IVD MAGPIX® Hardware Installation and User Manual
Luminex IVD MAGPIX Hardware Installation and User Manual © Luminex Corporation, 2010. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, or translated into any language or computer language, in any form or by any means without prior express, written consent of: LUMINEX CORPORATION 12212 Technology Boulevard Austin, Texas 78727-6115 U.S.A. Voice: (512) 219-8020 Fax: (512) 219-5195 Luminex® IVD MAGPIX® Hardware Installation and User Manual PN 89-00002-00-272 Rev.
Standard Terms and Conditions For Use of Instrument 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 agreeing that the following terms and conditions constitute a legally valid and binding contract that is enforceable against you.
Luminex IVD MAGPIX Hardware Installation and User Manual such Product failed to conform and shall furnish a detailed explanation of any alleged nonconformity; (ii) Buyer at it's expense will contract either Luminex or a Luminex trained service engineer to assess the issue and identify the defective FS-PART; and (ii) at Luminex's option and election, Buyer shall either return such nonconforming Product to Luminex's manufacturing facility or destroy such Product and provide Luminex with written certification
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 Product.
Luminex IVD MAGPIX Hardware Installation and User Manual 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.
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 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. 9. LIMITATION OF LIABILITY.
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Table of Contents Chapter 1: About This Manual ............................................................................................. 1 Overview ......................................................................................................................... 1 Warnings and Notes........................................................................................................ 1 Symbols .......................................................................................................
Luminex IVD MAGPIX Hardware Installation and User Manual Mechanical Subsystem............................................................................................. 42 Optical Subsystem.................................................................................................... 44 Recommended Additional Equipment............................................................................ 44 Uninterruptible Power Supply (UPS) or Surge Protector..........................................
Contents Fluid Leaks .................................................................................................................... Sample Probe Problems ............................................................................................... Calibration Slowness and Failure.................................................................................. Verification Slowness and Failure .................................................................................
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CHAPTER 1 About This Manual Overview Read this manual carefully before using the MAGPIX system. It provides vital information about the following aspects of MAGPIX: • • • • • • • • • Safety issues Regulatory considerations and labeling Installation Operation Maintenance Troubleshooting Storage Shipping Part Numbers Warnings and Notes The following informational notes and warnings appear as necessary in this manual. NOTE: This message is used to provide general helpful information.
Luminex IVD MAGPIX Hardware Installation and User Manual Symbols You may encounter these symbols throughout this manual. They represent warnings, conditions, identifications, instructions, and regulatory agencies. TABLE 1.
CHAPTER 2 Safety and Regulatory Considerations Become familiar with the safety information in this chapter before using MAGPIX. This system contains electrical and mechanical components that, if handled improperly, are potentially harmful. In addition, biological hazards may be present during system operation. Therefore, Luminex recommends that all system users become familiar with the specific safety advisories below in addition to adhering to standard laboratory safety practices.
Luminex IVD MAGPIX Hardware Installation and User Manual Regulatory Labels and Warnings The following fuse caution label appears on MAGPIX. FIGURE 1. Fuse Caution Label A voltage label appears on the back of MAGPIX. It displays the MAGPIX serial number, model number, power requirements, and manufacturer’s information. FIGURE 2. Serial Number and Voltage Label The WEEE (Waste Electrical and Electronic Equipment) label appears. FIGURE 3.
Safety and Regulatory Considerations A label with legal information appears on MAGPIX. FIGURE 4. Legal Information Because MAGPIX complies with European Union safety requirements, it displays an EC representative label. FIGURE 5. EC Representative Patient information appears on MAGPIX. FIGURE 6.
Luminex IVD MAGPIX Hardware Installation and User Manual Testing and Certifications MAGPIX has been tested by MET and complies with safety requirements for the United States and Canada. FIGURE 7. MET Mark E112918 In addition, MAGPIX complies with European Union (EU) safety requirements and therefore may be marketed in the Europe Single Market. The following European Union compliance label appears on the back of the MAGPIX instrument. FIGURE 8.
Safety and Regulatory Considerations Safety Practices In any situation in which you encounter this symbol, consult this manual or other Luminex documentation to determine the nature of the potential hazard and any necessary actions you must take. CAUTION: The protection provided by the equipment can be impaired or the warranty voided if the Luminex MAGPIX system is used in a manner not specified by the instructions or by Luminex Corporation.
Luminex IVD MAGPIX Hardware Installation and User Manual Bar Code Reader Laser The accessory bar code reader is classified under FDA 21 CFR 1040.10 and 1040.11 as a Class II laser product. In accordance with IEC 60825-1, the accessory bar code reader is classified as Class 2. The bar code reader laser presents a potential hazard to eyesight. WARNING: Do not stare into the barcode reader beam or shine it into other people’s eyes.
Safety and Regulatory Considerations Indicator Light The lights inside the front panel of MAGPIX indicate the status of the system and are harmless. The blue light-emitting diodes (LEDs) do not emit light in the UV spectrum. Decontamination Procedure Occasions may arise when it becomes necessary to decontaminate the entire MAGPIX instrument. If you must decontaminate the instrument, sanitize the accessible surfaces and the internal fluidics system.
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CHAPTER 3 Installation Procedure Before handling or unpacking MAGPIX, make certain that the selected site is appropriate. See “Installation Diagrams” on page 28 for handling and site installation requirements and detailed dimensions of MAGPIX.
Luminex IVD MAGPIX Hardware Installation and User Manual Within the overpack are separate cartons for the PC, the monitor, the 2-pack of Drive Fluid, and the MAGPIX instrument. In addition, a divided tray contains the cables, CDs, and printed material. FIGURE 10. Inside the Overpack 1 3 4 2 1 PC carton 2 Monitor carton 3 Accessory tray (monitor stand and Drive Fluid cartons are underneath) 4 MAGPIX carton Each individual carton can be handled by one person.
Installation Procedure FIGURE 11. The Assembled PC Unpacking and Assembling MAGPIX To install the MAGPIX instrument: 1. Remove the MAGPIX carton from the overpack. FIGURE 12.
Luminex IVD MAGPIX Hardware Installation and User Manual The MAGPIX instrument is inside a plastic bag and surrounded by foam inserts attached to a corrugated cardboard insert. FIGURE 13. The MAGPIX Carton, Opened 2. Remove MAGPIX from its carton by pulling on the handles that extend from the cardboard insert. NOTE: FIGURE 14. It is helpful to have another person hold down the carton while you pull out MAGPIX. Pulling MAGPIX from its Carton 3. Put the instrument on a stable, flat surface.
Installation Procedure 4. Fold down the cardboard panels from each side of the instrument. FIGURE 15. Removing the Packing Materials 5. Pull the plastic bag down from the top. 6. Place MAGPIX onto a lab bench or other flat, stable surface. This may require two people. Before proceeding with the installation, check the contents of the overpack with the checklist on page 29 and make certain you can locate all listed items. Check contents to make certain no damage has occurred during shipping.
Luminex IVD MAGPIX Hardware Installation and User Manual 2. Plug the power cord into the back of the instrument. 3. Connect the USB cable to the PC and to the connector labeled P1 on the back of MAGPIX. Use the top right USB port on the PC. FIGURE 17. Power Cord and USB Cable Connected 4. Connect the barcode scanner (if ordered) to the computer. FIGURE 18.
Installation Procedure Preparing MAGPIX Preparing MAGPIX includes removing the shipping plug, installing the Drive Fluid, and installing the sample probe. Removing the Shipping Plug Inside the side access door of MAGPIX, a shipping plug holds the sample probe assembly in place. Use the door access tool included in the accessory tray to open the side access door and remove the plug. CAUTION: MAGPIX should not be plugged into a power source when you open this compartment.
Luminex IVD MAGPIX Hardware Installation and User Manual FIGURE 21. Sliding Open the Door 4. Raise the probe assembly and locate the shipping plug. FIGURE 22. The Shipping Plug in Position 5. Pull the probe holder up, then, holding MAGPIX on the top with one hand to stabilize it, firmly push the probe assembly away from you with your other hand. Be prepared to use some strength.
Installation Procedure FIGURE 23. Pushing the Probe Assembly 6. With the probe assembly out of the way, lift out the shipping plug. FIGURE 24.
Luminex IVD MAGPIX Hardware Installation and User Manual Installing the Sample Probe MAGPIX comes with two sample probes, but the probe is not pre-installed. To install the sample probe: 1. Locate the sample probe, which is shipped in a tube in the accessory tray. FIGURE 25. The Sample Probe and Its Container 2. Pull the probe assembly toward you and push it down. 3. Completely unscrew the probe fitting on top of the probe holder by turning it counterclockwise. FIGURE 26.
Installation Procedure FIGURE 27. Inserting the Sample Probe 5. Reinstall the probe fitting, tightening it until it clicks into place. FIGURE 28. The Sample Probe in Position 6. Close and latch the side access door.
Luminex IVD MAGPIX Hardware Installation and User Manual Installing the Drive Fluid The overpack includes a carton containing two containers of Drive Fluid. Open the carton and remove one container to install in the instrument. To install the Drive Fluid container: 1. Locate the carton of Drive Fluid containers. FIGURE 29. Drive Fluid Carton and Container 2. Open the carton and remove a container of Drive Fluid.
Installation Procedure 3. Open the door of the fluid compartment on the front of MAGPIX. FIGURE 30. The Fluid Compartment 4. Pull the Drive Fluid tube and plug in the left side of the fluid compartment forward until it extends outside the compartment. Pull it to the left to allow room to insert the Drive Fluid container. FIGURE 31.
Luminex IVD MAGPIX Hardware Installation and User Manual 5. Insert the Drive Fluid container part of the way into the fluid compartment opening and remove the seal. FIGURE 32. Removing the Seal 6. Connect the Drive Fluid tube and plug to the opening on the top of the Drive Fluid container. FIGURE 33.
Installation Procedure 7. Slide the container into the tray on the left side of the fluid compartment. The container tray is constructed to hold the container in place. FIGURE 34. Sliding in the Drive Fluid Container 8. After the container is fully inserted, check the valve on the front of the waste fluid container to make certain it is securely attached and close the door of the fluid compartment. Powering Up MAGPIX MAGPIX has two on/off switches: a hard power switch and a soft power switch.
Luminex IVD MAGPIX Hardware Installation and User Manual FIGURE 35. The Hard Power Switch 3. When you are ready to begin testing, turn on the soft power switch on the front of MAGPIX. The blue LED in the hexagonal window lights up as confirmation that the power is on. MAGPIX requires approximately 45 seconds to start up. NOTE: FIGURE 36. The soft power switch activates and deactivates the unit. The Soft Power Switch 4.
Installation Procedure Performing an Initial Startup Before using MAGPIX to analyze samples, perform an initial startup routine. All the necessary procedures are described in the Luminex IVD xPONENT for MAGPIX Software User Manual and the Luminex xPONENT for MAGPIX Software Quick Guide. To perform an initial startup: 1. From the Home page, select Probe and Heater, then perform a probe height adjustment using a standard 96-well microtiter plate.
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Installation Procedure Shipping Checklist The MAGPIX overpack contains the following items: Item Qty Part Number MAGPIX Instrument 1 55-00022-00-002 PC 1 64-00087-00-001 Monitor 1 64-10049-00-001 All-in-One Monitor Stand 1 64-10050-00-001 Drive Fluid 2-pack 1 40-50014 Waste Bottle 1 CN-0261-01 Sample Probe 2 CN-0221-01 Power Cord 1 CN-P0XX-01 USB Cable 1 CN-0271-01 Side Access Door Tool 1 CN-0264-01 Sample Probe Height Adjustment Kit 1 CN-0263-01 Off-plate Reagent Block
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CHAPTER 4 Technical Overview This chapter describes the operation, components, subsystems, and technical specifications of MAGPIX. How MAGPIX Operates MAGPIX combines a fluidics system, a mechanical system, an electronic system and an optical system with magnetic microspheres and complex computer analysis to perform multiplex assays. The mechanical system begins the process. An operator places a 96-well microtiter plate on the plate carrier, which transports the plate into the instrument.
Luminex IVD MAGPIX Hardware Installation and User Manual FIGURE 37. MAGPIX Front & Right Side 1 2 6 3 5 4 32 1 Status indicator light 2 Soft on/off switch 3 Access door for plate carrier. 4 Access door for fluid compartment. For a more detailed illustration, see Figure 46 on page 41.
Technical Overview FIGURE 38.
Luminex IVD MAGPIX Hardware Installation and User Manual System Components The following topics describe details of the three components of the Luminex MAGPIX system: software, reagents, and hardware. Software Luminex xPONENT for MAGPIX software provides complete control of the MAGPIX instrument and performs the analysis. The software requires a dedicated PC. For updated information about the PC or operating system, see Luminex IVD xPONENT for MAGPIX Software User Manual or access http://www.luminexcorp.
Technical Overview • Side door access tool • Barcode reader (optional) • Heater block (optional) The hardware is shipped with a quick installation guide, a quick software user guide, a CD containing both the software user manual and the hardware installation and user manual, and a DVD containing the software. Reagents xMAP technology requires two kinds of reagents: common laboratory reagents and reagents created especially for Luminex instruments.
Luminex IVD MAGPIX Hardware Installation and User Manual Subsystems MAGPIX includes four subsystems: electronic, fluidic, mechanical and optical. Electronic Subsystem The electronics subsystem provides the power for operation and control of the MAGPIX system and communication between its parts. Power Input Module The power input module contains the input power plug, hard power toggle switch, and fuses. This is the protective earthing point for the MAGPIX system.
Technical Overview Communications Port The communications port connects MAGPIX to the computer. It is a USB port, labeled P1. FIGURE 40. Communications Port Printed Circuit Board Assemblies MAGPIX requires a series of printed circuit board assemblies (PCBAs), including four major boards: optics control, XY controller, imaging, and processor. These PCBAs are all contained within the same area as the optical system, are not accessible to the user, and require no user maintenance.
Luminex IVD MAGPIX Hardware Installation and User Manual 38 FIGURE 41. Side Access Door FIGURE 42.
Technical Overview Syringe Pump and Drive Fluid Filter The syringe pump draws fluid from the Drive Fluid container, in the bottom compartment of the instrument. The fluid first passes through the Drive Fluid filter, which removes particles greater than 35 microns in diameter.
Luminex IVD MAGPIX Hardware Installation and User Manual Sample Probe Assembly The stainless steel sample probe fits inside a holder. A probe fitting screws into the top of the holder, keeping the probe in place. From the probe, through the fitting, extends a tube that passes through a strain relief and attaches to the sample valve. The sample loop from the syringe pump also enters the sample value, and a tube extends from it into the optical chamber, carrying the sample mixed with Drive Fluid.
Technical Overview The Fluid Compartment At the bottom of the front panel of MAGPIX, a door folds down to provide access to the fluid compartment. Within that compartment, two trays hold the Drive Fluid and waste fluid containers. Internal sensors monitor the fullness of the waste fluid container and the emptiness of the Drive Fluid container. When either container reaches an unacceptable level, MAGPIX stops.
Luminex IVD MAGPIX Hardware Installation and User Manual 1 Drive Fluid container in place 2 Waste fluid container in place 3 Valve attaching waste tubing to waste fluid container Mechanical Subsystem x-Axis and y-Axis Movement The MAGPIX mechanical subsystem includes the plate carrier and the assembly that moves the sample probe. The carrier moves along the y axis, to allow the sample probe access to each row of the microtiter plate.
Technical Overview FIGURE 48. MAGPIX Sample Probe Assembly 1 2 1 Pulley wheel that moves sample probe assembly along x-axis (cover removed) 2 Sample probe Air Filters MAGPIX has two air filters, one on the bottom of the instrument and one on the back of the instrument. These filters require periodic cleaning to perform optimally. The filter on the bottom of MAGPIX can be slid out of its holder toward the front of the instrument. This requires lifting up or tilting the instrument.
Luminex IVD MAGPIX Hardware Installation and User Manual FIGURE 50. Back of MAGPIX showing filter in place in holder Optical Subsystem The MAGPIX optical subsystem consists of red and green LED illumination, a CCD-based imager, an imaging chamber, and a magnet to hold the magnetic microspheres in place during the imaging process. The optical subsystem is contained in the same area as the PCBAs. It is not accessible by the user and requires no user maintenance.
Technical Overview Printer Use a printer compatible with Microsoft® Windows XP Pro sp3. Barcode Labels Use Code 128 barcode label type when scanning barcode labels into the system. Vortex Use VWR product number 58816-12, with a speed range of 0 to 3200 rpm, or equivalent. Bath Sonicator Use Cole-Parmer® product number 08849-00, with an operating frequency of 55 kHz, or equivalent.
Luminex IVD MAGPIX Hardware Installation and User Manual • Operating altitude: up to 2400m (7874 ft) above mean sea level • Shipping temperature: 0-50°C (32-122°F) • Storage temperature: 10-40°C (50-104°F) Electronics • USB 2.0-compatible communications link for fast data transfer • Input voltage range: either 100-120 V~, 2.0 A 50/60 Hz or 200-240 V~, 1.
CHAPTER 5 Operational and Maintenance Procedures To ensure accurate test results, properly clean and maintain MAGPIX. Read and follow all instructions in this chapter. To facilitate your maintenance process, print out and use the maintenance logs on page 58.
Luminex IVD MAGPIX Hardware Installation and User Manual Accessing the Side Compartment The side compartment of MAGPIX contains the majority of user-maintainable components. The access door to this compartment must remain latched during operation of the instrument. Opening the access door requires a special tool provided with the MAGPIX system. FIGURE 51. Side Access Door Latch To open the latch: 1. Turn off and unplug MAGPIX. 2. Insert the latch tool into the slot of the latch and turn it clockwise. 3.
Operational and Maintenance Procedures Maintaining Fluids MAGPIX has a built-in compartment to hold a single-use disposable Drive Fluid container and a reusable waste fluid container. It comes with two waste fluid containers and a twopack of Drive Fluid containers. All fluid tubing is contained within the instrument. Monitor fluid levels daily. Replace the empty Drive Fluid container as needed.
Luminex IVD MAGPIX Hardware Installation and User Manual Weekly Procedures Cleaning MAGPIX Clean MAGPIX weekly using a 0.1N sodium hydroxide (NaOH) solution. Refer to the software manual for instructions for running the Clean command. Cleaning the Sample Probe WARNING: Avoid contact with moving parts. If a plate is running, use the software to execute Stop to avoid the possibility of exposure to moving parts. MAGPIX must not be performing any operations while you carry out this maintenance procedure.
Operational and Maintenance Procedures 4. Clean the sample probe using either a bath sonicator or a 10 mL syringe. If you are using a bath sonicator, place the tip of the sample probe in the bath sonicator for 2 to 5 minutes. If you are using a syringe, force distilled water through the tip of the sample probe to its large end. This dislodges any debris clogging the tip. 5. Replace the sample probe and tightly screw in the probe fitting. 6. Use the software to perform an automatic probe height adjustment.
Luminex IVD MAGPIX Hardware Installation and User Manual Monthly Procedures Clean the exterior surfaces monthly. To clean exterior surfaces: 1. Turn off MAGPIX and unplug the power cord. 2. Clean all exterior surfaces with mild detergent, followed by a household bleach solution diluted to 10% to 20%, followed by distilled water. 3. Open the side access door of the instrument. 4.
Operational and Maintenance Procedures FIGURE 54. Bottom of MAGPIX, Filter holder FIGURE 55.
Luminex IVD MAGPIX Hardware Installation and User Manual Replacing the Syringe Seal When you replace a syringe seal, also replace the black O-ring that fits inside it. One package contains four of each. 1. Turn off MAGPIX and unplug the power cord. WARNING: The plunger guide does NOT deactivate while the seal is being changed; unplugging is necessary to avoid injury. 2. Open the side access door of MAGPIX. 3. Locate the syringe (glass cylinder with a metal rod plunger). 4. Push the plunger guide down.
Operational and Maintenance Procedures Annual Procedures Replacing the Sample Probe Tube The tube that connects the sample probe to the valve is subject to wear because of the constant motion of the sample probe. Consequently, maintenance requires replacing it on a yearly basis. FIGURE 57. Sample Probe Tube 1 5 4 2 3 1 Sample probe tube (color-coded black at valve end) 2 Valve 3 1/4-28 flat-bottom fittings 4 Strain relief 5 Probe fitting FIGURE 58.
Luminex IVD MAGPIX Hardware Installation and User Manual To replace the sample probe tube: 1. 2. 3. 4. 5. 6. 7. 8. Turn off MAGPIX and unplug the power cord. Open the side access door on MAGPIX and locate the probe assembly. Unscrew the probe fitting completely. The sample probe tube is connected to it. Unscrew the 1/4-28 flat-bottom fitting at the valve end of the sample probe tube. The sample probe tube is connected to it. Use pliers to disconnect the 1/4-28 flat-bottom fitting if necessary.
Operational and Maintenance Procedures As Needed Maintenance Replacing Fuses Periodically, you may need to replace a fuse on MAGPIX. Use fuses with the following specifications: • F2A, 250 V The fuse cartridge will accept either 5 mm x 20 mm or 0.25” x 1.25” fuses. Fuses are available from Luminex Corporation. Replacing a fuse requires access to the back of MAGPIX. DANGER: To avoid serious injury or death by electric shock, turn off MAGPIX and unplug it from the wall before replacing a fuse.
Luminex IVD MAGPIX Hardware Installation and User Manual Maintenance Logs Reproduce the following forms as necessary and use them to record maintenance information. Fill in the dates in the first line of the table. The first table includes a sufficient number of columns for one week (7 days). The second table includes a sufficient number of columns for monthly maintenance (one task monthly), semi-annual maintenance (two tasks twice yearly), and annual maintenance (two tasks yearly).
Operational and Maintenance Procedures Long Term Maintenance - One Year Date Monthly Maintenance Clean exterior surfaces Semiannual Maintenance Clean air filter Replace syringe seal Annual Maintenance Replace Drive Fluid filter Replace sample probe tube 59
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CHAPTER 6 Troubleshooting Procedures Troubleshooting procedures help users identify and remedy problems with the instrument. Overview To troubleshoot a problem, locate the problem in one of the sections in this chapter, explore the possible causes, and take the described corrective action.
Luminex IVD MAGPIX Hardware Installation and User Manual Power Supply Problems Power supply problems often involve a blown fuse, faulty electronic component, or disconnected cable. CAUTION: Whenever you deal with a potential electrical problem, be careful to avoid electrical shocks. TABLE 2. Problem Possible Cause Corrective Action MAGPIX will not turn on. The power cord is disconnected. Plug in the power cord. The hard power switch on the back of the instrument is not turned on.
Troubleshooting Procedures Clogs Often, a clog somewhere in MAGPIX is the cause of a problem with calibration, verification, or data acquisition. To determine whether there is a clog, run performance verification to see if the fluidics function is operating properly. In the event you encounter a problem that is clog-related, use the following procedure. To troubleshoot a possible clog: 1. Clean and adjust the sample probe. See “Cleaning the Sample Probe” on page 50. 2.
Luminex IVD MAGPIX Hardware Installation and User Manual TABLE 4. Problem Possible Cause Corrective Action The syringe seal leaks. The seal is worn out or faulty. Replace the syringe seal. See “Replacing the Syringe Seal” on page 54. The syringe valve leaks. The valve is loose or faulty. Hand-tighten the syringe connection (silver knob) on the syringe valve. Run a Prime command. If leaking continues, contact Technical Support.
Troubleshooting Procedures Calibration Slowness and Failure Calibration problems can result from a variety of causes, many of them easily correctable human errors. TABLE 6. Possible Cause Corrective Action Possible Calibration Microsphere Causes: The calibration microspheres are not fully resuspended. Vortex the calibration vials to resuspend the microspheres. The wrong lot number or target values were entered in the software. Correct the lot number and target values in the software.
Luminex IVD MAGPIX Hardware Installation and User Manual Verification Slowness and Failure Like calibration problems, verification problems can have a variety of causes. TABLE 7. Verification Slowness and Failure Possible Cause Corrective Action Possible Verification Microsphere Causes: The verification microspheres are not fully suspended. Vortex the verification vials to resuspend the microspheres. The wrong lot number or target values were entered in the software.
Troubleshooting Procedures Acquisition Slowness and Failure Acquisition failure can result from many of the same causes as calibration and verification failure, in addition to sample and volume problems. TABLE 8. Possible Cause Corrective Action Possible xMAP Microsphere Causes: The xMAP microspheres are not fully suspended. Gently vortex the microtiter plate or resuspend beads with a multichannel pipettor to ensure that the microspheres are present in the solution.
Luminex IVD MAGPIX Hardware Installation and User Manual Carryover Problems Carryover from calibration can interfere with verification; likewise, carryover from an assay can interfere with correct reading of the following assay. Take the following steps to eliminate carryover: • Begin by performing four rinse cycles. • If that fails, run the Clean command twice using a 0.1N sodium hydroxide solution.
Troubleshooting Procedures TABLE 9. Types of Dot Plots Appearance Description Possible Problem Solution Normal Bead Grouping MagPlex verifiers form a tight bead population within the boundaries of the white region. Irregular Bead Grouping: Photobleached Microspheres vs. Out-of-Calibration Instrument MagPlex verifiers are outside of their region (above or to the right). Instrument is out of calibration. Recalibrate and verify. MagPlex verifiers are outside of their region (below or to the left).
Luminex IVD MAGPIX Hardware Installation and User Manual TABLE 9. Types of Dot Plots Appearance Description Possible Problem Solution Irregular Bead Grouping due to Out-of-Calibration Instrument MagPlex verifiers are anywhere outside of their region. The dot plot is elongated, horizontally or vertically. MagPlex beads fail to form a tight population within their regions. The dot plot is wide and possibly extends horizontally, vertically, or diagonally to the left. 70 MAGPIX is out of calibration.
APPENDIX A Storage If you need to put MAGPIX in long-term storage or prepare it for use after removing it from long-term storage, use the following procedures. Storing MAGPIX This procedure explains the steps you should take before placing MAGPIX into long-term storage. To prepare MAGPIX for storage: 1. Use the software to perform a preparation for storage routine. 2. Remove the sample probe from the instrument and flush it with distilled water from the narrow end out through the larger end. 3.
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Shipping APPENDIX B If a serious problem arises with MAGPIX, it may be necessary to return it to Luminex Corporation for repairs. If Luminex Technical Support directs you to return MAGPIX, the Technical Support representative will provide you with all necessary information as well as a Return Material Authorization (RMA) number. CAUTION: Before the instrument is returned, perform two procedures: Decontaminate the instrument and prepare the instrument for shipping.
Luminex IVD MAGPIX Hardware Installation and User Manual Shipment Checklist Complete the followingchecklist, sign and date it, and return it with MAGPIX. 1. Remove all specimens from the instrument. 2. Decontaminate the instrument. 3. Prepare the instrument for shipping.
APPENDIX C Part Numbers Hardware Product Description Customer Number Luminex MAGPIX with xPONENT for MAGPIX MAGPIX-XPON4.1 Access Door Tool CN-0264-01 Syringe Seal (Qty 4) CN-0014-01 Fuse 2AMP 250V Fast Acting (Qty 10) CN-0019-01 Sample Probe Needle CN-0221-01 Heater Block, 96 Wellplate CN--224-01 Cable, USB (A to B) CN-0271-01 Air Filter 4.5 x 4.
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