purposes. All Abbott Standard Interface RS-232 manuals provide the maximum allowable length of each field transmitted and received. Abbott Standard Interface: Abbotts implementation of the American Society for Testing and Materials (ASTM) Standard. E 1394-91, A Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems. E1381-91, Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems. Analysis to determine the presence, absence, or quantity of one or more analytes. The generation of a calibration curve for use in determining the concentration of an analyte present in samples. Settings that define specific characteristics or verify the performance of an assay. Assay processing steps that provide the system with information which allows pipetting, incubation, washing and reading to occur at specific volumes and times throughout the reaction sequence. Protocol types include: One-step, Two-step, and Pre-Treatment. Individual settings within each assay configuration category which you can edit to meet your site-specific requirements. American Society for Testing and Materials. Consists of specifications that define the transferring of information between laboratory instruments and computer systems. The solutions found in the supply and waste center which are used on the system (Pre-Trigger Solution, Trigger Solution, Wash Buffer). Created when an operator performs an assay calibration. Used for determining the concentration of analyte in a sample. Material with a known concentration of specific analyte used to create a calibration curve. A user interface input area where you can make one or more selections for an item. A black check mark in the box indicates that it has been selected.
ASI
Glossary-1
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Glossary
Chemiluminescense CMIA Configuration Consumables
Emission of light produced by a chemical reaction. Chemiluminescent Microparticle Immunoassay; the detection technology the ARCHITECT System uses to perform automated immunoassays. The process by which you can edit System, Assay, and QC-Cal settings that provide the system with information to meet your site-specific requirements. Items that are exhausted in the process of running assays (reagents, calibrators, controls, bulk solutions, septums, replacement caps, sample cups, reaction vessels) Material with a known concentration of a specific analyte. Controls are run with patient samples and are used to monitor assay and system performance over time. Overlay screens that display on top of, or in front of, full-frame screens. They provide additional information, details, or functions. They display after an item or function key has been selected on the primary full-frame screen. List of items that display when an icon is selected that represents each of the screens available for the specific icon. A frame is a subdivision of a message and allows transmission of up to 247 characters (240 data characters and 7 control characters). The Abbott instrument transmits one record per frame. Messages more than 247 characters long can be divided into multiple frames, as long as each frame contains only information from one record at a time. A block of data that is transmitted in a format consistent with the ASTM E 1381-91 Standard. Abbott ASI instruments use an E 1394-91 Record as the E1381-91 Message. Thus, an E1381-91 Message may be transmitted using multiple (one or more) frames, based on the length of the message. A block of data that is transmitted in a format consistent with the ASTM E 1394-91 Standard. Data is transmitted in a series of records starting with a Header Record (H) and ending with a Terminator Record (L). When a transmission is lost, the Abbott instrument retransmits or accepts only complete messages. An E1394 Record is a string of characters starting with a capital ASCII alphabet character and ending with a carriage return (ASCII 13), as defined by the ASTM E 1394-91 Standard. Test orders that fail to complete. A subdivision of a record containing one specific piece of information, such as an address. Screen displayed when a drop-down menu option is selected. Located at the bottom of the software screens containing function keys associated with a particular screen. An auxiliary computer system that can communicate back and forth with the ARCHITECT System. Symbol providing a graphic and name that represent a category of screens or additional functionality.
Control
Dialog windows
E1381-91 Message
E 1394-91 Message
E 1394-91 Record
Glossary-2
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Glossary
Icon zone
Located at the top of the software screens providing navigational and status indication support. Each icon in the icon zone has a drop-down menu that is displayed when you select the icon. Analytical procedure based on reactions between antigens and antibodies. The main area of the software screens containing information pertaining to a particular screen, including screen name. ARCHITECT System configuration containing more than one (1) i 2000 processing module. Overlay screens that display at the center of a full-frame screen and in front of the currently displayed window. All interaction with the user interface is suspended until you acknowledge the popup by selecting one of the buttons in the window. A covered temperature controlled circular track that moves RVs; provides liquid aspiration, and wash points as necessary for the assay. Area in which assay processing activities take place. Contains the process path. Light sealed area where sample processing takes place. Functions that occur here include mixing and delivering of reagents, solutions, and samples, incubations, all optical reads and disposal of used RVs. Located in the center of the Snapshot screen, and contains key information specific to the processing module, as well as navigational hot spots for accessing related screens. Information regarding the operational mode of the processing module. Status types include: Offline, Stopped, Warming, Ready, Scheduled Pause, Running, Initializing, and Scanning. A message sent to the LIS requesting test orders for a specific sample ID. A message sent to the ARCHITECT System containing orders for the sample ID specified in the prior Query Request. A Query Response may also indicate that no orders are required at the time the Query Request was made. A user interface input area where you can only make one selection from multiple options. A black-filled circle indicates that it has been selected. A disposable that carries a specified volume of sample, reagent, and solution through the processing center path. Carousels located in the refrigerated compartment of the processing center where reagent bottles are loaded. Related information which forms a subdivision of a complete ASTM message. A single data element which expresses a duplication of the field definition it represents. It is used for demographics, requests, orders and the like, where each element of a repeat field is to be treated as having equal priority to associated repeat fields. The following characters have special uses and should not be used for data: Vertical Bar (|) Backslash (\) Ampersand (&) Carriage Return (<CR>) Caret (^)
Processing module graphic Processing module status Query Request Query Response
Radio buttons Reaction Vessel (RV) Reagent carousels Record Repeat field
Reserved Characters
Glossary-3
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Glossary
Sample double load / Unload queues Sample handler Sample handler keypad Sample handler status Sample load queue Sample load queue bar code reader Sample processing queue Sample syringe (SS) Sample unload queue Serial port Snapshot screen
Configured on multi-module systems to provide two load queue lanes with a capacity of up to 125 samples each (25 sample carriers) for a total capacity of 250 samples (50 sample carriers). Module that transports samples from the load queue to the Processing Center queue and then to the unload queue. Used to provide extended system control center functionality at the sample handling center. Information regarding the operational mode of the sample handler. Status types include: Offline, Stopped, Ready, Running, and Load queue paused. Track on the left side of the processing module where sample carriers are loaded. Used to scan carrier ID bar codes, carrier position bar codes, and primary tube bar codes to identify the sample. Track in front of the processing module where sample carriers are transported from the load queue to the sample aspiration position and then down the track to the unload queue. Aspirates and dispenses sample by moving the piston in the syringe body. Track on the right side of the processing module where sample carriers are unloaded A connection point between the ARCHITECT System and an external device. The Main Menu screen of the ARCHITECT System. Monitors key system and processing module information. Also provides quick access to related screens through the use of icons and drop-down menus. Computer workstation that provides a centralized interface by which the operator can control one or more processing modules. Software that controls operation of the ARCHITECT System. Information regarding the operational modes of the system. The processing module and the sample handler each have separate statuses. Character encoding scheme that supports internationalization of textual information. The encoding scheme uses 16 data bits to represent each character which provides for definition of 65536 unique characters. Graphical screens that an operator uses to control and navigate through the ARCHITECT System software. Navigate by using a mouse, touch-screen monitor, and/or keyboard.
User interface
Glossary-4
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Index
A
allowed data formats, Glossary-1 ASI definition, Glossary-1 ASTM format details, 4-9 ASTM frames (UNICODE), 4-21
I
incoming messages, 5-1
L
LAS carousel sample handler pausing the, 3-13 logical record hierarchies incoming, 5-4 logical transmission error recovery incoming, 5-4
C
checksum (UNICODE), 4-21 comment record formats ARCHITECT i System to host, 4-17 host to system, 5-11, 8-35 communication AxSYM to Host, 4-3 Host to AxSYM, 5-3 communication setup configuration Host-release mode windows, 3-17 overview, 3-15 Serial ports windows, 3-28 System control center windows, 3-24 Configuration screen - System settings view accessing, 3-16 control characters UNICODE support, 4-21
M
Message Header Record (fields), 4-9, 5-6 Message Terminator Record (fields), 4-19, 5-13 messages comment record, 5-11, 8-35 definition, Glossary-2 negative query response record, 5-12, 8-36 terminator record, 4-18, 4-19, 5-13, 8-23, 8-24, 8-38
N
negative query response record, 5-12, 8-36 Negative Query Response Record (fields), 5-12 new error codes Computer hardware, 7-4 Temperature, 7-4
D
data formats, Glossary-1
F
frames definition, Glossary-2
P
Patient Information Record (fields), 4-10, 5-6 pausing c System sample carousel, 3-12 LAS carousel sample handler, 3-13 SSH sample load queue, 3-12
H
host computer transmission options, 3-20, 8-5 Host-release mode configuration windows, 3-17
Index-1
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Index Q
Quality Control (QC) field description Result Record, 4-14, 8-18 Test Order Record, 4-12 query request, Glossary-3 response, Glossary-3
U
UNICODE support ASTM Frames, 4-21 checksum, 4-21 control characters, 4-21
R
records comment, 8-35 definition, Glossary-2 fields Comment, 4-17, 5-11 Message Header, 4-9, 5-6 Message Terminator, 4-19, 5-13, 8-38 Negative Query Response, 5-12 Patient Information, 4-10, 5-6 Request Information, 4-18 Result, 4-14 Test Order, 4-12, 5-8 negative query response, 5-12, 8-36 terminator, 4-18, 4-19, 5-13, 8-23, 8-24, 8-38 repeat field, Glossary-3 Request Information Record (fields), 4-18 reserved characters definition, Glossary-3 Result Record (fields), 4-14
S
sample carousel (c System) pausing the, 3-12 Serial ports configuration windows, 3-28 SSH (i 2000) pausing the sample load queue, 3-12 system control center configuration windows, 3-24
T
terminator record, 4-18, 4-19, 5-13, 8-23, 8-24, 8-38 Test Order Record (fields), 4-12, 5-8 transmission error recovery incoming, 5-4
Index-2 Abbott Standard Interface RS-232 Manual/ARCHITECT System Edition
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Revision history
Revision history
The revision history table provides a high level summary of content that has changed in this document since the last revision (LN 06F71-03).
.
Updated description of Sections 2 - 9. 1. 2. Clarified information on Comment and Manufacturer Records Updated the following topics: Presentation Layer - Message Content ASI Defined fields - Action Codes, Record Sequence Number, Records and Fields 3. Updated the following tables: Message Header Record Patient Record Order Record Result Records Comment Record Terminator Record Special Control Characters Updated entire section. Updated entire section. 1. Updated the following topics: Patient and QC Results Transmission Order Query Transmission Logical Transmission Error Recovery Requirements 2. Updated the following records: Message Header Record Patient Information Record Test Order Record Result Record Comment Record Request Information Record Message Terminator Record Updated the following topics: Communication - Host to the ARCHITECT System Message Header Record Patient Information Record Test Order Record Comment Record Negative Query Response Record Message Terminator Record Moved the ARCHITECT System Support of ASI Options information from Section 3 to this section. Updated entire section. Added information about the ARCHITECT SCC Simulator (for LIS vendors) which includes installation instructions.
Section 2 Overview of the ARCHITECT System Section 3 Communications Setup Section 4 ARCHITECT System-specific Outgoing Messages
Section 6 ARCHITECT System Support of ASI Options Section 7 Troubleshooting Section 8 Abbott Host/Instrument Interface Tools
Revision History-1
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Revision history
Updated the following topics: Introduction Physical Layer - ARCHITECT System Baud rates Data Link Layer - ARCHITECT System Establishment Phase Message Content Layer - ARCHITECT System Transmission Modes, Transmission of Multiple Flags and Comment Record Document Comparison (System-specific Outgoing Messages) - Communication (ARCHITECT vs. AxSYM) to Host, Results Transmission Mode, ASTM Record Formats - Patient Information Record, Test Order Record, Result Record, and Comment Record Document Comparison (System-specific Incoming Messages) - Communication: Host to the System (ARCHITECT vs. AxSYM) - ASTM Record Formats - Message Header Record, Patient Information Record, Test Order Record, Comment Record, Negative Query Response Record, and Message Terminator Record
Revision History-2
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