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.
v
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.
Table of Contents
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
ix
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.
1
Symbols
You may encounter these symbols during the use and operation of the
Luminex® FLEXMAP
3D® system. They represent warnings, conditions, identifications, instructions, and regulatory
agencies. Warning symbols are further explained in the Safety Precautions section.
Symbol Description Symbol Description Symbol Description
Puncture/Pinch
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
3
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
5
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
7
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
9
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:
11
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
13
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
15
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.
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