Luminex® ISTM Software Manual For Version 2.3 For In Vitro Diagnostic Use
xLuminex IS Software Manual For Version 2.3 - For In Vitro Diagnostic Use xMAP Technology
90 Luminex IS Software Manual For Version 2.3 - For In Vitro Diagnostic Use xMAP TechnologyCL1 Refers to dyes embedded in the microsphere. Also see c
PN 89-00002-00-254 Rev. B 91xMAP Technology laserlaser Light Amplification by Stimulated Emission of Radiation (laser). This highly purified source o
92 Luminex IS Software Manual For Version 2.3 - For In Vitro Diagnostic Use xMAP Technologyquantify an analyte. Examples of acceptable reporters are
PN 89-00002-00-254 Rev. B 93Output.CSVOverview This chapter describes the file specification for the Luminex IS 2.3 Output.CSV file. Although this do
Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 94Sample2...SampleMStatNStatN Header: Sample Location, Sample Na
xMAP TechnologyPN 89-00002-00-254 Rev. B 95TemplateName, "value” (Optional) The name of the template used to create the batch. Limited to 30 c
Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 96Statistics Definitions Statistical calculations are performed f
xMAP TechnologyPN 89-00002-00-254 Rev. B 97Statistics Column DefinitionsThe blocks of statistical data are displayed such that the first row of data
Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 98Total Events The number of events that fell with in the defined
xMAP TechnologyPN 89-00002-00-254 Rev. B 99Luminex 100 IS Output.CSV file with no additional features enabled "Program","Luminex 100
PN 89-00002-00-254 Rev. B 1Luminex 2.3 SoftwareThis manual describes how to use the Luminex IS 2.3 software. It includes a glossary and information
Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 100Luminex 100 IS Output.CSV file with all additional features en
xMAP TechnologyPN 89-00002-00-254 Rev. B 101"Samples","8","Min Events","0""Results""DataType:
Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 102"3","Std l","4450.92","75&q
xMAP TechnologyPN 89-00002-00-254 Rev. B 103"1","Std s","69","75","""2","Std m"
Luminex IS Software Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technology 104"DataType:","Trimmed StdDev""Location
PN 89-00002-00-254 Rev. B Index-1Aanalysisview 74Analysis window, function keys 22assay errors 23assigning dilution factors to samples 61Bback up the
Index-2 Luminex 100 IS User Manual Version 2.3 - For In Vitro Diagnostic Use xMAP Technologyraw data 37systemdrain 84errors 23trend report 78Ttabssam
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 2.Figure 1 Luminex IS 2.3 Main WindowThere are five major pa
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 3Menu Bar The menu bar contains the following menus: File Menu, Tools Menu, and Help Me
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 4Toolbar The shortcut buttons on the toolbar can be found in o
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 5Favorites. You can use the Favorites list to create a list of often-used commands and
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 61. Microtiter plate/reservoir image 2. Temperature and Press
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 7for the DD temperature both appear at the bottom of the thermometer, and the thermomet
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 8Maintenance Tab Use the Maintenance tab to perform maintenanc
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 9Instructions for maintenance procedures begin on page 83. Table 8 on page 83 shows a r
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Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 10heater block temperature is out of range or experiencing un
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 11The Detailed Sample Progress section displays the percentage of completion for each b
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 12• Green text represents a successful system calibration, ver
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 13 Figure 11 Acquisition Detail TabThe Batch Name and Description section displays th
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 14Figure 12 Acquisition Detail Toolbar The Histogram, in the
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 15Figure 13 Set DD Gate ExampleThe Histogram contains the Show Bead menu and four but
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 16Figure 14 Dot Plot Display ExampleFour buttons appear at t
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 17Status Bar The Status Bar displays information about the Command State, Device Status
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 18The Status Bar displays status information as the software p
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 19Standby The Luminex analyzer is ready and waiting to perform a command.Yellow Connect
Standard Terms and Conditions For Use of ProductBy opening the packaging containing this product ("Product") or by using such Product in any
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 20Secondary WindowsIn addition to the main window, there are o
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 21• Control Info group box• New Lot buttonThe Batch Info group box has text boxes in wh
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 22• Errors tab—lists errors that occur during batch acquisitio
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 23Figure 16 Analysis Window - Errors Tab OpenStandards Tab The Standards tab lists al
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 24on the three tabs of the Analysis window is determined by th
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 25competitive assays are shown in Table 6. Figure 18 shows what a standard curve for a
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 26Figure 19 Competitive AssayThe standards tab displays an E
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 27The system does not flag results as normal or abnormal according to a defined range.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 28The AVG entry appears immediately after the wells being aver
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 29Commands This section describes the different commands used in the Luminex IS 2.3 sof
BUYER HEREBY GRANTS TO LUMINEX A NONEXCLUSIVE, WORLDWIDE, UNRE-STRICTED, ROYALTY-FREE, FULLY PAID-UP LICENSE, WITH THE RIGHT TO GRANT AND AUTHORIZE SU
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 30Create New Multi-Batch This command opens the Luminex Multi-
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 31Help Opens the help file. Use this command if you need instructions on using a featur
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 32Advanced Batch button, the Options dialog box opens, where y
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 33Print Batch Worklist Prints the status of each of the commands in the command list, a
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 34• DSP capture test• High voltage module• Channel backgrounds
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 35• Sequential by Region ID - the tests are sorted numerically by bead ID#. • Template
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 36Procedures This section explains how to perform functions in
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 37Setting Software Options Set up and select the system software and enter your company
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 38Figure 21 Options Dialog Box—General TabDefine CompanyInfo
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 39Define Data ExportTab InformationUse the Data Export tab to configure your export dat
End-User License Agreement (EULA) for Luminex® SoftwareThis Luminex End-User License Agreement (“EULA”) is a legal agreement between you (either an in
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 40Setting up the Favorites List To add templates to the Favor
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 41Startup ProceduresWarm Up theSystemWarm up the system to prepare the optics prior to
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 42During a backflush, the system draws sheath fluid from the s
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 43Set Luminex XYPInstrument HeaterTemperatureRefer to your assay kit instructions to se
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 44discriminator channel. Control xMAP microspheres are used to
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 456. On the Maintenance tab, click Prime. Click OK and wait for the Prime to finish (ab
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 4612. Click CAL2, then click OK. Wait until CAL2 completes. Th
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 47Figure 26 Update CON Targets Dialog Box4. Ensure that the analyzer is set to draw C
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 489. Click OK and wait until the wash completes. The device st
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 49the Backup folder (directory) found in C:\Program Files\Luminex\Luminex 100 IS\Backup
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.
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 50• Green well: with command number—sample notacquired.• Yello
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 51 Figure 27 Luminex Batch Setup Window4. Enter the batch name (if different from the
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 5210. To add a patient file to the batch, click Load Pa List.
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 53 Exporting BatchData To export Batch Data:Right-click in the Batch Data area of the
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 542. The Open Template dialog box opens. Click on the desired
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 55If you need to recover a deleted batch, select Open Incomplete Batch from the File me
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 564. To reassign the positions of the batches within the multi
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 574. Load the first microtiter plate onto the plate holder.5. Click Start Plate to retr
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 585. Click Resume. The system resumes the acquisition process.
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 59• The first line of text in the file must be “LX100IS Patient List”.• The second line
PN 89-00002-00-254 Rev. B viiLuminex 2.3 Software 1Main Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 60batch has an unassigned value, the system applies the first
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 61Figure 33 Edit Patient List Dialog BoxAssign SampleDilution FactorsIndicate the sam
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 62Figure 34 Luminex Batch Setup for Dilution4. To change the
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 63• If you have entered lot information and have used the template to set up a batch (e
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 64Figure 37 Update Lot Information Dialog Box4. Enter the ex
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 65 Figure 38 Update Lot Information Dialog Box3. Change or edit the expiration date a
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 66Import Lot to anExisting TemplateUse this procedure to impor
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 67 To export a lot from an existing template:1. On the Home tab, click New Lot. The Op
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 68You may direct the system to acquire samples in replicate re
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 69 Figure 40 Customization Dialog Box—General TabCustomization Dialog Box Buttons:OK:
viiiLuminex IS Software Manual For Version 2.3 - For In Vitro Diagnostic Use xMAP TechnologyHelp . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 70Customization dialog box tabs:• General Tab—Use this tab to
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 71Figure 42 Customization Dialog Box—Axis Tab• Font Tab—Use the Font tab to change th
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 72Graph Foreground: this is the color used for the bounding re
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 73 To modify features using the Graph Menu:Most of these menu items provide a shortcut
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 74Figure 47 Options Dialog Box—Select Auto-start Analysis2.
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 75tabs to observe the tests errors under the Errors tab and unknown results under the S
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 76 To validate or invalidate a standard or control entry usin
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 77Figure 50 Choose Lot Dialog Box—Standard Only3. To create a new lot from this dialo
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 78Batch Summary Report - prints batch information in a sample
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 79Figure 52 Batch Selection Dialog Box3. Enter the information (in this example, a pa
PN 89-00002-00-254 Rev. B ixxMAP Technology ContentsView Batch Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Warmup
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 80Figure 54 Open Batch Dialog Box—Select Batch2. Select the
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 81Figure 55 Data Interpretation Report (Print Preview)Database Management ProceduresT
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 822. Choose the file name and location of the database that yo
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 83information for CAL 1, CAL2, CON1, and CON2 reagents are correct.5. Click OK to verif
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 84Drain the Analyzer When draining, you do not need to supply
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 852. Click OK. The system processes the various self- diagnostic tests. When tests are
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 86the desired files to delete and click OK. Windows deletes th
xMAP Technology Luminex 2.3 SoftwarePN 89-00002-00-254 Rev. B 87 To sanitize the fluidics in the analyzer:1. On the Maintenance tab, click Eject/Ret
Luminex IS Software Manual for Version 2.3- For In Vitro Diagnostic Use xMAP Technology 88
PN 89-00002-00-254 Rev. B 89Glossaryagglutination The coalescing of small particles that are suspended in solution; these larger masses are then (usu
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