Luminex MAGPIX User Manual

®

IVD MAGPIX

Hardware

Installation and User

Manual

Luminex IVD MAGPIX Hardware Installation and User Manual

WMDE
Bergerweg 18
6085 AT Horn

The Netherlands

© Luminex Corporation, 2010. 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

Voice: [phone]

Fax: [phone]

U.S.A.

Luminex® IVD MAGPIX® Hardware Installation and User Manual

PN 89-00002-00-272 Rev. A

October 2010

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.

2

The following are trademarks or registered trademarks of Luminex: Lumine x, xMAP,
MagPlex,

All other trademarks, including Windows, Sporicidin, Cole-Parmer
are trademarks of their respective companies.

xPONENT, and MAGPIX.

, Parafilm, and ProClin

Standard Terms and Conditions For Use of Instrument Product

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

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

2. Warranties - THIS WARRANTY IS APPLICABLE FOR PARTS AND SERVICE FOR LUMINEX INSTRUMENTS
PURCHASED DIRECTLLY FROM LUMINEX TO BUYER AND ONLY TO THE EXTENT SUCH INSTRUMENTS ARE
LOCATED IN NORTH AMERICA AND THE COUNTRIES THAT COMPRISE THE EUROPEAN UNION. LUMINEX
MAKES NO WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO PRODUCTS SOLD,
DISTRIBUTED, LOCATED OR USED OUTSIDE OF NORTH AMERICA OR THE COUNTRIES COMPRISING THE
EUROPEAN UNION. PRODUCTS SOLD OUTSIDE OF NORTH AMERICA OR THE COUNTRIES COMPRISING
THE EUROPEAN UNION ARE SOLD ONLY ON AN "AS IS, WHERE IS" BASIS. NOTWITHSTANDING THE
FOREGOING, LUMINEX SHALL PROVIDE BUYER A WARRANTY ON FIELD SERVICE PARTS PROCURED
FROM LUMINEX FOR MAINTENANCE OF LUMINEX INSTRUMENTS IN ALL COUNTRIES IN THE WORLD AND
PER THE TERMS AND CONDITIONS HEREIN. TO THE EXTENT THAT THE FOREGOING DISCLAIMERS ARE
INVALID OR UNENFORCEABLE UNDER THE LAWS OF ANY JURISDICTION, THE WARRANTY, DISCLAIMER,
LIMIT ATION OF LIABILITY AND OTHER PROV ISIO NS SET FORTH BELOW SHALL THEREUPON BE EFFECTIVE
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW.

Notwithstanding Buyer's acceptance thereof, if Product is purchased directly from Luminex, Luminex warrants that for
a period of twelve (12) months from date of delivery that the Product sha ll conform in all material respects with the
Product Specifications provided by Luminex with the Product. The warranty provided herein specifically excludes any
software or hardware not provided by Luminex. If Product is purchased from a Luminex authorized reseller, any
warranty obligations shall be provided in writing directly by such Luminex authorized reseller to Buyer. THIS
WARRANTY IS EXCLUSIVE AND LUMINEX MAKES ANY OTHER WARRANTY, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. Seller's warranties made in connection with this sale shall not be effective if Seller has
determined, in its sole discretion, that Buyer has misused the Product in any manner, has failed to use the Product in
accordance with industry standards or practices or has failed to use the Product in accordance with instructions, if
any, furnished by Seller.

BUYER'S EXCLUSIVE REMEDY WITH RESPECT TO PRODUCT PROVED TO SELLER'S SATISFACTION TO BE
DEFECTIVE OR NONCONFORMING SHALL BE REPAIR OR REPLACEMENT OF SUCH PRODUCTS WITHOUT
CHARGE OR REFUND OF THE PURCHASE PRICE, IN SELLER'S SOLE DISCRETION, UPON THE RETURN OF
SUCH PRODUCTS IN ACCORDANCE WITH SELLER'S INSTRUCTIONS BELOW. NEITHER SELLER NOR
LUMINEX SHALL IN ANY EVENT BE LIABLE FOR INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES OF
ANY KIND RESULTING FROM ANY USE OR FAILURE OF THE PRODUCT, EVEN IF SELLER OR LUMINEX HAS
BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE INCLUDING, WITHOUT LIMITATION, LIABILITY FOR
LOSS OF WORK IN PROGRESS, DOWN TIME, LOSS OF REVENUE OR PROFITS, FAILURE TO REALIZE
SAVINGS, LOSS OF PRODUCTS OF BUYER OR OTHER USE OR ANY LIABILITY OF BUYER TO A THIRD
PARTY ON ACCOUNT OF SUCH LOSS, OR FOR ANY LABOR OR ANY OTHER EXPENSE, DAMAGE OR LOSS
OCCASIONED BY SUCH PRODUCT INCLUDING PERSONAL INJURY OR PROPERTY DAMAGE UNLESS SUCH
PERSONAL INJURY OR PROPERTY DAMAGE IS CAUSED BY SELLER'S GROSS NEGLIGENCE.

In the event that Product is located outside of North America or the European Unio n and fails to conform to the
warranty set forth herein, during the warranty period: (i) Buyer shall notify Luminex in a timely manner in writing that

Luminex IVD MAGPIX Hardware Installation and User Manual

such Product failed to conform and shall furnish a detailed explanation of any alleged
nonconformity; (ii) Buyer at it's expense will contract either Luminex or a Luminex trained service
engineer to assess the issue and identify the defective FS-PART; and (ii) at Luminex's option and
election, Buyer shall either return such nonconforming Product to Luminex's manufactu ring facility
or destroy such Product and provide Luminex with written certification of destruction. In the event
that a FS-PART is returned to Luminex's manufacturing facility, Luminex may analyze such FS­PART for defects. In the event that Luminex determines that su ch FS-PART is not defective, the
FS-PART shall be shipped to Buyer then Buyer shall be responsible for the payment for such FS­PART and related shipping charges. Furthermore, in the event that Luminex determine s that such
FS-PART is defective then Luminex shall be responsible for the payment for such FS-PART and
related shipping charges. Except as expressly provided herein, Buyer shall not have the right to
return a Product to Luminex without Luminex's prior written consent.

3. Buyer's Use of Product - Buyer shall not use this Product for any commercial purpose, including
without limitation performance of testing services, unless expressly agreed to in writing by Luminex
or as specifically authorized by Luminex through a Luminex distributor. Buyer agrees that no rights
or licenses under Luminex's patents shall be implied from the sale of the Product, except as
expressly provided herein or as specifically agreed to in writing by Luminex, and Buyer does not
receive any right under Luminex's patent rights hereunder. Buyer acknowledges and agrees that
the Product are sold and licensed only for use with Luminex's laser based fluorescent analytical test
instrumentation. Buyer further acknowledges that, unless otherwise indicated on the Product label,
the Product has not received approval from the United States Food and Drug Administration or
other federal, state or local regulatory agencies and have not been tested by Seller or Luminex for
safety or efficacy in food, drug, medical device, cosmetic, commercial or any other use, unless
otherwise stated in Seller's technical specifications or material data sheets furnished to Buyer.
Buyer expressly represents and warrants to Seller that Buyer will use the Product in accordance
with the Product label, if applicable, and will properly test and use any Product in accordance with
the practices of a reasonable person who is an expert in the field and in strict compliance with the
United States Food and Drug Administration and all applicable domestic and international laws and
regulations, now and hereinafter enacted.

BUYER HEREBY GRANTS TO LUMINEX A NONEXCLUSIVE, WORLDWIDE, UNRESTRICTED,
ROYALTY-FREE, FULLY PAID-UP LICENSE, WITH THE RIGHT T O GRANT AND AUTHORIZE
SUBLICENSES, UNDER ANY AND ALL PATENT RIGHTS IN INVENTIONS COMPRISING
MODIFICATIONS, EXTENSIONS, OR ENHANCEMENTS MADE BY BUYER TO THE PRODUCT
OR TO THE MANUFACTURE OR USE OF THE PRODUCT ("IMPROVEMENT PATENTS"), TO
MAKE, HAVE MADE, USE, IMPORT, OFFER FOR SALE OR SELL ANY AND ALL PRODUCT;
EXPLOIT ANY AND ALL METHODS OR PROCESSES; AND OTHERWISE EXPLOIT
IMPROVEMENT PATENTS FOR ALL PURPOSES. NOTWITHSTANDING THE FOREGOING,
"IMPROVEMENT PATENTS" SPECIFICALLY EXCLUDES PATENT CLAIMS CONCEIVED AND
REDUCED TO PRACTICE BY BUYER CONSISTING OF METHODS OF SAMPLE
PREPARATION, METHODS OF CONJUGATING PRODUCT TO ANAL YTES, THE COMPOSITION
OF MATTER OF THE SPE CIFIC CHEMISTRIE S OF THE ASSAYS DEVELOPED BY BUYER AND
METHODS OF PERFORMING THE ASSAYS (I.E ., THE PROTOCOL FOR THE ASSAY).

Buyer has the responsibility and hereby expressly assumes the risk to verify the hazards and to
conduct any further research necessary to learn the hazards involved in using the Product. Buyer
also has the duty to warn Buyer's customers, employees, agents, assigns, officers, successors and
any auxiliary or third party personnel (such as freight handlers, etc.) of any and all risks involved in
using or handling the Product. Buyer agrees to comply with instructions, if any, furnished by Seller
or Luminex relating to the use of the Product and not misuse the Product in any manner. Buyer
shall not reverse engineer, decompile, disassemble or modify the Product. Buyer acknowledges
that Luminex retains ownership of all patents, trademarks, trade secrets and other proprietary rights
relating to or residing in the Product and Buyer receives no rights to such intellectual property rights
by virtue of its purchase of Product other than as expressly set forth herein. Buyer shall have no
right to use any trademarks owned or licensed to Luminex without the express written permission of
Luminex.

4. Buyer's Representations, Release and Indemnity - Buyer represents and warrants that it shall
use the Product in accordance with Paragraph 2, "Buyer's Use of Product," and that any such use

4

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

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

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

This Luminex End-User License Agreement (“EULA”) is a legal agreement between you (either an individual or a
single entity, also referred herein as “you”) the end-user and Luminex Corporation (“Luminex”) regarding the use of the
xPONENT software product provided to yo u ab o v e , whi ch includes computer SOFTWARE and online or electronic
documentation and may include associated media and printed materials (if any) (“SOFTWARE”). The terms also apply
to any updates, supplements, web content or internet-based services, such as remote access.

BY USING THE SOFTWARE, YOU ACCEPT THESE TERMS. IF YOU DO NOT ACCEPT THEM, DO NOT USE THE
SOFTWARE. INSTEAD, RETURN IT TO LUMINEX OR THE LUMINEX AUTHORIZED THIRD PARTY FROM WHICH
YOU PURCHASED THE SOFTWARE FOR A REFUND OR CREDIT. IF YOU COMPLY WITH THESE LICENSE
TERMS, YOU HAVE THE RIGHTS TO USE THE SOFTWARE AS SPECIFICALLY SET FORTH BELOW.

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

2. ADDITIONAL LICENSING REQUIREMENTS AND/OR USE RIGHTS.

a) Trial and Conversion. Some or all of the SOFTWARE may be licensed on a trial basis. Your rights to use trial

SOFTWARE are limited to the trial period. The trial SOFTWARE and length of the trial period are set forth
during the activation process. The SOFTWARE may be used for evaluation purposes only during the trial
period and not for any commercial use, including without limitation to any diagnostic use. You may have the
option to convert your trial rights to perpetual rights. Conversion options will be presented to you at the
expiration of your trial period.

b) Activation. You can activate the SOFTWARE by obtaining a license key provided by Luminex Techn ical

Support at

c) Branding. You may only add additional branding or other graphics to SOFTWARE with Luminex’s express

written consent.

d) Upgrades. You may only obtain updates or upgrades for the SOFTWARE from Luminex Technical Support at

[e-mail] or authorized resellers. For more information on obtaining updates from authorized
resellers, see http://www.luminexcorp.com.

3. 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 on a single computer running with a single unit of a specific model of
Luminex instrument, as such model is identified on the packaging included with the SOFTWARE. You may make
one (1) copy of the SOFTWARE for backup or archival purposes only. You may also install the SOFTWARE on up

[e-mail] or 1-877-785-2323 or 1-512-381-4397.

Luminex IVD MAGPIX Hardware Installation and User Manual

to three (3) additional computers for purposes of performing ancillary tasks (i.e. preparing
templates/protocols, performing further analysis or re-running previous data), provided such
computers are at a single location and are NOT connected with a Luminex instrument. In
addition, You may purchase the right to use the SOFTWARE on additional computers, as
agreed to in writing with Luminex or its authorized reseller, for purposes of performing ancillary
tasks (i.e. preparing templates/protocols, performing further analysis or re-running previous
data), provided such computers are at a single location and are NOT connected with a Luminex
instrument. 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.

4. RESTRICTIONS

• SOFTWARE must only be installed and operated on a single computer running with a
Luminex instrument, as set forth above.

• You may not use this SOFTWARE for any commercial purpose, including in the
performance of testing services, unless expressly agreed to in writing by Luminex or as
authorized in writing by Luminex through an authorized reseller of the SOFTWARE.

• You may only use the SOFTWARE with microspheres manufactured by Luminex or with kits
developed, manufactured and distributed by licensees authorized in writing by Luminex.

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

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

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

• 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.

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

• You may not modify or prepare derivative works of the SOFTWARE, including modifying any
branding or graphics.

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

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

5. TERM AND TERMINATION. Your rights under this EULA are effective until termination. You
may terminate this EULA at any time by destroying the SOFTWARE, 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 and erase any copies residing on your computer equipment.

6. RIGHTS IN SOFTWARE. All rights and title in and to the SOFTWARE 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 reprodu ce
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 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.

7. EXPORT RESTRICTIONS. You agree that you will not export or re-export the SOFTWARE 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

8. NO WARRANTY. THE SOFTWARE IS LICENSED “AS IS.” ANY USE OF THE SOFTWARE IS AT YOUR OWN
RISK. THE SOFTWARE 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.

9. 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, EVEN IF LUMINEX HAS BEEN ADVISED OF THE POSSIBILITY OF
SUCH DAMAGES.

10. 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 provide d 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.

Luminex IVD MAGPIX Hardware Installation and User Manual

8

Table of Contents

Chapter 1: About This Manual............................................................................................. 1

Overview......................................................................................................................... 1

Warnings and Notes........................................................................................................ 1

Symbols .......................................................................................................................... 2

Chapter 2: Safety and Regulatory Considerations............................................................... 3

Intended Use .................................................................................................................. 3

Regulatory Labels and Warnings.................................................................................... 4

Testing and Certifications................................................................................................ 6

Safety Practices.............................................................................................................. 7

General...................................................................................................................... 7

Mechanical ................................................................................................................ 7

Electrical.................................................................................................................... 7

Electromagnetic Compatibility ................................................................................... 7

Bar Code Reader Laser............................................................................................. 8

Heat........................................................................................................................... 8

Fluids......................................................................................................................... 8

Biohazard .................................................................................................................. 8

Indicator Light............................................................................................................ 9

Decontamination Procedure............................................................................................ 9

Disposal of Instrument .................................................................................................... 9

Chapter 3: Installation Procedure ...................................................................................... 11

Unpacking and Assembling the PC............................................................................... 12

Unpacking and Assembling MAGPIX............................................................................ 13

Connecting the Components......................................................................................... 15

Preparing MAGPIX........................................................................................................ 17

Removing the Shipping Plug................................................................................... 17

Installing the Sample Probe..................................................................................... 20

Installing the Drive Fluid.......................................................................................... 22

Powering Up MAGPIX................................................................................................... 25

Performing an Initial Startup.......................................................................................... 27

Installation Diagrams..................................................................................................... 28

Shipping Checklist......................................................................................................... 29

Chapter 4: Technical Overview.......................................................................................... 31

How MAGPIX Operates................................................................................................ 31

System Components. .................................................................................................... 34

Software .................................................................................................................. 34

Hardware................................................................................................................. 34

Reagents................................................................................................................. 35

Subsystems .................................................................................................................. 36

Electronic Subsystem.............................................................................................. 36

Fluidics Subsystem.................................................................................................. 37

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Luminex IVD MAGPIX Hardware Installation and User Manual

Mechanical Subsystem............................................................................................. 42

Optical Subsystem.................................................................................................... 44

Recommended Additional Equipment............................................................................ 44

Uninterruptible Power Supply (UPS) or Surge Protector.......................................... 44

Printer....................................................................................................................... 45

Barcode Labels......................................................................................................... 45

Vortex....................................................................................................................... 45

Bath Sonicator.......................................................................................................... 45

System Specifications.................................................................................................... 45

General Specifications.............................................................................................. 45

Environmental Conditions......................................................................................... 45

Electronics................................................................................................................ 46

Optics ....................................................................................................................... 46

Fluidics ..................................................................................................................... 46

Microtiter Plates ........................................................................................................ 46

Microspheres............................................................................................................ 46

Chapter 5: Operational and Maintenance Procedures........................................................ 47

General Maintenance Precautions................................................................................. 47

Accessing the Side Compartment.................................................................................. 48

Daily Procedures ........................................................................................................... 48

Initializing MAGPIX ................................................................................................... 48

Verifying MAGPIX..................................................................................................... 48

Maintaining Fluids..................................................................................................... 49

Shutting Down MAGPIX........................................................................................... 49

Weekly Procedures ....................................................................................................... 50

Cleaning MAGPIX .................................................................................................... 50

Cleaning the Sample Probe...................................................................................... 50

Performing a Visual Inspection................................................................................. 51

Calibrating and Verifying MAGPIX ........................................................................... 51

Removing Clogs....................................................................................................... 51

Monthly Procedures....................................................................................................... 52

Semi-Annual Procedures............................................................................................... 52

Maintaining Air Filters............................................................................................... 52

Replacing the Syringe Seal...................................................................................... 54

Annual Procedures ........................................................................................................ 55

Replacing the Sample Probe Tube .......................................................................... 55

Replacing the Drive Fluid Filter ................................................................................ 56

As Needed Maintenance................................................................................................ 57

Replacing Fuses....................................................................................................... 57

Maintenance Logs.......................................................................................................... 58

Short Term Maintenance - One Week...................................................................... 58

Long Term Maintenance - One Year........................................................................ 59

Chapter 6: Troubleshooting Procedures............................................................................. 61

Overview........................................................................................................................ 61

Power Supply Problems................................................................................................. 62

Communication Problems.............................................................................................. 62

Clogs.............................................................................................................................. 63

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Contents

Fluid Leaks.................................................................................................................... 63

Sample Probe Problems ............................................................................................... 64

Calibration Slowness and Failure. ..... ............................................................................ 65

Verification Slowness and Failure................................................................................. 66

Acquisition Slowness and Failure ................................................................................. 67

Carryover Problems ...................................................................................................... 68

Bead Detail Irregularities............................................................................................... 68

Appendix A: Storage........................................................................................................ 71

Storing MAGPIX............................................................................................................ 71

Preparing MAGPIX for Use After Storage..................................................................... 71

Appendix B: Shipping....................................................................................................... 73

Preparing MAGPIX for Shipping ................................................................................... 73

Shipment Checklist ....................................................................................................... 74

Appendix C: Part Numbers .............................................................................................. 75

Hardware....................................................................................................................... 75

Reagents....................................................................................................................... 75

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Luminex IVD MAGPIX Hardware Installation and User Manual

iv

CHAPTER 1 About This Manual

Overview

Read this manual carefully before using the MAGPIX system. It provides vital information
about the following aspects of MAGPIX:

• Safety issues

• Regulatory considerations and labeling

• Installation

• Operation

• Maintenance

• Troubleshooting

• Storage

• Shipping

• Part Numbers

Warnings and Notes

The following informational notes and warnings appear as necessary in this manual.

NOTE: This message is used to provide general helpful information. No

safety or performance issues are involved.

CAUTION: This message is used in cases where the hazard is minor or only

a potential hazard is present. Failure to comply with the caution
may result in hazardous conditions.

WARNING: This message is used in cases where danger to the opera tor or to

the performance of the instrument is present. Failure to comply
with the warning may result in incorrect performance, instrument
failure, invalid results, or hazard to the operator.

DANGER: This message is used in cases where significant risk of serious

injury or death is present.

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Luminex IVD MAGPIX Hardware Installation and User Manual

Symbols

You may encounter these symbols throughout this manual. They represent war nings,
conditions, identifications, instructions, and regulatory agencies.

TABLE 1. Symbols

Symbol Meaning Symbol Meaning Symbol Meaning

Puncture/
Pinch Point 
Warning

Hand Crush/
Cut/Force
From Above

Caution, 
Risk of 
Electric
Shock

Protective
ground

In vitro
Diagnostic
Medical
Device

General
Warning,
Caution, Risk
of Danger

Heat/Hot 
Surface
Warning

Laser
Warning

~ Alternating

current (ac)

Serial 
Number

Warning,
Biological
Hazard

Burn Hazard/
Hot Surface

Consult
Instructions 
for Use

Catalog 
Number

Batch 
Code

Use By 
Expiration 
Date

Date of
Manufacture

Power Off



Power On

2

Temperature 
Limitation

Manufacturer 

MET Mark Fuse

Waste 
Electrical and
Electronic
Equipment
(WEEE)

European
Union
Conformity

CHAPTER 2 Safety and Regulatory

Considerations

Become familiar with the safety information in this chapter before using MAGPIX. This
system contains electrical and mechanical components that, if handled improperly, are
potentially harmful. In addition, biological hazards may be present during system
operation. Therefore, Luminex recommends that all system users become familiar with the
specific safety advisories below in addition to adhering to standard laboratory safety
practices. Do not perform procedures on MAGPIX that are not specifically described in
this manual, unless you are directed to do so by Luminex Technical Support.

Intended Use

The MAGPIX system is a clinical multiplex test system intended to measure and sort
multiple signals generated in an in vitro diagnostic assay from a clinical sample. This
instrument system is used with a specific assay to measure multiple analytes that aid in
diagnosis. The device includes a signal reader unit, raw data storage mechanisms, data
acquisition software and software to process detected signals.

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Luminex IVD MAGPIX Hardware Installation and User Manual

Regulatory Labels and Warnings

The following fuse caution label appears on MAGPIX.

FIGURE 1. Fuse Caution Label

A voltage label appears on the back of MAGPIX. It displays the MAGPIX serial number,
model number, power requirements, and manufacturer’s information.

FIGURE 2. Serial Number and Voltage Label

The WEEE (Waste Electrical and Electronic Equipment) label appears.

FIGURE 3. WEEE Symbol

4

Safety and Regulatory Considerations

A label with legal information appears on MAGPIX.

FIGURE 4. Legal Information

Because MAGPIX complies with European Union safety requirements, it displays an EC
representative label.

FIGURE 5. EC Representative

Patient information appears on MAGPIX.

FIGURE 6. Patent

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Luminex IVD MAGPIX Hardware Installation and User Manual

E112918

Testing and Certifications

MAGPIX has been tested by MET and complies with safety requirements for the United
States and Canada.

FIGURE 7.

In addition, MAGPIX complies with European Union (EU) safety requirements and
therefore may be marketed in the Europe Single Market. The following European Union
compliance label appears on the back of the MAGPIX instrument.

FIGURE 8. European Union Compliance Label

MET Mark

6

Safety and Regulatory Considerations

Safety Practices

In any situation in which you encounter this symbol, consult this manual or other Luminex
documentation to determine the nature of th e potentia l ha za rd and an y necessar y actio ns
you must take.

CAUTION: The protection provided by the equipment can be impaired or the

warranty voided if the Luminex MAGPIX system is used in a
manner not specified by the instructions or by Luminex
Corporation.

General

Keep the side access door closed and latched during normal operations.

DANGER: Do not, under any circumstances, remove the housing of the

instrument. Use of controls or adjustments or performance of
procedures other than those specified in Luminex MAGPIX
documentation can result in exposure to hazards.

Always observe standard laboratory

safety practices.

Mechanical

MAGPIX has parts that move during operation. Risk of personal injury is present. The
moving parts present puncture and pinching hazards. Keep your hands and fingers away
from the plate carrier slot, syringe pump, and sample probe during operation. The plate
carrier ejects without warning, especially during multiplate batches. Observe all warnings
and cautions. Keep the access door closed and latched during normal operations.

Electrical

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

Observe the fuse caution stated on the fus e ca ut ion labe l. See “Fuse Caution Label” on
page 4. Be aware of the voltage of the instrument. See “Serial Number and Voltage Label”
on page 4.

Electromagnetic Compatibility

MAGPIX complies with the emission and immunity requirements described in IEC 61326­1 and IEC 61326-2-6. The electromagnetic environment should be evaluated prior to
operation.

WARNING: Do not use this instrument in close proximity to sources of strong

electromagnetic radiation, for example, unshielded intentio nal RF
sources, as these may interfere with the proper operation.

WARNING: Always handle MAGPIX according to Luminex instructions to

avoid any possible interference from its electromagnetic fields.

7

Luminex IVD MAGPIX Hardware Installation and User Manual

Bar Code Reader Laser

The accessory bar code reader is classified under FDA 21 CFR 1040 .10 and 1040.11 as a
Class II laser product. In accordance with IEC 60825-1, the accessory bar code reader is
classified as Class 2.

The bar code reader laser presents a potential hazard to eyesight.

WARNING: Do not stare into the barcode reader beam or shine it into other

people’s eyes.

Heat

The heater plate, used to warm the plate carrier of the Y platfor m, can be heated between
35°C and 60°C.

CAUTION: Do not use the heater plate as an incubator. Its purpose is to

maintain the temperature of the microtiter pl ate while the plate is
in the MAGPIX instrument. Monitor the heater plate temperature
while it is in use. If it overheats, discontinue use and contact
Luminex Technical Support.

WARNING: The heater plate of the MAGPIX plate car rier may be ho t and can

cause personal injury if touched. Do not touch the heater plate.

Fluids

This instrument contains fluids. In the event of a fluid leak, turn off all power to the system
and disconnect all power cords. The on/off switch is not a method of disconnection; the
power cord must be removed from the outlet. Contact Luminex Technical Support for
further information.

DANGER: Do not operate the instrument in the presence of leaking fluid.

Monitor waste fluid levels periodically as a pre
container to overflow. Empty the waste fluid container each time you replace the Drive
Fluid container.

caution. Do not allow the waste fluid

Biohazard

Human and animal samples may contain biohazardous infectious agents. To avoid
pressurization problems, the waste fluid container is vented, so beware of biohazardous
aerosol material.

WARNING: Where exposure to potentially biohazardous material, including

aerosol, exists, follow appropriat e biosafety procedures and use
personal protective equipment (PPE). PPE includes gloves,
gowns, laboratory coats, face shields or mask and eye protection ,
respirators, and ventilation devices. Observe all local, state,
federal and country-specific biohazard handling regulations when
disposing of biohazardous waste material.

8

Safety and Regulatory Considerations

Indicator Light

The lights inside the front panel of MAGPIX indicate the status of the system and are
harmless. The blue light-emitting diodes (LEDs) do not emit light in the UV spectrum.

Decontamination Procedure

Occasions may arise when it becomes necessary to decontaminate the entire MAGPIX
instrument. If you must decontaminate the instrument, sanitize the accessible surfaces
and the internal fluidics system. This is particularly import ant when bioh azardous samples
have been run.

WARNING: Wear appropriate personal protective equipment when handling

parts that come into contact with potentially biohazardous
samples.

To decontaminate MAGPIX:

1. Remov
household bleach solution diluted to 10% to 20% in water in the off-plate rea gent block
of the system.

2. Use
bleach solution followed by two wash commands with distilled water.

3. Emp
to 20% bleach solution followed by a distilled water rinse.

4. T

5. Clea

diluted to 10% to 20%.

6. Op

7. Clea

(10% to 20%).

e all specimens and all Luminex MAGPIX reagents. Leave distilled water and

the software to run a sanitize command with the diluted (10% to 20%) household

ty the off-plate reagent block and the waste container and clean each with a 10%

urn off MAGPIX and unplug the power cord.

n all exterior surfaces with mild detergent followed by a ho usehold ble ach solution

en the side access door of the instrument.

n all accessible surfaces with detergent followed by the household bleach solution

Disposal of Instrument

Within the European Union, the W aste Electrical and Electronic Equipm ent Directive 2002/
96/EC requires that you properly dispose of electrical and electronic equipment when it
reaches its end of life.

If you are disposing of a Luminex MAGPIX instr ume nt, decontaminate the system. See
“Decontamination Procedure” on page 9. Next, contact Luminex Technical Support for a
Return Material Authorization (RMA) num be r at [phone] (o ut sid e of th e U.S. ).

n the equipment to the following Luminex location:

Retur
Luminex Corporation

12201 Technology Blvd., Suite 130
Austin, Texas 78727, USA

For information about disposal of MAGPIX outside of the European Union, contact

uminex Technical Support at 1-877-785-2323 within the US and at [phone]

L
outside of the US. For information about disposal of th e barcod e scann er , PC, or mon ito r,
refer to the manufacturer documentation.

9

Luminex IVD MAGPIX Hardware Installation and User Manual

10

CHAPTER 3 Installation Procedure

Before handling or unpacking MAGPIX, make certain th at the selected site is approp riate.
See “Installation Diagrams” on page 28 for handling and site installation requirements and
detailed dimensions of MAGPIX.

Check for these requirements:

• Indoors

• Operating temperature of 15-35°C (59-95°F)

• Operating relative humidity of 20-80%, noncondensing

• Operating altitude up to 2400m (7874 ft) above mean sea level

• Available electrical power outlet with protective earthing and easy accessibility

• Available area of approximately 3‘ X 3’ (91.44cm), including a 2” (5.08cm) clearance

between the back of MAGPIX and any wall or vertical surface.

• Stable, level surface

MAGPIX arrives in a large, corrug

FIGURE 9. The MAGPIX Overpack

ated cardboard overpack on skids.

CAUTION: This overpack is too heavy to be lifted by one person

(approximately 119lbs (53.97kg), a three-person lift) and should
be moved mechanically. Be careful the overpack is not punctur ed
during any necessary moving.

11

Luminex IVD MAGPIX Hardware Installation and User Manual

1

2

3

4

Within the overpack are separate cartons for the PC, the monitor, the 2-pack of Drive
Fluid, and the MAGPIX instrument. In addition, a divided tray contains the cables, CDs,
and printed material.

FIGURE 10. Inside the Overpack

1PC carton
2 Monitor carton
3 Accessory tray (monitor stand and Drive Fluid cartons are

underneath)

4 MAGPIX carton

Each individual carton can be handled by one person. The MAGPIX carton and the PC
carton each weigh less than 40 pounds (18.14 kg).

Unpacking and Assembling the PC

Begin the installation process with the PC. The computer and monitor are in the boxes at
the end of the overpack (See Figure 10.); the monitor stand is in a box underneath the
accessory tray.

The computer and monitor boxes include all the necessary cords and peripheral devices

well as complete installation instructions. Follow those instructions to set up the PC.

as
To set up the PC:

1. Remo

2. Asse

ve the three boxes containing PC components from the overpack.

mble the components using PC Installation Instructions or the instructions

provided by the PC vendor. Both are in the PC boxes.

12

FIGURE 11. The Assembled PC

Installation Procedure

Unpacking and Assembling MAGPIX

To install the MAGPIX instrument:

1. Remo

ve the MAGPIX carton from the overpack.

FIGURE 12. Removing the MAGPIX Carton

13

Luminex IVD MAGPIX Hardware Installation and User Manual

The MAGPIX instrument is inside a plastic bag and surrounded by foam inserts attached
to a corrugated cardboard insert.

FIGURE 13. The MAGPIX Carton, Opened

2. Remove MAGPIX from its carton by pulling on the handles that extend from the

cardboard insert.

NOTE: It

is helpful to have another person hold down the carton wh ile you

pull out MAGPIX.

FIGURE 14. Pulling MAGPIX from its Carton

14

3. Put the instrument on a stable, flat surface. This may require two people.

4. Fold down the cardboard panels from each side of the instrument.
FIGURE 15. Removing the Packing Materials

Installation Procedure

5. Pull the plastic bag down from the top.

6. Place MAGPIX on

people.

Before proceeding with the installation, che
checklist on page 29 and make certain you can locate all listed items. Check contents to
make certain no damage h as occurred du ring shipp
contact Luminex Technical Support (in the U.S. and Canada, 1-877-785-BEAD
(-2323); outside of the U.S. and Canada, [phone]; in Europe, [phone]).

to a lab bench or other flat, stable surface. This may require two

ck the contents of the overpack with the

ing. If anything is missing or damaged,

Connecting the Components

To connect the components:

ocate the cords in the accessory tray of the overpack.

1. L
FIGURE 16. Power Cord and USB Cable

15