Luminex 200 System User Manual Manual de usuario

Luminex® 200™ SystemUser ManualFor In Vitro Diagnostic Use

5. TERM AND TERMINATION. Your rights under this EULA are effective until termination.You may terminate this EULA at any time by destroying the SOFTWAR

Table of ContentsChapter 1 Safety ...1I

Chapter 3 Maintenance and Cleaning ...21Daily Maintenance ...

Please become familiar with the information in this chapter before using the equipment. Donot perform procedures on your Luminex® 200™ system that are

SymbolsThese symbols describe warnings, cautions, and general information used in the operation ofthis instrument. Some of these symbols are further d

impaired or the warranty voided if the system is used in a manner not specified by theinstructions or by Luminex Corporation.FluidicsThis system conta

FIGURE 1.Laser Radiation Caution LabelWARNING: Under NO circumstances should you remove the Luminex 200analyzer cover! When performing routine mainten

FIGURE 2.Laser Class LabelWARNING: Use of controls or adjustments or performance of proceduresother than those specified herein may result in hazardou

MechanicalWARNING: During operation, this system contains exposed, moving parts.Risk of personal injury is present. Observe all warnings andcautions.W

Decontaminating the Luminex 200 Analyzer for ReturnShipmentLuminex Technical Support will give you a Return Material Authorization (RMA) number ifthey

Luminex® 200™ System User Manual8For In Vitro Diagnostic Use

Theory of OperationLuminex xMAP technology is based on flow cell fluorometry with Luminex-developedinnovations. The fluidics, optics, robotics, temper

through the Luminex 200 analyzer. Results of the analyses are processed and provided in areport format.HardwareThe Luminex 200 system includes the fol

Required Laboratory Reagents• Household bleach• 70% isopropanol or 70% ethanol• Mild detergent• Distilled waterLuminex SoftwareLuminex software provid

• Internal sample carry over: < 0.9%• Soluble background fluorescence emission at 575 nm automatically subtracted fromfluorescence intensity values

• Shipping and storage: The allowable shipping and storage temperature and humidityranges are 0°C to + 50°C and 20-80% noncondensing, respectively• In

Luminex SD System General• Ambient temperature: 15°C to 30°C (59° to 86°F)• Humidity: 20% to 80%, noncondensing• Altitude: designed to operate at up t

VortexUse VWR product number 58816-12, with a speed range of 0 to 3200 rpm, or equivalent.Bath SonicatorUse Cole-Parmer® product number 08849-00, with

FIGURE 3.Back of the Luminex 200 Analyzer and Luminex XYPInstrument1 Air intake filter access door 5 Communication Ports (DB9)2 Power Switch 6 XYP Com

FIGURE 4.Fluidics Components1 Cheminert Fitting 3 Front thumbscrew2 Probe Holder 4 Luminex XYP Instrument Sample ProbeAccess DoorsThe Luminex 200 anal

© Luminex Corporation, 2011. All rights reserved. No part of this publication may bereproduced, transmitted, transcribed, or translated into any langu

FIGURE 5.Luminex 200 Analyzer Access Doors1 Left door, access to service panel 2 Center door, access to syringeAir Intake FilterA replaceable air inta

WARNING: The waste container should not be placed on top of theinstrument. Ensure that the waste tubing is not elevated abovethe level of the Luminex

Luminex® 200™ System User Manual20For In Vitro Diagnostic Use

To ensure accurate test results, properly clean and maintain the Luminex 200 system. Readand follow all instructions in this section. For your conveni

Adjust the Sample Probe Vertical HeightAdjust the sample probe vertical height each time you change the type or style of microtiterplate.1. Remove the

Sheath and Waste FluidsReplace the sheath fluid and empty the waste container as required. Be careful not to touchthe seal in the waste bottle cap or

Clean the Sample ProbeWARNING: Be sure that the system is not performing an operation whenyou remove the sample probe.CAUTION: The Luminex analyzer sa

Clean the Sample ProbeWARNING: Be sure that the system is not performing an operation whenyou remove the sample probe.CAUTION: The Luminex analyzer sa

3. Grasp the tubing and pull the filter 3 to 4 inches from the unit. See the following figure. FIGURE 6.Grasping the Tubing4. Remove the filter with o

Luminex XYP Instrument Air Intake Filter1. Disconnect the Luminex XYP instrument from AC power by turning off the power switchon the rear of the Lumin

Standard Terms and Conditions for Use of InstrumentProductBy opening the packaging containing this product ("Product") or by using such Prod

Syringe SealWARNING: The syringe arm does not deactivate when changing theplunger; injury could result if the system is not unplugged.1. Turn the powe

Replace the SyringeTo replace the syringe:1. Screw the syringe into place.2. Grab the base of the syringe plunger and gently pull down on it until it

AnnuallySheath Filter1. Disconnect the Luminex 200 analyzer from AC power by turning off the power switch onthe rear of the analyzer, then unplugging

1. Turn off the power switch on the rear of the analyzer or instrument, then unplug theinstrument power cord from the wall source. Remove the power co

9. If the pressure is equal to the value noted in step 2 (within +/-0.1psi), then the set up iscomplete. If not, continue with the next step. After ea

Luminex 200 Maintenance LogsMonth:Year:Use this form to record information over a four-week period. Fill in the month(s) and yearabove. Fill in the da

Loosensheath capTurn offsystem(optional)TABLE 2.Longer Term MaintenanceWEEKLYVisual inspection Date/Initials: Date/Initials: Date/Initials: Date/Initi

Troubleshooting procedures help users isolate, identify, and remedy problems with theLuminex 200 analyzer and Luminex XYP. This chapter does not troub

Symptom Possible problem SolutionAnalyzer will not turn on, or XYPwill not turn on.The power cord is disconnected. Verify that the power cord isplugge

Symptom Possible problem SolutionThere is a leak in the system. Check for system leaks. A leakwill be obvious if there is fluid onthe surface on which

hardware not provided by Luminex. If Product is purchased from a Luminex authorizedreseller, any warranty obligations shall be provided in writing dir

Symptom Possible problem SolutionFluid dripping from the sampleprobe.The sample probe is clogged Clean the sample probe. Seeinstructions.The sample th

Symptom Possible problem SolutionSample arm is stuck in the downposition.The sample probe height is toolow, or the path to the well isblocked.DO NOT t

Symptom Possible problem SolutionCalibration is slow or fails. The calibration microspheresare not fully suspended.Vortex the calibration vials toresu

Symptom Possible problem SolutionLaser-related issue. Verify fluid is moving through thesystem by performing a Wash,which causes fluid to go out towas

Symptom Possible problem SolutionThe waste line was movedduring system operation,resulting in unstable flow rate.Verify that the waste line is notmove

Symptom Possible problem SolutionThe acquisition volume is set toohigh.Set the acquisition volume to atleast 25 µL less than the actualvolume in your

FIGURE 13.Normal Bead DetailThe histogram for the bead detail above looks like this:FIGURE 14.Normal HistogramLuminex® 200™ System User Manual44For In

Symptom Possible problem SolutionxMAP microspheres classify toohigh.You may be usingphotobleached calibrationmicrospheres.Replace the calibrationmicro

Symptom Possible problem SolutionThe solvent is incompatible. View a list of incompatiblesolvents at the LuminexTechnical Support website -http://lumi

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 SheathB

indicated on the Product label, the Product has not received approval from the United StatesFood and Drug Administration or other federal, state or lo

Luminex® 200™ System User Manual48For In Vitro Diagnostic Use

HardwareNOTE: These part numbers are subject to change without notice.NOTE: Common description of product is enclosed in brackets.Product Description

Product Description Customer NumberPower Cord, USAPower Cord, AustraliaPower Cord, BrazilPower Cord, DenmarkPower Cord, Germany, Sweden, France,Belgiu

Product Description Customer NumberMicrospheres, LX100, CL1 CL2 Calibration (xMAP ClassificationCalibrator)L100-CAL1Microspheres, LX100, RP1 Calibrati

contract or any other theory of law or equity arising out of, directly or indirectly, the use of theProduct or by reason of Buyer's failure to pe

End-User License Agreement (EULA) for Luminex®xPONENT® SoftwareThis Luminex End-User License Agreement (“EULA”) is a legal agreement between you(eithe

3. GRANT OF LICENSE. Subject to the terms and conditions of this EULA, Luminex herebygrants to you a nonexclusive, nontransferable, nonassignable lice