Luminex FLEXMAP 3D User Manual

FLEXMAP 3D® Hardware

User Manual

Copyright Information

© Luminex Corporation, 2011. 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.

LUMINEX CORPORATION

12212 Technology Boulevard

Austin, Texas 78727-6115

U.S.A.

Voice: [phone]

Fax: [phone]

Luminex® FLEXMAP 3D® Hardware User Manual

PN 89-00002-00-187 Rev C

November 2011

MDCI Ltd.

Arundel House

1 Liverpool Gardens,

Worthing

West Sussex BN11 1SL

United Kingdom

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.

The following are trademarks of Luminex Corporation: Luminex®, xMAP®, xPONENT®, FLEXMAP 3D®.

All other trademarks, including ProClin®, Cheminert®, Windows® Pentium® and Dell® are trademarks of their respective companies.

i

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 DIRECTLY 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, LIMITATION OF LIABILITY AND OTHER PROVISIONS 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 shall conform in all material respects with the Product Specifications provided by Luminex with the Product. The warranty provided herein specifically excludes any software or

FLEXMAP 3D® Hardware User Manual ii

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 NO 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 Union 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 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 manufacturing 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 FS-PART for defects. In the event that Luminex determines that such FS-PART is not defective, the FSPART 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 determines that such FS-PART is defective then Luminex shall be responsible for the payment for such FSPART 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

iii

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 TO GRANT AND AUTHORIZE SUBLICENSES, UNDER ANY AND ALL PATENT RIGHTS IN INVENTIONS COMPRISING MODIFICATIONS, EXTENSIONS, OR ENHANCEMENTS MADE BY BUYER TO THE PRODUCT OR TO THE MANUFACTURE OR USE OF THE PRODUCT ("IMPROVEMENT PATENTS"), TO MAKE, HAVE MADE, USE, IMPORT, OFFER FOR SALE OR SELL ANY AND ALL PRODUCT; EXPLOIT ANY AND ALL METHODS OR PROCESSES; AND OTHERWISE EXPLOIT IMPROVEMENT PATENTS FOR ALL PURPOSES. NOTWITHSTANDING THE FOREGOING, "IMPROVEMENT PATENTS" SPECIFICALLY EXCLUDES PATENT CLAIMS CONCEIVED AND REDUCED TO PRACTICE BY BUYER CONSISTING OF METHODS OF SAMPLE PREPARATION, METHODS OF CONJUGATING PRODUCT TO ANALYTES, THE COMPOSITION OF MATTER OF THE SPECIFIC CHEMISTRIES OF THE ASSAYS DEVELOPED BY BUYER AND METHODS OF PERFORMING THE ASSAYS (I.E., THE PROTOCOL FOR THE ASSAY).

Buyer has the responsibility and hereby expressly assumes the risk to verify the hazards and to conduct any further research necessary to learn the hazards involved in using the Product. Buyer also has the duty to warn Buyer's customers, employees, agents, assigns, officers, successors and any auxiliary or third party personnel (such as freight handlers, etc.) of any and all risks involved in using or handling the Product. Buyer agrees to comply with instructions, if any, furnished by Seller or Luminex relating to the use of the Product and not misuse the Product in any manner. Buyer shall not reverse engineer, decompile, disassemble or modify the Product. Buyer acknowledges that Luminex retains ownership of all patents, trademarks, trade secrets and other proprietary rights relating to or residing in the Product 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 of Product will not violate any law, regulation, judicial order or injunction. Buyer agrees to release, discharge, disclaim and renounce any and all claims, demands, actions, causes of action and/or suits in law or equity, now existing or hereafter arising, whether known or unknown, against Seller and Luminex, and their respective officers, directors, employees, agents, successors and assigns (collectively the "Released Parties"), with respect to the use of the Product. Buyer agrees to indemnify and hold harmless the Released Parties from and against any suits, losses, claims, demands, liabilities, costs and expenses (including attorney, accounting, expert witness, and consulting fees) that any of the Released Parties may sustain or incur as a result of any claim against such Released Party based upon negligence, breach of warranty, strict liability in tort,

FLEXMAP 3D® Hardware User Manual iv

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.

v

End-User License Agreement (EULA) for Luminex® xPONENT® 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 you above, which 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 internetbased 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 Technical Support at [e-mail] or 1-877-785-2323 or 1-512-381-4397.

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.

FLEXMAP 3D® Hardware User Manual vi

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 to two (2) additional computers for purposes of performing ancillary tasks (i.e. preparing templates/protocols, performing further analysis or rerunning 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.

vii

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 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 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.

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 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.

89-30000-00-254 Rev. B

FLEXMAP 3D® Hardware User Manual viii

Table of Contents

Chapter 1 Safety ..................................................................................................................	1
Intended Use ...............................................................................................................................................	1
Warnings and Notes ....................................................................................................................................	1
Symbols .......................................................................................................................................................	2
Testing and Certification ..............................................................................................................................	3
Safety Precautions .......................................................................................................................................	3
General ..................................................................................................................................................	4
Electromagnetic Compatibility ...............................................................................................................	4
Lasers ....................................................................................................................................................	4
Fluidics ..................................................................................................................................................	5
Biological Samples ................................................................................................................................	6
Mechanical Components .......................................................................................................................	6
Swivel Base ...........................................................................................................................................	6
Indicator Lights ......................................................................................................................................	6
Electrical Components ..........................................................................................................................	7
Heat .......................................................................................................................................................	8
Decontamination Procedure ........................................................................................................................	8
Installation of Instrument ..............................................................................................................................	8
Disposal of Instrument .................................................................................................................................	9
Chapter 2 Technical Overview .........................................................................................	11
How the FLEXMAP 3D System Operates .................................................................................................	11
Subsystems ...............................................................................................................................................	11
Electronics ...........................................................................................................................................	12
Fluidics ................................................................................................................................................	13
Mechanics ...........................................................................................................................................	16
Optics ..................................................................................................................................................	18
System Components .................................................................................................................................	18
Luminex xPONENT® 4.0 Software ......................................................................................................	18
Reagents .............................................................................................................................................	18
Luminex® FLEXMAP 3D® Hardware ..................................................................................................	19
Recommended Additional Equipment .......................................................................................................	19
Uninterruptible Power Supply (UPS) or Surge Protector .....................................................................	20
Printer ..................................................................................................................................................	20
Barcode Labels ...................................................................................................................................	20
Vortex ..................................................................................................................................................	20
Bath Sonicator .....................................................................................................................................	20
Specifications .............................................................................................................................................	20
General ................................................................................................................................................	20
Electronics ...........................................................................................................................................	21
Optics ..................................................................................................................................................	21
Fluidics ................................................................................................................................................	22
Microspheres .......................................................................................................................................	22
Microtiter Plates ...................................................................................................................................	22

ix

Chapter 3 Maintenance and Cleaning .............................................................................	23
General Maintenance Precautions ............................................................................................................	23
Daily Maintenance .....................................................................................................................................	23
Initializing the FLEXMAP 3D Instrument .............................................................................................	24
Warming Up the FLEXMAP 3D Instrument .........................................................................................	24
Maintaining Fluids ...............................................................................................................................	24
Shutting Down the FLEXMAP 3D Instrument ......................................................................................	25
Weekly Maintenance .................................................................................................................................	25
Running Weekly Maintenance .............................................................................................................	25
Removing Clogs ..................................................................................................................................	26
Cleaning the Sample Probe ................................................................................................................	26
Calibrating the FLEXMAP 3D System .................................................................................................	27
Visually Inspect the FLEXMAP 3D Instrument ....................................................................................	27
Monthly Maintenance .................................................................................................................................	27
Semi-annual Maintenance .........................................................................................................................	28
Replacing the Syringe Teflon Seals ....................................................................................................	28
Replacing the HEPA Air Filter .............................................................................................................	29
Cleaning the Ventilation Filters ............................................................................................................	30
...................................................................................................................................................................	32
Storing the FLEXMAP 3D Instrument ........................................................................................................	33
Storing the FLEXMAP 3D Instrument ..................................................................................................	33
Preparing the FLEXMAP 3D Instrument for Use After Storage ...........................................................	33
Replacing Fuses ........................................................................................................................................	33
Maintenance Logs .....................................................................................................................................	35
Short Term Maintenance - One Week .................................................................................................	35
Long Term Maintenance - One Year ...................................................................................................	35
Chapter 4 Troubleshooting ..............................................................................................	37
Overview ....................................................................................................................................................	37
Power Supply Problems ............................................................................................................................	38
Communication Problems ..........................................................................................................................	38
Clogs ..........................................................................................................................................................	39
Pressurization Problems ............................................................................................................................	39
Fluid Leaks ................................................................................................................................................	40
Sample Probe Problems ............................................................................................................................	40
Calibration Problems .................................................................................................................................	41
Verification Problems .................................................................................................................................	42
Acquisition Problems .................................................................................................................................	43
Bead Detail Irregularities ...........................................................................................................................	44

FLEXMAP 3D® Hardware User Manual x

Chapter 1: Safety

Become familiar with the information in this chapter before using the equipment. Do not perform procedures on your system that are not specifically contained in this manual, unless you are directed to do so by Luminex Technical Support.

Intended Use

The Luminex® FLEXMAP 3D® system is a multiplex test system intended to measure and sort multiple signals generated in an assay from a sample. The system includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals.

The FLEXMAP 3D system is for research use only and is not for use in diagnostic procedures within the United States. The system has not been cleared or approved for clinical use by the US Food and Drug Administration (FDA). The FLEXMAP 3D system is CE marked for in vitro diagnostic use within the European Union (EU).

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

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

1

Symbols

You may encounter these symbols during the use and operation of the Luminex® FLEXMAP 3D® system. They represent warnings, conditions, identifications, instructions, and regulatory agencies. Warning symbols are further explained in the Safety Precautions section.

Symbol	Description	Symbol	Description	Symbol	Description
	Puncture/Pinch		General		Warning,
	Point Warning		Warning,		Biological
			Caution, Risk		Hazard
			of Danger
	Hand Crush/		Heat/Hot		Burn Hazard/
	Cut/Force		Surface		Hot Surface
	From Above		Warning
	Caution, Risk		Warning, Laser		Consult
	of Electric		Beam		Instructions for
	Shock				Use
	Protective		Alternating		Catalog
	ground		current (AC)		Number
	Use By		Temperature		Waste
	Expiration Date		Limitation		Electrical and
					Electronic
					Equipment
					(WEEE)
	Date of		Manufacturer		European
	Manufacture				Union
					Conformity
	Off (Power)		On (Power)		MET Mark
	Serial Number		Batch Code		European
					Representative
	In vitro Medical
	Diagnostic
	Device 1

1The FLEXMAP 3D system is for research use only and is not for use in diagnostic procedures within the US. The system has not been cleared or approved for clinical use by the US FDA.

FLEXMAP 3D® Hardware User Manual 2

Testing and Certification

The FLEXMAP 3D system has been tested by MET.

FIGURE 1. MET Mark

In addition, Luminex FLEXMAP 3D 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 FLEXMAP 3D instrument.

FIGURE 2. European Union Compliance Label

Safety Precautions

Read the following safety information before using the FLEXMAP 3D instrument. This instrument contains electrical, mechanical, and laser 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.

In any situation in which you encounter this symbol, consult this manual or other Luminex documentation to determine the nature of the potential hazard and any necessary actions you must take.

CAUTION: The protection provided by the equipment can be impaired or the warranty voided if the Luminex FLEXMAP 3D system is used in a manner not specified by the instructions or by Luminex Corporation.

Safety

3

General

CAUTION: Keep access doors closed during normal operation.

Always observe standard laboratory safety practices.

Electromagnetic Compatibility

The FLEXMAP 3D system complies with the emission and immunity requirements described in and . The electromagnetic environment should be evaluated prior to operation.

WARNING: Do not use this device in close proximity to sources of strong electromagnetic radiation, for example, unshielded intentional RF sources, as these may interfere with proper operation

WARNING: Always handle the FLEXMAP 3D system according to Luminex instructions to avoid any possible interference from its electromagnetic fields.

Lasers

The Luminex® FLEXMAP 3D® instrument is classified under FDA 21 CFR 1040.10 and 1040.11 as a Class I laser product consisting of two Class IIIb lasers within the instrument. The accessory bar code reader is classified as Class II. In accordance with IEC 60825-1, the instrument is classified as Class 1, containing two Class 3b lasers, and including an accessory Class 2 bar code reader. The FLEXMAP 3D complies with IEC 60825-1 and 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007.

The following label appears on the back of the FLEXMAP 3D instrument.

FIGURE 3. Laser Warning Label

The following label appears above the laser apertures located inside the optics enclosure inside the FLEXMAP 3D instrument.

FLEXMAP 3D® Hardware User Manual 4

FIGURE 4. Avoid Exposure Label

All Class 3b laser apertures are located within the FLEXMAP 3D instrument and are contained within a protective housing, accessible only to trained field service technicians. When performing routine maintenance, turn power to the system off and disconnect the power cord.

DANGER: Do not, under any circumstances, remove the FLEXMAP 3D instrument cover. Use of controls or adjustments or performance of procedures other than those specified in this manual can result in hazardous radiation exposure.

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

DANGER: Do not stare into the barcode reader beam or shine it into other people’s eyes.

Fluidics

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.

Optimally, the waste line should be routed to a laboratory drain. If you use a waste container, monitor waste fluid levels periodically. The volume of the waste container should be at least as large as the volume of the sheath container. Do not allow the waste fluid container to overflow. Empty the waste fluid container each time you replace or fill the sheath fluid container. Place the waste fluid container at least three feet below the surface on which the Luminex® FLEXMAP 3D® instrument rests. Do not place the waste fluid container on top of the instrument. Do not move the waste line vertically while the FLEXMAP 3D instrument is running, and make certain the waste container is properly vented. Contact Luminex Technical Support before relocating the waste fluid container or rerouting the waste line.

CAUTION: Reagents may contain sodium azide as a preservative. Sodium azide is toxic and may also react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush drains with a generous amount of cold water to prevent azide build-up. Consult the manual guideline “Safety Management No. CDC-22, Decontamination of Laboratory Sink Drains to remove Azide

Safety

5

salts” (Centers for Disease Control, Atlanta, Georgia, April 30, 1976).

Biological Samples

Human and animal samples may contain biohazardous infectious agents. Where exposure to potentially biohazardous materia exists, follow appropriate 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.

Mechanical Components

The FLEXMAP 3D instrument has parts that move during operation. Risk of personal injury is present. The moving parts present puncture, pinching, and hand-crushing hazards. Keep your hands and fingers away from the XY slot, syringe pumps, and sample probe during operation. The XY platform ejects without warning, especially during multiplate batches. Observe all warnings and cautions. Keep the access doors closed during normal operations.

Swivel Base

The optional swivel base available with the FLEXMAP 3D system includes moving parts and possible pinch points. Those factors present the possibility of injury.

Make certain the swivel base rests securely on a stable surface, to avoid any possibility of toppling.

Indicator Lights

The lights inside the front door of the Luminex® FLEXMAP 3D® instrument indicate the on/off status of the system and are harmless. The blue light-emitting diodes (LEDs) do not emit light in the UV spectrum.

FLEXMAP 3D® Hardware User Manual 6

Electrical Components

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

The following fuse caution label appears on the back of the FLEXMAP 3D.

FIGURE 5. Fuse Caution Label

The following voltage label appears on the back of the FLEXMAP 3D instrument. It displays the FLEXMAP 3D serial number, model number, power requirements, and manufacturer’s information.

FIGURE 6. Serial Number and Voltage Label

Safety

7

Heat

The heater plate, used to warm the heater block of the XY platform, can be heated between 35°C and 60°C.

WARNING: The heater plate of the FLEXMAP 3D XY platform may be hot and can cause personal injury if touched. Do not touch the heater plate.

Decontamination Procedure

Occasions may arise when it becomes necessary to decontaminate the entire Luminex® FLEXMAP 3D® instrument, for example, prior to shipping. If you must decontaminate the instrument, sanitize the accessible surfaces and the internal fluidics system. This is particularly important when biohazardous samples have been run.

WARNING: Wear appropriate personal protective equipment when handling parts that come into contact with potentially biohazardous samples.

To decontaminate the FLEXMAP 3D instrument:

1.Remove all specimens and all FLEXMAP 3D reagents.

2.Use the software to run a sanitize command with the diluted (10% to 20%) household bleach solution. Leave distilled water and household bleach solution diluted to 10% to 20% in water in the system.

3.Use the software to run two wash commands with distilled water.

4.Turn off the power switch and unplug the cord from the outlet.

5.Wash all exterior surfaces with a mild detergent followed by the diluted (10% to 20%) household bleach solution.

6.Open the front doors of the system. Clean all accessible surfaces with mild detergent followed by the diluted (10% to 20%) household bleach solution.

Installation of Instrument

Luminex handles the packing, shipping, unpacking, and installation of the Luminex® FLEXMAP 3D® system. Luminex recommends that users and laboratory personnel do not uninstall, move, or install the system.

For site preparation and facilities requirements, see the section titled Installation.

FLEXMAP 3D® Hardware User Manual 8

FIGURE 7. Installed FLEXMAP 3D System

Disposal of Instrument

Within the European Union, the Waste Electrical and Electronic Equipment 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® FLEXMAP 3D® instrument, decontaminate the system. See the section titled “Decontamination Procedure”. Next, contact Luminex Technical Support for a Return Material Authorization (RMA) number at [phone] (outside of the U.S.). Return the equipment to the following Luminex location:

Luminex Corporation

12201 Technology Blvd., Suite 130

Austin, Texas 78727

USA

For information about disposal of FLEXMAP 3D outside of the European Union, contact Luminex Technical Support at 1-877-785-2323 within the US and at [phone] outside of the US.

For information about disposal of the barcode scanner, PC, or monitor, refer to the manufacturer documentation.

Safety

9

FLEXMAP 3D® Hardware User Manual 10

Chapter 2: Technical Overview

This chapter reviews the technical aspects of theLuminex® FLEXMAP 3D® system: operation, system components, subsystems, recommended additional equipment, and specifications.

How the FLEXMAP 3D System Operates

The Luminex® FLEXMAP 3D® system, in combination with xMAP® (Multi-Analyte Profiling) technology, will simultaneously measure up to 500 analytes from a single sample. xMAP technology incorporates microspheres, proprietary dyeing processes, flow cytometry based fluidics, lasers, the latest in high-speed digital signal and advanced computer algorithms, enabling a multi-analyte detection system that demonstrates excellent sensitivity and specificity.

An established proprietary process created by Luminex to internally dye same-size polystyrene microspheres with multiple fluorophores facilitates the creation of five hundred distinguishable microspheres when these fluorophores are combined in varying concentrations. The microspheres, discriminated by color, are excited by two lasers in the FLEXMAP 3D instrument. The resulting emission is detected by avalanche photo diodes (APDs) in three classification channels (CL1, CL2, and CL3) that is then further analyzed using a separate APD in a doublet discriminator (DD) channel, which measures bead size through side-scatter.

Analytes are bound to xMAP microspheres using the same surface chemistry used with earlier Luminex instruments (LX100/200). Reporters, tagged with fluorescent labels excited at a different wavelength than the internal dyes, bind to the analyte of interest and are detected by a photomultiplier tube (PMT) in a reporter channel (RP1), allowing for quantitative analysis. As the microspheres in a fluid stream pass rapidly through the laser beams, highspeed digital signal and computer algorithms discriminate which analyte is being carried on each microsphere and quantifies the reaction based on fluorescent reporter signal. The results are analyzed by the system software and presented in a readable format for analysis.

Subsystems

The Luminex FLEXMAP 3D instrument includes four subsystems: electronic, fluidic, mechanical, and optical. The following topics describe the user-accessible components of each subsystem.

11