® ™ Luminex 200 Installation Manual For In Vitro Diagnostic Use
© Luminex Corporation, 2011. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, or translated into any language or computer language, in any form or by any means without prior express, written consent of Luminex Corporation. LUMINEX CORPORATION 12212 Technology Boulevard Austin, Texas 78727-6115 U.S.A.
Standard Terms and Conditions for Use of Instrument Product By opening the packaging containing this product ("Product") or by using such Product in any manner, you are consenting and agreeing to be bound by the following terms and conditions. You are also agreeing that the following terms and conditions constitute a legally valid and binding contract that is enforceable against you.
hardware not provided by Luminex. If Product is purchased from a Luminex authorized reseller, any warranty obligations shall be provided in writing directly by such Luminex authorized reseller to Buyer. THIS WARRANTY IS EXCLUSIVE AND LUMINEX MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
indicated on the Product label, the Product has not received approval from the United States Food and Drug Administration or other federal, state or local regulatory agencies and have not been tested by Seller or Luminex for safety or efficacy in food, drug, medical device, cosmetic, commercial or any other use, unless otherwise stated in Seller's technical specifications or material data sheets furnished to Buyer.
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.
End-User License Agreement (EULA) for Luminex® xPONENT® Software This Luminex End-User License Agreement (“EULA”) is a legal agreement between you (either an individual or a single entity, also referred herein as “you”) the end-user and Luminex Corporation (“Luminex”) regarding the use of the xPONENT software product provided to you above, which includes computer SOFTWARE and online or electronic documentation and may include associated media and printed materials (if any) (“SOFTWARE”).
3. GRANT OF LICENSE. Subject to the terms and conditions of this EULA, Luminex hereby grants to you a nonexclusive, nontransferable, nonassignable license (without right to sublicense) under Luminex's copyrights and trade secrets to use the SOFTWARE on a single computer running with a single unit of a specific model of Luminex instrument, as such model is identified on the packaging included with the SOFTWARE. You may make one (1) copy of the SOFTWARE for backup or archival purposes only.
5. TERM AND TERMINATION. Your rights under this EULA are effective until termination. You may terminate this EULA at any time by destroying the SOFTWARE, including all computer programs and documentation, and erasing any copies residing on your computer equipment. Luminex may terminate this EULA upon thirty (30) days written notice to you. Your rights under this EULA automatically terminate without further action on the part of Luminex if you do not comply with any of the terms or conditions of this EULA.
Table of Contents Chapter 1 About This Manual .............................................................................................1 Chapter 2 The Luminex 200 System ..................................................................................3 Hardware .....................................................................................................................................................3 xMAP Technology Reagents ....................................................................
Chapter 12 Equipment Disposal ......................................................................................39 Chapter 13 Installation Drawing .......................................................................................
Chapter 1: About This Manual This manual provides installation procedures for hardware and online documentation. A Luminex® Certified Installer performs initial system installation for new systems. The manual’s text and figures offer examples when necessary. Procedures are presented as step-by-step instructions. The conventions in this manual assume that the reader has a basic familiarity with computers, xMAP® technology, and a knowledge of Microsoft® Windows® software.
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Chapter 2: The Luminex 200 System The Luminex® 200™ benchtop system consists of the Luminex 200 analyzer, Luminex software, computer, monitor, keyboard, mouse, Luminex XY Platform instrument (LuminexXYP™), Luminex Sheath Delivery System (Luminex SD™), barcode reader, sheath and waste containers, and xMAP technology reagents.
• Classification control microspheres (CON1) • Reporter control microspheres (CON2) For xPONENT 3.1: Calibration and Verification Kits For both: xMAP Sheath Fluid Required Laboratory Reagents The following items are necessary to run the Luminex 200 system. They are not provided by Luminex. • Household bleach • 70% isopropanol or 70% ethanol • Mild detergent • Distilled water Luminex Software Luminex software provides complete control of the system and performs data analysis.
Chapter 3: Safety Symbols Please become familiar with the information in this chapter before installing the equipment. Do not perform procedures on your Luminex 200 system that are not specifically contained in this manual, unless you are directed to do so by Luminex Technical Support. These symbols describe warnings, cautions, and general information used in the operation of this instrument. Some of these symbols are further defined within the Safety Precautions section.
Symbol Description Symbol Description Manufacturer Underwriter's Laboratory European Union Conformity WEEE - Do not throw in trash Luminex® 200™ Installation Manual 6 Symbol In Vitro Diagnostic Use Description Canadian Underwriter's Laboratory
Chapter 4: Warnings and Notes Informational notes and warnings appear in this manual. NOTE: A note provides general helpful information. No safety or performance issues are involved. CAUTION: This message is used in cases where the hazard is minor or only potential hazard is present. Failure to comply with the caution may result in potentially hazardous conditions. WARNING: This message is used in cases where danger to the operator or to the performance of the instrument is present.
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Chapter 5: Safety Precautions Read the following safety information before setting up or using the Luminex 200 system. A user should be present during operation. This system contains electrical, mechanical, and laser components which, if handled improperly, are potentially harmful. In addition, biological hazards may be present during system operation.
Do not perform any maintenance or cleaning of the system’s electrical components, with the exception of replacing fuses. This label appears on the back panel of the Luminex 200 analyzer, the Luminex XYP instrument, and the Luminex SD system FIGURE 2. CE Label The Luminex 200 analyzer, XYP instrument, and SD system comply with European Union (EU) safety requirements and, therefore, may be marketed in the Europe Single Market.
FIGURE 4. Luminex XYP Serial Number Label FCC Label This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
FIGURE 5. FCC Label Electromagnetic Compatibility The Luminex 200 system complies with the emission and immunity requirements described in EN 61326-1 and EN 61236-2-6. The electromagnetic environment should be evaluated prior to operation. WARNING: Do not use this device in close proximity to sources of strong electromagnetic radiation, for example, unshielded intentional RF sources, as these may interfere with proper operation.
code reader. The Luminex 200 complies with IEC 60825-1 and 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007. The following label appears on the back of the Luminex 200 instrument. FIGURE 6. Laser Radiation Caution Label WARNING: Under NO circumstances should you remove the Luminex 200 analyzer cover! When performing routine maintenance, turn power to the Luminex 200 analyzer OFF and the disconnect the power cord.
FIGURE 7. Laser Class Label WARNING: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. This label appears above the laser apertures located inside the optics enclosure inside the Luminex 200 analyzer.
FIGURE 8. Avoid Exposure Label Barcode Reader Laser Do not stare into the beam or shine it into other people’s eyes. This label is attached to the barcode reader. FIGURE 9. Barcode Reader Laser Label Mechanical WARNING: During operation, this system contains exposed, moving parts. Risk of personal injury is present. Observe all warnings and cautions. WARNING: During operation, this system contains exposed, moving parts which could result in puncture hazard. Risk of personal injury is present.
Biological WARNING: Human and animal samples may contain biohazardous infectious agents. Where exposure (including aerosol) to potentially biohazardous material exists, follow appropriate biosafety procedures and use personal protective equipment, such as gloves, gowns, laboratory coats, face shields, or mask and eye protection, and ventilation devices. Observe all local, state, and federal biohazard handling regulations when disposing of biohazardous waste material.
Chapter 6: Technical Support Luminex Technical Support representatives are ready to help you, particularly when the system or software cause any questions or problems. If the question or problem relates to materials from the assay kit, you should contact the kit provider directly. Luminex Technical Support is available to users in the U.S. and Canada by calling 1-877-785-BEAD (-2323). Users outside of the U.S. and Canada can contact us at +1 512-381-4397.
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Chapter 7: Luminex Website Additional information is available on the Luminex website. Search on the desired topic or navigate through menus. Also, review the website’s FAQ section. 1. Enter http://www.luminexcorp.com in the browser's address field. 2. Click Support, then click Support Login to log into the Support FAQ site. 3. Click the Support tab.
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Chapter 8: Luminex User Manuals User manuals for Luminex software and hardware are available online in PDF format. To download a manual: 1. Enter http://www.luminexcorp.com in the browser’s address field. 2. Click Support, then click Support Login to log into the Support FAQ site, then click the Support tab. 3. Use the search engine in the browser for the manual to perform a search, or scroll down through the Title menu to find the desired manual to download.
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Chapter 9: Luminex 200 System Setup Before connecting the system components, ensure that the facility complies with all system and safety requirements. Read the safety information listed in the Warnings and Notes chapter of this manual. Position the instrument to minimize temperature fluctuations. The following sections describe how to connect the Luminex 200 system components. An Installation Drawing provides clearances and other related information.
7. Install the SD System. 8. Install the Luminex XYP Instrument Heater Block. FIGURE 10. Luminex 200 System Setup 1 Luminex 200 Analyzer 4 Luminex XYP Instrument 2 Monitor 5 Luminex SD system 3 PC Connect the Luminex 200 Analyzer and Luminex XYP to the PC You must set up and calibrate the Luminex 200 analyzer and Luminex XYP instrument before you can install the Luminex SD system. To connect and power on the system: 1.
7. Attach the power cord to the power input module of the Luminex XYP instrument and attach the serial cable to the Luminex XYP instrument. Do not plug the Luminex XYP instrument into the power outlet. NOTE: The cable that connects the analyzer to the PC is 5 feet long; the cable that connects the SD to the analyzer is 2.5 feet long. 8. Attach the power cord to the input module of the Luminex 200 analyzer, then attach the USB cable (PN 85-10011-00-046) to P1 on the analyzer.
Connect Sheath and Waste Containers To connect the sheath and waste containers: 1. Connect the color-coded tubing connectors to the Luminex 200 analyzer. Blue tubing = Sheath Green tubing = Air Orange tubing = Waste 2. Fill the sheath bottle with sheath fluid to just below the air intake fitting. 3. Place the sheath and waste containers to the left side of the analyzer, on the same surface as the Luminex XYP instrument.
3. Unscrew the cap from the Cheminert fitting. See the Sample Probe and Cheminert Fitting image below. FIGURE 12. Sample Probe and Cheminert Fitting 1 Cheminert Fitting 4 Adjustment Slide 2 Sample Probe Holder 5 Sample Probe 3 Thumbscrew 4. Insert the sample probe into the sample probe holder. Insert the Cheminert fitting into the sample probe holder, turning it clockwise. Be careful that the threads are correctly aligned. Hand tighten only. 5. Push the light housing back into place. 6.
1. Remove the clear plastic shield that covers the sample probe area. NOTE: Verify that the microtiter plate is not warped. Warped plates can lead to incorrect probe height adjustment. 2. In a 96-well microtiter plate where overall height is no more than 0.75 inches (19 mm), place the appropriate alignment tool in the plate: NOTE: Alignment discs can be placed in any well as long as the well is designated in the software. For a standard plate with flat-bottom wells - stack two of the larger (5.
Calibrate and Verify the System Run the System calibration. NOTE: For further details for running calibrations and controls, consult the Luminex Online Help or the applicable Luminex software manual. Install the SD System To install the Luminex SD system: 1. After performing system calibration, click Prime. When the pressure has stabilized, record the value of the Sheath pressure in the software. Air pressure: ____________psi. Sheath Pressure: ____________psi. NOTE: Save this information.
9. Connect the sheath fluid intake line (white fitting) to the Sheath In connector on the front of the Luminex SD system. FIGURE 13. Luminex Sheath Delivery Device 1 Power and Fault indicators 5 Sheath Out connector (blue) 2 Prime button 6 Sheath In connector (white) 3 Regulator adjust 7 Reservoir window 4 Air In connector (green) 10. Lower the stainless steel filter end of the sheath fluid line to the bottom of a full 20 liter box of Luminex xMAP Sheath Fluid.
12. Attach the power cord to the input module on the back of the Luminex SD system. Connect the CANBUS (short) cable to P1 on the back of the SD and to P2 on the back of the analyzer. Plug the power cord into the power outlet. See the Back of SD System, P1 Port image below. FIGURE 14. Back of SD System, P1 Port 13. Turn on the power to the Luminex SD system. It will automatically prime, and stop when the reservoir is 2/3 full.
14. Open the center access door on the Luminex 200 analyzer. Use a screwdriver to turn the regulator fully clockwise, about three to six full turns. The regulator must be fully closed to work properly. It is important to make sure that you turn it as far as it will go. Do not force the regulator past the fully closed position. Regulator is shown below the curved arrow in the Luminex 200 Analyzer Regulator Adjustment image below. FIGURE 15.
Install the Luminex XYP Instrument Heater Block Use the Luminex XYP instrument heater block as required by your assay kit instructions. This is an optional step. When not in use, store the heater block in the bracket inside the left access door of the Luminex 200 analyzer. To install the Luminex XYP instrument heater block: 1. Eject the plate holder. 2. Insert the Luminex XYP instrument heater block on the plate holder. 3. Retract the plate holder. 4. Turn the heater on and set the temperature.
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Chapter 10: Network Installation Advisory This section is intended for your network IT representative regarding Windows XP Settings. The Windows XP security settings “Virus Protection” and “Automatic Updates” alerts have been turned off by default. Please refer to your IT department when connecting to the network. NOTE: Luminex does not support network installations.
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Chapter 11: Prepare System for First Use After you install the hardware and software, run the following commands to prepare the system for first time use. Also, consider running these commands when the system has been idle for extended periods of time. Refer to the applicable Luminex software manual for command operation. Run the following commands in order: 1. Two Backflushes 2. Two Drains 3. Two Alcohol flushes with 70% isopropanol or 70% ethanol 4.
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Chapter 12: Equipment Disposal The Waste Electrical and Electronic Equipment Directive 2002/96/EC requires that you properly dispose of electrical and electronic equipment when it reaches its end of life. NOTE: This directive applies to customers in the European Union (EU) only. Users outside of the EU may disregard this section. If you are disposing of a Luminex® 200™ analyzer, SD™, or XYP™, you must decontaminate the system.
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Chapter 13: Installation Drawing 41
