Lum/nex ® Luminex 200™ System User Manual
© LUMINEX CORPORATION, 2001-2005. 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 12212 Technology Boulevard Austin, Texas 78727-6115 U.S.A. Voice: (512) 219-8020 Fax: (512) 219-5195 Luminex® 200™ System User Manual PN 89-00002-00-144 Rev. B October 2005 EC REP Paul. A.
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End-User License Agreement (EULA) for Luminex® 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 Luminex software product identified above, which includes computer software and online or electronic documentation and may include associated media and printed materials (if any) (“SOFTWARE PRODUCT” or “SOFTWARE”).
5. EXPORT RESTRICTIONS. You agree that you will not export or re-export the SOFTWARE PRODUCT to any country, person, entity, or end-user subject to U.S.A. export restrictions. You hereby warrant no state or federal agency has suspended, revoked, or denied your export privileges. 6. NO WARRANTY. THE SOFTWARE PRODUCT IS LICENSED “AS IS.” ANY USE OF THE SOFTWARE PRODUCT IS AT YOUR OWN RISK. THE SOFTWARE PRODUCT IS PROVIDED FOR USE ONLY WITH LUMINEX PRODUCTS.
Contents Safety 1-1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Warnings and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex 200 System User Manual xMAP Technology Fluidics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8 Optical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 xMAP Technology Reagents . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Maintenance and Cleaning 3-1 Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 Before Running Samples . . . . . . . . . . . . . . . . . . .
xMAP Technology Contents Sample Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14 Luminex SD Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16 Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16 Malfunction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17 Draining the Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex 200 System User Manual iv xMAP Technology PN 89-00002-00-144 Rev.
1 Safety Please become familiar with the information in this chapter before using the equipment. Do not perform procedures on your Luminex® 200TM 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 system is designed to perform a wide range of xMAP technology-based laboratory tests, measuring biomolecular reactions on the surface of xMAP microspheres. The system is intended For In-Vitro Diagnostics Use.
xMAP Technology Luminex 200 System User Manual Symbols Symbol These symbols describe warnings, cautions, and general information used in the operation of this instrument. Some of these symbols are further defined under “Safety Precautions.
xMAP Technology Safety 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. Do not allow the waste container to overflow! Empty the waste container each time the sheath fluid container is filled. Do not place the waste container on top of the instrument. Contact Luminex Technical Support before relocating the waste container or rerouting the waste line.
Luminex 200 System User Manual xMAP Technology Access doors must be closed while operating the Luminex 200 analyzer; the operator must be present during operation. Biological Warning: Human and animal samples may contain biohazardous infectious agents.
xMAP Technology Decontaminating the Luminex 200 Analyzer for Return Shipment Safety 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.
xMAP Technology PN 89-00002-00-144 Rev.
2 The System Theory of Operation Luminex 200 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.
xMAP Technology Luminex 200 System User Manual The optics assembly consists of two lasers. One laser excites the dye mixture inside the xMAP microspheres and the second laser excites the fluorophore bound to the surface of the xMAP microspheres.
xMAP Technology Required Laboratory Reagents Luminex IS 2.3 Software The System • • • • Household bleach 70% isopropanol or 70% ethanol Mild detergent Distilled water Luminex IS 2.3 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 CD should you need to reinstall the software. This software requires a dedicated system.
xMAP Technology Luminex 200 System User Manual Sensitivity • • Internal sample carry over: < 0.9% Soluble background fluorescence emission at 575 nm automatically subtracted from fluorescence intensity values • Detect 1000 fluorochromes phycoerythrin (PE) per xMAP microsphere • • Capacity The specifications below reflect minimum capacity values: • • • • • • • • • • • • • Luminex 200 Analyzer General • • • • • • 2-4 Reporter channel dynamic range: 3.
xMAP Technology The System • • • • • Optics • • • • • Fluidics Electronics Luminex XYP Instrument General Reporter laser: 532 nm, nominal output 10-16.5 mW, maximum 500 mW, frequency-doubled diode; mode of operation, continuous wave (CW) Classification laser: 635 nm, 9.
xMAP Technology Luminex 200 System User Manual Luminex SD System General • • Input voltage range: 100-240 V~ ± 10%, 1.8 Amps, 47-63 Hz AC inlet fuse: 3 A, 250 V~, fast acting • • • 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.
xMAP Technology The System Barcode Labels Vortex Bath Sonicator System Overview Use the Code 128 barcode label type when scanning barcode labels into the system as patient identities. VWR product number 58816-121: Speed range 0-3200 rpm or equivalent Cole-Parmer® product number 08849-00: Operating frequency 55 kHz or equivalent The system consists of three subsystems: electronic, fluidic, and optical. The following section describes the user-accessible components of each subsystem.
xMAP Technology Luminex 200 System User Manual 1 2 3 4 5 6 7 1 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 Figure 2-1 Back of the Luminex 200 Analyzer and Luminex XYP Instrument Fluidics 2-8 Luminex XYP Instrument Sample Probe A stainless steel sample probe acquires the sample.
xMAP Technology The System 1 2 3 4 1. Cheminert Fitting 2. Probe Holder 3. Probe Adjustment Screw 4. Luminex XYP Instrument Sample Probe Figure 2-2 Fluidics Components 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.
Luminex 200 System User Manual xMAP Technology 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.
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 Luminexapproved sheath fluid. USE OF NON-LUMINEX APPROVED SHEATH FLUID SHALL CONSTITUTE “IMPROPER USE” AND MAY VOID WARRANTY RIGHTS PROVIDED BY LUMINEX AND/OR ITS AUTHORIZED PARTNER.
xMAP Technology Luminex 200 System User Manual 4. Click Alcohol Flush. A confirmation dialog box opens. Click Eject/Retract to eject the Luminex XYP instrument tray. Place at least 1.2 mL of 70% isopropanol or 70% ethanol in the reservoir. Click OK. 5. Click Wash. In the confirmation dialog box, click on the dropdown arrow located to the right of the Eject/Retract button to choose the desired location. Click Eject/Retract. The Luminex XYP instrument tray ejects.
xMAP Technology Maintenance and Cleaning 5. Loosen the probe adjustment screw on the probe holder one-third to one-half turn. Pull it upward until it touches the top of the adjustment slide. Tighten the thumbscrew. 6. Click Sample Probe Down to lower the sample probe. 7. Gently push the probe down until it just touches the top of the alignment discs or sphere. 8. Tighten the probe adjustment screw. 9. Click Sample Probe Up to raise the sample probe. 10.
xMAP Technology Luminex 200 System User Manual Figure 3-4 Refill Sheath Fluid Warning (Circled in Photo) Refill the Sheath Fluid Container To refill the sheath fluid container: 1. Release system pressure by removing the lid from the sheath fluid container. 2. Refill the sheath fluid container. If the sheath container ever runs dry, prime the system at least twice until the air is removed from the system. Empty the Waste Container To empty the waste container: 1.
xMAP Technology Maintenance and Cleaning Weekly Visual Inspection Run Self-Diagnostics Open all of the Luminex 200 analyzer doors and visually inspect for leaks, corrosion, and other signs of improper function. Check all visible tubing connections. Check the Luminex XYP instrument air intake filter for buildup of dust. Check the SD system and its connection for leaks. If you see a leak, turn off the power to the Luminex SD system and contact Luminex Corporation.
xMAP Technology Luminex 200 System User Manual Monthly Clean Exterior Surfaces To clean exterior surfaces, follow these steps: 1. Disconnect the system from ac power by turning off the power switches and unplugging the Luminex 200 analyzer, the Luminex XYP instrument, and the Luminex SD system. 2. Wipe all exterior surfaces with mild detergent, then a 10% to 20% household bleach solution, and finally with plain distilled water. 3. Open both doors of the analyzer.
xMAP Technology Maintenance and Cleaning Figure 3-5 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 To replace the XYP instrument air intake filter: 1.
Luminex 200 System User Manual xMAP Technology Figure 3-6 Removing the Screen 3. Replace the filter and replace the screen. See Figure 3-7. Figure 3-7 Removing and Replacing the Filter 4. Plug in and turn on Luminex XYP instrument power. 3-8 PN 89-00002-00-144 Rev.
xMAP Technology Syringe Seal Maintenance and Cleaning To replace the syringe plunger seal: Danger: The syringe arm does not deactivate when changing the plunger; injury could result if the system is not unplugged. 1. Disconnect the Luminex 200 analyzer from ac power by turning off the power switch on the rear of the analyzer, then unplugging the power cord from the wall source. 2. Open the center-most door on the front of the Luminex 200 analyzer. 3.
xMAP Technology Luminex 200 System User Manual 11. Hand-tighten the screw on the syringe arm. 12. Plug in the power cord and turn the Luminex 200 analyzer power on. 13. Prime the system twice, watching for any leaks in the syringe area. 14. When the prime finishes, close the center door. Luminex 200 Analyzer Ventilation Filter To clean the Luminex 200 analyzer ventilation filter: 1.
xMAP Technology Maintenance and Cleaning Annually Sheath Filter To change the Luminex 200 analyzer 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 Figure 3-10.
xMAP Technology Luminex 200 System User Manual As required Fuses Danger: To avoid serious injury or death by electric shock, you must turn off the system and unplug it from the wall outlet. To replace the fuses in either the Luminex 200 analyzer or the Luminex XYP instrument: 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.
xMAP Technology Replacing the SD System with a Sheath Bottle Maintenance and Cleaning 1. Turn off the SD and disconnect the tubing from the Luminex 200 analyzer. 2. Turn the black regulator screw inside the center door of the Luminex 200 one full turn counter-clockwise. 3. Attach the sheath bottle. Make sure there is sheath fluid in the bottle (to the fill line) and the cap is tightened. 4. Prime the system. 5.
xMAP Technology Maintenance and Cleaning • The light above the sample probe on the Luminex 200 and the light next to the door of the XY platform are lit • The compressor starts in the Luminex 200. It is a low rumbling sound. • Place your hand behind the Luminex 200 to feel air coming out of the rear fan. • Observe movement of the syringe inside the front middle door of the Luminex 200 shortly after the instrument is powered on. 2. Turn on the PC and start up the IS software. 3.
Luminex 200 Maintenance Log Month(s): ________________________________________Year:_______________ Maintenance Log Procedure: 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.
4 Troubleshooting 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 call Dell Technical Support at 800-624-9896. To troubleshoot a problem, select a general symptom. Next, identify the possible problem and remedy it with one of the solutions listed.
xMAP Technology Luminex 200 System User Manual Users in Europe can call us at +31-162408333 between 8:30 and 5:30, Central European Time, Monday through Friday. Email inquiries in Europe can be sent to supporteurope@luminexcorp.com Power Supply Problems Power supply problems often involve a blown fuse, faulty electronic component, or even something as simple as a disconnected cable. Use extreme care when you replace a fuse. Symptom Analyzer will not turn on, or XYP will not turn on.
xMAP Technology Pressurization Symptom Pressurization fails or pressure is too low. Pressure too high. PN 89-00002-00-144 Rev. B Troubleshooting Normal air and sheath pressure readings vary between 6-9 psi while the compressor runs. If the system pressure is out of range, your sample acquisition will fail or return poor results. Possible problem Solution The sheath and waste lines are not fully connected. Make sure the lines between the sheath and waste bottles and the analyzer are fully connected.
xMAP Technology Luminex 200 System User Manual Fluid Leaks Symptom Pressure too low. Fluid leaks can result in poor pressurization and failed sample acquisition. Possible problem Solution The sample probe is clogged. Clean the sample probe. See page 3-5. The syringe seal leaks. Replace the syringe seal. See page 3-9. The syringe valve leaks. Hand-tighten the syringe connection (silver knob) on the syringe valve. Run a Prime command. If leaks continue, contact Technical Support.
xMAP Technology Sample arm is stuck in the down position Troubleshooting The sample probe height is too low, or the path to the well is blocked. 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.
xMAP Technology Luminex 200 System User Manual Calibration and Control Problems Symptom Calibration is slow or fails. 4-6 Possible problem Solution 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 wrong well on the plate.
xMAP Technology Zero events collected during calibration. Analyzer fails Controls. PN 89-00002-00-144 Rev. B Troubleshooting There is a problem with fluid levels. Check the sheath and waste fluid levels. Verify that tubing for both bottles is tightly connected to the instrument. Check that the waste bottle cap is vented. Laser-related issue. Verify fluid is moving through the system by performing a Wash, which causes fluid to go out to waste.
xMAP Technology Luminex 200 System User Manual There is air in the system. Verify sample probe height. Run three Prime commands, two Alcohol Flush commands, then three Washes with water The waste container is not properly vented. Verify that the waste container is properly vented and that the seal is not wet or soiled. 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.
xMAP Technology Bead Detail Irregularities Troubleshooting The air pressure is out of range. See Pressurization on page 4-3. The sample probe is not vertically aligned. Adjust the sample probe height. See page 3-2. Air is present in the system. Verify sample probe height. Run three Prime commands, two Alcohol Flush commands, then three Washes with water The acquisition volume is set too high. Set the acquisition volume to at least 25 µL less than the actual volume in your wells.
xMAP Technology Luminex 200 System User Manual A normal bead detail display is shown below. It depicts a tight bead population within a white region. Figure 4-1 Normal Bead Detail The histogram for the bead detail above looks like this: Figure 4-2 Normal Histogram Symptom xMAP microspheres classify too high. 4 - 10 Possible problem You may be using photobleached calibration microspheres. Solution Replace the calibration microspheres with a fresh batch.
xMAP Technology Troubleshooting 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. Beads appear scattered. There is air in the system. Verify sample probe height. Run three Prime commands, two Alcohol Flush commands, and then three washes with distilled water. The sheath fluid is empty. Make sure there is sheath fluid in the sheath container.
xMAP Technology Luminex 200 System User Manual Error States Error Message Disconnected The following error states display on the Status Bar on the Run Batch tab when an error occurs during system operation. Possible problem Solution The software has not made initial connection. On the toolbar, click Connect; wait for the status to change. The communication cables are not connected. Remove and reconnect the cable connections. Close the software application and reopen it.
xMAP Technology Troubleshooting Low Voltage Detected Possible laser failure. Turn off the analyzer, XYP, and PC, then turn them back on. Make sure system is completely warmed up. Calibrate and verify the system. If the error message occurs again, contact Luminex Technical Support. Runtime Sheath Pressure out of Limits (Too High) The sheath fluid pressure is too high. Ensure that the sheath fluid container is at the same level as the analyzer.
xMAP Technology Luminex 200 System User Manual Sample Error Messages Message Sample error messages occur when there is a problem with sample acquisition. These errors can display on the Diagnostics tab in the Message Log, in Reports, or on the Errors tab in a batch analysis. Possible problem Solution Insufficient Bead Count There are not enough beads seen to meet the minimum requested. Ensure there are 2000-5000 beads per set per well. Ensure proper beads are selected. Adjust sample probe height.
xMAP Technology Sample High or Low Troubleshooting The results do not fall within the highest and lowest standards. Verify that you selected the correct template. The wrong control lot number or target values are selected. Verify that the correct control lot number and target values were selected and entered correctly. Verify that the system is functioning properly by running system calibrators and controls.
xMAP Technology Luminex 200 System User Manual Cannot calculate inverse function Luminex SD Problems Filter 4 - 16 The sample probe is not properly aligned. Align the sample probe. See page 3-2. There is a clog in the fluid line. Clean the sample probe, then flush the system. See page 3-5. Delta Cal temp out of range. Verify that the delta cal temperature is within ± 3.0 degrees. Recalibrate if outside these limits and run the sample again. There is a problem with the kit.
xMAP Technology Malfunction Draining the Reservoir Troubleshooting If the alarm sounds even though the bulk sheath container has fluid and the sheath filter is in good condition, the system is reporting a malfunction. If this happens, contact Luminex Technical Support. If you need to ship the Luminex SD system back to Luminex Corporation, drain the reservoir before you pack the system. 1. In the IS 2.3 software, click Prime or Warmup to pressurize the system. 2.
Luminex 200 System User Manual 4 - 18 xMAP Technology PN 89-00002-00-144 Rev.
5 Product Numbers Hardware Note: These part numbers are subject to change without notice. Note: Common description of product is enclosed in brackets. PN 89-00002-00-144 Rev.
xMAP Technology Luminex 200 System User Manual Power Cord, USA Power Cord, Australia Power Cord, Brazil Power Cord, Denmark Power Cord, Germany, Sweden, France, Belgium, and Spain Power Cord, Switzerland Power Cord, Israel Power Cord, UK Power Cord, Italy Power Cord, Japan Power Cord, China CN-P001-01 CN-P002-01 CN-P003-01 CN-P004-01 CN-P005-01 Reservoir, XYP CN-0022-01 Sample Needle Height Alignment Kit [Sample Probe Alignment Kit] CN-0015-01 Short Sample Needle CN-0006-01 Long Sample Needle CN-
xMAP Technology PN 89-00002-00-144 Rev.
Luminex 200 System User Manual 5-4 xMAP Technology PN 89-00002-00-144 Rev.
