Luminex FLEXMAP 3D User Manual

Luminex® FLEXMAP 3D

Hardware User Manual

For research use only. Not for use in

diagnostic procedures.

Luminex Corporation, 2012. 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: (512) 219-8020

Fax: (512) 219-5195

Luminex® FLEXMAP 3D® Hardware User Manual (RUO)

PN 89-00002-00-410 Rev A

August 2012

European Union (EU)

Authorized

Representative:

Luminex B.V. Kombraak 15

4906 CR Oosterhout

The Netherlands

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.

Luminex® FLEXMAP 3D® Hardware User Manual ii

For research use only. Not for use

in diagnostic procedures.

Standard Terms and Conditions for Use of Instrument Product

By opening the packaging containing this instrument 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

iii

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, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. 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 NOR ANY OF ITS AFFILIATES 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 OR ITS AFFILIATE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, 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 its expense, will contact either Luminex or a Luminex trained service engineer to assess the issue and identify the defective FS-PART; and (iii) 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 an 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 and Buyer shall be responsible for the payment for such FSPART and related shipping charges. In the event that Luminex determines that such FSPART is defective, 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 is sold and licensed only for use with

Luminex® FLEXMAP 3D® Hardware User Manual iv

For research use only. Not for use

in diagnostic procedures.

Luminex's laser based fluorescent analytical test instrumentation. Buyer further acknowledges that the Product has not received approval from the United States Food and Drug Administration or other federal, state or local regulatory agencies and has 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 on the Product label or 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 OF THE 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 to 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 3, "Buyer's Use of Product," and that any such use of the 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

For research use only. Not for use in diagnostic procedures.

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.

89-30000-00-186 (Rev C.)

Luminex® FLEXMAP 3D® vi

Hardware User Manual

For research use only. Not for use

in diagnostic procedures.

Chapter 1 Safety ..................................................................................................................1

Description ...................................................................................................................................................1

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

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

Testing and Certification ..............................................................................................................................2

Safety Precautions .......................................................................................................................................3

General

Electromagnetic Compatibility ...............................................................................................................3

Lasers ....................................................................................................................................................4

Fluidics ..................................................................................................................................................5

Biological Samples ................................................................................................................................5

Mechanical Components .......................................................................................................................6

Swivel Base ...........................................................................................................................................6

Indicator Lights ......................................................................................................................................6

Electrical Components ..........................................................................................................................6

Heat .......................................................................................................................................................7

Decontamination Procedure ........................................................................................................................7

Installation of Instrument ..............................................................................................................................8

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

..................................................................................................................................................3

Chapter 2 Technical Overview .........................................................................................11

How the FLEXMAP 3D System Operates .................................................................................................11

Subsystems ...............................................................................................................................................12

Electronics ...........................................................................................................................................12

Fluidics ................................................................................................................................................13

Mechanics ...........................................................................................................................................17

Optics ..................................................................................................................................................19

System Components .................................................................................................................................19

Luminex® xPONENT® Software .........................................................................................................19

Reagents .............................................................................................................................................19

Luminex® FLEXMAP 3D® Hardware ..................................................................................................21

Recommended Additional Equipment .......................................................................................................21

Uninterruptible Power Supply (UPS) or Surge Protector .....................................................................21

Printer ..................................................................................................................................................22

Barcode Labels ...................................................................................................................................22

Vortex ..................................................................................................................................................22

Bath Sonicator .....................................................................................................................................22

Specifications and Limitations ...................................................................................................................22

General ................................................................................................................................................22

Electronics ...........................................................................................................................................24

Optics ..................................................................................................................................................24

Fluidics ................................................................................................................................................24

Microspheres .......................................................................................................................................24

Microtiter Plates ...................................................................................................................................25

vii

Chapter 3 Maintenance and Cleaning .............................................................................27

General Maintenance Precautions ............................................................................................................27

Daily Maintenance .....................................................................................................................................27

Initializing the Luminex® FLEXMAP 3D® Instrument ..........................................................................28

Warming Up the Luminex® FLEXMAP 3D® Instrument ......................................................................28

Maintaining Fluids ...............................................................................................................................28

Shutting Down the Luminex® FLEXMAP 3D® Instrument ...................................................................29

Weekly Maintenance .................................................................................................................................29

Running Weekly Maintenance .............................................................................................................29

Removing Clogs ..................................................................................................................................30

Cleaning the Sample Probe ................................................................................................................30

Calibrating the Luminex® FLEXMAP 3D® System ..............................................................................31

Visually Inspect the Luminex® FLEXMAP 3D® Instrument .................................................................31

Monthly Maintenance .................................................................................................................................32

Semi-Annual Maintenance .........................................................................................................................32

Replacing the Syringe Teflon Seals ....................................................................................................32

Replacing the HEPA Air Filter .............................................................................................................34

Cleaning the Ventilation Filters ............................................................................................................35

Annual Maintenance ..................................................................................................................................37

Storing the Luminex® FLEXMAP 3D® Instrument .....................................................................................38

Storing the Luminex® FLEXMAP 3D® Instrument ...............................................................................38

Preparing the Luminex® FLEXMAP 3D® Instrument for Use After Storage ........................................39

Replacing Fuses ........................................................................................................................................39

Maintenance Logs .....................................................................................................................................40

Chapter 4 Troubleshooting ..............................................................................................43

Overview ....................................................................................................................................................43

Power Supply Problems ............................................................................................................................44

Communication Problems ..........................................................................................................................44

Clogs ..........................................................................................................................................................45

Pressurization Problems ............................................................................................................................45

Fluid Leaks ................................................................................................................................................46

Sample Probe Problems ............................................................................................................................46

Calibration Problems .................................................................................................................................47

Verification Problems .................................................................................................................................48

Acquisition Problems .................................................................................................................................49

Bead Detail Irregularities ...........................................................................................................................50

Appendix A Shipping ........................................................................................................53

Shipping .....................................................................................................................................................53

Draining the Reservoir ...............................................................................................................................53

Shipment Checklist ....................................................................................................................................54

Appendix B Installation ....................................................................................................57

Installation of the Luminex® FLEXMAP 3D®.............................................................................................57

Appendix C Part Numbers ................................................................................................65

Luminex® FLEXMAP 3D® Hardware User Manual viii

For research use only. Not for use

in diagnostic procedures.

Appendix D FLEXMAP 3D® Probe Height Adjustment Tool .........................................67

Appendix E Maintenance Schedule .................................................................................71

Short Term Maintenance Schedule ...........................................................................................................71

Long Term Maintenance Schedule ............................................................................................................73

For research use only. Not for use in diagnostic procedures.

Table of Contents

Luminex® FLEXMAP 3D® Hardware User Manual x

For research use only. Not for use

in diagnostic procedures.

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.

Description

The Luminex® FLEXMAP 3D® system is a life science research multiplex test system intended to measure and sort multiple signals generated in an assay from a biological sample. The FLEXMAP 3D system is for research use only and is not for use in diagnostic procedures. The FLEXMAP 3D system is for laboratory and professional use only.

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.

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 Point Warning

Hand Crush/ Cut/Force From Above

Caution, Risk of Electric Shock

Protective ground

Use By Expiration Date

General Warning, Caution, Risk of Danger

Heat/Hot Surface Warning

Warning, Laser Beam

Alternating current (AC)

Temperature Limitation

Warning, Biological Hazard

Burn Hazard/ Hot Surface

Consult Instructions for Use

Catalog Number

Waste Electrical and Electronic Equipment (WEEE)

Date of Manufacture

Off (Power) On (Power) MET Mark

Serial Number Batch Code

Testing and Certification

The Luminex® FLEXMAP 3D®

Luminex® FLEXMAP 3D® Hardware User Manual 2

system has been tested by MET.

Manufacturer European

Union Conformity

For research use only. Not for use

in diagnostic procedures.

FIGURE 1.

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.

MET Mark

FIGURE 2.

European Union Compliance Label

Safety Precautions

Read the following safety information before using the 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.

NOTE: 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

Luminex® FLEXMAP 3D® instrument.

warranty voided if the manner not specified by the instructions or by Luminex Corporation.

FLEXMAP 3D® system is used in a

General

CAUTION: Keep access doors closed during normal operation.

Always observe standard laboratory safety practices.

Electromagnetic Compatibility

The Luminex® described in IEC/EN 61326-1. The electromagnetic environment should be evaluated prior to operation.

For research use only. Not for use in diagnostic procedures.

FLEXMAP 3D® system complies with the emission and immunity requirements

Safety

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 optional bar code reader is a Class II stand-alone component. In accordance with IEC 60825-1, the instrument is classified as Class 1, containing two Class 3b lasers. The optional bar code reader is a Class II stand-alone component. The 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.

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.

FLEXMAP 3D® complies with IEC

FIGURE 3.

The following label appears above the laser apertures located inside the optics enclosure inside the

FIGURE 4.

Laser Warning Label

FLEXMAP 3D® instrument.

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.

Luminex® FLEXMAP 3D® 4

DANGER: Do not, under any circumstances, remove the FLEXMAP 3D

instrument cover. Use of controls or adjustments or performance

Hardware User Manual

For research use only. Not for use

in diagnostic procedures.

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

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.

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 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.

of procedures other than those specified in this manual can result in hazardous radiation exposure.

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

people’s eyes.

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

FLEXMAP 3D® instrument is

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 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 material 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.

For research use only. Not for use in diagnostic procedures.

Safety

Mechanical Components

WARNING: The Luminex® 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.

Observe all warnings and cautions. Keep the access doors closed during normal operations.

Swivel Base

WARNING: The optional swivel base available with the Luminex® FLEXMAP

3D® system includes moving parts and possible pinch points. Those factors present the possibility of injury.

WARNING: Use care when handling the swivel base to avoid pinch point

injuries.

WARNING: 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 status of the system and are harmless. The blue light-emitting diodes (LEDs) do not emit light in the UV spectrum.

Electrical Components

WARNING: 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 Luminex®

Luminex® FLEXMAP 3D® instrument indicate the on/off

FLEXMAP 3D®.

Luminex® FLEXMAP 3D® Hardware User Manual 6

For research use only. Not for use

in diagnostic procedures.

FIGURE 5.

Fuse Caution Label

Heat

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

FIGURE 6.

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

Serial Number and Voltage Label

WARNING: The heater plate of the Luminex® FLEXMAP 3D®

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

instrument. It displays

XY platform

Decontamination Procedure

Occasions may arise when it becomes necessary to decontaminate the entire 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.

For research use only. Not for use in diagnostic procedures.

Luminex

Safety

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 deionized 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 deionized 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.

FIGURE 7.

Installed FLEXMAP 3D® System

Luminex® FLEXMAP 3D® Hardware User Manual 8

For research use only. Not for use

in diagnostic procedures.

Disposal of Instrument

NOTE: Within the European Union and other jurisdictions, in accordance

with Directive 2002/96/EC of the European Parliament and of the Council regarding Waste Electrical and Electronic Equipment

(WEEE), you must 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 +1-512-381-4397 (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 jurisdictions, contact Luminex Technical Support at 1-877-785-2323 within the US and at +1-512-381-4397 outside of the US.

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

FLEXMAP 3D® outside of the European Union and other

For research use only. Not for use in diagnostic procedures.

Safety

Luminex® FLEXMAP 3D® Hardware User Manual 10

For research use only. Not for use

in diagnostic procedures.

Chapter 2: Technical Overview

This chapter reviews the technical aspects of the Luminex® 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.

FLEXMAP 3D® system:

Subsystems

The Luminex® mechanical, and optical. The following topics describe the user-accessible components of each subsystem.

Electronics

The electronics system provides the power for operation and control of the FLEXMAP 3D system and communication between its parts.

Power Input Module

The power input module contains the input power plug and fuses. This is the protective earthing point for the Luminex® FLEXMAP 3D® system. The mating power cord connector type is IEC-320-C13. The mating power cord provides electrical power to the instrument when it is connected to an electrical outlet and is the means of disconnection. The power input auto-senses the voltage range. See the "Back of the FLEXMAP 3D® Instrument" image below.

WARNING: Do not obstruct this means of disconnection. Connect only to

Communications Ports (USB Type B Connector)

FLEXMAP 3D® instrument includes four subsystems: electronic, fluidic,

outlets that contain protective earthing. Before changing a fuse, turn off the instrument and unplug the power cord to avoid any danger of electrical shock.

The communications port connects the See the "Back of the FLEXMAP 3D® Instrument" image below.

Luminex® FLEXMAP 3D® instrument to the computer.

Luminex® FLEXMAP 3D® 12

Hardware User Manual

For research use only. Not for use

in diagnostic procedures.

FIGURE 8.

Back of the FLEXMAP 3D® Instrument

Fluidics

The fluidics system handles the flow of liquid through the instrument.

Access Doors

The Luminex® FLEXMAP 3D® system has two front access doors. The left door supplies access to a door ventilation filter and the sheath filter. The right door supplies access to a door ventilation filter, the sample probe, and the syringe pumps. See the "Front of the FLEXMAP 3D® Instrument" image below.

1 Power Input Module

2 Communications Port P1 (USB type B)

Luminex® FLEXMAP 3D

For research use only. Not for use in diagnostic procedures.

Technical Overview

FIGURE 9.

Front of the FLEXMAP 3D® Instrument

1 Left door, with access to sheath filter and door ventilation filter

2 Right door, with access to syringe pumps, door ventilation filter, and sample probe

Sample Probe

A stainless steel sample probe acquires the sample. See the "Sample Probe" image below.

WARNING: Avoid contact with moving parts.

Cheminert® Fitting

This fitting attaches the sample probe to the sample tubing. Disconnect this fitting when you remove the sample probe. See the "Sample Probe" figure below.

WARNING: Wear appropriate personal protective equipment when handling

parts that come into contact with potentially biohazardous samples.

Luminex® FLEXMAP 3D® Hardware User Manual 14

For research use only. Not for use

in diagnostic procedures.

FIGURE 10.

Sample Probe

1 Cheminert fitting

2 Attachment point on Cheminert fitting for sample tubing

3 Sample probe, in up position

Syringe Pump

The syringe delivers a sample from the microtiter plate to the cuvette. See the "Syringe Pump" image below.

WARNING: Avoid contact with moving parts.

For research use only. Not for use in diagnostic procedures.

Technical Overview

FIGURE 11.

Syringe Pump

1 Syringe arm (within dotted lines)

2 Glass syringe barrel

3 Syringe plunger

Sheath Filter

The sheath filter removes particles greater than ten microns in diameter from the sheath fluid. See the "Fluidics Bay" image below.

Fluidics Bay

The waste and sheath connectors, located on the front of the fluidics bay, connect to the sheath fluid and waste fluid containers using clear tubing. The sheath fluid connector is blue and the waste connector is orange. See the "Fluidics Bay" image below.

CAUTION: Wear appropriate personal protective equipment when handling

parts that come into contact with potentially biohazardous samples.

Luminex® FLEXMAP 3D® Hardware User Manual 16

For research use only. Not for use

in diagnostic procedures.

FIGURE 12.

Fluidics Bay

Waste Fluid Container

The waste fluid container receives waste from the system. To maintain a stable flow rate, do not move the waste line or container during system operation and make certain the waste fluid container is properly vented. Place the container at least three feet below the surface on which the instrument rests. You can place it as far away from the instrument as the tubing allows. Never place it on top of the instrument. Refer to safety instructions for the waste fluid container within the Fluidics section of the manual.

WARNING: Wear appropriate personal protective equipment when handling

Mechanics

The mechanical subsystem of the system.

Replaceable ventilation filters clean the air used to cool the instrument and pressurize sheath fluid. The four filters must be checked and cleaned as prescribed in the Maintenance chapter

1 Sheath filter

2 Blue tubing attached to sheath fluid container

3 Orange tubing attached to waste fluid container

parts that come into contact with potentially biohazardous samples.

Luminex® FLEXMAP 3D® instrument includes a filter

For research use only. Not for use in diagnostic procedures.

Technical Overview

of this manual. The "Fluidics Bay" image above and "Front Door Ventilation Filters" image below show the location of these filters.

FIGURE 13.

Front Door Ventilation Filters

View A Right front door, viewed from inside

View B Left front door, viewed from inside

FIGURE 14.

1 Filter

2 Holding clamp

XY and HEPA Filters

View A Front of XY, with XY cover removed

View B Front of fluidics bay, behind left front door

1 XY filter

Luminex® FLEXMAP 3D® Hardware User Manual 18

For research use only. Not for use

in diagnostic procedures.

TABLE .

Continued

2 Holding clamp

3 Cover over HEPA air filter

Optics

The optical system consists of the optical assembly and the excitation lasers. The optical components do not require manual adjustment by the user.

System Components

The following topics describe details of the three components of the system: software, reagents, and hardware.

Luminex® xPONENT® Software

Luminex® xPONENT® software provides complete control of the Luminex® FLEXMAP 3D instrument and performs the analysis. The software requires a dedicated PC. For updated information about the PC or operating system, access http://www.luminexcorp.com. Click the Support link to open the FAQ list.

Under most circumstances, the PC that comes with the FLEXMAP 3D® system is preloaded with xPONENT software. Luminex provides a software CD to use if you need to reinstall the software or need to install it on another computer. If you install the software on another PC, be sure that the PC meets the minimum specifications, including 4.0 GB of RAM and a 2.66 GHz processor. The number of installations you can perform is limited by your license.

The software CD automatically installs the basic software only. To install the various upgrades, contact Luminex Technical Support. A Technical Support representative can supply you with the correct license number to install upgrades.

CAUTION: If you need to uninstall the software, follow carefully the

procedure provided by Luminex Technical Support.

The software is documented in two ways: online help, which can be accessed from within the application itself, and in PDF form, which is available on the Luminex website and on CDs included with the system.

Luminex® FLEXMAP 3D

Reagents

Luminex® xMAP® technology requires two kinds of reagents:

•

Common laboratory reagents

• Reagents created especially for Luminex instruments

For research use only. Not for use in diagnostic procedures.

CAUTION: Luminex recommends that you do not install additional software

on the PC that runs xPONENT. The operation of xPONENT has been validated only when it is the only program running on the dedicated PC.

Technical Overview

CAUTION: Adhere to standard laboratory safety practices when handling

hazardous, toxic, or flammable reagents and chemicals. Contact Luminex Technical Support when in doubt about compatibility of cleaning and decontamination agents or materials.

Required Laboratory Reagents

•

10 - 20% household bleach

• 70% isopropanol or 70% ethanol

• 0.1N NaOH

• Sporicidin® Disinfectant

• Mild detergent

• Deionized water

WARNING: Isopropanol and ethanol are flammable liquids. Keep them away

from heat, open flames, and sparks in a well-ventilated area. Remove them from the instrument when they are not in use.

Luminex® xMAP® Technology Reagents

•

F3DCAL1 - Classification Calibrator (calibrates DD, CL1, CL2, CL3 - for all xMAP microsphere applications other than MagPlex microspheres)

• F3DeCAL1 - Classification Calibrator (calibrates DD, CL1, CL2, CL3 - for MagPlex

microsphere-based applications only)

• F3DCAL2 - Reporter Calibrator (calibrates RP1 standard and enhanced range - for all

xMAP microspheres)

• F3DCAL3 - EDR Calibrator (calibrates RP1 extended range - for all xMAP microspheres)

• F3DVER1 - Classification Verifier (verifies DD, CL1, CL2, CL3 - for all xMAP microsphere-

based applications other than MagPlex microspheres)

• F3DeVER1 - Classification Verifier (verifies DD, CL1, CL2, CL3 - for MagPlex microsphere-

based applications only)

• F3DVER2 - Reporter Verifier (verifies RP1 standard and enhanced PMT and extended

range - for all xMAP microspheres)

• Fluidics1 - xMAP Fluidics 1 (verifies fluidic integrity and well-to-well microsphere carryover)

• Fluidics2 - xMAP Fluidics 2 (verifies fluidic integrity and well-to-well microsphere carryover)

• Luminex xMAP Sheath Fluid

CAUTION: Protect xMAP reagents from light at all times to avoid

photobleaching of the microspheres.

CAUTION: Luminex reagents contain ProClin® as a preservative. This can

cause allergic reactions in some people.

Luminex® FLEXMAP 3D® Hardware User Manual 20

For research use only. Not for use

in diagnostic procedures.

CAUTION: Luminex calibrators and verifiers contain sodium azide. Sodium

Decontamination of Laboratory Sink Drains to remove Azide Salts (Centers for Disease Control, Atlanta, Georgia, April 30,

1976).

Luminex® FLEXMAP 3D® Hardware

The Luminex® FLEXMAP 3D®

• The FLEXMAP 3D® instrument

• Personal computer (PC) and accessories

• Stereo speakers

• Power cables

• Three sample probes

• Off-plate reagent area

• 96 and 384 heater blocks

• Empty cubitainer for waste

• Sheath fluid intake line

• Waste fluid outtake line

• USB communication cable

• Barcode reader (optional)

• Sample probe height alignment kit and 384-well plate Probe Height Adjustment tool

• Monitor arm

NOTE: For information on calibrating the probe correctly, refer to the

FLEXMAP 3D 384-Well Plate Probe Height Adjustment Tool section.

system includes the following hardware:

Recommended Additional Equipment

Successful operation of the equipment.

Uninterruptible Power Supply (UPS) or Surge Protector

Luminex recommends using either an uninterruptible power supply (UPS) or a surge protector to protect your system from power outages. Use a UPS that provides 1300 watts for at least 45 minutes. Select a surge protector that fits your requirements with regard to electrical environment, endurance, suppressed voltage rating, and method of protection. The surge protector requires three outlets and a minimum rating of 1500 watts. Either piece of equipment should be listed by Underwriters Laboratory (UL) or a similar listing body, certified by Canadian Standards Association (CSA), and marked Conformité Europeénne (CE) for nondomestic use.

For research use only. Not for use in diagnostic procedures.

Luminex® FLEXMAP 3D® system may require additional

Technical Overview

Printer

Use a printer compatible with

Microsoft® Windows XP SP3.

Barcode Labels

Use Code 128 barcode label type when scanning barcode labels into the system.

Vortex

Use VWR product number 58816-12, with a speed range of 0 to 3200 rpm, or equivalent.

Bath Sonicator

Use Cole-Parmer® product number 08849-00, with an operating frequency of 55 kHz, or equivalent.

Specifications and Limitations

The Luminex® FLEXMAP 3D® system is designed to fit a series of standards for speed, accuracy, sensitivity, and capacity. The following topics provide the specifications and limitations for the Luminex FLEXMAP 3D® system.

CAUTION: Read and observe specifications and limitations carefully.

General

Indoor laboratory and professional use only

Physical dimensions: 58.4 cm (23 inches) W x 65.3 cm (25.7 inches deep, including the required 1.25 inches for

proper cooling) D x 54.7 cm (18.0 inches) H. Additional space required for the arm, monitor, keyboard, mouse and optional barcode scanner does not exceed 64.8 cm (25.5 inches) W by 61 cm (24.0 inches) D.

Weight: up to 91 kg (200 lbs), including the instrument, monitor arm, monitor and accessories such

as the keyboard, mouse, and barcode scanner.

Installation Category: II

Pollution degree: 2

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

Operating humidity: 20% to 80%, noncondensing

Shipping and storage temperature:

Shipping and storage humidity:

0 to 50°C (32° F to 122° F)

20% to 80%, noncondensing

Luminex® FLEXMAP 3D® Hardware User Manual 22

For research use only. Not for use

in diagnostic procedures.

TABLE .

Temperature control: Maintains samples using the heater block at a constant temperature from 35°C to 60°C

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

Automatic transfer of assay protocols and new reagent information into the system using a large capacity read/write DVD

Automatic sampling from a 96- or 384-well microtiter plate, beginning from any well position

Automatic real-time analysis

Analyzes multiple assay protocols per microtiter plate

Barcode reader entry of sample IDs

System initialization: < 45 minutes (including laser warmup, required software procedures, and weekly

System verification: 5 minutes

FLEXMAP 3D® warmup: 30 minutes. A system that remains inactive for at least four hours requires a warm-up to

Produces sound pressure levels below 85 dBA

Operating Shock: The instrument will be able to operate while experiencing limited shock.

Continued

(95°F to 131°F), +/- 1°C of setpoint.

calibration)

restart the lasers. The system resets the four-hour internal clock after acquiring the sample, running system calibrators, running system controls, or warming up the instrument.

Pulse amplitude: 1 m/s2 maximum

•

• Pulse direction: along any axis defined by a rear corner of the instrument, in either direction

• Reference IEC 60068-2-27 Basic Environmental Testing Procedures Part 2: Tests -Test Ea and Guidance: Shock

Note: This specification is not meant to comprehensively describe all forms of shock the instrument may be exposed to in use; it is only intended to serve as a measure of the system's robustness.

Although the system shall be able to withstand a shock pulse as described above without compromising reliable operation, extended exposure to shock whether or not it exceeds the pulse defined above is not recommended and may result in instrument failure.

Operating Vibration: The instrument will be able to operate while experiencing limited vibration.

• Direction shall be along any axis defined by a rear corner of the instrument.

• Sinusoidal, limited to frequency ranges in table below

Frequency Range Limit Type of Limit

0 to 10 Hz 0.35 mm ± 10% (0.7 mm peak-to-peak) Displacement

10 Hz to 100 Hz 1 m/s2 ± 10% peak Acceleration

Reference IEC 60068-2-6 Environmental Testing Procedures Part 2: Tests - Test Fc: Vibration (Sinusoidal).

Note: Although the instrument shall be able to operate while experiencing vibration as described above, extended exposure to vibration whether or not it exceeds these limits is not recommended and may result in instrument failure.

For research use only. Not for use in diagnostic procedures.

Technical Overview

Electronics

USB 2.0-compatible communications link for fast data transfer

Input voltage range: 100-120 V~, 6.0 A, 50/60 Hz or, 200-240 V~, 3.0 A, 50-60 Hz

Optics

Reporter channel detection: A/D resolution 16 bits

Reporter channel dynamic range:

Reporter laser: 532 nm, nominal output 15.0+5%/-0% mW, diode-pumped; mode of

Classification laser: 638 nm, nominal output 12.0 to 12.5 mW, diode; mode of operation,

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

Classification detector: Avalanche photo diodes with temperature compensation

Doublet discrimination detector:

Fluidics

Cuvette: 200 micron square flow channel

Sample injection rate: 2μL/second

Sample uptake volume: 20 to 200μL

Sheath flow rate: 7.9 (+/- 0.9) mL/min

Sheath pressure: 8 to 13 psi for normal operations; 15 psi maximum

≥ 4.5 decades of detection (verified with beads dyed with high levels of organic dyes)

operation, continuous wave (CW); maximum output power 50 mW

continuous wave (CW); maximum output power 15 mW

Avalanche photo diodes with temperature compensation

Microspheres

Distinguishes 1 to 500 unique xMAP microspheres in a single sample

Classification of xMAP microspheres:

Total system misclassification of xMap microspheres:

Internal sample carryover: < 1.5%

Detects a minimum of 500 fluorochromes of phycoerythrin (PE) per xMAP microsphere

Luminex® FLEXMAP 3D® Hardware User Manual 24

≥ 80%

≤ 4%

For research use only. Not for use

in diagnostic procedures.

TABLE .

Detects and distinguishes surface reporter fluorescence emissions at 575 nm on the surface of 1 to 500 unique xMAP microspheres in a single sample

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

Continued

Microtiter Plates

The Luminex® FLEXMAP 3D® system processes a 96-well microtiter plate in less than 20 minutes and a 384-well microtiter plate within 1 hour and 15 minutes, with 2500 microspheres per region per well, counting 100 microspheres in each region.

Microtiter plates with 96 and 384 wells must be compatible with the microtiter heater block temperature (from 35 to 60°C or 95° to 131°F) when the heater block is in use.

All microtiter plates (96 or 384 wells) have standard width (85.6 mm) and length (127.9 mm). Depth varies depending on the type of well. To be compatible with the instrument, the maximum allowable depth is 1”. Plates must have minimum 0.06” lip height, standard distance from well center to well center (9 mm on 96-well plate), and standard distance from A1 center to plate center in both length and width. To be compatible in size with the microtiter heater block, the plate must fit into the heater block so that the top is flush with the heater block.

FLEXMAP 3D

For research use only. Not for use in diagnostic procedures.

Technical Overview

Luminex® FLEXMAP 3D® Hardware User Manual 26

For research use only. Not for use

in diagnostic procedures.

Chapter 3: Maintenance and Cleaning

To ensure accurate test results, properly clean and maintain the Luminex® FLEXMAP 3D system. Read and follow all instructions in this section. Perform adequate maintenance and cleaning to avoid inaccurate results and potential hazards. To facilitate your maintenance process, print out and use the maintenance logs found

General Maintenance Precautions

Observe the following general maintenance precautions, which were explained in more detail in the previous chapters:

Personnel who use, maintain, or clean the Luminex® should be trained in standard laboratory safety practices and should follow those practices when handling the instrument.

Samples and waste fluid can contain biohazardous material. Where exposure to biohazardous material, including in an aerosol form, exists, follow appropriate biosafety procedures, use personal protective equipment, and use ventilation devices.

Do not remove the cover of the FLEXMAP 3D® instrument under any circumstances.

in the Maintenance Log section.

FLEXMAP 3D® instrument

Avoid contact with moving parts. Disconnect the instrument from the power source when the procedure instructs you to do so.

Daily Maintenance

NOTE: Most of the daily maintenance tasks for the Luminex®

system, including system initialization, warmup, and shutdown, can be performed using available software commands. For details about

FLEXMAP 3D

the performance of these activities, see the appropriate Luminex software manual or Luminex online help.

Initializing the Luminex® FLEXMAP 3D® Instrument

NOTE: Use the software to perform system initialization.

The software provides three options for system initialization:

• Warmup, fluidics

• Warmup, fluidics, verification

• Warmup, fluidics, verification, and calibration

Select the option you want. Warmup, fluidics, and verification should be part of the daily maintenance of the instrument; calibration can be limited to weekly maintenance unless otherwise specified by assay instructions.

NOTE: If the instrument temperature falls out of the delta cal range,

recalibrate it. For information about the delta cal range, see the appropriate Luminex software manual or Luminex online help.

Warming Up the Luminex® FLEXMAP 3D® Instrument

NOTE: If the Luminex® FLEXMAP 3D® instrument is powered on but idle for

more than four hours, both lasers turn off. Consequently, the instrument should be warmed up again. Use the software to perform a warmup.

Maintaining Fluids

Periodically monitor fluid levels. Replace the empty sheath fluid container as needed. If the Luminex® FLEXMAP 3D® instrument operates with an empty sheath fluid container, the lack of sheath fluid may interrupt a sample and prevent further samples from being collected.

CAUTION: Use only xMAP Sheath Fluid or another Luminex-approved

sheath fluid. Use of any other sheath fluid constitutes improper use and can void the warranty provided by Luminex and/or its authorized partner.

Place the waste fluid container at least three feet below the surface on which the 3D® instrument rests.

FLEXMAP

WARNING: Do not place the waste fluid container on top of the instrument.

Luminex® FLEXMAP 3D® Hardware User Manual 28

For research use only. Not for use

in diagnostic procedures.

WARNING: Do not move the waste line vertically while the FLEXMAP 3D

instrument is running.

Contact Luminex Technical Support before relocating the waste fluid container or rerouting the waste line. You can move the line temporarily for cleaning and maintenance.

To empty the waste fluid container:

1. Disconnect the waste fluid container from the FLEXMAP 3D® instrument.

2. Discard the waste from the waste fluid container in accord with all local, state, federal, and country specific biohazard handling regulations.

WARNING: Waste fluid can contain biohazardous infectious agents. Where

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

Shutting Down the Luminex® FLEXMAP 3D® Instrument

NOTE: Use the software to perform system shutdown. The shutdown

procedure is intended to shut down the Luminex® FLEXMAP 3D instrument for short periods, for example, overnight, for a weekend, or up to a week.

To shut down the FLEXMAP 3D instrument for a long period, see the section titled Storing

the FLEXMAP 3D Instrument.

Weekly Maintenance

NOTE: Some of the weekly maintenance tasks for the Luminex® FLEXMAP

3D® system can be performed using available software commands. For details about the performance of these activities, see the Luminex® xPONENT® Software User Manual or Luminex online help. Weekly maintenance includes using the software to perform a weekly maintenance routine, removing clogs, cleaning the sample probe, calibrating the system, and visually inspecting the instrument.

Running Weekly Maintenance

NOTE: Use the software to perform a weekly maintenance routine.

For research use only. Not for use in diagnostic procedures.

Maintenance and Cleaning

Removing Clogs

NOTE: If you frequently use the Luminex®

concentrated serum or other debris ridden samples, Luminex recommends that you use the software to perform a clog removal routine weekly. Luminex recommends using sodium hydroxide (NaOH) to remove clogs.

To remove clogs:

1. Add 0.1N sodium hydroxide solution to reservoir RB1 on the off-plate reagent block.

2. Use the software to perform a clog removal routine.

WARNING: Sodium hydroxide is extremely caustic. If it comes into contact

with skin, it can burn and cause tissue damage without causing pain. Always wear gloves and goggles when working with sodium hydroxide.

Cleaning the Sample Probe

WARNING: Avoid contact with moving parts. If a plate is running, use the

software to execute Stop to prohibit exposure to moving parts. Refer to the software manual for instructions. The FLEXMAP 3D® system must not be performing any operations while you carry out this maintenance procedure.

To clean the sample probe:

FLEXMAP 3D® system to test

Luminex

1. Use the software to execute STOP if a plate is running. Refer to the software manual for instructions. The FLEXMAP 3D® system must not be performing any operations while you carry out this maintenance procedure.

2. Remove the sample probe.

a. Open the right front door of the FLEXMAP 3D® instrument.

b. Unscrew the Cheminert fitting on top of the probe completely.

c. Grasp the probe gently and push up.

d. Lift the probe out of the top of the probe holder.

3. Clean the sample probe using either a bath sonicator or a 10 mL syringe. If you are using a bath sonicator, place the tip of the sample probe in the bath sonicator for 2 to 5 minutes. If you are using a syringe, force deionized water through the tip of the sample probe to its large end. This dislodges any debris clogging the tip.

Luminex® FLEXMAP 3D® Hardware User Manual 30

For research use only. Not for use

in diagnostic procedures.

4. Replace the sample probe and tightly screw in the Cheminert fitting.

Use the software to perform an automatic probe height adjustment.

NOTE: Perform an automatic probe height adjustment any time the probe is

removed.

NOTE: For information on calibrating the probe correctly, refer to the

xPONENT Software User Manual.

FIGURE 15.

The Sample Probe

1 Cheminert Fitting - Unscrew as shown in Step 2.

2 Probe Holder

3 Sample Probe - Push up and out of probe holder in Step 2.

Calibrating the Luminex® FLEXMAP 3D® System

NOTE: Calibrate the Luminex® FLEXMAP 3D®

regularly scheduled maintenance. There are several different ways to calibrate the system using the software.

system weekly as part of

Visually Inspect the Luminex® FLEXMAP 3D® Instrument

Make sure the instrument is idle, so there are no moving parts. Open all of the FLEXMAP 3D® instrument doors and visually inspect for leaks, corrosion, and other signs of improper function. Check all visible tubing connections.

For research use only. Not for use in diagnostic procedures.

Maintenance and Cleaning

Luminex

Monthly Maintenance

Clean the exterior surfaces monthly.

To clean exterior surfaces:

Turn off the Luminex® FLEXMAP 3D® instrument and unplug the power cord.

2. Wipe all exterior surfaces with mild detergent, followed by a household bleach solution diluted to 10% to 20%, followed by deionized water.

3. Open both doors of the instrument.

4. Clean all accessible surfaces with detergent, followed by the household bleach solution (10% to 20%), followed by deionized water.

WARNING: Avoid contact with the tubing and electronic parts of the

instrument.

5. Dry any unpainted metal surfaces to prevent corrosion.

6. Plug in the power cord and turn on the FLEXMAP 3D® instrument.

Semi-Annual Maintenance

Semi-annual maintenance tasks include replacing and cleaning air filters and replacing the syringe seal.

Replacing the Syringe Teflon Seals

To replace each syringe seal:

1. Turn off the Luminex® FLEXMAP 3D® instrument and unplug the power cord.

WARNING: A syringe arm does NOT deactivate while the seal is being

changed; unplugging is necessary to avoid injury.

2. Open the right front door of the FLEXMAP 3D instrument.

Locate the syringe (glass cylinder with a metal rod plunger).

4. Loosen the set screw on the syringe arm (at the bottom of the syringe) and push the syringe arm down.

NOTE: The syringe arm is tight. Be prepared to use some force to push it

down.

5. Unscrew the syringe from the top of its housing.

Pull the plunger out of the syringe.

7. Remove and replace the white plunger seal (at the top of the plunger) and the black Oring inside the seal.

8. Return the plunger to the syringe.

Luminex® FLEXMAP 3D® Hardware User Manual 32

For research use only. Not for use

in diagnostic procedures.

9. Screw the syringe back into its housing.

Return the syringe arm to its original position. The bottom of the plunger fits into the

10. indentation in the syringe arm.

11. Hand-tighten the set screw on the syringe arm.

12. Plug in the power cord and turn on the FLEXMAP 3D instrument.

13. Use the software to run the prime command twice, watching for any leaks in the syringe area.

14. Close the right front door.

FIGURE 16.

Syringe Assembly (Inside Right Door)

1 Glass Syringe Barrel 4 Syringe Plunger - Pull out as indicated in Step 6 and

replace as referenced in Step 9.

2 Syringe Arm (between dotted lines) - Press down as

indicated in Step 4 and up as referenced in Step 10.

3 Set Screw - Loosen as indicated in Step 4 and

tighten as referenced in Step 11

For research use only. Not for use in diagnostic procedures.

5 Plunger Seal (contains O ring) - Replace as

indicated in Step 7.

Maintenance and Cleaning

Replacing the HEPA Air Filter

The HEPA air filter is the round filter behind the panel on the left side of the front of the fluidics bay. Tubing from the interior of the fluidics bay is attached to the stem in the center back of the filter.

To replace the HEPA air filter:

Turn off the Luminex® FLEXMAP 3D® instrument and unplug the power cord.

2. Open the left door and locate the HEPA air filter panel on the front of the fluidics bay as shown in the HEPA Air Filter image below.

3. Remove the screw at the top of the panel and open the panel door as shown in the HEPA Air Filter image below.

4. Grasp the tubing and pull the filter 3 to 4 inches from the unit.

5. Remove the filter with one hand and hold the tubing with the other hand.

CAUTION: Do not allow the tubing to fall inside the instrument.

6. Connect a new filter to the tubing and position the filter inside the panel.

7. Reattach the panel door to the unit and close the access door.

8. Plug in the power cord and turn on the FLEXMAP 3D® instrument.

FIGURE 17.

View A Front of fluidics bay View B HEPA Filter

1 Filter panel 3 Filter Stem

2 Screw - Remove as indicated in Step 3. 4 Attachment point for tubing

HEPA Air Filter

Luminex® FLEXMAP 3D® Hardware User Manual 34

For research use only. Not for use

in diagnostic procedures.

Cleaning the Ventilation Filters

Each filter has at least one imprinted arrow on its metal frame. This arrow indicates the direction of the air flow. Filters should be installed so that the arrows are at the correct locations and point in the correct direction.

To clean the Luminex® FLEXMAP 3D® ventilation filters:

Turn off the FLEXMAP 3D® instrument and unplug the power cord.

2. Remove the XY cover by gently grasping its ventilation holes and pulling it straight out.

3. Slide clamps off the silver filter inside the cover and remove the filter.

NOTE: For filter location, reference the "Ventilation Filter on XY Platform"

image below.

4. Open the front doors. Slide clamps off the left and right silver door filters and remove the filters.

NOTE: For clamp location, reference the "Ventilation Filters inside Doors"

image below.

5. Clean the filters with a vacuum or with deionized water.

Stand the filters upright to air dry.

CAUTION: Filters must be completely dry prior to reinstallation.

7. Reinstall filters. The arrows on the door filters should point to the inside of the door. The arrow on the XY filter should point up.

For research use only. Not for use in diagnostic procedures.

Maintenance and Cleaning

8. Reinstall the XY cover and close the access doors.

Plug in the power cord and turn on the FLEXMAP 3D® instrument.

FIGURE 18.

View A Front of the FLEXMAP 3D® instrument with XY

cover in place

1 XY Cover (inside dotted lines) 3 Filter

2 Location of ventilation holes on top of XY cover

(visible only when doors are open)

Ventilation Filter on XY Platform

View B Front of the FLEXMAP 3D® instrument with XY

cover removed

4 Filter Clamp

FIGURE 19.

5 Incised Arrow

Ventilation Filters inside Doors

Luminex® FLEXMAP 3D® Hardware User Manual 36

For research use only. Not for use

in diagnostic procedures.

View A Right front door, viewed from inside 2 Filter Clamp

View B Left front door, viewed from inside 3 Incised Arrow

1 Filter

Annual Maintenance

Annual maintenance requires replacing the sheath filter.

To replace the Luminex®

1. Turn off the FLEXMAP 3D® instrument and unplug the power cord.

2. Open the left door on the FLEXMAP 3D® instrument and locate the sheath filter on the front of the fluidics bay.

3. Disconnect the filter by pushing down on the metal clamps at each quick-disconnect point.

NOTE: For information on the location of the disconnection clamps,

reference the "Front of Fluidics Bay (Inside Left Door)" image below.

4. Connect the new sheath filter, matching up the color-coded fittings. The arrow on the sheath filter should be pointing up.

Close the left door.

FLEXMAP 3D® instrument sheath filter:

For research use only. Not for use in diagnostic procedures.

Maintenance and Cleaning

6. Plug in the power cord and turn on the FLEXMAP 3D® instrument.

Use the software to run the prime command twice.

FIGURE 20.

Front of Fluidics Bay (Inside Left Door)

1 Top quick-disconnect point

2 Sheath Filter

3 Bottom quick-disconnect point

Storing the Luminex® FLEXMAP 3D®

If you need to put the Luminex® FLEXMAP 3D® instrument in long-term storage or prepare it for use after removing it from long-term storage, use the following procedures.

Storing the Luminex® FLEXMAP 3D® Instrument

This procedure explains the steps you should take before placing the Luminex® FLEXMAP 3D® instrument into long-term storage.

To prepare the FLEXMAP 3D® instrument for storage:

1. Use the software to perform a Preparation for storage routine.

Luminex® FLEXMAP 3D® Hardware User Manual 38

For research use only. Not for use

in diagnostic procedures.

Instrument

2. Remove the sample probe from the instrument and flush it with deionized water from the narrow end out through the larger end.

Replace the sample probe in the sample arm and wrap the end of the probe with

3. Parafilm®.

Preparing the Luminex® FLEXMAP 3D® Instrument for Use After Storage

Follow this procedure before you begin using the Luminex® FLEXMAP 3D® instrument after its removal from long-term storage.

To prepare the FLEXMAP 3D® instrument for use after storage:

1. Make sure that the sheath container has a sufficient amount of sheath fluid and that the waste fluid container is empty.

2. Remove the Parafilm from the end of the sample probe.

3. Turn on the FLEXMAP 3D® instrument and watch for the following indications of correct response:

• The compressor starts. It has a low rumbling sound.

• Air blows out of the rear fans. Place your hand behind the FLEXMAP 3D® instrument,

on the upper part of the back, to feel it.

NOTE: For the fan location, see the "Back of the FLEXMAP 3D®

• The syringes inside the right door of the FLEXMAP 3D® instrument initialize.

4. Turn on the PC and start up the software. Use the software to run a revival after storage routine.

Replacing Fuses

Periodically, you may need to replace a fuse on the Luminex® FLEXMAP 3D® instrument. The instrument requires fuses with the following specifications:

F6A, 250 V

The fuse cartridge will accept either 5 mm x 20 mm or 0.25” x 1.25” fuses. Fuses are available from Luminex Corporation. Replacing a fuse requires access to the back of the FLEXMAP 3D® instrument. Be aware before attempting any necessary lifting or movement of the instrument that it weighs approximately 91 kg (200 lbs). Lifting it requires five people.

DANGER: To avoid serious injury or death by electric shock, you must turn

To replace a fuse:

image below.

off the FLEXMAP 3D® before replacing a fuse.

Instrument"

instrument and unplug it from the wall

Unplug the power cable from the instrument.

2. Use a small, flat-blade screwdriver to open the module door on the lower left corner of the back of the instrument. The door opens downward. Inside are two cartridges, a red one on top and a black one on the bottom.

3. Use the screwdriver to remove the red cartridge.

For research use only. Not for use in diagnostic procedures.

Maintenance and Cleaning

4. Check both of the fuses in the cartridge for damage. A fuse can display physical evidence of damage, for example, broken wire or blackened glass; if it displays no physical evidence, test it for continuity with a voltmeter.

Replace damaged fuses with the type specified on the sticker to the right of the power

5. input module.

6. Replace the red cartridge.

7. Shut the module door.

8. Plug in the power cord and turn on the FLEXMAP 3D® instrument.

NOTE: If your FLEXMAP 3D® instrument is not on a swivel base and it

requires moving in order for you to access the back of the instrument, use the software to re-calibrate and re-verify the instrument after it is restored to its original location.

FIGURE 21.

Back of the FLEXMAP 3D® Instrument

1 Power Module

2 Location to insert screwdriver to open module door, as referenced in Step 2

3 Fuse Information

Maintenance Logs

Use the Maintenance Logs (located in Appendix E) to record maintenance information. Fill in the dates in the first line of the table. The first table includes a sufficient number of columns for one week (7 days). The second table includes a sufficient number of columns for monthly

Luminex® FLEXMAP 3D® Hardware User Manual 40

For research use only. Not for use

in diagnostic procedures.

maintenance (one task monthly), semi-annual maintenance (two tasks twice yearly), and annual maintenance (two tasks yearly). For each item listed at the left, enter your initials under each date on which you perform the task.

Use the Maintenance Logs (located in Appendix E) to record maintenance information. In the Short Term Maintenance Schedule, the first table includes a sufficient number of columns for daily maintenance recordings for one week (7 days). The second table provides space for a weekly maintenance recording (one column).

In the Long Term Maintenance Schedule, the first table includes a sufficient amount of space to record monthly maintenance tasks. The second table, provides space to record semi-annual maintenance (two tasks twice yearly), and the third table includes a sufficient amount of space to record annual maintenance tasks. For each item listed, enter your initials under each date on which you perform the task.

For research use only. Not for use in diagnostic procedures.

Maintenance and Cleaning

Luminex® FLEXMAP 3D® Hardware User Manual 42

For research use only. Not for use

in diagnostic procedures.

Chapter 4: Troubleshooting

Troubleshooting procedures help users identify and remedy problems with the instrument.

Overview

To troubleshoot a problem, locate the symptom in one of the tables in this chapter, determine the cause from the listed possibilities, and remedy it with the provided solution.

This chapter supplies information about the following topics:

Power Supply Problems

•

• Communication Problems

• Clogs

• Pressurization Problems

• Fluid Leaks

• Sample Probe Problems

• Calibration Problems

• Verification Problems

• Acquisition Problems

• Bead Detail Irregularities

Contact Luminex Technical Support in the U.S. and Canada by calling 1-877-785-BEAD (-2323). Outside of the U.S. and Canada, call +1 512-381-4397. Contact Luminex Technical Support in Europe by calling +31 162 408 333. Email inquiries to support@luminexcorp.com.

Additional information is available on the Luminex website. Search the desired topic or navigate through menus. Also, review the website’s FAQ section. Enter http://

www.luminexcorp.com in your browser’s address field. Click Support> Support Login to log

into the Support FAQ site.

This chapter does not troubleshoot problems with the PC. For help with PC problems, please contact the technical support department for the manufacturer of your PC.

Power Supply Problems

Power supply problems often involve a blown fuse, faulty electronic component, or disconnected cable.

CAUTION: Whenever you deal with a potential electrical problem, be careful

to avoid electrical shocks.

TABLE 1.

Symptom Possible cause Solution

The Luminex® FLEXMAP 3D instrument will not turn on.

Fuses continue to open (blow). A component has a short circuit. Contact Technical Support.

Power Supply Problems

The power cord is disconnected. Plug in the power cord.

No voltage is coming from the electrical outlet.

The power supply is faulty. Contact Technical Support.

A fuse has burned out See the section titled Replacing Fuses.

Communication Problems

Communication problems described in this section involve the links between the data system (PC and software) and the address communication issues with other peripheral devices.

“Communication” refers to the transfer of data between the PC and the FLEXMAP 3D instrument, including the current status of the instrument, instrument control, sample acquisition, session uploading, and start, stop, and pause features.

Luminex® FLEXMAP 3D® instrument. This section does not

Verify that the electrical outlet is operational.

Use extreme care when replacing a fuse.

TABLE 2.

Symptom Possible cause Solution

The PC cannot establish communication with the FLEXMAP 3D® instrument.

Communication Problems

The communication cable is unplugged or plugged into the wrong port.

The FLEXMAP 3D® instrument is not turned on.

Luminex® FLEXMAP 3D® Hardware User Manual 44

Plug in or move the communications cable.

Turn off the PC. Turn on the FLEXMAP 3D® instrument and then turn on the PC.

For research use only. Not for use

in diagnostic procedures.

Clogs

Often, a clog somewhere in the Luminex® FLEXMAP 3D® instrument is the cause of a fluid leak, a pressurization or sample probe problem, or a problem with calibration, verification, or data acquisition.

To determine whether there is a clog, check the bead count during calibration. During calibration you should see 300 bead events per second or more. If there are fewer than that, there is probably a clog in the instrument.

In the event you encounter a problem that is clog-related, use the following procedure.

To troubleshoot a possible clog:

Clean and adjust the sample probe. See the section titled “Cleaning the Sample Probe”.

2. Perform the procedure for removing clogs. See the section titled “Removing Clogs”.

3. Replace all fluids.

4. Use the software to run the weekly maintenance routine.

5. Run calibration and verification.

If this procedure is unsuccessful, call Luminex Technical Support.

Pressurization Problems

Normal air and sheath pressure readings vary between 8 and 13 psi while the compressor runs. If the instrument pressure is out of range, sample acquisition either can fail or can return inadequate results.

TABLE 3.

Symptom Possible cause Solution

Pressurization fails or pressure is too low.

Pressurization Problems

The sheath and waste lines are not fully connected.

The sheath or waste fittings are cracked. Inspect the fittings to be sure they form a

There is a leak in the instrument. Check for leaks. A leak is obvious if there

The compressor does not engage. Use the software to run a prime command.

Check the lines between the sheath and waste bottles and the 3D® instrument.

tight seal. If not, call Technical Support.

is fluid on the surface where the FLEXMAP 3D instrument sits. See the section titled “Fluid Leaks”.

If you do not hear the compressor turn on, contact Technical Support.

Luminex® FLEXMAP

For research use only. Not for use in diagnostic procedures.

Troubleshooting

Fluid Leaks

Fluid leaks can result in poor pressurization and failed sample acquisition.

TABLE 4.

Symptom Possible cause Solution

Fluid is pooled around the Luminex® FLEXMAP 3D instrument.

Fluid drips from the sample probe. The sample probe is clogged. See the section titled “Clogs”.

Fluid leaks from the front of the instrument.

Fluid Leaks

Fittings or fluid lines are damaged. Turn off and disconnect the instrument to

The sample valve is faulty. Contact Technical Support.

The syringe seal leaks. Replace the syringe seal. See the section

The syringe valve leaks. Hand-tighten the syringe connection (silver

Sample Probe Problems

Problems with the sample probe can lead to fluid leaks and pressurization problems, and they can inhibit sample acquisition.

avoid electrical shock and contact Technical Support.

titled “Replacing the Syringe Teflon Seals”.

knob) on the syringe valve. Use the software to run a prime command. If leaks continue, contact Technical Support.

TABLE 5.

Symptom Possible cause Solution

The sample probe leaks. The sample probe is clogged. See the section titled “Clogs”.

The sample arm is stuck in the up or down position.

The sample arm does not go down smoothly.

Sample Probe Problems

The sample probe motor connections are loose.

The sample probe motor is faulty. Contact Technical Support.

Probe calibration not done. Perform Automatic Probe Height

The microtiter plate is incorrectly seated. Adjust the microtiter plate.

Luminex® FLEXMAP 3D® Hardware User Manual 46

Contact Technical Support.

Adjustment using the software.

For research use only. Not for use

in diagnostic procedures.

TABLE 5.

Symptom Possible cause Solution

Sample Probe Problems Continued

Calibration Problems

The microtiter plate is warped. Inspect the microtiter plate. Replace it if it

is warped.

The sample probe is bent. Remove the sample probe from the

instrument. Roll it on a flat surface. If a sample probe has been bent and rolled straight more than once, discard it and replace it with a new sample probe. Perform an automatic sample probe height adjustment using the software.

TABLE 6.

Symptom Possible cause Solution

Calibration is slow or fails. The calibration microspheres are not fully

Calibration Problems

suspended.

The wrong lot number or target values are entered in the appropriate software user interface.

The instrument calibrators are in the wrong well.

There are not enough calibrator microspheres in the well.

The calibrator lot is expired. Use an unexpired bottle of calibrator

The sample probe height is incorrect. Perform an automatic sample probe height

The sample probe is clogged. See the section titled "Clogs".

There is a partial clog in the instrument. See the section titled "Clogs".

Vortex the calibration vials to resuspend the microspheres.

Check the lot number and target values to make sure they are correct.

Verify that calibration microspheres are in the correct well.

Add at least five drops of calibrator microspheres to the well. For accurate drop volume, hold the vial upside down at a 90 degree angle to the microtiter plate while dispensing them.

microspheres.

adjustment.

There is air in the instrument. The waste line was moved during instrument operation, resulting in an unstable flow rate.

The waste line was moved during instrument operation, resulting in an unstable flow rate.

For research use only. Not for use in diagnostic procedures.

Perform an automatic sample probe height adjustment. Use the software to run a prime command three times, an alcohol flush command twice, then a wash command three time with deionized water.

Stabilize the waste line during instrument operation. See the section titled “Maintaining Fluids”.

Troubleshooting

TABLE 6.

Symptom Possible cause Solution

Calibration Problems Continued

There is a problem internal to the instrument.

No events are collected during calibration.

There is a problem with fluid levels. Check the sheath and waste fluid levels.

The sample probe is clogged. See the section titled "Clogs".

The Cheminert fitting is loose. Tighten the Cheminert fitting.

Verification Problems

TABLE 7.

Symptom Possible cause Solution

The instrument fails verification. The verification microspheres are not fully

Verification Problems

suspended.

Review the log of calibration reports. Check for dramatic changes in temperature, sheath pressure, or voltage. If any of these are present, contact Technical Support.

Verify that tubing for both bottles is tightly connected to the instrument. Check that the waste fluid container cap is vented.

Vortex the verification vials to resuspend the microspheres.

The wrong lot number or target values are entered in the appropriate page of the software UI.

The instrument verification microspheres are in the wrong well.

There are not enough verification microspheres in the well.

The verification lot is expired. Use an unexpired bottle of verification

The verification microspheres have been diluted.

The sample probe height is incorrect. Perform an automatic sample probe height

The sample probe is clogged. See the section titled “Clogs”.

There is air in the instrument. Verify the sample probe height. Use the

Check the lot number and target values to make sure they are correct.

Verify that verification microspheres are in the correct well.

Add at least five drops of verification microspheres to the well. For accurate drop volume, hold the vial upside down at a 90 degree angle to the microtiter plate while dispensing them.

microspheres.

Do not dilute the verification microspheres.

adjustment.

software to run a prime command three times, an alcohol flush command twice, then a wash command three times with deionized water.

Luminex® FLEXMAP 3D® Hardware User Manual 48

For research use only. Not for use

in diagnostic procedures.

TABLE 7.

Symptom Possible cause Solution

Verification Problems Continued

The waste line was moved during instrument operation, resulting in an unstable flow rate.

There is a problem internal to the instrument.

Acquisition Problems

TABLE 8.

Symptom Possible cause Solution

Acquisition fails or is slow. The air pressure is out of range. See the section titled “Pressurization

Verification Problems

The sample probe height is incorrect. Perform an automatic sample probe height

The sample probe is clogged. See the section titled “Clogs”.

Stabilize the waste line during instrument operation. See the section titled “Maintaining Fluids”.

Review the log of calibration reports. Check for dramatic changes in temperature, sheath pressure, or voltage. If any of these are present, contact Technical Support.

Problems”.

adjustment.

The sheath or waste lines are not fully connected.

The calibration microspheres have expired. Replace old microspheres with an

The wrong wells are selected for the calibration microspheres.

The wrong lot number or target values are entered in the appropriate page of the software UI.

Air is present in the instrument. Verify the sample probe height. Use the

The acquisition volume is set too high. Set the acquisition volume to at least 25μL

The Luminex® xMAP® microspheres are not fully suspended.

Disconnect and reconnect the lines; you should hear them click.

unexpired lot.

Ensure that the correct wells are selected in the software.

Check the lot number and target values to make sure they are correct.

software to run a prime command three times, an alcohol flush command twice, then a wash command three times with deionized water.

less than the actual volume in your wells. This enables the probe to acquire sample more efficiently with less chance of incorporating air in the sample.

Gently vortex the microtiter plate or resuspend beads with a multichannel pipettor to ensure that the microspheres are present in the solution.

For research use only. Not for use in diagnostic procedures.

Troubleshooting

TABLE 8.

Symptom Possible cause Solution

Verification Problems Continued

The microspheres are photobleached. Replace the microspheres with

unphotobleached microspheres.

There are an insufficient number of beads in the sample.

The sample is too concentrated. Dilute concentrated biological fluids, such

Bead Detail Irregularities

Use these tools to assist in diagnosing system and kit-related problems:

instrument calibrators

•

• instrument verifiers

• assay standards

• assay controls

• error messages

Review calibration/control trend reports routinely to detect trends.

Use instrument Luminex® xMAP® verification microspheres to check the success of the instrument calibration and to troubleshoot. If there is a problem with kit results, xMAP verifiers can help determine if the problem is related to the instrument. If calibration and verification are successful, contact the kit manufacturer.

The Bead Detail Irregularities table displays irregular groupings of beads. Compare the displays to the following bead detail of a normal bead grouping - a tight bead population within a white region.

Ensure that there are 2000 to 5000 beads per bead set per well.

as serum or plasma, at least 1:5.

FIGURE 22.

Luminex® FLEXMAP 3D® Hardware User Manual 50

Normal Bead Detail

For research use only. Not for use

in diagnostic procedures.

TABLE 9.

Symptom Description Possible Problem Solution

xMAP and calibrator microspheres form a group in the wrong location.

Bead Detail Irregularities

Calibrator microspheres group together at the top of the region.

xMAP microspheres group together at the lower right of the region.

xMAP microspheres form an unusual shape.

xMAP microspheres form a long diagonal line.

xMAP microspheres form a group with extending tails.

The calibrator microspheres are photobleached.

The xMAP microspheres are photobleached.

The xMAP microspheres have agglutinated.

The solvent is incompatible. The Luminex Technical Support website

Replace the calibrator microspheres with unphotobleached calibrator microspheres. To avoid photobleaching, protect microspheres from light.

Replace the xMAP microspheres with unphotobleached xMAP microspheres. To avoid photobleaching, protect microspheres from light.

Contact Technical Support.

(http://www.luminexcorp.com/Support) lists incompatible solvents. If the solvent you are using is listed, switch solvents.

xMAP microspheres fail to form a group.

xMAP microspheres do not form a cohestive group.

For research use only. Not for use in diagnostic procedures.

The sheath fluid is incompatible.

Use only Luminex xMAP sheath fluid in the Luminex® FLEXMAP 3D® fluids can damage the instrument and void your warranty.

instrument. Other

Troubleshooting

TABLE 9.

Symptom Description Possible Problem Solution

Bead Detail Irregularities Continued

xMAP microspheres do not form a cohesive group and are somewhat scattered.

xMAP microspheres are widely scattered.

There is air in the instrument. Verify the sample probe height. Use the

software to run a prime command three times, an alcohol flush command twice, then a wash command three times with deionized water.

The sheath fluid is empty. Make sure there is sheath fluid in the sheath

container. Use the software to run a prime command until all air is pushed out of the instrument.

Luminex® FLEXMAP 3D® Hardware User Manual 52

For research use only. Not for use

in diagnostic procedures.

Appendix A: Shipping

Shipping

If a serious problem arises with the return it to Luminex Corporation for repairs. If Luminex Technical Support directs you to return the FLEXMAP 3D® system, the Technical Support representative will provide you with all necessary information as well as give you a Return Material Authorization (RMA) number.

NOTE: Before the instrument is returned, two procedures must be

performed: The instrument must be decontaminated and its reservoir must be drained. For the decontamination procedure, see the section titled “Decontamination Procedure”. For instructions on draining the reservoir, see the section titled “Draining the Reservoir”.

Draining the Reservoir

To drain the reservoir:

1. Make sure the waste fluid container can hold at least one additional liter of fluid.

2. Disconnect the sheath fluid tubing from the sheath fluid container.

3. Disconnect the sheath filter tubing (white connector) from its bottom quick disconnect point (white connection) on the fluidics bay.

4. Disconnect the waste fluid tubing (orange connector) from the orange connection on the fluidics bay.

5. Disconnect the sheath fluid tubing (blue connector) from the blue connection on the fluidics bay.

Luminex® FLEXMAP 3D® system, it may be necessary to

6. Connect the waste fluid tubing (orange connector) to the bottom quick disconnect point (white connection) of the sheath filter tubing.

Use the software to run a warmup command. This starts the compressor, which drains

7. the sheath fluid from the reservoir into the waste fluid container.

NOTE: To refill the reservoir, reconnect each connector to its color-matched

connection and use the software to run a prime command.

FIGURE 23.

1 White connection for sheath fluid tubing - Disconnect as referenced in Step 3

2 Orange connection for waste fluid tubing - Disconnect as referenced in Step 4

Front of Fluidics Bay

3 Blue connection for sheath filter tubing - Disconnect as referenced in Step 5

Shipment Checklist

Complete the following checklist, sign and date it, and return it with the 3D® system.

1. Remove all specimens from the instrument.

2. Decontaminate the instrument. See the section titled “Decontamination Procedure”.

3. Drain the reservoir. See the section titled “Draining the Reservoir”.

Was there an internal leak in the system?

Luminex® FLEXMAP 3D® Hardware User Manual 54

Luminex® FLEXMAP

For research use only. Not for use

in diagnostic procedures.

Yes

Printed Name _____________________________________________________

Signature ________________________________________________________

Company/Institution ________________________________________________

Date________________ Instrument Serial No.___________________________

For research use only. Not for use in diagnostic procedures.

Shipping

Luminex® FLEXMAP 3D® Hardware User Manual 56

For research use only. Not for use

in diagnostic procedures.

Appendix B: Installation

Installation of the Luminex® FLEXMAP 3D

The following installation instructions for prep, assessing facilities requirement and in the event cabling or tubing must be reconnected.

NOTE: If you do not intend to keep the packing material for future use,

return the packaging of the product, spare parts, and options to the manufacturer with the Field Service Engineer. Within the European Union and other jurisdictions, in accordance with the European Parliament and Council Directive 94/62/EC packaging waste, the manufacturer is responsible for the disposal of packing material.

To install FLEXMAP 3D®:

1. Place the PC and monitor on the right side of the instrument.

Luminex® FLEXMAP 3D® are to be used for site

regarding packaging and

2. Connect the FLEXMAP 3D® instrument and all necessary peripheral devices to the PC.

FIGURE 24.

1. Monitor Plug 5. Monitor Plug (Touchscreen monitors only)

2. FLEXMAP 3D Communications Plug (USB

type A )

3. Mouse Plug 7. Stereo Speaker Audio Connection

4. Barcode Scanner Plug 8. Power Inlet

Back of PC

6. Stereo Speaker Power (USB connection)

FIGURE 25.

Back of FlexMAP 3D Instrument

Luminex® FLEXMAP 3D® Hardware User Manual 58

For research use only. Not for use

in diagnostic procedures.

1. Power Inlet 2. PC Communications plug (USB type B)

3. Connect the USB communications cable between the FLEXMAP 3D® instrument (P1) and the PC, and connect the power cables for the PC, monitor, and

FLEXMAP 3D

instrument to outlets but do not turn on any of the devices.

4. Place the sheath container below the instrument with the container opening facing up.

5. Remove the existing container cap and install the cap from the blue tubing accessory in its place.

6. Connect the blue sheath line to both the disconnect on the sheath container and the blue connector on the outside of the instrument.

FIGURE 26.

Sheath and Waste Container Connections

7. Place the empty waste container below the instrument with the container opening facing up.

Remove the existing container cap and install the cap from the orange tubing accessory

8. in its place.

9. Connect the orange waste line to both the disconnect on the waste container and the orange connector on the outside of the instrument.

10. Open the two front access doors.

11. Turn on the FLEXMAP 3D® instrument using the power switch on the right side of the instrument, toward the back.

12. Observe the indicators associated with powering up a FLEXMAP 3D® instrument.

13. Visually inspects for leaks.

14. Turn on the PC and monitor.

15. Close the access doors.

16. If the system includes a touch screen monitor, test it by touching the screen. The mouse cursor should move to the location you touched. If monitor does not respond, use the supplied CD to install the drivers. If the mouse cursor responds correctly, calibrate the monitor using the software preloaded onto the PC.

17. Access the Luminex® xPONENT® software on the PC and confirm that the instrument is communicating with the software.

For research use only. Not for use in diagnostic procedures.

Installation

18. Calibrate the probe height using the instructions in the software user manual.

NOTE: For information on calibrating the probe height when using soft-

bottom 384-well plates, refer to the FLEXMAP 3D 384-Well Plate

Probe Height Adjustment Tool section.

19. Calibrate the instrument using the instructions in the software user manual.

Luminex® FLEXMAP 3D® Hardware User Manual 60

For research use only. Not for use

in diagnostic procedures.

For research use only. Not for use in diagnostic procedures.

Installation

Luminex® FLEXMAP 3D® Hardware User Manual 62

For research use only. Not for use

in diagnostic procedures.

For research use only. Not for use in diagnostic procedures.

Installation

Luminex® FLEXMAP 3D® Hardware User Manual 64

For research use only. Not for use

in diagnostic procedures.

Appendix C: Part Numbers

Hardware

Product Description Customer Number

Luminex® FLEXMAP 3D®

Heater Block for 96-well microtiter plates CN-0224-01

Heater Block for 384-well microtiter plates CN-0223-01

Bar Code Scanner CN-PC03-01

Air Filter: Access Door CN-0222-01

Air Filter: XY Platform CN-0229-01

Air Filter: HEPA CN-0228-01

Syringe Cylinder with seal CN-0013-01

Syringe Seal (Quantity 4) CN-0014-01

Sheath Filter with quick disconnect CN-0010-01

Sample Probe Height Adjustment Kit CN-0015-01

Cable, USB (A to B) CN-0227-01

Cable, Power CN-PXXX-01

Fuse (6 amp) CN-0226-01

Sample Probe Needle CN-0221-01

Off-plate Reservoir CN-0225-01

Automated Maintenance Plate CN-0206-01

with xPONENT FLEXMAP-3D-RUO

PM (Preventive Maintenance) Kit CN-0215-01

Software

Product Description Customer Number

Luminex xPONENT Software for FLEXMAP 3D

Reagents

Product Description Customer Number

xMAP Sheath Fluid, LX100 40-50000

FLEXMAP 3D® Calibration Kit F3D-CAL-K25

Microspheres, F3DCAL1 - Classification Calibrator F3DCAL1-05

Microspheres, F3DeCAL1 - Classification Calibrator F3DeCAL1-05

Microspheres, F3DCAL2 - Reporter Calibrator F3DCAL2-05

Microspheres, F3DCAL3 - EDR Calibrator F3DCAL31-05

FLEXCAP 3D Performance Verification Kit F3D-PVER-K25

CN-SW16-01

Microspheres, F3DVER1 - Classification Verifier F3DVER1-05

Microspheres, F3DeVER1 - Classification Verifier F3DeVER2-05

Microspheres, F3DVER2 - Reporter Verifier F3DVER3-05

Microspheres, Fluidics1 - xMAP Fluidics 1 FLUID1-05

Microspheres, Fluidics2 - xMAP Fluidics 2 FLUID2-05

Luminex® FLEXMAP 3D® Hardware User Manual 66

For research use only. Not for use

in diagnostic procedures.

Appendix D: FLEXMAP 3D®

Adjustment Tool

NOTE: The Luminex® FLEXMAP 3D® Probe Height Adjustment Tool is to be

used for 384 well mylar bottom and 384 well filter bottom plates only.

To calibrate the probe correctly, perform the following steps:

Using data sheet for the plate you intend to calibrate the probe to, subtract the "well

1. depth" from the "plate height" as shown in the example below:

Probe Height

Plate Height: 14.2mm - Well Depth: 11.43mm = 2.77mm (2.8mm)

Example 1: 2.8mm or well C7 on the probe height adjustment tool for this example.

2. Click Eject from the System Status bar to eject the XY platform.

Place the probe height adjustment tool on the XY platform.

4. From the Home page click Probe and Heater.

5. On the Probe and Heater page, select the plate type (384 well) and enter a plate name.

6. Select the appropriate well to calibrate probe height (C7 for the example shown above).

7. Click Auto Adjust Height.

8. Click Save to save the plate settings.

Example 2: "C" Plate Height 14.4mm - "F" Well Depth 11.5mm = 2.9mm

2.9mm or well D7 on the probe height adjustment tool for this example.

Luminex® FLEXMAP 3D® Hardware User Manual 68

For research use only. Not for use

in diagnostic procedures.

For research use only. Not for use in

diagnostic procedures.

FLEXMAP 3D® Probe Height Adjustment Tool

Luminex® FLEXMAP 3D® Hardware User Manual 70

For research use only. Not for use

in diagnostic procedures.

Appendix E: Maintenance Schedule

Short Term Maintenance Schedule

Luminex® FLEXMAP 3D® Hardware User Manual 72

For research use only. Not for use in diagnostic procedures.

Appendix E: Maintenance Schedule

Long Term Maintenance Schedule

Luminex® FLEXMAP 3D® Hardware User Manual 74

For research use only. Not for use in diagnostic procedures.

Appendix E: Maintenance Schedule

Luminex® FLEXMAP 3D® Hardware User Manual 76

For research use only. Not for use

in diagnostic procedures.

Luminex FLEXMAP 3D User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

Description

Warnings and Notes

Symbols

Testing and Certification

Safety Precautions

General

Electromagnetic Compatibility

Lasers

Fluidics

Biological Samples

Mechanical Components

Swivel Base

Indicator Lights

Electrical Components

Heat

Decontamination Procedure

Installation of Instrument

Disposal of Instrument

How the FLEXMAP 3D System Operates

Subsystems

Electronics

Power Input Module

Communications Ports (USB Type B Connector)

Fluidics

Access Doors

Sample Probe

Cheminert® Fitting

Syringe Pump

Sheath Filter

Fluidics Bay

Waste Fluid Container

Mechanics

Optics

System Components

Luminex® xPONENT® Software

Reagents

Required Laboratory Reagents

Luminex® xMAP® Technology Reagents

Luminex® FLEXMAP 3D® Hardware

Recommended Additional Equipment

Uninterruptible Power Supply (UPS) or Surge Protector

Printer

Barcode Labels

Vortex

Bath Sonicator

Specifications and Limitations

General

Electronics

Optics

Fluidics

Microspheres

Microtiter Plates

General Maintenance Precautions

Daily Maintenance

Initializing the Luminex® FLEXMAP 3D® Instrument

Warming Up the Luminex® FLEXMAP 3D® Instrument

Maintaining Fluids

Shutting Down the Luminex® FLEXMAP 3D® Instrument

Weekly Maintenance

Running Weekly Maintenance

Removing Clogs

Cleaning the Sample Probe

Calibrating the Luminex® FLEXMAP 3D® System

Visually Inspect the Luminex® FLEXMAP 3D® Instrument

Monthly Maintenance

Semi-Annual Maintenance

Replacing the Syringe Teflon Seals

Replacing the HEPA Air Filter

Cleaning the Ventilation Filters

Annual Maintenance

Storing the Luminex® FLEXMAP 3D® Instrument

Preparing the Luminex® FLEXMAP 3D® Instrument for Use After Storage

Replacing Fuses

Maintenance Logs

Overview