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Revision Status Document Control Number(s)

Revision Date

Originally Issued- 42325-101

11/87

Section(s) Revised Not Applicable

42325-102 42325-103

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1/93

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Document Control Number(s)

Revision Date

69-5736/R18

12/01

Front Matter, Master Table of Contents, Sections 2, 5, 8, 9, 10, Index

All pages

74001-101 69-6304/R14 69-6305/R5 69-6306/R6 69-6307/R10

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Pages Revised And Added

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Current Configuration of this Operations Manual COMMANDER Parallel Processing Center (PPC) Operations Manual (List No. 1A05-57) (74001-101) 69-6304/R14 - Front Matter 69-6305/R5 - Master Table of Contents 69-0106/R2 - How to Use this Manual 69-0107/R2 - Section 1. Use or Function 69-5740/R4 - Section 2. Installation Procedures and Special Requirements 69-0109/R2 - Section 3. Principles of Operation 69-3751/R3 - Section 4. Performance Characteristics and Specifications 69-5741/R3 - Section 5. Table of Contents 69-5742/R3 - Section 5. Pre-Operating Procedures 69-5743/R3 - Section 5. Operating Procedures 69-5744/R3 - Section 5. Special Operating Procedures 69-0115/R2 - Section 6. Calibration Procedures 69-0116/R2 - Section 7. Operational Precautions and Limitations 69-5745/R3 - Section 8. Hazards 69-6306/R6 - Section 9. Service and Maintenance 69-5746/R3 - Section 10. Troubleshooting and Diagnostics 69-0120/R2 - Bibliography 69-0121/R2 - Glossary 69-0122/R7 - Appendix A: Cutoff Assay Protocol Reference Guide 69-0123/R7 - Appendix B: Point-to-Point Assay Protocol Reference Guide 69-0124/R7 - Appendix C: System Integration Guide 69-6307/R10 - 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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Foreword The COMMANDER Parallel Processing Center (PPC) is designed to automate reagent dispensing, bead washing, inthe-well spectrophotometric readings and data reduction for specified Abbott assays. Congratulations on incorporating the PPC into your laboratory operation. The PPC system is backed by dedicated professionals who excel in engineering, training, and technical information. For continuing service, we provide telephone technical assistance should you need help in diagnosing a problem. This service is available by calling Abbott Customer Support. Abbott Laboratories looks forward to serving you in any way possible.

Technical Customer Support Technical customer support is provided to answer any questions you may have about the system, and to help with any serious or recurring error messages. United States-Call the Customer Support Center (CSC) at 1-800-323-9100. All other countries-Contact your Abbott Representative.

Proprietary Statement Copyright © 2003 by Abbott Laboratories Diagnostics Division. All rights reserved. Printed in the United States of America. No part of this document may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior written permission of Abbott Laboratories.

Pictorial Disclaimer The sample printouts, screens and figures 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 and figures in this manual; and their information is not to be used for clinical or maintenance evaluation.

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Abbott Instrument 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 90 days, commencing twenty-one (21) days from the date of shipment to the original purchaser, or until title is transferring from the original purchaser, whichever occurs first (the “Warranty Period”). If any defects occur during the Warranty Period, contact your Abbott Customer Support Center immediately. In U.S., call toll free at 800-323-9100. 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. 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. NOTE: The length of the Warranty Period and the telephone number of the Customer Support Center (CSC) are only valid in the U.S. x

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Safety Agency Approvals Refer to the left side of the instrument to identify safety agency approvals for your instrument.

Trademark Statements COMMANDER®, Auszyme® Monoclonal, Corzyme®, PMTS®, and AARTS® are registered trademarks, and Abbott DMS™, Abbott BBS™, Quantum™ II, FPC™, PPC™, and TPC™ are trademarks of Abbott Laboratories. Terg-A-Zyme® is a registered trademark of Alconox, Inc. TRI-CONTINENT STAT-MATIC I® is a registered trademark of Tri-Continent Scientific, Inc.

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Master Table of Contents

Master Table of Contents Revision Status...iii Current Configuration of this Operations Manual... v Revision Log... viii Foreword... ix Technical Customer Support... ix Proprietary Statement... ix Pictorial Disclaimer... ix Abbott Instrument Warranty... x Safety Agency Approvals... xi Trademark Statements... xi

List of Safety Icons... Master TOC-11 Special Modes Flow Charts... Master TOC-13 Flow Diagrams... Master TOC-13 Example... Master TOC-13 The Special Modes Menu... Master TOC-14 Database... Master TOC-15 Assay Tools... Master TOC-16 Configure... Master TOC-17 Diagnostics... Master TOC-18 Verification... Master TOC-21 Setup... Master TOC-22 Reconstitution Procedure... Master TOC-24 Bead Drop Procedure... Master TOC-24

How To Use This Manual Introduction... How-1 Manual Organization... How-1 Text Conventions... How-3 Icons... How-3 Graphic Conventions... How-4

Section 1. Use or Function Introduction... 1-1 Instrument Overview... 1-2 Main Processing Center... 1-2 Wash & Waste Cart... 1-3 PPC Control Center... 1-4 Control Electronics... 1-4 Display... 1-4 Keypad... 1-4

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Master Table of Contents

Printer... 1-5 External Bar Code Reader... 1-5 System Description... 1-5 Tray Transport Function... 1-5 Load Module... 1-6 Main Drive Module... 1-7 Exit Module... 1-8 Wash Function... 1-8 Wash System... 1-9 Wash Head Stepper Motor... 1-9 Water and Air Solenoids... 1-10 Water Level and Air Pressure Sensors... 1-10 Manifold Assembly... 1-11 Compressor Cart or CDCM... 1-11 Compressor/Regulator System... 1-12 Water Canister... 1-12 Waste Container... 1-13 Dispense Function... 1-14 Read Function... 1-16 The Read Station... 1-16 Lens, Optical Sensors and Analog/Digital Read Board... 1-17 Memory... 1-17

Section 2. Installation Procedures and Special Requirements Introduction... 2-1 Unpacking... 2-1 Setting the Voltage... 2-2 Instruments With CE Mark Label... 2-2 Instruments Without CE Mark Label... 2-3 Setting Up the Wash & Waste Cart... 2-4 Software Installation... 2-6 Powering Up... 2-7 Configuring the PPC... 2-9 The Reread Function... 2-9 To Disable... 2-9 To Enable... 2-10 OPD Timing... 2-10 To Disable... 2-10 To Enable (verify)... 2-11 TPC™ Functions... 2-11 Defining/Changing Deviation Password... 2-11 Specifying A Tech ID Prompt... 2-13 Maximum Sample ID Length... 2-13 Retransmit... 2-14

Master Table of Contents-2

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Master Table of Contents

Port Characteristics... 2-15 Connecting Pipettor Systems... 2-15 Protocol Select... 2-17 Printing Pipettor/PPC Protocol Assignments... 2-17 Assigning a Test Number to a PPC Protocol... 2-18 Reassigning Protocol Select Password... 2-18 Connecting An Abbott DMS System or Data Collection Device... 2-19 Connecting an External Bar Code Reader (optional) . . 2-20 Adjusting the Display Angle... 2-22 Setting Date And Time... 2-22 Date Setting Procedure... 2-22 Date Format Setting Procedure... 2-23 Clock Setting Procedure... 2-24 If Using the NIST Clock... 2-24 If Using a NIST-traceable or Alternate Clock . 2-24 Setting Internal Bar Code Length and Types... 2-25 Editing Protocols... 2-26 Set Password for Editing... 2-27 Add A New Protocol... 2-27 Changing an Edited Protocol... 2-29 Save A Changed Assay Protocol... 2-30 Delete An Edited Assay Protocol... 2-31 Delete An Abbott-Supplied Assay Protocol... 2-31 Printing the Assay Directory... 2-33 Printing an Assay Protocol... 2-34 Adding an Abbott-Supplied Assay Protocol... 2-34 Post-Installation Procedures... 2-37 Software Installation and Validation Protocols... 2-37 Verifying Optical Reader Operation... 2-37 Manual Wash Procedure... 2-37 Verifying Wash Volume... 2-37 Calibration... 2-37 External Bar Code Reader... 2-37 Relocation Procedures... 2-38 Verifying Optical Reader Operation... 2-38 Manual Wash Procedure... 2-38 Verifying Wash Volume... 2-38 Calibration... 2-38

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Master Table of Contents

Section 3. Principles of Operation Introduction... 3-1 Read Function... 3-2 Optical Density and Timing Checks... 3-2 Maximum OPD Dispense – Read Time... 3-2 Initial Read Check... 3-3 Blanks Check – Minimum and Maximum Limits... 3-3 Blanks Check – Standard Deviation and Minimum Number... 3-4 Total Process Control (TPC™)... 3-4

Section 4. Performance Characteristics and Specifications Physical Dimensions... 4-1 Main Processor... 4-1 Wash & Waste Cart... 4-1 Environmental Requirements for Instrument Operation... 4-1 Temperature... 4-1 Humidity... 4-1 Electrical Safety Parameters... 4-1 Installation Category (Overvoltage Category)... 4-1 Pollution Degree... 4-1 Altitude... 4-1 Electrical Requirements... 4-2 Line Voltage (selectable)... 4-2 Voltage Extremes Accepted... 4-2 Power... 4-2 Fuses... 4-2 Data Communications... 4-3 Reader... 4-3 Principle... 4-3 Wavelength Selection... 4-3 Absorbance Range... 4-3 Repeatability... 4-3 Linearity... 4-4 Drift... 4-4 Light Source... 4-4 Bar Code Labels... 4-4 Bar Code Label Characteristic Specifications... 4-5 Processing... 4-5 Washing... 4-5 Dispensing... 4-5 Throughput... 4-5

Master Table of Contents-4

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Master Table of Contents

Section 5. Operating Instructions Pre-Operating Procedures... 5-1 Introduction... 5-1 Wash and Waste Cart Preparation... 5-1 Empty Waste Container... 5-2 Anti-Foaming Agents... 5-2 Approved Anti-Foaming Agents... 5-3 Empty Drip Cup... 5-4 Fill the Water Canister... 5-5 Check the Tubing... 5-6 Prime the Wash System... 5-6 Clear the Exit Station... 5-6 Tray Bar Coding... 5-7 Pipetting Samples... 5-8 Operating Procedures... 5-9 Introduction... 5-9 Tray Entry... 5-9 Reagent Blanking... 5-10 Assay Timing... 5-10 OPD Timing... 5-11 Sample ID Entry... 5-12 Manual Entry... 5-12 Database Special Mode Entry... 5-13 “Tray Tickets”... 5-14 The Bead Drop Procedure... 5-15 With Blanks Trays... 5-17 With Controls, Standards and Sample Trays... 5-18 The Reconstitution Procedure... 5-19 Performing the Reconstitution Procedure... 5-20 Reagent Loading... 5-21 Proper Tray Insertion... 5-23 Routine PPC Operations... 5-26 TPC™ Mode = Record or Verify Pipettor = FPC... 5-26 First Pass... 5-26 Subsequent Passes... 5-27 TPC™ Mode = Record Pipettor = Compatible (non-FPC)... 5-28 First Pass... 5-28 Subsequent Passes... 5-29 TPC™ Mode = Off Pipettor = Any... 5-30 First Pass... 5-30 Subsequent Passes... 5-31

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Master Table of Contents

TPC™ Mode = Record Pipettor = None... 5-32 First Pass... 5-32 Subsequent Passes... 5-33 TPC™ Mode = Off Pipettor = None... 5-34 First Pass... 5-34 Subsequent Passes... 5-35 Post Operating Procedures... 5-36 Special Operating Procedures... 5-37 Introduction... 5-37 Batch Tools... 5-37 Print A Batch Status List... 5-37 Void Tray From Batch... 5-39 Truncate Batch (Shorten)... 5-39 Delete One Batch... 5-40 Delete All Batches... 5-40 Retransmit A Batch Record... 5-40 Tray Tools... 5-42 Print Tray Data... 5-42 Void a Well on a Tray in Process... 5-44 The PPC Keypad... 5-45

Section 6. Calibration Required Materials... 6-1 Storage Requirements... 6-2 TPC™ Mode For Calibration... 6-2 Pre-Calibration Procedures... 6-3 Procedure... 6-3 Post-Calibration Procedures... 6-5 Results... 6-5 Printing Calibration Data... 6-6

Section 7. Operational Precautions and Limitations General... 7-1 Emergency Stop... 7-1 Dispense System... 7-1 Reader... 7-1 External Bar Code Reader... 7-1 Wash System... 7-2 Trays... 7-2 Calibration... 7-2 Assay Timing... 7-2 Reagent Kit Blanking Beads... 7-3

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Section 8. Hazards 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... 8-4 Chemical Safety... 8-4 Chemical Hazards... 8-5 Hazardous Waste... 8-5 Reagents Containing Sodium Azide... 8-5 Removal of Sodium Azide from Laboratory Plumbing . . 8-5

Section 9. Service and Maintenance Introduction... 9-1 General... 9-1 Maintenance Schedule... 9-2 Decontamination Procedure... 9-4 Transport System Maintenance... 9-5 Load/Urge Belt Replacement... 9-6 Removing the Slide Assembly... 9-6 Installing New Urge Belts... 9-8 Replacing the Slide Assembly... 9-8 Auger Cleaning Tray Procedure (Optional)... 9-9 Wash System Maintenance... 9-10 Tubing and Connections... 9-10 Filter Change... 9-11 Water Canister and Waste Container... 9-11 Water Canister Cleaning... 9-12 Wash Manifold Replacement... 9-13 Air Line Check Valve Replacement... 9-14 Manifold Gaskets... 9-15 Manual Wash Procedure... 9-16 Wash Volume Verification Procedure... 9-16 Dispense System Maintenance... 9-17 Dispenser Backlights... 9-17 Tri-Continent STAT MATIC I® Dispenser Maintenance . . . 9-18 Dispenser and Outlet Tube Cleaning and Storage... 9-18 Outlet Tube Dispensing Tip and Tip Adapter Cleaning... 9-19

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Master Table of Contents

Optical Read System... 9-20 Reader Window... 9-20 Lamp... 9-20 Reader Verification... 9-24 Entering New Standards Tray Concentration Values . . 9-25 Linearity Test... 9-25 Reader Drift Test... 9-28 Repeatability Test... 9-29 Calibration... 9-31 Setting Date and Time... 9-31 Fuses... 9-32 Fuse Replacement... 9-32 Instruments With CE Mark Label... 9-32 Instruments Without CE Mark Label... 9-33 Fan/Fan Filter... 9-34 For PPC instruments that have a fan filter... 9-34 For PPC instruments that do not have a fan filter... 9-34 Printer... 9-35 Printer Replacement... 9-35 Paper... 9-35 External BCR Replacement... 9-37 Component Station Label Replacement... 9-37 Parts... 9-38 Main Unit... 9-38 Wash and Waste Cart... 9-40 Maintenance Log (Page 1 of 2)... 9-41 Maintenance Log (Page 2 of 2)... 9-43

Section 10. Troubleshooting and Diagnostics Troubleshooting... 10-1 Introduction... 10-1 Technical Customer Support... 10-2 Observed Problems... 10-2 DISPLAY... 10-2 DISPENSE... 10-3 INTERNAL BAR CODE READER... 10-5 PORT COMMUNICATIONS... 10-6 PRINTER... 10-7 READ... 10-7 WASH... 10-9 Error Codes... 10-10 TPC™ Codes and Flags... 10-81

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