Lum/nex ® International English Version Luminex 100™ IS User Manual Version 2.
© LUMINEX CORPORATION, 2001-2003. 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® 100™ IS User Manual Version 2.1 REF CN-M011-01 PN 89-00002-00-070 Rev. A January 2004 EC REP Paul. A.
End-User License Agreement (EULA) for Luminex® 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”) regarding the use of the Luminex software product identified above, which includes computer software and online or electronic documentation and may include associated media and printed materials (if any) (“SOFTWARE PRODUCT” or “SOFTWARE”).
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. NO WARRANTY. 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.
Contents Introduction 1-1 About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 What is the Luminex 100 IS? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Customer Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Safety 2-1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex 100 IS User Manual Version 2.1 The System xMAP Technology 5-1 Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 xMAP Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Required Laboratory Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Software . . . . . . . . . . . . . . . . . . . . . . . .
xMAP Technology System Calibration 6-1 System Calibration and Verification Overview . . . . . . . . . . . . . . . 6-1 Calibrate the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Run System Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Run System Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4 Calibration and System Control Trend Reports . . . . . . . . . . . . 6-5 Print or View a Calibration or System Control Trend Report . . .
xMAP Technology Luminex 100 IS User Manual Version 2.1 Calibration and Verification . . . . . . . . . . . . . . . . . . . . . . . . . Set Well Locations for Calibration and Controls . . . . . . Enter System Calibration Targets . . . . . . . . . . . . . . . . . . Enter System Control Targets . . . . . . . . . . . . . . . . . . . . . Eject and Retract the XYP Instrument Plate Holder . . . . Lower and Raise the Sample Probe. . . . . . . . . . . . . . . . . Diagnostics Tab . . . . . . . . . . . . . . . . . .
xMAP Technology Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-60 Export Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-63 Database Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-64 Back Up the Database. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-64 Erase Data from the Database. . . . . . . . . . . . . . . . . . . . . . . . . 7-64 Restore a Previously Saved Database. . . .
Luminex 100 IS User Manual Version 2.1 Troubleshooting xMAP Technology 9-1 Troubleshooting the Luminex 100 IS. . . . . . . . . . . . . . . . . . . . . . . 9-1 Problem Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1 Verify the System With System Controls . . . . . . . . . . . . . 9-2 Luminex 100 Analyzer Fails Calibration. . . . . . . . . . . . . . . . . 9-3 Luminex 100 Analyzer Fails System Controls . . . . . . . . . . . . 9-3 Failure During Self-Diagnostics Tests. . .
xMAP Technology Product Numbers 10-1 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3 xMAP Reagents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3 Glossary 11-1 Luminex Sheath Delivery System Intended Use . . .
Luminex 100 IS User Manual Version 2.1 viii xMAP Technology PN 89-00002-00-070 Rev.
1 Introduction About This Manual This manual introduces you to the system, and with step-by-step instructions, it guides you through system features with procedures and explanations. Once you have a working knowledge of the system, the manual’s text and figures demonstrate what you might see along the way, offering examples when necessary. Glossary and index sections assist as references. In short, this manual instructs you through each operational stage for running the instrument.
Luminex 100 IS User Manual Version 2.1 Customer Support xMAP Technology Luminex Customer Support representatives are ready to help you, particularly when the instrument itself or its software causes any questions or problems. If the question or problem relates to materials from the assay kit, you should contact the kit provider directly. Customer Support is available to users in the U.S. and Canada by calling 1-877-785-BEAD (-2323) between the hours of 7:00 a.m. and 7:00 p.m.
2 Safety Symbols Number These symbols describe warnings, cautions, and general information used in the operation of this instrument. These symbols are further defined under “Safety Precautions.” Symbol Description Number Symbol Description 1 Alternating current 7 Warning (refer to manual) 2 Protective ground 8 Warning (refer to manual) 3 On 9 Warning (refer to manual) 4 Off 10 Warning (refer to manual) Serial number 11 Warning (refer to manual) 5 SN 6 PN 89-00002-00-070 Rev.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Safety Precautions Electrical Read the following safety information before setting up or using the Luminex 100 IS instruments. A user should be present during operation. The system contains electrical, mechanical, and laser components which, if handled improperly, are potentially harmful. In addition, biological hazards may be present during system operation.
xMAP Technology Safety This label appears on the back of the XYP instrument. Figure 3. Fuse Replacement Warning Label - XYP This label appears on the back panel of the Luminex 100 analyzer and the back panel of the XYP instrument. Figure 4. European Safety Requirement Label The Luminex 100 analyzer and XYP instrument comply with European Union (EU) safety requirements and, therefore, may be marketed in the Europe Single Market.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Figure 6. Luminex 100 Voltage Label (Uniphase) The Luminex 100 analyzer has been tested by Underwriter Laboratories, Inc® (UL). This label appears on the back of the XYP instrument. Figure 7. Luminex XYP Voltage Label The XYP instrument has been tested by UL. This system contains fluidics. In the event of a fluidic leak, turn off all power to the system and disconnect all power cords.
xMAP Technology Safety Warning: If biological samples have been tested with the system, use your standard laboratory safety practices when handling system waste. Luminex 100 IS Laser Classification The Luminex 100 IS system classifies per FDA 21 CFR 1040.10 as a Class II laser product consisting of a class I laser component (Luminex 100 analyzer) and a Class II laser component (barcode reader).
Luminex 100 IS User Manual Version 2.1 xMAP Technology All laser apertures are located within the Luminex 100 analyzer and are contained within a protective housing. This label appears on the optics cover within the Luminex 100 analyzer. Figure 10. Laser Caution Label on Optics Cover Caution: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
xMAP Technology Bar Code Reader Laser Safety This label appears on the bar code reader. Figure 12. Bar Code Reader Laser Information Label Do not stare directly into the beam or shine the beam into other people’s eyes. Mechanical 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.
Luminex 100 IS User Manual Version 2.1 xMAP Technology Biological Warning: Human/animal samples may contain biohazardous infectious agents. Where exposure (including aerosol) to potentially biohazardous materials exists, operators should follow appropriate biosafety procedures and use personal protective equipment, such as gloves, gowns, laboratory coats, face shields or masks, and eye protection and ventilation devices.
xMAP Technology Decontamination of the Luminex 100 IS for Return Shipment Safety Sanitize and deconaminate the accessible surfaces and internal fluidics of the Luminex 100 analyzer before you ship it back to Luminex. This is particularly important when biohazardous samples have been analyzed. Make a copy of this page to fill out and return with the instrument. Complete and return this checklist with the Luminex 100 analyzer. 1.
xMAP Technology Safety PN 89-00002-00-070 Rev.
3 Basic Concepts Background Information Fluidics Excitation PN 89-00002-00-070 Rev. A xMAP technology is a versatile system that measures soluble analytes. The 100 IS performs simultaneous, discrete measurements of multiple microsphere-based reactions from a single specimen aliquot. For more conceptual information, refer to Practical Flow Cytometry, 3rd edition, by Howard M. Shapiro, M.D. (New York: Wiley-Liss Inc., 1995). There are two fluidic paths in the 100 analyzer.
Luminex 100 IS User Manual Version 2.1 xMAP Technology Photodiodes and a photomultiplier tube receive fluorescent signals from xMAP microspheres. The Luminex 100 analyzer digitizes the waveforms and delivers the signals to a digital signal processor (DSP). Proprietary algorithms function with the DSP to greatly increase sensitivity. xMAP Microspheres Note: Protect the xMAP microspheres from light.
xMAP Technology Basic Concepts System calibrators and controls are provided as part of the system. Calibrate at least once monthly or when dCal temperature changes by ±3 degrees. You must run system controls following calibration and as often as you like to ensure that your system continues to operate optimally. The software provides you with a variety of reports, including: • • • • • • Analyte reports with batch results grouped by the test in a batch.
Luminex 100 IS User Manual Version 2.1 3-4 xMAP Technology PN 89-00002-00-070 Rev.
4 Installation Assemble and Power the Luminex 100 IS System Hardware Setup Connect the Luminex 100 Analyzer and XYP Instrument Before installing the system, ensure that the facility complies with all system and safety requirements. Read the safety information that begins in “Safety Precautions” on page 2-2. Try to position the instrument to minimize temperature fluctuations. The following sections describe how to set up the hardware components of the Luminex 100 IS.
xMAP Technology Luminex 100 IS User Manual Version 2.1 instrument. Do not plug the XYP instrument into the power outlet. 5. Place the Luminex 100 analyzer onto the XYP instrument. 6. Attach the power cords to the input module of the Luminex 100 analyzer and attach the USB cable to port 1 on the Luminex 100 analyzer. Do not plug into the power outlet. Make sure that the power switches to the Luminex 100 analyzer and to the XYP instrument are off.
xMAP Technology Note: Do not place the PC or monitor on top of the Luminex 100 analyzer. Installation Refer to the documentation that came with your PC to determine if changing the voltage selection switch is required, and for instructions on changing the switch setting. 9. Place the PC to the right of the Luminex 100 and XYP instruments. 10. Place the monitor on top of the PC and connect the monitor cable to the PC. 1 2 3 4 5 1. Monitor 4. Computer 2. Barcode Reader 5. XYP 3. Analyzer Figure 15.
xMAP Technology Luminex 100 IS User Manual Version 2.1 10 8 1 11 9 7 6 2 5 4 14 16 3 15 1. USB Communication Cable 13 12 9. Instrument USB Cables 2. Luminex XYP Instrument 10. Network Connection 3. Luminex XYP Instrument to PC Serial Cable 11. Monitor Cable 4. Power Cords 12. Y-Cable (to keyboard port) 5. Luminex XYP Instrument Power Switch 13. Mouse Cable (top port) 6. Luminex 100 Analyzer Power Switch 14. Com 2 Port 7. Luminex 100 analyzer 15.
xMAP Technology Installation 4 1 2 3 1. Keyboard 3. Y-Cable 2. Barcode Reader 4. Mouse Figure 17. Connecting the PC, Mouse, Barcode Reader, and Keyboard Note: The sheath and waste containers must be placed on the same surface as the XYP instrument. Do not place the containers on top of the Luminex 100 analyzer. PN 89-00002-00-070 Rev. A 13. Fill the sheath bottle with sheath fluid to just below the air intake fitting.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Install or Replace the XYP Instrument Sample Probe To install the XYP instrument Sample Probe, which is longer than the probe shipped with the system, follow these steps: 1. Make sure the Luminex 100 analyzer power switch is off and that the XYP instrument and the Luminex 100 analyzer power cords are unplugged from the outlet. 2. Remove the light housing directly above the Sample Arm by grasping and firmly pulling out.
xMAP Technology Installation 3. Remove the Cheminert fitting by turning the connector counterclockwise. If the tubing is difficult to remove, push up gently on the sampling probe. 1 2 1. Cheminert Fitting 2. Sample Probe Figure 19. Cheminert Fitting 4. Remove the sampling probe by grasping the probe and gently pushing up. Caution: The XYP instrument sampling probe should slide up easily while removing it from the Sample Arm. If you feel resistance, do not force the probe up. Contact Customer Support.
Luminex 100 IS User Manual Version 2.1 xMAP Technology Figure 20. The XYP Instrument Sampling Probe 6. Re-install the light housing by pushing until it snaps into place. 7. Install the shield to cover the sampling probe area. This shield should only be removed for making adjustments to the probe. Figure 21. The Clear Plastic Shield 4-8 PN 89-00002-00-070 Rev.
xMAP Technology Installation 8. Plug in the XYP instrument and the Luminex 100 analyzer. Install the XYP Instrument Reservoir The XYP instrument reservoir is used for maintenance functions in the Luminex 100 analyzer. To install the XYP instrument reservoir: 1. Turn on the XYP instrument, the Luminex 100 analyzer, and the PC. Wait for the Luminex 100 IS software to start. 2.
xMAP Technology Luminex 100 IS User Manual Version 2.1 heater block in the bracket inside the left access door of the Luminex 100 analyzer. To install the XYP instrument heater block: 1. Click the Eject/Retract button to eject the plate holder. 2. Insert the XYP instrument heater block on the plate holder. Figure 23. The XYP Instrument Heater Block 3. Click the Eject/Retract button to retract the plate holder.
xMAP Technology Installation To adjust the vertical height of the Sample Probe: 1. Turn on the XYP instrument, the Luminex 100 analyzer, and PC. Wait for the Luminex 100 IS software to start. 2. Remove the clear plastic shield that covers the sampling probe area. 3. In a 96-well microtiter plate where overall height is no more than 0.75 inches, place appropriate alignment tool in the plate. For a standard plate with flat-bottomed wells, stack two of the larger (5.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Initialization Initialize the PC Upon powering your system, the PC runs through several selfdiagnostic tests to verify that the computer system is set up to run the system software application. To initialize the PC: 1. Turn on the power button on the back of the Luminex 100 analyzer and turn on the PC.
Clearance for cooling and intake/exhaust, and cable clearance for power switch access . PN 89-00002-00-070 Rev. A 8 Cooling Air Intake Back View 6 Cooling Air Exhaust Possible Aerosol Exhaust Cooling Air Exhaust Possible Aerosol Exhaust 7.50 (190.50mm) Cable clearance. 7 2.0 (50.8mm) 4.0 3.0 (101.6mm) 7 (76.2mm) 6 Supporting Surface Luminex XYP Tray Clearance Cooling Air Intake 8 2.0 (50.8mm) Right Side View Isometric View Luminex 100 53.92 lb. (24.46 kg.
xMAP Technology PN 89-00002-00-070 Rev.
5 The System Theory of Operation Luminex 100 IS technology is based on flow cell fluorometry with Luminex-developed innovations. The fluidics, optics, robotics, temperature control, software, and 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 XYP instrument heater block. There are two fluidics paths in the Luminex 100 analyzer.
xMAP Technology Luminex 100 IS User Manual Version 2.1 photo diode (APD) detectors measure the excitation emission intensities of the color coding classification dye mixtures inside the microspheres and a photomultiplier tube detects the excitation emission intensity of the reporter dye bound to the surface of the microspheres. High speed digital signal processors and advanced computer algorithms provide analysis of the xMAP microspheres as they are processed through the Luminex 100 analyzer.
xMAP Technology Required Laboratory Reagents Software The System • • • Household bleach 70% isopropanol Mild detergent Luminex 100 IS software provides complete control of the system and performs data analysis. Your Luminex 100 IS is preloaded with the Luminex 100 IS software. However, we supply a software CD in case 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.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Accuracy and Precision • • • • • • Sample uptake volume ± 5% Classification of microspheres > 80% Misclassification of microspheres < 0.5% Temperature control 0°C to +3°C of target Internal sample carry over < 0.9% Soluble background fluorescence emission at 575 nm automatically subtracted from fluorescence intensity values Sensitivity • • Detect 1000 fluorochromes phycoerythrin (PE) per microsphere Reporter channel dynamic range: 3.
xMAP Technology The System Luminex 100 Analyzer General • • • • • • • • • • • Optics • • • • • Fluidics PN 89-00002-00-070 Rev. A • • • • Operating temperature: 15°C to 30°C (59°F to 86°F) Storage temperature: 0°C to 50°C (32°F to 122°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 inches) D x 24.5 cm (9.5 inches) H Weight: maximum of 25 kg (60 lbs.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Electronics • • • Reporter channel detection: A/D resolution 14 bits Communications interface: USB XYP instrument, communications interface: RS 232 • • • • Ambient temperature: 15°C to 30°C (59°F to 86°F) Humidity: 20% to 80%, noncondensing Altitude: operation up to 2400 m (7874 ft) above mean sea level Physical dimensions: 44 cm (17.25 inches) W x 60 cm (23.5 inches) D x 8 cm (3 inches) H Weight: 15 kg (33 lbs.
xMAP Technology The System • • Power cords: Power cords specific to the country of use are included in the system as required Power: 115-230 V~, 5.6 Amps, 50-60 Hz Recommended Additional Equipment Uninterruptible Power Supply (UPS) Luminex highly recommends using an uninterruptible power supply (UPS) to protect your system from a power outage. Choose a supply that can provide 1050 Watts for at least 45 minutes. The UPS should be UL listed, CSA certified, CE marked when used internationally.
Luminex 100 IS User Manual Version 2.1 xMAP Technology Figure 25. Luminex 100 IS Setup Electronics 5-8 Power Input Module The power input module operates from 100 to 120 Vac, 200 to 240 Vac and 47 to 63 Hz. The power input module contains the Luminex 100 analyzer on/off switch and fuses. P1 Communications Port (SB9-PIN) Used to connect the Luminex 100 analyzer or the XYP instrument to the computer.
xMAP Technology The System 1 2 3 4 5 6 1. Air intake filter access door 2. Power input module 3. Power switch 4. XYP instrument ventilation filter 5. Communications ports (DB9) 6. Analyzer ventilation filter (on bottom) Figure 26. Back of the Luminex 100 Analyzer and XYP Instrument Fluidics Sample Arm PN 89-00002-00-070 Rev. A The Sample Arm transports the sample from the sample tube to the cuvette. Upon operation, the carriage drops automatically to the microtiter well for sample retrieval.
xMAP Technology Luminex 100 IS User Manual Version 2.1 XYP Instrument Sample Probe A stainless steel Sample Probe acquires a sample. A shorter probe is provided for shipping and troubleshooting. Warning: During operation, this system contains exposed moving parts that result in puncture hazard. Risk of personal injury is present. Keep hands and fingers away from the Sample Probe. The shield should be in place.
xMAP Technology Access Doors The System Two access doors are on the face of the Luminex 100 analyzer. The center door gives you access to the syringe. The left door provides service panel access. 2 1 1. Left door, access to service panel 2. Center door, access to syringe Figure 28. Access Doors to Luminex 100 Analyzer Air Intake Filter A replaceable air filter cleans the air used to pressurize sheath fluid.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Syringe Located in this compartment behind the center door, the syringe delivers a sample in the 96-well microtiter plate to the cuvette. 1 2 Figure 30. Syringe (1) and Syringe Seal (2) Sheath Filter Behind the left door, the service panel houses a sheath filter. This filter removes particles greater than 10 microns in diameter from the sheath fluid. Figure 31. Sheath Filter 5 - 12 PN 89-00002-00-070 Rev.
xMAP Technology Air, Waste, and Sheath Fluid Connectors The System Located on the side of the instrument, these connectors couple directly to the sheath and waste fluid containers. The air connector is green, the sheath fluid connector is blue, and the waste fluid connector is orange. 1 2 3 1. Sheath Connector (Blue) 2. Air Connector (green) 3. Waste Connector (orange) Figure 32.
Luminex 100 IS User Manual Version 2.1 xMAP Technology Optical The optical system consists of the optical assembly and the excitation lasers. The optical assemblies do not require manual adjustment by the user. xMAP Reagents The xMAP reagent system consists of classification xMAP calibration microspheres, reporter xMAP calibration microspheres, classification xMAP control microspheres, and reporter xMAP control microspheres. 5 - 14 PN 89-00002-00-070 Rev.
6 System Calibration System Calibration and Verification Overview xMAP calibrator microspheres are used to normalize the settings for the reporter channel, both classification channels, and the doublet discriminator channel for the Luminex 100 IS. xMAP control microspheres are used to verify the calibration and optical integrity for the system.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Calibrate the System Run System Calibrators To calibrate your system: 1. Vortex xMAP calibrators and controls containers to ensure homogeneity. 2. Load a microtiter plate with at least three drops of each: CAL1 in well A1, CAL2 in well B1, CON1 in well C1, CON2 in well D1 and sheath fluid in well E1. (You may assign different well locations, if desired.) 3. Click Eject/Retract from the toolbar. The plate holder ejects. 4.
xMAP Technology System Calibration Figure 33. Update Calibration Targets Dialog Box Note: Ensure that you enter the correct target values for each parameter before clicking OK. If necessary, re-enter the information to correct any incorrect information. 10. Enter the values listed from the Certificates of Analysis included with your calibrators into the CAL1 and CAL2 entry fields. 11. Click OK. The dialog box disappears. 12.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Run System Controls To run system controls, follow these steps: 1. Click New CON Targ. from the Maintenance tab to enter or confirm system control lot numbers. An Update CON Target Information dialog box appears. Figure 34. Update CON Targets Dialog Box 2. Enter the values listed from the Certificates of Analysis included with your system controls into the CON1 and CON2 entry fields. 3. Click OK. The dialog box disappears. 4.
xMAP Technology System Calibration 6. Click OK and wait until CON1 completes. The device status section in the status bar changes from “Running” to “Standby”. 7. Click CON2 from the Maintenance tab. A Confirmation Screen dialog box appears. 8. Click OK and wait until CON2 completes. The device status section in the status bar changes from “Running” to “Standby”. Note: The message log on the Diagnostics tab shows the status of the CON1 and CON2 commands.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Print or View a Calibration or System Control Trend Report You must enter information about the date range you want to print a report about. To create a trend report for a date range: 1. Click the Print button on the Home tab. A Report Selection dialog box appears. Figure 36. Report Selection Dialog Box 2. Select Calibration Trend Report or System Control Trend Report and click Next.
xMAP Technology System Calibration 3. Select the product for the trend report and click the Next button. A new dialog box appears. Figure 38. Lot and Date Selection Dialog Box 4. Select the reagent lot and expiration date, and the date range (with the starting and ending date) that you want and click Finish. A Calibration Trend Report Print Preview appears using the information you entered. Figure 39. Report Print Preview 5. If desired, click the Print button on the toolbar.
Luminex 100 IS User Manual Version 2.1 6-8 xMAP Technology PN 89-00002-00-070 Rev.
7 Software Tour Luminex 100 IS 2.1 Software The Luminex 100 IS (IS 2.1) software starts automatically when you turn on the system, which includes the Luminex 100 analyzer, XYP instrument, and PC. An animated splash screen (shown below) appears for about ten seconds. Figure 40. Luminex 100 IS Software Splash Screen The system requires you to enter essential information before the system can open fully. Getting Started PN 89-00002-00-070 Rev.
100 IS S Users Manual Version 2.1 xMAP Technology The calibration and control target values can be found on the certificate of analysis included in the shipment of products. After the initial splash screen disappears, the system prompts you to enter calibration and control target values. The system stores the information you enter into the database and proceeds to the main software screen. When entering information into the system, you may see an asterisk (*) at the top-right corner of the entry field.
xMAP Technology Software Tour IS 2.1 Main Screen After entering the calibration and control target values, the main screen appears. 1 2 3 4 5 1. Main Screen 2. Menu Bar 3. Toolbar 4. Tabs 5. Status Bar Figure 42. IS 2.1 Main Screen It includes menus and tools that help you to use the software and to monitor the progress of the acquisition and diagnostic processes.
xMAP Technology 100 IS S Users Manual Version 2.1 Menu Bar The main screen in the IS 2.1 software has three menus: File, Tools, and Help. You may access other system operations through these menus. Enter General Information The system lets you set up and, to a degree, customize the system software as well as enter information about your company. You may change or update this information as often as you feel it is necessary.
xMAP Technology Note: A confirmation screen dialog box appears after you initiate certain commands. This dialog box tells you what is required to complete the task that you initiate and verifies that you want to proceed with that command. Enter Company Information Software Tour 4. Enter a new batch directory if you want the batch located in a location other than C:\My Batches (the system default location). 5. Select whether to display confirmation screens. 6. Enter the current user name and click OK.
xMAP Technology 100 IS S Users Manual Version 2.1 Toolbar The main screen has a toolbar that contains several buttons to initiate IS commands. 1 2 12 3 4 5 6 7 1. Import Templates 8 9 10 11 7. Export Batch Data 2. New Batch 8. Print Report 3. Open Batch 9. Connect to the Instrument 4. Create New Multi-Batch 10. Disconnect from the Instrument 5. Open Multi-Batch 11. Eject/Retract 6. Start Analysis 12. Open Help Files Figure 45.
xMAP Technology Software Tour The following table describes the color coding with relation to types of message received in the status bar. Table 1.
xMAP Technology 100 IS S Users Manual Version 2.1 Table 1. Status Bar Color Coding (Continued) Total Events/ Second Number of total bead events detected per second Region Events/ Second Number of sample reactions detected per second Both template and manual commands appear on the status bar as the system processes the command. Errors also appear in the message log. The Diagnostics tab should turn red if the system encounters an error.
xMAP Technology Software Tour Table 2. Status Bar Communication Message Details Status Bar Color Red Tabs PN 89-00002-00-070 Rev. A Message Indicates Paused This term appears when the software stops processing the list of commands. A “resume” function becomes available to change the state back to “processing.” Disconnected This term appears when the software has not yet attempted to connect or fails to connect to the instrument.
xMAP Technology 100 IS S Users Manual Version 2.1 Home Tab The home tab appears as part of the main screen and contains a favorites section as well as five categories representing different phases of data acquisition, including daily startup, instrument calibration, batch setup, reports and analysis, and daily shutdown. Figure 47. Home Tab Favorites Section 7 - 10 The Favorites section contains a list in which you can add frequently-used templates and commands for easy access.
xMAP Technology Software Tour The templates and commands appear in alphabetical order for easy locating. Figure 48. Favorites Section Add Templates To Favorites To add templates to the favorites section: 1. Click the Add Template button from the favorites section. An Open Template dialog box appears. 2. Select the template that you want to add to your favorites section. 3. Click Open. The template name that you selected appears on the Favorites section list. PN 89-00002-00-070 Rev.
xMAP Technology 100 IS S Users Manual Version 2.1 Add Commands to Favorites To add commands to the favorites section: 1. Click the Add Command button from the favorites section. A Command List appears. Figure 49. Command List Dialog Box 2. Select the command that you want to add to your favorites list. Note: Ensure that the location you select is compatible with the volume intended for that location. The location’s capacity may vary depending on the microtiter plate sizes used. 3.
xMAP Technology Remove Items From Favorites Software Tour To remove items from the favorites section: 1. Select the item you want to remove from the favorites list. 2. Click Remove. The item disappears from the favorites list. Data Acquisition Categories The main screen contains categories representing different phases of data acquisition. Each category consists of a group of command buttons associated with typical phases of data acquisition.
xMAP Technology 100 IS S Users Manual Version 2.1 Run Batch Tab The Run Batch tab contains an information area for batch statistics, a microtiter plate image, plate command buttons, and XYP command buttons and settings. 1 2 1. Reservoir 2. Pressure Range Figure 51. Run Batch Tab Microtiter Plate The Run Batch tab shows an image representing the microtiter plate where you place samples.
xMAP Technology Software Tour Reservoir The reservoir holds fluids used in system maintenance operations such as washing, draining, or sanitizing. You can find the reservoir at the top right of the XYP plate holder. The vertical rectangle to the right of the microtiter plate represents the reservoir on the run batch tab of the IS software screen. Temperature and Pressure Gauges Proper temperature and sheath pressure are essential to optimal system performance.
100 IS S Users Manual Version 2.1 Set the XYP Instrument Heater Temperature Note: The heating function is not intended for use with standard 96-well microtiter plates. xMAP Technology Refer to your assay kit instructions to see if the assay needs to be analyzed at a particular temperature. If the instructions indicate that the XYP instrument heater is needed, you must manually set the heater to the specified heat setting. Use the heater only with the XYP instrument heater block in place.
xMAP Technology Software Tour command list also tells you whether the command completed successfully or if it failed. Figure 54. Command List Section on the Run Batch Tab An example of a failed command in the command list on the Run Batch tab follows below: Figure 55. Command Failure Notation In Command List PN 89-00002-00-070 Rev.
xMAP Technology 100 IS S Users Manual Version 2.1 Maintenance Tab The maintenance tab lets you perform several maintenance operations, XYP commands, and calibration and verification commands as you feel appropriate during system use. Figure 56. Maintenance Tab As-Needed Maintenance Operations Note: The Sanitize command performs a similar function to the alcohol flush command. However, the sanitize command uses 10% household bleach to decontaminate sample lines and the cuvette after biohazard contact.
xMAP Technology Software Tour Table 3.
xMAP Technology 100 IS S Users Manual Version 2.1 Table 3. Maintenance Operations: Recommended Use Schedule (Continued) Maintenance Operation Recommended Use Schedule Soak • • daily, at the end of the day for shutdown to prevent salt crystals from forming in the probe due to exposure to air. Soaking the probe replaces sheath fluid in the probe with water. The system uses at least 250 µL of distilled water.
xMAP Technology Prime the System Software Tour Prime the system as necessary to remove air from the system’s fluidic pathways after: • • • • refilling the sheath container removing and replacing the sheath container changing the sheath fluid filter changing the syringe seal When priming, sheath fluid from the sheath fluid container is used. You do not need to supply solution in a plate. Priming takes approximately one minute. To prime the system: 1. Click Prime.
100 IS S Users Manual Version 2.1 Alcohol Flush the System xMAP Technology Alcohol flush the system to remove air bubbles from the cuvette using 70% isopropanol. The cuvette is the principal fluid pathway within the optics component of the system through which the system reads sample. The alcohol flush takes about six minutes. To remove air bubbles from the cuvette, follow this step: 1. Click Alcohol Flush.
xMAP Technology Wash the System Software Tour Use the wash cycle as needed using sheath fluid. For example, wash with sheath fluid after calibration. Place at least 200 µL in a microtiter well or fill the XYP instrument reservoir with the sheath fluid. Washing takes about 30 seconds. Luminex recommends that you wash after calibration, verification using controls, between batches and multi-batches, and daily shutdown To wash the system: 1. Click Wash.
xMAP Technology 100 IS S Users Manual Version 2.1 Drain the System The cuvette in the system can be drained temporarily and refilled in preparation for running. Draining the system helps to remove debris from the bottom of the cuvette. We do not recommend routinely draining the cuvette. Use Drain only for troubleshooting purposes. When draining, you do not need to supply solution. Draining takes approximately two minutes and should be followed by an alcohol flush with 70% isopropanol.
xMAP Technology Software Tour To soak the probe: 1. Click Soak. A confirmation dialog box appears. Figure 58. Confirmation Screen Dialog Box 2. Click the drop-down arrow to the right of the Eject/Retract button. An image of the microtiter plate and reservoir appears in the plate holder. Note: The system may show a Figure 59. Microtiter Plate Image For Location Selection default location from which to draw fluid. In this case, the microtiter plate shows that well with a yellow line inside the well.
xMAP Technology 100 IS S Users Manual Version 2.1 Run Self Diagnostics Run self diagnostics to see if the device and all system operations are running correctly. The system tests these functions when running self diagnostics: • • • • • • • • • • • Flash memory test Microcontroller RAM test Nonvolatile memory test DSP program CRC test DSP capture test High voltage module Channel backgrounds test Pressurization test Actuator test Syringe pump test Backflush valve test To run self diagnostics: 1.
xMAP Technology View Failed SelfDiagnostic Details Software Tour To view details regarding which of the self-diagnostics tests passed or failed: 1. Select the Diagnostics tab and view the message log. At least one error from a failed self-diagnostics test appears with a yellow background. 2. Double click the yellow row for which you want to see a more detailed description. An Errors dialog box appears showing a list of passed and failed self-diagnostic tests. 3. Click OK to close the dialog box.
100 IS S Users Manual Version 2.1 xMAP Technology 1. Click New CAL Targ. from the Maintenance tab. An Update Cal Targets dialog box appears. Figure 60. Update Calibration Targets Dialog Box Note: Ensure that the correct target values are added for each parameter before clicking OK. If necessary, re-enter the information to correct any incorrect information.
xMAP Technology Enter System Control Targets Software Tour To enter new and changed control targets: 1. Click New CON Targ. from the Maintenance tab. An Update CON Targets dialog box appears. Figure 61. Update Control Targets Dialog Box Note: Ensure that the correct target values are added for each parameter before clicking OK. If necessary, re-enter the information to correct any incorrect information. PN 89-00002-00-070 Rev. A 2.
xMAP Technology 100 IS S Users Manual Version 2.1 Eject and Retract the XYP Instrument Plate Holder To eject the XYP instrument plate holder: 1. Click Eject/Retract from the toolbar on the Maintenance tab. The XYP instrument plate holder ejects. 2. Click Eject/Retract. The XYP instrument plate holder retracts. Lower and Raise the Sample Probe Lower the Sample Probe when you are adjusting the Sample Arm, adjusting the Sample Probe height when using different plates, or as necessary.
xMAP Technology Software Tour These tools help you find information about the system and what happens during sample acquisition, data reduction, and other functions. For instance, if you return to the system to run an operation after taking a break, you can look at the Diagnostics tab at the system monitor to verify if you need to recalibrate. System Monitor The system monitor provides information on the status of the system and various components within the system. Figure 63.
xMAP Technology 100 IS S Users Manual Version 2.1 The system monitor provides values and units of measure for each property.
xMAP Technology Software Tour and commands that the system has performed as well as each operation’s progress, time and date, and results. Figure 65. Message Log You also see a message in the log if multiple microtiter plates have been used during a batch. The log also displays actions in color-coded text and shading. Items in the message log appear in the following color code: • • • • Green text represents a successful system calibration, verification command, an acquisition, or maintenance functions.
xMAP Technology 100 IS S Users Manual Version 2.1 click that row. An error dialog box appears with details about that error. Batches A batch is a group of samples that will be processed using a single template. Batches consist of templates, lots, and samples for acquisition and can span more than one plate. Templates are provided by the assay kit manufacturer via CD ROM or floppy disk. When creating a new batch, you must use a template.
xMAP Technology Software Tour Figure 66. Import Template Dialog Box 3. Select your floppy disk drive as the Look in location. 4. The kit manufacturer’s template appears on the selection list. Click the name of the template. 5. Click Open. The template is now loaded and available for use. You can import templates from other areas within your computer such as another drive or a CD ROM. To select a different location using the Look in drop down box, click the drop down arrow.
xMAP Technology 100 IS S Users Manual Version 2.1 Note: Depending on the types of products associated with the template you select, the screen may vary from this example 2. Select the template in which you want to apply the new lot and click Open. The system applies the lot you are creating to the template. An Update Lot Information dialog box appears. Figure 68. Update Lot Information Dialog Box 3. Click New Lot. A New Lot dialog box appears, prompting you to enter the new lot’s number. Figure 69.
xMAP Technology Update Lot Information Software Tour To update information to an existing lot: 1. Click New Lot from the Home tab. An Open Template dialog box appears. Figure 70. Open Template To Update Existing Lots 2. Select the template to which you want to apply the new lot and click Open. The system applies the lot to the template you select. An Update Lot Information dialog box appears. Figure 71. Update Lot Information Dialog Box 3.
xMAP Technology 100 IS S Users Manual Version 2.1 Import Lots To Existing Templates You may need to import a lot from another computer or from a diskette or CD ROM when you are adding or updating lots to be associated with a template. To import lots to an existing template: 1. Click New Lot from the Home tab. An Open Template dialog box appears. 2. Select the template to which you want to associate the imported lot and click Open. An Update Lot Information dialog box appears. Figure 72.
xMAP Technology Software Tour 3. Click Export Lot. A Lot Exported dialog box appears confirming the location to which the system exported and saved the lot. Batch Commands Create a New Batch Batches can include more than one plate. When all of the wells on the first microtiter plate have been tested, the system pauses and prompts you to insert the next plate. See “Process a Multi-Batch” on page 7-46 if you are running more than one template and more than one batch. To create a batch: 1.
100 IS S Users Manual Version 2.1 xMAP Technology Figure 74. Luminex Batch Setup Dialog Box 4. Enter the batch name (if different from the system default name provided), a description (optional), and the creator name. 5. If you want to add samples for processing in addition to the template commands in the batch you are creating, scroll down to the last item on the command list section (to the left of the Finish, Cancel, Load Patient List, and Help buttons).
xMAP Technology Software Tour Figure 75. Entering Additional Samples 7. Enter the sample ID for the sample you want to add to the batch. Repeat this step as many times as it takes to add all of the additional samples to the batch. 8. If you want to add a patient file to the batch, click Load Patient List. An Open Patient List File dialog box appears. Figure 76. Open Patient List File Dialog Box If you do not want to add a patient list to the batch, see step 11. 9.
xMAP Technology 100 IS S Users Manual Version 2.1 patient ID in the list to the unassigned sample acquisition command. The system appends any remaining patient IDs to the end of the command list in order as they appear in the patient list. If all patient IDs in the batch or multi-batch are identified, the system appends the patient list items to the first empty location after the batch’s or multi-batch’s last command list activity.
xMAP Technology Delete a Batch Software Tour The system allows you to delete batches that have not been processed. Make sure that the batch that you want to delete is the batch that you selected. Once you have deleted a batch, you cannot recover it. To delete an unprocessed batch: 1. Click File. 2. Click Delete Batch. A dialog box appears listing only the batches in the database that have never been processed. 3. Select the unprocessed batch that you want to delete. 4. Click Open.
100 IS S Users Manual Version 2.1 xMAP Technology Figure 77. Luminex Multi-Batch Setup Dialog Box 2. If you want to add an existing batch to the multi-batch, click Add Batch. 3. Select the batch you want to process first in the multi-batch and click Open. The batch appears beginning in well A1 of the microtiter plate on the Luminex Multi-Batch Setup dialog box. A thick red line appears above well A1 and another thick red line below the last well in the batch.
xMAP Technology Software Tour 6. Select the template that you want to use in your new batch. 7. Click the Open button. The setup adds the data from your selected batch to the microtiter plate. Repeat this process to add additional existing batches. Go to step 5 to create a new batch or go to step 15 to finish processing the multi-batch. 8. If you do not want to add a patient list to the current batch, continue to step 10.
xMAP Technology 100 IS S Users Manual Version 2.1 16. Select a starting location on the microtiter plate if necessary. 17. Enter the patient accession numbers (or sample IDs) and dilution factors for samples with dilution factors other than 1. See “Assign Dilution Factors to Samples” on page 7-52 for more information. 18. Click the New Lot button as needed. 19. Click Save and Load to save the multi-batch and load it for immediate processing, or click Save only to save the multi-batch for later use. 20.
xMAP Technology Software Tour plate appears on the screen to make room for additional samples. The new plate appears to the immediate right of the existing plate image on the screen with a dark line between the adjacent columns of the two plates. Figure 78. Processing Multiple Plates Note: You may need to scroll to the right of the screen to see the additional plate(s). The samples on the next plate use the same template that the samples in the first plate use.
xMAP Technology 100 IS S Users Manual Version 2.1 Figure 79. New Plate Added 2. Open the batch, as necessary. 3. Load the first plate for the batch. 4. Click Start Plate to begin processing the batch. When the initial plate is through, the system pauses and displays a message in the acquisition area prompting you to insert the new microtiter plate. 1 2 1. Insert New Plate Prompt 2. Resume Button Figure 80. Insert Next Plate Warning 5. Load the next plate for the batch.
xMAP Technology Software Tour 6. Click Resume. The system resumes the acquisition process. Scan in New Samples with the Barcode Reader The barcode reader lets you quickly enter the sample identification numbers, or accession numbers. The barcode reader is particularly useful when you have many samples to enter into the system. See “Bar Code Labels” on page 5-7 to find the acceptable types of bar code labels. Warning: Laser light. Do not stare into the beam. Class II laser product.
xMAP Technology 100 IS S Users Manual Version 2.1 • • any other comma delimited values in the same line will be ignored (for example, in text x, y, z; the parameter z will be ignored) if the dilution factor is omitted, a default value of one will be assumed An example of a typical patient list file follows below: LX100IS Patient List [Accession#, Dilution Factor] a001,1 a002,2 a003,1 b001,4 b002,0.6 c917,4 cee4gf,1 To add a patient list text file to a batch or multi-batch: 1.
xMAP Technology Software Tour 3. Click Load Patient List. An Open Patient List File dialog box appears. Figure 83. Open Patient List File Dialog Box 4. Select a patient list text file to append to the batch and click Open. The patients from that patient list append to the latest batch. The rest of the list appends to the last well occupied with a command.
xMAP Technology 100 IS S Users Manual Version 2.1 Establish Where to Begin Acquiring Data When you are creating a batch or multi-batch, the system lets you establish where you want to begin acquiring samples, if in a location other the first available empty microtiter well. Once you have loaded a batch for processing, you cannot change the location where you will begin acquiring data. To establish where on the microtiter plate to begin acquiring data during batch or multi-batch creation: 1.
xMAP Technology Software Tour 2. Select the template that uses the product for which you are assigning a dilution factor and click Open. A Luminex Batch Setup dialog box appears. 3. Scroll down the template command list to the item that uses the dilution factor that you are changing. 4. Click the Dilution Factor field, which is white to indicate that you can enter text into the field. 5. Enter the dilution factor used if the factor is other than 1. Enter each dilution factor as a decimal, not as a ratio.
xMAP Technology 100 IS S Users Manual Version 2.1 well for failed acquisitions. Samples may fail analysis for many reasons, including lack of sufficient events, cancel command, heater out of range, or plate cancellation. The system automatically analyzes samples according to the kit manufacturer’s template commands. Once you start processing a batch, you cannot use it to reacquire data. If you click the Open Batch button and then hit the cancel button, the system defaults to the last open batch.
xMAP Technology Software Tour Selecting Cancel All stops batch acquisition, and you will be able to process it again. Therefore, be very sure that you want to cancel the current batch, multi-batch, command series, or operation. To cancel an acquisition once it has begun: 1. Click Cancel All on the main screen. The current series of commands or batches clear from the system. Upon cancelling, the system stops its activity regardless of its status.
100 IS S Users Manual Version 2.1 xMAP Technology To analyze data from processed batches and multi-batches: 1. Click Analysis from the home tab. An Open Batch dialog box appears showing only processed batches so that you cannot inadvertently open an unprocessed batch. 2. Select a batch or multi-batch to analyze and click Open. The system loads the batch or multi-batch that you selected, and a Data Reduction dialog box appears. Figure 84.
xMAP Technology Software Tour Use the F2 key to select the next test or the F3 key to select the previous test in the batch or multi-batch. You may also click on the test name in the left grid control. PN 89-00002-00-070 Rev.
xMAP Technology 100 IS S Users Manual Version 2.1 Errors Tab View Detailed Error Information The Errors tab shows a list of errors that occurred during acquisition. To view details about errors: 1. Click the Errors (F9) tab, if necessary. Figure 85. Data Reduction Dialog Box: Errors Tab 2. Click OK to close the errors tab.
xMAP Technology Software Tour There are six function keys on the standards tab: • • • • • • F2 - Next Test F3 - Previous Test F4 - Invalidate Standard F5 - Validate Standard F6 - Invalidate Control F7 - Validate Control You might need to invalidate a standard if one of the standards to create your standard curve or high and low limits skews your expected results. You can also invalidate a control. However, Luminex does not recommend invalidating your controls.
xMAP Technology 100 IS S Users Manual Version 2.1 Perform Batch Data Reduction Note: Data reduction does not apply to batches using maintenance templates since maintenance templates do not include assay standards. Do not attempt to use the data reduction command with maintenance templates. To perform batch data reduction: 1. Click the Data Reduction button from the File menu. A list of available batches appears from which you may choose a batch to open. 2. Select the batch you want to analyze.
xMAP Technology Software Tour Calibration Trend Report. This report provides information about all calibration operations that occurred during the date range entered by the operator. System Control Trend Report. This report provides information about all verification operations that were performed during the date range entered by the operator. You must enter information about the batch for which you want to print a report.
100 IS S Users Manual Version 2.1 xMAP Technology Figure 88. Batch Selection Dialog Box 3. Enter the information (for example, a patient report) and click Next. Another information dialog box appears where you need to enter the information specific to the type of report the system is compiling. Figure 89. Patient Selection Dialog Box 4. Select the patient about which you want to compile the report. 5. Click the Finish button. A report appears using the information you entered.
xMAP Technology Software Tour Figure 90. Report Print Preview Dialog Box 6. Click Next until you get to the Finish button. 7. Click the Print button on the toolbar. Export Data To export batch data: 1. Click the Export Data button on the toolbar. This dialog box appears. Figure 91. Open Batch Dialog Box 2. Select a batch from which to export data. 3. Click the Open button. The system exports the information. A dialog box appears to show the name and location of the exported data file.
xMAP Technology 100 IS S Users Manual Version 2.1 Figure 92. Batch Data Exported Dialog Box 4. Click the OK button. Database Management You can manage the database by backing up and deleting saved data and files. The system can store data results for instrument calibrators, instrument controls, assay calibrators, and assay controls. It records acquisition and maintenance data in real-time to minimize data loss in case of system failure.
xMAP Technology Software Tour When the database is 98% full, sample acquisition is prevented. System calibration and control information is not affected when you erase sample information. To erase information from the database: 1. Click Tools on the main menu. 2. Select Erase Database. A control appears to the right of the menu command where you can select the range of information to delete. 3. Click the down arrow button to select the number of days for which you want to keep.
xMAP Technology 100 IS S Users Manual Version 2.1 Edit Menu Copy Information From Your Batch Information from batches may be copied into other documents or batches. The edit menu serves this purpose. It lets you copy and paste data from your batch. To copy information from the current batch: 1. Select the information or area of information you want to copy. 2. Right-click on the information with your mouse and drag to Copy. The system copies the information to the PC’s clipboard.
xMAP Technology Software Tour To clear the message log: 1. Right-click the information with your mouse and drag to Clear. A dialog box prompts you to see if you are sure. Figure 94. Clear Screen Verification Dialog Box 2. Click Yes. The batch clears from the screen. Help Menu Open System Help To open the system online help: 1. Click the Open Help File button on the toolbar. A help dialog box appears. 2. Scroll through the online help information to find the topic for which you are searching.
xMAP Technology 100 IS S Users Manual Version 2.1 Figure 95. About Device Dialog Box 3. Click the OK button to close the box. Display About the IS Software Information To display information about the system software: 1. Click the Help menu. 2. Click About IS. A dialog box appears that lists information about the system software, such as the system version and build numbers, a description of the system, and the system copyright information. 7 - 68 PN 89-00002-00-070 Rev.
xMAP Technology Software Tour Figure 96. About IS Software Dialog Box 3. Click the OK button. Shut Down the Luminex 100 Analyzer Luminex recommends sanitizing with 10% household bleach as part of your daily shutdown routine after biohazard contact. Sanitizing uses the XYP instrument reservoir location because only the reservoir can accommodate the amount of fluid necessary to sanitize the instrument.
100 IS S Users Manual Version 2.1 xMAP Technology 5. Click Soak to fill the Sample Probe and sample lines with distilled water to prevent sheath fluid crystals from forming in the sample lines. A confirmation dialog box appears. Figure 97. Confirmation Screen Dialog Box 6. Click the drop-down arrow to the right of the Eject/Retract button. An image of the microtiter plate and reservoir appears in the plate holder. Note: The system may show a default location from which to draw fluid.
xMAP Technology Exit the Luminex 100 IS Software Software Tour If you try to exit the system for any reason, a dialog box prompts you to see if you really want to exit the system. To exit the system: 1. From the file menu, select Exit. An Exit dialog box appears prompting to make sure you want to exit the system. Figure 99. Exit System Verification Dialog Box 2. Click Yes. The IS 2.1 software closes. PN 89-00002-00-070 Rev.
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8 Maintenance and Cleaning Proper maintenance and cleaning of the Luminex 100 IS is required Read and follow all instructions in this section. For your convenience, a maintenance log form is included at the end of this chapter. Do not remove the system cover under any circumstances! Warning: When analyzing potentially infectious biological samples on the instrument, follow standard laboratory safety practices. These safety precautions should also be taken when cleaning or maintaining the instrument.
xMAP Technology 100 IS User Manual Version 2.1 After Running Samples After running samples, follow these steps: 1. Note: If you turn off the instrument, you will need to recalibrate the system upon turning it on again. Sanitize with a 10% household bleach solution. 2. Soak with filtered water. Wait until the soak completes. 3. Release pressure by loosening the sheath fluid container cap. 4. If desired, turn off the instrument.
xMAP Technology Maintenance and Cleaning 2. Wipe all exterior surfaces with mild detergent, followed by a 10% bleach solution. 3. Open both doors of the system and clean all accessible surfaces with detergent followed by a 10% bleach solution. 4. Dry the sheet metal surfaces to prevent corrosion. 5. Plug in and power on the Luminex 100 analyzer and XYP instruments. 6. Calibrate the system.
xMAP Technology 100 IS User Manual Version 2.1 Figure 100. Grasping the Tubing 4. Remove the filter with one hand, and hold the tubing with the other hand. 5. Connect a new filter to the tubing and position the filter inside the panel. 6. Reattach the panel door to the unit. 7. Plug in and power on the Luminex 100 analyzer. XYP Instrument Air Intake Filter To replace the air intake filter: 1.
xMAP Technology Maintenance and Cleaning Figure 101. Removing the Screen 3. Replace the filter and replace the screen. Figure 102. Removing and Replacing the Filter 4. Plug in and power the XYP instrument. PN 89-00002-00-070 Rev.
xMAP Technology 100 IS User Manual Version 2.1 Syringe Seal Warning: Turn the unit OFF and unplug the power cord before replacing the syringe plunger! The syringe arm does not deactivate when changing the plunger; injury could result if the system is not unplugged. To replace the syringe plunger seal: 1. Open the center-most door on the front of the analyzer. 2. Locate the syringe (a glass cylinder with a metal rod). Syringe seal Syringe Figure 103. Syringe and Syringe Seal 3.
xMAP Technology Maintenance and Cleaning 10. Hand-tighten the screw on the syringe arm. 11. Plug in the power cord and turn the analyzer on. 12. Prime the system twice, watching for any leaks in the syringe area. 13. When the prime finishes, close the center door. Luminex 100 Analyzer Ventilation Filter Clean the filter only when soiled. To check the Luminex 100 analyzer ventilation filter, follow these steps: 1.
xMAP Technology 100 IS User Manual Version 2.1 Annually Sheath Filter To change the sheath filter within the analyzer: 1. Disconnect the Luminex 100 analyzer from ac power by turning off the power switch on the rear of the Luminex 100 analyzer, then unplugging the instrument power cord from the wall source. 2. Disconnect the sheath fluid bottle before changing the filter. 3. Open the left door of the Luminex 100 analyzer and disconnect the filter by pushing down on the metal clamps on each connection.
xMAP Technology Maintenance and Cleaning As Required Sheath and Waste Fluids Replace the sheath fluid and empty the waste container as required. You must manually monitor sheath fluid and waste container levels. The system warns you when you need to refill the sheath fluid container. The system shows this warning when it runs out of sheath fluid. Refill Sheath warning Figure 106. Refill Sheath Fluid Warning Refill the Sheath Fluid Container To refill the sheath fluid container: 1.
xMAP Technology 100 IS User Manual Version 2.1 If the sheath container ever runs dry, prime the system at least twice until the air is removed from the system. Fuses To replace the fuses in the Luminex 100 analyzer or the XYP instrument: 1. Turn off the power switch on the rear of the instrument, then unplug the instrument power cord from the wall source and remove the power cord from the instrument. 2.
xMAP Technology Maintenance and Cleaning Sample Arm Vertical Height The vertical height determines how far the XYP instrument Sample Probe goes into the microtiter well when aspirating a sample. It is set when the instrument is shipped. If you need to adjust the vertical height, see the “Adjust the Sample Probe Vertical Height” on page 410. Accessories Refer to the instructions that came with your Luminex 100 IS accessory for maintenance and cleaning information. PN 89-00002-00-070 Rev.
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Luminex 100 IS Maintenance Log Month(s): ________________________________________Year:_______________ Maintenance Log Procedure: To use this log, fill in the month(s) and year above. This form is designed to record information for four weeks. Fill in the dates for which this log will be used in the first line of the table below. For each item listed at the left, fill in your initials under each date that you perform the item.
9 Troubleshooting Troubleshooting the Luminex 100 IS Customer support is available to users in the U.S. and Canada by calling 1-877-785-BEAD (-2323) between the hours of 7:00 a.m. and 7:00 p.m. Central Time, Monday through Friday. Users outside of the U.S. and Canada can call us at +1 512-381-4397 between the hours of 7:00 a.m. and 7:00 p.m. Central Time, Monday through Friday. Inquiries may also be sent by email to support@luminexcorp.com.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Verify the System With System Controls To verify your system: 1. Vortex xMAP reagent containers to ensure homogeneity. 2. Load a microtiter plate with CON1, CON2, and sheath fluid in the designated wells. 3. Click Eject/Retract. The plate holder ejects. 4. Place the plate on the plate holder. 5. Fill the XYP instrument reservoir with a solution of 70% isopropanol. 6. Click Eject/Retract. The plate holder retracts. 7.
xMAP Technology Luminex 100 Analyzer Fails Calibration Troubleshooting Perform the following items in the order they appear. If you find that your problem is solved before getting too the last item, you do not need to perform the rest of the items. • • • • • • • • • Luminex 100 Analyzer Fails System Controls • • • • • • • • • PN 89-00002-00-070 Rev. A View the calibration trend report. Check for any dramatic changes in temperature, sheath pressure, or voltages.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Failure During SelfDiagnostics Tests If the self diagnostics routine fails, the Diagnostics tab will show a red error message with the description: The Luminex 100 analyzer reported a failed self-diagnostics test. The background to this message will be yellow if the routine failed. Double click the yellow row to display a detailed device error window. This window shows specific details about which test failed the routine.
xMAP Technology System Error Messages Troubleshooting The following error messages can be displayed in the message log on the Diagnostics tab, in a message log located in the windows directory or in the Errors tab located within the Analysis command. Unknown Diagnostic Error • • APD Temperature Range Exceeded Select the Diagnostics tab to perform these tasks: • • XYP Instrument Heater Stability Range Exceeded • • Record the error code number and message. Contact Luminex Customer Support.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Low Laser Power Detected • • • • Command Encountered Time Out Error System Error States Disconnected • Warm up the system. This takes approximately 30 minutes. Calibrate and verify the system. Open the calibration trend report for L100-CAL2 and record the last three reporter voltages. Contact Luminex Customer Support with this information. Calibrate and verify the system daily before use.
xMAP Technology Insufficient Bead Count Troubleshooting • • • • • • • • • • • • • Temperature Divergence from Calibration Temperature • • Do not select Cancel during sample acquisition. Selecting the Cancel function while a sample is acquiring causes an error message to occur. Ensure that you selected the correct template. If applicable, see if all of the tests (beads) were added to the samples. See if the samples were properly mixed before they were dispensed into the wells.
xMAP Technology Luminex 100 IS User Manual Version 2.1 • • • Sample High/Low This message occurs if the sample results do not fall within the highest and lowest standards. • • • • • Failed Standard in Batch • • • • • • • • • • • 9-8 Ensure that you selected the correct template. Ensure that the correct standard lot number and target values were selected and entered correctly. Verify that the system is functioning properly by running the system controls.
xMAP Technology Sample Empty Detected Troubleshooting This error message occurs when the system completely acquires the entire sample volume. • • • • • • • • • Unknown Formula Failure • • See if the samples were properly mixed before they were dispensed into the wells. See if you loaded the sample to the correct well on the plate. Check if the sample volume added to the well is correct. Remove and sonicate or flush the XYP instrument Sample Probe to remove possible clogs.
xMAP Technology Luminex 100 IS User Manual Version 2.1 • • • Progress Bar Indicates No Events Being Collected During Calibration or Verification • • • • • • • • • • • • Complete the following analyzer functions from the Maintenance tab: Drain, Backflush, and Alcohol Flush. Empty the waste container. Prime the system and check if sheath fluid is dripping into the waste container. Contact Luminex Customer Support with this information.
xMAP Technology Troubleshooting Heater Block Will Not Reach Desired Temperature • Ensure that the XYP instrument door is completely closed. There Is a Grinding Noise When the Plate Carrier Moves • Ensure that the red shipping pin is removed from the XYP instrument. Ensure that the alignment guide is installed correctly. Software Installation • The Luminex 100 IS arrives preloaded with the IS 2.1 software. However, rare circumstances may require software reinstallation.
Luminex 100 IS User Manual Version 2.1 9 - 12 xMAP Technology PN 89-00002-00-070 Rev.
10 Product Numbers Hardware PN 89-00002-00-070 Rev.
xMAP Technology Luminex 100 IS User Manual Version 2.
xMAP Technology Product Numbers Software Luminex 100 IS software CD CN-SW05-01 xMAP Reagents Microspheres, LX100, CL1 CL2 Calibration (xMAP Classification Calibrator) L100-CAL1 Microspheres, LX100, RP1 Calibration (xMAP Reporter Calibrator) L100-CAL2 Microspheres, LX100, CL1 CL2 Control (xMAP Classification Control) L100-CON1 Microspheres, LX100, RP1 Control (xMAP Reporter Control L100-CON2 Sheath Fluid, LX100 40-50000 Luminex 100 IS Training Call for details Training PN 89-00002-00-070 Rev
Luminex 100 IS User Manual Version 2.1 10 - 4 xMAP Technology PN 89-00002-00-070 Rev.
11 Glossary ambient temperature The temperature of the surrounding environment. analyte A substance that is detected through assay analysis. Each test or unique microsphere type will test for a specific analyte. analyzer This term is used in the documentation to refer to the Luminex 100 IS instrument.
xMAP Technology Luminex 100 IS User Manual Version 2.1 CL2 Refers to dyes embedded in the microsphere. Also see classification channel. classification channel A specific range of wavelengths in which light intensity is measured. Includes the emission of a given classification dye. Classification channels are abbreviated as CL1 and CL2. control, assay Used to verify standards within the kit. Tells you that the curve or thresholds are correct.
xMAP Technology Glossary laser Light Amplification by Stimulated Emission of Radiation (laser). This highly purified source of light is an efficient way to excite fluorochrome electrons. microparticle A solid substance with a diameter in the micrometer range. Often used as a synonym for a microsphere. microspheres Polystyrene spheres with a diameter in the micrometer range. Also called beads. multi-analyte Several assays or tests performed simultaneously in the same reaction container.
Luminex 100 IS User Manual Version 2.1 xMAP Technology sample reaction The reaction that occurs between your reagents and the beads. signal Detectable measurement unit of the reporter molecule. suspension Solution consisting of homogeneously dispersed microspheres in an aqueous medium. system controls Include the reporter and classification control microspheres. They are used to verify the calibration of the analyzer.
A Luminex Sheath Delivery System Intended Use The Luminex SD™ (sheath delivery) system is designed as an accessory for use with a UL-listed Luminex 100 analyzer. With the SD system, you can run samples continuously without needing to refill sheath bottles. The SD system 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.
xMAP Technology Luminex 100 IS User Manual Version 2.1 • • • • • • Waste line tubing (orange fitting) Sheath fluid line (blue fitting) Air line (green fitting) Sheath fluid intake line (white fitting) Power cord Screwdriver Figure 96. Sheath Delivery System Device Installation To install the SD system: 1. Start with the original Luminex sheath fluid and waste containers connected to the Luminex 100 analyzer. Check that the sheath fluid container is filled to just below the air intake valve. 2.
xMAP Technology 3. Calibrate your system according to the instruction in the “System Calibration” chapter. 4. From the Home tab, select Prime after the pressure has stabilized. Record the maximum air and sheath pressure, as displayed in the Luminex System Monitor window on the Diagnostic tab. Air pressure: _______ psi. Sheath Pressure: _______ psi. Save this information.
xMAP Technology Luminex 100 IS User Manual Version 2.1 8. Lower the stainless steel filter end of the sheath fluid line to the bottom of a full box of sheath fluid. Secure the cap on the sheath fluid box. Be sure to place the sheath fluid container so that the cap is on the top. 9. Turn on the power to the SD system device. It automatically primes itself and you hear the system pump turn on. When the SD system device reservoir is about 3/4 full it automatically stops priming. 10.
xMAP Technology 12. Calibrate your system again and run the system controls. Check the calibration trend report. Compare voltages between this calibration and the calibration you did at the beginning of installation. If corresponding voltages are within 10% of each other, installation was successful and you can begin using your Luminex SD. If you see variation of more than 10%, contact Luminex Customer Support for assistance.
xMAP Technology Luminex 100 IS User Manual Version 2.1 Regularly, as required. Replace the sheath fluid as required. Weekly. Visually inspect the SD system device and its connections for leaks. If you see a leak, turn off the power to the SD system device and contact Luminex Corporation. Monthly. Turn off the power to the SD system device. Clean the exterior surfaces by wiping with mild germicidal detergent, followed by a 10% bleach solution.
xMAP Technology This reverses the sheath flow and allows the reservoir to drain slowly and completely. SD system device is empty or does not fill. • • • • • • • • Verify that the SD system device is on a level surface and at the same height as the Luminex 100 analyzer. Verify that the system is turned on and connected to a power supply. Verify that the sheath, air, and waste tubings are correctly connected to the Luminex 100 analyzer. Press the Prime button on the front of the SD system device.
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Index Symbols 4 A about device 67 about IS 68 software 68 access doors 7 accessories 11 see accessory instructions 11 see user manual 11 accuracy and precision specifications 4 acquisition area 3 add new lot button 46 add sheath fluid 9 additional equipment 7 bar code labels 7 uninterruptible power supply (UPS) 7 vortex 7 additional equipment, uninterruptible power supply (UPS) 7 additional software 3 adjust Sample Probe, vertical height 10 adjust Sample Probe 10 adjust vertical height 10, 2, 11 after runni
Luminex 100 IS User Manual Version 2.
xMAP Technology connect 3 barcode reader 4 keyboard 4 mouse 4 PC 4 connect Luminex 100 instrument 1 connect the XYP instrument 1 connectors air, waste, and sheath fluid 13 contact email 2 contact information 1 continue interrupted acquisition 54 controls 1 copy information from batch 66 create new batch, more than 1 plate 34 create a calibration trend report 5, 6 create a new session 34 create multiple batches 43 create new multi-batch run 43 create new multi-batch run button 43 create new session button t
Luminex 100 IS User Manual Version 2.
xMAP Technology problem detected 12 initialize the PC 12 inquiries customer support 2 via email 2 email address 1 install the XYP instrument heater block 9 install the XYP instrument reservoir 9 install, XYP instrument Sample Probe 6 installation, SD system 2 instrument cover 5 instrument not calibrated system error message 3 instrument operation 1, 7 instrument status 8 insufficient bead count 7 integrity 2 intended use, general system 1 interrupts acquisition 54 IS software 68 IS 2.
Luminex 100 IS User Manual Version 2.
xMAP Technology problem diagnosis system calibrators 1 tools 1 procedure 12 process multiple plates 46 process multiple sessions 43 product numbers 1 product selection 5 product selection dialog box 6 progress bar indications 10 prompt insert new plate 48 protect 2 protection provided 2 protective housing 6 R radiation exposure 6 rate 1 reaction 1 reagent specifications 2 reagents 3 specifications 2 recommended additional equipment bath sonicator 7 refill sheath container 9 refill sheath warning 9 release
Luminex 100 IS User Manual Version 2.
xMAP Technology specifications, vortex 7 specified volume 53 speed specifications 3 stability 2 start a plate begins acquisition 53 start plate, begin processing 48 startup 12 start-up procedure 1 Status bar 6 status bar 3 Status communication 8 Status communication, messages 8 status of instrument 8 subsystems 7 successful acquisition 53 successful initialization 12 support 2, 1 surge suppressor protector UPS 12 symbols 1 syringe 1, 12 syringe cylinder product number 2 syringe seal maintenance 6 product n
Luminex 100 IS User Manual Version 2.
