Luminex 100 IS User Manual, Version 2.1

Lum/nex

International English Version

Luminex 100™ IS

User Manual Version 2.1

© LUMINEX CORPORATION, 2001-2003. 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 CORPORATION

12212 Technology Boulevard

Austin, Texas 78727-6115

U.S.A.

Voice: (512) 219-8020

Fax: (512) 219-5195

Luminex

Luminex Corporation (Luminex) reserves the right to modify its products 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 2.1

REF

PN 89-00002-00-070 Rev. A

CN-M011-01

January 2004

REP

Paul. A. Rowden 33 Stapleford Road Middlesbrough Cleveland TS39ES England (TQMUK@aol.com)

The following are trademarks of 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 VideoSoft, 2001.

The contents of this manual and the associated Luminex software are the property of Luminex 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

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 SOFTWARE 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 SOFTWARE or the sale 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 TERMINATION. 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 patent, copyright, trade secret, trade name, 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. You 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 AT 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 WARRANTIES OF MERCHANTABILITY, 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 INFORMATION, 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 DAMAGES.

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

Contents

Introduction 1-1

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

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

What is the Luminex 100 IS? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Safety 2-1

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

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

Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Luminex 100 IS Laser Classification . . . . . . . . . . . . . . . . . . . . 2-5

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

Bar Code Reader Laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

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

Biological . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8

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

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

Decontamination of the Luminex 100 IS for Return Shipment . . . 2-9

Basic Concepts 3-1

Background Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Excitation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

xMAP Microspheres . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Installation 4-1

Assemble and Power the Luminex 100 IS System . . . . . . . . . . . . . 4-1

Hardware Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Connect the Luminex 100 Analyzer and XYP Instrument 4-1

Install or Replace the XYP Instrument Sample Probe . . . . . . . 4-6

Install the XYP Instrument Reservoir . . . . . . . . . . . . . . . . 4-9

Install the XYP Instrument Heater Block (Optional). . . . . 4-9

Adjust the Sample Probe Vertical Height . . . . . . . . . . . . 4-10

Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Initialize the PC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Initialize the Luminex 100 IS Software . . . . . . . . . . . . . . 4-12

Installation Drawing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

PN 89-00002-00-070 Rev. A i

Luminex 100 IS User Manual Version 2.1 xMAP Technology

The System 5-1

Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

xMAP Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Required Laboratory Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Luminex 100 IS Performance Specifications. . . . . . . . . . . . . . . . . 5-3

Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Accuracy and Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Luminex 100 Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

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

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

Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

XYP Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

PC Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Recommended Additional Equipment. . . . . . . . . . . . . . . . . . . 5-7

Uninterruptible Power Supply (UPS) . . . . . . . . . . . . . . . . 5-7

Surge Protector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Vortex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Bath Sonicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

Power Input Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

P1 Communications Port (SB9-PIN) . . . . . . . . . . . . . . . . 5-8

Luminex 100 Analyzer Ventilation Filter . . . . . . . . . . . . . 5-8

XYP Instrument Ventilation Filter . . . . . . . . . . . . . . . . . . 5-8

Fluidics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Sample Arm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

XYP Instrument Sample Probe . . . . . . . . . . . . . . . . . . . . 5-10

Cheminert® Fitting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Access Doors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Air Intake Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Syringe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Sheath Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Air, Waste, and Sheath Fluid Connectors . . . . . . . . . . . . 5-13

Sheath Fluid Container (not shown) . . . . . . . . . . . . . . . . 5-13

Waste Fluid Container (not shown). . . . . . . . . . . . . . . . . 5-13

Optical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

xMAP Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

ii PN 89-00002-00-070 Rev. A

xMAP Technology

System Calibration 6-1

Software Tour 7-1

System Calibration and Verification Overview . . . . . . . . . . . . . . . 6-1

Calibrate the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Run System Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2

Run System Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4

Calibration and System Control Trend Reports . . . . . . . . . . . . 6-5

Print or View a Calibration or System Control

Trend Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Luminex 100 IS 2.1 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Enter xMAP Calibration and Control Targets For the First

Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2

IS 2.1 Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Enter General Information . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Enter Company Information. . . . . . . . . . . . . . . . . . . . . . . .7-5

Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6

Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Status Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

Tabs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

Home Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10

Favorites Section. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Add Templates To Favorites . . . . . . . . . . . . . . . . . . . . . . 7-11

Add Commands to Favorites . . . . . . . . . . . . . . . . . . . . . . 7-12

Remove Items From Favorites . . . . . . . . . . . . . . . . . . . . .7-13

Data Acquisition Categories . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13

Run Batch Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14

Microtiter Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14

Reservoir. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15

Temperature and Pressure Gauges . . . . . . . . . . . . . . . . . . . . . 7-15

Set the XYP Instrument Heater Temperature . . . . . . . . .7-16

Command List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16

Maintenance Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

As-Needed Maintenance Operations . . . . . . . . . . . . . . . . . . . 7-18

Warm Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-20

Prime the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-21

Backflush the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21

Alcohol Flush the System . . . . . . . . . . . . . . . . . . . . . . . . 7-22

Sanitize the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-22

Wash the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23

Drain the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24

Soak the Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-24

Run Self Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-26

View Failed Self-Diagnostic Details . . . . . . . . . . . . . . . . 7-27

XYP Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27

PN 89-00002-00-070 Rev. A iii

Luminex 100 IS User Manual Version 2.1 xMAP Technology

Calibration and Verification . . . . . . . . . . . . . . . . . . . . . . . . . 7-27

Set Well Locations for Calibration and Controls . . . . . . 7-27

Enter System Calibration Targets . . . . . . . . . . . . . . . . . . 7-27

Enter System Control Targets . . . . . . . . . . . . . . . . . . . . . 7-29

Eject and Retract the XYP Instrument Plate Holder . . . . 7-30

Lower and Raise the Sample Probe. . . . . . . . . . . . . . . . . 7-30

Diagnostics Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-30

System Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-31

Detailed Sample Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-32

Message Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-32

Error Messages in the Message Log . . . . . . . . . . . . . . . . . . . 7-33

Batches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34

Templates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34

Import a Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34

Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-35

Create New Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-35

Update Lot Information. . . . . . . . . . . . . . . . . . . . . . . . . . 7-37

Import Lots To Existing Templates. . . . . . . . . . . . . . . . . 7-38

Export Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-38

Batch Commands. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-39

Create a New Batch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-39

Open a Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-42

Delete a Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-43

Create a

Multi-Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-43

Process a Multi-Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-46

Process Multiple Plates in a Batch . . . . . . . . . . . . . . . . . 7-46

Scan in New Samples with the Barcode Reader . . . . . . . 7-49

Add a Patient List to a Batch or Multi-Batch . . . . . . . . . 7-49

Establish Where to Begin Acquiring Data . . . . . . . . . . . 7-52

Change Where to Begin Acquiring Data in

Multi-Batches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-52

Assign Dilution Factors to Samples . . . . . . . . . . . . . . . . 7-52

Start a Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-53

Pause a Batch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-54

Resume Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-54

Cancel a Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-54

Cancel Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-54

Analyze Batches and Multi-Batches . . . . . . . . . . . . . . . . . . . . . . 7-55

Begin Data Reduction Immediately Upon Completing

Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-55

Analyze Data From Processed Batches. . . . . . . . . . . . . . 7-55

View Detailed Analyses For Selected Tests . . . . . . . . . . 7-56

Errors Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-58

View Detailed Error Information . . . . . . . . . . . . . . . . . . 7-58

Standards Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-58

Samples Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-59

Perform Batch Data Reduction . . . . . . . . . . . . . . . . . . . . 7-60

Data Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-60

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Maintenance and Cleaning 8-1

Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-60

Export Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-63

Database Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-64

Back Up the Database. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-64

Erase Data from the Database. . . . . . . . . . . . . . . . . . . . . . . . . 7-64

Restore a Previously Saved Database. . . . . . . . . . . . . . . . . . . 7-65

Edit Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-66

Copy Information From Your Batch . . . . . . . . . . . . . . . . . . . 7-66

Paste Information From Your Batch. . . . . . . . . . . . . . . . . . . . 7-66

Clear Your Batch From the System . . . . . . . . . . . . . . . . . . . .7-66

Clear the Message Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-66

Help Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-67

Open System Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-67

Display About the Device Information. . . . . . . . . . . . . . . . . . 7-67

Display About the IS Software Information . . . . . . . . . . . . . . 7-68

Shut Down the Luminex 100 Analyzer. . . . . . . . . . . . . . . . . . . . .7-69

Exit the Luminex 100 IS Software . . . . . . . . . . . . . . . . . . . . . . . . 7-71

Daily . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Before Running Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

After Running Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

Weekly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

Monthly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Clean the Sample Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

Clean Exterior Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Calibration and System Controls . . . . . . . . . . . . . . . . . . . . . . .8-3

Semi-Annually. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Luminex 100 Analyzer Air Intake Filter . . . . . . . . . . . . . . . . . 8-3

XYP Instrument Air Intake Filter . . . . . . . . . . . . . . . . . . . . . . . 8-4

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

Luminex 100 Analyzer Ventilation Filter. . . . . . . . . . . . . . . . . 8-7

Annually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8

Sheath Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8

As Required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9

Sheath and Waste Fluids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9

Refill the Sheath Fluid Container. . . . . . . . . . . . . . . . . . . . 8-9

Empty the Waste Container . . . . . . . . . . . . . . . . . . . . . . . .8-9

Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10

Sample Arm Vertical Height . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

Maintenance Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13

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Troubleshooting 9-1

Troubleshooting the Luminex 100 IS. . . . . . . . . . . . . . . . . . . . . . . 9-1

Problem Diagnosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Verify the System With System Controls . . . . . . . . . . . . . 9-2

Luminex 100 Analyzer Fails Calibration. . . . . . . . . . . . . . . . . 9-3

Luminex 100 Analyzer Fails System Controls . . . . . . . . . . . . 9-3

Failure During Self-Diagnostics Tests. . . . . . . . . . . . . . . . . . . 9-4

System Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

Unknown Diagnostic Error . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

APD Temperature Range Exceeded . . . . . . . . . . . . . . . . . . . . 9-5

XYP Instrument Heater Stability Range Exceeded . . . . . . . . . 9-5

Low Voltage Detected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

Runtime Sheath Pressure Out of Limits (Too High) . . . . . . . . 9-5

Runtime Sheath Pressure Out of Limits (Too Low) . . . . . . . . 9-5

Low Laser Power Detected . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Command Encountered Time Out Error . . . . . . . . . . . . . . . . . 9-6

System Error States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Disconnected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Locked Out. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Refill Sheath. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Running: Sheath Empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Sample Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6

Insufficient Bead Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

Temperature Divergence from Calibration Temperature . . . . 9-7

Failed Control in Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

Failed Curve Fit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

Sample High/Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

Failed Standard in Batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

Sample Timed Out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8

Sample Empty Detected. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

Unknown Formula Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

Luminex 100 Analyzer Problems. . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

Power On Indicator Light Is Not On . . . . . . . . . . . . . . . . . . . . 9-9

PC Is Not Powered On. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

Sheath Fluid Is Leaking Onto the Plate Holder . . . . . . . . . . . . 9-9

Progress Bar Indicates No Events Being Collected During

Calibration or Verification. . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10

XYP Instrument Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10

Power On Indicator Light Is Not On . . . . . . . . . . . . . . . . . . . 9-10

Heater Block Will Not Reach Desired Temperature . . . . . . . 9-11

There Is a Grinding Noise When the Plate Carrier Moves . . 9-11

Software Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11

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Product Numbers 10-1

Glossary 11-1

Luminex Sheath Delivery System A-1

Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

xMAP Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3

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

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Using the Sheath Delivery System . . . . . . . . . . . . . . . . . . . . . . . . A-5

Audible Alarm and Fault LED . . . . . . . . . . . . . . . . . . . . . . . . A-5

Maintenance and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6

Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

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viii PN 89-00002-00-070 Rev. A

Introduction

About This Manual This manual introduces you to the system, and with step-by-step

instructions, it guides you through system features with procedures and explanations. Once you have a working knowledge of the system, the manual’s text and figures demonstrate what you might see along the way, offering examples when necessary. Glossary and index sections assist as references. In short, this manual instructs you through each operational stage for running the instrument.

The conventions in this manual assume a basic familiarity with computers and a knowledge of MS Windows typically document only one method of accessing a command, although many commands are available through more than one method, such as from the main menu bar, from the toolbar, and from menus that appear when you right-click an area of the screen.

® software. We

Intended Use

General System The Luminex 100 Integrated System (100 IS) is designed for a wide

range of laboratory testing applications that measure biomolecular reactions on the surfaces of xMAP intended for For In-Vitro Diagnostics Use for Export Only.

What is the Luminex 100 IS?

PN 89-00002-00-070 Rev. A 1 - 1

The 100 IS is a benchtop system consisting of a 100 analyzer, PC, monitor, keyboard, mouse, XY Platform (XYP instrument), software, bar code reader, sheath, and xMAP reagents.

The Luminex software is designed to use xMAP technology with assay kits available through kit manufacturers.

® microspheres. This system is

Luminex 100 IS User Manual Version 2.1 xMAP Technology

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

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

Customer 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 Time, Monday through Friday. Users outside of the U.S. and Canada can contact us at +1 512-381-4397 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.

1 - 2 PN 89-00002-00-070 Rev. A

Safety

Symbols 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 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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Luminex 100 IS User Manual Version 2.1 xMAP Technology

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

Luminex 100 IS instruments. A user should be present during operation. The system contains electrical, mechanical, and laser components which, if handled improperly, are potentially harmful. In addition, biological hazards may be present during system operation. 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.

Electrical The Luminex 100 analyzer and Luminex XYP must be connected to

approved power sources. Do not perform maintenance or cleaning of the system’s electrical components (except for fuses).

One of the following fuse replacement warning labels appears on the back of the Luminex 100 analyzer, depending if the instrument contains a Coherent or Uniphase laser: .

Figure 1. Fuse Replacement Warning Label - Coherent Laser

Figure 2. Fuse Replacement Warning - Uniphase Laser

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xMAP Technology Safety

This label appears on the back of the XYP instrument.

Figure 3. Fuse Replacement Warning Label - XYP

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

Figure 4. European Safety Requirement Label

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

One of the following voltage labels displays on the back of the Luminex 100 analyzer, depending if the instrument uses a Coherent or Uniphase laser:

Figure 5. Luminex 100 Voltage Label (Coherent)

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Luminex 100 IS User Manual Version 2.1 xMAP Technology

Figure 6. Luminex 100 Voltage Label (Uniphase)

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

This label appears on the back of the XYP instrument.

Figure 7. Luminex XYP Voltage Label

The XYP instrument has been tested by UL.

This system contains fluidics. In the event of a fluidic 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.

You must manually monitor waste levels—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.

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xMAP Technology Safety

Warning: If biological samples have been tested with the

system, use your standard laboratory safety practices when handling system waste.

Luminex 100 IS Laser Classification

Luminex 100 Analyzer Laser

The Luminex 100 IS system classifies per FDA 21 CFR 1040.10 as a Class II laser product consisting of a class I laser component (Luminex 100 analyzer) and a Class II laser component (barcode reader).

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

Figure 8. Laser Class Label

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

Figure 9. Laser Caution Label

Under NO circumstances should the user remove the instrument cover! When routine maintenance is performed, power to the

instrument must be OFF and the power cord must be disconnected.

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Luminex 100 IS User Manual Version 2.1 xMAP Technology

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 10. Laser Caution Label on Optics Cover

Caution: 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 être cause 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 11. Avoid Exposure Label

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xMAP Technology Safety

Bar Code Reader Laser This label appears on the bar code reader.

Figure 12. Bar Code Reader Laser Information Label

Do not stare directly into the beam or shine the beam 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.

Note: Access doors must be

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

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 sample needle. If you use the optional XYP, keep hands and fingers out of the XYP slot during operation.

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 syringe arm. If you use the optional XYP, keep hands and fingers out of the XYP slot during operation.

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Biological

Warning: Human/animal samples may contain biohazardous

infectious agents. Where exposure (including aerosol) to potentially biohazardous materials exists, operators should follow appropriate biosafety procedures and use personal protective equipment, such as gloves, gowns, laboratory coats, face shields or masks, and eye protection and ventilation devices.

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

Heat

Warning: The heater plate of the optional 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 Sample Arm simply indicates the on/off status of the instrument, and is harmless. The blue light-emitting diode (LED) does not emit light in the UV spectrum.

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xMAP Technology Safety

Decontamination of the Luminex 100 IS for Return Shipment

Sanitize and deconaminate the accessible surfaces and internal fluidics of the Luminex 100 analyzer before you ship it back to Luminex. This is particularly important when biohazardous samples have been analyzed. Make a copy of this page to fill out and return with the instrument.

Complete and return this checklist with the Luminex 100 analyzer.

1. Replace the fluid in the sheath bottle with a solution of 10%

household bleach and water.

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

3. Using a solution of 10% household bleach and water, sanitize the system using the Sanitize command on the main screen of the system. Follow this by washing twice with distilled water.

4. Disconnect the system from ac power by turning off the power switch on the rear of the system, then unplug the Luminex 100 analyzer power cord from the wall source.

5. Disconnect the sheath fluid and waste containers.

6. Drain the sheath fluid and waste containers.

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

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

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

10. Pack the system within a biohazard bag, place it in the corrugated box, then insert it in proper packaging materials. 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: _______________________

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xMAP Technology Safety

PN 89-00002-00-070 Rev. A 2 - 10

Basic Concepts

Background Information

xMAP technology is a versatile system that measures soluble analytes. The 100 IS performs simultaneous, discrete measurements of multiple microsphere-based reactions from a single specimen aliquot. For more conceptual information, refer to Practical Flow Cytometry, 3rd edition, by Howard M. Shapiro, M.D. (New York: Wiley-Liss Inc., 1995).

Fluidics There are two fluidic paths in the 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 effectively removes residual sample within the tubing, valves, and probe. Approximately 160 µL of sheath fluid is dispelled into each well following sample acquisition. The second fluidics path is driven under positive air pressure and supplies sheath fluid to the cuvette and sample path.

Excitation The excitation system in the Luminex 100 analyzer involves two

solid-state lasers. A reporter laser excites fluorescent molecules bound to biological reactants at the microsphere surface, and a classification laser excites fluorochromes embedded in the microsphere. The lasers illuminate the xMAP microspheres as they flow single file through the cuvette. RP1 refers to the excitation wavelength. CL1 and CL2 refer to the dyes embedded in the microsphere. DD refers to the channel that discriminates against doublets based on size.

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Luminex 100 IS User Manual Version 2.1 xMAP Technology

Photodiodes and a photomultiplier tube receive fluorescent signals from xMAP microspheres. The Luminex 100 analyzer digitizes the waveforms and delivers the signals to a digital signal processor (DSP). Proprietary algorithms function with the DSP to greatly increase sensitivity.

xMAP Microspheres The xMAP microspheres are highly uniform, polystyrene particles

that have been crosslinked during polymerization for physical and

Note: Protect the xMAP

microspheres from light.

thermal stability. Varying amounts of fluorochromes embedded within each microsphere give each microsphere set an unique fluorescent signal. To ensure the stability of this signal, it is essential to protect the microspheres from light. Follow package instructions for storage procedures for xMAP microspheres and assay kits.

xMAP calibrator microspheres are used to normalize the settings for the reporter channel, both classification channels and the doublet discriminator channel for the Luminex 100 analyzer.

xMAP control microspheres are used to verify the calibration and optical integrity of the system.

Software Overview This section provides a brief overview for using the Luminex 100 IS

version 2.1 software.

With the Luminex 100 IS, you work with assay kits provided by a kit manufacturer. A template is included with each kit and is imported to the Luminex 100 IS. The template includes a sequence of commands required for the assay.

Once you select the template, you enter sample data into a “batch.” Sample input can be done quickly with either the keyboard or a barcode scanner. A batch can include as many samples as you have for the assay and can include multiple microtiter plates. You can even group multiple batches together into a multi-batch for efficient processing. You can process a batch immediately or choose to archive the batch for testing later.

As testing proceeds through the plate, you will see the display update to show which wells have been processed. Progress is shown in both graphic and tabular form.

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xMAP Technology Basic Concepts

System calibrators and controls are provided as part of the system. Calibrate at least once monthly or when dCal temperature changes by ±3 degrees. You must run system controls following calibration and as often as you like to ensure that your system continues to operate optimally.

The software provides you with a variety of reports, including:

• Analyte reports with batch results grouped by the test in a batch.

• Patient summary reports with batch results grouped by each patient or unknown in a batch.

• Levy-Jennings reports with information about calibrators and system controls as well as assay standards and controls.

• Maintenance reports with a history of all maintenance operations performed during a specified period of time.

• Calibration trend reports with results of calibration commands performed over a specified time period.

• Verification trend reports with results of system controls performed over a specified time period.

These reports let you look at specific details regarding the samples you process through the Luminex 100 IS as well as system operation.

System tools help you monitor the system including a display showing real-time system property values and a message log. Errors are shown in the message log and also on your reports. You can even add comments to specific results in some of these reports as needed.

To keep track of your reagents, the Luminex 100 IS stores lot numbers, expected values, and expiration information.

A comprehensive set of self-diagnostic tests ensure that your system is working correctly. These tests are performed at startup and can be requested at any time. If any problem is detected, an error message appears in the message log to inform you.

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Installation

Assemble and Power the Luminex 100 IS System

Hardware Setup The following sections describe how to set up the hardware

Connect the

Luminex 100

Analyzer and XYP

Instrument

Before installing the system, ensure that the facility complies with all system and safety requirements. Read the safety information that begins in instrument to minimize temperature fluctuations.

components of the Luminex 100 IS.

 To assemble and power on the system:

1. Unpack the Luminex 100 analyzer, the XYP instrument, and the

2. Place the XYP instrument on a clean, flat surface.

“Safety Precautions” on page 2-2. Try to position the

PC and monitor. Review “Hardware” on page 5-2 and identify each system component.

Note: Due to the weight of the

Luminex 100 analyzer, two people are required for lifting.

PN 89-00002-00-070 Rev. A 4 - 1

3. Remove the red shipping pin. Leave the silver knob in the XYP instrument.

4. Attach the power cord to the power input module of the XYP instrument and attach the communication cable to the XYP

Figure 13. XY Platform with Red Shipping Pin

Luminex 100 IS User Manual Version 2.1 xMAP Technology

instrument. Do not plug the XYP instrument into the power outlet.

5. Place the Luminex 100 analyzer onto the XYP instrument.

6. Attach the power cords to the input module of the Luminex 100 analyzer and attach the USB cable to port 1 on the Luminex 100 analyzer. Do not plug into the power outlet. Make sure that the power switches to the Luminex 100 analyzer and to the XYP instrument are off. See connections photos on page 4-3 or the diagram on page 4-4.

7. Install the alignment guide (translucent plastic tube) by screwing it into the XYP instrument where shown. Adjust the position of the Luminex 100 analyzer with the XYP instrument until the alignment guide threads screw in completely.

Note: The ac power

requirements may vary from location to location and region to region.

Alignment guide

Figure 14. Alignment Guide

8. Set the voltage selection switch on the PC’s power supply to match the ac power available at your location to prevent damage to your PC.

Set it to 115 volts (V) in most of North and South America and some Far Eastern countries such as Japan, South Korea, and Taiwan.

Set it to 230 volts (V) in most of Europe, the Middle East, and the Far East.

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Refer to the documentation that came with your PC to determine if changing the voltage selection switch is required, and for

Note: Do not place the PC or

monitor on top of the Luminex 100 analyzer.

instructions on changing the switch setting.

9. Place the PC to the right of the Luminex 100 and XYP instruments.

10. Place the monitor on top of the PC and connect the monitor cable to the PC.

1. Monitor 4. Computer

2. Barcode Reader 5. XYP

3. Analyzer

Figure 15. Luminex 100 IS Setup

11. Connect the Luminex 100 analyzer and the XYP instrument communications cables to the PC. See the following iillustration.

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1. USB Communication Cable 9. Instrument USB Cables

2. Luminex XYP Instrument 10. Network Connection

3. Luminex XYP Instrument to PC Serial Cable

4. Power Cords 12. Y-Cable (to keyboard port)

5. Luminex XYP Instrument Power Switch 13. Mouse Cable (top port)

6. Luminex 100 Analyzer Power Switch 14. Com 2 Port

7. Luminex 100 analyzer 15. Luminex XYP Instrument Serial

8. PC 16. Com 1 Port

11. Monitor Cable

Cable

Figure 16. Luminex 100 IS Connections

12. Connect the barcode reader, mouse, and keyboard as shown in Figure 17.

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Note: The sheath and waste

containers must be placed on the same surface as the XYP instrument. Do not place the containers on top of the Luminex 100 analyzer.

1. Keyboard 3. Y-Cable

2. Barcode Reader 4. Mouse

Figure 17. Connecting the PC, Mouse, Barcode Reader, and

Keyboard

13. Fill the sheath bottle with sheath fluid to just below the air intake fitting. Install the sheath and waste containers to the left side of the Luminex 100 analyzer, connecting them with tubing to the color-coordinated connectors on the side of the Luminex 100 analyzer.

If your system uses the Luminex Sheath Delivery system, see “Appendix A: Luminex Sheath Delivery System” on page A-1.

14. Plug the Luminex 100 analyzer, XYP instrument, PC, and monitor power cords into approved outlets. We strongly recommend using an uninterruptible power supply to protect the system from power variations. Refer to “Recommended Additional Equipment” on page 5-7 for more information.

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Install or Replace the XYP Instrument Sample Probe

 To install the XYP instrument Sample Probe, which is longer

than the probe shipped with the system, follow these steps:

1. Make sure the Luminex 100 analyzer power switch is off and that the XYP instrument and the Luminex 100 analyzer power cords are unplugged from the outlet.

2. Remove the light housing directly above the Sample Arm by grasping and firmly pulling out. The housing remains attached by a wire. Place the housing on top of the analyzer.

Figure 18. Light Housing

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3. Remove the Cheminert fitting by turning the connector counterclockwise. If the tubing is difficult to remove, push up gently on the sampling probe.

1. Cheminert Fitting 2. Sample Probe

Figure 19. Cheminert Fitting

4. Remove the sampling probe by grasping the probe and gently pushing up.

Caution: The XYP instrument sampling probe should slide up

easily while removing it from the Sample Arm. If you feel resistance, do not force the probe up. Contact Customer Support.

5. Insert the XYP instrument sampling probe and replace the tubing connector. Tighten the connector by turning the connector clockwise, being careful that the threads are correctly aligned.

Hand tighten only.

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Figure 20. The XYP Instrument Sampling Probe

6. Re-install the light housing by pushing until it snaps into place.

7. Install the shield to cover the sampling probe area. This shield should only be removed for making adjustments to the probe.

Figure 21. The Clear Plastic Shield

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xMAP Technology Installation

8. Plug in the XYP instrument and the Luminex 100 analyzer.

Install the XYP

Instrument

Reservoir

The XYP instrument reservoir is used for maintenance functions in the Luminex 100 analyzer.

 To install the XYP instrument reservoir:

1. Turn on the XYP instrument, the Luminex 100 analyzer, and the PC. Wait for the Luminex 100 IS software to start.

2. Enter the lot numbers and target information (found in Certificate of Quality) for the calibrators and system controls, if necessary. Click the Apply and Save button. If there is information in the database, the system does not require you to enter the information. Click Done.

3. Click the Eject/Retract button to eject the plate holder.

4. Insert the reservoir in the upper right corner of the plate holder.

Figure 22. The XYP Instrument Reservoir

5. Click the Eject/Retract button to retract the plate holder.

Install the XYP

Instrument Heater

Use the XYP instrument heater block as required by your assay kit instructions. When not in use, you can store the XYP instrument

Block (Optional)

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heater block in the bracket inside the left access door of the Luminex 100 analyzer.

 To install the XYP instrument heater block:

1. Click the Eject/Retract button to eject the plate holder.

2. Insert the XYP instrument heater block on the plate holder.

Adjust the Sample

Probe Vertical

Height

Figure 23. The XYP Instrument Heater Block

3. Click the Eject/Retract button to retract the plate holder.

You need to adjust the vertical height of the Sample Probe each time the type or style of microtiter plate is changed.

1. Thumb Wheel 2. Height Adjustment Locking Screw

Figure 24. Thumb Wheel and Height Adjustment Locking Screw

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xMAP Technology Installation

 To adjust the vertical height of the Sample Probe:

1. Turn on the XYP instrument, the Luminex 100 analyzer, and PC. Wait for the Luminex 100 IS software to start.

2. Remove the clear plastic shield that covers the sampling probe area.

3. In a 96-well microtiter plate where overall height is no more than

0.75 inches, place appropriate alignment tool in the plate.

For a standard plate with flat-bottomed wells, stack two of the larger (5.08 mm diameter) alignment discs together and place into well A1.

For a half-volume plate with flat-bottomed wells, stack two of the smaller (3.35 mm diameter) alignment discs together and place into well A1.

For a plate with conical wells, place one alignment sphere into well A1.

4. Click Eject/Retract to eject the plate. Place the 96-well microtiter plate on the plate with position A1 in the top left corner and click Eject/Retract to retract the plate.

5. Use the 3/32 inch hexagonal allen wrench to loosen the height adjustment locking screw. See Figure 24.

6. Click the Maintenance tab.

7. Click the Sample Probe Down button to lower the Sample Probe.

8. Using the thumb wheel, lower the probe until it is just touching the top of the alignment discs or sphere.

9. Use a 3/32 inch hexagonal allen wrench to tighten the height adjustment locking screw.

10. Click Sample Probe Up to raise the sampling probe.

11. Replace the clear plastic shield that covers the sampling probe area.

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Initialization

Initialize the PC Upon powering your system, the PC runs through several self-

diagnostic tests to verify that the computer system is set up to run the system software application.

 To initialize the PC:

1. Turn on the power button on the back of the Luminex 100 analyzer and turn on the PC. If you have these devices plugged into a UPS or surge suppressor protector rather than directly into the wall outlet, turn on the surge protection power strip power switch.

2. The PC and system begin initializing automatically.

If the system initializes successfully, the software application launches. If the system does not run through its initial tests successfully, the software application does not launch and a warning appears on your PC’s monitor screen.

Initialize the

Luminex 100 IS

Software

The PC runs through the following tests during initialization:

•RAM

•ROM

• Communications with hard drive

• Communications with mouse

• Communications with keyboard

After the PC has been initialized, the Luminex 100 IS software runs through self-diagnostic tests. If a problem is detected, a warning appears on the screen. See “Unknown Diagnostic Error” on page 9-5 for more information.

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xMAP Technology Installation

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xMAP Technology Installation

PN 89-00002-00-070 Rev. A 4 - 14

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 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 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 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 microspheres are introduced to the optics path as a series of single events.

The optics assembly consists of two lasers. One laser excites the dye mixture inside the xMAP microspheres and the second laser excites the dye bound to the surface of the xMAP microspheres. Avalanche

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Luminex 100 IS User Manual Version 2.1 xMAP Technology

photo diode (APD) detectors measure the excitation emission intensities of the color coding classification dye mixtures inside the microspheres and a photomultiplier tube detects the excitation emission intensity of the reporter dye bound to the surface of the 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 allows you to test clinical samples. The system

includes the following hardware:

• Luminex 100 analyzer

• PC, monitor, and accessories

• XYP instrument

• Power cables

• Alignment guide

• Short ampling probe

• XYP instrument sampling probe

• Sample tube holder, 1.2 mL

• Sample tube holder, 1.5 mL

• Reservoir

•Shield

•Heater block

• Alignment tools

• Sheath fluid container

• Waste container

• Communications: 1 serial communication cable

• Communications: 1 USB communication cable

• Bar code reader

• Hexagonal allen wrench

xMAP Reagents • Classification calibration microspheres (CAL1)

• Reporter calibration microspheres (CAL2)

• Classification control microspheres (CON1)

• Reporter control microspheres (CON2)

• Sheath fluid

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xMAP Technology The System

Required Laboratory

• Household bleach

• 70% isopropanol

• Mild detergent

Reagents

Software Luminex 100 IS software provides complete control of the system

and performs data analysis. Your Luminex 100 IS is preloaded with the Luminex 100 IS software. However, we supply a software CD in case 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 Specifications

Speed • Speed: greater than or equal to 933 MHz Intel® Pentium® III

processor with 256 MB RAM

• USB communications link for fast data transfer

• Automatic transfer of assay templates and new reagent information into the system via a 3½” floppy disk or 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 acquiring sample, running system calibrators, running system controls, and warming up the instrument, the system resets the four-hour internal clock.

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Accuracy and Precision • Sample uptake volume ± 5%

• Classification of microspheres > 80%

• Misclassification of microspheres < 0.5%

• Temperature control 0°C to +3°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 microsphere

• Reporter channel dynamic range: 3.5 decades

Capacity The specifications below reflect minimum capacity values:

• 10 GB hard drive

• Store data for up to 240,000 test results

• 1.4 MB 3½” floppy disk

• 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

• Reporter channel range: 3.5 decades of detection

• Sample 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

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

• Microtiter plates with 96 wells must be compatible with XYP instrument heater block temperature from 35°C to 55°C (95°F to 131°F) when performing heated assays and using the heater block.

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xMAP Technology The System

Luminex 100 Analyzer

General • Operating temperature: 15°C to 30°C (59°F to 86°F)

• Storage temperature: 0°C to 50°C (32°F to 122°F)

• Humidity: 20% to 80%, noncondensing

• Altitude: Operation up to 2400 m (7874 ft.) above mean sea level

• Physical dimensions: 43 cm (17 inches) W x 50.5 cm (20 inches) D x 24.5 cm (9.5 inches) H

• Weight: maximum of 25 kg (60 lbs.)

• UL installation category: UL Installation Category II, as defined in Annex J of UL 61010A-1

• Pollution degree: UL Pollution Degree 2, as defined in Section

3.7.3.2 of UL 61010A-1

• Shipping and storage: The allowable shipping and storage temperature and humidity ranges are 0°C to +50°C and 20-80% noncondensing, respectively

• Input voltage range: 100 - 240 Vac, 1.5 Amp, 47-63 Hz or 100 120 Vac, 1.4 Amp, 47-63 Hz. (refer to the serial number label on the rear panel of the instrument)

• AC inlet fuse: 3 Amp, 250 Vac, fast acting or 2 Amp, 250 Vac, fast acting (refer to the fuse label on the rear panel of the instrument)

Optics • Reporter laser: 532 nm, nominal output 10-16.5 mW, maximum

500 mW, frequency-doubled diode; mode of operation, continuous wave (CW)

• Classification laser: 635 nm, 8 mW, maximum output 25 mW, diode; mode of operation, continuous wave (CW)

• Reporter detector: Photomultiplier tube, detection bandwidth of 565 - 585 nm

• Classification detector: Avalanche photo diodes with temperature compensation

• Doublet discrimination detector: Avalanche photo diodes with temperature compensation

Fluidics • Sheath flow rate: 90 µL ±5 µL/seconds

• Cuvette: 200 micron square flow channel

• Sample injection rate: 1 µL/second

• Sample uptake volume: 20 - 200 µL

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Electronics • Reporter channel detection: A/D resolution 14 bits

• Communications interface: USB

• XYP instrument, communications interface: RS 232

XYP Instrument

General • Ambient temperature: 15°C to 30°C (59°F to 86°F)

• Humidity: 20% to 80%, noncondensing

• Altitude: operation up to 2400 m (7874 ft) above mean sea level

• Physical dimensions: 44 cm (17.25 inches) W x 60 cm (23.5 inches) D x 8 cm (3 inches) H

• Weight: 15 kg (33 lbs.)

• UL installation category: UL Installation Category II, as defined in Annex J of UL 61010A-1

• Pollution degree: UL Pollution Degree 2, as defined in Section

3.7.3.2 of UL 61010A-1

• Heater operating range: 35°C to 55°C (95°F to 131°F) with tolerance 0°C to +2°C

• XY Platform, input voltage range: 100 - 240 V~, 1.8 Amps, 47 - 63 Hz

• AC inlet fuse: 3 Amp, 250 Vac, fast acting

PC Specifications • Computer: a Pentium® III or equivalent class PC, minimum

speed 933 MHz

• Main memory: minimum of 256 MB

• Hard disk drive: 10 GB minimum storage capacity

• Communications, serial ports: Minimum of 2 RS-232 compatible serial ports

• Communications, parallel pointing device and serial ports: Minimum of 1 parallel, 1 PS/2 compatible pointing device, and 2 RS-232 compatible serial ports

• Communications, USB port: Minimum of one USB Version 1.1 compatible high speed port

• Read, write removable media: CDR/W-type drive, standard 1.44 MB 3.5-inch disk drive

• Operating system support: MS Windows

• CE marked and UL listed

• Two-button mouse or equivalent

• Monitor: A minimum of 17-inch diagonal monitor

• Keyboard: a 104-key keyboard or equivalent

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• Power cords: Power cords specific to the country of use are included in the system as required

• Power: 115-230 V~, 5.6 Amps, 50-60 Hz

Recommended Additional Equipment

Uninterruptible Power

Supply (UPS)

Luminex highly recommends using an uninterruptible power supply (UPS) to protect your system from a power outage. Choose a supply that can provide 1050 Watts for at least 45 minutes. The UPS should be UL listed, CSA certified, CE marked when used internationally.

Surge Protector If you do not use a UPS, as a minimum, use a surge protector.

Choose a protector that meets your needs. Factors to consider include electrical environment, endurance, suppressed voltage rating, and method of protection. It should have six outlets, rated at least 1500 Watts, and be UL listed, CSA certified, CE marked for nondomestic use when used internationally

Printer • Printer, HP LaserJet 2100xi

Bar Code Labels Use the Code 128 barcode label type when scanning bar code labels

into the system as patient identities.

Vortex • VWR product number 58816-121: Speed range 0 - 3200 rpm or

equivalent

Bath Sonicator • Parmer product number 08849-00: Operating frequency 55 kHz

or equivalent

System Overview The system consists of three subsystems: electronic, fluidic, and

optical. The following section describes the user-accessible components of each subsystem.

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Figure 25. Luminex 100 IS Setup

Electronics

Power Input

Module

Communications

Port (SB9-PIN)

Luminex 100

Analyzer

Ventilation Filter

XYP Instrument

Ventilation Filter

The power input module operates from 100 to 120 Vac, 200 to 240 Vac and 47 to 63 Hz. The power input module contains the Luminex 100 analyzer on/off switch and fuses.

Used to connect the Luminex 100 analyzer or the XYP instrument to the computer.

Located on the bottom of the Luminex 100 analyzer, the filter must be checked and cleaned as necessary. For proper ventilation, do not obstruct the area below and allow at least 2 inches (5 cm) of clearance around the instrument.

Located at the back of the XYP instrument, the filter cleans the air that cools the internal components of the XYP instrument.

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Fluidics

1. Air intake filter access door

2. Power input module

3. Power switch

4. XYP instrument ventilation filter

5. Communications ports (DB9)

6. Analyzer ventilation filter (on bottom)

Figure 26. Back of the Luminex 100 Analyzer and XYP Instrument

Sample Arm The Sample Arm transports the sample from the sample tube to the

cuvette. Upon operation, the carriage drops automatically to the microtiter well for sample retrieval.

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XYP Instrument

Sample Probe

A stainless steel Sample Probe acquires a sample. A shorter probe is provided for shipping and troubleshooting.

Warning: During operation, this system contains exposed moving

parts that result in puncture hazard. Risk of personal injury is present. Keep hands and fingers away from the Sample Probe. The shield should be in place.

Cheminert® Fitting This fitting may be disconnected to allow replacement of the Sample

Probe as necessary.

This guides the Sample Probe into the XYP instrument.

Cheminert fitting

Sample arm

XYP sampling probe (see

Shield

Alignment guide

Figure 27. Cheminert Fitting

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Access Doors Two access doors are on the face of the Luminex 100 analyzer. The

center door gives you access to the syringe. The left door provides service panel access.

1. Left door, access to service panel

2. Center door, access to syringe

Figure 28. Access Doors to Luminex 100 Analyzer

Air Intake Filter A replaceable air filter cleans the air used to pressurize sheath fluid.

This filter is enclosed behind an access door located on the back of the Luminex 100 analyzer.

Figure 29. Air Intake Filter

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Syringe Located in this compartment behind the center door, the syringe

delivers a sample in the 96-well microtiter plate to the cuvette.

Figure 30. Syringe (1) and Syringe Seal (2)

Sheath Filter Behind the left door, the service panel houses a sheath filter. This

filter removes particles greater than 10 microns in diameter from the sheath fluid.

Figure 31. Sheath Filter

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Air, Waste, and

Sheath Fluid

Connectors

Located on the side of the instrument, these connectors couple directly to the sheath and waste fluid containers. The air connector is green, the sheath fluid connector is blue, and the waste fluid connector is orange.

1. Sheath Connector (Blue)

2. Air Connector (green)

3. Waste Connector (orange)

Figure 32. Air, Waste, and Sheath Fluid Connectors

Sheath Fluid

Container (not

shown)

Note: Sheath fluid levels

must be monitored manually. Check the sheath fluid level before starting a run or procedure.

Waste Fluid

Container (not

shown)

If your system uses the Luminex Sheath Delivery system, see “Luminex Sheath Delivery System” in the appendix for more information about the Sheath Delivery system and its installation.

For proper operation, this container must be placed at the same level as the base of the XYP instrument. The sheath fluid container should not be placed on top of the Luminex 100 analyzer. The sheath fluid level should be below the air inlet connection and above the sheath outlet connection.

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

use your standard laboratory safety practices.

This receives waste from the system. Waste levels must be manually monitored—do not allow the waste container to

overflow! Empty the waste container each time the sheath fluid container is filled. The waste container should not be placed on top of the instrument.

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Optical The optical system consists of the optical assembly and the excitation

lasers. The optical assemblies do not require manual adjustment by the user.

xMAP Reagents The xMAP reagent system consists of classification xMAP

calibration microspheres, reporter xMAP calibration microspheres, classification xMAP control microspheres, and reporter xMAP control microspheres.

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System Calibration

System Calibration and Verification Overview

xMAP calibrator microspheres are used to normalize the settings for the reporter channel, both classification channels, and the doublet discriminator channel for the Luminex 100 IS.

xMAP control microspheres are used to verify the calibration and optical integrity for the system.

You must calibrate at least once a month and:

• following installation

• if the system is powered off

• if the system is moved

• if a part is replaced

• if the delta calibration temperature shown on the system monitor is more than ±3 degrees.

Each step usually takes less than one minute. You must run xMAP

controls after each calibration.

Once calibrated, the calibration values remain until you calibrate again. You can track system calibration and verification results through the Calibration Trend Report and the System Control Trend Report.

Ensure that you warm up the system before calibrating.

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Calibrate the System

Run System

Calibrators

 To calibrate your system:

1. Vortex xMAP calibrators and controls containers to ensure homogeneity.

2. Load a microtiter plate with at least three drops of each: CAL1 in well A1, CAL2 in well B1, CON1 in well C1, CON2 in well D1 and sheath fluid in well E1. (You may assign different well locations, if desired.)

3. Click Eject/Retract from the toolbar. The plate holder ejects.

4. Place the plate on the plate holder.

5. Fill the XYP instrument reservoir with a solution of 70% isopropanol.

6. Click Eject/Retract from the toolbar.

7. Click Alcohol Flush from the Maintenance tab. A Confirmation Screen dialog box appears.

8. Click OK and wait until the alcohol flush completes. The Device Status section in the status bar changes from yellow to green and says “Standby”. This takes about five minutes.

9. Click New CAL Targ. from the Maintenance tab to enter or confirm the calibration lot numbers. An Update CAL Targets dialog box appears.

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Note: Ensure that you enter

the correct target values for each parameter before clicking OK. If necessary, re-enter the information to correct any incorrect information.

Note: The message log on the

Diagnostics tab shows the status of the CAL1 and CAL2 commands. If an error occurs during system calibration, the Diagnostics tab turns red.

Figure 33. Update Calibration Targets Dialog Box

10. Enter the values listed from the Certificates of Analysis included with your calibrators into the CAL1 and CAL2 entry fields.

11. Click OK. The dialog box disappears.

12. Ensure that the IS is set to draw the CAL1 and CAL2 beads from the wells where you loaded them (in step 2).

13. Click CAL1 from the Maintenance tab. A Confirmation Screen dialog box appears.

14. Click OK and wait until CAL1 completes. The device status section in the status bar changes from “Running” to “Standby”.

15. Click CAL2 from the Maintenance tab. A Confirmation Screen dialog box appears.

16. Click OK and wait until CAL2 completes. The device status section in the status bar changes from “Running” to “Standby”.

You must run system controls following calibration. Continue on to the “Run System Controls” on page 6-4.

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Run System

Controls

To run system controls, follow these steps:

1. Click New CON Targ. from the Maintenance tab to enter or confirm system control lot numbers. An Update CON Target Information dialog box appears.

Figure 34. Update CON Targets Dialog Box

2. Enter the values listed from the Certificates of Analysis included with your system controls into the CON1 and CON2 entry fields.

3. Click OK. The dialog box disappears.

4. Ensure that the IS is set to draw CON1 and CON2 beads from from the wells where you loaded them, as described in step 2 of “Run System Calibrators” on page 6-2.

5. Click CON1 from the Maintenance tab. A Confirmation Screen dialog box appears.

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6. Click OK and wait until CON1 completes. The device status section in the status bar changes from “Running” to “Standby”.

7. Click CON2 from the Maintenance tab. A Confirmation Screen dialog box appears.

8. Click OK and wait until CON2 completes. The device status section in the status bar changes from “Running” to “Standby”.

9. The message log on the Diagnostics tab shows the status of the

Note: The message log on the

Diagnostics tab shows the status of the CON1 and CON2 commands. If an error occurs during system calibration, the Diagnostics tab turns red.

CON1 and CON2 commands.

10. Ensure the IS is set to draw the sheath fluid from the well where you loaded it in step 2 of “Run System Calibrators” on page 6-2.

11. Click Wash to wash the system after running the system calibrators. A Confirmation Screen dialog box appears.

Note: If an error occurs during

system calibration, an X appears in front of the Diagnostics tab title, and the text turns red. The command list on the Run Batch tab also reports that the command failed. The picture below shows these error warnings.

Calibration and System Control Trend Reports

12. Click OK and wait until the wash completes. The device status section in the status bar changes from “Running” to “Standby”.

Figure 35. Command List and Diagnostics Tab Error Warnings

You can track the results of calibrations and system controls by accessing the Calibration Trend Report or the System Control Trend Report. You can also see information about the expiration date of calibrators and system controls in these reports. These trend reports display a history of calibrations or system controls for a selected date range.

You can print these trend reports. However, you must install the printer on the computer system prior to initiating the print command.

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Print or View a

Calibration or

System Control

Trend Report

You must enter information about the date range you want to print a report about.

 To create a trend report for a date range:

1. Click the Print button on the Home tab. A Report Selection dialog box appears.

Figure 36. Report Selection Dialog Box

2. Select Calibration Trend Report or System Control Trend Report and click Next. A product selection dialog box appears

displaying the selected report.

Figure 37. Product Selection Dialog Box

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3. Select the product for the trend report and click the Next button. A new dialog box appears.

Figure 38. Lot and Date Selection Dialog Box

4. Select the reagent lot and expiration date, and the date range (with the starting and ending date) that you want and click Finish. A Calibration Trend Report Print Preview appears using the information you entered.

Figure 39. Report Print Preview

5. If desired, click the Print button on the toolbar. Wait for the report to print on your printer.

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Luminex 100 IS 2.1 Software

The Luminex 100 IS (IS 2.1) software starts automatically when you turn on the system, which includes the Luminex 100 analyzer, XYP instrument, and PC. An animated splash screen (shown below) appears for about ten seconds.

Figure 40. Luminex 100 IS Software Splash Screen

The system requires you to enter essential information before the system can open fully.

Getting Started When using a new system for the first time, the system has no pre-

existing data in its database, so you must enter xMAP calibration and control targets before the system can proceed to the main menu.

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The calibration and control target values can be found on the certificate of analysis included in the shipment of products.

After the initial splash screen disappears, the system prompts you to enter calibration and control target values.

The system stores the information you enter into the database and proceeds to the main software screen.

When entering information into the system, you may see an asterisk (*) at the top-right corner of the entry field. The asterisk indicates that this information is required. If a field does not have an asterisk by it, then that information is optional and not required.

Figure 41. Entry Field With Asterisk Example

Enter xMAP

Calibration and

Control Targets

For the First Time

A dialog box appears telling you that you must enter xMAP calibration and control target values if you have never entered these values into the system.

 To enter xMAP calibration and control targets:

1. Click OK on the initial dialog box to enter these target values.

2. Enter the lot number, expiration date, and target values for CAL1 and CAL2. This area includes an optional area in which you may enter comments regarding the calibration and control lots.

3. Enter the lot number, expiration date, and target values for CON1 and CON2.

4. Click OK. The Update CON Targets dialog box closes. The main screen of the IS software appears.

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IS 2.1 Main Screen After entering the calibration and control target values, the main

screen appears.

2 3

1. Main Screen

2. Menu Bar

3. Toolbar

4. Tabs

5. Status Bar

Figure 42. IS 2.1 Main Screen

It includes menus and tools that help you to use the software and to monitor the progress of the acquisition and diagnostic processes. These tools include: menus, button categories organized in groups of typical user activities; a status bar; tabs providing access to specific types of information, commands, and features.

The main screen contains several command buttons separated into categories according to phases of typical use during a batch. These categories include: Daily Startup, Instrument Calibration, Batch Setup, Reports and Analysis, and Daily Shutdown.

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Menu Bar The main screen in the IS 2.1 software has three menus: File, Tools,

and Help. You may access other system operations through these menus.

Enter General

Information

The system lets you set up and, to a degree, customize the system software as well as enter information about your company. You may change or update this information as often as you feel it is necessary.

You may configure the system’s operation when raw data, exporting batches, and saving batches. You can also disable the confirmation screen display option so that commands initiated from the Maintenance tab do not display confirmation screens before performing the command. The confirmation screens still appear for commands initiated from the Home tab. You can also enter your user name into the software as you feel it is necessary.

 To enter general information into the system, follow these steps:

1. Click Too ls from the menu bar and select Options. A Luminex 100 IS Software - Options dialog box appears.

Figure 43. Options Dialog Box: General Tab

2. Click the General tab, if necessary.

3. Select whether or not to enable raw data storage, report raw fluorescence values to appear on reports, and automatically export batches by clicking the check boxes. The need to select these options may vary according to each assay kit that the system analyzes.

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Note: A confirmation screen

dialog box appears after you initiate certain commands. This dialog box tells you what is required to complete the task that you initiate and verifies that you want to proceed with that command.

Enter Company

4. Enter a new batch directory if you want the batch located in a location other than C:\My Batches (the system default location).

5. Select whether to display confirmation screens.

6. Enter the current user name and click OK. The system saves the general information.

 To enter your company information into the system:

Information

1. Click Too ls from the menu bar and select Options. A Luminex 100 IS Software - Options dialog box appears.

2. Click the Company Information tab.

Figure 44. Options Dialog Box: Company Information Tab

3. Enter your company’s name, address, phone, and fax numbers.

4. Click OK. The system saves the company information in the database.

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Toolbar The main screen has a toolbar that contains several buttons to initiate

IS commands.

1. Import Templates 7. Export Batch Data

2. New Batch 8. Print Report

3. Open Batch 9. Connect to the Instrument

4. Create New Multi-Batch 10. Disconnect from the Instrument

5. Open Multi-Batch 11. Eject/Retract

6. Start Analysis 12. Open Help Files

Figure 45. System Toolbar

Status Bar The main screen includes a status bar along the bottom of the screen

that shows the system’s status. Check the status bar periodically while running a batch to ensure that the system is performing accurately.

Figure 46. System Status Bar

The system displays information about the command state, device status, device activity, laser status, total events per second, and region events per second using color coding to indicate the urgency of each item’s status (excluding device activity).

The device activity section on the status bar uses no color coding.

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The following table describes the color coding with relation to types of message received in the status bar.

Table 1. Status Bar Color Coding

Category Indicates

Command State

Green Idle or processing

Yellow Connecting, pausing, or paused

Red Disconnected or locked out

Device Status Indicates the current process of or warning

Green Running or standby

Yellow Busy, pressurizing, sheath is empty, or warming

Red Not ready or disconnected

Device Activity

Possible activities include:

Indicates communication with the analyzer or operations being processed

about the analyzer

Indicates the activity the Analyzer is performing

Note: The device activity has no color code.

• Idling: waiting for a command

• Aspirating: drawing in sample

• Collecting Data: collecting data

• Sanitizing: sanitizing the instrument

• Washing: washing the instrument

• Priming: priming the instrument

• Calibrating: calibrating the instrument

• Canceling: canceling a command

• Backflushing: backflushing the instrument

• Draining: draining the instrument

• Warming Up: warming up the instrument

• Verifying: verifying calibration

• Self Diagnosing: performing self diagnostic routine

• Soaking: soaking the probe

Laser Status Laser temperature and readiness status

Green Lasers warmed up

Yellow Warmup timer countdown

Red Lasers off

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Table 1. Status Bar Color Coding (Continued)

Total Events/ Second

Region Events/ Second

Number of total bead events detected per second

Number of sample reactions detected per second

Both template and manual commands appear on the status bar as the system processes the command. Errors also appear in the message log.

The Diagnostics tab should turn red if the system encounters an error. The message log on the Diagnostics tab should indicate where the error occurred.

Status Communication The table below shows details regarding typical messages that appear

in the status bar.

Table 2. Status Bar Communication Message Details

Status Bar

Color

Green Idle This term appears when the

Message Indicates

instrument is ready and waiting for a command from you.

Standby This term indicates that the

analyzer is ready and waiting for a command to perform.

Yellow Connecting This term appears when the

software attempts to connect to the instrument.

Processing This term appears when the

instrument communicates with the software as it processes commands.

Pausing This term appears when the

software asks the instrument to stop processing the list of commands and the instrument finishes up the active command.

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Table 2. Status Bar Communication Message Details

Status Bar

Color

Red Disconnected This term appears when the

Message Indicates

Paused This term appears when the

software stops processing the list of commands. A “resume” function becomes available to change the state back to “processing.”

software has not yet attempted to connect or fails to connect to the instrument. To connect the instrument, power on the analyzer, then the XY Platform and click Connect on the toolbar.

Locked Out This term appears when another

application currently has control of the instrument. The software locks out as long as the other application runs. To remove the locked out status, close the other application or wait until the application completes.

Tabs The main screen contains four tabs: Home, Run Batch, Maintenance,

and Diagnostics. These tabs contain different features and commands performed during various stages of the sample acquisition process.

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Home Tab The home tab appears as part of the main screen and contains a

favorites section as well as five categories representing different phases of data acquisition, including daily startup, instrument calibration, batch setup, reports and analysis, and daily shutdown.

Figure 47. Home Tab

Favorites Section The Favorites section contains a list in which you can add

frequently-used templates and commands for easy access. You can tailor the favorites section to your specific needs. For instance, if there is a template that you use often, such as a calibration and controls template, you may want to include this template in your favorites list.

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The templates and commands appear in alphabetical order for easy locating.

Add Templates To

Favorites

Figure 48. Favorites Section

 To add templates to the favorites section:

1. Click the Add Template button from the favorites section. An Open Template dialog box appears.

2. Select the template that you want to add to your favorites section.

3. Click Open. The template name that you selected appears on the Favorites section list.

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Add Commands to

Favorites

Note: Ensure that the location

you select is compatible with the volume intended for that location. The location’s capacity may vary depending on the microtiter plate sizes used.

 To add commands to the favorites section:

1. Click the Add Command button from the favorites section. A Command List appears.

Figure 49. Command List Dialog Box

2. Select the command that you want to add to your favorites list.

3. For certain commands, select the location from which you want to draw or expel fluid using the location drop-down arrow and clicking the mouse to the location on the microtiter plate image. This location “tells” the system the reservoir or well from which you want the system to draw or to which you want to expel fluid.

Figure 50. Well and Reservoir Selection Image

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Remove Items

From Favorites

Data Acquisition Categories

 To remove items from the favorites section:

1. Select the item you want to remove from the favorites list.

2. Click Remove. The item disappears from the favorites list.

The main screen contains categories representing different phases of data acquisition. Each category consists of a group of command buttons associated with typical phases of data acquisition. At the click of a button, the system performs or initiates the process to perform the function for the button you click.

The Daily Startup section allows you to perform the recommended daily startup procedure by selecting the buttons in the order they appear. These buttons include warm up, prime, alcohol flush, and wash the system (sheath fluid). See “Maintenance Tab” on page 7-18 for more detailed information regarding startup functions.

The Instrument Calibration section lets you perform system calibration and control functions. This section within the home tab contains CAL1, CAL2, CON1, and CON2 buttons.

The Batch Setup section lets you create a new batch, create a multibatch, and create new lots for an assay’s standards and controls.

The Reports and Analysis section lets you analyze the data acquired from your batches as well as compile and print reports from this analysis.

The Daily Shutdown section consists of two operations typically recommended during daily shutdown procedures. This section lets you sanitize (bleach) and soak (distilled water) the system.

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Run Batch Tab The Run Batch tab contains an information area for batch statistics, a

microtiter plate image, plate command buttons, and XYP command buttons and settings.

1. Reservoir 2. Pressure Range

Figure 51. Run Batch Tab

Microtiter Plate The Run Batch tab shows an image representing the microtiter plate

where you place samples. The system analyzes sample from wells on the microtiter plate vertically, from top-to-bottom (A1) within the column and left-to-right after each column, as shown below.

Figure 52. Microtiter Plate Image

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Reservoir The reservoir holds fluids used in system maintenance operations

such as washing, draining, or sanitizing. You can find the reservoir at the top right of the XYP plate holder. The vertical rectangle to the right of the microtiter plate represents the reservoir on the run batch tab of the IS software screen.

Temperature and Pressure Gauges

Note: While warming, the

temperature can fluctuate. Wait for the temperature to stabilize before acquiring sample.

Proper temperature and sheath pressure are essential to optimal system performance. When you calibrate and verify the system, it warms the temperature and pressurizes for the system’s peak performance.

The XYP heater temperature measures the internal XYP plate temperature. The DD temperature measures the doublet discriminator temperature.

DD temperature shifting often indicates a need for system recalibration. If you see that your DD temperatures are out of range (indicated when the DD Temperature thermometer turns red), recalibrate the instrument.

These gauges monitor the temperature and sheath pressure and show them to you:

Figure 53. Temperature and Pressure Gauges

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Set the XYP

Instrument Heater

Temperature

Note: The heating function is

not intended for use with standard 96-well microtiter plates.

Refer to your assay kit instructions to see if the assay needs to be analyzed at a particular temperature. If the instructions indicate that the XYP instrument heater is needed, you must manually set the heater to the specified heat setting. Use the heater only with the XYP instrument heater block in place.

Any temperature that you set remains in effect until you set another temperature or turn off the XYP instrument plate heater.

The system displays the target temperature in the entry field below the ON button. Before the heater block temperature reaches the new temperature setting, the XYP Heater Temperature thermometer appears red. Upon reaching the target temperature, the thermometer turns green. See “System Monitor” on page 7-31 for more information about the system monitor.

Warning: The heater plate of the XYP instrument is hot when in

use and may cause personal injury. Do not touch the heater plate.

Prior to being turned on or set, the ON button appears gray and disabled.

 To set the XYP instrument heater temperature:

1. Insert the XYP instrument heater block into the plate holder.

2. Click the ON button. The light on the button turns green and the thermometer fluid turns red as it raises to reach the target temperature.

3. Click and drag the blue arrow on the XYP instrument Heater Temperature thermometer to the temperature you want the XYP instrument heater block to maintain.

4. Wait for the heater to reach your selected temperature and stabilize, and the thermometer to turn green before processing samples.

Command List The Command List lists commands associated with batches or multi-

batches that you have loaded for processing on the system. The command list also tells you the status of each command as the system begins processing it. For instance, the command list shows that the system is washing while processing a wash command. The

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command list also tells you whether the command completed successfully or if it failed.

Figure 54. Command List Section on the Run Batch Tab

An example of a failed command in the command list on the Run Batch tab follows below:

Figure 55. Command Failure Notation In Command List

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Maintenance Tab The maintenance tab lets you perform several maintenance

operations, XYP commands, and calibration and verification commands as you feel appropriate during system use.

As-Needed Maintenance Operations

Note: The Sanitize command

performs a similar function to the alcohol flush command. However, the sanitize command uses 10% household bleach to decontaminate sample lines and the cuvette after biohazard contact.

Figure 56. Maintenance Tab

Performing these operations helps maintain your system and keep it in optimal working condition. Follow the step-by-step instructions for each operation (found after this section) when using as-needed maintenance operations:

•Warmup

•Prime

• Backflush

• Alcohol Flush

• Sanitize - may be restricted to reservoir due to volume requirement

•Wash

•Drain

•Soak

• Self Diagnostics

The following table shows a recommended use schedule for asneeded maintenance operations.

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Table 3. Maintenance Operations:

Recommended Use Schedule

Maintenance

Operation

Warmup • daily

• after 4 hours of system inactivity

Prime After:

• refilling the sheath container

• removing and replacing sheath container

• changing the sheath fluid filter

• changing the syringe seal

Backflush troubleshooting purposes only:

• to remove obstructions from the cuvette

• if fluid does not flow through the waste

• if fluid drips from the Sample Probe during

Alcohol Flush • to remove air bubbles from the cuvette

Sanitize • to decontaminate sample lines and

Recommended Use Schedule

tubing during prime cycles or during sample acquisition

priming and forms puddles of fluid on the plate

using 70% isopropanol

cuvette after biohazard contact using 10% household bleach

Wash • as needed using sheath fluid or distilled

water

Drain • troubleshooting purposes only

The cuvette in the system can be drained temporarily and refilled in preparation for running. Draining the system helps to remove debris from the bottom of the cuvette.

When draining, you do not need to supply solution. Draining takes approximately two minutes and should be followed by an alcohol flush using 70% isopropanol.

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Table 3. Maintenance Operations:

Recommended Use Schedule (Continued)

Warm Up the

System

Maintenance

Operation

Soak • daily, at the end of the day for shutdown

• to prevent salt crystals from forming in the

Self Diagnostics • to see if the device and all system

Recommended Use Schedule

probe due to exposure to air. Soaking the probe replaces sheath fluid in the probe with water. The system uses at least 250 µL of distilled water.

operations are running correctly

If an error occurs, the Diagnostics tab appears (with the tab heading in red text) and the row where the error occurred highlighted. You can double click that row to see a detailed description of the error in a dialog box.

Warming up the system is essential to ensure successful data acquisition.

Caution: Failure to properly warm up the system will effect

system performance.

Warm up the system to prepare the optics prior to sample acquisition. The system automatically begins warming up upon powering on. Warmup takes approximately thirty minutes (shown in seconds in the status bar). Wait until the warmup completes before processing samples.

After four hours of inactivity (e.g., you have not analyzed samples), the status bar appears red and indicates that the lasers are off. You need to warm up the system again by manually initiating warmup procedures.

 To warm up the system:

1. Click Warmup. A confirmation dialog box appears to verify that you want to warm up the system.

2. Click OK to continue. The Device Activity section in the status bar indicates that the lasers are warming. Upon completion, the Laser Status area in the status bar becomes green and says, “Warmed Up.”

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Prime the System Prime the system as necessary to remove air from the system’s

fluidic pathways after:

• refilling the sheath container

• removing and replacing the sheath container

• changing the sheath fluid filter

• changing the syringe seal

When priming, sheath fluid from the sheath fluid container is used. You do not need to supply solution in a plate. Priming takes approximately one minute.

 To prime the system:

1. Click Prime. A confirmation dialog box appears to verify that you want to prime the system.

2. Click OK to continue. The command list on the Run Batch tab indicates that the system is priming. Upon completion, the command list indicates whether the command succeeded with green text or the command failed with red text.

Backflush the

System

Backflush the system to perform these tasks:

• to remove obstructions from the cuvette

• if fluid does not flow through the waste tubing during prime cycles or during sample acquisition

• if fluid drips from the Sample Probe during priming and forms puddles of fluid on the plate

When backflushing, the system uses sheath fluid from the sheath fluid container. You do not need to supply solution in a plate. Backflushing takes about seven seconds.

 To backflush obstructions from the cuvette:

1. Click Backflush. A confirmation dialog box appears verifying that you want to backflush the system.

2. Click OK to continue. The command list on the Run Batch tab indicates that the system is backflushing. Upon completion, the command list indicates whether the command succeeded with green text or the command failed with red text.

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Alcohol Flush the

System

Sanitize the

System

Alcohol flush the system to remove air bubbles from the cuvette using 70% isopropanol. The cuvette is the principal fluid pathway within the optics component of the system through which the system reads sample. The alcohol flush takes about six minutes.

 To remove air bubbles from the cuvette, follow this step:

1. Click Alcohol Flush. A confirmation dialog box appears to tell you to place alcohol flush solution (70% isopropanol) in the reservoir.

2. Click Eject/Retract. The plate holder ejects.

3. Place the solution in the location you indicated and click Eject/ Retract to retract the plate holder.

4. Click OK to continue. The command list on the Run Batch tab indicates that the system is sanitizing. Upon completion, the command list indicates whether the command succeeded with green text or the command failed with red text.

Sanitize the system to decontaminate the sample lines and the cuvette after biohazard contact using 10% household bleach. Luminex recommends sanitizing as part of your daily shutdown routine after biohazard contact. Sanitizing uses the XYP reservoir location because only the reservoir can accommodate the amount of fluid necessary to sanitize the instrument.

 To sanitize for decontamination (10% bleach):

1. Click Sanitize. A confirmation dialog box appears telling you to place sanitize solution (10% bleach) in the reservoir.

2. Click Eject/Retract. The plate holder ejects.

3. Place the solution in the reservoir and click Eject/Retract to retract the plate holder.

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Wash the System Use the wash cycle as needed using sheath fluid. For example, wash

with sheath fluid after calibration. Place at least 200 µL in a microtiter well or fill the XYP instrument reservoir with the sheath fluid. Washing takes about 30 seconds.

Luminex recommends that you wash after calibration, verification using controls, between batches and multi-batches, and daily shutdown

 To wash the system:

1. Click Wash. A confirmation dialog box appears telling you to place wash solution into the reservoir or well indicated.

2. Click the drop-down arrow to the right of the Wash button. An image of the microtiter plate and reservoir in the plate holder appears.

Figure 57. Well and Reservoir Selection Image

3. Select the location for the wash solution and click Eject/Retract. The plate holder ejects.

4. Place the solution in the location you indicated and click Eject/ Retract to retract the plate holder.

5. Click OK. The command list on the Run Batch tab indicates that the system is washing.

6. Wait for the wash to complete. Upon completion, the command list indicates whether the command succeeded with green text or the command failed with red text.

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Drain the System The cuvette in the system can be drained temporarily and refilled in

preparation for running. Draining the system helps to remove debris from the bottom of the cuvette. We do not recommend routinely draining the cuvette. Use Drain only for troubleshooting purposes.

When draining, you do not need to supply solution. Draining takes approximately two minutes and should be followed by an alcohol flush with 70% isopropanol.

Note: Ensure that the location

you select to expel fluid to is compatible with the volume expelled.

Any fluid that drains from the system drains to the reservoir as the default. However, you can set the system to drain to any unused well on the microtiter plate. The drain function normally expels 125 µL of fluid.

 To drain the system:

1. Click Drain. A confirmation dialog box appears.

2. Click the drop-down arrow to the right of the Drain button. An image of the microtiter plate and reservoir appears in the plate holder.

3. Select a location in which the fluid can drain using the image of the microtiter plate and reservoir, and click Eject/Retract. The plate holder ejects.

4. Verify that the location you indicated is empty and click Eject/ Retract to retract the plate holder.

5. Click OK to continue. The command list on the Run Batch tab indicates that it is draining. Upon completion, the command list indicates whether the command succeeded with green text or the command failed with red text.

Soak the Probe Use the Soak command to prevent salt crystals from forming in the

probe due to exposure to air. Soaking the probe replaces sheath fluid in the probe with water. You should perform the soak function at the end of each day.The system uses at least 250 µL of distilled water.

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 To soak the probe:

1. Click Soak. A confirmation dialog box appears.

Figure 58. Confirmation Screen Dialog Box

2. Click the drop-down arrow to the right of the Eject/Retract button. An image of the microtiter plate and reservoir appears in the plate holder.

Note: The system may show a

default location from which to draw fluid. In this case, the microtiter plate shows that well with a yellow line inside the well.

Figure 59. Microtiter Plate Image For Location Selection

3. Select a location from which to draw fluid using the image of the microtiter plate and reservoir, and click Eject/Retract. The plate holder ejects.

Click the X button at the top-right corner of the screen to close the image of the microtiter plate. The image disappears.

4. Verify that the location you indicated is empty, place the distilled water in the location, and click Eject/Retract to retract the plate holder.

5. Click OK to continue. The command list on the Run Batch tab indicates that it is soaking. Wait until the soak command completes before initiating another command. Upon completion, the command list indicates whether the command succeeded with green text or the command failed with red text.

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Run Self

Diagnostics

Run self diagnostics to see if the device and all system operations are running correctly. The system tests these functions when running self diagnostics:

• Flash memory test

• Microcontroller RAM test

• Nonvolatile memory test

• DSP program CRC test

• DSP capture test

• High voltage module

• Channel backgrounds test

• Pressurization test

• Actuator test

• Syringe pump test

• Backflush valve test

 To run self diagnostics:

1. Click the Self-Diagnostics button from the maintenance tab. A confirmation dialog box appears.

2. Click OK. The system begins processing the various self diagnostic tests. As it completes the tests, the status bar changes from a “Processing” command state to an “Idle” command state.

The self-diagnostic test should take less than one minute to complete. If the self diagnosis failed, the system lets you obtain more detailed information regarding the results of the selfdiagnostic test.

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View Failed Self-

Diagnostic Details

 To view details regarding which of the self-diagnostics tests

passed or failed:

1. Select the Diagnostics tab and view the message log. At least one error from a failed self-diagnostics test appears with a yellow background.

2. Double click the yellow row for which you want to see a more detailed description. An Errors dialog box appears showing a list of passed and failed self-diagnostic tests.

3. Click OK to close the dialog box. A dialog box appears indicating which of the self-diagnostic tests passed or failed. Click OK to close this dialog box.

See the Troubleshooting chapter in this manual if the self-diagnostic routine reports a failure.

XYP Commands XYP commands let you eject or retract the plate holder on the XYP

instrument, command the Sample Probe up or down, and run self diagnostics.

Calibration and Verification

Set Well Locations for Calibration and

Enter System

Controls

Calibration

Targets

You can run calibration and verification commands from the Maintenance tab on the main screen.

 To set the locations on the microtiter plate for calibration and

control solutions:

1. Click the drop down arrow at the end of the entry cell. A list of well locations appears below the arrow.

2. Click the well location on the microtiter plate image.

 To enter new and changed system calibration targets:

Refer to the Certificates of Quality included with the xMAP calibrators to find the reagent.

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1. Click New CAL Targ. from the Maintenance tab. An Update Cal Targets dialog box appears.

Note: Ensure that the correct

target values are added for each parameter before clicking OK. If necessary, re-enter the information to correct any incorrect information.

Figure 60. Update Calibration Targets Dialog Box

Enter the values listed in the kit manufacturer’s instructions or Certificate of Analysis included with your kit into the CAL1 and CAL2 entry fields.

2. Click OK. The database saves the updated calibration and control values.

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Enter System

Control Targets

 To enter new and changed control targets:

1. Click New CON Targ. from the Maintenance tab. An Update CON Targets dialog box appears.

Figure 61. Update Control Targets Dialog Box

Note: Ensure that the correct

target values are added for each parameter before clicking OK. If necessary, re-enter the information to correct any incorrect information.

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2. Enter the values listed in the kit manufacturer’s instructions or Certificates of Analysis included with your controls into the CON1 and CON2 entry fields.

3. Click OK.

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Eject and Retract

the XYP

Instrument Plate

Holder

Lower and Raise

the Sample Probe

 To eject the XYP instrument plate holder:

1. Click Eject/Retract from the toolbar on the Maintenance tab. The XYP instrument plate holder ejects.

2. Click Eject/Retract. The XYP instrument plate holder retracts.

Lower the Sample Probe when you are adjusting the Sample Arm, adjusting the Sample Probe height when using different plates, or as necessary.

 To lower the Sample Probe:

1. Click the Sample Probe Down button from the maintenance tab. The Sample Probe lowers. Red text appears above the Eject button in the XYP commands section warning you to raise the Sample Probe after the Sample Arm adjustment is complete.

The Sample Probe Down button toggles to show Sample Probe Up after you tell the system to lower.

2. Click the Sample Probe Up button. The Sample Probe raises back up to the ready position.

The Sample Probe Up button toggles to show Sample Probe Down after you tell the system to raise.

Diagnostics Tab The Diagnostics tab lets you see the progress of commands you

initiate within the system as well as specific details regarding each sample analysis and the state of system components. The tab contains the system monitor, message log, detailed sample progress chart, and the status bar.

Figure 62. Diagnostics Tab

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These tools help you find information about the system and what happens during sample acquisition, data reduction, and other functions.

For instance, if you return to the system to run an operation after taking a break, you can look at the Diagnostics tab at the system monitor to verify if you need to recalibrate.

System Monitor The system monitor provides information on the status of the system

and various components within the system.

Figure 63. System Monitor

Table 4 lists representative values. Your values may vary from those shown.

Table 4. System Monitor Values

Property Value

Air Pressure 7.5 ± 1.5 PSI

Sheath Pressure 7 PSI

Delta Cal Temperature 0°C

Board Temperature 30°C

CL1 Temperature 25°C

CL2 Temperature 25°C

XYP Instrument Board Temperature

XYP Instrument Heater Temperature

XYP Instrument Heater Temperature In Range

40°C

45°C

Yes

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The system monitor provides values and units of measure for each property. It uses the following units for the displayed values:

• Air Pressure, PSI (used during sample acquisition, only)

• Sheath Pressure, PSI

• Delta Cal Temperature, ºC

• Board Temperature, ºC

• CL1 Temperature, ºC

• CL2 Temperature, ºC

• XYP Board Temperature, ºC

• XYP Heater Temperature, ºC

• XYP Heater In Range, Yes or No or N/A if the heater block is not turned on

The system monitor provides information about the physical state of the IS device, lasers, and acquisition.

The values in the system monitor are reported directly from the Luminex 100 analyzer and the XYP instrument.

The system monitor also indicates whether CAL1, CAL2, CON1, and CON2 results completed successfully or not by displaying the text in green if the event is successful and in red text if the event is unsuccessful.

Detailed Sample Progress The detailed sample progress shows you, in chart form, how much of

each operation has elapsed. The chart shows real-time progress, so that as each sample is analyzed, the chart adjusts to show progress.

Show no more than 20 tests at a time. A scroll bar lets you shift the test frame.

Toggle bead ID or test name.

Figure 64. Detailed Sample Progress

Message Log The software shows you a list of completed commands as well as

errors and warnings in the message log on the lower part of the diagnostics tab. The message log shows a history of past functions

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and commands that the system has performed as well as each operation’s progress, time and date, and results.

Figure 65. Message Log

You also see a message in the log if multiple microtiter plates have been used during a batch.

The log also displays actions in color-coded text and shading. Items in the message log appear in the following color code:

Error Messages in the Message Log

• Green text represents a successful system calibration, verification command, an acquisition, or maintenance functions.

• Red text represents failed commands or errors.

• Black text represents normal processes and actions.

• Yellow shading behind the text represents that a detailed description about the processes or actions is available. This color may vary from system to system depending on your tool tip color system settings.

This color shading appears only when a more detailed explanation exists for the item.

To see this detailed description, double-click the row that is shaded in yellow. A dialog box appears providing details about that action or process. This function is particularly helpful if you need to diagnose a problem with the system or reagents.

If an error occurs during the batch, it is recorded in the message log. See the subsection below this paragraph for more information about errors.

If an error occurs within your operations, click the diagnostics tab and look at the message log. The error will appear as a row with red text. If the row with the red text has a yellow background, double

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click that row. An error dialog box appears with details about that error.

Batches A batch is a group of samples that will be processed using a single

template. Batches consist of templates, lots, and samples for acquisition and can span more than one plate.

Templates are provided by the assay kit manufacturer via CD ROM or floppy disk. When creating a new batch, you must use a template. Information that you enter does not override or change the template.

The kit manufacturer includes reagent assays in your assay kit. The system requires you to provide information about the reagent assays you want to use in the batch.

A batch can include more than one plate. If you run out of wells on the microtiter plate, another plate appears for additional samples. The new plate appears to the immediate right of the existing plate image on the screen with a dark line between the adjacent columns of the two plates.

Templates When creating batches or multi-batches, you must select a template

to associate with the batch.

Templates are pre-defined sequences of commands that an kit manufacturer has determined must be performed during each batch acquisition.

Import a Template Your assay kit provides a template on a diskette specific to the kit.

You need to import new templates to the system only once. Templates can include standards or controls, maintenance commands, and patient acquisition commands.

 To import a template from diskette:

1. Insert the kit’s diskette into the disk drive.

2. Click the Import Template button on the toolbar. This dialog box appears.

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Figure 66. Import Template Dialog Box

3. Select your floppy disk drive as the Look in location.

4. The kit manufacturer’s template appears on the selection list. Click the name of the template.

Lots

5. Click Open. The template is now loaded and available for use.

You can import templates from other areas within your computer such as another drive or a CD ROM. To select a different location using the Look in drop down box, click the drop down arrow.

Before you can build a batch, you must enter lot information for the reagents that you want to use in the batch.

Create New Lots  To create a new lot:

1. Click New Lot from the Home tab. An Open Template dialog box appears.

Figure 67. Open Template For New Lot Dialog Box

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Note: Depending on the types

of products associated with the template you select, the screen may vary from this example

2. Select the template in which you want to apply the new lot and click Open. The system applies the lot you are creating to the template. An Update Lot Information dialog box appears.

Figure 68. Update Lot Information Dialog Box

3. Click New Lot. A New Lot dialog box appears, prompting you to enter the new lot’s number.

Figure 69. Add Lot Dialog Box

4. Enter the new lot’s number and click OK.

5. Enter the expiration date, and the lot information target values provided in the kit manufacturer’s instructions.

6. Click Save.

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Specifications and Main Features

Frequently Asked Questions

User Manual