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
EC
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
iv PN 89-00002-00-070 Rev. A
xMAP Technology
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
PN 89-00002-00-070 Rev. A v
Luminex 100 IS User Manual Version 2.1 xMAP Technology
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
vi PN 89-00002-00-070 Rev. A
xMAP Technology
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
PN 89-00002-00-070 Rev. A vii
Luminex 100 IS User Manual Version 2.1 xMAP Technology
viii PN 89-00002-00-070 Rev. A
Introduction
1
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
2
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)
PN 89-00002-00-070 Rev. A 2 - 1
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
2 - 2 PN 89-00002-00-070 Rev. A
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)
PN 89-00002-00-070 Rev. A 2 - 3
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.
2 - 4 PN 89-00002-00-070 Rev. A
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.
PN 89-00002-00-070 Rev. A 2 - 5
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
2 - 6 PN 89-00002-00-070 Rev. A
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.
PN 89-00002-00-070 Rev. A 2 - 7
Luminex 100 IS User Manual Version 2.1 xMAP Technology
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.
2 - 8 PN 89-00002-00-070 Rev. A
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: _______________________
PN 89-00002-00-070 Rev. A 2 - 9
xMAP Technology Safety
PN 89-00002-00-070 Rev. A 2 - 10
3
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.
PN 89-00002-00-070 Rev. A 3 - 1
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.
3 - 2 PN 89-00002-00-070 Rev. A
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.
PN 89-00002-00-070 Rev. A 3 - 3
Luminex 100 IS User Manual Version 2.1 xMAP Technology
3 - 4 PN 89-00002-00-070 Rev. A
4
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.
4 - 2 PN 89-00002-00-070 Rev. A
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