Luminex MAGPIX Installation and Hardware User (IVD) User Manual

IVD MAGPIX® Hardware Installation and User Manual

iiLuminex IVD MAGPIX Hardware Installation and User ManualMechanical Subsystem...

iiiContentsFluid Leaks... 63Sample Pr

ivLuminex IVD MAGPIX Hardware Installation and User Manual

1CHAPTER 1 About This ManualOverviewRead this manual carefully before using the MAGPIX system. It provides vital information about the following aspec

Luminex IVD MAGPIX Hardware Installation and User Manual2SymbolsYou may encounter these symbols throughout this manual. They represent warnings, condi

3CHAPTER 2 Safety and Regulatory ConsiderationsBecome familiar with the safety information in this chapter before using MAGPIX. This system contains e

Luminex IVD MAGPIX Hardware Installation and User Manual4Regulatory Labels and WarningsThe following fuse caution label appears on MAGPIX. FIGURE 1.

5Safety and Regulatory ConsiderationsA label with legal information appears on MAGPIX. FIGURE 4. Legal InformationBecause MAGPIX complies with Europe

Luminex IVD MAGPIX Hardware Installation and User Manual6Testing and CertificationsMAGPIX has been tested by MET and complies with safety requirements

7Safety and Regulatory ConsiderationsSafety PracticesIn any situation in which you encounter this symbol, consult this manual or other Luminex documen

Luminex IVD MAGPIX Hardware Installation and User Manual2© Luminex Corporation, 2010. All rights reserved. No part of this publication may be reproduc

Luminex IVD MAGPIX Hardware Installation and User Manual8Bar Code Reader LaserThe accessory bar code reader is classified under FDA 21 CFR 1040.10 and

9Safety and Regulatory ConsiderationsIndicator LightThe lights inside the front panel of MAGPIX indicate the status of the system and are harmless. Th

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11CHAPTER 3 Installation ProcedureBefore handling or unpacking MAGPIX, make certain that the selected site is appropriate. See “Installation Diagrams”

Luminex IVD MAGPIX Hardware Installation and User Manual12Within the overpack are separate cartons for the PC, the monitor, the 2-pack of Drive Fluid,

13Installation ProcedureFIGURE 11. The Assembled PCUnpacking and Assembling MAGPIXTo install the MAGPIX instrument:1. Remove the MAGPIX carton from t

Luminex IVD MAGPIX Hardware Installation and User Manual14The MAGPIX instrument is inside a plastic bag and surrounded by foam inserts attached to a c

15Installation Procedure4. Fold down the cardboard panels from each side of the instrument.FIGURE 15. Removing the Packing Materials5. Pull the plast

Luminex IVD MAGPIX Hardware Installation and User Manual162. Plug the power cord into the back of the instrument.3. Connect the USB cable to the PC an

17Installation ProcedurePreparing MAGPIXPreparing MAGPIX includes removing the shipping plug, installing the Drive Fluid, and installing the sample pr

Standard Terms and Conditions For Use of Instrument ProductBy opening the packaging containing this product ("Product") or by using such Pro

Luminex IVD MAGPIX Hardware Installation and User Manual18FIGURE 21. Sliding Open the Door 4. Raise the probe assembly and locate the shipping plug.F

19Installation ProcedureFIGURE 23. Pushing the Probe Assembly6. With the probe assembly out of the way, lift out the shipping plug.FIGURE 24. Liftin

Luminex IVD MAGPIX Hardware Installation and User Manual20Installing the Sample ProbeMAGPIX comes with two sample probes, but the probe is not pre-ins

21Installation ProcedureFIGURE 27. Inserting the Sample Probe5. Reinstall the probe fitting, tightening it until it clicks into place.FIGURE 28. The

Luminex IVD MAGPIX Hardware Installation and User Manual22Installing the Drive FluidThe overpack includes a carton containing two containers of Drive

23Installation Procedure3. Open the door of the fluid compartment on the front of MAGPIX.FIGURE 30. The Fluid Compartment4. Pull the Drive Fluid tube

Luminex IVD MAGPIX Hardware Installation and User Manual245. Insert the Drive Fluid container part of the way into the fluid compartment opening and r

25Installation Procedure7. Slide the container into the tray on the left side of the fluid compartment. The container tray is constructed to hold the

Luminex IVD MAGPIX Hardware Installation and User Manual26FIGURE 35. The Hard Power Switch3. When you are ready to begin testing, turn on the soft po

27Installation ProcedurePerforming an Initial StartupBefore using MAGPIX to analyze samples, perform an initial startup routine. All the necessary pro

Luminex IVD MAGPIX Hardware Installation and User Manual4such Product failed to conform and shall furnish a detailed explanation of any alleged noncon

Luminex IVD MAGPIX Hardware Installation and User Manual28Installation Diagrams

29Installation ProcedureShipping ChecklistThe MAGPIX overpack contains the following items:NOTE: A MAGPIX Calibration Kit and a MAGPIX Performance V

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31CHAPTER 4 Technical OverviewThis chapter describes the operation, components, subsystems, and technical specifications of MAGPIX.How MAGPIX Operates

Luminex IVD MAGPIX Hardware Installation and User Manual32FIGURE 37. 135426MAGPIX Front & Right Side1 Status indicator light2 Soft on/off switch3

33Technical OverviewFIGURE 38. 123MAGPIX Back & Left Side1 Communications port (P1)2 Power input module 3 Rear air filter

Luminex IVD MAGPIX Hardware Installation and User Manual34System ComponentsThe following topics describe details of the three components of the Lumine

35Technical Overview• Side door access tool• Barcode reader (optional)• Heater block (optional)The hardware is shipped with a quick installation guide

Luminex IVD MAGPIX Hardware Installation and User Manual36SubsystemsMAGPIX includes four subsystems: electronic, fluidic, mechanical and optical.Elect

37Technical OverviewCommunications PortThe communications port connects MAGPIX to the computer. It is a USB port, labeled P1.FIGURE 40. Communication

of Product will not violate any law, regulation, judicial order or injunction. Buyer agrees to release, discharge, disclaim and renounce any and all c

Luminex IVD MAGPIX Hardware Installation and User Manual38FIGURE 41. Side Access DoorFIGURE 42. Interior of Side Access Door

39Technical OverviewSyringe Pump and Drive Fluid FilterThe syringe pump draws fluid from the Drive Fluid container, in the bottom compartment of the i

Luminex IVD MAGPIX Hardware Installation and User Manual40Sample Probe AssemblyThe stainless steel sample probe fits inside a holder. A probe fitting

41Technical OverviewThe Fluid CompartmentAt the bottom of the front panel of MAGPIX, a door folds down to provide access to the fluid compartment. Wit

Luminex IVD MAGPIX Hardware Installation and User Manual42Mechanical Subsystemx-Axis and y-Axis MovementThe MAGPIX mechanical subsystem includes the p

43Technical OverviewFIGURE 48. MAGPIX Sample Probe Assembly121 Pulley wheel that moves sample probe assembly along x-axis (cover removed)2 Sample pro

Luminex IVD MAGPIX Hardware Installation and User Manual44FIGURE 50. Back of MAGPIX showing filter in place in holderOptical SubsystemThe MAGPIX opti

45Technical OverviewPrinterUse a printer compatible with Microsoft® Windows XP Pro sp3.Barcode LabelsUse Code 128 barcode label type when scanning bar

Luminex IVD MAGPIX Hardware Installation and User Manual46• Operating altitude: up to 2400m (7874 ft) above mean sea level• Shipping temperature: 0-50

47CHAPTER 5 Operational and Maintenance ProceduresTo ensure accurate test results, properly clean and maintain MAGPIX. Read and follow all instruction

Luminex IVD MAGPIX Hardware Installation and User Manual6to three (3) additional computers for purposes of performing ancillary tasks (i.e. preparing

Luminex IVD MAGPIX Hardware Installation and User Manual48Accessing the Side CompartmentThe side compartment of MAGPIX contains the majority of user-m

49Operational and Maintenance ProceduresMaintaining FluidsMAGPIX has a built-in compartment to hold a single-use disposable Drive Fluid container and

Luminex IVD MAGPIX Hardware Installation and User Manual50Weekly Procedures Cleaning MAGPIXClean MAGPIX weekly using a 0.1N sodium hydroxide (NaOH) so

51Operational and Maintenance Procedures4. Clean the sample probe using either a bath sonicator or a 10 mL syringe. If you are using a bath sonicator,

Luminex IVD MAGPIX Hardware Installation and User Manual52Monthly ProceduresClean the exterior surfaces monthly.To clean exterior surfaces:1. Turn off

53Operational and Maintenance ProceduresFIGURE 54. Bottom of MAGPIX, Filter holderFIGURE 55. AfterBeforeBack of MAGPIX, before and after removal of f

Luminex IVD MAGPIX Hardware Installation and User Manual54Replacing the Syringe SealWhen you replace a syringe seal, also replace the black O-ring tha

55Operational and Maintenance ProceduresAnnual ProceduresReplacing the Sample Probe Tube The tube that connects the sample probe to the valve is subje

Luminex IVD MAGPIX Hardware Installation and User Manual56To replace the sample probe tube:1. Turn off MAGPIX and unplug the power cord.2. Open the si

57Operational and Maintenance ProceduresAs Needed MaintenanceReplacing FusesPeriodically, you may need to replace a fuse on MAGPIX. Use fuses with the

8. NO WARRANTY. THE SOFTWARE IS LICENSED “AS IS.” ANY USE OF THE SOFTWARE IS AT YOUR OWN RISK. THE SOFTWARE IS PROVIDED FOR USE ONLY WITH LUMINEX PROD

Luminex IVD MAGPIX Hardware Installation and User Manual58Maintenance LogsReproduce the following forms as necessary and use them to record maintenanc

59Operational and Maintenance ProceduresLong Term Maintenance - One YearDateMonthly MaintenanceClean exterior surfacesSemiannual MaintenanceClean a

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61CHAPTER 6 Troubleshooting ProceduresTroubleshooting procedures help users identify and remedy problems with the instrument. OverviewTo troubleshoot

Luminex IVD MAGPIX Hardware Installation and User Manual62Power Supply ProblemsPower supply problems often involve a blown fuse, faulty electronic com

63Troubleshooting ProceduresClogsOften, a clog somewhere in MAGPIX is the cause of a problem with calibration, verification, or data acquisition. To d

Luminex IVD MAGPIX Hardware Installation and User Manual64Sample Probe ProblemsProblems with the sample probe can lead to both fluid leaks and acquisi

65Troubleshooting ProceduresCalibration Slowness and FailureCalibration problems can result from a variety of causes, many of them easily correctable

Luminex IVD MAGPIX Hardware Installation and User Manual66Verification Slowness and FailureLike calibration problems, verification problems can have a

67Troubleshooting ProceduresAcquisition Slowness and FailureAcquisition failure can result from many of the same causes as calibration and verificatio

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Luminex IVD MAGPIX Hardware Installation and User Manual68Carryover ProblemsCarryover from calibration can interfere with verification; likewise, carr

69Troubleshooting ProceduresTABLE 9. Types of Dot PlotsAppearance Description Possible Problem SolutionNormal Bead GroupingMagPlex verifiers form a ti

Luminex IVD MAGPIX Hardware Installation and User Manual70Appearance Description Possible Problem SolutionIrregular Bead Grouping due to Out-of-Calibr

71APPENDIX A StorageIf you need to put MAGPIX in long-term storage or prepare it for use after removing it from long-term storage, use the following p

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73APPENDIX B ShippingIf a serious problem arises with MAGPIX, it may be necessary to return it to Luminex Corporation for repairs. If Luminex Technic

Luminex IVD MAGPIX Hardware Installation and User Manual74Shipment ChecklistComplete the followingchecklist, sign and date it, and return it with MAGP

75APPENDIX C Part NumbersHardwareReagentsProduct Description Customer NumberLuminex MAGPIX with xPONENT for MAGPIX MAGPIX-XPON4.1Access Door Tool CN-

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iTable of ContentsChapter 1: About This Manual....................... 1Overview