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1. 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 Luminex 200 System User Manual Empty the Waste Container Note There is NO warning of a high waste volume Empty the waste container each time you fill the sheath container Weekly Visual Inspection Clean the Sample Probe 20 9 To empty the waste 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 3 Discard the waste from the waste container by appropriate means 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 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 Warning Be sure that the system is not performing an operation when you remove the sample probe Caution The Luminex XYP instrument sample probe should
2. USB communications link for fast data transfer e Automatic transfer of assay templates and new reagent information into the system via a 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 x MAP microsphere sets per sample 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 e Misclassification of xMAP microspheres lt 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 Luminex 200 System User Manual Sensitivity Capacity Internal sample carry over 0 996 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 Analyze multiple 96 well plates p
3. Figure 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 3 huminex 1 2 1 Left door access to service panel 2 Center door access to syringe Figure 3 Luminex 200 Analyzer Access Doors Luminex 200 System User Manual Air Intake Filter Syringe Sheath Filler Air Waste and Sheath Fluid Connectors Luminex Sheath Delivery System Waste Fluid Container Optical xMAP Technology Reagents 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 sheath 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 XYP instrument Do not put it on top of the Lu
4. it just touches the top of the alignment discs or sphere Tighten the front thumbscrew Raise the sample probe using the Luminex software 10 Replace the plastic shield that covers the sample probe area xMAP Technology After Running Samples Routine Tasks Sheath and Waste Fluids Refill the Sheath Fluid Container Maintenance and Cleaning After running samples 1 Sanitize with a 10 to 20 household bleach solution 2 Runtwo 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 cap or allow it to become wet or dirty This could cause the bottle to become pressurized causing pressure errors in the system If the seal gets wet let it 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 To refill the sheath fluid container Release system pressure by removing the lid from the sheath fluid container
5. throw in trash ders 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 xMAP Technology Luminex 200 Analyzer Laser Barcode Reader Laser Mechanical 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 Warning If biological samples
6. LOSS OF BUSINESS PROFITS BUSINESS INTERRUPTION LOSS OF BUSINESS INFORMATION OR ANY OTHER PECUNIARY LOSS ARISING OUT OF THE USE OF OR INABILITY TO USE THE SOFTWARE PRODUCT EVEN IF LUMINEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES MISCELLANEOUS This EULA is governed by the laws of the State of Texas U S A without reference to conflicts of laws principles You shall not assign or sublicense or otherwise transfer the rights or license granted hereunder by agreement or by operation of law without the prior written consent of Luminex and all assignments in violation of this prohibition shall be null and void This EULA is the complete and exclusive agreement of Luminex and you and supersedes all other communications oral or written relating to the subject matter hereof No change to this EULA shall be valid unless in writing and signed by the party against whom enforcement is sought The waiver or failure of Luminex or you to exercise in any respect any right or rights provided for herein shall not be deemed a waiver of any further right hereunder If any provision of this EULA is held unenforceable the remainder of this EULA will continue in full force and effect 89 30000 00 122 Rev A Contents Safety 1 Intended Use dl ERIS RETI dae 1 Warnings and Notes 0 cece cece eee eee ene 1 Symbols 2d era ette eae beeper Seedy Ie E Ed bear dena 2 Safety Precautions 0 0 0 0 e cece eere 2 Fluidics iubere RE
7. System Power Supply Problems 0 00 e eee eee eee eee Communication 00 cece eee eee Pressurization z ieu Wi sa wes po n X EROR AO eee cee RU ga Fluid Ieaksesi oio tee Ond e ades e Sample Probe oon ache pee eek aes LEEREN Calibration and Control Problems 00 0000 Acquisition Problems 0 0 cee cece eee eee Bead Detail Irregularities 0 0 eee eee ee eee Luminex SD Problems 0 0 c eee eee eee eee Filt sabran ciu bri MER nie NER a MER MERE ES Malfunction oe eene te 0 ccc cette enn eee Draining the Reservoir 0 0 0 0 cee eee eee Product Numbers Hardware 5A ah sata bene donnie eh tats kine de ik eo LESS S afety Intended Use Warnings and Notes 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 The Luminex software is designed to use xMAPe 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 This system is intended for general laboratory use Informational notes and warnings appear in this manual Note A note provides general helpful information No
8. again in order to obtain an accurate pressure reading Any time the compressor turns off while making adjustments perform another warm up to maintain pressure in the system On the analyzer turn the regulator clockwise right to increase the pressure or counterclockwise to decrease the perssure There is no exact measurement of pressure increase or decrease for each turn of the regulator Try one full turn in the required direction to start Release the pressure by opening and closing the sheath bottle cap Repeate the last two steps until you obtain the original Sheath pressure reading noted in step 2 within 0 1 psi Do not move the sheath bottle or sheath line while the system is in use This procedure explains the steps you should take before placing the system into long term storage xMAP Technology Taking the System out of Storage Maintenance and Cleaning Before storing the system 1 2 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 i
9. backup or archival copy distribute sublicense rent lease transfer or grant any rights in or to all or any portion of the SOFTWARE PRODUCT You must comply with all applicable laws regarding the use of the SOFTWARE PRODUCT You may not modify or prepare derivative works of the SOFTWARE PRODUCT You may not use the SOFTWARE PRODUCT in a computer based service business or publicly display visual output of the SOFTWARE PRODUCT You may not transmit the SOFTWARE PRODUCT over a network by telephone or electronically by any means TERM AND TERMINATION Your rights under this EULA are effective until termination You may terminate this EULA at any time by destroying the SOFTWARE PRODUCT including all computer programs and documentation and erasing any copies residing on your computer equipment Luminex may terminate this EULA upon thirty 30 days written notice to you Your rights under this EULA automatically terminate without further action on the part of Luminex if you do not comply with any of the terms or conditions of this EULA Upon any termination of this EULA you agree to destroy the SOFTWARE PRODUCT and erase any copies residing on your computer equipment 4 RIGHTS IN SOFTWARE All rights and title in and to the SOFTWARE PRODUCT and any copies thereof are owned by Luminex or its suppliers This EULA is not a sale and does not transfer to you any title or ownership interest in or to the SOFTWARE or any patent copyright trade
10. eR eeu dene 2 Luminex 200 Analyzer Laser 0000000005 3 Barcode Reader Laser 00 cece eee eee 3 Mechanical s s esa ae Ee ee ee doe 3 Biol gi al sci et os ag cste gS ierni penina ae esed T 4 lC 4 Blue Indicator Light 0 0 0 0 cee eee eee eee 4 Decontaminating the Luminex 200 Analyzer for Return Shipment 5 The System 7 Theory of Operation 0 0 0 cece eee ee eee 7 Hardwaie d v ker RESP He es a eee wh 8 xMAP Technology Reagents 00 0 0 e eee eee eee 8 Required Laboratory Reagents 0 0 0 00 ce eee ee 9 Luminex Software eee cee eee eens 9 Luminex 200 Performance Specifications 9 Speeds uota ows nanea nea a tae nga dos ag ewer 9 Accuracy and Precision 0 cee eee eee eee 9 Sensitvity e eho ssp gti ee aces 10 Capacity neis jede Hearne oe Leve eee 10 Luminex 200 Analyzer General 0 anura 10 Optics e ety yes are SE aie ee edere a ee am ud 11 ETuidics i 7 essi Ee b rettet mb eise ad tund 11 Electronics douter ee REID Rud PIQUE A 11 Luminex XYP Instrument General 0 00 11 Luminex SD System General 0 0 0 0 00s eee eee 12 PC Specifications suce bo bee eR e pedi ek enei 12 Recommended Additional Equipment 12 System OVetvieW orci REA NERE REL E Sb 13 Electronics iet or varied bed etit tee ocean as 13 Eluidicsz sales ip peu aa eh SUR IO a eS AE 14 Opticals cere
11. in the down position Troubleshooting Problems with the sample probe can lead to fluid leaks and pressurization problems as well as inhibit sample acquisition Possible problem The sample probe is clogged The system isn t properly pressurized The sample probe height is too low or the path to the well is blocked Solution Clean the sample probe See page 20 Check pressure settings Ensure that the sample probe is not clogged and there are no leaks in the syringe seal or syringe valve 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 software 5 Turn the analyzer back on and restart the software 6 Runa Wash with distilled water to remove air from the system 7 Verify probe height 37 Luminex 200 S ystem User Manual Sample arm does not go down smoothly Calibration and Control Problems 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 Adjust the 96 well plate Inspect th
12. 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 Pressurization fails or pressure is too low Pressure too high 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 1s overfilled The Sheath Delivery System is overfilled 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 36 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 lines 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 a
13. procedures help users isolate identify and remedy problems with the Luminex 200 analyzer and Luminex XYP This chapter does not troubleshoot problems with the PC For help with PC problems please contact the technical support system for your PCs manufacturer 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 Printing Errors Verification Luminex Technical Support is available to users in the U S and Canada by calling 1 877 785 BEAD 2323 Users outside of the U S and Canada can contact us at 1 512 381 4397 Inquiries may also be sent by email to support luminexcorp com Additional information is available on the Luminex website Search on the desired topic or navigate through menus Also review the website s FAQ section Enter http www luminexcorp com in your browser s address field Click Support gt Support Login to log into the Support FAQ site 33 Luminex 200 System User Manual Power Supply Power supply problems often involve a blown fuse faulty electronic component or even something as simple as a disconnected cable P roblems Use extreme care when you replace a fuse Symptom Possible probl
14. 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 Luminex 200 System User Manual Symbols 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 ac Symbol Description Description Description Warning Warning MN Alternating current refer to manual refer to manual Protective ground Warning refer to manual Warning refer to manual PPPI Warning Warning refer to On refer to manual manual Catalog Number Consult instructions Q Off REF for use In vitro Diagnostic Medical Device Batch Code Serial Number r o y ud ce Temperature Limitation Manufacturer European Union Conformity Expiration Date Date of Manufacture 6 BD bP Bi Underwriter s Canadian Laboratory Underwriter s Laboratory WEEE Do not
15. secret trade name trademark or other intellectual property right therein You shall not remove alter or obscure any proprietary notices contained on or within the SOFTWARE and shall reproduce such notices on any back up copy of the SOFTWARE All title and intellectual property rights in and to the content which may be accessed through use of the SOFTWARE PRODUCT is the property of the respective content owner and may be protected by applicable copyright or other intellectual property laws and treaties This EULA grants you no rights to use such content 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 NOWARRANTY 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 TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW LUMINEX AND ITS SUPPLIERS DISCLAIM ALL WARRANTIES EITHER EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT 7 LIMITATION OF LIABILITY IN NO EVENT SHALL LUMINEX OR ITS SUPPLIERS BE LIABLE FOR ANY SPECIAL INCIDENTAL INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER INCLUDING WITHOUT LIMITATION DAMAGES FOR
16. slide up easily while removing it from the sample arm If you feel resistance do not force the probe up Contact Luminex Technical Support Toclean 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 xMAP Technology Flush the System Monthly Clean Exterior Surfaces Calibrate the system Maintenance and Cleaning using a syringe force distilled water through the bottom of the sample probe Replace the sample probe and adjust the vertical height You should adjust the vertical height anytime the probe is removed Alcohol Flush the system with 70 isopropanol or 70 ethanol Run 3 backflushes 3 drains 2 alcohol flushes and 3 washes with distilled water 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
17. the intake labeled Sheath In 5 Turn the unit off and then on again 6 Press the Prime button on the front panel of the SD system 7 Sheath fluid will pump from the Sheath Delivery System reservoir into the 20L Sheath Box To refill the Sheath Delivery System reconnect the tubing according to color coding and press the Prime button on the SD Contact Technical Support for additional information 45 Luminex 200 System User Manual 46 Product Numbers Hardware Note These part numbers are subject to change without notice Note Common description of product is enclosed in brackets Product Description XR i Rear Air Filter CN 0001 01 Bottom Air Filter CN 0002 01 Air Filter Intake CN 0027 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 Luminex 200 System with IS 2 3 LX200 1S2 3 Luminex 200 System with IS 2 3 Developer s Workbench LX200 IS2 3WB Luminex 100 IS Developer Guide to x MAP Technology Version 2 3 CN M029 01 Luminex 200 System with xPONENT LX200 xPONENT 47 Luminex 200 System User Manual Software 48 Power Cord USA CN P001 01 Power Cord Australia CN P002 01 Power Cord Brazil CN P003 01 Powe
18. 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 The System Theory of Operation Luminex xMAP technology is based on flow cell fluorometry with Luminex developed innovations The fluidics optics robotics temperature control software and xMAP microspheres work together to enable simultaneous analysis of up to 100 analytes in a single test sample Assay analysis requiring temperature control is provided through the Luminex XYP instrument heater block There are two fluidics paths in the Luminex 200 analyzer The first path involves a syringe driven mechanism that controls the sample uptake This mechanism permits small sample uptake volumes from 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 ac
19. CL1 CL2 MCON1 05 Control 5mL MagPlex Classification Control Microspheres xMAP Sheath Fluid LX100 40 50000 49 Luminex 200 System User Manual 50 Index A access doors 3 15 accessories see accessory instructions 27 accuracy precision specifications 9 add sheath fluid 19 additional equipment barcode labels 13 bath sonicator 13 printer 13 surge protector 12 vortex 13 additional software 9 after running samples releasing pressure 19 sanitize 19 wash twice 19 air connector 16 air intake 14 air intake filter 14 22 replacing 23 XYP 13 23 analyzer 13 connections 13 ventilation filter 25 avoid beam exposure 3 shining beam into people s eyes 3 staring into beam 3 B barcode label 13 biohazard 2 biological 1 warning 4 blue indicator light 1 4 C calibration 21 capacity specifications 10 caution 2 CD supplied 9 cheminert fitting 14 classification laser 11 clean accessible surfaces 21 clinical samples 8 component of Luminex 100 IS 3 components 1 8 connectors air waste and sheath fluid 16 D daily activities 17 decontamination 1 5 discard waste 19 disconnect from AC power 21 during operation 1 E electronics 11 13 specifications 11 F filter 14 air intake 15 replacing air intake 23 sheath 15 16 flow rate 11 fluidics 11 components 14 illustration 14 leak 2 specifications 11 51 Luminex XPONENT Software Manual warning 14 fluorescence 10 fuses product number 47 replacing 27
20. G general Luminex 100 analyzer specifications 10 H hardware specifications 8 testing 8 heat 1 4 heat warning labels 4 heater block 47 high waste volume 20 I idle more than 4 hours 17 improper system operation 9 instrument operation 2 status 4 instrument operation 3 L label type specifications 13 labels 3 laboratory reagents 9 laser analyzer 3 apertures 3 bar code reader 3 information 3 location 3 leaks 2 light emission 4 location 4 Luminex 100 IS specifications 13 Luminex XYP specifications 11 M maintenance schedule annual 26 52 as required 27 daily 17 monthly 21 routine tasks 19 semi annual 22 weekly 20 manual adjustment 16 mechanical 1 3 monitor waste fluid refill sheath container 19 O operation of instrument 2 optical 16 optical assembly 16 optics 11 specifications 11 P PC specifications 12 performance specifications 9 power down 21 preventing corrosion 21 prime remove air in waste line 19 printer 13 product numbers 47 protection provided 1 protective housing 3 R radiation exposure 3 reagent specifications 8 reagents 9 49 specifications 8 refill sheath warning 19 release system pressure 19 replace fuses 27 replace syringe plunger 24 reporter channel 11 reporter laser specifications 11 responsibility 5 return shipment 5 running samples after 17 before 17 once a day 17 sheath container cap 17 verify 17 S safety advisories 1 safety precautions 1 2 sample arm adjusting vertical
21. Luminex Luminex 200 System User Manual LUMINEX CORPORATION 2001 2006 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 PN 89 00002 00 173 Rev A January 2007 ESL Paul A Rowden 33 Stapleford Road Middlesbrough Cleveland TS39ES Angleterre TQMUK aol com 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 xPONENT LabMAP xMAP Luminex SeroMAP LumAvidin Luminex XYP Luminex FlexMAP and Luminex SD All other trademarks including Windows Cheminert Pentium and Dell are trademarks of their respective companies 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 reproduction in whole or in part is strictly prohibi
22. PECIFICALLY DISCLAIMS ALL WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICU LAR PURPOSE NEITHER SELLER NOR LUMINEX SHALL IN ANY EVENT BE LIABLE FOR INCI DENTAL CONSEQUENTIAL OR SPECIAL DAMAGES OF ANY KIND RESULTING FROM ANY USE OR FAILURE OF THE PRODUCT EVEN IF SELLER OR LUMINEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE INCLUDING WITHOUT LIMITATION LIABILITY FOR LOSS OF WORK IN PROGRESS DOWN TIME LOSS OF REVENUE OR PROFITS FAILURE TO REAL IZE SAVINGS LOSS OF PRODUCTS OF BUYER OR OTHER USE OR ANY LIABILITY OF BUYER TO A THIRD PARTY ON ACCOUNT OF SUCH LOSS OR FOR ANY LABOR OR ANY OTHER EXPENSE DAMAGE OR LOSS OCCASIONED BY SUCH PRODUCT INCLUDING PERSONAL INJURY OR PROPERTY DAMAGE UNLESS SUCH PERSONAL INJURY OR PROPERTY DAMAGE IS CAUSED BY SELLER S GROSS NEGLIGENCE Buyer s Use of Product Buyer agrees that no rights or licenses under Luminex s patents shall be implied from the sale of the Product except as expressly provided herein and Buyer does not receive any right under Luminex s patent rights hereunder Buyer acknowledges and agrees that the Product is sold and licensed only for use with Luminex s standard fluorescently dyed microspheres Buyer fur ther acknowledges that the Product have not received approval from the United States Food and Drug Administration or other federal state or local regulatory agencies and have not been tested by Seller or Luminex for safety or e
23. 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 Warmup Wait 30 minutes for the Luminex 200 analyzer and the optics system to warm up 1 Turn the Luminex 200 analyzer on The system begins warming 2 Verify the levels of sheath fluid and waste fluid 3 Prime the analyzer 4 Perform an alcohol flush using at least 1 2 mL of 70 isopropanol or 70 ethanol in the reservoir 5 Runtwo wash commands using distilled water 6 Check that the Luminex XYP instrument sample probe has been vertically aligned for the plate used in the kit Luminex 200 System User Manual Adjust the sample probe vertical height Note Verify that the micro titer 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 Adjust the sample probe vertical height each time you change the type or style of microtiter
24. 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 Connecta sheath bottle filled with a solution of 1096 to 2096 household bleach solution to the analyzer 4 Sanitize the system using the Sanitize command in the Luminex software 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 Disconnect 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
25. 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 Luminex XYP instrument e Luminex Sheath Delivery System Luminex SD Power cables Two long sample probes e Reservoir Shield e Heater block e Sheath fluid container e Waste container e Sheath fluid line e Air line e Sheath fluid intake line e Communications 1 serial communication cable Communications 1 USB communication cable e Communications 1 CANBUS cable short cable e Barcode reader e Sample probe height alignment kit e Classification calibration microspheres CAL1 e Reporter calibration microspheres CAL2 e Classification control microspheres CONI e Reporter control microspheres CON2 e Luminex xMAP Sheath Fluid xMAP Technology Required Laboratory Reagents Luminex Software Luminex 200 Performance Specifications Speed Accuracy and Precision The System e Household bleach e 70 isopropanol or 70 ethanol Mild detergent e Distilled water Luminex software provides complete control of the system and performs data analysis Your Luminex 200 system is preloaded with the Luminex software However we supply a software 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
26. ches 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 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 15 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 0 05 uL Sample uptake volume 20 200 uL Reporter channel detection A D resolution 14 bits Communications interface USB Luminex XYP instrument communications interface RS 232 Luminex 200 System User Manual Luminex XYP Instrument General Luminex SD System General PC Specifications Recommended Additio
27. cols performing further analysis or re running previous data provided such computers are at a single location and are NOT connected with a Luminex instrument Although no rights or licenses under any of Luminex s patents are granted by or shall be implied from the license of the SOFTWARE or the sale of Luminex instrumentation to you the purchaser you may obtain a license under Luminex s patents if any to use this unit of Luminex instrumentation with fluorescently labeled microsphere beads authorized by Luminex by purchasing such beads from Luminex or an authorized Luminex reseller RESTRICTIONS Each SOFTWARE PRODUCT must only be installed and operated on a single Luminex instrument computer You may not use this SOFTWARE PRODUCT for any commercial purpose including in the performance of testing services unless expressly agreed to in writing by Luminex or as authorized in writing by Luminex through an authorized reseller of the SOFTWARE PRODUCT You may only use the SOFTWARE PRODUCT with microspheres manufactured by Luminex or with kits developed manufactured and distributed by licensees authorized in writing by Luminex You must maintain all proprietary notices on all copies of the SOFTWARE PRODUCT You may not distribute copies of the SOFTWARE PRODUCT to third parties You may not reverse engineer decompile disassemble or otherwise attempt to derive source code from the SOFTWARE PRODUCT You may not copy other than one
28. e 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 18 Symptom Possible problem Solution Calibration is slow or fails 38 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 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 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 18 Clean the sample probe See page 20 xMAP Technology Zero events collected during calibration Analyzer fails Controls 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 resulti
29. e the red cartridge use a flathead screwdriver 4 Check both fuses for damage 5 Replace damaged fuses with the type specified on the sticker to the right of the power input module 6 Replace the module door 7 Plugin and power on the analyzer or instrument 27 Luminex 200 System User Manual Replacing the SD System with a Sheath Bottle Storing the System 28 You may need to replace the Sheath Delivery SD system with sheath bottles for maintenance or troubleshooting To replace the SD system with sheath bottles 1 10 11 12 With the SD still connected perform a Warm Up via the software When the pressure has stabilized note the value of the Sheath pressure in the software Open the access door on the analyzer Use a screwdriver to turn the regulator approximately five full turns to the left counterclockwise Shut down the SD and disconnect it from the analyzer Attach the sheath bottle preferably full to the analyzer Open and close the sheath bottle cap in order to release any remaining pressure within the system Perform a Warm Up via the software if the compressor has turned off When the pressure has stabilized note the Sheath pressure If the pressure is equal to the value noted in step 2 within 0 1psi then the set up is complete If not continue with the next step After each adjustment you will have to release the pressure and let it build back up
30. em Solution Analyzer will not turn on or XYP will not turn on Fuses continue to open blow Communication The power cord is disconnected No voltage is coming from the electrical outlet The power supply is faulty A fuse has burned out A component has a short circuit Verify that the power cord is plugged in Verify that the electrical outlet is operational Contact Technical Support See page 27 for instructions on changing fuses Contact Technical Support Communication problems described in this section involve the links between the data system PC and 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 Instrument readbacks nstrument control sample acquisition session uploading and start stop and pause features Symptom Possible problem Solution PC cannot initialize communication with analyzer 34 The communication cable is unplugged or plugged into the wrong port The XYP or the analyzer power is not turned on Check the communications cable connections Turn off the PC and then turn on the analyzer XYP and then the PC xMAP Technology Pressurization Symptom Troubleshooting Normal air and sheath
31. er Manual 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 in the UV spectrum xMAP Technology Decontaminating the Luminex 200 Analyzer for Return Shipment Note It is the user s responsibility to decontaminate the analyzer before 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
32. er 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 sample 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 X YP 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 xMAP Technology Luminex 200 Analyzer General Optics Fluidics Electronics The System Indoor use only Operating 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 43 cm 17 inches W x 50 5 cm 20 in
33. etails Figure 11 Normal Bead Detail The histogram for the bead detail above looks like this Figure 12 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 43 Luminex 200 System User Manual xMAP microspheres hit the lower right of the region ze Beads appear scattered gt r Microspheres appear as a long diagonal line Pg P ad 44 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 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 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 0 196 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 s
34. fficacy in food drug medical device cosmetic commercial or any other use unless otherwise stated in Seller s technical specifications or material data sheets fur nished to Buyer Buyer expressly represents and warrants to Seller that Buyer will properly test and use any Product in accordance with the practices of a reasonable person who is an expert in the field and in strict compliance with the United States Food and Drug Administration and all applicable domestic and international laws and regulations now and hereinafter enacted BUYER HEREBY GRANTS TO LUMINEX A NONEXCLUSIVE WORLDWIDE UNRESTRICTED ROYALTY FREE FULLY PAID UP LICENSE WITH THE RIGHT TO GRANT AND AUTHORIZE SUBLICENSES UNDER ANY AND ALL PATENT RIGHTS IN INVENTIONS COMPRISING MODIFI CATIONS EXTENSIONS OR ENHANCEMENTS MADE BY BUYER TO THE PRODUCT OR TO THE MANUFACTURE OR USE OF THE PRODUCT IMPROVEMENT PATENTS TO MAKE HAVE MADE USE IMPORT OFFER FOR SALE OR SELL ANY AND ALL PRODUCT EXPLOIT ANY AND ALL METHODS OR PROCESSES AND OTHERWISE EXPLOIT IMPROVEMENT PAT ENTS FOR ALL PURPOSES NOTWITHSTANDING THE FOREGOING IMPROVEMENT PAT ENTS SPECIFICALLY EXCLUDES PATENT CLAIMS CONCEIVED AND REDUCED TO PRACTICE BY BUYER CONSISTING OF METHODS OF SAMPLE PREPARATION METHODS OF CONJU GATING PRODUCT TO ANALYTES THE COMPOSITION OF MATTER OF THE SPECIFIC CHEM ISTRIES OF THE ASSAYS DEVELOPED BY BUYER AND METHODS OF PERFORMING THE ASSAYS I E THE PROTOCOL FOR THE ASSAY Buye
35. 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 Warning During operation this system contains exposed moving parts which could result in puncture hazard Risk of personal injury is present Keep hands and fingers away from the Luminex XYP instrument slot during operation Warning During operation this system contains exposed moving parts which could result in pinch point hazard Risk of personal injury is present Keep hands and fingers away from the Luminex XYP instrument slot during operation Luminex 200 System Us
36. height 27 sample probe clean 20 sanitize 17 sensitivity 10 sheath filter 16 48 sheath flow rate 11 sheath fluid connector 16 filling 19 filter 26 levels 17 product number 49 sheath fluid container 16 software 9 48 software specifications 9 dedicated system 9 specifications 11 accuracy precision 9 capacity 10 classification laser 11 electronics 11 fluidics 11 hardware 8 Luminex 100 analyzer 10 Luminex 100 IS 9 11 13 Luminex XYP 11 PC 12 reporter laser 11 sensitivity 10 speed 9 vortex 13 speed specifications 9 start up procedure 17 Index status of instrument 4 subsystems 13 surge protector 12 surge protector specifications 12 symbols 2 syringe 16 syringe seal 24 48 system overview 13 T technical support 33 email address 33 hours 33 phone numbers 33 testing clinical samples 8 troubleshooting 33 U unauthorized additional software 9 user accessible components 13 V ventilation filter XYP 13 visual inspection 20 vortex 13 W warmup 17 warnings 2 3 4 24 biological 4 warranty 1 waste connector 16 container 16 19 high volume 20 wipe exterior surfaces 21 X xMAP 10 reagents 8 XYP air intake filter 23 ventilation filter 13 53
37. ing the use of the Luminex software product provided to you above which includes computer software and online or electronic documentation and may include associated media and printed materials if any SOFTWARE PRODUCT or SOFTWARE The SOFTWARE PRODUCT is protected by copyright laws and international copyright treaties as well as other intellectual property laws and treaties The SOFTWARE PRODUCT is licensed not sold 1 GRANT OF LICENSE Subject to the terms and conditions of this EULA Luminex hereby grants to you a nonexclusive nontransferable nonassignable license without right to sublicense under Luminex s copyrights and trade secrets to use the SOFTWARE PRODUCT on a single computer running with a Luminex instrument purchased from Luminex or a Luminex partner pursuant to Luminex s terms and conditions of sale You may make one 1 copy of the SOFTWARE PRODUCT for backup or archival purposes only You may also install the SOFTWARE PRODUCT on up to three 3 additional computers for purposes of performing ancillary tasks i e preparing templates protocols performing further analysis or re running previous data provided such computers are at a single location and are NOT connected with a Luminex instrument In addition You may purchase the right to use the SOFTWARE PRODUCT on additional computers as agreed to in writing with Luminex or its authorized reseller for purposes of performing ancillary tasks i e preparing templates proto
38. ition 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 41 Luminex 200 System User Manual Bead Detail Irregularities 42 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 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 is 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 A normal bead detail display is shown below It depicts a tight bead population within a white region xMAP Technology Troubleshooting Bead D
39. minex 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 sys tem use your standard laboratory safety practices 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 Warning 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 Maintenance and Cleaning Daily Maintenance Before Running Samples 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
40. nal Equipment Uninterruptible Power Supply UPS e Ambient temperature 15 C to 30 C 59 F to 86 F Humidity 20 to 80 noncondensing e Altitude operation up to 2400 m 7874 ft above mean sea level e Physical dimensions 44 cm 17 25 inches W x 60 cm 23 5 inches D x 8 cm 3 inches H e Weight 15 kg 33 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 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 updated information regarding the PC notebook or operating system go to http www luminexcorp com then click on the Support link to open the FAQ list Lumine
41. nalyzer 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 1 Luminex 200 System User Manual 2 3 Fluidics Luminex XYP Instrument Sample Probe Cheminert Fitting 4 5 6 7 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 1 Back of the Luminex 200 Analyzer and Luminex XYP Instrument A stainless steel sample probe acquires the sample 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 This fitting attaches the sample probe to the sample tubing Disconnect this fitting when you remove the sample probe See Figure 2 xMAP Technology Access Doors The System 1 Cheminert Fitting 3 Front thumbscrew 2 Probe Holder 4 Luminex XYP Instrument Sample Probe
42. nd refill it See page 45 35 Luminex 200 System User Manual Fluid Leaks Regulator not adjusted properly 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 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 36 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 20 Replace the syringe seal See page 24 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 20 Contact Technical Support Replace the syringe seal See page 24 Hand tighten the syringe connection silver knob on the syringe valve Run a Prime If leaks continue contact Technical Support xMAP Technology Sample Probe Symptom Sample probe leaks Sample arm is stuck in the up position Sample arm is stuck
43. ndications that the instruments are responding correctly 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 Turn on the PC and start up the software Complete a Warmup command which will take 30 minutes Remove the Parafilm from the end of the sample probe 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 29 xMAP Technology Maintenance and Cleaning 30 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 a
44. ng in unstable flow rate Possible problem with the laser 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 Troubleshooting Clean the sample probe then flush the system See page 20 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 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 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 20 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 39 Luminex 200 System User Ma
45. nual 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 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 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 18 Clean the sample probe See page 20 Verify sample probe height Run three Prime commands two Alcohol Flush commands then three Washes with water Verify that the waste container 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 40 xMAP Technology Troubleshoo
46. ny circumstances Dates Daily maintenance Startup Initials 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 nitials analyzer Replace air intake filter XYP Date lnitials Replace syringe plunger seal or Date I nitials syringe Check analyzer ventilation filter Date I nitials Yearly Replace sheath filter Date I nitials As required Replace fuses Date I nitials Comments 33 This Page Left Intentionally Blank Troubleshooting the Luminex 200 System Troubleshooting Troubleshooting
47. olvents Use only Luminex sheath fluid in the Luminex 200 analyzer Other fluids may damage your analyzer and may void your warranty xMAP Technology Luminex SD Problems Filter Malfunction Draining the Reservoir Troubleshooting 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 interrupt 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 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 Perform a warmup to pressurize the system 2 Leave the green air tubing connected between the Luminex 200 analyzer and the SD system 3 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 4 Insert the white tubing into the intake labeled Sheath Out and insert the blue tubing into
48. plate 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 place one alignment sphere into the selected well 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 well location is selected in the Luminex software and that you are using the appropriate number of alignment discs Retract the plate Loosen the front thumbscrew 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 Use the Luminex software to lower the sample probe Loosen the front thumbscrew Gently push the probe down until
49. quired 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 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 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
50. r 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 0010 01 Sheath Bottle CN 0011 01 Syringe Cylinder with Seal CN 0013 01 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 SOR Customer Product Description Number Luminex 100 IS Version 2 3 Software CD CN SW08 01 Luminex xPONENT Software CD CN SWI5 01 xMAP Technology xMAP Reagents Product Numbers m Customer Product Description 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 Microspheres MagPlex DD CL1 CL2 MCAL1 05 Calibrator 5mL MagPlex Classification Calibrator Microspheres Microspheres MagPlex DD
51. r has the responsibility and hereby expressly assumes the risk to verify the hazards and to con duct any further research necessary to learn the hazards involved in using the Product Buyer also has the duty to warn Buyer s customers employees agents assigns officers successors and any auxiliary or third party personnel such as freight handlers etc of any and all risks involved in using or handling the Product Buyer agrees to comply with instructions if any furnished by Seller or Luminex relating to the use of the Product and not misuse the Product in any manner Buyer shall not reverse engineer decompile disassemble or modify the Product Buyer acknowledges that Luminex retains ownership of all patents trademarks trade secrets and other proprietary rights relating to or residing in the Product Buyer s Representations Release and Indemnity Buyer represents and warrants that it shall use the Product in accordance with Paragraph 2 Buyer s Use of Product and that any such use of Product will not violate any law regulation judicial order or injunction Buyer agrees to release discharge disclaim and renounce any and all claims demands actions causes of action and or suits in law or equity now existing or hereafter arising whether known or unknown against Seller and Luminex and their respective officers directors employees agents successors and assigns collectively the Released Parties with respect to the use of the Prod
52. ri otin oia ih Gees ede ee Pls qeu 16 xMAP Technology Reagents 0 0005 16 Luminex 200 System User Manual Maintenance and Cleaning Daily Maintenance 0 0 eee eee eee Before Running Samples 0 000000 eee ee After Running Samples 0 0 eee eee eee ee Routine Tasks 2 2 bees bere ee bbe SY PIDE Ri Sheath and Waste Fluids 0 0 0 0 ee eee eee Weekly arare enen me LESE ed S E REA eae ees VisualInspection seeeeeeeee e Clean the Sample Probe eee ee eee Flush the System 0 0 cee eee ee eee BAY C0010 bee te hoe S be pr ee Clean Exterior Surfaces 0 0 0 0 cee eee ee eee Calibrate the system 2 6 0 cee ee eee eee Every Six Montlis guess e Mack Rea ee eee Luminex 200 Analyzer Air Intake Filter Luminex XYP Instrument Air Intake Filter Synnge Seal se sje eee be Rent ed sey ode Luminex 200 Analyzer Ventilation Filter Annually 22 ee Pees SEN oe PSs bed cran HOMES Sero SUD Sheath Filter iu css bein md seen biben haan acai AS required i 2x5 sio epu boni chew Ie MOSS DO UNS qu lr C Siggae Sony puvcaln O ki N Mays Replacing the SD System with a Sheath Bottle Storing the System eree ierat e eee ee eee Taking the System out of Storage 005 Maintenance Log itv aie ie A EUIS ied kee Troubleshooting Troubleshooting the Luminex 200
53. ted Standard Terms and Conditions For Use of Product By opening the packaging containing this product Product or by using such Product in any manner you are consenting and agreeing to be bound by the following terms and conditions You are also agree ing that the following terms and conditions constitute a legally valid and binding contract that is enforce able against you If you do not agree to all of the terms and conditions set forth below you must promptly return the Product for a full refund prior to using them in any manner 1 Acceptance ALL SALES ARE SUBJECT TO AND EXPRESSLY CONDITIONED UPON THE TERMS AND CONDITIONS CONTAINED HEREIN AND UPON BUYER S ASSENT THERETO NO VARIATION OF THESE TERMS AND CONDITIONS SHALL BE BINDING UPON LUMINEX CORPO RATION LUMINEX UNLESS AGREED TO IN WRITING AND SIGNED BY AN AUTHORIZED REPRESENTATIVE OF LUMINEX For purposes of this agreement Seller shall mean the Luminex authorized reseller that sells the Product to Buyer Buyer by accepting the Product shall be deemed to have assented to the terms and conditions set forth herein notwithstanding any terms contained in any prior or later communications from Buyer and whether or not Seller shall specifically or expressly object to any such terms Warranties Any warranty obligations for the Product shall be exclusively provided in writing to Buyer directly by Seller LUMINEX MAKES NO WARRANTY WHATSOEVER REGARDING THE PROD UCT AND LUMINEX S
54. the panel door to the unit Plug in and power on the Luminex 200 analyzer xMAP Technology Luminex XYP Instrument Air Intake Filter Maintenance and Cleaning 9 To replace the XYP instrument air intake filter 1 Disconnect the Luminex XYP instrument from ac power by turning off the power switch on the rear of the Luminex XYP instrument then unplugging the Luminex XYP instrument power cord from the wall source 2 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 5 Figure 5 Removing the Screen 3 Replace the filter and replace the screen See Figure 6 Figure 6 Removing and Replacing the Filter 4 Plug in and turn on Luminex XYP instrument power 23 Luminex 200 System User Manual Syringe Seal 24 9 To replace the syringe plunger seal 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 Openthe center most door on the front of the Luminex 200 analyzer 3 Locate the syringe a glass cylinder with a metal rod See Figure 7 1 Syringe Seal 2 Syringe Figure 7 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 5 Unscrew the syringe from the top of its housing 6 Pull the pl
55. ting 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 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 See Pressurization on page 35 Adjust the sample probe height See page 18 Clean the sample probe See page 20 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 20 See Pressurization on page 35 Adjust the sample probe height See page 18 Verify sample probe height Run three Prime commands two Alcohol Flush commands then three Washes with water Set the acquis
56. uct Buyer agrees to indemnify and hold harmless the Released Parties from and against any suits losses claims demands liabilities costs and expenses including attorney accounting expert witness and consulting fees that any of the Released Parties may sustain or incur as a result of any claim against such Released Party based upon negligence breach of warranty strict liability in tort contract or any other theory of law or equity arising out of directly or indirectly the use of the Product or by reason of Buyer s failure to perform its obligations contained herein Buyer shall fully cooperate with the Released Parties in the investiga tion and determination of the cause of any accident involving the Product which results in personal injury or property damage and shall make available to the Released Parties all statements reports recordings and tests made by Buyer or made available to Buyer by others Patent Disclaimer Neither Seller nor Luminex warrants that the use or sale of the Product will not infringe the claims of any United States or other patents covering the product itself or the use thereof in combination with other products or in the operation of any process End User License Agreement EULA for Luminex amp 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 regard
57. unger out of the syringe 7 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 xMAP Technology Luminex 200 Analyzer Ventilation Filter 10 11 12 13 14 Maintenance and Cleaning Return the syringe arm to its original position 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 1 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 source 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 8 Remove the filter from the left side of the Luminex 200 analyzer Figure 8 Luminex 200 Analyzer Ventilation Filter 4 Clean the filter with a vacuum or with distilled water Stand the filter upright to air dry 25 Luminex 200 System User Manual 5 Re install it with the arrows facing up The filter should click into place 6 Plugin and turn on the Lumine
58. 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 applicable Luminex software manual 21 Luminex 200 System User Manual Every Six Months Luminex 200 Analyzer Air Intake Filter Note Hold on to the tub ing Do not allow the tub ing to fall inside the the 22 9 To replace the analyzer air intake filter l 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 to 4 inches from the unit See Figure 4 aont di Model No g garni X S N LX 100002450 E Lumines Corey Bld h Figure 4 Grasping the Tubing Remove the filter with one hand and hold the tubing with the other hand Connect a new filter to the tubing and position the filter inside the panel Reattach
59. x 200 analyzer power 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 9 Figure 9 Sheath Filter 4 Connect the new sheath filter matching up the color coded fittings The arrow on the sheath filter should be pointing up 5 Reconnect the sheath fluid tubing 6 Plug in and power on the Luminex 200 analyzer 7 Close the left analyzer door 8 Prime twice 26 xMAP Technology Maintenance and Cleaning As required Fuses Warning To avoid serious injury or death by electric shock you must turn off the system and unplug it from the wall 9 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 With a small flathead screwdriver open the module door on the lower left corner of the back of the analyzer or instrument See Figure 10 p J Figure 10 Opening the Module Door 3 Remov
60. x 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 xMAP Technology Surge Protector Printer Barcode Labels Vortex Bath Sonicator System Overview Electronics Power Input Module Communications Ports DB9 PIN Luminex 200 Analyzer Ventilation Filter Luminex XYP Instrument Ventilation Filter The System 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 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 input modules contain the on off switch and fuses The communications port connects the Luminex 200 a

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