COMMANDER Flexible Pipetting Center (FPC) Operations Manual June 2004

NOTES

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Revision Status Document Control Number(s)

Revision Date

Section(s) Revised

Content or Pages Revised, Added or Deleted

Originally Issued

6/90

Not Applicable

Not Applicable

Version 2.0

6/92

All Sections

All Pages

Version 2.0

1/93

Table of Contents, Section 7, 11, 15, 17, Index

All Pages

Version 2.0

6/93

Table of Contents, Sections 1, 3, 4, 5, 6, 8, 9, 12, 14, 16

All Pages

Version 2.0

2/94

Sections 1, 8, 15

All Pages

Version 2.5 (66-5171/R4)

9/95

Entire Manual

Version 2.5 (66-8818/R5)

12/96

Front Matter, Master Table of Contents, Sections 4, 5 (Registration and Assay Protocol), 9, Bibliography, Appendix A, Index

All Pages

Version 2.5 (69-3540/R6)

8/99

Front Matter, Sections 2 and 9

All Pages

Version 2.5 (69-5748/R7)

5/02

Front Matter, Master Table of Contents, Sections 4, 5, 8, 9, 10, Appendix A, Index

All Pages

Version 2.5 (74005-101)

6/04

Front Matter, Section 9, Appendix D, Index

Front Matter, pages i, iii, iv, and vii through xii Section 9, page 9-18 Appendix D, all pages (footer) Index, pages Index-2, Index-5, Index-6, Index8, and Index-10 through Index-13

NOTE: See next page for Operations Manual’s current configuration.

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Current Configuration of this Operations Manual COMMANDER Flexible Pipetting Center (FPC) Operations Manual (List No. 6A97-27) (74005-101). Information presented in this configuration is consistent for FPC System software version 2.5. 69-6308/R5 — Front Matter 69-5751/R3 — Master Table of Contents 66-5177/R1 — How to Use this Manual 66-5179/R1 — Section 1 Use or Function 69-3742/R2 — Section 2. Installation Procedures and Special Requirements 66-5183/R1 — Section 3. Principles of Operation 69-5752/R3 — Section 4. Performance Characteristics and Specifications 69-5753/R3 — Section 5. Table of Contents 69-5824/R5 — Section 5. Registration 66-5190/R3 — Section 5. Pipetting 66-5192/R1 — Section 5. Component Library 66-8824/R3 — Section 5. Assay Protocol 66-5196/R3 — Section 5. Files Mode 66-5198/R2 — Section 5. Transfers 66-5200/R1 — Section 6. Calibration Procedures 66-5202/R1 — Section 7. Operational Precautions and Limitations 69-5754/R2 — Section 8. Hazards 69-6309/R5 — Section 9. Service and Maintenance 69-5756/R4 — Section 10. Troubleshooting and Diagnostics 66-8826/R2 — Bibliography 66-5212/R1 — Glossary 69-5757/R3 — General Pipetting, Assay and Reagent Information 66-5217/R1 — Example Printouts 66-5219/R3 — RBC Pipetting 69-6310/R3 — System Integration Guide 69-6311/R6 — Index

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Revision Log Instructions: Use this log as a permanent record to verify that a revised section(s) has been added to this manual. 1. Write the document control number in the first column. You will find the number in the footer of each section or tab. Make an entry for each section or tab you receive to be placed in the manual. 2. Write the revision date, also found in the footer, in the second column. 3. Write the version of the software to which the revised pages or sections refer in the third column. 4. Sign your name in the fourth column to verify that you have placed the revised pages into the manual. 5. Write the date that you added the revised section to the manual in the fifth column.

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Revision Date

Software Version (if applicable)

Revision Incorporated by

Date Incorporated

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NOTES

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COMMANDER® Flexible Pipetting Center (FPC™) Operations Manual

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Foreword Congratulations on the addition of the COMMANDER® Flexible Pipetting Center (FPC) to the operation of your laboratory. Using state-of-the-art technology, we have designed an instrument that will function consistently and dependably on a daily basis. The FPC system is backed by dedicated professionals who provide support in engineering, training and technical information. For continuing service, we provide telephone technical assistance should you need help in diagnosing a problem. If a problem should arise that cannot be resolved by telephone, Abbott Field Service Representatives (FSRs) are available for on-site support. FSRs are trained in all disciplines of Abbott instrumentation to assure proficiency in diagnosing, isolating and correcting problems. Abbott Laboratories looks forward to serving your needs in any way possible.

Customer Support United States: 1-877-4ABBOTT (1-877-422-2688) Canada: 1-800-387-8378 International: Call your Abbott Representative.

Proprietary Statement Copyright© 1992, 2004 by Abbott Laboratories Diagnostics Division. Abbott Laboratories software programs are protected by copyright. All rights are reserved. This software was developed solely for use with Abbott Laboratories’ equipment and for in vitro diagnostic applications as specified in the operating instructions. No part of this document may be reproduced, stored, or transmitted in any form or by any means electronic, mechanical, photocopied, recorded, or otherwise without the prior written permission of Abbott Laboratories. All operating instructions must be followed.

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Legal Disclaimers The sample printouts/screens contained in this manual are for information and illustration purposes only. Abbott Laboratories makes no representations or warranties about the accuracy and reliability of the information on the printouts/screens in this manual, and their information is not to be used for clinical or maintenance evaluation. 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. Qualifications: • 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. • Any product information in training materials should be used in conjunction with the latest version of the Operations Manual, Operations Manual addendum, or Product Information Letter. If discrepancies in information exist within training materials or any other materials, the latest version of the Operations Manual, Operations Manual addendum, or Product Information Letter takes precedence. • Abbott Laboratories is not engaged in rendering medical advice or services. viii

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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. Master Table of Contents and/or Index – Incremental manual updates may cause the Master Table of Contents or Master Index page numbering to change.

Warranty Abbott Laboratories (“Abbott”) warrants instruments sold by the Abbott Diagnostics Division to be free from defects in workmanship and materials during normal use by the original purchaser. This warranty shall continue for a period of one (1) year, commencing twenty-one (21) days from the date of shipment to the original purchaser, or until title is transferred from the original purchaser, whichever occurs first (the “Warranty Period”). If any defects occur during the Warranty Period, contact your Abbott Customer Support immediately. Be prepared to furnish pertinent details concerning the defect, the model number, and the serial number. Warranty service is provided from 8:30 a.m. through 5:00 p.m., Monday through Friday, except on Abbott observed holidays. Any service performed at other times, and all service required to correct defects or malfunctions not covered by this Warranty, will be billed at Abbott’s labor rates then in effect. This Warranty does not cover defects or malfunctions which: (1) are not reported to Abbott during the Warranty Period and within one week of occurrence; (2) result from chemical decomposition or corrosion; (3) are caused primarily by failure to comply with any requirement or instruction contained in the applicable Abbott Operations Manual; or (4) result from maintenance, repair or modification performed without Abbott’s authorization. Abbott’s 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 Abbott’s 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, indirect or consequential damages or lost profits.

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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 of fitness for a particular purpose. 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 NON-INFRINGEMENT. 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.

Trademark Statements 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. AIM® is a registered trademark of Automatic Identification Manufacturers, Inc. COMMANDER®, IMx®, Quantum® and Quantumatic® are registered trademarks and TPC™ and PMTS™ are trademarks of Abbott Laboratories. DeepWell™ is a trademark of Beckman Instrument Co.

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HP®, DeskJet® and ThinkJet® are registered trademarks of Hewlett-Packard Company. Oracle® is a registered trademark of Oracle Corporation. Terg-A-Zyme® is a registered trademark of Alconox Co. UNIX® is a registered trademark of Unix Systems Lab.

Regulations and Standards The FPC complies with the following standards: • City of L.A. (U.L. 1262, Laboratory Equipment, May 23, 1988) • VDE 0871 (VDE B) Radio Interference Suppression of Radio Frequency • FCC Part 15, Subpart B Class A Radio Emission • CE (meets applicable New Approach directives of the European Union)

Federal Communications Commission Radio Frequency Interference Statement: Section 15.105: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Section 15.21: The user is cautioned that any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Canadian Department of Communication Radio Frequency Interference Statement: English Version: This digital apparatus does not exceed the Class A limits for radio noise emissions from digital apparatus set out in the radio interference regulations of the Canadian Department of Communications. COMMANDER® Flexible Pipetting Center (FPC™) Operations Manual

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French Version: Cet appareil numérique n’émet pas de bruits radioélectriques dépassant les limites applicables aux appareils numériques de la classe A prescrites dans le Règlement sur le brouillage radioélectrique édicté par le ministère des Communications du Canada.

ZZF Germany Statement for Class B Devices: English Version: This is to certify that the Flexible Pipetting Center, model 03A46-01/03A46-09/03A46-47, and the Automatic Bar Code reader, model 03A46-24, is shielded against radio interference in accordance with the provisions of Vfg 1046/1984. The German Postal Services have been advised that this device has been marketed and has been provided the right to verify the device or system for compliance with the regulations. Compliance with applicable regulations depends on the use of shielded cables. It is the user who is responsible for procuring the appropriate cables. German Version: Hiermit wird bescheinigt, daß das System zur Flexiblen Probenverteilung, 03A46-01/03A46-09/03A46-47, und der Automatische Barcodeleser, Best.-Nr. 03A46-24, in Übereinstimmung mit den Bestimmungen des AmtsblVfg 1046/1984 funkentstört ist. Der Deutschen Bundespost wurde das Inverkehrbringen dieses Gerätes angezeigt und die Berechtigung zur Überprüfung der Serie auf Einhaltung der Bestimmungen eingeräumt. Zur Einhaltung der geltenden Bestimmungen ist es erforderlich, daß abgeschirmte Kabel verwendet werden. Für die Beschaffung der richtigen Kabel ist der Betreiber verantwortlich. The FPC computer and monitor comply with the IEC 950 standard.

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Master Table of Contents

Master Table of Contents

How To Use This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How To Use-1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How To Use-1 Manual Organization . . . . . . . . . . . . . . . . . . . . . How To Use-1 Text Conventions . . . . . . . . . . . . . . . . . . . . . . . . How To Use-3

Section 1. Use or Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Pipetting Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Computer Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 ABC Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Sources and Destinations . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Bottle Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Platen Extension Assembly and Sample Tube Rack . . . . 1-8 Library Rack and Platform . . . . . . . . . . . . . . . . . . . . . . . 1-9 Microtiter Plates and Adapter . . . . . . . . . . . . . . . . . . . . . 1-9 MEIA and FPIA Carousels . . . . . . . . . . . . . . . . . . . . . . . 1-10 Tray Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 Destination Options . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Section 2. Installation Procedures and Special Requirements . . . . . . . . . . . . . . . 2-1 System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Cable Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Powering Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Pipetting Unit Power Up . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Computer, Monitor, and Printer Power Up . . . . . . . . . . 2-4 Power Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 Configuration Menu Bar Definitions . . . . . . . . . . . . . . . . . 2-10 System Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Database Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 Manual Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15 Automatic Initialization . . . . . . . . . . . . . . . . . . . . . . . . 2-16 Tip Threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18 RS-232 Port Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 2-20 Reset Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

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Master Table of Contents-1

Master Table of Contents

Password Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27 Special Password Conditions . . . . . . . . . . . . . . . . . . . . 2-29 Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30

Section 3. Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 Total Process Control (TPC™) . . . . . . . . . . . . . . . . . . . . . . . 3-2 FPC Software Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Pipetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Component Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Assay Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Files Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Transfers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Working with FPC Software . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Using the Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 The Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 On-Screen Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 Scroll Bars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 FPC Software Version 2.5 Menu Flow Chart . . . . . . . . . . . 3-11

Section 4. Performance Characteristics and Specifications . . . . . . . . . . . . . . . . . 4-1 Physical Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Environmental Requirements for Instrument Operation . . 4-1 Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 UPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 FPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 ABC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Electrical Safety Parameters . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Installation Category (Overvoltage Category) . . . . . . . . 4-3 Pollution Degree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Data Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 FPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 ABC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Pipettor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Sample Tube Diameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 General Bar Code Requirements . . . . . . . . . . . . . . . . . . . . . 4-4 Label Characteristics Specifications . . . . . . . . . . . . . . . . 4-6

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Labels Required for Samples . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Codabar Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Code 39 Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7 Code 128 Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7 Interleaved 2 of 5 Labels . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Label Requirements for Sources and Destinations . . . . . . . . 4-8 FPC Software Configurations . . . . . . . . . . . . . . . . . . . . . . . 4-10

Section 5. Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 Registration Menu Bar Definitions . . . . . . . . . . . . . . . . . . . . 5-2 ABC Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4 ABC Auto Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9 Source Registration—Abbott 60-Tube Rack . . . . . . . . . . . . 5-14 Source Registration— Previously Registered Abbott 60-Tube Rack . . . . . . . . . . . 5-19 Source Registration—Other Source Types . . . . . . . . . . . . . 5-24 Source Registration— Other Previously Registered Source Types . . . . . . . . . . . . 5-28 Manual Work List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33 Pipetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37 Pipetting Menu Bar Definitions . . . . . . . . . . . . . . . . . . . . . 5-38 Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38 When Using A Sensor Module . . . . . . . . . . . . . . . . . . . 5-39 When Using An Automatic Barcode Reader (ABC) . . . 5-39 Pipetting Setup with TPC™ . . . . . . . . . . . . . . . . . . . . . . . . 5-41 When a Run Requires Additional Destinations . . . . . . 5-52 Replacing a Dilutor Tray . . . . . . . . . . . . . . . . . . . . . . . . 5-58 When a Run Requires Additional Sources . . . . . . . . . . . 5-59 Pipetting Setup Without TPC™ . . . . . . . . . . . . . . . . . . . . . 5-60 When a Run Requires Additional Destinations . . . . . . 5-70 Replacing a Dilutor Tray . . . . . . . . . . . . . . . . . . . . . . . . 5-74 When a Run Requires Additional Sources . . . . . . . . . . 5-74 Pipetting with an ABC . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-75 Pipetting Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-75 Recovering from an ABC Jam . . . . . . . . . . . . . . . . . . . . 5-76 Pipetting with the “Manual” ID Convention . . . . . . . . 5-77 Pipetting with the “Sequential” ID Convention . . . . . 5-78 Tube Not Detected . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-79 When Pipetting Is Complete (ABC) . . . . . . . . . . . . . . . . . . 5-79 If There Were No Problems During Pipetting . . . . . . . . 5-80 If Problems Were Encountered During Pipetting . . . . . 5-80

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When Pipetting Is Complete (non-ABC) . . . . . . . . . . . . . . 5-83 To Pause During a Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-84 To Cancel a Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-84 Pipetting Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-85 Pipetting Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-87 Samples Completed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-88 Component Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-91 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-91 Component Library Menu Bar Definitions . . . . . . . . . . . . 5-92 Viewing Master Lots and Components . . . . . . . . . . . . . . . 5-92 Deleting Master Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-94 Entering Master Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-96 Kit Card Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-96 Manual Kit Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-102 Entering Non-Master Lot Components . . . . . . . . . . . . . . 5-106 Deleting Non-Master Lot Components . . . . . . . . . . . . . . 5-108 Adding User-Created Component Types . . . . . . . . . . . . . 5-110 Deleting User-Created Component Types . . . . . . . . . . . . 5-114 Adding Allowed Mixtures . . . . . . . . . . . . . . . . . . . . . . . . . 5-116 Deleting Allowed Mixtures . . . . . . . . . . . . . . . . . . . . . . . . 5-120 Assay Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-123 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-123 Assay Protocol Menu Bar Definitions . . . . . . . . . . . . . . . . 5-124 Viewing Assay Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . 5-125 Deleting Assay Protocols . . . . . . . . . . . . . . . . . . . . . . . . . 5-127 Creating Assay Protocols . . . . . . . . . . . . . . . . . . . . . . . . . 5-128 Editing Assay Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . 5-141 Backing Up Assay Protocols to Diskette . . . . . . . . . . . . . . 5-153 Installing Assay Protocols From Diskette . . . . . . . . . . . . . 5-154 If installing Abbott assays: . . . . . . . . . . . . . . . . . . . . . 5-155 If installing user-created assays: . . . . . . . . . . . . . . . . . 5-156 Activating Abbott Assay Protocols From Diskette . . . . . . 5-158 Creating Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-160 Deleting Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-162 Configuring Assay Protocols . . . . . . . . . . . . . . . . . . . . . . 5-164 Files Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-167 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-167 Files Mode Menu Bar Definitions . . . . . . . . . . . . . . . . . . . 5-167 Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-169 Viewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-171 Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-171 Deleting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-171 Uploading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-172

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Archiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-172 Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-173 Saving to Diskette . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-174 Destinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-175 Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-177 Deleting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-177 Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-178 Creating Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-180 Editing Maps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-182 Archiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-184 Uploading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-185 Saving To Diskette . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-186 Unlocking a Destination Map . . . . . . . . . . . . . . . . . . . . . 5-187 Work Lists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-188 Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-191 Uploading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-191 Saving to Diskette . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-191 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-192 Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-197 Deleting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-197 Approving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-198 Blocking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-199 Uploading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-200 Saving to Diskette . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-201 Editing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-202 Analyzer Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-203 Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-206 Deleting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-206 Uploading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-206 Saving To Diskette . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-207 View Diskette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-208 Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-209 Deleting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-210 Viewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-210 Transfers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-211 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-211 Transfers Menu Bar Definitions . . . . . . . . . . . . . . . . . . . . 5-211 Transferring Tray To Box . . . . . . . . . . . . . . . . . . . . . . . . . . 5-212 Transferring Source To Destination . . . . . . . . . . . . . . . . . 5-213 Transferring Destination To Source . . . . . . . . . . . . . . . . . 5-215

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Section 6. Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Section 7. Operational Precautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . 7-1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Pipettor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Tip Disposal Bin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Pipette Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 ABC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Sensor Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Hand-Held Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Section 8. Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Biological Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Waste Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Spill Cleanup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 Decontamination Procedure . . . . . . . . . . . . . . . . . . . . . 8-2 Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 Physical and Mechanical Safety . . . . . . . . . . . . . . . . . . . . . . 8-3 Physical and Mechanical Hazards . . . . . . . . . . . . . . . . . 8-3 Chemical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Hazardous Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Reagents Containing Sodium Azide . . . . . . . . . . . . . . . . 8-4 Removal of Sodium Azide from Laboratory Plumbing . 8-4

Section 9. Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3 Syringe Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4 Removing Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4 Attaching Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6 Replacing Diluent Syringe Plunger . . . . . . . . . . . . . . . . . . . 9-9 Tubing Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10 Sample Pipette Tubing . . . . . . . . . . . . . . . . . . . . . . . . . 9-10 Diluent Delivery Tubing . . . . . . . . . . . . . . . . . . . . . . . . 9-11 Diluent Suction Tubing . . . . . . . . . . . . . . . . . . . . . . . . 9-12 Dilutor Connection Tubing . . . . . . . . . . . . . . . . . . . . . 9-13 Replacing Filter in Dilutor System . . . . . . . . . . . . . . . . . . . 9-13 Cleaning Tip Nozzle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14

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Priming the Dilutor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14 Loading the Pipette Tip Rack . . . . . . . . . . . . . . . . . . . . . . . 9-16 Cleaning the Diluent Line . . . . . . . . . . . . . . . . . . . . . . . . . 9-17 Terg-A-Zyme Cleaning Procedure . . . . . . . . . . . . . . . . . 9-18 Cleaning and Decontaminating the FPC Unit . . . . . . . . . . 9-18 Cleaning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19 Decontamination Procedure . . . . . . . . . . . . . . . . . . . . . 9-19 Replacing the Three-Way Electromagnetic Valve . . . . . . . . 9-20 Tip Threshold Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22 Leak Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-24 Reset Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-26 Dilution Verification Procedure . . . . . . . . . . . . . . . . . . . . . 9-28 Data Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-30 ABC Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-32 Cleaning Track/Removing Sample Tube Carriers . . . . . 9-32 Replacing Burnt Out Bulbs . . . . . . . . . . . . . . . . . . . . . . 9-34 Replacing Sample Carrier Flags . . . . . . . . . . . . . . . . . . . 9-35 Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-35 Replacing Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-35 FPC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-35 ABC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-36 Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-38 FPC Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-38 ABC Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-41 Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-43

Section 10. Troubleshooting and Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 General Troubleshooting Suggestions . . . . . . . . . . . . . . . . 10-1 Air Bubble in Diluent Line . . . . . . . . . . . . . . . . . . . . . . 10-1 Communication Problems . . . . . . . . . . . . . . . . . . . . . . 10-1 Computer Operation Slowed . . . . . . . . . . . . . . . . . . . . 10-2 Computer Lockups . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2 Dilutor Nozzle Problems . . . . . . . . . . . . . . . . . . . . . . . . 10-3 Hand-Held Bar Code Reader . . . . . . . . . . . . . . . . . . . . . 10-3 Homing Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4 Keyboard Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5 Monitor Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5 Printer Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6 Sensor Module Problems . . . . . . . . . . . . . . . . . . . . . . . . 10-6 ABC Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7 Bar Code Observed Problems . . . . . . . . . . . . . . . . . . . . . . 10-13

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Communication Observed Problems . . . . . . . . . . . . . . . . 10-16 Diagnostics Observed Problems . . . . . . . . . . . . . . . . . . . . 10-17 General Observed Problems . . . . . . . . . . . . . . . . . . . . . . . 10-17 IMx®-Specific Observed Problems . . . . . . . . . . . . . . . . . . 10-19 Pipetting Observed Problems . . . . . . . . . . . . . . . . . . . . . . 10-20 PPC-Specific Observed Problems . . . . . . . . . . . . . . . . . . . 10-21 Quantum®/Quantumatic®-Specific Observed Problems . 10-21 Registration Observed Problems . . . . . . . . . . . . . . . . . . . 10-21 TPC™ Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . 10-22 Error Codes and System Messages . . . . . . . . . . . . . . . . . . 10-24 FPC Trace File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24 Cautionary Message Queue . . . . . . . . . . . . . . . . . . . . 10-25 During Pipetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-26 ABC Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-26 Pipettor Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-28 Registration Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-33 Reader (Analyzer) Errors . . . . . . . . . . . . . . . . . . . . . . . 10-33 Host (LIS) Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-36 System Error Messages . . . . . . . . . . . . . . . . . . . . . . . . 10-38 Error Log Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-42 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-67 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-67 Diagnostics Menu Bar Definitions . . . . . . . . . . . . . . . . . . 10-68 Pipettor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-69 Leak Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-70 X-Y Function of Arm . . . . . . . . . . . . . . . . . . . . . . . . . 10-72 Syringe Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 10-76 Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-77 Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-78 ABC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-79 Internal Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . 10-80 Hand Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . 10-83 Cycle ABC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-84 Flag Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-86 Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-88 Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-89 Sensor Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-90 Hand Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-91 RS-232 Port Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . 10-93 Loopback Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-94 Echo Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-95 Data Stream . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-95 Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-96 Printer Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-98 Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-98

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Master Table of Contents

Bibliography. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography-1 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1 Appendix A General Pipetting, Assay and Reagent Information . . . . . . . . . . . . . . . . Appendix A-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-1 General Pipetting Information . . . . . . . . . . . . . . Appendix A-3 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-3 Allowed Mixtures . . . . . . . . . . . . . . . . . . . . . Appendix A-3 Analyzer Test Number . . . . . . . . . . . . . . . . . . Appendix A-6 Aspirate Height . . . . . . . . . . . . . . . . . . . . . . . Appendix A-6 Assay Code . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-6 Assay Name . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-7 Assay Protocol . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-7 Assay-Specific Issues . . . . . . . . . . . . . . . . . . . Appendix A-7 Corzyme . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-7 Chlamydiazyme . . . . . . . . . . . . . . . . . . . . Appendix A-7 HIVAB HIV-1 HIV-2 . . . . . . . . . . . . . . . . . Appendix A-8 HTLV I/II . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-8 Checksum . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-9 Modulus 10 . . . . . . . . . . . . . . . . . . . . . . . Appendix A-10 Modulus 11 . . . . . . . . . . . . . . . . . . . . . . . Appendix A-10 Modulus 11 “-” . . . . . . . . . . . . . . . . . . . . Appendix A-11 Modulus 11 “+” . . . . . . . . . . . . . . . . . . . Appendix A-11 Modulus 43 . . . . . . . . . . . . . . . . . . . . . . . Appendix A-12 Component Location . . . . . . . . . . . . . . . . . Appendix A-13 Component Type . . . . . . . . . . . . . . . . . . . . Appendix A-13 Data Input Fields . . . . . . . . . . . . . . . . . . . . . Appendix A-18 Database Capacity . . . . . . . . . . . . . . . . . . . . Appendix A-20 Database Initialization . . . . . . . . . . . . . . . . Appendix A-21 Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-22 Destination Types . . . . . . . . . . . . . . . . . . . . Appendix A-22 Destination Location . . . . . . . . . . . . . . . . . Appendix A-22 Destination Volume . . . . . . . . . . . . . . . . . . Appendix A-23 Diluent Dispense Option . . . . . . . . . . . . . . Appendix A-24 Diluent Source . . . . . . . . . . . . . . . . . . . . . . . Appendix A-24 Diluent Type . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-26 Diluent Volume . . . . . . . . . . . . . . . . . . . . . . Appendix A-26 Dispense Height . . . . . . . . . . . . . . . . . . . . . Appendix A-26 Error Handling . . . . . . . . . . . . . . . . . . . . . . Appendix A-27 Extra Sample Volume . . . . . . . . . . . . . . . . . Appendix A-28 General Information Section . . . . . . . . . . . Appendix A-28 Inner Tube Diameter . . . . . . . . . . . . . . . . . . Appendix A-28 Jam Sensing . . . . . . . . . . . . . . . . . . . . . . . . . Appendix A-28

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Master Table of Contents

Large Volume Pipetting . . . . . . . . . . . . . . . Level Sensing . . . . . . . . . . . . . . . . . . . . . . . Library Racks . . . . . . . . . . . . . . . . . . . . . . . . List Number . . . . . . . . . . . . . . . . . . . . . . . . Mandatory Flag . . . . . . . . . . . . . . . . . . . . . . Microtiter Plates . . . . . . . . . . . . . . . . . . . . . New Tip Required . . . . . . . . . . . . . . . . . . . . Number of Replicates . . . . . . . . . . . . . . . . . Pipette Tips . . . . . . . . . . . . . . . . . . . . . . . . . Pipetting Direction . . . . . . . . . . . . . . . . . . . Pipetting Sequence . . . . . . . . . . . . . . . . . . . Placement of Sources, Destinations and Control Bottles . . . . . . . . . . . . . . . . . . . . Platform Placement . . . . . . . . . . . . . . . . . . Predispense Assays . . . . . . . . . . . . . . . . . . . Print Map . . . . . . . . . . . . . . . . . . . . . . . . . . Procedure Code . . . . . . . . . . . . . . . . . . . . . . Random Pipetting . . . . . . . . . . . . . . . . . . . . Red Blood Cell (RBC) Pipetting . . . . . . . . . Sample Results Screen . . . . . . . . . . . . . . . . . Source Return Volume . . . . . . . . . . . . . . . . Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . Touch-Off Direction . . . . . . . . . . . . . . . . . . Touch-Off Value . . . . . . . . . . . . . . . . . . . . . IMx Information . . . . . . . . . . . . . . . . . . . . . . . . IMx Assay Protocols . . . . . . . . . . . . . . . . . . IMx Calibrator and Control Bottles . . . . . . IMx Data Collection . . . . . . . . . . . . . . . . . . IMx Dilution Protocols . . . . . . . . . . . . . . . . IMx System Integration . . . . . . . . . . . . . . . Diskette File Formats . . . . . . . . . . . . . . . . . . . . Analyzer File Format . . . . . . . . . . . . . . . . . . Destination Object File Format . . . . . . . . . Results File Format . . . . . . . . . . . . . . . . . . . Source Object File Format . . . . . . . . . . . . . . Work List File Format . . . . . . . . . . . . . . . . . TPC™ Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . Destination Maps . . . . . . . . . . . . . . . . . . . . Deviation Codes . . . . . . . . . . . . . . . . . . . . . Deviation Code Error Handling . . . . . . . . IMx Processing in Verify Mode . . . . . . . . . . Record Mode Processing . . . . . . . . . . . . . . . Verification of Aspiration and Dispense . . . . . Volume Verification . . . . . . . . . . . . . . . . . . . . .

Master Table of Contents-10

Appendix A-29 Appendix A-29 Appendix A-29 Appendix A-30 Appendix A-30 Appendix A-30 Appendix A-31 Appendix A-31 Appendix A-31 Appendix A-32 Appendix A-32 Appendix A-32 Appendix A-33 Appendix A-33 Appendix A-34 Appendix A-34 Appendix A-34 Appendix A-34 Appendix A-35 Appendix A-37 Appendix A-37 Appendix A-37 Appendix A-38 Appendix A-39 Appendix A-39 Appendix A-39 Appendix A-40 Appendix A-41 Appendix A-41 Appendix A-43 Appendix A-43 Appendix A-44 Appendix A-45 Appendix A-46 Appendix A-46 Appendix A-48 Appendix A-48 Appendix A-49 Appendix A-50 Appendix A-52 Appendix A-54 Appendix A-55 Appendix A-56

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Master Table of Contents

Appendix B Example Printouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-1 60-Well Destination Map/Tray Map, TPC = Off: . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-2 60-Well Destination Map/Tray Map, TPC = Verify (page 1 of 2): . . . . . . . . . . . . . Appendix B-3 60-Well Destination Map/Tray Map, TPC = Verify (page 2 of 2): . . . . . . . . . . . . . Appendix B-4 Analyzer File (IMx example, page 1 of 2): . . Appendix B-5 Analyzer File (IMx example, page 2 of 2): . . Appendix B-6 Assay Template (page 1 of 2): . . . . . . . . . . . . Appendix B-7 Assay Template (page 2 of 2): . . . . . . . . . . . . Appendix B-8 Error Log Report: . . . . . . . . . . . . . . . . . . . . . . Appendix B-9 Microtiter Plate Map: . . . . . . . . . . . . . . . . . Appendix B-10 Microtiter Protocol for Specimen Dilution: Appendix B-11 Microtiter Protocol for Neat Dispensing: . . Appendix B-12 Library Rack Protocol: . . . . . . . . . . . . . . . . . Appendix B-13 Printer Diagnostic Test Pattern: . . . . . . . . . Appendix B-14 Results List: . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-15 Source Map (60 tube rack): . . . . . . . . . . . . . Appendix B-16 Work List: . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B-17

Appendix C Red Blood Cell Pipetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C-1 Creating a Basic Red Blood Cell Protocol . . . . . . Appendix C-2 Creating RBC Protocols that Dispense Sample in Patterns to Simplify Reading. . . . . . . . . . . . Appendix C-10 The basic principles . . . . . . . . . . . . . . . . . . . Appendix C-11 Microtiter Pipetting Pattern “A” . . . . . . . . . Appendix C-16 Microtiter Pipetting Pattern “B” . . . . . . . . . Appendix C-22 Microtiter Pipetting Pattern “C” . . . . . . . . . Appendix C-28 Creating Antisera Protocols . . . . . . . . . . . . . . . Appendix C-33 For Microtiter Pipetting Pattern “A” . . . . . . Appendix C-34 For Microtiter Pipetting Pattern “B” . . . . . . Appendix C-40

Appendix D FPC System Integration Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix D-1 General Information . . . . . . . . . . . . . . . . . . . . . . Appendix D-1 Quantum and Quantumatic Information . . . . . Appendix D-3 PPC Information . . . . . . . . . . . . . . . . . . . . . . . . . Appendix D-3 Host/Data Output Information . . . . . . . . . . . . . Appendix D-4 Port Configuration Options . . . . . . . . . . . . . . . . Appendix D-5 Configuration Examples . . . . . . . . . . . . . . . . . . . Appendix D-7

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Configuration A . . . . . . . . . . . . . . . . . . . . . . Appendix D-7 Configuration B . . . . . . . . . . . . . . . . . . . . . . Appendix D-7 Configuration C . . . . . . . . . . . . . . . . . . . . . . Appendix D-8 Configuration D . . . . . . . . . . . . . . . . . . . . . . Appendix D-8 Configuration E . . . . . . . . . . . . . . . . . . . . . . Appendix D-9 Configuration F . . . . . . . . . . . . . . . . . . . . . . Appendix D-10 Configuration G . . . . . . . . . . . . . . . . . . . . . Appendix D-11 Configuration H . . . . . . . . . . . . . . . . . . . . . Appendix D-12 Configuration I . . . . . . . . . . . . . . . . . . . . . . Appendix D-13

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1

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List of Safety Icons

Symbol

Label

Page Number

WARNING: Potential Biohazard

8-1, 9-18

CAUTION:

2-2, 2-4, 2-6, 5-5, 5-9, 5-39, 5-51, 5-69, 5-76, 5-84, 5-94, 5-109, 5-132, 5-147, 8-3, 9-7, 9-14, 9-17, Appendix A-5, Appendix A-6, Appendix A-8

WARNING:

2-2, 8-2, 8-3, 8-4

! ! ! Refer to Section 7, Precautions and Limitations and Section 8, Hazards for more details on the specific precautions and hazards.

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Master Table of Contents

NOTES

Master Table of Contents-14

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Section 1. How To Use This Manual

How To Use This Manual

Overview This section presents information on making the most productive use of the COMMANDER Flexible Pipetting Center (FPC) Operations Manual. The manual has been designed to provide guidance for new and proficient operators alike.

Manual Organization The Manual is tabbed and divided into sections as listed in the Master Table of Contents. Primary sections begin with a sectional table of contents and an introductory overview. Taskoriented information is presented in step-by-step format. Sections include: • Revision Log/Status—Provides a history of manual revisions and the methods for updating the manual. • Use and Function—A complete description of the system and its components, and its impact on laboratory workflow, features and benefits. • Installation Procedures and Special Requirements— Installation of the FPC including: – Site Preparation: site description and specifications, electrical requirements, environmental requirements, location of hardware, pre-site inspection – Unpacking – Installation – Configuration and adjustments • Principles of Operation—A detailed description of how the FPC accomplishes the task of pipetting samples. • Performance Characteristics and Specifications—The general physical, electrical, data communications, operating environment, bar code and label requirements, and software configurations of the FPC system.

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How To Use This Manual

• Operating Instructions—A step-by-step guide to daily operations of the FPC, including: – Sample registration and test ordering – Pipetting procedures – Entering assay reagent information into the Component Library – Customizing FPC assay protocols – Reporting – Transferring sample information between sources and destinations and vice-versa, including from tray to tube box • Calibration—A description of the procedures that establish internal references used by the FPC when pipetting assays or performing other functions. • Operational Precautions and Limitations—Conditions that can affect performance including environmental requirements, precautions and limitations for the system and its components. • Hazards—Describes the possible electrical, mechanical and physical hazards you may encounter while using the FPC. • Service and Maintenance—Details the care and upkeep of the FPC, including: cleaning, adjustments, component replacement, reporting problems to Abbott Customer Support. Maintenance schedules are also included. • Troubleshooting and Diagnostics—Provides methods for identifying and responding to error codes and observed hardware and software problems. • Bibliography—A reference section for regulations and technical documents to enhance your use of FPC. • Glossary—Contains information on the technical terms, jargon, and abbreviations used throughout FPC operations. • Appendices—Additional supporting material, including a tutorial for pipetting Red Blood Cells (RBCs). • Index

How To Use This Manual-2

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How To Use This Manual

Text Conventions Descriptions and instructions in this manual are concise and well illustrated. Procedures are explained using numbered steps. All of the information related to an activity is generally covered in one place to minimize the need to reference different between sections. Illustrations appear where they are useful to the explanation. Throughout the text, icons appear where the nature of the information warrants special attention: NOTE: This icon is used to indicate important information, or information that represents an exception to conventional methods. This icon is used to indicate performance and features pertaining to Total Processing Control (TPC™). For a further explanation of the principles of TPC, refer to Section 3, Principles of Operation.

!

CAUTION: The general CAUTION icon appears adjacent to explanations of conditions that could interfere with proper functioning of the system.

!

WARNING: The general WARNING icon identifies a physical, mechanical or procedural situation where the operator must be aware, alert and cautious to prevent physical injury. This icon, when present on a label on the systemhardware, refers the operator to the manual for information about the hazard.

!

WARNING: Potential Biohazard. The BIOHAZARD icon labels an activity or area where the operator may be exposed to infectious materials or substances. HINT: This icon is used to indicate a helpful hint to ease FPC operation. Step-by-step instructions are provided throughout the manual using graphics that depict screens and pop-up windows. It is recommended that you read and understand this manual before proceeding.

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How To Use This Manual-3

How To Use This Manual

NOTES

How To Use This Manual-4

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Section 1 Section 1. Use or Function

Use or Function Section Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Pipetting Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Computer Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 ABC Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Sources and Destinations . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Bottle Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Platen Extension Assembly and Sample Tube Rack . . . . 1-8 Library Rack and Platform . . . . . . . . . . . . . . . . . . . . . . . 1-9 Microtiter Plates and Adapter . . . . . . . . . . . . . . . . . . . . . 1-9 MEIA and FPIA Carousels . . . . . . . . . . . . . . . . . . . . . . . 1-10 Tray Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 Destination Options . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

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Table of Contents-1

Use or Function

Section 1

NOTES

Table of Contents-2

COMMANDER® Flexible Pipetting Center Operations Manual

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Section 1 Section 1. Use or Function

Use or Function

Introduction The Flexible Pipetting Center (FPC) is a precision liquid delivery instrument capable of performing sample transfer and dilution. It is designed to assist the laboratorian in the pipetting of samples and management of results. The FPC combines a robotic pipetting component, an optional Automatic Bar Code reader (ABC), and a computer configured with the UNIX® operating system for multitasking capability. The FPC can be interfaced to the analyzers and host computer (LIS) systems and/or data output devices via a multi-port serial connector cable (digi-cable). The FPC is capable of maintaining a database of reagent lot numbers and expiration dates. This database can be used during pipetting and can be shared with connected COMMANDER Parallel Processing Center(s) (PPC), enabling the laboratory to record and verify operations, providing Total Process Control (TPC™). In summary, the FPC provides: • Automated positive identification of samples with the ABC or sensor module (F-link). • Simultaneous pipetting of up to four different assays in batch or random mode. • Capability of adding up to three different diluents and 15 controls, calibrators or reagents per run. • Capability of storing reagent lot number information, and recording/verifying use of correct reagent lot numbers. • Multitasking capability—the simultaneous identification of samples, pipetting, and communication with multiple analyzers and a host computer. • Liquid level detection and positive volume verification with confirmation of aspiration and dispense volumes. • Sample transfer directly from a variety of sources to a variety of destinations, including tube racks, 20- and 60-well reaction trays, FPIA and MEIA carousels, microtiter plates, and library sample racks. • Red Blood Cell (RBC) pipetting. • User-programmable pipetting protocols. • Analyzer result collection, operator-initiated editing, approval, and transmission to host of the result file. • Bidirectional host interface. COMMANDER® Flexible Pipetting Center Operations Manual

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1-1

Use or Function

Section 1

System Components The FPC can pipette in a variety of configurations. In the illustration below, the system is configured to pipette into four trays and is shown with the FPC computer module that accompanies all installations.

C A E D

O P K N L J M G

F B

Q R

U

H

I

S

T

Figure 1.1

1-2

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Section 1

Use or Function

Pipetting Unit A. Two syringes provide the pumping necessary to pipette the volumes specified in the protocols. The diluent syringe can dispense up to 2500 µL; the sample syringe up to 1000 µL. Tubing connects the syringes to the pipette tip nozzle assembly. B. The XYZ-axis pipette tip nozzle loads a fresh tip for each sample, diluent or control it pipettes. C. The diluent nozzle is part of the pipette tip assembly. D. A pipette tip rack holding 90 disposable tips, each capable of pipetting up to 500 µL in a single operation. E. Waste bin for disposal of used pipette tips. F. Platform for holding pipetting sources and destinations. G. Pause switch, which allows the operator to interrupt the pipetting operation without involving the computer. When the pause switch is pressed again, pipetting resumes at the point of interruption. H. Sensor module matches and tracks each sample ID to its location in the source rack as the sample ID is read and the tube is placed in the Abbott sample tube rack. I. The hand-held bar code reader is used to read bar code identifications from sample tubes and sources/destinations, and TPC™ information. The bar code reader is connected to the sensor module or to the ABC by an extended cable. J. Assay trays/carousels K. Control bottle rack L. Power switch M. Source rack N. Dilutor bottle position O. Power-on lamp P. Telescoping Guard Bars

Computer Unit Q. Monitor R. Computer (CPU) S. Keyboard T. Printer U. Digi-cable (multi-port serial connector cable) COMMANDER® Flexible Pipetting Center Operations Manual

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When installed with the optional Automatic Bar Code reader (ABC), the FPC provides automated reading of bar coded ID data on sample tubes. The ABC transmits this data to the FPC for storage and later communication to laboratory analyzers. When the FPC is configured for the ABC reader, the sensor module cannot be used. In the illustration below the FPC/ABC is configured to pipette into four trays. The computer component of the installation (not shown) is the same as on the previous page.

D

C G A

B

E

F

Figure 1.2

ABC Unit A. Accessory tube rack B. Control Panel C. Cover D. Hand-held bar code reader E. Internal bar code reader F. The 48 sample tube carriers, capable of holding 240 tubes, transports tubes into position for pipetting. G. Orange-colored mechanical “flag” on the carrier alerts the operator that a bar code was not detected or that an aspiration error occurred. The base of the flag also helps position the sample tube within the carrier. 1-4

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In addition to reading bar codes, the ABC transports tubes to a position from which the FPC can aspirate sample from the tubes. The transport component of the ABC is comprised of 48 Sample Tube Carriers (Figure 1.3), each capable of holding up to 5 sample tubes, for a total capacity of 240 positions. Sample Tube Carriers provide a “flag” for each tube position which, when raised, indicates that the ABC was unable to read the bar code of the tube, a tube was not detected, or a pipetting aspiration error was detected in that position.

Figure 1.3

Figure 1.4

A special “end-of-batch” plug (EOB) (Figure 1.4) is provided for placement in the final position of a run to signal to the ABC that the last tube has been read. During pipetting, any tubes in the same sample tube carrier following the EOB plug will not be read. After an EOB plug has been read, the carriers are advanced and the ABC is reset. The ABC is integrated with the FPC through the FPC personal computer. The ABC control panel provides an Advance Button to move the sample tube carriers forward, and a Pause Button to halt all operations until the button has been pressed a second time to resume. The Power Light indicates that power is on to the ABC unit. The Status Light, when flashing, indicates that the bar codes on one or more sample tubes could not be read by the internal ABC reader, a tube was not detected, or a pipetting aspiration error was detected. (Figure 1.5).

Figure 1.5

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Sources and Destinations The FPC is a pipetting system capable of using a variety of objects: trays, racks, microtiter plates and carousels. Because of the flexibility of the software that manages its pipetting protocols, the FPC can be configured to pipette not only from sample tubes to carousels, trays and other destinations, but can also reverse its strategy, using trays, plates and racks as sources. The table below details FPC source/destination capabilities. NOTE: Sources other than the ABC can only be used when the ABC is not configured to the FPC. All sources must be placed on the platen extension, using appropriate adapters when necessary. GUIDE TO USE OF PIPETTING OBJECTS

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Source

Destination

Abbott 20/60 Well Tray

Yes

Yes

Automatic Bar Code Reader (ABC)

Yes

No

FPIA Carousel

No

Yes

Library Rack

Yes

Yes

MEIA Carousel

No

Yes

Microtiter Plate

Yes

Yes

Sample Tube Rack

Yes

Yes

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Platform The platform of the FPC is specifically designed to work with a variety of destination types. By making use of adapters, the platform provides positions for use with Abbott 20-well and 60-well trays, Abbott tube racks, microtiter plates and library racks (locations P1-P4), and FPIA/MEIA carousels (locations C1-C3). Positioning holes and artwork on the platform provide a guide for correct placement of the destinations. To accommodate controls, the platform also includes positions for control bottle racks (locations R1-R5). In addition, the platform provides TPC™ bar codes for each position, to be scanned when identifying platform position (Platform ID) during TPC operation (optional).

Figure 1.6

Bottle Racks The control bottle rack provides 5 positions (X1-X5) and the TPC reagent rack provides 10 positions, as shown. The TPC reagent rack in Figure 1.7 provides TPC bar codes for each position (position ID), to be scanned when identifying a control bottle position during TPC operation (optional). Positions are capable of holding any of the following: • • • • • • •

5 mL bottle 12 mL bottle 35 mL bottle IMx—10 mL bottle IMx—5 mL bottle TDx—1 dram bottle Sample tube (13x100mm, see Figure 1.8)

Figure 1.7: Control Bottle Rack, left, and TPC Reagent Rack (List No. 03A46-14) COMMANDER® Flexible Pipetting Center Operations Manual

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NOTE: Bottle dimensions are in inches.

Figure 1.8: Bottle and Tube Dimensions

Platen Extension Assembly and Sample Tube Rack When not installed with the ABC (optional), the FPC must be configured with the platen extension assembly (Figure 1.9) as the location for sources, whether pipetting from a tube rack or sample tray. The platen extension assembly is attached to the left side of the destination platform. A sample tube rack (Figure 1.10)can hold tubes from 12 to 16mm in diameter and 75 to 100mm in height. Tube positions are labeled A1 through M5. Standard inserts are used to accommodate tubes from 12 to 13mm.

Figure 1.9: Platen Extension Assembly (List No. 03A46-12)

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Figure 1.10: Sample Tube Rack (List No. 03A46-13)

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Library Rack and Platform

A1

The FPC is designed to pipette to or from most types of library racks. When using these racks, a microtiter plate adapter is positioned on a library rack platform to assure proper height and position. The library rack platform is different from the standard tray platform. When placing a library rack on the adapter, position A1 must be as designated. See Appendix A, General Pipetting, Reagent and Assay Information, for a listing of recommended Library Racks.

Figure 1.11: Library Rack (top), Microtiter Plate Adapter (List No. 03A46-50), and Library Rack Platform (List No. 03A46-39)

Microtiter Plates and Adapter

A1

The FPC is designed to pipette to or from microtiter plates. When using these plates, a microtiter plate adapter (Figure 1.12) is positioned on a tray platform to assure the correct position for the microtiter plate. When placing a microtiter plate on the adapter, position A1 must be as designated.

Figure 1.12: Microtiter Plate (top), Microtiter Plate Adapter (List No. 03A46-50) and Abbott Tray Platform (List No. 03A46-51) COMMANDER® Flexible Pipetting Center Operations Manual

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MEIA and FPIA Carousels The FPC is designed to pipette into the MEIA and FPIA carousels. A carousel adapter is necessary for positioning a carousel on the platform. When placing an MEIA carousel on the adapter, it must be aligned so the adapter post is wedged between carousel positions 1 and 24 (Figure 1.13). With TPC™-configured systems, the adapter provides a TPC bar code and a 5-position bottle rack with TPC bar codes, to be scanned when identifying it during a TPC pipetting operation.

Figure 1.13: MEIA Carousel (List No. 8373-01) and Carousel Adapter (List No. 03A46-75)

An additional sleeve (A) (FPIA sleeve) is needed to resize the adapter post when using an FPIA carousel. When placing an FPIA carousel on the adapter, it must be aligned so the adapter post with sleeve is wedged between carousel positions 1 and 20.

A

Figure 1.14: FPIA Carousel (List No. 9518-11), FPIA Carousel Adapter Sleeve (List No. 03A46-57) and Carousel Adapter (List No. 03A46-75) 1-10

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Tray Platform The FPC is designed to pipette to or from 20-well and 60-well Abbott assay trays. These assay trays are placed on tray platforms that are positioned on the FPC platform in predetermined positions. When placing the tray on the tray platform, well A1 must be located in the upper right position.

5

4

3

2

1

A

Figure 1.15: Abbott 20-Well Tray (List No. 7803-15, 7803-17)

Figure 1.16: Abbott 60-Well Tray (List No. 7803-16, 7803-18)

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Figure 1.17: Abbott Tray Platform (List No. 03A46-51)

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Section 1

Destination Options The tray platform can be configured with any of the following combinations of destinations. 1. FOUR TRAY PLATFORMS can accommodate four Abbott 60-well trays as represented. Four 20-well trays can be substituted for 60-well trays. By using microtiter adapters, tray platforms can also accommodate microtiter plates. Library racks can be used by combining the library tray platform and microtiter adapters. Shown in Figure 1.18 are two control bottle racks and four 60-well trays. With TPC™, a single, 10-position control bottle rack replaces the two 5-position racks.

Figure 1.18

2. TWO TRAY PLATFORMS and ONE CAROUSEL ADAPTER can be combined to accommodate FPIA or MEIA carousels, Abbott 60- or 20-well trays, microtiter plates or library racks. Represented in Figure 1.19 are three control bottle racks, one MEIA carousel and two 60-well trays. With TPC, a single, 10-position control bottle rack replaces two of the 5-position racks.

Figure 1.19 1-12

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3. ONE TRAY PLATFORM and TWO CAROUSEL ADAPTERS, shown in Figure 1.20, varies the configuration shown in Figure 1.19 with three control bottle racks, two MEIA carousels and one 60-well tray. In systems configured with TPC™, a single 10-position control bottle rack replaces two of the 5-position racks.

Figure 1.20

4. THREE CAROUSEL ADAPTERS can accommodate FPIA or MEIA carousels, with the adapter sleeves used in FPIA carousel installations. Represented in Figure 1.21 are three control bottle racks and three MEIA carousels.

Figure 1.21

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NOTES

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Section 2 Section 2. Installation Procedures and Special Requirements

Installation Procedures and Special Requirements Section Table of Contents

System Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Cable Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Powering Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Pipetting Unit Power Up . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Computer, Monitor, and Printer Power Up . . . . . . . . . . 2-4 Power Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 Configuration Menu Bar Definitions . . . . . . . . . . . . . . . . . 2-10 System Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Database Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 Manual Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15 Automatic Initialization . . . . . . . . . . . . . . . . . . . . . . . . 2-16 Tip Threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18 RS-232 Port Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 2-20 Reset Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24 Password Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27 Special Password Conditions . . . . . . . . . . . . . . . . . . . . 2-29 Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30

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Installation Procedures and Special Requirements

Section 2

NOTES

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Section 2

Installation Procedures and Special Requirements

Section 2. Installation Procedures and Special Requirements

System Preparation

Introduction The System Preparation Section of this manual describes the hardware installation procedures and provides information for connecting the FPC to other laboratory systems. This section includes the following instructions: • Installation, which includes the connection of cables between computer, bar code reader, sensor module, FPC unit, and printer, and installation of the platen assembly for non-ABC configurations, connections of interfaced analyzers, and a host computer. • Powering Up, which activates both the FPC computer and pipetting instrument. Following installation, Abbott advises that you review FPC Software Operation in Section 3, Principles of Operation to familiarize yourself with the basic routines of working with the FPC software. In addition, several functions detailed in Section 6, Calibration and Section 9, Service and Maintenance must be performed before operating the FPC. These include but are not restricted to loading paper into the printer, priming the dilutor, and loading the pipette tip rack.

Installation The COMMANDER® Flexible Pipetting Center Installation and Validation Protocols document, which accompanies the software, includes instructions that must be completed before operating the FPC. An Abbott Field Service Representative (FSR) must install all FPC hardware and perform the power and homing checks for the system. Your laboratory’s system administrator should be present for software installation to determine use of passwords, port assignments, and other details of FPC installation and use that are specific to the laboratory. In addition, an installation validation protocol is provided that must be completed before operating the FPC. Contact the Abbott Customer Support Center (CSC) at 1-800-323-9100 (U.S. only) for assistance.

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Installation Procedures and Special Requirements Section 2

System Preparation

!

CAUTION: The FPC weighs more than 150 lbs. (68 kg) and the ABC weighs more than 75 lbs. (34 kg). Do not attempt to unpack these systems or lift them without the assistance of the Abbott FSR. You may cause serious injury to yourself and/or damage to the instrument. WARNING: Use only power cords supplied by Abbott.

Install the instrument in a clean, dust-free room on a flat surface strong enough to easily support its weight, and with plenty of work space on both sides of the unit for sample tubes, assay trays, carousels, and plates.

Cable Connections 1. Verify the correct configuration of RS-232 ports and printer connection according to your laboratory’s particular need. Follow procedures outlined in “RS-232 Ports” found in Configuration, elsewhere in this section. NOTE: When connecting a Quantumatic analyzer to an accessory port, a special adaptor is needed (List No. 03A46-76). 2. Interconnect the FPC unit, ABC or sensor module (if nonABC configured), hand-held bar code reader, and FPC computer according to the drawing that resembles your laboratory’s configuration. (Figures 2.1 or 2.2) For complex installations, consult the System Integration Guide in the Appendices section of this manual. 3. Verify that all connections are secure. To prevent accidental disconnection, Abbott recommends that mounting screws and connector clips be used. 4. If applicable, verify that printer dip or function switches are set correctly: For ThinkJet® printers, dip switches are located at the rear of the unit. Switches #6 and #7 must be set in the “up” position to configure the printer for the FPC computer. For DeskJet® printers with function switches, switches are located on the printer’s front base, under the IN tray. All switches in both banks must be set in the “down” position. Consult the operator’s manual accompanying your printer for additional information. 2-2

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