Luminex 100 IS User Manual, Version 2.3

Lum/nex

Luminex 100™ IS

User Manual Version 2.3

© LUMINEX CORPORATION, 2001-2005. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, or translated into any language or computer language, in any form or by any means without prior express, written consent of:

LUMINEX CORPORA TION

12212 Technology Boulevard

Austin, Texas 78727-6115

U.S.A.

V oice: (512) 219-8020

Fax: (512) 219-5195

Luminex

Luminex Corporation (Luminex) reserves the right to modify its product s and services at any time. This guide is subject to change without notice. Although prepared to ensure accuracy, Luminex assumes no liability for errors or omissions, or for any damages resulting from the application or use of this information.

® 100™ IS User Manual Version 2.3

REF

CN-M017-01

PN 89-00002-00-071 Rev. C

October 2005

The following are trademarks of Luminex: Luminex, Luminex 100, Luminex 100 IS, LabMAP, xMAP, LumAvidin, Luminex XYP, Luminex FlexMAP, and Luminex SD. All other trademarks, including Windows,

Cheminert, Pentium, and Dell The Luminex 100 IS software uses the VideoSoft

ActiveX controls, which are copyrighted by VideoSof t, 2001. The contents of this manual and the associated Luminex software are the proper ty of L uminex and are

copyrighted. Except as specified in the End User License Agreement, any reproduction in whole or in part is strictly prohibited.

are trademarks of their respective companies.

® VsFlexGrid Pro 7.0, VsPrinter 7.0, and VsView 3.0

Standard Terms and Conditions For Use of Product

By opening the packaging containing this product ("Product") or by using such Product in any manner, you are consenting and agreeing to be bound by the following terms and conditions. You are also agreeing that the following terms and conditions constitute a legally valid and binding contract that is enforceable against you. If you do not agree to all of the terms and conditions set forth below, you must promptly return the Product for a full refund prior to using them in any manner.

1. Acceptance - ALL SALES ARE SUBJECT TO AND EXPRESSLY CONDITIONED UPON THE TERMS AND CONDITIONS CONTAINED HEREIN, AND UPON BUYER'S ASSENT THERETO. NO VARIATION OF THESE TERMS AND CONDITIONS SHALL BE BINDING UPON LUMINEX CORPORATION ("LUMINEX") UNLESS AGREED TO IN WRITING AND SIGNED BY AN AUTHORIZED REPRESENTATIVE OF LUMINEX. For purposes of this agreement, "Seller" shall mean the Luminex authorized reseller that sells the Product to Buyer. Buyer, by accepting the Product shall be deemed to have assented to the terms and conditions set forth herein, notwithstanding any terms contained in any prior or later communications from Buyer and whether or not Seller shall specifically or expressly object to any such terms.

2. Warranties - Any warranty obligations for the Product shall be exclusively provided in writing to Buyer directly by Seller. LUMINEX MAKES NO WARRANTY WHATSOEVER REGARDING THE PRODUCT AND LUMINEX SPEFICALLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. NEITHER SELLER NOR LUMINEX SHALL IN ANY EVENT BE LIABLE FOR INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES OF ANY KIND RESULTING FROM ANY USE OR FAILURE OF THE PRODUCT, EVEN IF SELLER OR LUMINEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE INCLUDING, WITHOUT LIMITATION, LIABILITY FOR LOSS OF WORK IN PROGRESS, DOWN TIME, LOSS OF REVENUE OR PROFITS, FAILURE TO REALIZE SAVINGS, LOSS OF PRODUCTS OF BUYER OR OTHER USE OR ANY LIABILITY OF BUYER TO A THIRD PARTY ON ACCOUNT OF SUCH LOSS, OR FOR ANY LABOR OR ANY OTHER EXPENSE, DAMAGE OR LOSS OCCASIONED BY SUCH PRODUCT INCLUDING PERSONAL INJURY OR PROPERTY DAMAGE UNLESS SUCH PERSONAL INJURY OR PROPERTY DAMAGE IS CAUSED BY SELLER'S GROSS NEGLIGENCE.

3. Buyer's Use of Product -Buyer agrees that no rights or licenses under Luminex's patents shall be implied from the sale of the Product, except as expressly provided herein, and Buyer does not receive any right under Luminex's patent rights hereunder. Buyer acknowledges and agrees that the Product is sold and licensed only for use with Luminex's standard fluorescently dyed microspheres. Buyer further acknowledges that the Product have not received approval from the United States Food and Drug Administration or other federal, state or local regulatory agencies and have not been tested by Seller or Luminex for safety or efficacy in food, drug, medical device, cosmetic, commercial or any other use, unless otherwise stated in Seller's technical specifications or material data sheets furnished to Buyer. Buyer expressly represents and warrants to Seller that Buyer will properly test and use any Product in accordance with the practices of a reasonable person who is an expert in the field and in strict compliance with the United States Food and Drug Administration and all applicable domestic and international laws and regulations, now and hereinafter enacted.

BUYER HEREBY GRANTS TO LUMINEX A NONEXCLUSIVE, WORLDWIDE, UNRESTRICTED, ROYALTY-FREE, FULLY PAID-UP LICENSE, WITH THE RIGHT TO GRANT AND AUTHORIZE SUBLICENSES, UNDER ANY AND ALL PATENT RIGHTS IN INVENTIONS COMPRISING MODIFICATIONS, EXTENSIONS, OR ENHANCEMENTS MADE BY BUYER TO THE PRODUCT OR TO THE MANUFACTURE OR USE OF THE PRODUCT ("IMPROVEMENT PATENTS"), TO MAKE, HAVE MADE, USE, IMPORT, OFFER FOR SALE OR SELL ANY AND ALL PRODUCT; EXPLOIT ANY AND ALL METHODS OR PROCESSES; AND OTHERWISE EXPLOIT IMPROVEMENT PATENTS FOR ALL PURPOSES. NOTWITHSTANDING THE FOREGOING, "IMPROVEMENT PATENTS" SPECIFICALLY EXCLUDES PATENT CLAIMS CONCEIVED AND REDUCED TO PRACTICE BY BUYER CONSISTING OF METHODS OF SAMPLE PREPARATION, METHODS OF CONJUGATING PRODUCT TO ANALYTES, THE COMPOSITION OF MATTER OF THE SPECIFIC CHEMISTRIES OF THE ASSAYS DEVELOPED BY BUYER AND METHODS OF PERFORMING THE ASSAYS (I.E., THE PROTOCOL FOR THE ASSAY). Buyer has the responsibility and hereby expressly assumes the risk to verify the hazards and to conduct any further research necessary to learn the hazards involved in using the Product. Buyer also has the duty to warn Buyer's customers, employees, agents, assigns, officers, successors and any auxiliary or third party personnel (such as freight handlers, etc.) of any and all risks involved in using or handling the Product. Buyer agrees to comply with instructions, if any, furnished by Seller or Luminex relating to the use of the Product and not misuse the Product in any manner. Buyer shall not reverse engineer, decompile, disassemble or modify the Product. Buyer acknowledges that Luminex retains ownership of all patents, trademarks, trade secrets and other proprietary rights relating to or residing in the Product.

4. Buyer's Representations, Release and Indemnity - Buyer represents and warrants that it shall use the Product in accordance with Paragraph 2, "Buyer's Use of Product," and that any such use of Product will not violate any law, regulation, judicial order or injunction. Buyer agrees to release, discharge, disclaim and renounce any and all claims, demands, actions, causes of action and/or suits in law or equity, now existing or hereafter arising, whether known or unknown, against Seller and Luminex, and their respective officers, directors, employees, agents, successors and assigns (collectively the "Released Parties"), with respect to the use of the Product. Buyer agrees to indemnify and hold harmless the Released Parties from and against any suits, losses, claims, demands, liabilities, costs and expenses (including attorney, accounting, expert witness, and consulting fees) that any of the Released Parties may sustain or incur as a result of any claim against such Released Party based upon negligence, breach of warranty, strict liability in tort, contract or any other theory of law or equity arising out of, directly or indirectly, the use of the Product or by reason of Buyer's failure to perform its obligations contained herein. Buyer shall fully cooperate with the Released Parties in the investigation and determination of the cause of any accident involving the Product which results in personal injury or property damage and shall make available to the Released Parties all statements, reports, recordings and tests made by Buyer or made available to Buyer by others.

5. Patent Disclaimer - Neither Seller nor Luminex warrants that the use or sale of the Product will not infringe the claims of any United States or other patents covering the product itself or the use thereof in combination with other products or in the operation of any process.

End-User License Agreement (EULA) for Luminex® Software

This Luminex End-User License Agreement (“EULA”) is a legal agreement between you (either an individual or a single entity , also referred herein as “you”) the end-user and Luminex Corporation (“Luminex”) regarding the use of the Luminex software product identified above, which includes computer software and online or electronic documentation and may include associated media and printed materials (if any) (“SOFTWARE PRODUCT” or “SOFTWARE”).

The SOFTWARE PRODUCT is protected by copyright laws and international copyright treaties, as well as other intellectual property laws and treaties. The SOFTWARE PRODUCT is licensed, not sold.

1. GRANT OF LICENSE. Subject to the terms and conditions of this EULA, Luminex hereby grants to you a nonexclusive, nontransferable, nonassignable license (without right to sublicense) under Luminex’s copyrights and trade secrets to use the SOFTW ARE PRODUCT on a hardware platform purchased from Luminex pursuant to Luminex’s terms and conditions of sale. You may make one (1) copy of the SOFTWARE PRODUCT for backup or archival purposes only. Although no rights or licenses under any of Luminex's patents are granted by or shall be implied from the license of the SOFTW ARE or the sal e of Luminex instrumentation to you, the purchaser, you may obtain a license under Luminex’ s patents, if any, to use this unit of Luminex instrumentation with fluorescently labeled microsphere beads authorized by Luminex by purchasing such beads from Luminex or an authorized Luminex reseller.

2. RESTRICTIONS.

• You must maintain all proprietary notices on all copies of the SOFTWARE PRODUCT.

• You may not distribute copies of the SOFTWARE PRODUCT to third parties.

• You may not reverse-engineer, decompile, disassemble, or otherwise attempt to derive source code from the SOFTWARE PRODUCT.

• You may not copy (other than one backup or archival copy), distribute, sublicense, rent, lease, transfer or grant any rights in or to all or any portion of the SOFTWARE PRODUCT.

• You must comply with all applicable laws regarding the use of the SOFTWARE PRODUCT.

• You may not modify or prepare derivative works of the SOFTWARE PRODUCT.

• You may not use the SOFTWARE PRODUCT in a computer-based service business or publicly display visual output of the SOFTWARE PRODUCT.

• You may not transmit the SOFTWARE PRODUCT over a network, by telephone, or electronically by any means.

3. TERM AND TERMINA TION. Your rights under this EULA are effective until termination. You may terminate this EULA at any time by destroying the SOFTWARE PRODUCT, including all computer programs and documentation, and erasing any copies residing on your computer equipment. Luminex may terminate this EULA upon thirty (30) days written notice to you. Your rights under this EULA automatically terminate without further action on the part of Luminex if you do not comply with any of the terms or conditions of this EULA. Upon any termination of this EULA, you agree to destroy the SOFTWARE PRODUCT and erase any copies residing on your computer equipment.

4. RIGHTS IN SOFTWARE. All rights and title in and to the SOFTWARE PRODUCT and any copies thereof are owned by Luminex or its suppliers. This EULA is not a sale and does not transfer to you any title or ownership interest in or to the SOFTWARE or any p atent, copyright, trade secret, trade n ame, trademark or other intellectual property right therein. You shall not remove, alter, or obscure any proprietary notices contained on or within the SOFTWARE and shall reproduce such notices on any back-up copy of the SOFTWARE. All title and intellectual property rights in and to the content which may be accessed through use of the SOFTWARE PRODUCT is the property of the respective content owner and may be protected by applicable copyright or other intellectual property laws and treaties. This EULA grants you no rights to use such content.

5. EXPORT RESTRICTIONS. You agree that you will not export or re-export the SOFTWARE PRODUCT to any country , person, entity, or end-user subject to U.S.A. export restrictions. Y ou hereby warrant no state or federal agency has suspended, revoked, or denied your export privileges.

6. NO WARRANTY. THE SOFTWARE PRODUCT IS LICENSED “AS IS.” ANY USE OF THE SOFTWARE PRODUCT IS A T YOUR OWN RISK. THE SOFTWARE PRODUCT IS PROVIDED FOR USE ONLY WITH LUMINEX PRODUCTS. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, LUMINEX AND ITS SUPPLIERS DISCLAIM ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING , BUT NOT LIMITED TO, IMPLIED W ARRANTIES OF MERCHANT ABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT.

7. LIMITATION OF LIABILITY. IN NO EVENT SHALL LUMINEX OR ITS SUPPLIERS BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL DAMAGES WHATSOEVER (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS INTERRUPTION, LOSS OF BUSINESS INFORMA TION, OR ANY OTHER PECUNIARY LOSS) ARISING OUT OF THE USE OF OR INABILITY TO USE THE SOFTWARE PRODUCT, EVEN IF LUMINEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE S.

MISCELLANEOUS. This EULA is governed by the laws of the State of Texas, U.S.A., without reference to conflicts of laws principles. You shall not assign or sublicense or otherwise transfer the rights or license granted hereunder, by agreement or by operation of law, without the prior written consent of Luminex, and all assignments in violation of this prohibition shall be null and void. This EULA is the complete and exclusive agreement of Luminex and you and supersedes all other communications, oral or written, relating to the subject matter hereof. No change to this EULA shall be valid unless in writing and signed by the party against whom enforcement is sought. The waiver or failure of Luminex or you to exercise in any respect any right or rights provided for herein shall not be deemed a waiver of any further right hereunder. If any provision of this EULA is held unenforceable, the remainder of this EULA will continue in full force and effect.

EULA PN: 89-30000-00-070

Introduction 1-1

About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

The Luminex 100 IS 2.3 System. . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Luminex Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Safety 2-1

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Warnings and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2

Safety Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2

FCC Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Luminex 100 Analyzer Laser . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Barcode Reader Laser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

Mechanical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

Biological . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

Heat. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8

Blue Indicator Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8

Decontaminating the Luminex 100 Analyzer for

Return Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

The System 3-1

Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

xMAP Technology Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Required Laboratory Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

Luminex 100 IS 2.3 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Luminex 100 IS Performance Specification . . . . . . . . . . . . . . . . . .3-3

Speed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Accuracy and Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Luminex 100 Analyzer General . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

PN 89-00002-00-071 Rev. C i

Luminex 100 IS User Manual Version 2.3 xMAP Technology

Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Luminex XYP Instrument General. . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Luminex SD System General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

PC Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Recommended Additional Equipment. . . . . . . . . . . . . . . . . . . 3-7

Uninterruptible Power Supply (UPS) . . . . . . . . . . . . . . . . 3-7

Surge Protector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Barcode Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Vortex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Bath Sonicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Power Input Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Communications Ports(SB9-PIN). . . . . . . . . . . . . . . . . . . 3-7

Luminex 100 Analyzer Ventilation Filter. . . . . . . . . . . . . 3-7

Luminex XYP Instrument Ventilation Filter. . . . . . . . . . . 3-8

Fluidics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Sample Arm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Luminex XYP Instrument Sample Probe. . . . . . . . . . . . . 3-8

Cheminert® Fitting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Access Doors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Air Intake Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Syringe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Sheath Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Air, Waste, and Sheath Fluid Connectors . . . . . . . . . . . . 3-11

Luminex Sheath Delivery System . . . . . . . . . . . . . . . . . 3-12

Waste Fluid Container. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Optical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

xMAP Technology Reagents. . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Basic Concepts 4-1

Background Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Fluidics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Excitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

xMAP Microspheres. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Software Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Using Luminex 100 IS 2.3 Software 5-1

Main Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Toolbar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Home tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Run Batch Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Maintenance Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Diagnostics tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Acquisition Detail Tab . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

ii PN 89-00002-00-071 Rev. C

xMAP Technology Contents

Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Secondary Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20

Batch Setup Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20

Analysis Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-22

Errors Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-23

Standards Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-24

Samples Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28

Replicate Averaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-29

Commands. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31

Acquire Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31

Add Batch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Alcohol Flush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Autoscale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Autosize . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -31

Backflush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

CAL1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31

CAL2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31

Cancel (Command). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31

Cancel All. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31

Change Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

CON1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31

CON2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31

Connect to Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32

Create New Multi-Batch. . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32

Delete Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32

Density/Decaying . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

Display Confirmation Screens . . . . . . . . . . . . . . . . . . . . . . . .5-32

Disconnect from the Instrument . . . . . . . . . . . . . . . . . . . . . . .5-32

Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32

Eject/Retract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32

Enable Raw Data Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32

Export Batch Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32

Export CAL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32

Export CON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32

Export Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-33

Help. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

Import Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-33

Import Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-33

Import Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

Insert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-33

Invalidate Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-33

Invalidate Standard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-33

Load Patient List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

Log/Linear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

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Maximize/Minimize. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

Next Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

New Advanced Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

New Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

New CAL Targ. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

New CON Targ.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

New Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

Open Batch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

Open Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

Open Incomplete Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

Open Multi-Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34

Previous Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Prime . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Print Batch Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Print Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Recalc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Replay Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Report Raw Fluorescence . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Resume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Sample Probe Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Sanitize. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Save and Load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36

Save Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36

Self Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36

Show Bead. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36

Single Step. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36

Skip [wells] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36

Soak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36

Start Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Start (Plate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Statistics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Test Sort Orders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Validate Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Validate Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

View Batch Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Warmup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Zoom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38

Using the Online Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38

Setting Software Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39

Define General Tab Information. . . . . . . . . . . . . . . . . . . 5-39

Define Company Information Tab . . . . . . . . . . . . . . . . . 5-40

iv PN 89-00002-00-071 Rev. C

xMAP Technology Contents

Define Data Export Tab Information. . . . . . . . . . . . . . . .5-41

Setting up the Favorites List. . . . . . . . . . . . . . . . . . . . . . . . . .5-42

Startup Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43

Warm Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-43

Prime the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-43

Backflush the System. . . . . . . . . . . . . . . . . . . . . . . . . . . .5-44

Run an Alcohol Flush. . . . . . . . . . . . . . . . . . . . . . . . . . . .5-44

Run a Wash Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-44

Set Luminex XYP Instrument Heater Temperature. . . . .5-45

Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-46

Run System xMAP Calibrators . . . . . . . . . . . . . . . . . . . .5-47

Run System xMAP Controls . . . . . . . . . . . . . . . . . . . . . .5-49

Selecting Existing CAL or CON Lots . . . . . . . . . . . . . . .5-50

Importing CAL or CON Lots. . . . . . . . . . . . . . . . . . . . . .5-50

Exporting CAL or CON lots . . . . . . . . . . . . . . . . . . . . . .5-51

Batch Setup Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-51

Importing Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-52

Create a New Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-53

Open a Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-55

Copying and Exporting Batch Data . . . . . . . . . . . . . . . . .5-55

Clear a Batch from the System. . . . . . . . . . . . . . . . . . . . .5-55

Replay a Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-56

Delete a Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-57

Create a Multi-Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-58

Open a Multi-Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-59

Process Multiple Plates . . . . . . . . . . . . . . . . . . . . . . . . . .5-60

Re-Run or Recover Incomplete Batch . . . . . . . . . . . . . . .5-61

Scan in Samples With a Barcode Reader. . . . . . . . . . . . .5-61

Add a Patient List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-62

Edit a Patient List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-63

Assign Sample Dilution Factors. . . . . . . . . . . . . . . . . . . .5-64

Create a New Advanced Batch. . . . . . . . . . . . . . . . . . . . .5-65

Managing Assay Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-71

Create a New Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-71

Edit Lot Information on an Unused Template . . . . . . . . .5-73

Edit Lot Information on a Used Template . . . . . . . . . . . .5-74

Import Lot to an Existing Template. . . . . . . . . . . . . . . . .5-74

Export a Lot from an Existing Template . . . . . . . . . . . . .5-75

Analyzing Batches and Multi-Batches . . . . . . . . . . . . . . . . . .5-76

Customize Data Analysis Settings . . . . . . . . . . . . . . . . . .5-77

Enable Automatic Analysis . . . . . . . . . . . . . . . . . . . . . . .5-82

Analyze Processed Batch Data. . . . . . . . . . . . . . . . . . . . .5-83

View Detailed Test Analysis . . . . . . . . . . . . . . . . . . . . . .5-83

Validating or Invalidating Standards and Controls . . . . . 5-83

Change Lot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-85

Running Reports and Analyses. . . . . . . . . . . . . . . . . . . . . . . .5-86

Report Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-86

Export Batch Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-89

Print Data Analysis Report. . . . . . . . . . . . . . . . . . . . . . . .5-89

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Database Management Procedures . . . . . . . . . . . . . . . . . . . . 5-90

Back Up the Database . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-90

Delete Database Entries . . . . . . . . . . . . . . . . . . . . . . . . . 5-91

Restore Database Data. . . . . . . . . . . . . . . . . . . . . . . . . . . 5-91

Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-92

Drain the Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-93

Run Self-Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-94

Using the Cleanup Utility . . . . . . . . . . . . . . . . . . . . . . . . 5-94

Daily Shutdown Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . 5-96

Sanitize the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-96

Run a Wash Command . . . . . . . . . . . . . . . . . . . . . . . . . . 5-96

Perform a Soak Command . . . . . . . . . . . . . . . . . . . . . . . 5-97

Exit Luminex IS 2.3 Software. . . . . . . . . . . . . . . . . . . . . 5-97

Maintenance and Cleaning 6-1

Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Before Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

After Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Routine Tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Sheath and Waste Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Refill the Sheath Fluid Container . . . . . . . . . . . . . . . . . . . 6-3

Empty the Waste Container. . . . . . . . . . . . . . . . . . . . . . . . 6-3

Weekly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Run Self-Diagnostics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Clean Sample Probe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Flush the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Monthly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Clean the Sample Probe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Clean Exterior Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Calibration and System Controls. . . . . . . . . . . . . . . . . . . . . . . 6-5

Every Six Months. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Luminex 100 Analyzer Air Intake Filter . . . . . . . . . . . . . . . . . 6-5

Luminex XYP Instrument Air Intake Filter. . . . . . . . . . . . . . . 6-6

Syringe Seal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

Luminex 100 Analyzer Ventilation Filter . . . . . . . . . . . . . . . . 6-9

Annually. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Sheath Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

As required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13

Troubleshooting 7-1

Troubleshooting the Luminex 100 IS System . . . . . . . . . . . . . . . . 7-1

Power Supply Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

vi PN 89-00002-00-071 Rev. C

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Pressurization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Fluid Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4

Sample Probe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Calibration and Control Problems. . . . . . . . . . . . . . . . . . . . . . . . . .7-7

Acquisition Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9

Bead Detail Irregularities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10

Error States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13

System Error Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13

Sample Error Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 -15

Luminex SD Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 -18

Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

Malfunction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

Draining the Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19

Product Numbers 8-1

Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

xMAP Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Glossary A-1

Luminex 100 IS System Installation B-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Luminex 100 IS System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Connect the Luminex 100 analyzer and

Luminex XYP to the PC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

Install the Luminex XYP Instrument Sample Probe . . . . . . . B-6

Power On System Components . . . . . . . . . . . . . . . . . . . . . . . B-8

Accept the Luminex 100 IS 2.3 Software

License Agreement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8

Adjust the Sample Probe Vertical Height. . . . . . . . . . . . . . . . B-8

Install the Luminex XYP Instrument Reservoir. . . . . . . . . . . B-9

Calibrate and Verify the System. . . . . . . . . . . . . . . . . . . . . . B-10

Install the SD System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-10

Install the Luminex XYP Instrument Heater Block . . . . . . . B-13

Luminex 100 IS 2.3 Software Installation. . . . . . . . . . . . . . . . . . B-14

Luminex 100 Version 1.7 with Windows 98 to

Luminex 100 IS Version 2.3. . . . . . . . . . . . . . . . . . . . . . . . . B-15

Install New PC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-15

Install Luminex 100 IS 2.3 Software . . . . . . . . . . . . . . . B-15

Verify Successful Upgrade. . . . . . . . . . . . . . . . . . . . . . . B-16

Luminex 100 Version 1.7 with Windows 2000 to

Luminex 100 IS Version 2.3. . . . . . . . . . . . . . . . . . . . . . . . . B-17

PN 89-00002-00-071 Rev. C vii

Luminex 100 IS User Manual Version 2.3 xMAP Technology

Archive “My Sessions” folder. . . . . . . . . . . . . . . . . . . . . B-17

Remove Luminex LMAT Software . . . . . . . . . . . . . . . . B-17

Remove Luminex 100 Version 1.7 Software . . . . . . . . . B-18

Install Luminex 100 IS 2.3 Software. . . . . . . . . . . . . . . .B-19

Luminex 100 IS Version 2.1/2.2 to Luminex 100 IS

Version 2.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-19

Backup Luminex 100 IS 2.1 or 2.2 Database . . . . . . . . . B-19

Remove Luminex 100 IS 2.1 or 2.2 . . . . . . . . . . . . . . . . B-20

Install Luminex 100 IS 2.3 Software. . . . . . . . . . . . . . . .B-20

Luminex 100 IS 2.3 Firmware Installation. . . . . . . . . . . . . . . . . .B-21

Firmware Upgrade Cable Configurations . . . . . . . . . . . . . . . B-21

Luminex 100 Analyzer Firmware Upgrade. . . . . . . . . . . . . . B-22

Connect Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-22

Upgrade Firmware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-22

Verify Successful Firmware Upgrade . . . . . . . . . . . . . .B-23

Update Interface Cable . . . . . . . . . . . . . . . . . . . . . . . . . .B-23

Luminex XYP Instrument Firmware Update. . . . . . . . . . . . . B-24

Update Firmware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-24

Verify Successful Firmware Upgrade. . . . . . . . . . . . . . . B-24

Luminex SD System Firmware Update. . . . . . . . . . . . . . . . .B-25

Update Firmware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-25

Verify Successful Firmware Upgrade. . . . . . . . . . . . . . . B-25

Network Installation Advisory. . . . . . . . . . . . . . . . . . . . . . . . . . .B-26

Prepare System for First Use . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-26

Installation Drawing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-27

Output.CSV C-1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1

Overall Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1

Blank Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

Field Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-2

Statistics Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-4

Statistics Column Definitions . . . . . . . . . . . . . . . . . . . . . . . . . C-5

Luminex 100 IS OUTPUT.CSV file with no

additional features enabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7

Luminex 100 IS OUTPUT.CSV file with all

additional features enabled. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-8

Index Index-1

viii PN 89-00002-00-071 Rev. C

Introduction

About This Manual This manual provides you with information to understand and use the

Luminex appendices that take you from this introduction to complete system operation.

The manual’s text and figures offer examples when necessary. Procedures are presented as step-by-step instructions. Glossary and index sections assist as references.

The conventions in this manual assume that the reader has a basic familiarity with computers, xMAP Microsoft common methods of accessing a command, such as from the main menu bar, from the toolbar, and from menus that appear when you right-click an area of the screen. Refer to the Glossary appendix for unfamiliar terminology.

® 100™ IS system. It consists of multiple chapters and

® technology, and a knowledge of

® Windows® software. We typically document the

The Luminex 100 IS

2.3 System

The Luminex 100 IS 2.3 system is a benchtop system consisting of the Luminex 100 analyzer, computer, monitor, keyboard, mouse, Luminex XY Platform instrument (Luminex XYP™), Luminex Sheath Delivery System (Luminex SD™), software, barcode reader, sheath and waste containers, and xMAP technology reagents.

Intended Use The Luminex software is designed to use xMAP technology with

assay kits available through kit manufacturers.The Luminex 100 IS

2.3 system performs a wide range of xMAP technology-based laboratory tests, measuring biomolecular reactions on the surface of xMAP microspheres. This system is intended for general laboratory use.

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Technical Support Luminex Technical Support representatives are ready to help you,

particularly when the system or software cause any questions or problems. If the question or problem relates to materials from the assay kit, you should contact the kit provider directly.

Luminex Technical Support is available to users in the U.S. and Canada by calling 1-877-785-BEAD (-2323) between the hours of 7:00 a.m. and 7:00 p.m. Central T ime, Mon day through Fri day. Users outside of the U.S., Canada, Europe can contact us at +1 512-3814397 between the hours of 7:00 a.m. to 7:00 p.m. Central Time, Monday through Friday. Inquiries may also be sent by email to support@luminexcorp.com.

Luminex Technical Support is also a vailable to users in Europe by calling +31-162408333 between the hours of 8:30 and 5:30, Central European Time, Monday through Friday. Email inquiries in Europe can be sent to supporteurope@luminexcorp.com.

Luminex Website Additional information is available on the Luminex website. Search

on the desired topic or navigate through menus. Also, review the website’s FAQ section.

 To access Luminex website FAQ section:

In your browser’s address field, enter: http://luminexcorp.custhelp.com. This address takes you directly to the FAQ section.

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Safety

Symbols Please become familiar with the information in this chapter before

using the equipment. Do not perform procedures on your Luminex 100 IS 2.3 system that are not specifically contained in this manual, unless you are directed to do so by Luminex Technical Support.

These symbols describe warnings, cautions, and general information used in the operation of this instrument. These symbols are further defined under “Safety Precautions.”

Number Symbol Description Number Symbol Description

1 Alternating current (ac) 7 Warning (refer to manual)

2 Protective ground 8 Warning (refer to manual)

3 On 9 Warning (refer to manual)

4 Off 10 Warning (refer to manual)

5 SN Serial number 11 Warning (refer to manual)

6 Warning (refer to manual)

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Warnings and Notes Informational notes and warnings appear in this manual.

Note: A note provides general helpful information. No safety or performance issues are involved.

Caution: This message is used in cases where the hazard is minor or only potential hazard is present. Failure to comply with the caution may result in potentially hazardous conditions.

Warning: This message is used in cases where danger to the operator or to the performance of the instrument is present. Failure to comply with the warning may result in incorrect performance, instrument failure, invalid results, or hazard to the operator.

Danger: This message is used in cases where significant risk of serious injury or death is present.

Safety Precautions Read the following safety information before setting up or using the

Luminex 100 IS 2.3 system. A user should be present during operation. This system contains electrical, mechanical, and laser components which, if handled improperly, are potentially harmful. In addition, biological hazards may be present during system operation. Therefore, we recommend that all system users become familiar with the specific safety advisories below, in addition to adhering to standard laboratory safety practices. The protection provided by the equipment may be impaired or the warranty voided if the system is used in a manner not specified by the instructions or by Luminex Corporation.

This caution label appears on the back of the Luminex 100 analyzer and on the Luminex XYP instrument.

Figure 2-1 Fuse Caution Label

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xMAP Technology Safety

Do not perform any maintenance or cleaning of the system’s electrical components, with the exception of replacing fuses.

This label appears on the back panel of the Luminex 100 analyzer and on the back panel of the Luminex XYP instrument.

Figure 2-2 CE Label

The Luminex 100 analyzer and the Luminex XYP instrument comply with European Union (EU) safety requirements and, therefore, may be marketed in the Europe Single Market.

This voltage label appears on the back of the Luminex 100 analyzer:

Figure 2-3 Luminex 100 Serial Number Label

The Luminex 100 analyzer has been tested by Underwriter Laboratories, Inc.® (UL).

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The following label appears on the back of the Luminex XYP instrument.

Figure 2-4 Luminex XYP Serial Number Label

The Luminex XYP instrument has been tested by UL.

FCC Label This equipment has been tested and found to comply with the limits

for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and the receiver.

• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

• Consult the dealer or an experienced radio/TV technician for help.

Fluidics This system contains fluidics. In the event of a fluid leak, turn off all

power to the system and disconnect all power cords. Remember that the on/off switch is not a disconnect means; the power cord must be removed from the outlet. Contact Luminex Corporation for further information.

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xMAP Technology Safety

You must monitor waste levels manually. Do not allow the waste container to overflow! Empty the waste container each time the sheath fluid container is filled. Do not place the waste container on top of the instrument.

Warning: If biological samples have been tested with the system,

use your standard laboratory safety practices when handling system waste.

Luminex 100 Analyzer Laser

The Luminex 100 IS system classifies per FDA 21 CFR 1040.10 and

1040.11 as a Class II laser product consisting of a Class I laser product (Luminex 100 analyzer) and a Class II laser product (barcode reader).

Figure 2-5 Laser Product Class Label

United States and international regulations require the following warnings to appear on the instrument during operation and maintenance.

This label appears on the back panel of the Luminex 100 analyzer.

Figure 2-6 Laser Radiation Caution Label

Under NO circumstances should you remove the Luminex 100 analyzer cover! When performing routine maintenance, turn power

to the Luminex 100 analyzer OFF and the disconnect the power cord.

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All laser apertures are located within the Luminex 100 analyzer and are contained within a protective housing. This label appears on the optics cover within the Luminex 100 analyzer.

Figure 2-7 Laser Class Label

Warning — Use of controls or adjustments or performance of

procedures other than those specified herein may result in hazardous radiation exposure.

Attention — L’utilisation des commandes ou réglages ou

l’exécution des procédures autres que celles spécifiées dans les présentes prescriptions peuvent entraîner d’une exposition à un rayonnement dangereux.

This label appears above the laser apertures located inside the optics enclosure inside the Luminex 100 analyzer.

Figure 2-8 Avoid Exposure Label

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xMAP Technology Safety

Barcode Reader Laser This label is attached to the barcode reader.

Figure 2-9 Barcode Reader Laser Label

Do not stare into the beam or shine it into other people’s eyes.

Mechanical

Warning: During operation, this system contains exposed,

moving parts. Risk of personal injury is present. Observe all warnings and cautions.

Warning: During operation, this system contains exposed,

moving parts which could result in puncture hazard. Risk of personal injury is present. Keep hands and fingers away from the Luminex XYP instrument slot during operation.

Note: Access doors must be

closed while operating the Luminex 100 analyzer; the operator must be present during operation.

Biological

Warning: During operation, this system contains exposed,

moving parts which could result in pinch point hazard. Risk of personal injury is present. Keep hands and fingers away from the Luminex XYP instrument slot during operation.

Warning: Hum an and animal samples ma y cont ain biohazardo us

infectious agents. Where exposure (including aerosol) to potentially biohazardous

material exists, follow appropriate biosafety procedures and use personal protective equipment, such as gloves, gowns, laboratory coats, face shields, or mask and eye protection, and ventilation devices.

Observe all local, state, and federal biohazard handling regulations when disposing of biohazardous waste material.

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Heat

Warning: The heater plate of the Luminex XYP instrument may

be hot and could cause personal injury if touched. Do not touch the heater plate.

Blue Indicator Light

The blue light above the Luminex 100 analyzer sample arm indicates the on/off status of the Luminex 100 analyzer, and is harmless. The blue light-emitting diode (LED) does not emit light in the UV spectrum.

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xMAP Technology Safety

Decontaminating the Luminex 100 Analyzer for Return Shipment

Note: It is the user’s

responsibility to decontaminate the analyzer before shipment.

Luminex Technical Support will give you a Return Material Authorization (RMA) number if they direct you to return the system. They will explain how to return the system according to Luminex procedures.

The accessible surfaces and the internal fluidics system must be sanitized and decontaminated before returning the analyzer. This is particularly important when biohazardous samples have been run. Make a copy of this page to fill out and return with the system.

Complete the following checklist, signed and dated, and return it with the Luminex 100 analyzer.

1. Remove all specimens, disposables, and reagents from the system.

2. Disconnect the sheath line going from the SD system to the analyzer.

3. Connect a sheath bottle filled with a solution of 10% to 20% household bleach and water to the analyzer.

4. Sanitize the system using the Sanitize command on the main screen of the system. Follow this by washing twice with distilled water.

5. Disconnect the system from AC power by turning off the power switch on the rear of the system, then unplugging the analyzer power cord from the wall source.

6. Disconnect the SD system and waste and sheath containers.

7. Rinse the waste container with 10% to 20% household bleach solution and drain.

8. Wash all exterior surfaces with a mild detergent, followed by a 10% to 20% bleach solution.

9. Open both front doors of the analyzer and clean all accessible surfaces with mild detergent followed by a 10% to 20% bleach solution.

10. Pack the system within a biohazard bag, place it in the corrugated box, then insert it in its original packaging or an approved shipping container. Attach this checklist to the top of the corrugated box prior to packaging in the crate.

Was there an internal leak in the system? Yes No

Print Name:

Signature:

Date: Instrument Serial No.

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The System

Theory of Operation Luminex 100 IS technology is based on flow cell fluorometry with

Luminex-developed innovations. The fluidics, optics, robotics, temperature control, software, and xMAP microspheres work together to enable simultaneous analysis of up to 100 analytes in a single test sample. Assay analysis requiring temperature control is provided through the Luminex XYP instrument heater block.

There are two fluidics paths in the Luminex 100 analyzer. The first path involves a syringe-driven mechanism that controls the sample uptake. This mechanism permits small sample uptake volumes from small reaction volumes. The syringe-driven system transports a specified volume of sample from a sample container to the cuvette. The sample is injected into the cuvette at a steady rate for analysis. Following analysis, the sample path is automatically purged with sheath buffer by the second fluidics path. This process removes residual sample within the tubing, valves, and probe. The second fluidics path is driven by positive air pressure and supplies sheath fluid to the cuvette and sample path.

Sheath fluid is the delivery medium of the sample to the optics component. The analysis sample is acquired using a sample probe from a 96-well microtiter plate via the Luminex XYP instrument and injected into the base of the cuvette. The sample then passes through with sheath fluid at a reduced rate resulting in a narrow sample core to ensure that each microsphere is illuminated individually. The sample injection rate is such that the xMAP microspheres are introduced to the optics path as a series of single events. The Luminex SD system lets you run samples continuously without refilling sheath bottles. It automatically draws sheath from a non pressurized bulk sheath container to constantly maintain a reservoir

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of pressurized sheath fluid. A single 20 liter sheath container provides enough fluid for 48 hours or more of normal operation.

The optics assembly consists of two lasers. One laser excites the dye mixture inside the xMAP microspheres and the second laser excites the fluorosphere bound to the surface of the xMAP microspheres. Avalanche photo diode detectors measure the excitation emission intensities of the color coding classification dye mixtures inside the xMAP microspheres and a photomultiplier tube detects the excitation emission intensity of the reporter molecule bound to the surface of the xMAP microspheres. High speed digital signal processors and advanced computer algorithms provide analysis of the xMAP microspheres as they are processed through the Luminex 100 analyzer. Results of the analyses are processed and provided in a report format.

Hardware The Luminex 100 IS system includes the following hardware:

• Luminex 100 analyzer

• Computer (PC), monitor, and accessories

• Luminex XYP instrument

• Luminex Sheath Delivery System (Luminex SD™)

• Power cables

• Alignment guide

• Two long sample probes

• Luminex XYP instrument sample probe

• Reservoir

•Shield

•Heater block

• Sheath fluid container

• Waste container

• Sheath fluid line

• Air line

• Sheath fluid intake line

• Communications: 1 serial communication cable

• Communications: 1 USB communication cable

• Communications: 1 CANBUS communication cable (short cable)

• Barcode reader

• Sample probe height alignment kit

• 3/32 Hexdrive, Balldriver wrench

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xMAP Technology The System

xMAP Technology Reagents

Required Laboratory Reagents

Luminex 100 IS 2.3 Software

• Classification calibration microspheres (CAL1)

• Reporter calibration microspheres (CAL2)

• Classification control microspheres (CON1)

• Reporter control microspheres (CON2)

• Sheath fluid

• Household bleach

• 70% isopropanol or 70% ethanol

• Mild detergent

Luminex 100 IS 2.3 software provides complete control of the system and performs data analysis. Your Luminex 100 IS 2.3 system is preloaded with the Luminex software. However, we supply a software CD should you need to reinstall the software.

This software requires a dedicated system. Unauthorized additional software is prohibited and may result in improper operation of the system.

Luminex 100 IS Performance Specification

Speed • USB communications link for fast data transfer

• Automatic transfer of assay templates and new reagent information into the system via a large capacity read/write CD

• Installation: < 4 hours

• System calibration: < 10 minutes

• System controls: < 10 minutes

• Barcode reader entry of sample IDs

• Automatic post-analysis

• Analyze one 96-well plate/hour depending on manufacturer’s kit

• Up to 100 xMAP microsphere sets per sample

• Sheath flowrate: 90 µL/sec ± 5 µL

• Sample injection rate into detector area: 1 µL/sec ± 0.05 µL

• System warmup: 30 minutes. Systems that remain inactive for at least four hours will require a warm-up to restart the lasers. After

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acquiring sample, running system calibrators, running system controls, and warming up the instrument, the system resets the four-hour internal clock.

Accuracy and Precision • Sample uptake volume: ± 5%

• Classification of xMAP microspheres: > 80%

• Misclassification of xMAP microspheres: ≤ 2% - may vary by xMAP microsphere product lines. Refer to the specific product information sheet for further details.

• Temperature control: 0°C to + 2°C of target

• Internal sample carry over: < 0.9%

• Soluble background fluorescence emission at 575 nm automatically subtracted from fluorescence intensity values

Sensitivity • Detect 1000 fluorochromes phycoerythrin (PE) per xMAP

microsphere

• Reporter channel dynamic range: 3.5 decades of detection

Capacity The specifications below reflect minimum capacity values:

• 10 GB hard drive

• 100 MB read/write CD ROM

• Analyze multiple 96-well plates per batch

• Analyze multiple assay templates per plate

• Distinguish a minimum of 1 to a maximum of 100 unique xMAP microsphere sets in a single sample

• Detect and distinguish surface reporter fluorescence emissions at 575 nm on the surface of 1-100 unique xMAP microspheres sets in a single sample

• S ample core: 15-20 µm core at 1 µL/sec. sample inject rate

• Maintain samples at a constant temperature from 35°C to 55°C (95°F to 131°F)

• Automatic sampling from a 96-well plate

• Start sampling from any well position

• Sheath container and waste container hold enough volume to run up to two 96-well plates between refills

• M icrotiter plates with 96 wells must be compatible with the Luminex XYP instrument plate holder. The following microtiter plate types are compatible with the Luminex XYP instrument plate holder: flatbottom, conical, round, filter bottom, half plates [overall height no more than 0.75” (19 mm)], any color

• M icrotiter plates with 96 wells must be compatible with Luminex XYP instrument heater block temperature from 35°C to

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