System User Manual.book
Contents
1. Access Doors PN 89 00002 00 109 Rev A The System 1 Cheminert Fitting 2 Probe Holder 3 Probe Adjustment Screw 4 Luminex XYP Instrument Sample Probe Figure 2 2 Fluidics Components 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 Figure 2 3 z Lumi nex 1 2 1 Left door access to service panel 2 Center door access to syringe Figure 2 3 Luminex 200 Analyzer Access Doors Luminex 200 System User Manual Air Intake Filter Syringe Sheath Filter Air Waste and Sheath Fluid Connectors Luminex Sheath Delivery System Waste Fluid Container Optical xMAP Technology Reagents 2 10 xMAP Technology 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 The syringe delivers a sample from the 96 well microtiter plate to the cuvette The sheath filter removes particles greater than ten microns in diameter from the sheath fluid The air waste and sheath connectors located on the left side of the analyzer connect to the SD system and waste fluid containers using clear tubing The air connector is green the s2. PN 89 00002 00 109 Rev A xMAP Technology Pressurization Symptom Pressurization fails or pressure is too low Pressure too high PN 89 00002 00 109 Rev A 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 The sheath and waste lines are not fully connected The sheath or waste bottle fittings are cracked There is a leak in the system The compressor does not engage The Cheminert fitting is loose Fluid leaks in the system The sheath bottle has an air leak The sheath bottle is overfilled The Sheath Delivery System is overfilled Regulator not adjusted properly Solution Make sure the lines between the sheath and waste bottles and the analyzer are fully connected Inspect the fittings to be sure they form a tight seal Check for system leaks A leak will be obvious if there is fluid on the surface on which the system sits Run a Prime command If you do not hear the compressor turn on contact Technical Support Ensure that the fitting connects tightly above the sample probe below the blue light See Fluid Leak on page 4 4 Disconnect the sheath and waste bottle connections from the analyzer Run a Prime command If pressure builds remove and retighten the sheath fluid bottle cap then reconnect fluid l
3. Warning Warning refer to On refer to manual manual Catalog Number Consult instructions O Off for use SPP In vitro Diagnostic Medical Device Batch Code Serial Number o 4 y ud ce Temperature Limitation Manufacturer European Union Conformity Expiration Date Date of Manufacture SBOE Underwriter s Canadian Laboratory Underwriter s Laboratory WEEE Do not throw in trash id K Safety Precautions Fluidics Read the following safety information before setting up or using the Luminex 200 analyzer 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 Therefore we recommend that all system users become familiar with the specific safety advisories below in addition to adhering to standard laboratory safety practices The protection provided by the equipment may be impaired or the warranty voided if the system is used in a manner not specified by the instructions or by Luminex Corporation 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 PN 89 00002 00 109 Rev A xMAP Technology Luminex 200 Analyzer Laser Barcode Reader Laser Mechanical PN 89 00002 00 109 Rev A Safety switch
4. place one alignment sphere into the selected well Select the Maintenance tab then click Eject Retract to eject the plate holder Place the 96 well microtiter plate on the Luminex XYP instrument plate holder with position A1 in the top left corner Verify that the correct location is selected in the Luminex IS 2 3 Software and that you are using the appropriate number of alignment discs Click Eject Retract to retract the plate PN 89 00002 00 109 Rev A xMAP Technology After Running Samples Routine Tasks Sheath and Waste Fluids PN 89 00002 00 109 Rev A 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 Replace the plastic shield that covers the sample probe area After running samples 1 Sanitize with a 10 to 20 household bleach solution 2 Run two Wash cycles with distilled water 3 Soak with distilled water Wait until the soak completes 4 If desired turn off the Luminex 200 analyzer Replace the sheath fluid and empty the waste container as required Be careful not to touch the seal in the waste bottle ca
5. e Classification control microspheres CONI e Reporter control microspheres CON2 e Luminex xMAP Sheath Fluid PN 89 00002 00 109 Rev A xMAP Technology Required Laboratory Reagents Luminex IS 2 3 Software Luminex 200 Performance Specifications Speed Accuracy and Precision PN 89 00002 00 109 Rev A The System e Household bleach e 70 isopropanol or 70 ethanol Mild detergent e 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 Unauthorized additional software is prohibited and may result in improper operation of the system e Speed greater than or equal to1 7 GHz Intel Pentium IV processor with 256 MB RAM USB communications link for fast data transfer e Automatic transfer of assay templates and new reagent information into the system via a 32 diskette or large capacity read write CD e Installation lt 4 hours e System calibration lt 10 minutes e System controls lt 10 minutes e Barcode reader entry of sample IDs e Automatic post analysis e Analyze one 96 well plate hour depending on manufacturer s kit e Up to 100 xMAP microsphere sets per sample e Sheath flowrate 90 uL sec 5 uL e Sample injection rate into detector area 1 uL sec 0
6. water Make sure there is sheath fluid in the sheath container Prime the system until all air is out of the system Add additional detergent to the assay buffer For example add 02 to 0 1 Tween 20 Triton X100 or SDS 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 Use only Luminex sheath fluid in the Luminex 200 analyzer Other fluids may damage your analyzer and may void your warranty Luminex 200 System User Manual Error States Error Message Disconnected Refill Sheath Running Sheath Empty System Error Messages xMAP Technology The following error states display on the Status Bar on the Run Batch tab when an error occurs during system operation Possible problem The software has not made initial connection The communication cables are not connected Sheath fluid is low Sheath fluid is empty Solution On the toolbar click Connect wait for the status to change Remove and reconnect the cable connections Close the software application and reopen it Close the software application then turn off the Luminex system Power on the system and check the status Refill the sheath container then click Resume Replace or fill the sheath fluid container with sheath fluid Run two Prime commands There are two types of error messages system error me
7. 05 uL e System warmup 30 minutes Systems that remain inactive for at least four hours will require a warm up to restart the lasers After acquiring sample running system calibrators running system controls and warming up the instrument the system resets the four hour internal clock e Sample uptake volume 5 e Classification of xMAP microspheres gt 80 Luminex 200 System User Manual Sensitivity Capacity Luminex 200 Analyzer General xMAP Technology Misclassification of xMAP microspheres 2 may vary by xMAP microsphere product lines Refer to the specific product information sheet for further details Temperature control 0 C to 2 C of target Internal sample carry over lt 0 9 Soluble background fluorescence emission at 575 nm automatically subtracted from fluorescence intensity values Detect 1000 fluorochromes phycoerythrin PE per xMAP microsphere Reporter channel dynamic range 3 5 decades of detection The specifications below reflect minimum capacity values 10 GB hard drive Store data for up to 240 000 test results 1 4 MB 3 diskette 100 MB read write CD ROM Analyze multiple 96 well plates per batch Analyze multiple assay templates per plate Distinguish a minimum of 1 to a maximum of 100 unique xMAP microsphere sets in a single sample Detect and distinguish surface reporter fluorescence emissions at 575 nm on the surface of 1 100 unique xMAP microspheres sets in a single sa
8. CN M020 01 German Luminex 100 IS User Manual Version 2 3 CN MO030 01 Greek Luminex 100 IS User Manual Version 2 3 CN M022 01 Italian Luminex 100 IS User Manual Version 2 3 CN M021 01 Spanish Luminex 100 IS Developer Guide to xMAP CN M029 01 Technology Version 2 3 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 CN P005 01 Belgium and Spain Power Cord Switzerland CN P006 01 Power Cord Israel CN P007 01 Power Cord UK CN P008 01 Power Cord Italy CN P009 01 Power Cord Japan CN P010 01 Power Cord China CN P012 01 Reservoir XYP CN 0022 01 Sample Needle Height Alignment Kit CN 0015 01 Sample Probe Alignment Kit Short Sample Needle CN 0006 01 Long Sample Needle CN 0007 01 Sample Holder Large 1 5 mL CN 0008 01 Sample Holder Small 1 2 mL CN 0009 01 Sheath Filter with Quick Disconnect CN 001 0 01 Sheath Bottle CN 0011 01 Syringe Cylinder with Seal CN 0013 01 PN 89 00002 00 109 Rev A xMAP Technology Software XMAP Reagents Training PN 89 00002 00 109 Rev A Product Numbers Syringe Seal Qty 4 CN 0014 01 Cable USB CN 0018 01 Waste Bottle CN 0012 01 Luminex SD Luminex Sheath CN S001 01 Delivery System Product Description Customer Number Luminex 100 IS Version 2 3 Software CD CN SW0
9. Maintenance and Cleaning 3 1 Daily Maintenance 3 1 Before Running Samples 0 0 0 0 00 eee ee 3 1 After Running Samples 0 0 0 0 c eee eee eee 3 3 Routine Tasks eene eres bb E REP VpS E 3 3 Sheath and Waste Fluids 0 000000 000005 3 3 Weekly oet d d etia Pais wean dete e du esta 3 5 Visual Inspection 3 5 Run Self Diagnostics 0 0 0 0 cee cee eee 3 5 Clean the Sample Probe 0 0 0 0 0c ee eee ee 3 5 Flush the System 0 0 2 eee eee ee eee 3 5 Monthly sesser errit ata Teno a oe vale E REEC RET EE 3 6 Clean Exterior Surfaces 0 0 0 0 0 cc eee eee ee 3 6 Calibrate the system 0 2 cece ee eee 3 6 Every Six Months ssa 0 0 0 0 cece cece 3 6 Luminex 200 Analyzer Air Intake Filter 3 6 Luminex XYP Instrument Air Intake Filter 3 7 Syringe Seal sc ce bee cesis ma eh b he rry 3 9 Luminex 200 Analyzer Ventilation Filter 3 10 Amnually 52 decani aede s o pa eda eura ESA buried 3 11 Sheath Filtri ii coe dae eee c eceet ECT ted 3 11 AS requited i iciesseuc nie hi pev pd e eb Rd cer LAGOS 3 12 Ju PR m 3 12 Replacing the SD System with a Sheath Bottle 3 13 Storing the System 0 0 0 eee 3 13 Taking the System out of Storage 0 3 13 Maintenance Log 0 0 0 cece cette 6 13 Troubleshooting 4 1 Troubleshooting the Luminex 200 System 4 1 Power
10. Supply Problems eese 4 2 Communication 0 0 0 eee ee n 4 2 Pressuriz ti n iaoee ansie ea ee eee ea ye ee 4 3 Fluid Leaks eso ies tt eee eh See Er ee et 4 4 sample Probe os sese esu dee e ted e does 4 4 Calibration and Control Problems 00005 4 6 Acquisition Problems l sleeeeeeeeeeA 4 8 Bead Detail Irregularities 2 0 0 0 0 eee eee ee eee 4 9 Brror States ia cea hei ned hese eet tae eee ee EU ears 4 12 System Error Messages 2 0 0 0 c eee eee eee 4 12 ii PN 89 00002 00 109 Rev A xMAP Technology Sample Error Messages lee ees 4 14 Luminex SD Problems lseseeeeeeeeeens 4 16 luli ET 4 16 Malin cui On sss sare oa keene we Re eee are e ute etre 4 17 Draining the Reservoir 4 17 Product Numbers 5 1 Hard Wwate el oie eee Re ER E E a OR RN ree 5 1 SOTUWAEG Lu i wale phates te lhe a UR Rete Nahe aa te edo ene cicer oe 5 3 XMAP Reagents 22 e600 bc eae eee e he 5 3 Tr ting 22v epe p idee b ute dap tede a podeis cs 5 3 PN 89 00002 00 109 Rev A Contents iii Luminex 200 System User Manual xMAP Technology PN 89 00002 00 109 Rev A 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 U se The Luminex softwar
11. at a 90 degree angle to the plate while dispensing them Use a fresh bottle of calibrator microspheres Adjust the sample probe height See page 3 2 Clean the sample probe See page 3 5 Clean the sample probe then flush the system See page 3 5 Verify sample probe height Run three Prime commands two Alcohol Flush commands then three Washes with water Check that the seal in the waste container cap is dry and that the waste container cap is vented Verify that the waste line is not moved during system operation View the calibration trend report Check for dramatic changes in temperature sheath pressure or voltages If any of these are evident on the report contact Technical Support PN 89 00002 00 109 Rev A xMAP Technology Zero events collected during calibration Analyzer fails Controls PN 89 00002 00 109 Rev A There is a problem with fluid levels Laser related issue The waste container is not vented The Cheminert fitting is loose The control microspheres are not fully suspended Wrong control lot number or target values are entered in Update CON Targets box The system controls are in the wrong well on the plate Not enough control microspheres added to the well Control lot is expired Control microspheres have been diluted The sample probe height is incorrect The sample probe is clogged Troubleshooting Check the sheath and waste fluid levels
12. in the UV spectrum 1 4 PN 89 00002 00 109 Rev A xMAP Technology Decontaminating the Luminex 200 Analyzer for Return Shipment Note It is the user s responsibility to decontaminate the analyzer before shipment PN 89 00002 00 109 Rev A 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 Make a copy of this page to fill out and return with the system Complete the following checklist signed and dated and return it with the Luminex 200 analyzer 1 Remove all specimens disposables and reagents from the system 2 Disconnect the sheath line going from the SD system to the analyzer 3 Connect a sheath bottle filled with a solution of 10 to 20 household bleach solution to the analyzer 4 Sanitize the system using the Sanitize command on the main screen of the system Follow this by washing twice with distilled water 5 Disconnect the system from AC power by turning off the power switch on the rear of the system then unplugging the analyzer power cord from the wall source 6 Dis
13. 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 Warning If biological samples have been tested with the system use your standard laboratory safety practices when handling system waste The Luminex 200 system classifies per FDA 21 CFR 1040 10 and 1040 11 as a Class II laser product consisting of a Class I laser product Luminex 200 analyzer and a Class II laser product barcode reader Under NO circumstances should you remove the Luminex 200 analyzer cover When performing routine maintenance turn power to the Luminex 200 analyzer OFF and disconnect the power cord All laser apertures are located within the Luminex 200 analyzer and are contained within a protective housing Warning Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure Do not stare into the beam or shine it into other people s eyes Warning During operation this system contains exposed moving parts Risk of personal injury is present Observe all warnings and cautions War
14. line and the cap is tightened Prime the system As the system is priming adjust the black regulator screw inside the center door of the Luminex 200 Turn clockwise to increase or counterclockwise to decrease until the sheath pressure value is within 0 1 psi of the normal level of your instrument Visually monitor the pressure gauge on the Run Batch tab Make sure pressure is centered within the green tolerance range When the prime function is complete loosen the sheath bottle cap to release pressure Tighten sheath cap and prime the system once again Make sure that the sheath and air pressure values increase to the normal level once again This procedure explains the steps you should take before placing the system into long term storage Before storing the system 1 Run a sanitize with 10 to 20 household bleach solution Run a sanitize with distilled water Run four washes with distilled water Remove the sample probe from the instrument flush with distilled water from the narrow end out through the larger end replace it in the sample arm and wrap the end with Parafilm Follow this procedure before you begin using the system after it has been stored long term Before using the system 1 Turn on the Luminex 200 and XY Platform and watch for the following indications that the instruments are responding correctly xMAP Technology Maintenance and Cleaning The light above the sample probe o
15. sample probe then flush the system See page 3 5 Verify that the delta cal temperature is within 3 0 degrees Recalibrate if outside these limits and run the sample again Verify that the system is functioning properly by running system calibration and controls If they pass contact the kit manufacturer Cannot calculate inverse function This error message encompasses a range of mathematical errors often indicating the sample result was negative or invalid This is according to the parameters defined by the formula used to analyze the sample results Standards assay controls and unknowns may be flagged with Unknown Formula Failure A standard curve is plotted using the MFI and expected concentration value An Unknown Formula Failure message may occur when the system is unable to calculate a standard concentration from the standard curve You are using the wrong template You are using incorrect lot information There is a problem with the kit Verify that you are using the correct template Consult the online help Verify that you have entered the correct lot information Run system calibration and controls If they pass contact the kit manufacturer Luminex SD Problems Filter If the empty sheath fluid container is not replaced and the system continues to operate the Luminex SD system eventually vents pressure to prevent air from being introduced into the Luminex 200 analyzer This may interrup
16. system performs self diagnostic tests The results display on the Diagnostics tab The lasers shut off during Self Diagnostics and must warm up again for 30 minutes after Self Diagnostics completes Danger Be sure that the system is not performing an operation when you remove the sample probe Caution The Luminex XYP instrument 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 To clean the sample probe 1 Remove the sample probe as follows Unsnap the light housing located above the probe Then unscrew the Cheminert fitting on top of the probe completely Next gently grasp the probe and push up Remove the probe out of the top of the sample arm 2 Clean the sample probe using a bath sonicator or using a 10 mL syringe If you are using a bath sonicator place the bottom of the sample probe in the bath sonicator for 2 to 5 minutes If you are using a syringe force distilled water through the bottom of the sample probe 3 Replace the sample probe and adjust the vertical height You should adjust the vertical height anytime the probe is removed 4 Alcohol Flush the system with 70 isopropanol or 70 ethanol Run 3 backflushes 3 drains 2 alcohol flushes and 3 washes with distilled water Luminex 200 System User Manual Monthly Clean Exterior Surfaces Calibrate the system Every Six Months Lumin
17. 109 Rev A The air pressure is out of range The sample probe is not vertically aligned Air is present in the system The acquisition volume is set too high The xMAP microspheres are not fully suspended You are using photobleached microspheres There is an insufficient number of beads in the sample The sample is too concentrated Troubleshooting See Pressurization on page 4 3 Adjust the sample probe height See page 3 2 Verify sample probe height Run three Prime commands two Alcohol Flush commands then three Washes with water Set the acquisition volume to at least 25 uL less than the actual volume in your wells This setting lets the analyzer acquire sample more efficiently with less chance of acquiring air Gently vortex the plate or resuspend beads with a multichannel pipettor to ensure that the microspheres are present in the solution Replace the microspheres with a fresh batch Ensure that there are 2000 5000 beads per beadset per well Dilute concentrated biological fluids such as serum or plasma at least 1 5 Use these tools to assist in diagnosing system and kit related problems system calibrators system controls assay standards assay controls error messages Review calibration control trend reports routinely to detect trends Use system xMAP control microspheres to check the success of the system calibration and for troubleshooting purposes If there i
18. 8 01 Product Description Customer Number Microspheres LX100 CL1 CL2 Calibration L100 CAL1 xMAP Classification Calibrator Microspheres LX100 RP1 Calibration L100 CAL2 xMAP Reporter Calibrator Microspheres LX100 CL1 CL2 Control L100 CON1 xMAP Classification Control Microspheres LX100 RP1 Control xMAP L100 CON2 Reporter Control xMAP Sheath Fluid LX100 40 50000 Product Description Customer Number Basic Training Course CN 0070 01 Luminex 200 System User Manual xMAP Technology PN 89 00002 00 109 Rev A
19. Luminex 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 12212 Technology Boulevard Austin Texas 78727 6115 U S A Voice 512 219 8020 Fax 512 219 5195 i LUMINEX CORPORATION Luminex 200 System User Manual CN M064 01 PN 89 00002 00 109 Rev A July 2005 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 Luminex Luminex 100 Luminex 100 IS Luminex 200 LabMAP XMAP LumAvidin Luminex XYP Luminex SeroMAP Luminex FlexMAP and Luminex SD All other trade marks including Windows Cheminert Pentium and Dell are trademarks of their respective companies The Luminex 100 IS software uses the VideoSoft VsFlexGrid Pro 7 0 VsPrinter 7 0 and VsView 3 0 ActiveX controls which are copyrighted by VideoSoft 2001 The contents of this manual and the associated Luminex software are the property of Luminex and are copyrighted Except as specified in the End User License Agreement any
20. UL 61010A 1 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 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 1 mW 6 maximum output 25 mW diode mode of operation continuous wave CW Reporter detector Photomultiplier tube detection bandwidth of 565 585 nm Classification detector Avalanche photo diodes with temperature compensation Doublet discrimination detector Avalanche photo diodes with temperature compensation Sheath flow rate 90 uL 5 uL second Cuvette 200 micron square flow channel Sample injection rate 1 uL second Sample uptake volume 20 200 uL Reporter channel detection A D resolution 14 bits Communications interface USB Luminex XYP instrument communications interface RS 232 Ambient temperature 15 C to 30 C 59 F to 86 F Humidity 20 to 80 noncondensing Altitude operation up to 2400 m 7874 ft above mean sea level Physical dimensions 44 cm 17 25 inches W x 60 cm 23 5 inches D x 8 cm 3 inches H Weight 15 kg 33 Ibs UL installation category UL Installation Category II as defined in Annex J of UL 61010A 1 Luminex 200 S ystem U
21. Verify that tubing for both bottles is tightly connected to the instrument Check that the waste bottle cap is vented 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 page 3 5 If the issue does not resolve contact Technical Support Check that the seal in the waste container cap is dry and that the waste container cap is vented Make sure that the Cheminert fitting is tightened Vortex the control vials to resuspend the microspheres Verify that the correct lot number and target values are used Verify that control microspheres are in the correct well Add at least five drops of control microspheres to the well For accurate drop volume hold the vial upside down at a 90 degree angle to the plate while dispensing them Use a fresh bottle of control microspheres Do not dilute the control microspheres Adjust the sample probe height See page 3 2 Clean the sample probe See page 3 5 Luminex 200 System User Manual There is air in the system The waste container is not properly vented The waste line was moved during system operation resulting in unstable flow rate Possible problem with the lasers xMAP Technology Verify sample probe height Run three Prime commands two Alcohol Flush commands then three Washes with water Verify that the waste co
22. alyzer On systems with a Luminex Sheath Delivery system ensure that the sheath fluid pressure reading is equal to the original reading If it is not contact Technical Support for instructions to adjust the regulator Calibrate and verify the system See Pressurization on page 4 3 Warm up the system This takes approximately 30 minutes Calibrate and verify the system Open the calibration trend report for CAL2 and record the last three reporter voltages Contact Luminex Technical Support with this information Check the system to verify that it is warmed up and that there are no pressurization problems Repeat the command If the command continues to time out contact Technical Support Calibrate the instrument Luminex 200 System User Manual Sample Error xMAP Technology Sample error messages occur when there is a problem with sample Mess ag es acquisition These errors can display on the Diagnostics tab in the Message Log in Reports or on the Errors tab in a batch analysis Message Possible problem Solution Insufficient Bead Count Temperature Divergence from Calibration Temperature Failed Control in Batch Failed Curve Fit There are not enough beads seen to meet the minimum requested You are running the system at an ambient temperature that is out of range of the temperature at which the system was initially calibrated One or more of the assay controls are not within the expected ran
23. an 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 USE OF NON LUMINEX APPROVED SHEATH FLUID SHALL CONSTITUTE IMPROPER USE AND MAY VOID WARRANTY RIGHTS PROVIDED BY LUMINEX AND OR ITS AUTHORIZED PARTNER Warning When analyzing potentially infectious biological samples on the Luminex 200 analyzer follow standard laboratory safety practices These safety precautions should also be taken when cleaning or maintaining the analyzer Do not remove the analyzer cover under any circumstances If the system is powered on but idle for more than four hours click the Maintenance tab Click Warmup Wait 30 minutes for the Luminex 200 analyzer and the optics system to warm up Before you run samples 1 Turn the Luminex 200 analyzer on The system begins warming automatically 2 Verify the levels of sheath fluid and waste fluid 3 Click Prime to prime the analyzer then click OK Luminex 200 System User Manual Adjust the sample probe vertical height Note Verify that the microtiter plate is not warped Warped plates can lead to incorrect probe height adjustment Note Alignment discs can be placed in any well as long as the well is designated in the software xMAP Technology 4 Click Alcohol Flush A confi
24. ce While facing the Luminex 200 analyzer place your index finger up under the right side of the analyzer in the space between the Luminex 200 analyzer and the Luminex XYP instrument When you feel the filter push the filter toward the left of the analyzer See Figure 3 9 Remove the filter from the left side of the Luminex 200 analyzer Figure 3 9 Luminex 200 Analyzer Ventilation Filter Clean the filter with a vacuum or with distilled water Stand the filter upright to air dry Re install it with the arrows facing up The filter should click into place Plug in and turn on the Luminex 200 analyzer power PN 89 00002 00 109 Rev A xMAP Technology Annually Sheath Filter PN 89 00002 00 109 Rev A Maintenance and Cleaning To change the Luminex 200 analyzer sheath filter 1 N A M 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 Disconnect the sheath fluid tubing before changing the filter 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 Figure 3 10 Sheath Filter Connect the new sheath filter matching up the color coded fittings The arrow on the sheath filter should be pointing up Reconnect the sheath fluid tubing Plug in and power on the Luminex 200 analyzer Close the left a
25. connect the SD system and waste and sheath containers 7 Rinse the waste container with 10 to 20 household bleach solution and drain 8 Wash all exterior surfaces with a mild detergent followed by a 10 to 2096 household bleach solution 9 Open the front doors of the analyzer Clean all accessible surfaces with mild detergent followed by a 1096 to 2096 household bleach solution 10 Pack the system within a biohazard bag place it in the corrugated box then insert it in its original packaging or an approved shipping container Attach this checklist to the top of the corrugated box prior to packaging in the crate Was there an internal leak in the system Yes No Print Name Signature Date Instrument Serial No xMAP Technology Safety PN 89 00002 00 109 Rev A 1 6 The System Theory of Operation PN 89 00002 00 109 Rev A 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 The first path involves a syringe driven mechanism that controls the sample uptake This mechanism permits small sample uptake volumes fro
26. d press the Prime button on the SD Contact Technical Support for additional information Luminex 200 System User Manual xMAP Technology PN 89 00002 00 109 Rev A 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 00 109 Rev A Product Description Customer Number Rear Air Filter CN 0001 01 Bottom Air Filter CN 0002 01 Air Filter Intake CN 0027 01 Alignment guide XYP instrument CN 0016 01 Bar Code Scanner CN PCO03 01 Serial Cable 5 feet CN 0005 01 PC Luminex 100 IS CN PC04 01 2 Amp 250 Volts Fast Acting Fuse Qty 10 CN 0019 01 3 Amp 250 Volts Fast Acting Fuse CN 0051 01 Heater Block XYP CN 0017 01 Wrench Hexdrive Ball Driver CN 0025 01 3 32 Luminex 100 IS Version 2 3 complete CN L005 01 system Luminex 100 IS Version 2 3 complete CN L007 01 system with laptop Luminex 200 System User Manual xMAP Technology Luminex 100 IS Documentation Version 2 3 CN M032 01 Manuals on CD Luminex 100 IS User Manual Version 2 3 CN M01 7 01 North American Luminex 100 IS User Manual Version 2 3 CN M018 01 International English Luminex 100 IS User Manual Version 2 3 CN M031 01 Danish Luminex 100 IS User Manual Version 2 3 CN M019 01 French Luminex 100 IS User Manual Version 2 3
27. e is designed to use xMAP technology with assay kits available through kit manufacturers The Luminex 200 system performs a wide range of xMAP technology based laboratory tests measuring biomolecular reactions on the surface of xMAP microspheres Wa rn ings 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 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 PN 89 00002 00 109 Rev A 1 1 Luminex 200 System User Manual Symbols xMAP Technology 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 Symbol Description Description Description Warning Warning MN Alternating current refer to manual refer to manual ac Protective ground Warning refer to manual Warning refer to manual
28. e sheath container ever runs dry prime the system at least twice until the air is removed from the system Empty the Waste To empty the waste container Container 1 Disconnect the waste container from the Luminex 200 analyzer 2 Unscrew the waste container lid being careful not to touch the Gore Tex seal If the seal becomes wet or soiled it may impair venting Note There is NO warning of 3 Discard the waste from the waste container by appropriate a high waste volume Empty m ns the waste container each time YOL TEO sel container 4 Reconnect the waste container to the Luminex 200 analyzer and replace the cap Any time the sheath container is disconnected from the Luminex 200 analyzer you must remove air from the sample lines by priming 3 4 PN 89 00002 00 109 Rev A xMAP Technology Weekly Visual Inspection Run Self Diagnostics Clean the Sample Probe Flush the System PN 89 00002 00 109 Rev A Maintenance and Cleaning 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 Run Self Diagnostics on a weekly basis to check system integrity On the Maintenance tab click Self Diag The
29. ex 200 Analyzer Air Intake Filter Note Hold on to the tubing Do not allow the tubing to fall inside the the analyzer xMAP Technology 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 Wipe all exterior surfaces with mild detergent then a 10 to 20 household bleach solution and finally with plain distilled water Open both doors of the analyzer Clean all accessible surfaces with detergent followed by a 10 to 20 household bleach solution and then plain distilled water Dry the sheet metal surfaces to prevent corrosion Plug in and power on the Luminex 200 analyzer the Luminex XYP instrument and the Luminex SD system You should calibrate the system on a monthly basis as part of regularly scheduled maintenance For instructions on calibrating the system and verifying calibration see the Luminex online help or the Luminex IS Software Manual For Version 2 3 To replace the analyzer air intake 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 power cord from the wall source On the back of the Luminex 200 analyzer in the upper left corner remove the screw at the top of the panel and open the panel door Grasp the tubing and pull the filter 3
30. ge The calculation could not occur for the assay standards for data interpretation Ensure there are 2000 5000 beads per set per well Ensure proper beads are selected Adjust sample probe height See page 3 2 Resuspend beads in the wells Check for clogs Calibrate and verify the system If this message still appears after calibration contact Technical Support Verify that you selected the correct template Verify that the correct assay lot number and concentration values were selected and entered correctly Verify that the system is functioning properly by running system calibration and controls If the system controls pass contact the kit manufacturer Verify that you selected the correct template 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 calibration and controls If the system controls pass contact the kit manufacturer PN 89 00002 00 109 Rev A xMAP Technology Sample High or Low Sample Timed Out Sample Empty Detected PN 89 00002 00 109 Rev A The results do not fall within the highest and lowest standards The wrong control lot number or target values are selected The samples are concentrated Not enough sample loaded into the well The sample probe is clogged Sample probe height is incorrect There is a clog in the sample line The system c
31. ging 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 Locate the syringe a glass cylinder with a metal rod See Figure 3 8 1 Syringe Seal 2 Syringe Figure 3 8 Syringe and Syringe Seal 4 Unscrew the knob on the syringe arm at the bottom of the syringe and forcefully push the syringe arm down Unscrew the syringe from the top of its housing Pull the plunger out of the syringe D 9v d Remove and replace the plunger seal and the black O ring 8 Return the plunger to the syringe 9 Screw the syringe back into its housing 10 Return the syringe arm to its original position Luminex 200 System User Manual Luminex 200 Analyzer Ventilation Filter 11 12 13 14 xMAP Technology Hand tighten the screw on the syringe arm Plug in the power cord and turn the Luminex 200 analyzer power on Prime the system twice watching for any leaks in the syringe area When the prime finishes close the center door To clean the Luminex 200 analyzer ventilation filter Disconnect the Luminex 200 analyzer from ac power by turning off the power switch on the rear of the analyzer then unplug the analyzer power cord from the wall sour
32. he 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 Avalanche photo diode detectors measure the excitation emission intensities of the color coding classification dye mixtures inside the xMAP microspheres and a photomultiplier tube detects the excitation emission intensity of the reporter molecule bound to the surface of the xMAP microspheres High speed digital signal processors and advanced computer algorithms provide analysis of the xMAP microspheres as they are processed through the Luminex 200 analyzer Results of the analyses are processed and provided in a report format The Luminex 200 system includes the following hardware e Luminex 200 analyzer e Computer PC monitor and accessories e Luminex XYP instrument e Luminex Sheath Delivery System Luminex SD e Power cables e Alignment guide Two long sample probes e Reservoir e Shield e Heater block e Sheath fluid container e Waste container e Sheath fluid line Air line Sheath fluid intake line e Communications 1 serial communication cable e Communications 1 USB communication cable e Communications 1 CANBUS cable short cable e Barcode reader e Sample probe height alignment kit e 3 32 Hexdrive Balldriver wrench e Classification calibration microspheres CAL 1 e Reporter calibration microspheres CAL2
33. heath fluid connector is blue and the waste fluid connector is orange For proper operation place the Luminex SD system at the same level as the base of the Luminex X YP instrument Do not put it on top of the Luminex 200 analyzer If you are not using the SD system sheath fluid levels must be monitored manually Check the sheath fluid level before starting a run or procedure Warning If biological samples have been tested with the The waste fluid container receives waste from the system 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 Caution Waste levels must be manually monitored Do not allow the waste container to overflow The optical system consists of the optical assembly and the excitation lasers The optical assemblies do not require manual adjustment by the user The xMAP technology reagent system consists of classification calibration microspheres reporter calibration microspheres classification control microspheres and reporter control microspheres PN 89 00002 00 109 Rev A Maintenance and Cleaning Daily Maintenance Before Running Samples PN 89 00002 00 109 Rev A To ensure accurate test results properly cle
34. hen click on the Support link to open the FAQ list Luminex highly recommends using an uninterruptible power supply UPS to protect your system from power outages Choose one that can provide 1050 Watts for at least 45 minutes The UPS should be UL listed CSA certified and CE marked when used internationally If you do not use a UPS use a surge protector Choose a protector that meets your needs Factors to consider include electrical environment endurance suppressed voltage rating and method of protection It should have six outlets rated at least 1500 Watts and PN 89 00002 00 109 Rev A xMAP Technology Printer Barcode Labels Vortex Bath Sonicator System Overview Electronics Power Input Module Communications Ports SB9 PIN Luminex 200 Analyzer Ventilation Filter Luminex XYP Instrument Ventilation Filter PN 89 00002 00 109 Rev A The System be UL listed CSA certified CE marked for nondomestic use when used internationally Printer HP LaserJet 2300 or available equivalent 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 The power i
35. ines to the analyzer If pressurization fails again replace the sheath bottle Ensure that the sheath bottle is not filled above the fill line Drain the SD reservoir and refill it See page 4 17 If using bottles open the center door on the Luminex analyzer Use a screwdriver to adjust the regulator to fit in the center of the green region on the Run Batch tab Luminex 200 System User Manual Fluid Leaks xMAP Technology Fluid leaks can result in poor pressurization and failed sample acquisition Symptom Possible problem Solution Pressure too low Large amount of fluid pooled around instrument Fluid dripping from the sample probe Fluid is leaking from the front of the analyzer Sample Probe The sample probe is clogged The syringe seal leaks The syringe valve leaks Fittings or fluid lines are damaged The sample probe is clogged The sample three way valve is faulty The syringe seal leaks The syringe valve leaks Clean the sample probe See page 3 5 Replace the syringe seal See page 3 9 Hand tighten the syringe connection silver knob on the syringe valve Run a Prime command If leaks continue contact Technical Support Contact Technical Support Clean the sample probe See page 3 5 Contact Technical Support Replace the syringe seal See page 3 9 Hand tighten the syringe connection silver knob on the syringe valve Run a Prime If leak
36. m small reaction volumes The syringe driven system transports a specified volume of sample from a sample container to the cuvette The sample is injected into the cuvette at a steady rate for analysis Following analysis the sample path is automatically purged with Luminex xMAP Sheath Fluid by the second fluidics path This process removes residual sample within the tubing valves and probe The second fluidics path is driven by positive air pressure and supplies sheath fluid to the cuvette and sample path Luminex xMAP Sheath Fluid is the delivery medium of the sample to the optics component The analysis sample is acquired using a sample probe from a 96 well microtiter plate via the Luminex XYP instrument and injected into the base of the cuvette The sample then passes through with sheath fluid at a reduced rate resulting in a narrow sample core to ensure that each microsphere is illuminated individually The sample injection rate is such that the xMAP microspheres are introduced to the optics path as a series of single events The Luminex SD system lets you run samples continuously without refilling sheath bottles It automatically draws sheath from a non pressurized bulk sheath container to constantly maintain a reservoir of pressurized sheath fluid A single 20 liter sheath container provides enough fluid for 48 hours or more of normal operation Luminex 200 System User Manual Hardware xMAP Technology Reagents xMAP Technology T
37. mple Sample core 15 20 um core at 1 uL sec sample inject rate Maintain samples at a constant temperature from 35 C to 55 C 95 F to 131 F Automatic sampling from a 96 well plate Start sampling from any well position Sheath container and waste container hold enough volume to run up to two 96 well plates between refills Microtiter plates with 96 wells must be compatible with the Luminex XYP instrument plate holder The following microtiter plate types are compatible with the Luminex XYP instrument plate holder flatbottom conical round filter bottom half plates overall height no more than 0 75 19 mm any color Microtiter plates with 96 wells must be compatible with Luminex XYP instrument heater block temperature from 35 C to 55 C 95 F to 131 F when performing heated assays and using the heater block Indoor use only Operating temperature 15 C to 30 C 59 F to 86 F Humidity 20 to 80 noncondensing PN 89 00002 00 109 Rev A xMAP Technology Optics Fluidics Electronics Luminex XYP Instrument General PN 89 00002 00 109 Rev A The System Altitude Operation up to 2400 m 7874 ft above mean sea level Physical dimensions 43 cm 17 inches W x 50 5 cm 20 inches D x 24 5 cm 9 5 inches H Weight maximum of 25 kg 60 Ibs 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 2 of
38. n 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 Turn on the PC and start up the IS software Complete a Warmup command which will take 30 minutes B5 ow om Remove the Parafilm from the end of the sample probe 5 After Warmup is complete run three Backflush commands three Drain commands two Alcohol Flush commands and three Washes with distilled water Make sure that the sheath bottle or Luminex SD has a sufficient amount of sheath fluid and that the waste container is empty Verify that the pressure during each of the maintenance commands reads between 6 and 9 psi in the System Monitor PN 89 00002 00 109 Rev A 3 14 Luminex 200 Maintenance Log Month s Year 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 Do not remove the instrument cover under any circumstances Dates Daily maintenance Startup Initial
39. nalyzer door Prime twice Luminex 200 System User Manual As required Fuses xMAP Technology 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 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 With a small flathead screwdriver open the module door on the lower left corner of the back of the analyzer or instrument See Figure 3 11 eres 2 Figure 3 11 Opening the Module Door Remove the red cartridge use a flathead screwdriver Check both fuses for damage Replace damaged fuses with the type specified on the sticker to the right of the power input module Replace the module door Plug in and power on the analyzer or instrument PN 89 00002 00 109 Rev A xMAP Technology Replacing the SD System with a Sheath Bottle Storing the System Taking the System out of Storage PN 89 00002 00 109 Rev A Maintenance and Cleaning Turn off the SD and disconnect the tubing from the Luminex 200 analyzer Turn the black regulator screw inside the center door of the Luminex 200 one full turn counter clockwise Attach the sheath bottle Make sure there is sheath fluid in the bottle to the fill
40. ng as simple as a disconnected cable Use extreme care when you replace a fuse Symptom Possible problem Solution Analyzer will not turn on or XYP will not turn on Fuses continue to open blow Communication The power cord is disconnected Verify that the power cord is plugged in 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 page 3 12 for instructions on changing fuses A component has a short circuit Contact Technical Support Communication problems described in this section involve the links between the data system PC and IS 2 3 software and the Luminex 200 analyzer and XYP instrument This section does not address communication issues with other peripheral devices The term Communication refers to The transfer of data between the PC and the analyzer The current status of the analyzer and XYP instrument nstrument readbacks nstrument control sample acquisition session uploading and start stop and pause features Symptom Possible problem Solution PC cannot initialize communication with analyzer Check the communications cable connections The communication cable is unplugged or plugged into the wrong port Turn off the PC and then turn on the analyzer XYP and then the PC The XYP or the analyzer power is not turned on
41. ning 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 Risk of personal injury is present Keep hands and fingers away from the Luminex XYP instrument slot during operation 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 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 Heat Warning The heater plate of the Luminex XYP instrument may be hot and could cause personal injury if touched Do not touch the heater plate Blue Indicator Light The blue light above the Luminex 200 analyzer sample arm indicates the on off status of the Luminex 200 analyzer and is harmless The blue light emitting diode LED does not emit light
42. nput modules contain the on off switch and fuses The communications port connects the Luminex 200 analyzer or the Luminex XYP instrument to the computer and the Luminex SD system to the Luminex 200 analyzer Located on the bottom of the Luminex 200 analyzer the filter must be checked and cleaned as necessary For proper ventilation do not obstruct the area below and allow at least two inches 5 cm of clearance around the Luminex 200 analyzer The XYP instrument ventilation filter cleans the air that cools the internal parts of the Luminex XYP instrument See Figure 2 1 Luminex 200 System User Manual xMAP Technology 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 Luminex XYP A stainless steel sample probe acquires the sample Instrument Sample Probe Warning During operation this system contains exposed moving parts that can result in a puncture hazard Risk of personal injury is present Keep hands and fingers away from the sample probe The shield should be in place Cheminert Fitting This fitting attaches the sample probe to the sample tubing Disconnect this fitting when you remove the sample probe See Figure 2 2 2 8 PN 89 00002 00 109 Rev A xMAP Technology
43. ntainer is properly vented and that the seal is not wet or soiled Verify that the waste line is not moved during system operation Check the system control trend report for consistent failures If any are evident on the report contact Technical Support Acquisition Problems Symptom Possible problem Solution Acquisition fails or slows Slow or unsuccessful sample acquisition The air pressure is out of range The sample probe height is incorrect The sample probe is clogged The sheath bottle has a leaky seal The sheath or waste lines are not fully connected The calibration microspheres have expired The wrong wells are selected for the calibration microspheres The calibration lot number or target values selected in setup is incorrect The sample probe is clogged See Pressurization on page 4 3 Adjust the sample probe height See page 3 2 Clean the sample probe See page 3 5 Make sure that the sheath bottle lid is tightened Remove and replace the sheath bottle lid Disconnect and reconnect the lines you should hear them click Replace old microspheres with a fresh lot Ensure that the correct wells are selected in the Maintenance tab Enter the correct calibration lot number and target values in the Update CAL Targets box Clean the sample probe See page 3 5 PN 89 00002 00 109 Rev A xMAP Technology Bead Detail Irregularities PN 89 00002 00
44. ompletely acquired the entire sample volume There is no sample in the designated well The probe is clogged Troubleshooting Verify that you selected the correct template 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 If the sample is noted as High dilute the sample following the kit manufacturer s suggestions If the sample is noted as Low vortex the sample to ensure homogeneity Verify that the samples are properly mixed Verify that you loaded the correct sample volume to the well Clean the sample probe See page 3 5 Adjust the sample probe height See page 3 2 Clean the sample probe then flush the system See page 3 5 Verify that the delta cal temperature is within 3 0 If the system is not within these limits recalibrate then run the sample again Verify that you properly mixed the samples before dispensing into the wells Verify that you loaded the sample to the correct well on the plate Verify that the sample volume added to the well is correct Clean the sample probe See page 3 5 Luminex 200 System User Manual The sample probe is not properly aligned There is a clog in the fluid line Delta Cal temp out of range There is a problem with the kit xMAP Technology Align the sample probe See page 3 2 Clean the
45. p 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 air dry 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 While you can move the line along a horizontal surface do not permanently reroute the waste line elevation without first contacting Technical Support You can move the line temporarily for cleaning and maintenance purposes You must manually monitor waste container levels The Run Batch tab displays a warning when you need to refill or replace the sheath fluid container See Figure 3 4 Luminex 200 System User Manual xMAP Technology Yh Lumines 100 IS Software angl xl File Tools Help i Loma Run Batch Maintenance nuc mer integrated System 2 3 lt No Batch Loaded gt 112 8 4 5 6 7 8 9 10 11 12 s AOQOQOOOOO00000 e be BC OOOOOOOOOOOQO Fs Zy X eCOOCOGOOCQOOO CQOOOQO re A Se A BO00000000000 CmdNo Command PlateLoc __ Cmd Status 1 Wash A1 Plate1 Succeeded 23 sec Inna Warmed Up o al Figure 3 4 Refill Sheath Fluid Warning Circled in Photo Refill the Sheath To refill the sheath fluid container Fluid Container 1 Release system pressure by removing the lid from the sheath fluid container 2 Refill the sheath fluid container If th
46. reproduction in whole or in part is strictly prohibited Contents Safety Intended Use irec aite dade 4a re o DE CE SEP ded Warnings and Notes 2 0 cee eee eee ene Syinbols 3 exstat eaedem e acean ved eade Urea case Safety Precautions llle PIUIGICS EE Luminex 200 Analyzer Laser esee Barcode Reader Laser 0 0 ee ee Blue Indicator Light 0 0 0 2c eee ee eee Decontaminating the Luminex 200 Analyzer for Return Sliipment 2 a tae tat Sah ade ah ah ed ees ke ied ae The System Theory of Operation 0 0 0 eee eee eee Hardwate iu esie dere gare ip E Rabe PR eL S ina A xMAP Technology Reagents lesser Required Laboratory Reagents lllleeleeeeesss Luminex IS 2 3 Software Capacity AP Luminex 200 Analyzer General 0000000000 OPCS soi seed ee bed Pe ek nib hed ee eee ae EluidiGs eee toD ees iege tate owls BlectrODiCs iu x el Ra ede es Ex a dee Luminex XYP Instrument General 000 Luminex SD System General 0 000000 eee eee PC Specifications 0 0 eee e Recommended Additional Equipment System Overview 0 cece eee eee BlectrOnICS 3 2 bI aa ee le PN 89 00002 00 109 Rev A Luminex 200 System User Manual xMAP Technology Fluidics ies l lA ea weRREREORIPEFGG 2 8 Optical sisted ii i hd No eR ent eR e dope ama 2 10 xMAP Technology Reagents 0 000000 2 10
47. rmation 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 Click Wash In the confirmation dialog box click on the drop down arrow located to the right of the Eject Retract button to choose the desired location Click Eject Retract The Luminex XYP instrument tray ejects Place distilled water in the selected well or reservoir on the plate Click OK Perform this step twice Check that the Luminex XYP instrument sample probe has been vertically aligned for the plate used in the kit To adjust the sample probe vertical height Remove the clear plastic shield that covers the sample probe area 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 For a filter bottom plate stack three of the larger 5 08 mm diameter alignment discs together and place them into the selected well For a half volume plate with flat bottom wells stack two of the smaller 3 35 mm diameter alignment discs together and place them into the selected well For a round bottom U bottom plate stack two of the smaller 3 35 mm diameter alignment discs in the selected well For a plate with conical wells
48. s for each item listed at the left fill in your initials under each date that you perform the item Laser warmup Check sheath fluid Check waste level Tighten sheath cap Alcohol Flush 70 isopropanol or 70 ethanol Wash twice with distilled water Shut down Initials for each item listed at the left fill in your initials under each date that you perform the item Sanitize 10 to 20 household bleach solution Wash twice distilled water Soak distilled water Loosen sheath cap Tum system off optional Weekly Visual inspection Date I nitials Date I nitials Date I nitials Date I nitials Monthly Clean sample probe Date I nitials Wipe exterior surfaces Date I nitials Calibrate and verify Date I nitials Every six months Replace air intake filter Date I nitials analyzer Replace air intake filter XYP Date I nitials Replace syringe plunger seal or Date nitials syringe Check analyzer ventilation filter Date I nitials Yearly Replace sheath filter Date I nitials As required Replace fuses Date I nitials Comments PN 89 00002 00 109 Rev A Troubleshooting the Luminex 200 System PN 89 00002 00 109 Rev A Troubleshooting Troubleshooting procedures help users isolate identify and remedy problem
49. s a problem with your kit results xMAP controls can help determine if the problem is analyzer related If Calibration and Controls are successful contact the kit manufacturer Luminex 200 System User Manual xMAP Technology A normal bead detail display is shown below It depicts a tight bead population within a white region Bead Details Figure 4 1 Normal Bead Detail The histogram for the bead detail above looks like this Figure 4 2 Normal Histogram Symptom Possible problem Solution xMAP microspheres classify You may be using Replace the calibration too high photobleached calibration microspheres with a fresh batch microspheres To avoid photobleaching protect your microspheres from light 4 100 2 00000000 PN 89 00002 00 109 Rev A xMAP Technology xMAP microspheres hit the lower right of the region Beads appear scattered UT IU Microspheres appear as a long diagonal line r Pg PN 89 00002 00 109 Rev A You may be using photobleached xMAP microspheres There is air in the system The sheath fluid is empty The xMAP microspheres have agglutinated The solvent is incompatible You are using incompatible sheath fluid Troubleshooting Replace microspheres with a fresh batch To avoid photobleaching protect your microspheres from light Verify sample probe height Run three Prime commands two Alcohol Flush commands and then three washes with distilled
50. s continue contact Technical Support Problems with the sample probe can lead to fluid leaks and pressurization problems as well as inhibit sample acquisition Symptom Possible problem Solution Sample probe leak Sample arm is stuck in the up position The sample probe is clogged The system isn t properly pressurized Clean the sample probe See page 3 5 Check pressure settings Ensure that the sample probe is not clogged and there are no leaks in the syringe seal or syringe valve PN 89 00002 00 109 Rev A xMAP Technology Sample arm is stuck in the down position Sample arm does not go down smoothly PN 89 00002 00 109 Rev A The sample probe height is too low or the path to the well is blocked The 96 well plate is incorrectly seated in the XYP instrument The 96 well plate is warped The sample arm is misaligned The sample probe is bent Troubleshooting 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 Ifthe sample arm does not raise save the data that has been collected Turn off the analyzer but keep the XYP instrument on 4 Exit the Luminex IS Software 5 Turn the analyzer back on and restart the
51. s 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 This chapter supplies information for the following topics Power Supply Problems Communication Pressurization Fluid Leaks e Sample Probe Calibration Problems Acquisition Problems Bead Detail Irregularities Error Messages Printing Errors Verification You can find answers to frequently asked questions FAQs on our website http luminexcorp custhelp com Luminex Technical Support is available to users in the U S and Canada by calling 1 877 785 BEAD 2323 between 7 00 a m and 7 00 p m Central Time Monday through Friday Users outside of the U S Canada and Europe can call us at 1 512 381 4397 between 7 00 a m and 7 00 p m Central Time Monday through Friday Inquiries may also be sent by email to support luminexcorp com Luminex 200 System User Manual Power Supply xMAP Technology 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 often involve a blown fuse faulty electronic P roblems component or even somethi
52. ser Manual Luminex SD System General PC Specifications Recommended Additional Equipment Uninterruptible Power Supply UPS Surge Protector xMAP Technology e Pollution degree UL Pollution Degree 2 as defined in Section 3 7 3 2 of UL 61010A 1 e Heater operating range 35 C to 55 C 95 F to 131 F with tolerance 0 C to 2 C e Input voltage range 100 240 V 10 1 8 Amps 47 63 Hz e AC inlet fuse 3 A 250 V fast acting e Ambient temperature 15 C to 30 C 59 to 86 F Humidity 20 to 80 noncondensing e Altitude designed to operate at up to 2400m 7874 feet above mean sea level e Physical dimensions 20 cm 8 inches W x 30 cm 11 75 inches D x 24 75 cm 9 75 inches H e Weight 9 kg 20 lbs e UL installation category UL Installation Category II as defined in Annex J of UL 61010A 1 e Pollution degree UL Pollution Degree 2 as defined in Section 3 7 3 2 of UL 61010A 1 e Input voltage range 100 240 V 10 0 4 Amps 47 63 Hz e AC inlet fuse 2 Amp 250 V time lag For systems using a PC A Dell OptiPlex GX280 or Dell Optiplex GX520 or newer PC is shipped with the Luminex 200 system For systems using a laptop a Dell D610 Notebook is shipped with the system Microsoft Windows XP is pre installed on the computers The power requirements are 115 230 V 6 Amps 50 60 Hz For updated information regarding the PC notebook or operating system go to http www luminexcorp com t
53. software 6 Runa Wash with distilled water to remove air from the system 7 Verify probe height Adjust the 96 well plate Inspect the 96 well plate Replace it if it is warped Readjust the sample arm horizontal alignment Remove the sample probe from the Luminex 200 analyzer Roll it on a flat surface If it does not roll smoothly replace it with a new sample probe Adjust the sample probe height see page 3 2 Luminex 200 System User Manual Calibration and Control Problems xMAP Technology Symptom Possible problem Solution Calibration is slow or fails The calibration microspheres are not fully suspended Wrong lot number or target values are entered in Update CAL Targets dialog box The system calibrators are in the wrong well on the plate Not enough calibrator microspheres added to the well Calibrator lot is expired The sample probe height is incorrect The sample probe is clogged There is a partial clog in the system There is air in the system The waste container is not vented The waste line was moved during system operation resulting in unstable flow rate Possible problem with the laser Vortex the calibration vials to resuspend the microspheres Verify that correct lot number and target values are used Verify that calibrators are in the correct well Add at least five drops of calibrator microspheres to the well Hold the vial upside down
54. ssages and sample error messages System error messages are displayed in three places the Message Log on the Diagnostics Tab the message log located in the Windows message log folder the Errors tab on the Analysis window Error Message Possible problem Solution Unknown Diagnostic Error XYP Instrument Heater Stability Range Exceeded Unknown varied The heater block temperature is not hitting the target value Record the error code number and message Contact Luminex Technical Support Verify the heater temperature is set correctly in the software PN 89 00002 00 109 Rev A xMAP Technology Low Voltage Detected Runtime Sheath Pressure out of Limits Too High Runtime Sheath Pressure Out of Limits Too Low Low Laser Power Detected Command Encountered Time Out Error Instrument Not Calibrated PN 89 00002 00 109 Rev A Possible laser failure The sheath fluid pressure is too high There is a pressurization problem with the sheath fluid The system is not sufficiently warmed up Possible Laser Failure The current command failed The instrument is out of calibration Troubleshooting Turn off the analyzer X YP 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 Ensure that the sheath fluid container is at the same level as the an
55. t a sample and prevent further samples from being collected If the filter attached to the sheath intake line becomes clogged from extended use an alarm will sound even though the bulk sheath container is not empty If this happens replace the filter part number CN 0037 01 PN 89 00002 00 109 Rev A xMAP Technology Malfunction Draining the Reservoir PN 89 00002 00 109 Rev A 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 Leave the green air tubing connected between the Luminex 200 analyzer and the SD system On the SD front panel disconnect the blue tubing from the intake labeled Sheath Out and disconnect the white tubing from the intake labeled Sheath In Insert the white tubing into the intake labeled Sheath Out and insert the blue tubing into the intake labeled Sheath In Turn the unit off and then on again Press the Prime button on the front panel of the SD system 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 an
56. to 4 inches from the unit See Figure 3 5 PN 89 00002 00 109 Rev A xMAP Technology Maintenance and Cleaning ot d Model No g urnire x S N LX 100002450 Lumines Corey Blvd h Figure 3 5 Grasping the Tubing inex 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 To replace the XYP instrument air intake filter 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 Onthe back of the Luminex XYP instrument to the left side gently remove the screen from the Luminex XYP instrument filter Do not remove the screws See Figure 3 6 PN 89 00002 00 109 Rev A 3 7 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 00 109 Rev A xMAP Technology Syringe Seal PN 89 00002 00 109 Rev A Maintenance and Cleaning To replace the syringe plunger seal Danger The syringe arm does not deactivate when chan
Download Pdf Manuals
Related Search