® ™ Luminex 200 System User 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 Safety ..................................................................................................................1 Intended Use ...............................................................................................................................................1 Warnings and Notes ....................................................................................................................................1 Symbols .........................................
Chapter 3 Maintenance and Cleaning .............................................................................21 Daily Maintenance .....................................................................................................................................21 Before Running Samples .................................................................................................................... 21 After Running Samples ..............................................................................
Chapter 1: Safety Please become familiar with the information in this chapter before using 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. Intended Use The Luminex 200 Instrument is a clinical multiplex test system intended to measure and sort multiple signals generated in an In Vitro Diagnostic assay from a clinical sample.
Symbols These symbols describe warnings, cautions, and general information used in the operation of this instrument. Some of these symbols are further defined in various safety precautions.
impaired or the warranty voided if the system is used in a manner not specified by the instructions or by Luminex Corporation. Fluidics This system contains fluidics. 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 disconnect means; power cords must be removed from the outlet. Contact Luminex Corporation for further information. You must monitor waste levels manually.
FIGURE 1. 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. All laser apertures are located within the Luminex 200 analyzer and are contained within a protective housing. This label appears on the optics cover within the Luminex 200 analyzer.
FIGURE 2. Laser Class Label WARNING: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Barcode Reader Laser Do not stare into the beam or shine it into other people’s eyes.
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. Keep hands and fingers away from the Luminex XYP instrument slot during operation WARNING: During operation, this system contains exposed, moving parts which could result in pinch point hazard.
Decontaminating the Luminex 200 Analyzer for Return Shipment Luminex Technical Support will give you a Return Material Authorization (RMA) number if they direct you to return the system. They will explain how to return the system according to Luminex procedures. The accessible surfaces and the internal fluidics system must be sanitized and decontaminated before returning the analyzer. This is particularly important when biohazardous samples have been run.
Luminex® 200™ System User Manual 8 For In Vitro Diagnostic Use
Chapter 2: The System Theory of Operation Luminex xMAP technology is based on flow cell fluorometry with Luminex-developed innovations. The fluidics, optics, robotics, temperature control, software, and xMAP microspheres work together to enable simultaneous analysis of up to 100 analytes in a single test sample. Assay analysis requiring temperature control is provided through the Luminex XYP instrument heater block. There are two fluidics paths in the Luminex 200 analyzer.
through the Luminex 200 analyzer. Results of the analyses are processed and provided in a report format.
Required Laboratory Reagents • 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. Your Luminex 200 system is preloaded with the Luminex software. However, we supply a software DVD should you need to reinstall the software. This software requires a dedicated system. Unauthorized additional software is prohibited and may result in improper operation of the system.
• Internal sample carry over: < 0.9% • Soluble background fluorescence emission at 575 nm automatically subtracted from fluorescence intensity values Sensitivity • Detect 1000 fluorochromes phycoerythrin (PE) per xMAP microsphere • Reporter channel dynamic range: 3.
• Shipping and storage: The allowable shipping and storage temperature and humidity ranges are 0°C to + 50°C and 20-80% noncondensing, respectively • Input voltage range: 100 - 120 V~ ± 10%, 1.4 Amp, and 200-240 V~ ± 10%, 0.8 Amp, 47-63 Hz. • AC inlet fuse: 3 Amp, 250 V~, fast acting Optics • Reporter laser: 532 nm, nominal output 10-15 mW, maximum 500 mW, frequency-doubled diode; mode of operation, continuous wave (CW) • Classification laser: 635 nm, 9.
Luminex SD System General • Ambient temperature: 15°C to 30°C (59° to 86°F) • Humidity: 20% to 80%, noncondensing • Altitude: designed to operate at up to 2400m (7874 feet) above mean sea level • Physical dimensions: 20 cm (8 inches) W x 30 cm (11.75 inches) D x 24.75 cm (9.75 inches) H • Weight: 9 kg (20 lbs) • UL installation category: UL Installation Category II, as defined in Annex J of UL 61010A-1 • Pollution degree: UL Pollution Degree 2, as defined in Section 3.7.3.
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. System Overview The system consists of three subsystems: electronic, fluidic, and optical. The following section describes the user-accessible components of each subsystem. Electronics Power Input Module The power input modules contain the on/off switch and fuses.
FIGURE 3. Back of the Luminex 200 Analyzer and Luminex XYP Instrument 1 Air intake filter access door 5 Communication Ports (DB9) 2 Power Switch 6 XYP Communication Port (DB9) 3 Power Input Module 7 Analyzer ventilation filter (on bottom of analyzer) 4 XYP Ventilation Filter Fluidics Luminex Instrument Sample Probe A stainless steel sample probe acquires the sample. WARNING: During operation, this system contains exposed moving parts that can result in a puncture hazard.
FIGURE 4. Fluidics Components 1 Cheminert Fitting 3 Front thumbscrew 2 Probe Holder 4 Luminex XYP Instrument Sample Probe Access Doors The Luminex 200 analyzer has three access doors. Two of the access doors are on the front, and the third is on the back. The front left access door supplies access to the sheath filter. The front center access door supplies access to the syringe. The rear access door supplies access to the air intake filter. See the following figure.
FIGURE 5. Luminex 200 Analyzer Access Doors 1 Left door, access to service panel 2 Center door, access to syringe Air Intake Filter A replaceable air intake filter cleans the air used to pressurize sheath fluid. This filter is enclosed behind an access door located on the back of the Luminex 200 analyzer. Syringe The syringe delivers a sample from the 96-well microtiter plate to the cuvette. Sheath Filter The sheath filter removes particles greater than ten microns in diameter from the sheath fluid.
WARNING: The waste container should not be placed on top of the instrument. Ensure that the waste tubing is not elevated above the level of the Luminex 200 analyzer at any point. Contact Luminex Technical Support before you relocate the waste fluid container. To maintain a stable flow rate, do not move the waste line or container during system operation. WARNING: Waste levels must be manually monitored. Do not allow the waste container to overflow.
Luminex® 200™ System User Manual 20 For In Vitro Diagnostic Use
Chapter 3: Maintenance and Cleaning To ensure accurate test results, properly clean and maintain the Luminex 200 system. Read and follow all instructions in this section. For your convenience, a maintenance log form is included at the end of this chapter. It is important to use only xMAP Sheath Fluid or other Luminex-approved sheath fluid. WARNING: Use of non-Luminex approved sheath fluid shall constitute “Improper Use” and may void warranty rights provided by Luminex and/or its authorized partner.
Adjust the Sample Probe Vertical Height Adjust the sample probe vertical height each time you change the type or style of microtiter plate. 1. Remove the clear plastic shield that covers the sample probe area. 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: • For a standard plate with flat-bottom wells - stack two of the larger (5.08 mm diameter) alignment discs together and place them into the selected well.
Sheath and Waste Fluids Replace the sheath fluid and empty the waste container as required. Be careful not to touch the seal in the waste bottle cap or allow it to become wet or dirty. This could cause the bottle to become pressurized, causing pressure errors in the system. If the seal gets wet, let it airdry. Touching the seal can contaminate it. If it gets dirty, you should replace the waste bottle cap. If you are using the waste line, do not move it while the system is running.
Clean the Sample Probe WARNING: Be sure that the system is not performing an operation when you remove the sample probe. CAUTION: The Luminex analyzer sample probe should slide up easily while removing it from the sample arm. If you feel resistance, do not force the probe up. Contact Luminex Technical Support. 1. Remove the sample probe as follows: a. Unsnap the light housing located above the probe. b. Then, unscrew the Cheminert fitting on top of the probe completely. c.
Clean the Sample Probe WARNING: Be sure that the system is not performing an operation when you remove the sample probe. CAUTION: The Luminex analyzer sample probe should slide up easily while removing it from the sample arm. If you feel resistance, do not force the probe up. Contact Luminex Technical Support. 1. Remove the sample probe as follows: a. Unsnap the light housing located above the probe. b. Then, unscrew the Cheminert fitting on top of the probe completely. c.
3. Grasp the tubing and pull the filter 3 to 4 inches from the unit. See the following figure. FIGURE 6. Grasping the Tubing 4. Remove the filter with one hand, and hold the tubing with the other hand. 5. Connect a new filter to the tubing and position the filter inside the panel. 6. Reattach the panel door to the unit. 7. Plug in and power on the Luminex 200 analyzer.
Luminex XYP Instrument Air Intake Filter 1. Disconnect the Luminex XYP instrument from AC power by turning off the power switch on the rear of the Luminex XYP instrument, then unplugging the Luminex XYP instrument power cord from the wall source. 2. On the back of the Luminex XYP instrument, to the left side, gently remove the screen from the Luminex XYP instrument filter. NOTE: Do not remove the screws. FIGURE 7. Removing the Screen 3. Replace the filter and replace the screen. FIGURE 8.
Syringe Seal WARNING: The syringe arm does not deactivate when changing the plunger; injury could result if the system is not unplugged. 1. Turn the power switch on the back of the analyzer to the off position. 2. Open the door on the front center of the analyzer to gain access to the syringe. The syringe is the glass cylinder with a metal plunger inside, shown in the following graphic. FIGURE 9. Frontal view of a Luminex system with door open and syringe exposed 3.
Replace the Syringe To replace the syringe: 1. Screw the syringe into place. 2. Grab the base of the syringe plunger and gently pull down on it until it is fully seated into the opening of the arm. 3. Tighten the thumbscrew at the base of the syringe completely. If the thumbscrew does not go in as far as it did before, reposition the plunger and try again. 4. Turn on the analyzer. The syringe will return to its home position before the analyzer begins its normal start up process. 5.
Annually Sheath Filter 1. Disconnect the Luminex 200 analyzer from AC power by turning off the power switch on the rear of the analyzer, then unplugging the analyzer power cord from the wall source. 2. Disconnect the sheath fluid tubing before changing the filter. 3. Open the left door on the Luminex 200 analyzer. Disconnect the filter by pushing down on the metal clamps on each connection. See the following figure. FIGURE 11. Sheath Filter 4.
1. Turn off the power switch on the rear of the analyzer or instrument, then unplug the instrument power cord from the wall source. Remove the power cord from the analyzer or instrument. 2. With a small, flathead screwdriver, open the module door on the lower left corner of the back of the analyzer or instrument. See the following figure. FIGURE 12. Opening the Module Door 3. Remove the red cartridge (use a flathead screwdriver). 4. Check both fuses for damage. 5.
9. If the pressure is equal to the value noted in step 2 (within +/-0.1psi), then the set up is complete. If not, continue with the next step. After each adjustment, you will have to release the pressure and let it build back up again in order to obtain an accurate pressure reading. Any time the compressor turns off while making adjustments, perform another warm-up to maintain pressure in the system. 10.
Luminex 200 Maintenance Logs Month: Year: Use this form to record information over a four-week period. Fill in the month(s) and year above. Fill in the dates in the first line of the table. For each item listed at the left, enter your initials under each date that you perform the item. NOTE: Follow your standard laboratory safety practices when cleaning or maintaining the system. Do not remove the instrument cover under any circumstances. TABLE 1.
Loosen sheath cap Turn off system (optional) TABLE 2.
Chapter 4: Troubleshooting the Luminex 200 System Troubleshooting procedures help users isolate, identify, and remedy problems with the Luminex 200 analyzer and Luminex XYP. This chapter does not troubleshoot problems with the PC. For help with PC problems, please contact the technical support system for your PC’s manufacturer. To troubleshoot a problem, select a general symptom. Next, identify the possible problem and remedy it with one of the solutions listed.
Symptom Possible problem Solution Analyzer will not turn on, or XYP The power cord is disconnected. Verify that the power cord is will not turn on. plugged in. Fuses continue to open (blow). No voltage is coming from the electrical outlet. Verify that the electrical outlet is operational. The power supply is faulty. Contact Technical Support. A fuse has burned out. See instructions for changing fuses. A component has a short circuit. Contact Technical Support.
Symptom Pressure too high. Possible problem Solution There is a leak in the system. Check for system leaks. A leak will be obvious if there is fluid on the surface on which the system sits. The compressor does not engage. Run a Prime command. If you do not hear the compressor turn on, contact Technical Support. The Cheminert fitting is loose. Ensure that the fitting connects tightly above the sample probe, below the blue light. Fluid leaks in the system. See the Fluid Leaks topic.
Symptom Possible problem Solution Fluid dripping from the sample probe. The sample probe is clogged Clean the sample probe. See instructions. The sample three-way valve is faulty. Contact Technical Support. The syringe seal leaks. Replace the syringe seal. See instructions. The syringe valve leaks. Hand-tighten the syringe connection (silver knob) on the syringe valve. Run a Prime. If leaks continue, contact Technical Support. Fluid is leaking from the front of the analyzer.
Symptom Possible problem Solution Sample arm is stuck in the down The sample probe height is too position. low, or the path to the well is blocked. Sample arm does not go down smoothly. DO NOT turn off the Luminex XYP instrument. 1. Remove the blue light housing from the analyzer. 2. Unscrew the Cheminert fitting. The system monitor changes from “Busy” to “Running” and sample acquisition continues. Click Cancel to make adjustments before continuing with the rest of the samples. 3.
Symptom Possible problem Solution Calibration is slow or fails. The calibration microspheres are not fully suspended. Vortex the calibration vials to resuspend the microspheres. Wrong lot number or target values are entered in Update CAL Targets dialog box. Verify that correct lot number and target values are used. The system calibrators are in the Verify that calibrators are in the wrong well on the plate. correct well. Zero events collected during calibration.
Symptom Analyzer fails Controls. Possible problem Solution Laser-related issue. Verify fluid is moving through the system by performing a Wash, which causes fluid to go out to waste. If no fluid is going to waste, clean the sample probe, then flush the system (See the section titled Clean the Sample Probe). If the issue does not resolve, contact Technical Support. The waste container is not vented Check that the seal in the waste container cap is dry and that the waste container cap is vented.
Symptom Possible problem Solution The waste line was moved during system operation, resulting in unstable flow rate. Verify that the waste line is not moved during system operation. Possible problem with the lasers. Check the system control trend report for consistent failures. If any are evident on the report, contact Technical Support. Symptom Possible problem Solution Acquisition fails or slows. The air pressure is out of range. See the Pressurization section.
Symptom Possible problem Solution The acquisition volume is set too Set the acquisition volume to at high. least 25 µL less than the actual volume in your wells. This setting lets the analyzer acquire sample more efficiently with less chance of acquiring air. The xMAP microspheres are not Gently vortex the plate or fully suspended. resuspend beads with a multichannel pipettor to ensure that the microspheres are present in the solution. You are using photobleached microspheres.
FIGURE 13. Normal Bead Detail The histogram for the bead detail above looks like this: FIGURE 14.
Symptom Possible problem Solution xMAP microspheres classify too high. You may be using photobleached calibration microspheres. Replace the calibration microspheres with a fresh batch. To avoid photobleaching, protect your microspheres from light. xMAP microspheres hit the lower right of the region. You may be using photobleached xMAP microspheres. Replace microspheres with a fresh batch. To avoid photobleaching, protect your microspheres from light. There is air in the system.
Symptom Possible problem Solution The solvent is incompatible. View a list of incompatible solvents at the Luminex Technical Support website http://luminexcorp.custhelp.com. If the solvent you are using is listed, switch solvents. You are using incompatible sheath fluid. Use only Luminex sheath fluid in the Luminex 200 analyzer. Other fluids may damage your analyzer and may void your warranty.
6. Press the Prime button on the front panel of the SD system. 7. Sheath fluid will pump from the Sheath Delivery System reservoir into the 20L Sheath Box. To refill the Sheath Delivery System, reconnect the tubing according to color coding and press the Prime button on the SD. Contact Technical Support for additional information.
Luminex® 200™ System User Manual 48 For In Vitro Diagnostic Use
Chapter 5: Product Numbers Hardware NOTE: These part numbers are subject to change without notice. NOTE: Common description of product is enclosed in brackets.
Product Description Customer Number Power Cord, USA CN-P001-01 Power Cord, Australia CN-P002-01 Power Cord, Brazil CN-P003-01 Power Cord, Denmark CN-P004-01 Power Cord, Germany, Sweden, France, Belgium, and Spain CN-P005-01 Power Cord, Switzerland Power Cord, Israel Power Cord, UK Power Cord, Italy Power Cord, Japan CN-P006-01 CN-P007-01 CN-P008-01 CN-P009-01 CN-P010-01 CN-P012-01 Power Cord, China Reservoir, XYP CN-0022-01 Sample Needle Height Alignment Kit [Sample Probe Alignment Kit] CN-
Product Description Customer Number Microspheres, LX100, CL1 CL2 Calibration (xMAP Classification Calibrator) L100-CAL1 Microspheres, LX100, RP1 Calibration (xMAP Reporter Calibrator) L100-CAL2 Microspheres, LX100, CL1 CL2 Control (xMAP Classification Control) L100-CON1 Microspheres, LX100, RP1 Control (xMAP Reporter Control) L100-CON2 Microspheres, MagPlex, DD CL1 CL2 Calibrator, 5mL (MagPlex Classification Calibrator Microspheres) MCAL1-05 Microspheres, MagPlex, DD CL1 CL2 Control, 5mL, (MagPl
