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Luminex 100 IS User Manual. To be used only by Scott Placke.

1. Unknown 4 B start SlumnexicoIssoRware 7w analysis Fushat 99 Q3 EAS zm Figure 5 20 Analysis Window Samples Tab Open Replicate Averaging PN 89 00002 00 071 Rev C Standard and control replicates are predefined in the template You define unknown sample replicates in batch setup indicated by replicate Sample ID The data analysis function supports replicate sampling It calculates each sample as an individual sample which is then averaged to obtain a replicate average e Standards tab displays standard and control average values e Samples tab displays sample average values Replicate averages are displayed with AVG in the Loc location column The AVG entry appears immediately after the wells being averaged or at the end of the list depending on what you select under Sort Sequentially or Alphabetically Luminex 100 IS User Manual Version 2 3 xMAP Technology If the system fails to determine the results for a replicate due to an excessive skew of one of the samples you can invalidate the out of tolerance value Use the Invalidate Standard F4 or Invalidate Control F6 buttons at the bottom of the Analysis window Be aware that this fixes standards and controls not patient sample If any of the replicate standards and or controls are invalidated the Avg results reflects the average of the remaining standard and or control replicates
2. llus B 20 Install Luminex 100 IS 2 3 Software B 20 Luminex 100 IS 2 3 Firmware Installation B 21 Firmware Upgrade Cable Configurations B 21 Luminex 100 Analyzer Firmware Upgrade B 22 Connect Cable 0 0 0 cece eee eee B 22 Upgrade Firmware B 22 Verify Successful Firmware Upgrade B 23 Update Interface Cable 0 000000 B 23 Luminex XYP Instrument Firmware Update B 24 Update Firmware 0 0 0 0c eee eee ee B 24 Verify Successful Firmware Upgrade B 24 Luminex SD System Firmware Update B 25 Update Firmware 1 0 0 0 e eee eee eee eee B 25 Verify Successful Firmware Upgrade B 25 Network Installation Advisory 00 0 e eee eee ee B 26 Prepare System for First Use 0 0 0 2 cee eee eee B 26 Installation Drawing 0 cee eee B 27 Output C SV C 1 OVERVIEW ia sse RR ee eb Ie GbR e dre par SR RN a C 1 Overall Desigti 2 40 0644 sabes ebbe ede de a C 1 Blank LINES 12 rere eom doe deo og o ae C 2 Field Definitions lllleleeeeeleleeeen C 2 Statistics Definitions 0 cece eee eee C 4 Statistics Column Definitions 0 0 00008 C 5 Luminex 100 IS OUTPUT CSV file with no additional features enabled 0 c eee eee eee C 7 Luminex 100 IS OUTPUT CSV file with all additional features enabled
3. 5 65 Managing Assay Lots 00 cece eee eee eee 5 71 Create a New Lot 0 0c c cee eee ee 5 71 Edit Lot Information on an Unused Template 5 73 Edit Lot Information on a Used Template 5 74 Import Lot to an Existing Template 5 74 Export a Lot from an Existing Template 5 75 Analyzing Batches and Multi Batches 5 76 Customize Data Analysis Settings 5 77 Enable Automatic Analysis 2 00 5 82 Analyze Processed Batch Data 5 83 View Detailed Test Analysis 00 5 83 Validating or Invalidating Standards and Controls 5 83 Change Dot ies eee RERO RADAR ER 5 85 Running Reports and Analyses 000005 5 86 Report Types 4 eee ee Re RP 5 86 Export Batch Data 0 0 eee eee eee 5 89 Print Data Analysis Report 20005 5 89 PN 89 00002 00 071 Rev C Contents Luminex 100 IS User Manual Version 2 3 xMAP Technology Database Management Procedures 5 90 Back Up the Database eese 5 90 Delete Database Entries 0 00 5 9 Restore Database Data 0 00000 eee 5 91 Maintenance Procedures 00 0 0 e ee eee eee 5 92 Drain the Analyzer 0 0 eee eee eee 5 93 Run Self Diagnostics 0 0 c eee eee eee 5 94 Using the Cleanup Utility lessen 5 94
4. 3 Std l 3985 75 A Std xI 31 76 75 5 Std xxI 1 2044 75 6 Low Control 58 75 7 Patient 1 430 75 Sample Comment for Patient 1 8 Patient 2 371 75 Sample Comment for Patient 2 DataType StdDev Location Sample Test 22 Total Events Notes 1 Std s 1593 82742065973 75 2 Std m 211 690384143302 75 3 Std I 1270 33151408429 75 4 Std xI 4104 5788483744 75 5 Std xxl 4302 66591643698 75 6 Low Control 20 9703780785363 75 7 Patient 1 155 634790802404 75 Sample Comment for Patient 1 8 Patient 2 4172 74723003512 75 Sample Comment for Patient 2 DataType Trimmed Count Location Sample Test 22 Total Events Notes PN 89 00002 00 071 Rev C xMAP Technology 1 Std s 69 75 2 Std m 69 75 3 Std I 69 75 A Std xl 69 75 5 Std xxl 69 75 6 Low Control 69 75 7 Patient 1 69 75 Sample Comment for Patient 1 8 Patient 2 69 75 Sample Comment for Patient 2 DataType Trimmed Mean Location Sample Test 22 Total Events Notes 1 Std s 56 9855072463768 75 2 Std m 494 463768115942 75 3 Std 4466 08695652174 75
5. General Bead Set Plate Layout Name ss s sS S CsisCS Description La RR Opeatr DD Gate Timeout 25 sec 0 HL 7500 to 15000 Sample size 5 Bead Events 100 regions Per Bead C Total Beads 100 OK Cancel Figure 5 35 Options Dialog Box General Tab 3 Enter the Name Description and Operator information 4 Edit the following information as desired Sample Size use values from 20 to 200 uL To avoid air uptake we recommend that your sample well contains at least 25 uL in addition to the sample size DD Gate use values within the range of 0 to 32767 Timeout use values of 0 to 400 where 0 no timeout 5 Click the arrow down next to 100 regions to select the desired bead map you want to view The available bead maps are 25 50 64 and 100 default regions Select whether you want the Bead Events results to be displayed as Per Bead or Total Beads If you select Total Beads enter the number of total beads in the text box Select Per Bead to continue analyzing until each bead set has met at least the minimum events as determined on the Bead Set tab Select Total Beads to continue analyzing until the selected beads meet total beads value Use Total Beads when you are not using all of your selected bead sets in each well Set the total to desired high value 5 66 PN 89 00002 00 071 Rev C xMAP Technology Note The leg
6. 1 10 100 1000 10000 7500 15000 Doublet Discriminator p 1 Gate Boundaries 2 Aggregate Beads 3 Numerical Gate Position Figure 5 13 Set DD Gate Example The Histogram contains the Show Bead menu and four buttons Autoscale Zoom Log Linear Maximize For more information on these commands see the Commands section beginning on page 5 31 The Dot Plot or bead map appears in the lower right section of the Acquisition Detail tab See Figure 5 14 The dot plot shows a graphical display of real time data collection Luminex recommends using the default settings to collect data The default axes are Classification 1 on the X axis and Classification 2 on the Y axis To see the dot plot you must use the default axis To display the bead set information hover the mouse pointer over the desired region You can change the X axis and Y axis of the dot plot for troubleshooting purposes although you should use the default settings in all other scenarios Luminex 100 IS User Manual Version 2 3 xMAP Technology L1 belo 10000 1000 Classification 2 100 10 1 10 100 1000 10000 Classification 1 Figure 5 14 Dot Plot Display Example Four buttons appear at the top of the frame to control the display Density Decaying Log Linear Zoom Maximize You can toggle between two types of dot plots using the Density Decaying button The Decaying Dot Plot plots o
7. 1 On the Maintenance tab click Eject Retract to eject the plate holder 2 Insert the reservoir in the upper right corner of the plate holder See Figure B 10 gt Figure B 10 The XYP Instrument Reservoir 3 Click Eject Retract to retract the plate holder Calibrate and Verify the Run system calibration See Calibration Procedures page 5 46 to System complete the installation process by running the system calibrators and controls Install the SD System To install the Luminex SD system 1 After performing system calibration and the pressure has stabilized select Prime from the Home or Maintenance tab Then at the Diagnostic tab System Monitor section record the air and sheath pressure Air pressure psi Sheath Pressure psi Save this information You will need it later in the installation procedure and also if you return to the original sheath fluid and waster bottle configuration 2 Atthe end of the Prime cycle disconnect the sheath fluid bottle Store it in a safe place If you plan to use the Luminex SD system waste line disconnect the waste bottle Connect the system waste line to the instrument and insert the end into a large waste container B 10 PN 89 00002 00 071 Rev C xMAP Technology Note Do not place the Luminex SD on top of the Luminex 100 Analyzer PN 89 00002 00 071 Rev C Luminex 100 IS System Setup Place the Luminex SD system near the sheath fluid connection on the lef
8. After you power on the PC Windows automatically starts up and then the Luminex 100 IS software automatically starts up Continue with Configure the Luminex 100 IS 2 3 Software section The first time the Luminex 100 IS 2 3 software starts up you have to acknowledge the License Read the agreement and click Accept to continue You must adjust the sample probe vertical height each time you change the type or style of microtiter plate Since this is a new installation you need to adjust the sample probe for your microtiter plates See Figure B 9 Lumit 1 Thumb Wheel 2 Height Adjustment Locking Screw Figure B 9 Thumb Wheel and Height Adjustment Locking Screw To adjust the sample probe vertical height 1 Remove the clear plastic shield that covers the sample probe area PN 89 00002 00 071 Rev C xMAP Technology Note Alignment discs can be placed in any well as long as the well is designated in the software Luminex 100 IS System Setup In a 96 well microtiter plate where overall height is no more than 0 75 inches 19 mm place the appropriate alignment tool in the plate For a standard plate with flat bottom wells stack two of the larger 5 08 mm diameter alignment discs together and place them into the selected well For a filter bottom plate stack three of the larger 5 08 mm diameter alignment discs together and place them into the selected well For a half volume plate with flat b
9. Figure 3 1 Back of the Luminex 100 Analyzer and Luminex XYP Instrument Fluidics Sample Arm The sample arm transports the sample from the sample tube to the cuvette The carriage drops to the microtiter well for sample retrieval Luminex XYP A stainless steel sample probe acquires the sample A shorter probe Instrument Sample is provided for shipping and troubleshooting Probe Warning During operation this system contains exposed moving parts that can result in a puncture hazard Risk of personal injury is present Keep hands and fingers away from the sample probe The shield should be in place Cheminert Fitting This fitting attaches the Luminex 100 analyzer sample arm tubing to the sample arm Disconnect this fitting when you remove the sample probe See Figure 3 2 3 8 PN 89 00002 00 071 Rev C xMAP Technology The System The alignment guide directs the sample probe into the Luminex XYP instrument 1 Cheminert Fitting 2 Sample Arm 3 Luminex XYP Instrument Sample Probe 4 Shield 5 Alignment Guide Figure 3 2 Cheminert Fitting Access Doors The Luminex 100 analyzer has three access doors Two of the access doors are on the front and the third 1s on the back The front left access door supplies access to the sheath filter The front center access door supplies access to the syringe The rear access door supplies access to the air intake filter See Figure 3 3 and Figure 3 4 Luminex 9 1 Left doo
10. PN 89 00002 00 071 Rev C xMAP Technology The analyzer is misaligned with the XYP instrument The sample probe is bent Troubleshooting Reposition the Luminex 100 analyzer on top of the Luminex XYP instrument so that the holes match up correctly The alignment guide should tighten and loosen fairly easily if the instruments are aligned correctly Continue to square the instruments until the guide loosens and tightens easily Remove the sample probe from the Luminex 100 analyzer Roll it on a flat surface If it does not roll smoothly replace it with a new sample probe Calibration and Control Problems Symptom Possible problem Solution Calibration is slow or fails PN 89 00002 00 071 Rev C The calibration microspheres are not fully suspended Wrong calibration lot number or target values are entered in Update CAL Targets dialog box The system calibrators are in the wrong well on the plate Not enough calibrator microspheres added to the well Calibrator lot is expired The sample probe height is incorrect The sample probe is clogged Vortex the calibration vials to resuspend the microspheres Verify that the correct lot number and target values are used See page 5 46 for further information Verify that you placed the calibrator into the correct well See page 5 46 Make sure that you use four or five drops of calibrator microspheres to the well Use a new bo
11. Luminex 100 IS 2 3 Software page B 15 Software Luminex 100 IS Version Overview of upgrade to Luminex IS 2 3 procedure 2 1 2 2 to Luminex 100 IS e Backup your Luminex 100 IS 2 1 or 2 2 database Version 2 3 e Remove Luminex 100 IS Version 2 1 or 2 2 e Install Luminex IS 2 3 software e Verify successful upgrade Backup Luminex Important Backup your database before you uninstall 100 IS 2 10r 2 2 Version 2 1 or 2 2 software Database To back up your Luminex 100 IS 2 1 or 2 2 database 1 On the Tools menu click Database Backup The Backup Database To dialog box opens See Figure B 18 Backup Database To Database To 2 x Save in ja Backup FEM Ex E3 mp Luminex 100 IS E1 in LX1001504232002 bak History is LX100I506112002 bak E Desktop My Documents My Computer ao L lt 1 001507032002 bak we Save as type Y Cancel My Network P File name Figure B 18 Backup Database To Dialog Box PN 89 00002 00 071 Rev C B 19 Luminex 100 IS User Manual Version 2 3 Remove Luminex 100 IS 2 1 or 2 2 Note During the Luminex 100 IS Version 2 1 or 2 2 software removal error dialog boxes may appear They are of no consequence to the uninstall Just click OK or Yes in response and continue with the uninstall Install Luminex 100 IS 2 3 Software 2 xMAP Technology Choose the file name and location of the database that you want to back up and click Save T
12. 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 Each batch file records the date and time command cancellation if applicable and voltages used for the commands performed during the batch Back up the system database following the schedule set by your laboratory Your laboratory may require you to back the system up weekly daily or after you complete each batch If your laboratory has no schedule for database backups the system does inform you when your database approaches its size limit You should back up the database according to a periodic schedule PN 89 00002 00 071 Rev C xMAP Technology Delete Database Entries Restore Database PN 89 00002 00 071 Rev C Data Using Luminex 100 IS 2 3 Software To back up the database 1 Onthe Tools menu click Database Backup The Backup Database To dialog box opens 2 Choose the file name and location of the database that you want to back up The default name is LX100IS month date year 3 Click Save The LX100 IS Database Backup dialog box opens informing you the backup is in progress to the specified location You can erase sample information from the database at any time You will see a warning when the database is 80 full approximately 200 MB free of a two GB hard drive limit This provides advanced warning to erase database information
13. soccer QUE Santas sats 6 10 Asrequited c ciee e sick eei iae eI er dn ber eee d 6 11 BUSES crei ob teniente ein EE E e LR SEE d 6 11 Maintenance Log sseeeeeeee e 6 13 Troubleshooting 7 1 Troubleshooting the Luminex 100 IS System 7 1 Power Supply Problems 0 0 0 0 cece eee eee nee 7 2 Communication secesia ereh a a cette 7 2 vi PN 89 00002 00 071 Rev C xMAP Technology Pressurization lees n 7 3 lJunnab i cq 7 4 Sample Probe acu ees ena epe nau ebbe dedere 7 5 Calibration and Control Problems 200000 0 7 1 Acquisition Problems 0 0 cece cece eee eee 7 9 Bead Detail Irregularities 0 0 eee ee eee eee 7 10 Error States Lio eue hee helen we aig nga 7 13 System Error Messages leere 7 13 Sample Error Messages lesen 7 15 Luminex SD Problems 0 000 cece eee eee 7 18 lul Em 7 18 Malfunction eee ene me Re el oe n 7 18 Draining the Reservoir 0 0 0 0 7 18 Verificato eco eoe eR eet hau ye Obie Lad dee 7 19 Product Numbers 8 1 Hardware slc Dee Xu br vue he Pee E PY 8 1 SONWALE iasi marai ese Gehan aie Gohan mwah yd ae ale byte i in dehy a 8 3 xMAP Reagents eod ue ed aci RI Ra C Pues 8 3 TPAD ican PP E 8 3 Glossary A 1 Luminex 100 IS System Installation B 1 OVEIVIEW i weddden ged b ERO E E Y Gr EA ER EORR e B 1 Luminex 100 IS System Setup 0 000005 B 1 Connect the Luminex 100 analyzer and Lu
14. 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 The xMAP microspheres are highly uniform polystyrene particles that have been crosslinked during polymerization for physical and thermal stability Varying amounts of fluorochromes embedded within each xMAP microsphere give each xMAP microsphere set an unique fluorescent signal To ensure the stability of this signal it is essential to protect the microspheres from light Follow the product information sheet instructions for storage procedures for xMAP microspheres and assay kits Calibrator xMAP microspheres are used to normalize the settings for the reporter channel both classification channels and the doublet discriminator channel for the Luminex 100 analyzer The control xMAP microspheres are used to verify the calibration and optical integrity of the system This section provides a brief overview for using the Luminex 100 IS 2 3 software With the Luminex 100 IS 2 3 software you work with assay kits provided by a kit manufacturer A template may be included with each kit that is imported into the software The template includes a sequence of commands required for the assay Once you select the template you enter sample data into a ba
15. 1 Std S 57 75 2 Std m 525 75 3 Std l 4341 75m A Std xI 1 431 6 75 5 Std xxl 25694 75 6 Low Control 58 75 7 Patient 1 532 75 8 Patient pu 4567 75 DataType Result Location Sample Test 22 Total Events Notes 1 Std s 2 99 pg mL 75 2 Std m 5 79 pg mL 75 3 Std I 126 71 pg mL 75 A Std xl 61 6 93 pg mL 75 5 Std xxl 31 94 84 pg mL 75 6 Low Control 3 02 pg mL 75 7 Patient 1 1 5 98 pg mL 75 8 Patient 2 636 38 pg mL 75 DataType Count Location Sample Test 22 Total Events Notes 1 Std s 75 75 2 Std m 75 75 3 Std 75 75 A Std xI 75 75 5 Std XxI 75 75 6 Low Control 75 75 7 Patient 1 75 75 8 Patient 2 75 7b PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 xMAP Technology Luminex 100 IS OUTPUT CSV file with all additional features enabled Program Luminex 100 IS Build 2 3 BETA Date 7 28 2004 2 16 30 PM SN LX10001298011BE Session Bead 22 Quant Batch Operator TemplatelD 4 TemplateName Quant Batch TemplateVersion 2 3c TemplateDescription IS 2 3
16. 10 11 12 13 14 Vortex xMAP reagent containers to ensure homogeneity Load a microtiter plate with CON1 CON2 and four wells with sheath fluid in the six desired wells Click Eject Retract The plate holder ejects Place the plate on the plate holder Fill the Luminex XYP reservoir with a solution of 70 isopropanol or 70 ethanol Click Eject Retract The plate holder retracts If you are using a new lot click New Control Targets from the Maintenance tab fill in the required information and click OK Click Prime The Confirmation dialog box opens Click OK to begin priming Wait until the Prime is completed Click Eject Retract to eject the Luminex XYP instrument tray Place 70 isopropanol or 70 ethanol in the reservoir Click Alcohol Flush The Confirmation dialog box opens Click OK to begin the Alcohol Flush Click OK and wait until the alcohol flush completes The Device Status section on the Status Bar changes from yellow to green and indicates Standby This takes about five minutes Select the well where CONI is located from Step 2 using the drop down arrow located to the right of the CONI button Verify the location Click CONI The Confirmation Screen dialog box opens Click OK Wait until CONI completes Select the well where CON2 is located from Step 2 using the drop down arrow located to the right of the CON2 button Verify the location Click CON2 The Confirmation Screen dialog box opens C
17. Hesume 5 Cancel Command Figure 5 12 Acquisition Detail Toolbar The Histogram in the lower left section of the Acquisition Detail tab defaults to display the Doublet Discriminator DD on the X axis and Events on the Y axis Doublets appear when two microspheres stick together creating undesired results When you enable the gate two vertical red dashed lines appear to represent gate positions determined by the template or settings established within the New Advanced Batch After setting the gate everything outside the gate is ignored You cannot change the gate position during batch acquisition You can change the gate positions before data acquisition after the system finishes acquiring data or after pausing the system The change is visual The data is still collected according to the gate positions set in the assay template or New Advanced Batch setup The gate in effect when the system collects data determines which values to use to obtain the result Applying a gate or changing a gate for existing data does not change your calculated values The gate positions also located in the lower corner of the histogram are used while collecting data are the numerical values selected in the template or the New Advanced Batch PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software e o s Show Bead lt all gt w Ee 9 fl 150 Events 100 50
18. Instrument Serial No Luminex 100 IS User Manual Version 2 3 xMAP Technology PN 89 00002 00 071 Rev C The System Theory of Operation PN 89 00002 00 071 Rev C Luminex 100 IS technology is based on flow cell fluorometry with Luminex developed innovations The fluidics optics robotics temperature control software and xMAP 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 Luminex XYP instrument heater block There are two fluidics paths in the Luminex 100 analyzer The first path involves a syringe driven mechanism that controls the sample uptake This mechanism permits small sample uptake volumes from small reaction volumes The syringe driven system transports a specified volume of sample from a sample container to the cuvette The sample is injected into the cuvette at a steady rate for analysis Following analysis the sample path is automatically purged with sheath buffer by the second fluidics path This process removes residual sample within the tubing valves and probe The second fluidics path is driven by positive air pressure and supplies sheath fluid to the cuvette and sample path Sheath fluid is the delivery medium of the sample to the optics component The analysis sample is acquired using a sample probe from a 96 well microtiter plate via the Luminex XYP instrument and injected into t
19. Name Mean SD Trimmed Mean lean SD Trimmed Mean zj Select Cancel Figure 5 60 Open Batch Dialog Box Select Batch 2 Select the desired batch to export 3 Click Select The system exports the information The Export Batch dialog box opens showing the name and location of the exported data file Click OK A printed batch report includes the following criteria that is applied to the batch during analysis e batch name and test name e formula used curve fit e standards controls samples e graph this is the only way to print a graph of standards To print data analysis reports 1 On the Home tab click Analysis 2 In the Open Batch dialog box select the desired batch to analyze 3 Inthe Analysis window click Print Report The Data Interpretation Report displays a print preview See Figure 5 61 4 Select any print options along the title bar and then click the print button printer icon Luminex 100 IS User Manual Version 2 3 Database Management Procedures Back Up the Database xMAP Technology 5 Atthe Microsoft Windows Print window select your printer options and click Print Data Interpretation Report we 14 5 Q e Sl Figure 5 61 Data Interpretation Report Print Preview To manage the system database back up and delete saved data and files The system stores data results for instrument calibrators
20. To ensure accurate test results properly clean and maintain the Luminex 100 IS system Read and follow all instructions in this section For your convenience a maintenance log form is included at the end of this chapter Warning When analyzing potentially infectious biological samples on the Luminex 100 analyzer follow standard laboratory safety practices These safety precautions should also be taken when cleaning or maintaining the analyzer Do not remove the analyzer cover under any circumstances If the system is powered on but idle for more than four hours click the Maintenance tab Click Warmup Wait 30 minutes for the Luminex 100 analyzer and the optics system to warm up Before you run samples 1 Turn the Luminex 100 analyzer on The system begins warming automatically 2 Verify the levels of sheath fluid and waste fluid 3 When the system is warmed up click Prime to prime the analyzer then click OK 4 Click Alcohol Flush A confirmation dialog box opens Click Eject Retract to eject the Luminex XYP instrument tray Place at least 1 2 mL of 70 isopropanol or 70 ethanol in the reservoir Click OK Luminex 100 IS User Manual Version 2 3 xMAP Technology 5 Click Wash In the confirmation dialog box click on the drop down arrow located to the right of the Eject Retract button to choose the desired location Click Eject Retract The Luminex XYP instrument tray ejects Place sheath fluid in the selecte
21. between batches and multi batches after sanitize and before daily shutdown To perform a Wash command Onthe Maintenance tab click Eject Retract 2 Select Reservoir from the dropdown menu next to the Wash button then click Wash A confirmation dialog box opens telling you to place solution in the reservoir 3 Putdistilled water in the reservoir 4 Click OK The plate holder retracts and the system performs the Wash command 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 Luminex XYP instrument heater is needed set the heater to the specified heat setting The user definable heater range is 35 C to 60 C Use the heater only with the heater block in place Luminex recommends using a Costar Thermowell thin wall polycarbonate 96 well plate nonskirted model P over the heater block sent with the Luminex System Do not use standard 96 well microtiter plates if you are using the heater block Any temperature that you set remains in effect until you set another temperature or turn off the Luminex X YP instrument plate heater or exit the software The system displays the target temperature in the box below the Turn ON button Before the heater block temperature reaches the new temperature setting the XYP Heater Temperature thermometer is red Upon reaching the target temperature the thermometer turns green See page 5 9
22. create new session 5 52 D daily activities 6 1 database backup 5 90 compressed patient reports 4 3 management 5 91 restore 5 91 decontamination 2 2 2 9 5 45 5 96 detailed sample progress 5 11 digital signal processor 4 1 dilution factor 5 64 discard waste 6 2 disconnect from AC power 6 4 draining the system 5 94 during operation 2 2 E efficiency 4 1 eject retract XYP plate holder B 10 electronics 3 5 3 7 specifications 3 5 enable raw data storage 5 39 Index 2 xMAP Technology entering sample data 4 2 erasing data from database 5 91 errors tab 5 22 establish insert off plate commands 5 70 European Union EU safety requirements 2 3 excitation 4 1 excitation wavelength 4 1 exit the Luminex 100 IS software 5 97 export batch data 5 89 batches 5 41 F filter 3 8 air intake 3 9 replacing air intake 6 6 sheath 3 9 3 11 flow cytometry 4 1 flow rate 3 5 fluidics 2 3 3 5 4 1 components 3 8 illustration 3 8 leak 2 4 path 4 1 specifications 3 5 warning 3 8 fluorescence 3 4 4 2 5 39 fluorescent signal 4 2 fuses product number 8 1 replacing 6 11 G general Luminex 100 analyzer specifications 3 5 H hardware specifications 3 2 testing 3 2 heat 2 2 2 8 heat warning labels 2 8 heater block 5 46 8 1 height adjustment locking screw B 8 help menu 5 38 PN 89 00002 00 071 Rev C xMAP Technology high waste volume 6 3 idle more than 4 hours 6 1 improper system operatio
23. diagnostic tests The results display on the Diagnostics tab Clean the sample probe Remove the sample probe and sonicate the narrow end for 2 3 minutes Use a syringe to flush the sample probe with distilled water from the narrow end out through the larger end Replace the sample probe and readjust the sample probe height for the plates you are using with the Luminex XYP instrument Luminex 100 IS User Manual Version 2 3 xMAP Technology Flush the System Run 3 backflushes 3 drains 2 alcohol flushes and 3 washes with distilled water Monthly Clean the Sample Probe Danger Be sure that the system is not performing an operation when you remove the sample probe Caution The Luminex XYP instrument sample probe should slide up easily while removing it from the sample arm If you feel resistance do not force the probe up Contact Luminex Technical Support To clean the sample probe 1 Remove the sample probe as follows First unsnap the light housing located above the probe Then unscrew the Cheminert fitting on top of the probe completely Next gently grasp the probe and push up Remove the probe out of the top of the sample arm 2 Clean the sample probe using a bath sonicator or using a 10 mL syringe If you are using a bath sonicator place the smaller end of the sample probe in the bath sonicator for 2 to 5 minutes If you are using a syringe force 10 to 20 bleach through the larger end of the sample probe 3 R
24. l uminex Corporation 8 Address 12212 Technology Boulevard Austin TX 78727 6115 Phone 512 219 8020 FAX 512 219 5195 a fa Logo Figure 5 22 Options Dialog Box Company Information Tab Use the Data Export tab to configure your export data See Figure 5 23 The following options are available Auto Export Batches Select this feature to automatically export the csv file formats when the system finishes analyzing the batch This allows you to run your own programs on exported data without having to manually start the export This feature also takes place after acquisition completes If this is not selected while running a New Advanced Batch you must right click on the data grid to get your output csv file Copy Output csv file to Common Output Dir Select to send a copy of the Output csv file to the My Batches Output folder Prompt for Batch Comment Check this button to initiate a prompt for batch commenting when a batch is finished Write Sample Comments Select to add sample comments to the Notes column in the output csv file Additional Export Stats Select to define which sample statistics to export outside the Luminex IS 2 3 software to the Output csv file Test Sort Order Choose an option to define the sorting order For more information on the options see the Command section beginning on page 5 31 Additional Batch Information Select one or more options to add additional informati
25. located on the Diagnostics tab is more than 3 degrees Each step usually takes less than one minute You must run xMAP controls after each calibration See Run System xMAP Controls on page 5 49 To replace the analyzer air intake filter 1 Disconnect the Luminex 100 analyzer from ac power by turning off the power switch on the rear of the analyzer then unplugging the power cord from the wall source On the back of the Luminex 100 analyzer in the upper left corner remove the screw at the top of the panel and open the panel door Grasp the tubing and pull the filter 3 to 4 inches from the unit See Figure 6 2 Luminex 100 IS User Manual Version 2 3 xMAP Technology 5 E Model No g urne x S N LX 100002450 Ed Lumine C Blvd Figure 6 2 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 Plugin and power on the Luminex 100 analyzer Luminex XYP Instrument To replace the XYP instrument air intake filter Air Intake Filter 1 Disconnect the Luminex XYP instrument from ac power by turning off the power switch on the rear of the Luminex XYP instrument then unplugging the Luminex XYP instrument power cord from the wall source 2 Onthe back of the Luminex XYP instrument to the left side gently remove the screen from the
26. number and developing company for the template that you are using in a batch The Insert command lets you insert a patient into a batch or skip a well The Command list displays the commands that were imported from the template plus commands added using the Insert command or manually entered The lock in the far left column indicates that the command was imported from the template and cannot be changed in the Batch Setup window The Microtiter Plate image reflects the command information for each well as defined in the template The Command button group contains the Finish Cancel Load Pa List and Help command buttons For more information on these commands see the Commands section beginning on page 5 31 The Save group box contains the Save and Load and Save only option buttons For more information on these commands see the Commands section beginning on page 5 31 The Standard Info group box is visible only if the template you are using requires the use of standards If standards are used in the template the Standard Info group box reflects the Standard information as defined in the template product The Control Info group box is visible only if the template you are using requires the use of controls If controls are used in the template the Control Info group box reflects the Control information as defined in the template products Luminex 100 IS User Manual Version 2 3 Analysis Window xMAP Technology The New L
27. the system allows editing without requiring a new lot name However if you have analyzed a previous batch using this lot the system will require that you rename the lot if edited or modified Background samples are commonly used in the assay process Although recommended the discretion on whether to use or not is left to the assay or kit developer If background samples are included they are defined in the assay template Background samples are samples with no active test substance The system uses background samples to remove assay background noise from the sample results Typical background samples contain coupled beads assay buffer detection reagents and reporter fluorophore Background samples do not contain target analytes If the background sample is designated accordingly the system subtracts the background sample s reported fluorescence from all other samples in a batch to report net MFI If a batch contains more Luminex 100 IS User Manual Version 2 3 xMAP Technology than one background sample the fluorescence values of the two background samples are averaged together and subtracted from the other samples to obtain a net fluorescence intensity Samples Tab The Samples tab lists tests from your batch and displays the results for each sample Figure 5 20 shows a Sample tab example listing three tests Notice that the left pane displays Test IL 4 IL 6 and IL 8 with Test IL 4 selected The right pane shows the IL 4 sample r
28. xMAP Technology Sample2 SampleM StatN StatN Header Sample Location Sample Name Test1 Test2 TestN Total Count Notes Sample1 Sample2 SampleM Blank Lines e Field Definitions There is one blank line between the Date and SN fields There are four blank lines between the Operator field or last optional field and Samples field There is one blank line between the Samples and Results fields There is one blank line between the Results field and the first statistical data block There is one blank line between each of the statistical data blocks Table D 1 Field Definitions Field Name Field Value Description Program value lt CC gt The name of the Luminex application that created the OUTPUT CSV file If the file is generated by a non US operating system the country code in hex is appended Build value The version of the Luminex application that created the OUTPUT CSV file Date date time The date amp time that the OUTPUT CSV file was created This field is not related to batch execution time Note that the date and time values are separated into distinct adjacent fields Date 04 14 2003 02 46 45 PM to maintain compatibility with previous versions of software SN value The serial number of the Luminex 100 device with which the batch was executed Session value The name of the batch The term Session was used here to maint
29. 00 00 e eee eee eee C 8 Index Index 1 Vili PN 89 00002 00 071 Rev C Introduction About This Manual The Luminex 100 IS 2 3 System Intended Use PN 89 00002 00 071 Rev C This manual provides you with information to understand and use the Luminex 100 IS system It consists of multiple chapters and appendices that take you from this introduction to complete system operation The manual s text and figures offer examples when necessary Procedures are presented as step by step instructions Glossary and index sections assist as references The conventions in this manual assume that the reader has a basic familiarity with computers xMAP technology and a knowledge of Microsoft Windows software We typically document the common methods of accessing a command such as from the main menu bar from the toolbar and from menus that appear when you right click an area of the screen Refer to the Glossary appendix for unfamiliar terminology The Luminex 100 IS 2 3 system is a benchtop system consisting of the Luminex 100 analyzer computer monitor keyboard mouse Luminex XY Platform instrument Luminex XYP Luminex Sheath Delivery System Luminex SD software barcode reader sheath and waste containers and xMAP technology reagents The Luminex software is designed to use xMAP technology with assay kits available through kit manufacturers The Luminex 100 IS 2 3 system performs a wide range of xMAP technology b
30. 00 071 Rev C The System 55 C 95 F to 131 F when performing heated assays and using the heater block Indoor use only Operating 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 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 Ibs UL installation category UL Installation Category II as defined in Annex J of UL 61010A 1 Pollution degree UL Pollution Degree 2 as defined in Section 3 7 3 2 of UL 61010A 1 Shipping and storage The allowable shipping and storage temperature and humidity ranges are 0 C to 50 C and 20 80 noncondensing respectively Input voltage range 100 120 V 10 1 4 Amp and 200 240 V 1096 0 8 Amp 47 63 Hz AC inlet fuse 3 Amp 250 V fast acting Reporter laser 532 nm nominal output 10 15 mW maximum 500 mW frequency doubled diode mode of operation continuous wave CW Classification laser 635 nm 9 1 mW x 6 maximum output 25 mW diode mode of operation continuous wave CW Reporter detector Photomultiplier tube detection bandwidth of 565 585 nm Classification detector Avalanche photo diodes with temperature compensation Doublet discrimination detector Avalanche photo diodes with temperature compensation Sheath flow rate 90 uL 5 uL second Cuvette 200 micron square flow channel Sample inje
31. 071 Rev C Luminex 100 IS 2 3 Software Installation About Luminex100 IS Software Luminex100 IS Software Version 2 3 147 Data acquisiton application for Luminex100 IS 1996 2004 Luminex Corporation All rights reserved Warning This computer program is protected by copyright law and international treaties Unauthorized reproduction or distribution of this program or any portion of it may result in severe criminal and civil penalties and will be prosecuted to the maximum extent possible under law E nfo Figure B 16 Software Information Window 3 Run system calibration See Calibration Procedures page 5 46 to complete the verification process by running the system calibrators and controls To upgrade to Luminex IS 2 3 software you perform these procedures in the following order Optionally archive your My Sessions folder Remove LMAT software Remove Luminex 100 Version 1 7 software Install Luminex IS 2 3 software Verify successful upgrade To preserve your Luminex 100 Version 1 7 session data archive your C My Sessions folder Copy the files to another folder or save them to a diskette or CD Luminex 100 IS Version 2 3 software maintains session data in a database not in the My Sessions folder Remove the Luminex LMAT software using the Windows Control Panel 1 On the PC desktop select Start gt Settings gt Control Panel The Control Panel opens on the desktop 2 Double clic
32. 3 Std 75 75 A Std xI 75 75 5 Std xxI 75 75 6 Low Control 75 75 7 Patient 1 75 75 Sample Comment for Patient 1 8 Patient 2 75 75 Sample Comment for Patient 2 DataType Mean Location Sample Test 22 Total Events Notes 1 Std s 240 733333333333 75 2 Std m 503 213333333333 75 PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 3 Std l 4450 92 75 xMAP Technology 4 Std xI 13478 6666666667 75 5 Std xxI 24817 8933333333 75 6 Low Control 60 75 7 Patient 1 561 12 75 Sample Comment for Patient 1 8 Patient 2 14402 3466666667 75 Sample Comment for Patient 2 DataType CV Location Sample Test 22 Total Events Notes 1 Std s 662 071761559013 75 2 Std m 42 0677216044823 75 3 Std I 28 540875012004 75 4 Std xl 30 4524100927965 75 5 Std xxl 17 3369506373774 75 6 Low Control 34 9506301308939 75 7 Patient 1 27 7364540209588 75 Sample Comment for Patient 1 8 Patient 2 28 9726898443063 75 Sample Comment for Patient 2 DataType Peak Location Sample Test 22 Total Events Notes 1 Std S 45 75 2 Std m 447 75
33. 4 Std xI 13634 5217391304 75 5 Std xxl 25095 75 6 Low Control 58 8695652173913 75 7 Patient 1 551 36231884058 75 Sample Comment for Patient 1 8 Patient 2 14594 7391304348 75 Sample Comment for Patient 2 DataType Trimmed CV Location Sample Test 22 Total Events Notes 1 Std s 23 9771317653444 75 2 Std m 26 4392256987905 75 3 Std I 20 718201051022 75 4 Std xl 25 4309644452528 75 5 Std xxl 14 0816389192424 75 6 Low Control 22 0787072692933 75 7 Patient 1 21 231629005304 75 Sample Comment for Patient 1 8 Patient 2 20 5061473536575 75 Sample Comment for Patient 2 DataType Trimmed Peak Location Sample Test 22 Total Events Notes 1 Std S 45 75 2 Std m 447 75 3 Std I 3985 75 A Std xl 371 5 75 5 Std xxl 1 5788 75 6 Low Control 58 75 7 Patient 1 430 75 Sample Comment for Patient 1 8 Patient 2 8163 75 Sample Comment for Patient 2 PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 DataType Trimmed StdDev xMAP Technology Location Sample Test 22 Total Events Notes 1 Std s 13 6634901596136 75 2 Std m 130 7323916509
34. 40 view 5 83 Analysis window function keys 5 22 analyzer 2 3 3 7 4 1 connections 3 7 maintenance functions B 9 ventilation filter 6 9 analyzing results 4 2 assay errors 5 24 assay kits 1 1 1 2 4 2 PN 89 00002 00 071 Rev C assembling and powering system B 1 assigning dilution factors to samples 5 64 auto start analysis 5 40 avoid beam exposure 2 6 shining beam into people s eyes 2 7 staring into beam 2 7 back up the database 5 90 background information 4 1 analytes 4 1 flow cytometry 4 1 measure 4 1 soluble analytes 4 1 barcode label 3 7 barcode reader 4 2 batch analyze processed batch 5 83 data export 5 89 reprocess 5 56 Batch Summary Report 5 87 biohazard 2 2 biological 2 2 warning 2 7 blue indicator light 2 2 2 8 C calibration 6 4 definition A 1 schedule 4 2 trend report 4 3 5 87 verification 5 47 capacity specifications 3 4 caution 2 1 2 5 2 6 CD supplied 3 3 CE mark 2 3 cheminert fitting 3 8 B 7 classification laser 3 5 4 1 Index 1 Luminex 100 IS User Manual Version 2 3 clean accessible surfaces 6 4 Clear Preliminary Off plate commands 5 69 Clinical Assay Report 5 86 clinical samples 3 2 commands off plate 5 69 component of Luminex 100 IS 2 7 components 2 2 3 2 xMAP reagents 1 1 conceptual information 4 1 confirmation screen 5 39 connect barcode reader B 5 keyboard B 5 Luminex 100 IS analyzer B 3 mouse B 5 PC B 5 XYP B 3 connectors air waste and sheath fluid 3 11
35. 47 To verify system calibration with controls 1 Inthe Maintenance tab click New CON Targ The Update CON Target Information dialog box opens See Figure 5 26 2 Enter the CONI lot number expiration date and the values listed from the COQ included with your system controls into the CONI entry boxes If you are using a previously entered lot select it from the drop down menu in the Current CON 1 group box or click Import to import the information See page 5 50 for more details on importing a lot 3 Repeat step 2 for the CON2 lot information Update CON Targets CON 1 Product Information Lot Information Number Value L100 CON1 Lot Number E 682 Name Expiration Date 12 06 2002 a Classification Control T Target Information MEDIE Reference Target Al Target Bl Target C1 emner 1 9861 769 218 Current CONI Lot A1682 e 2P Lo 953 3 10675 23422 5607 A1682 4 8946 2573 17803 por CONT sed Owens LS 9886 233 5795 ooe Product Information r Lot Information Number Value L100 CON2 Lot Number A1440 Name Expiration Date 09 21 2002 zl Reporter Control Manufacturer Target Information Luminex Reference Target A1 1 29 1 Current CON2 Lot A1440 2 197 e 1910 Import CON 2 Export CON 2 aliai 17429 NewLot Lot Change the current lot by saving selected lot Luminex 100 IS User Manual V
36. 5 10 Plate Layout Tab Selection Shortcuts Click column heading to select entire column Click row heading to select entire row Click the top left corner of the plate to select entire plate Each well can have a series of off plate commands that run before the next well is read You can insert preliminary off plate commands that run before the first well PN 89 00002 00 071 Rev C xMAP Technology Managing Assay Lots Create a New Lot PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software You can edit standard and control lot information Once a lot is used changing or modifying it will prompt you for a new lot name This includes batches that have been set up but not yet acquired You can modify known lot concentration values If you change the known concentration for a used lot the system prompts you to enter a new lot name If you change the concentration values in an unused lot the system updates the lot with the new concentration values For assay reagents specified in templates you can create new lots edit lot information select pre existing lots for reuse import lots and export lots When editing lot numbers follow these lot handling rules If you have entered lot information for a template but you have not used the template to set up a batch you can edit the lot value If you have entered lot information and have used the template to set up a batch even if it has not b
37. C Luminex 100 IS User Manual Version 2 3 xMAP Technology PN 89 00002 00 071 Rev C Output C SV Overview Overall Design PN 89 00002 00 071 Rev C This chapter describes the file specification for the Luminex 100 IS 2 3 OUTPUT CSV file Although this document may refer to older versions of Luminex software for historical purposes it is intended only to describe the OUTPUT CSV file for the Luminex 100 IS 2 3 system Although this chapter was prepared to ensure accuracy Luminex assumes no liability for errors or omissions or for damages resulting from the application or use of this information The OUTPUT CSV file was created to provide a simple data report The file displays general batch information and statistical results Note that the term Batch is synonymous with Session in other versions of Luminex Software The OUTPUT CSV file contains two blocks of information The first is the header which contains general batch information The second block of information is the results section which contains several subsections displaying statistical analyses in a Sample versus Test format as illustrated in the following example Batch Header Results Stati Stati Header Sample Location Sample Name Test1 Test2 TestN Total Count Notes Sample1 Sample2 SampleM Stat2 StatN Header Sample Location Sample Name Test1 Test2 TestN Total Count Notes Sample1 Luminex 100 IS User Manual Version 2 3
38. Errors tab in a batch analysis Message Possible problem Solution Insufficient Bead Count There are not enough beads seen to meet the minimum requested Ensure there are 2000 5000 beads per set per well Ensure proper beads are selected Adjust sample probe height Resuspend beads in the wells Check for clogs Temperature Divergence from Calibration Temperature You are running the system at an ambient temperature that is out of range of the temperature at which the system was initially calibrated Calibrate and verify the system If this message still appears after calibration contact Technical Support Failed Control in Batch PN 89 00002 00 071 Rev C One or more of the assay controls are not within the expected range Verify that you selected the correct template Verify that the correct assay lot number and concentration values were selected and entered correctly Luminex 100 IS User Manual Version 2 3 xMAP Technology Verify that the system is functioning properly by running the system controls If the system controls pass contact the kit manufacturer Failed Curve Fit The calculation could not occur for the assay standards for data interpretation Verify that you selected the correct template Verify that the correct control lot number and target values were selected and entered correctly Verify that the system is functioning properly by running the system controls
39. Faresi Figure 5 53 Options Dialog Box Select Auto start Analysis PN 89 00002 00 071 Rev C xMAP Technology Analyze Processed Batch Data View Detailed Test Analysis Validating or Invalidating Standards and Controls PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software 2 Click the Auto Start Analysis checkbox then click OK When the system completes the batch acquisition it will automatically begin analyzing data You can analyze only processed batches If you acquire or process batches as a multi batch the system lists them separately and they must be analyzed separately All batches within a multi batch have the multi batch name listed under the multi batch ID name column This allows you to see the batches that have been processed as a multi batch To analyze data from processed batches and multi batches 1 On the Home tab click Analysis The Open Batch dialog box opens showing only processed batches 2 Selecta batch to analyze and click Select The system loads the batch and the Analysis window displays the Standards tab To view detailed test analysis 1 On the Home tab click Analysis The Open Batch dialog box opens 2 Click on the desired batch to analyze and click Select The Analysis window opens showing the progress as the system opens the batch and analyzes the data Each test displays Analyzing as the system calculates 3 Onthe Standards tab select the test or ana
40. Finish Do not close the Add Remove Programs dialog box Continue with the following Remove Luminex 100 Version 1 7 Software section You remove the Luminex 100 Version 1 7 software through the Windows Control Panel If you are continuing from the previous section then skip to step 3 1 On the PC desktop select Start gt Settings gt Control Panel The Control Panel dialog box opens on the desktop Double click the Add Remove Programs icon The Add Remove Programs dialog box opens Under the Currently installed programs list select the Luminex Data Collector entry The entry expands to include the Change Remove button Click Change Remove The InstallShield Wizard dialog box opens Select Remove and click Next PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 IS 2 3 Software Installation 5 Click OK in the Confirmation File Deletion dialog box If a Shared File Detected dialog box opens select the Don t display this message again checkbox then click Yes If a Self registration error dialog box opens Click OK 6 When the InstallShield Wizard Maintenance Complete dialog box opens click Finish 7 Click Close on the Add Remove Programs dialog box Click the X on the Control Panel to close 8 Ifthe LMAT and the Luminex Data Collector icons are still present on the desktop drag the icons to the Recycle Bin Install Luminex To install the Luminex 100 IS 2 3 software continue with Install 1001S 2 3
41. Luminex XYP instrument PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Table 5 1 System Monitor Values Continued Property Value Units of Measure XYP Heater Temperature In Indicates if the XYP heater is in Range the set range The Detailed Sample Progress section displays the percentage of completion for each bead ID or test The graph shows real time progress so that as each sample is analyzed the graph adjusts to show progress Use the zoom button to view up to 20 tests at a time Use the toggle button to view the bead ID or test name Use the Expand Margin up down and left right arrows to expand the chart margins and view longer test names See Figure 5 9 1 2 Detailed Sample Progress 1 23 Complete 34 73 77 Tests Bead ID 1 Zoom button 2 Toggle button 3 Expand Margin arrows Figure 5 9 Detailed Sample Progress The Message Log is the lower pane on the Diagnostic tab It displays a list of completed commands errors and warnings It also displays command progress time and date and results See Figure 5 10 Luminex 100 IS User Manual Version 2 3 xMAP Technology 55 Database age 5i 1001 11 10 06 AM Batch data exported Wy BatchesiDNA Batch_ID2 oukg 54 Commands Finished Time 5 25 2001 11 10 05 AM 53 Device State Change Time 5 25 2001 11 10 05 AM Old State Processing New State Idle 52 Command Co
42. Luminex XYP instrument filter Note Do not remove the screws See Figure 6 3 6 6 PN 89 00002 00 071 Rev C xMAP Technology Maintenance and Cleaning Figure 6 3 Removing the Screen 3 Replace the filter and replace the screen See Figure 6 4 Figure 6 4 Removing and Replacing the Filter 4 Plug in and turn on Luminex XYP instrument power PN 89 00002 00 071 Rev C 6 7 Luminex 100 IS User Manual Version 2 3 Syringe Seal xMAP Technology To replace the syringe plunger seal Danger The syringe arm does not deactivate when changing the plunger injury could result if the system is not unplugged 1 Disconnect the Luminex 100 analyzer from ac power by turning off the power switch on the rear of the analyzer then unplugging the power cord from the wall source 2 Open the center most door on the front of the Luminex 100 analyzer 3 Locate the syringe a glass cylinder with a metal rod See Figure 6 5 wc 1 Syringe Seal 2 Syringe Figure 6 5 Syringe and Syringe Seal 4 Unscrew the knob on the syringe arm at the bottom of the syringe and forcefully push the syringe arm down 5 Unscrew the syringe from the top of its housing 6 Pull the plunger out of the syringe 7 Remove and replace the plunger seal Keep the black O ring 8 Return the plunger to the syringe 9 Screw the syringe back into its housing 10 Return the syringe arm to its original position PN
43. Message Log Directory e Delete the Batch Directory To display the Cleanup Utility dialog box On the Tools menu click Cleanup The Cleanup Utility dialog box opens See Figure 5 62 PN 89 00002 00 071 Rev C xMAP Technology Using Luminex 100 IS 2 3 Software Pele P Delete Delete E Batch Directo Directo Figure 5 62 Cleanup Utility Dialog Box 28 Luminex100 IS Software Cleanup UG Cleanup To perform a disk cleanup l 2 In the Cleanup Utility dialog box click Disk Cleanup In the Select Drive dialog box select the desired drive and click OK The Disk Cleanup dialog box opens showing it is calculating progress This can take several minutes When Windows finishes calculating the cleanup it displays the Disk Cleanup for dialog box See Figure 5 63 Check or uncheck the desired files to delete and click OK Windows deletes the files and closes the dialog box 28 Disk Cleanup for C Disk Cleanup More Options xi You can use Disk Cleanup to free up to 858 175 KB of disk m space on EL Files to delete z9 Downloaded Program Files a Temporary Internet Files 765 KB Ma Recycle Bin 118KB Es Temporary files 64KB V 53 Temporary Offline Files 0KB v Total amount of disk space you gain 858111 K r Description Downloaded Program Files are ActiveX controls and Java applets downloaded automatically from the Intemet when you view certain pages They are temporari
44. New Lot Figure 5 56 Choose Lot Dialog Box Standard Only 3 To create a new lot from this dialog box as an alternate method click New Lot and follow the steps in the Create New Lot procedure on Create a New Lot on page 5 71 To create a new lot for use within a batch 1 Click New Lot 2 Inthe Update Lot Info dialog box select Standard lot or Control lot then click Save to display the Choose Lot dialog box An asterisk identifies the selected lot See Figure 5 55 Running Reports and You can output data by printing reports and exporting batch data Analyses Report Types The Luminex IS 2 3 software can format your batch or multibatch results in a variety of export formats and provide different types of information in different types of reports Analyte Report prints some or all of the samples grouped by the test in a batch Clinical Patient Report provides a breakdown of samples according to the test analysis with that sample Patient Summary Report prints all of the test results for a patient may include all tests or selected tests on the report Quality Control Report used to track the trends of assay standards and assay controls over a period of time 5 86 PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Maintenance Report provides a history of all maintenance operations performed during the date range entered by the operator B
45. See Figure 5 4 Luminex 100 IS User Manual Version 2 3 xMAP Technology Elle Tools Help 4s m o j m zi E S A 2 J Single Step Home Run Batch Maintenance Diagnostics Acq Detail Luminex100 Integrated System 2 3 lt No Batch Loaded KOOOOOOOOOOOO a0OOOOOOOOOOQOO QOOOOOOOOOOO a 0OOOOOOOOOQOO EIN sheath g 0D0DX0O0O0O0OOOOO gKOOOOOOOOOOQO s000000O0O0O0O0O0OQ amp OOOOOOOOOOOO CmdNo Command Plate Loc Cmd Status E a Eject neta i ee Mite Warmedup 0 Standby tating 1 Microtiter plate reservoir image 2 Temperature and Pressure Gauges 3 Command List Figure 5 4 Run Batch Tab The command buttons on the Run Batch tab are e Print Worklist e Bject Retract e Start Plate e Resume e Cancel Command e Pause e Cancel all For more information on these commands see the Commands section starting on page 5 31 For more information on setting up batches see See Batch Setup Procedures on page 51 The microtiter plate and reservoir image represents where you place samples or other fluids used in running or maintaining the system Samples are analyzed vertically from top to bottom within the column and then from left to right for subsequent columns The Temperature and Pressure Gauges show information about the analyzer and the XYP instrument The XYP heater temperature measures the internal Luminex XYP instrument plate temper
46. This label is attached to the barcode reader 4 460 120 4 593 186 4 652 750 4 673 805 e 4 736 095 e 4 816 660 4 845 350 e 4 861 972 e 4 866 257 4 897 456 5 179 270 e 5 810 904 5 237 161 5 247 161 5 247 162 5 258 604 e 5 260 554 e 5 298 728 5 311 000 5 330 370 5 468 949 5 474 206 5 481 098 Other patents pending COVERED BY ONE OR MORE OF THE FOLLOWING PATENTS 4 387297 e 4 409 470 Figure 2 9 Barcode Reader Laser Label Do not stare into the beam or shine it 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 Risk of personal injury is present Keep hands and fingers away from the Luminex XYP instrument slot during operation Warning During operation this system contains exposed moving parts which could result in pinch point hazard Risk of personal injury is present Keep hands and fingers away from the Luminex XYP instrument slot during operation Note Access doors must be closed while operating the Luminex 100 analyzer the operator must be present during operation Biological Warning Human and animal samples may contain biohazardous infectious agents Where exposure including aerosol to potentially biohazardous material exists follow appropr
47. Unauthorized additional software is prohibited and may result in improper operation of the system USB communications link for fast data transfer e Automatic transfer of assay templates and new reagent information into the system via a large capacity read write CD e Installation lt 4 hours e System calibration lt 10 minutes e System controls lt 10 minutes e Barcode reader entry of sample IDs e Automatic post analysis e Analyze one 96 well plate hour depending on manufacturer s kit e Up to 100 x MAP microsphere sets per sample e Sheath flowrate 90 uL sec 5 uL e Sample injection rate into detector area 1 uL sec 0 05 uL e System warmup 30 minutes Systems that remain inactive for at least four hours will require a warm up to restart the lasers After Luminex 100 IS User Manual Version 2 3 Accuracy and Precision Sensitivity Capacity xMAP Technology acquiring sample running system calibrators running system controls and warming up the instrument the system resets the four hour internal clock Sample uptake volume 5 Classification of xMAP microspheres gt 80 Misclassification of xMAP microspheres lt 2 may vary by xMAP microsphere product lines Refer to the specific product information sheet for further details Temperature control 0 C to 2 C of target Internal sample carry over 0 996 Soluble background fluorescence emission at 575 nm automatically subtracted from fluor
48. When the database is 98 full sample acquisition is prevented System calibration and control information is not affected when you erase sample information The system also does not affect standard and control information while erasing data from the database To erase information from the database 1 On the Tools menu click Erase Database The Choose Date calendar opens 2 Choose the day after the last day of the database entries that you want to erase For example all data prior to January 16 are erased January 16 is kept 3 Click OK The Delete Database Entries dialog box opens and warns that you are about to delete database records 4 Ifyou are sure you want to delete this data click Yes The system deletes all events stored before the day you select Restore the database from a previously saved database To restore information to the database 1 On the Tools menu click Database Restore The Restore Database dialog box warns you that the Luminex IS 2 3 software will shut down after restoring the database 2 Click Yes to continue to restore a database Luminex 100 IS User Manual Version 2 3 Maintenance Procedures xMAP Technology 3 From the Restore Database From dialog box select a database backup file to restore and click Open The system restores the previously saved database Notice that the files are organized by date month day year 4 ADatabase Restored dialog box opens the next time you star
49. a Class II laser product consisting of a Class I laser product Luminex 100 analyzer and a Class II laser product barcode reader Figure 2 5 Laser Product Class Label United States and international regulations require the following warnings to appear on the instrument during operation and maintenance This label appears on the back panel of the Luminex 100 analyzer Figure 2 6 Laser Radiation Caution Label Under NO circumstances should you remove the Luminex 100 analyzer cover When performing routine maintenance turn power to the Luminex 100 analyzer OFF and the disconnect the power cord Luminex 100 IS User Manual Version 2 3 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 2 7 Laser Class Label Warning Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure des commandes ou r glages ou l ex cution des proc dures autres que celles sp cifi es dans les pr sentes prescriptions peuvent entrainer d une exposition un rayonnement dangereux This label appears above the laser apertures located inside the optics enclosure inside the Luminex 100 analyzer Figure 2 8 Avoid Exposure Label PN 89 00002 00 071 Rev C xMAP Technology Safety Barcode Reader Laser
50. a dialog box related to the specific report opens The system information may vary depending on the type of report you select Luminex 100 IS User Manual Version 2 3 xMAP Technology Batch Selection Select the batch that contains the patient information AM DNA Quant Run by 5P formula Figure 5 58 Batch Selection Dialog Box Enter the information in this example a patient report and click Next Another information dialog box opens Enter specific information for the type of report the system is compiling Figure 5 59 shows a Patient Selection example is Patient Selection xj Select available Patients from the list on the left Patient 2 Patient 3 Patient 4 Previous Finish Cancel Figure 5 59 Patient Selection Dialog Box Select the desired entry or click the double arrow gt gt to select all the entries Click Finish A report print preview appears using the information you entered You may have more than one dialog box in which to enter information Click Print Report to print the report The Print dialog box opens Select the desired parameters and click Print PN 89 00002 00 071 Rev C xMAP Technology Export Batch Data Print Data Analysis Report PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software To export batch data 1 On the File menu click Export Batch Data The Open Batch dialog box opens See Figure 5 60 Description Multi Batch ID
51. an analyte Pertaining to calculations that determine the precise numerical measurement of an analyte A molecule or combination of molecules with a specific range of excitation and emission wavelengths that is used to identify or quantify an analyte Examples of acceptable reporters for the Luminex 100 IS are Phycoerythrin and Alexa 532 A specific range of wavelengths that includes the emission wavelength of a designated reporter molecule Refers to the dyes bound to the surface of the xMAP microsphere Also see reporter channel See reporter channel Luminex 100 IS User Manual Version 2 3 sample sample reaction signal standards microspheres assay suspension system controls template verification xMAP xMAP Technology The mixture of assay components microspheres reporter patient diluent that are analyzed The reaction that occurs between your reagents and the beads Detectable measurement unit of the reporter molecule Assay standards are substances of know concentrations used to derive a standard curve with which unknown samples and controls are compared to determine their concentration or quantity See control microspheres assay Solution consisting of homogeneously dispersed microspheres in an aqueous medium Include the xMAP reporter and classification control microspheres They are used to verify the calibration of the Luminex 100 analyzer A sequence of commands and predetermined sett
52. begin on page 5 92 Table 5 11 on page 5 92 shows a recommended use schedule for maintenance operations Use the Diagnostics tab to monitor the progress of commands you initiate in the system Features on this tab monitor the state of system components This tab displays the System Monitor Detailed Sample Progress chart and Message Log The Text on the Diagnostics tab turns red if the system encounters an error The Message Log on the Diagnostics tab indicates where the error occurred s fs Luminex tics Acq Detail Luminex100 Integrated System 2 3 System Monitor Property Detailed Sample Progress 96 Pal 123 Air Pressure 06 06 2002 4 42 43 PM Sheath Pressure 06 06 2002 4 44 04 PM Delta Cal Temp 06 06 2002 4 45 42 PM Board Temp 06 06 2002 4 46 45 PM DD Temp 288 CL1 Temp 285 CL2 Temp 275 XYP Board Temp 288 XYP Htr Temp 285 XYP Htr In Range 215 18 Device Chang 17 Command Completed 16 Command Started New State Idle CommandNo 1 of 1 Plate Location D1 Plat CommandNo 1 of 1 Plate Location D1 Plat ge 02 4 46 45 PM Old State Proc g Time 06 06 2002 4 46 45 PM CommandName CON2 Time 06 06 2002 4 46 07 PM 15 Device State Change 14 Device State Change 13 Command Completed 12 Command Started 11 Device State Change 10 Device State Change CommandName CON2 Time 06 06 2002 4 46 0
53. by default Please 1 refer to your IT department when connecting to the network If you 2 have questions please call Luminex Technical Support To change the computer name on Luminex 100 IS 2 3 systems Change the computer name following the Windows process When you reboot the system an error message appears warning about database errors Reinstall Luminex 100 IS 2 3 software using the Repair option After the reinstall the database is available you do not need to reboot P repa re System for After you install the hardware and software run the following F irst U se commands to prepare the system for first time use Also consider running these commands when the system has been idle for extended periods of time Refer to Maintenance Procedures page 5 92 for command operation Run the following commands in order 2 Backflushes 2 Drains 2 Alcohol flushes 3 Washes with water PN 89 00002 00 071 Rev C Installation Drawing eoueJeo o 3 4 uuor est l g 009 k A BY 8 04 al S0 Z6 dAX xeuium eoeung Bunioddns W ge x c e z i gt e Oo 9 e o o c FE o 0 d a u c R M8IA epis flH M8IA 2uU1eulos uuug 9Z jsneux3 1 uug ioI josoley M8IA YOR DE jq ssod exelu uy Burooo ysneuxg exe AV AN a eyxelul Buljoo5 Buljoo9 jneux3 e resp m z x BuljooD gt 9 8 eoueJeo o js i ES Kell dAX wwg 0
54. commands and acquisition commands PN 89 00002 00 07 1 Rev C xMAP Technology Create a New 9 Batch PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software To import a template from a diskette or CD p 2 5 Luminex Uatch Setup Insert the kit s diskette or CD into the appropriate drive On the File menu click Import Template The Import Template dialog box opens Click the Look in drop down arrow and navigate to the diskette or CD drive containing the template The diskette drive is typically drive A and the CD drive is typically drive D The kit manufacturer s template appears on the selection list Click the name of the template Click Open to load the template To create a new batch Read the instructions provided with the assay kit you are using Follow the kit instructions for any preparations Click New Batch The Open Template dialog box opens Double click the template you want to apply to the new batch The template loads and the Luminex Batch Setup window opens See Figure 5 27 Please establish the starting location for the batch and enter the appropriate patient information Note indicates a required field inset Acquire Patient v X 1 Apply r Batch Info x No Location Command SamplelD Dil Factor Name 8 1 A1 Plate Acquire Standard Std M 1 va petens 16 36 3 2 B1 Plate1 Acquire Standard StdM 1 v S 3 C1 Plate1 Acquire Stan
55. custhelp com Luminex Technical Support is available to users in the U S and Canada by calling 1 877 785 BEAD 2323 between 7 00 a m and 7 00 p m Central Time Monday through Friday Users outside of the U S Canada and Europe can call us at 1 512 381 4397 between Luminex 100 IS User Manual Version 2 3 Power Supply xMAP Technology 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 Users in Europe can call us at 31 162408333 between 8 30 and 5 30 Central European Time Monday through Friday Email inquiries in Europe can be sent to supporteurope uminexcorp com Power supply problems often involve a blown fuse faulty electronic P roblems component or even something as simple as a disconnected cable Use extreme care when you replace a fuse Symptom Possible problem Solution Analyzer will not turn on or XYP will not turn on Fuses continue to open blow Communication The power cord is disconnected Verify that the power cord is Plugged in No voltage is coming from the Verify that the electrical outlet is electrical outlet operational The power supply is faulty Contact Technical Support A fuse has burned out See Fuses on page 6 11 for instructions on changing fuses A component has a short circuit Contact Technical Support The communication problems described in this section involve the links between the data
56. display MFI values on all reports In the Luminex IS 2 3 software the only report affected by this selection is the Analyte Report All others are hard coded by the system Luminex 100 IS User Manual Version 2 3 Define Company Information Tab xMAP Technology Auto Start Analysis Select this feature to enable the software to begin analyzing data immediately after processing batches The automatic analysis feature takes place after the system finishes acquiring data while processing batches Luminex100 15 Software Options lol x General Company Information Data Export Default Batch Directory CAMy Batches Eg Current User P Analysis Display Digits 2 iv Display Confirmation Screens Enable Raw Data Storage I Report Raw Fluorescence F Auto start Analysis E i Figure 5 21 Options Dialog Box General Tab You can enter information about your company and a company logo into the Company Information tab This information is stored in the Registry for reference The logo will not alter any Luminex IS 2 3 report or screen Company Information name address phone and fax numbers and location of company logo Use the browse button Em to navigate to the location where the logo is stored PN 89 00002 00 071 Rev C xMAP Technology Define Data Export Tab Information PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software General Company Information Data Export Name
57. for more information about the system monitor Warning The heater plate of the Luminex X YP instrument is hot when in use and may cause burns Do not touch the heater plate Luminex 100 IS User Manual Version 2 3 Calibration Procedures xMAP Technology To set the Luminex XYP instrument heater temperature 1 Click Eject Retract to eject the plate holder 2 Set the Luminex XYP heater block on the plate holder 3 Click Eject Retract to retract the plate holder 4 Inthe Temperature and Gauges area of the Run Batch tab click Turn ON The light on the button turns green and the thermometer fluid turns red as it raises to reach the target temperature 5 Use the up and down arrows beneath the target temperature box to set the temperature you want the Luminex XYP instrument heater block to maintain The user definable heater range is 35 C to 60 C 6 Wait for the heater to reach your selected temperature and stabilize before processing samples The thermometer turns green when the temperature is stabilized Calibrator xMAP microspheres are used to normalize the settings for the reporter channel both classification channels and the doublet discriminator channel Control xMAP microspheres are used to verify calibration and optical integrity for the system Calibrate the system at least once a month and Following installation ifthe system is moved ifa part is replaced if the delta calibration temperature shown
58. none gt Plate1 lt none gt Platel Pending 4 Prim lt none gt Platel Pending Wash Reservoir Plate Pending 5 Calibrate CAL1 E11 Platet Pending 7 Wash Reservoir Plate Pending 8 Calibrate CAL2 F11 Piate1 Pending E CTI ueni T rm ama et Region Events See Figure 5 31 Processing Multiple Plates After the first microtiter plate in a multiple plate batch has been acquired the system pauses and prompts you to insert the next plate To process multiple plates during a batch or multi batch 1 Create the batch or multi batch See Create a New Batch on page 5 53 or Create a Multi Batch on page 5 58 PN 89 00002 00 07 1 Rev C xMAP Technology Re Run or Recover Incomplete Batch Scan in Samples With a Barcode Reader PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software 2 Insert the first plate 3 Onthe Run Batch tab click Start Plate to begin processing the batch When the initial plate is through the system pauses and displays the Insert Next Plate message in red underneath the sheath pressure gauge 4 Click Eject then remove the acquired plate and load the next plate for processing 5 Click Resume The system resumes the acquisition process An incomplete batch can be caused by situations such as a power failure software failure marking a batch for deletion or clicking Cancel All Use this procedure to re run or recover an incomplete batch To open an incompl
59. officers directors employees agents successors and assigns collec tively the Released Parties with respect to the use of the Product Buyer agrees to indemnify and hold harmless the Released Parties from and against any suits losses claims demands liabilities costs and expenses including attorney accounting expert witness and consulting fees that any of the Released Parties may sustain or incur as a result of any claim against such Released Party based upon negligence breach of warranty strict liability in tort contract or any other theory of law or equity arising out of directly or indirectly the use of the Product or by reason of Buyer s failure to perform its obligations contained herein Buyer shall fully cooperate with the Released Parties in the investigation and determination of the cause of any accident involving the Product which results in personal injury or property damage and shall make available to the Released Parties all statements reports recordings and tests made by Buyer or made available to Buyer by others Patent Disclaimer Neither Seller nor Luminex warrants that the use or sale of the Product will not infringe the claims of any United States or other patents covering the product itself or the use thereof in combination with other products or in the operation of any process End User License Agreement EULA for Luminex Software This Luminex End User License Agreement EULA is a legal agreement b
60. on your computer equipment 4 RIGHTS IN SOFTWARE All rights and title in and to the SOFTWARE PRODUCT and any copies thereof are owned by Luminex or its suppliers This EULA is not a sale and does not transfer to you any title or ownership interest in or to the SOFTWARE or any patent copyright trade secret trade name trademark or other intellectual property right therein You shall not remove alter or obscure any proprietary notices contained on or within the SOFTWARE and shall reproduce such notices on any back up copy of the SOFTWARE All title and intellectual property rights in and to the content which may be accessed through use of the SOFTWARE PRODUCT is the property of the respective content owner and may be protected by applicable copyright or other intellectual property laws and treaties This EULA grants you no rights to use such content 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 NOWARRANTY 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 TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW LUMINEX AND ITS SUPPLIERS DISCLAIM ALL WARRANTIES EITHER EXPRESS OR IMPLIED INCLUDING BUT N
61. sad Chee nee ends dau dada 5 35 Save and Load cue e e REA E rs 5 36 Save Only edu tet Rte d gd scan 5 36 Self Diagnostics lese 5 36 Show Bead scence saeit eai TER eee nee nee 5 36 Single Step ca GAG exea Sha Bh ONG Slane rcs 5 36 Skip wells 44 er orb rehenes 5 36 Soak sch waded a elds ws aA sea aid det aes SORE a eh eta deka Se 5 36 Start Analysis e ecra cee cere eee e 5 37 Start Plate usb EEE E a e dec en 5 37 StatiStlCS s ic Led deh ad ber CEU deor made e 5 37 Test Sort Orders 2 ix soi c e CU Rue VH DERE et 5 37 Validate Control 0 0 0 0 oc eens 5 37 Validate Standard 2 0 eens 5 37 View Batch Data 0 0 0 cee eee 5 37 Warmup esada i see s hes beer e Bea a eas hee a ee eae a 5 37 Wai seeen e cers wah na ase dient PERO Re e 5 37 ZOOM Leia dece dvo EROR ESSA ed d cR eR Ca eee aes 5 37 Procedures uu eod dee e AE A dave Reed ER er EUR 5 38 Using the Online Help 0 0 0 0 cece eee eee 5 38 Setting Software Options 0 0 00 cece eee eee 5 39 Define General Tab Information 5 39 Define Company Information Tab 5 40 iv PN 89 00002 00 071 Rev C xMAP Technology Define Data Export Tab Information 5 41 Setting up the Favorites List llle esee 5 42 Startup Procedures 0 0 cece ee eee eee 5 43 Warm Up the System 0 0 0 0 ee eee 5 43 Prime the System 0 0 0 c eee eee eee 5 43 Backf
62. sample acquisitions Units 2 seconds BatchAuthor value Optional The name of the person who created the batch Limited to 30 characters BatchStartTime date time Optional The date amp time that the batch was started BatchStopTime date time Optional The date amp time that the batch was finished BatchDescription value Optional The batch description Limited to 200 characters BatchComment value Optional Comment entered after the batch has run CALInfo Optional Indicates the start of the CAL1 amp CAL2 machine calibration information logged just prior to and anytime during batch acquisition CONInfo Optional Indicates the start of the CON1 amp CON2 machine verification information logged just prior to and anytime during batch acquisition AssayLotlnfo Optional Indicates the start of the Lot information for any standards and or controls associated with the batch Samples num MinEvents 0 Samples indicate the number of samples run in the batch The MinEvents field is unused and will always be zero Note that this field is adjacent to the Samples field Samples 28 Min Events 0 rather than below it to maintain compatibility with previous versions of software Min Events See Samples field above PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 xMAP Technology Table D 1 Field Definitions Continu
63. section PN 89 00002 00 071 Rev C Safety Symbols Please become familiar with the information in this chapter before using the equipment Do not perform procedures on your Luminex 100 IS 2 3 system that are not specifically contained in this manual unless you are directed to do so by Luminex Technical Support These symbols describe warnings cautions and general information used in the operation of this instrument These symbols are further defined under Safety Precautions Number Symbol Description Number Symbol Description 1 PN Alternating current ac 7 A Warning refer to manual 2 Protective ground 8 A Warning refer to manual 3 On 9 A Warning refer to manual 4 O Off 10 A Warning refer to manual 5 SN Serial number 11 A Warning refer to manual BE Warning refer to manual PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 Warnings and Notes Safety Precautions xMAP Technology Informational notes and warnings appear in this manual Note A note provides general helpful information No safety or performance issues are involved Caution This message is used in cases where the hazard is minor or only potential hazard is present Failure to comply with the caution may result in potentially hazardous conditions Warning This message is used in cases where danger to the operator or to the performance of the instrument is present Failure
64. standard Lowest Right of Curve max concentration standard Highest STDS Median Fluorescent Intensity MFI Unknown B Concentration gt STDS Unknown A Concentration lt STD1 Concentration Figure 5 18 Non Competitive Assay Examples of out of range sample labeling for competitive assays are shown in Table 5 7 Figure 5 19 shows what a standard curve for a competitive assay should look like Table 5 7 Competitive Out Of Range Labeling Condition Concentration Label MFI of Standard Referenced Left of Curve lt min concentration standard Highest Right of Curve gt max concentration standard Lowest 5 26 PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Unknown C STD 1 Median Fluorescent Concentration STO 3 Unknown D Intensity STD 1 Concentration MFI gt STOS Concentration Figure 5 19 Competitive Assay The standards tab displays an Expected Concentration column for standard and control samples The Standards Expected Concentration column allows users to edit the standard concentrations You can edit controls however you must select the control name or Expected Concentration box for that control then click Change Lot When editing standard and control lot values the system may prompt you for a new number If this is the first batch you analyze using this lot number
65. the designated plate well To make a correction select the wells selected wells are outlined in blue right click over the selected wells to display the Command menu and then click Clear Selection from the list Table 5 10 following lists Plate Layout selection shortcuts PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Acquire Data CAL1 CAL2 CONI CON2 Wash Drain Soak JA MM UM JA Clear Selection JA JM Jt Add Command Label s Clear Command Label s Insert Off Plate Cmd s Clear Off Plate Cmd s Preliminary Off Plate Cmd s Figure 5 38 Plate Layout Tab Command Menu 11 Establish preliminary off plate commands The system performs preliminary off plate commands before the first well command To establish a preliminary off plate command right click anywhere over the plate layout and select Preliminary Off Plate Cmd s from the menu The command list dialog box appears similar to Figure 5 40 Click the OK button next to the Command List after you select the desired commands The white corner marker in the top left corner of the plate above the letter A turns green to indicate an off plate command is established The selected commands run before the plate begins p Preliminary Off Plate Cmd s E X Clear Off Plate Cmd s Bi VC MCCC MCCC Figure 5 39 Preliminary Off Plate Command Corner Marker To clear preliminary off plate co
66. to comply with the warning may result in incorrect performance instrument failure invalid results or hazard to the operator Danger This message is used in cases where significant risk of serious injury or death is present Read the following safety information before setting up or using the Luminex 100 IS 2 3 system A user should be present during operation This system contains electrical mechanical and laser components which if handled improperly are potentially harmful In addition biological hazards may be present during system operation Therefore we recommend that all system users become familiar with the specific safety advisories below in addition to adhering to standard laboratory safety practices The protection provided by the equipment may be impaired or the warranty voided if the system is used in a manner not specified by the instructions or by Luminex Corporation This caution label appears on the back of the Luminex 100 analyzer and on the Luminex XYP instrument Caution Double Pole Neutral Fusing Disconnect power before changing fuse Attention Double pole fusible sur le neutre Couper le courant avant de remplacer le fusible Fuse 2 ULiseG c zarast 39m Figure 2 1 Fuse Caution Label PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Safety Do not perform any maintenance or cleaning of the system s electrical components with the exception of replacing fuses Thi
67. to perform the firmware upgrade Then replace the serial interface cable with the USB interface cable supplied in the upgrade kit e Luminex XYP instrument Continue to use the serial interface cable between the PC and Luminex XYP e Upgrading a Luminex 100 IS Version 2 1 2 2 system If you are upgrading a Luminex 100 IS Version 2 1 or 2 2 system Luminex SD system Remove the serial interface cable between the Luminex XYP and the Luminex 100 analyzer then attach it to the Luminex SD system to perform the firmware upgrade After completing the SD firmware upgrade reattach the serial cable to the back of the XYP Then replace the serial interface cable with the SD interface cable the shorter cable supplied in the upgrade kit If you are upgrading the firmware for more than one component for instance the SD and the XYP you must upgrade the SD system first Luminex 100 analyzer cable Continue to use the existing USB interface cable between the PC and Luminex 100 analyzer Luminex 100 IS User Manual Version 2 3 Luminex 100 Analyzer Firmware Upgrade Connect Cable Note If you are not familiar with connecting the cables refer to Luminex 100 IS System Setup page B 1 Upgrade Firmware xMAP Technology Luminex XYP instrument Continue to use the serial interface cable between the PC and Luminex XYP Follow the steps in this section to update and verify the Luminex 100 analyzer firmware Perform the Lumine
68. want to set options A full description of each tab and its options is listed below 3 After you have entered and selected all of your preferences click OK You define the following options on the General tab Default Batch Directory Names the default directory to store batch information Click the browse button and navigate to the desired folder directory Current User Enter the name of the current user or operator The name appears on reports Analysis Display Digits Use this feature to customize the number of digits shown on the Data Analysis dialog box and printed reports The data is stored with its full precision that is including all digits but the data appears as requested The default analysis digit display is for two digits to show in the analysis Display Confirmation Screens Enables confirmation dialog boxes to display when you initiate many maintenance commands If you disable the confirmation screen display option the confirmation screens remain for commands initiated from the Home tab Enable Raw Data Storage Select this feature to save bead event data that is acquired while processing batches in the database The system defaults to Enable Raw Data Storage Raw data storage is necessary particularly when you use file mode Replay Batch Report Raw Fluorescence Select this feature to enable the median fluorescence intensity MFI display to appear on the Analyte Report This feature was previously used to
69. 00 IS 2 3 Firmware Installation The Luminex 100 analyzer the Luminex XYP instrument and the Luminex SD system use firmware to perform internal control functions Although seldom required firmware updates may become available to enhance functionality If you are directed to update the firmware due to an upgrade kit or other enhancement follow the appropriate procedure in this section There is a separate section for the Luminex 100 analyzer Luminex XYP instrument and the Luminex SD system Review the following Firmware Upgrade Cable Configurations section then continue with the desired firmware upgrade section e Upgrading a Luminex 100 Version 1 7 system lIf you are upgrading your firmware from a system previously using the Luminex 100 Version 1 7 software with Windows 98 or 2000 e Luminex SD system lIf you have the optional Luminex SD system remove the serial interface cable between the Luminex XYP and the Luminex 100 analyzer then attach it to the Luminex SD system to perform the firmware upgrade After completing the SD firmware upgrade reattach the serial cable to the back of the XYP Then replace the serial interface cable with the SD interface cable supplied in the upgrade kit If you are upgrading the firmware for more than one component for instance the SD and the XYP you must upgrade the SD system first Luminex 100 analyzer cable Use the existing serial interface cable between the PC and Luminex 100 analyzer
70. 0002 00 071 Rev C xMAP Technology Connect the Luminex 100 analyzer and Luminex XYP to the PC A Caution Due to the weight of the analyzer use two people for lifting Note Do not place the PC or monitor on top of the Luminex 100 analyzer or XYP instrument PN 89 00002 00 071 Rev C Luminex 100 IS System Setup You must set up and calibrate the Luminex 100 analyzer and Luminex XYP instrument before you can install the Luminex SD system To connect and power on the system 1 Install the PC and monitor according to the instructions provided by the PC manufacturer Place the monitor on top of the PC Unpack the Luminex 100 analyzer and the Luminex XYP instrument Review Hardware page 3 2 to verify that each system component came with the system Place the Luminex X YP instrument on a clean flat surface to the left of the PC Figure B 2 Red Shipping Pin Remove the red shipping pin from the X YP Leave the silver knob in the Luminex XYP instrument See Figure B 2 Place the Luminex 100 analyzer onto the Luminex XYP instrument See Figure B 1 and Figure B 3 for positioning Thread the alignment guide translucent plastic tube through the opening on the Luminex analyzer into the Luminex XYP instrument See Figure B 3 Adjust the position of the Luminex 100 analyzer with the Luminex XYP instrument until the alignment guide threads screw in completely Luminex 100 IS User Manual Version 2 3 Note T
71. 1 PM Time 06 06 2002 4 45 43 PM Time 06 06 2002 4 45 43 PM Time 06 06 2002 4 45 03 PM Time 06 06 2002 4 44 56 PM Time 06 06 2002 4 44 04 PM Old State Idle Old State Processing CommandName CON1 CommandName CON1 Old State Idle Old State Processing New State Processing New State Idle CommandNo 1 of 1 CommandNo 1 of 1 New State Processing New State Idle Plate Location C1 Plat Plate Location C1 Plat 9 Command Completed Carmand Ctartad 4 PN 89 00002 00 071 Rev C Time 06 06 2002 4 44 04 PM Tima iR IQ Iani AANS DNA CommandName CAL2 Carmmandilama CAIA CommandNo 1 of 1 Cammandnig 1 af 4 Plate Location B1 Plat Dlata acatian B4 Diac Ts n dl Figure 5 8 Diagnostics Tab Use these tools to find information about the system and what occurs during sample acquisition and other functions For example you may look on the Message Log to see the last completed command or the one currently in progress The System Monitor provides information about the physical state of the Luminex analyzer including lasers and system calibration status The values displayed are reported directly from the Luminex analyzer and the Luminex XYP instrument It shows whether the calibration or control results completed successfully by displaying green text for successful events and red text for failed events Luminex 100 IS User Manu
72. 100 IS Version 2 3 complete CN L007 01 system with laptop Luminex 100 IS User Manual Version 2 3 xMAP Technology Luminex 100 IS Documentation Version 2 3 CN M032 01 Manuals on CD Luminex 100 IS User Manual Version 2 3 CN M01 7 01 North American Luminex 100 IS User Manual Version 2 3 CN M0168 01 International English Luminex 100 IS User Manual Version 2 3 CN MO031 01 Danish Luminex 100 IS User Manual Version 2 3 CN MO01 9 01 French Luminex 100 IS User Manual Version 2 3 CN MO020 01 German Luminex 100 IS User Manual Version 2 3 CN MO030 01 Greek Luminex 100 IS User Manual Version 2 3 CN MO022 01 Italian Luminex 100 IS User Manual Version 2 3 CN MO21 01 Spanish Luminex 100 IS Developer Guide to xMAP CN M029 01 Technology Version 2 3 Power Cord USA CN P001 01 Power Cord Australia CN P002 01 Power Cord Brazil CN P003 01 Power Cord Denmark CN P004 01 Power Cord Germany Sweden France CN P005 01 Belgium and Spain Power Cord Switzerland CN P006 01 Power Cord Israel CN P007 01 Power Cord UK CN P008 01 Power Cord Italy CN P009 01 Power Cord Japan CN P010 01 Power Cord China CN P012 01 Reservoir XYP CN 0022 01 Sample Needle Height Alignment Kit CN 0015 01 Sample Probe Alignment Kit Short Sample Needle CN 0006 01 Long Sample Needle CN 0007 01 Sample Holder Large 1 5 mL CN 0008 01 Sample Holder Sm
73. 137 TemplateDevelopingCompany Luminex TemplateAuthor MAC SampleVolume 50 uL DDGate 8000 to 15000 SampleTimeout 50 sec BatchAuthor Name BatchStartTime 7 28 2004 2 06 44 PM BatchStopTime 7 28 2004 2 10 50 PM BatchDescription Software Testing BatchComment Batch Comment for Bead 22 Quant Batch This field should be used for general batch information entered by the end user CALInfo ProductName ProductNo LotName ExpirationDate CalibrationTime BoardTemp DDTemp CL1Temp CL2Temp Pressure DDVolts CL1 Volts CL2Volts RP1 Volts DDRVal CL1RVal CL2RVal Passed MachineSerialNo Classification Calibrator L100 CAL1 A4206 06 07 2006 12 00 00 AM 07 28 2004 09 39 32 AM 26 5625 25 26 25 04 25 26 6 3 74 04 81 33 62 83 1 556 719 450 True LX10001298011BE Reporter Calibrator L100 CAL2 A4071 02 18 2006 12 00 00 AM 07 28 2004 09 43 01 AM 26 7795138888889 1 n 1 td 6 3 1 a nef 590 5 1 o 1 True LX1 0001 298011 BE CONInfo ProductName ProductNo LotName ExpirationDate VerificationTime GatedBeads MachineSerialNo Passed Classification Control L100 CON1 A4153 04 13 2006 12 00 00 AM 07 28 2004 09 45 39 AM 5222 LX10001298011BE True Reporter Control L100 CON2 A4137 04 06 2006 12 00 00 AM 07 28 2004 09 52 49 AM 4345 LX1000129801
74. 18 75 9 Std 925 292874765645 75 4 Std xI 3467 39037575852 75 5 Std xxl 3533 78728678387 75 6 Low Control 12 9976389750536 75 7 Patient 1 117 063202011273 75 Sample Comment for Patient 1 8 Patient 2 2992 81871196887 75 Sample Comment for Patient 2 DataType Avg Result Location Sample Test 22 Total Events Notes 1 Std s 2 99 pg mL 75 2 Std m 15 79 pg mL 75 3 Std 126 71 pg mL 75 A Std xI 61 6 93 pg mL 75 5 Std xxI 31 94 84 pg m L 75 6 Low Control 3 02 pg mL 75 7 Patient 1 15 98 pg mL 75 Sample Comment for Patient 1 8 Patient 2 636 38 pg mL 75 Sample Comment for Patient 2 CRG CRC32 A398CCAD PN 89 00002 00 071 Rev C Index A access doors 2 7 3 9 accessories see accessory instructions 6 11 accuracy precision specifications 3 4 add sheath fluid 6 2 additional equipment barcode labels 3 7 bath sonicator 3 7 printer 3 7 surge protector 3 7 vortex 3 7 additional software 3 3 adjust sample probe vertical height B 8 adjust sample probe B 8 adjust sample probe height B 8 after running samples releasing pressure 6 2 sanitize 6 2 wash twice 6 2 air connector 3 11 air intake 3 8 air intake filter 3 8 6 5 replacing 6 6 XYP 3 8 6 6 alignment discs B 8 analysis 5
75. 1BE True AssayLotinfo ManufacturerName ProductName ProductNo ProductType LotName ExpirationDate LMNX Quant Kit 200 Assay Standard B22std 08 01 2006 11 59 59 PM LMNX Quant Kit 200 Assay Control B22con 08 02 2006 11 59 59 PM C 8 PN 89 00002 00 071 Rev C xMAP Technology Samples 8 Min Events 0 Results DataType Median Location Sample Test 22 Total Events Notes 1 Std S 57 75 2 Std m 525 75 3 Std I 4344 75 A Std x 1 431 6 75 5 Std xxl 25694 75 6 Low Control 58 75 7 Patient 1 532 75 Sample Comment for Patient 1 8 Patient 2 14567 75 Sample Comment for Patient 2 DataType Result Location Sample Test 22 Total Events Notes 1 Std s 2 99 pg mL 75 2 Std m 15 79 pg mL 75 3 Std I 126 71 pg mL 75 A Std xI 61 6 93 pg mL 75 5 Std xxl 31 94 84 pg m L 75 6 Low Control 3 02 pg mL 75 7 Patient 1 15 98 pg mL 75 Sample Comment for Patient 1 8 Patient 2 636 38 pg mL 75 Sample Comment for Patient 2 DataType Count Location Sample Test 22 Total Events Notes 1 Std s 75 75 2 Std m 75 75
76. 89 00002 00 071 Rev C xMAP Technology Luminex 100 Analyzer Ventilation Filter PN 89 00002 00 071 Rev C 11 12 13 14 Maintenance and Cleaning Hand tighten the screw on the syringe arm Plug in the power cord and turn the Luminex 100 analyzer power on Prime the system twice watching for any leaks in the syringe area When the prime finishes close the center door To clean the Luminex 100 analyzer ventilation filter Disconnect the Luminex 100 analyzer from ac power by turning off the power switch on the rear of the analyzer then unplug the analyzer power cord from the wall source While facing the Luminex 100 analyzer push your index finger up under the right side of the analyzer in the space between the Luminex 100 analyzer and the Luminex XYP instrument When you feel the filter push the filter toward the left of the analyzer See Figure 6 6 Remove the filter from the left side of the Luminex 100 analyzer Figure 6 6 Luminex 100 Analyzer Ventilation Filter Clean the filter with a vacuum or with distilled water Stand the filter upright to air dry Re install it with the arrows facing up The filter should click into place Plug in and turn on the Luminex 100 analyzer power Luminex 100 IS User Manual Version 2 3 Annually Sheath Filter xMAP Technology To change the Luminex 100 analyzer sheath filter 1 B1 9 mM Disconnect the Luminex 100 analyzer from ac power by
77. ARRANTY WHATSOEVER REGARDING THE PRODUCT AND LUMINEX SPEFICALLY DISCLAIMS ALL WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FIT NESS FOR A PARTICULAR PURPOSE NEITHER SELLER NOR LUMINEX SHALL IN ANY EVENT BE LIABLE FOR INCIDENTAL CONSEQUENTIAL OR SPECIAL DAMAGES OF ANY KIND RESULTING FROM ANY USE OR FAILURE OF THE PRODUCT EVEN IF SELLER OR LUMINEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE INCLUDING WITHOUT LIMITATION LIABILITY FOR LOSS OF WORK IN PROGRESS DOWN TIME LOSS OF REVENUE OR PROFITS FAILURE TO REALIZE SAVINGS LOSS OF PRODUCTS OF BUYER OR OTHER USE OR ANY LIABILITY OF BUYER TO A THIRD PARTY ON ACCOUNT OF SUCH LOSS OR FOR ANY LABOR OR ANY OTHER EXPENSE DAMAGE OR LOSS OCCASIONED BY SUCH PRODUCT INCLUDING PERSONAL INJURY OR PROPERTY DAMAGE UNLESS SUCH PERSONAL INJURY OR PROPERTY DAMAGE IS CAUSED BY SELLER S GROSS NEGLIGENCE Buyer s Use of Product Buyer agrees that no rights or licenses under Luminex s patents shall be implied from the sale of the Product except as expressly provided herein and Buyer does not receive any right under Luminex s patent rights hereunder Buyer acknowledges and agrees that the Product is sold and licensed only for use with Luminex s standard fluorescently dyed microspheres Buyer further acknowledges that the Product have not received approval from the United States Food and Drug Administration or other federal sta
78. C3 Con1000 1000 6390 850 1150 934 46 pgimL D3 Con1000 1000 6874 850 1150 1028 27 pgimL Avg Con 100 806 87 87 1 587 pg mL Con 1000 SS B Sequentially by order acquired pec v Auto PN 89 00002 00 071 Rev C Figure 5 17 Analysis Window Standards Tab Open When a median fluorescence intensity MFI value for an unknown sample or control lies outside the standard curve MFI range the concentration is not calculated The unknown sample or control result is reported as less than or greater than gt next to the corresponding standard expected concentration The out of range samples and controls will also have a Sample High Low statement in the comment column If a sample lies within the standard curve MFI range but the sample s MFI value does not intersect the curve the result will be reported as Error A cannot calculate inverse function statement displays in the comments column This error condition usually occurs when a standard curve flattens out at the high or low end Examples of out of range sample labeling for non competitive assays are shown in Table 5 6 Figure 5 18 shows what a standard curve for a non competitive assay should look like Luminex 100 IS User Manual Version 2 3 xMAP Technology Table 5 6 Non Competitive Out Of Range Labeling Condition Concentration Label MFI of Standard Referenced Left of Curve min concentration
79. D New York Wiley Liss Inc 1995 There are two fluidic paths in the Luminex 100 analyzer The first path involves a syringe driven mechanism that controls the sample uptake This mechanism permits small sample uptake volumes from small reaction volumes The syringe driven system transports a specified volume of sample from a sample container to the cuvette The sample is injected into the cuvette at a steady rate for analysis Following analysis the sample path is automatically purged with sheath fluid by the second fluidics path This process effectively removes residual sample within the tubing valves and probe Approximately 160 uL of sheath fluid is dispelled into each well following sample acquisition The second fluidics path is driven under positive air pressure and supplies sheath fluid to the cuvette and sample path The excitation system in the Luminex 100 analyzer involves two solid state lasers A reporter laser excites fluorescent molecules bound to biological reactants at the x MAP microsphere surface and a classification laser excites fluorochromes embedded in the xMAP microsphere The lasers illuminate the xMAP microspheres as they flow single file through the cuvette RP1 refers to the excitation wavelength CL1 and CL2 refer to the dyes embedded in the microsphere DD refers to the channel that discriminates against doublets based on size Luminex 100 IS User Manual Version 2 3 xMAP Microspheres Software Overview
80. Daily Shutdown Procedures 0 000000 eee eee 5 96 Sanitize the System 0 0 0 e eee eee eee 5 96 Run a Wash Command 0 0 0 0 e eee 5 96 Perform a Soak Command 2004 5 97 Exit Luminex IS 2 3 Software 0 5 97 Maintenance and Cleaning 6 1 Daily Maintenance 1 0 0 eee eee eee ee 6 1 Before Running Samples 0 0 0 0 eee eee 6 1 After Running Samples 0 0 0 0 0 ce eee eee 6 2 Routine Tasks asses eck dee DOR dia tel REDE eel 6 2 Sheath and Waste Fluids 0 0000 000005 6 2 Refill the Sheath Fluid Container 6 3 Empty the Waste Container 000 6 3 Weekly ser bee uirtute eed pota eden tae 6 3 Visual Inspection 6 3 Run Self Diagnostics 0 0 0 00 cece ee eee 6 3 Clean Sample Probe 0 0 0 s cernes ee eee 6 3 Flush the System 0 0 eee eee ee 6 4 Monthly 12 eater decente ee eae eet 6 4 Clean the Sample Probe 0 0 0 0 200 6 4 Clean Exterior Surfaces 6 4 Calibration and System Controls 000 6 5 Every Six Months ou eed wad eee I Rd nce edet 6 5 Luminex 100 Analyzer Air Intake Filter 6 5 Luminex XYP Instrument Air Intake Filter 6 6 5ynnpeseal ece te er aai RE ao aay ERE TG 6 8 Luminex 100 Analyzer Ventilation Filter us 6 9 Amnually 2 2 sek bnt ata Re eed qe ace debel Re bus 6 10 Sheath Filter
81. H Luminex100 Integrated System 2 3 Favorites Daily Startup Add Add Template Command Fou lo xi cd Fi me a instrument Calibration Gare Niger MO eich Soup E T Reports and Analysis E me Sy Daily Shutdown e New B 5 CORREA TAT VR ERR BSS HARA CRR SER VIVECA VOIRE Mig Wido 05 5 5 0 0 0509 050000 1 Title bar 4 Tabs 2 Menu bar 5 Status bar 3 Tool bar Figure 5 1 Luminex IS 2 3 Main Window There are five major parts in the Main window Title bar Menu bar Tool bar Tabs and Status bar A brief description of each of these components is shown below The Title Bar displays the name of the software The Menu Bar contains three menus File Tools and Help menu A more thorough description of the Menu is shown on page 5 3 The Toolbar has shortcut buttons for frequently used commands A more thorough description of the Toolbar is shown on page 5 4 There are five Tabs organized by function The tab that displays when the software starts up is the Home tab A more thorough description of each of these tabs begins on page 5 4 The Status bar displays the system status at the bottom of the main window A more thorough description of the Status bar is shown on page 5 17 5 2 PN 89 00002 00 071 Rev C xMAP Technology Menu Bar PN 89 00002 00 071 Rev C Using Lumi
82. High Limit Test 54 mg dL 405 Figure 5 45 Update Lot Information Dialog Box Use this procedure to export a lot for use on another instrument Depending on the template and its associated products you may have standards controls or both Standards and controls can be grouped into the same lot number To export a lot from an existing template 1 On the Home tab click New Lot The Open Template dialog box opens 2 Double click the template containing the lot to export The Update Lot Information dialog box opens See Figure 5 45 3 Click Export Lot A standard or control confirmation dialog box opens verifying that you want to export the current lot for the standard or control If you want to export the lot information for the standards click Yes If you only want to export the lot controls click No A second dialog box opens to verify if you want to export the current control lot or current lot for a control Luminex 100 IS User Manual Version 2 3 Analyzing Batches and Multi Batches xMAP Technology After responding to the confirmation dialog boxes regarding standards or controls a Save As dialog box opens 4 Click the drop down arrow to select the Save in location where you want to save the lot information 5 Enter the lot file name into the File Name box 6 Click Save The system saves the lot You can analyze an acquired batch using the analysis features of Qual
83. If the system controls pass contact the kit manufacturer Sample High or Low The results do not fall within the highest and lowest standards The wrong control lot number or target values are selected Verify that you selected the correct template Verify that the correct control lot number and target values were selected and entered correctly Verify that the system is functioning properly by running the system controls If the sample is noted as High dilute the sample following the kit manufacturer s suggestions If the sample is noted as Low vortex the sample to ensure homogeneity Sample Timed Out The samples are concentrated Not enough sample loaded into the well Sample probe is clogged Verify that the samples are properly mixed Verify that you loaded the correct sample volume to the well Remove and sonicate or flush the sample probe to remove any clogs PN 89 00002 00 071 Rev C xMAP Technology Sample probe height is set incorrectly There is a clog in the sample line Troubleshooting Adjust the sample probe height Run the following commands Backflush Drain Alcohol Flush and Wash Verify that the delta cal temperature is within 3 0 If the system is not within these limits recalibrate then retry Sample Empty Detected The system completely acquired the entire sample volume There is no sample in the designated well The probe is clogged The sa
84. Luminex Luminex 100 IS User Manual Version 2 3 LUMINEX CORPORATION 2001 2005 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 12212 Technology Boulevard Austin Texas 78727 6115 U S A Voice 512 219 8020 Fax 512 219 5195 LUMINEX CORPORATION Luminex amp 100 IS User Manual Version 2 3 CN MO017 01 PN 89 00002 00 071 Rev C October 2005 Luminex Corporation Luminex reserves the right to modify its products and services at any time This guide is subject to change without notice Although prepared to ensure accuracy Luminex assumes no liability for errors or omissions or for any damages resulting from the application or use of this information The following are trademarks of Luminex Luminex Luminex 100 Luminex 100 IS LabMAP xMAP LumAvidin Luminex XYP Luminex FlexMAP and Luminex SD All other trademarks including Windows Cheminert Pentium and Dell are trademarks of their respective companies The Luminex 100 IS software uses the VideoSoft VsFlexGrid Pro 7 0 VsPrinter 7 0 and VsView 3 0 ActiveX controls which are copyrighted by VideoSoft 2001 The contents of this manual and the associated Luminex software are the property of Luminex and are copyrighted Except as specified in the End User License Agreement any reproduc
85. Luminex 100 IS 2 3 Startup Splash Screen At the Luminex 100 IS Setup Welcome dialog box click Next to continue At the Luminex 100 IS Setup License Agreement dialog box read the End User License Agreement EULA Use the scroll bar to display all the text Click Yes to continue At the Luminex 100 IS Setup InstallShield Complete dialog box remove any floppy disks from their drives and click Finish The system restarts Windows and auto starts the Luminex 100 IS software The first time Luminex 100 IS starts up it displays the End User License To continue click Accept Uncheck the Show Next Time checkbox to bypass this dialog box on the next startup If you click Decline the application closes Start up software The main screen of the IS software appears Verify software upgrade information From the Help menu click About the Software The About Luminex 100 IS Software dialog box opens Verify that the version number on your screen begins with 2 3 as shown in Figure B 16 The numbers after the 2 3 do not need to match those in Figure B 16 PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 Version 1 7 with Windows 2000 to Luminex 100 IS Version 2 3 Archive My Sessions folder Remove Luminex LMAT Software Note During the LMAT software removal error dialog boxes may open They are of no consequence to the uninstall Just click OK or Yes in response and continue with the uninstall PN 89 00002 00
86. MISTRIES OF THE ASSAYS DEVELOPED BY BUYER AND METHODS OF PERFORMING THE ASSAYS LE THE PRO TOCOL FOR THE ASSAY Buyer has the responsibility and hereby expressly assumes the risk to verify the hazards and to con duct any further research necessary to learn the hazards involved in using the Product Buyer also has the duty to warn Buyer s customers employees agents assigns officers successors and any auxiliary or third party personnel such as freight handlers etc of any and all risks involved in using or han dling the Product Buyer agrees to comply with instructions if any furnished by Seller or Luminex relating to the use of the Product and not misuse the Product in any manner Buyer shall not reverse engineer decompile disassemble or modify the Product Buyer acknowledges that Luminex retains ownership of all patents trademarks trade secrets and other proprietary rights relating to or residing in the Product Buyer s Representations Release and Indemnity Buyer represents and warrants that it shall use the Product in accordance with Paragraph 2 Buyer s Use of Product and that any such use of Prod uct will not violate any law regulation judicial order or injunction Buyer agrees to release dis charge disclaim and renounce any and all claims demands actions causes of action and or suits in law or equity now existing or hereafter arising whether known or unknown against Seller and Luminex and their respective
87. OT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT 7 LIMITATION OF LIABILITY IN NO EVENT SHALL LUMINEX OR ITS SUPPLIERS BE LIABLE FOR ANY SPECIAL INCIDENTAL INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF BUSINESS PROFITS BUSINESS INTERRUPTION LOSS OF BUSINESS INFORMATION OR ANY OTHER PECUNIARY LOSS ARISING OUT OF THE USE OF OR INABILITY TO USE THE SOFTWARE PRODUCT EVEN IF LUMINEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES MISCELLANEOUS This EULA is governed by the laws of the State of Texas U S A without reference to conflicts of laws principles You shall not assign or sublicense or otherwise transfer the rights or license granted hereunder by agreement or by operation of law without the prior written consent of Luminex and all assignments in violation of this prohibition shall be null and void This EULA is the complete and exclusive agreement of Luminex and you and supersedes all other communications oral or written relating to the sub ject matter hereof No change to this EULA shall be valid unless in writing and signed by the party against whom enforcement is sought The waiver or failure of Luminex or you to exercise in any respect any right or rights provided for herein shall not be deemed a waiver of any further right hereunder If any provision of this EULA is held unenforceable the remainder of this EULA will
88. Reservoir Plate1 Succeeded 23 sec 3 Acquire Lstand A1 Plate1 AILEI 5 Acquire C1 Plate1 Pending 6 XY Heater Off nones Plate1 Pending Figure 5 6 Command Failure Notation in the Command List Errors are recorded in the Message Log on the Diagnostics tab See page 5 9 for more information about the Diagnostics tab Double click on failed commands in the Message Log for additional information You can right click a highlighted row to copy data to the clipboard or clear the batch from the screen Luminex 100 IS User Manual Version 2 3 xMAP Technology Maintenance Tab Use the Maintenance tab to perform maintenance XYP daily startup calibration and verification commands to maintain your system and keep it in optimal working order tn Luminex100 IS Software File Too help mu Qu EMO Luminex Diaane Ac a Luminex100 Integrated System 2 3 Reservoir ain r F Figure 5 7 Maintenance Tab See the Commands section starting on page 5 31 for detailed information about these commands Warmup Prime Backflush Alcohol Flush Sanitize Wash Drain Soak Self Diagnostics Calibration Commands CAL 1 CAL2 CON 1 CON2 New CAL target and New CON target Sample Probe Down Eject Retract PN 89 00002 00 07 1 Rev C xMAP Technology Diagnostics tab x Luminex100 IS Software File Tools Help Using Luminex 100 IS 2 3 Software Instructions for maintenance procedures
89. Select The Luminex Batch Setup dialog box opens See Figure 5 34 5 64 PN 89 00002 00 071 Rev C xMAP Technology Using Luminex 100 IS 2 3 Software 3 Select the item that uses the dilution factor that you are setting You cannot change any item that is grayed out or locked into the command list Luminex Batch Setup Please establish the starting location for the batch and enter the appropriate patient information Note indicates a required field Insert Acquire Patient X fi Apply Eaa m No Location Command Sample ID Dil Factor Name 8 1 A1 Plate1 Acquire Standard Standard Conc 1 i y Batch 6 3 02 10 36 8 2 B1 Plate1 Acquire Standard 1 E Pi 5 3 Acquire Standard Sta 1 Finish Description 8 4 D1 Plate1 Acquire Standard 1 lt None gt E 8 5 1 Plate1 Acquire Standard Standard Conc 5 1 amp 6 F1 Plate1 Acquire Control Control Reagent il c i H 7 G1 Plate1 Acquire Patient 3 ance 8 H1 Plate1 Acquire Patient 3 Created By 9 A2 Plate1 Acquire Patient 3 Ld Names B2 Plate1_ Acquire Patient Dd uli r Template Info e Name Help auant Dese 1 Save and Load Quantitative 5 Stadards 1 A yO M New Lot Control O Save only 7 r Standard Info Expired ied QO Product No 1 QO Product Name Producti Version No Lot Name A123456 Bzw C Expiration Date 05 30 2002 VY r Control Info Expir
90. Software Opens the Open Batch dialog box from which you select a batch to analyze Once you select the batch the Analysis window opens This command initiates data acquisition on New Advanced Batches and New Batches using system templates During acquisition the system draws sample from the microtiter plate for processing This command enables you to display selected statistics for sample data There are eleven different statistics CV Trimmed 96C V Count Trimmed Count Mean Trimmed Mean Median Trimmed Peak Peak Trimmed Std Dev and StdDev This command is in the Data Export Tab of the Options tab You can select Alphabetical by test name Sequential by Region ID or by Template Setup Order Alphabetical by Test Name the tests are sorted by alphabetical order Sequential by Region ID the tests are sorted numerically by bead ID Template Setup Order the tests are sorted n the order set up in template regardless of name or ID Opens the Validate Control dialog box In this box you choose to validate all control tests click Yes or only a single test click No Opens the Validate Standard dialog box In this box you choose to validate all control tests click Yes or only a single test click No Click to open a previously acquired batch that is stored in the database You cannot view New Advanced Batches Warms up the system to prepare the optics prior to sample acquisition The system automatically be
91. The Command List dialog box opens w Command List dre x Location Reservoir BackFlush Drain Sanitize Alcohol Flush CAL1 CAL2 CON1 CON2 Figure 5 24 Command List Dialog Box 5 42 PN 89 00002 00 071 Rev C xMAP Technology Using Luminex 100 IS 2 3 Software Startup Procedures Warm Up the System Prime the System 2 Select the command that you want to add to your Favorites list For certain commands you will need to select the location where you want to draw or expel fluid Use the Location drop down menu to open the microtiter plate image Click on the microtiter plate location on the image Ensure that the location you select is compatible with the volume intended for that location 3 Click OK to add the command The command displays in the Favorites list To remove items from the Favorites list Select the item you want to remove from the Favorites list then click Remove The item disappears from the list Warm up the system to prepare the optics prior to sample acquisition The system automatically begins warming up when you turn power on This procedure takes approximately thirty minutes Caution Failure to properly warm up the system will effect assay results and system performance After four hours of inactivity the status bar appears red and indicates that the lasers are off You need to warm up the system again by manually initiating warmup To warm up the system Clic
92. The system calibrators are in the wrong well on the plate Vortex the control vials to resuspend the microspheres Verify that the correct lot number and target values are used See page 5 46 for further information Verify that you placed the control microspheres into the correct well See page 5 46 PN 89 00002 00 071 Rev C xMAP Technology Not enough control microspheres added to the well Control lot is expired The sample probe height is incorrect The sample probe is clogged There is air in the system Possible problem with the lasers Troubleshooting Make sure that you use at least four or five drops of control microspheres to the well Use a new bottle of control microspheres Adjust the sample probe height See page B 8 Clean the sample probe See page 6 4 Run a prime and alcohol flush View the system control trend report Check for dramatic changes in temperature sheath pressure or voltages If any of these situations are evident on the report Contact Technical Support Acquisition Problems Symptom Possible problem Solution Acquisition fails or slows PN 89 00002 00 071 Rev C The air pressure is out of range The sample probe is not vertically aligned The sample probe is clogged The sheath bottle has a leaky seal The sheath or waste lines are not fully connected The Calibration microspheres have expired See Pressurization on p
93. The system flags the failed sample so you may calculate the replicate set s average without including the failed result in the equation You can sort the batch samples Sequentially by the order in which they are acquired or Alphabetically by sample ID Select the sorting method in the Sort group box PN 89 00002 00 071 Rev C xMAP Technology Commands Acquire Patient Add Batch Alcohol Flush Autoscale Autosize Backflush CAL1 CAL2 Cancel Command Cancel All Change Lot CONI CON2 PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software This section describes the different commands used in the Luminex IS 2 3 software They are grouped Alphabetically This command which is part of the Insert command menu adds patients to the command list After adding the patients you define the Sample ID and Dilution Factor for each new patient The Dilution Factor defaults to 1 When creating a multibatch adds an existing batch to a multi batch Removes air bubbles from the sample tubing and the cuvette using 70 isopropanol or 70 ethanol The alcohol flush takes about five minutes Uses the Luminex XYP reservoir due to volume requirement Automatically adjusts the maximum number of events shown on the Y axis on the histogram Click during acquisition to readjust the Y axis scale Automatically adjusts column widths to fit the data and header sizes Removes obstructions from the fluidics pathways by d
94. To avoid photobleaching protect your microspheres from light xMAP microspheres hit the lower right of the region You may be using photobleached xMAP microspheres Replace microspheres with a fresh batch To avoid photobleaching protect your microspheres from light Beads appear scattered T mr There is air in the system The sheath fluid is empty Verify sample probe height Run 2 3 Alcohol Flush commands Make sure there is sheath fluid in the sheath container Prime the system until all air is out of the system Microspheres appear as a long diagonal line The xMAP microspheres have agglutinated The solvent is incompatible Add additional detergent to the assay buffer For example add 02 to 0 1 Tween 20 Triton X100 or SDS View a list of incompatible solvents at the Luminex Technical Support website http luminexcorp custhelp com If the solvent you are using is listed switch solvents PN 89 00002 00 071 Rev C xMAP Technology You are using incompatible sheath fluid Troubleshooting Use only Luminex sheath fluid in the Luminex 100 analyzer Other fluids may damage your analyzer Error States The following error states display on the Status Bar on the Run Batch tab when an error occurs during system operation Error Message Possible problem Solution Disconnected The software hasn t made initial On the toolbar click Connect connec
95. age 7 3 Adjust the sample probe height See page B 8 Clean the sample probe See page 6 4 Make sure that the sheath bottle lid is tightened Remove and replace the sheath bottle lid Check to make sure all tubes are tightly connected Replace old microspheres with a fresh lot Luminex 100 IS User Manual Version 2 3 The calibration lot number selected in setup is incorrect Target values for chosen calibration lot number are incorrect The wrong wells are selected in the Setup XY tab xMAP Technology Enter the correct calibration lot number in the Update CAL Targets dialog box Enter the correct target values in the Update CAL Targets dialog box Ensure that the correct wells are selected in the Run Batch tab Slow or unsuccessful sample acquisition The air pressure is out of range The sample probe is clogged The sample probe is not vertically aligned Air is present in the system The acquisition volume is set too high The xMAP microspheres are not fully suspended You are using photobleached microspheres See Pressurization on page 7 3 Clean the sample probe See page 6 4 Adjust the sample probe height See page B 8 Run three Prime commands then resume sample acquisition Set the acquisition volume to at least 25 uL less than the actual volume in your wells This setting lets the analyzer acquire sample more efficiently with less chance of acquiring air Vort
96. ain compatibility with previous versions of software Limited to 30 characters Operator value The name contained in the Current User field on the General tab of the Options dialog in the Luminex 100 IS software TemplatelD value Optional The database ID that is unique to the template used to create the batch PN 89 00002 00 071 Rev C xMAP Technology Table D 1 Field Definitions Continued Field Name Field Value Description TemplateName value Optional The name of the template used to create the batch Limited to 30 characters TemplateVersion value Optional The version of the template used to create the batch Limited to 10 characters TemplateDescription value Optional The description of the template used to create the batch Limited to 200 characters TemplateDevelopingCompany value Optional The name of the company that developed the template used to create the batch Limited to 30 characters TemplateAuthor value Optional The name of the person who created the template used to create the batch Limited to 30 characters SampleVolume value Optional The sample volume defined in the template for sample acquisitions Units microliters DDGate value Optional The DD gate defined in the template for sample acquisitions SampleTimeout value Optional The sample timeout defined in the template for
97. al Version 2 3 xMAP Technology The system diagnoses real time system problems related to fluidics and optics The system also detects and reports if the Luminex XYP heater block temperature is out of range or experiencing unacceptable temperature conditions including these items e Luminex XYP heater block temperature time out heat circuit failure temperature out of range sensing temperature change since calibration or a change in channel temperature Table 5 1 defines the values listed in the System Monitor These values are useful for diagnostic purposes when communicating with Luminex Technical Support Table 5 1 System Monitor Values Property Value Units of Measure Air Pressure PSI air pressure to the sheath container from the air pump Sheath Pressure PSI sheath pressure from the sheath container through the system Delta Cal Temperature C temperature deviation from the last calibration Board Temperature C temperature of the analog board DD Temperature C DD temperature at the U block inside the optics platform CL1 Temperature C CL1 temperature at the U block inside the optics platform CL2 Temperature C CL2 temperature at the U block inside the optics platform XYP Board Temperature C temperature of the XYP board inside the Luminex XYP instrument XYP Heater Temperature C temperature of the XYP heaters inside the
98. all 1 2 mL CN 0009 01 Sheath Filter with Quick Disconnect CN 001 0 01 Sheath Bottle CN 0011 01 Syringe Cylinder with Seal CN 0013 01 PN 89 00002 00 071 Rev C xMAP Technology Software xMAP Reagents Training PN 89 00002 00 071 Rev C Product Numbers Syringe Seal Qty 4 CN 0014 01 Cable USB CN 0018 01 Waste Bottle CN 0012 01 Luminex SD Luminex Sheath CN S001 01 Delivery System Product Description Customer Number Luminex 100 IS Version 2 3 Software CD CN SW08 01 Product Description Customer Number Microspheres LX100 CL1 CL2 Calibration L100 CAL1 xMAP Classification Calibrator Microspheres LX100 RP1 Calibration L100 CAL2 xMAP Reporter Calibrator Microspheres LX100 CL1 CL2 Control L100 CON1 xMAP Classification Control Microspheres LX100 RP1 Control xMAP L100 CON2 Reporter Control Sheath Fluid LX100 40 50000 Product Description Customer Number Basic Training Course CN 0070 01 Luminex 100 IS User Manual Version 2 3 xMAP Technology 8 4 PN 89 00002 00 071 Rev C Glossary agglutination ambient temperature analyte analyzer APD background noise batch bead calibration calibrators PN 89 00002 00 071 Rev C The coalescing of small particles that are suspended in solution these larger masses are then usually precipitated The temperature of the surrounding environment A subst
99. ance that is detected through assay analysis Each test or bead set will test for a specific analyte This term is used to refer to the Luminex 100 analyzer Avalanche Photo Diode Measures the excitation emission intensity of the color coding classification dye mixtures inside the microsphere and the amount of light scattered as particles pass by the lasers That portion of a bead set result that can be attributed to excess reporter molecules in the solution nonspecific binding or fluorescent spillover from another fluorochrome A group of samples that are processed using a selected template Shorthand terminology for an xMAP microsphere A process used to normalize the settings for the reporter channel both classification channels and the doublet discriminator channel for the Luminex 100 IS Calibration ensures optimal and consistent microsphere classifications and reporter readings xMAP microspheres used to normalize the settings for the reporter channel both classification channels and the doublet discriminator channel for the Luminex 100 IS Luminex 100 IS User Manual Version 2 3 CL1 CL2 classification channel control microspheres assay control microspheres system cuvette data reduction delta cal temperature DD temperature emission spectrum event excitation spectrum fluorescence fluorochrome fluorophore immunofluorescence xMAP Technology Refers to dyes embedded in the microspher
100. and load the first plate of the multi batch Click Start Plate to being acquiring data from the multiple batches in the sequence that you set up Use this procedure to open an existing multi batch Each batch in a multi batch appears on the list of available multi batches The software differentiates them according to batch ID name and description The software gives all batches comprising a multi batch the same multi batch ID number and name Luminex 100 IS User Manual Version 2 3 xMAP Technology To open a multi batch 1 Click Open Multi Batch The Open Multi Batch dialog box opens listing the available multi batches Double click on the multi batch you want to open Click Eject Retract to eject the plate holder Load the first microtiter plate onto the plate holder Click Start Plate to retract the plate holder and begin acquiring the multi batch data Process Multiple You can process multiple plates per batch or multi batch After Plates loading a batch or multi batch that spans more than one plate a new plate appears to the immediate right of the existing plate image on the screen A dark blue line separates the adjacent columns of the two plates You can use the scroll bar to see additional plates See Figure 5 31 fi ELLIT His O4 Home Gun Batch ene D Batch Name Batch 3 20 02 13 42 Batch Description Protein Demo 284 5 6 7 8 9 1011 12 1 2 Pnme 3 Prime lt
101. arity with computers and Microsoft Windows Commands are often available through more than one method such as from the main menu bar the toolbar or on different windows However each procedure in this manual will describe only one method of accessing commands This chapter has the following sections Main Window This section describes the main window of the Luminex IS 2 3 software including tabs and commands Use this section to become familiar with the main functions of the software e Secondary Windows This section describes the secondary windows in the Luminex IS 2 3 software including the Analysis Window and Batch Setup Window e Commands This section describes the functions of the commands in the Luminex IS 2 3 software e Procedures This section describes how to perform tasks using the Luminex IS 2 3 software When using microtiter plates use plates with wells that will hold at least 185 uL the extra 25 uL from the sample plus an extra 160 uL that is dispensed back into the well following acquisition The Luminex IS 2 3 software starts automatically when you log into Windows When the first software User window opens the Main window is open with the Home tab displayed as shown in Figure 5 1 Luminex 100 IS User Manual Version 2 3 xMAP Technology 1 Sh Luminext00 IS Software frm 2 File Tools Hel Luminex 3 mE 3 E 7 AA a mJ Single Step Home Run Batch Maintenance Diagnostics Acq Detail
102. ased laboratory tests measuring biomolecular reactions on the surface of xMAP microspheres This system is intended for general laboratory use Luminex 100 IS User Manual Version 2 3 Technical Support Luminex Website xMAP Technology Luminex Technical Support representatives are ready to help you particularly when the system or software cause any questions or problems If the question or problem relates to materials from the assay kit you should contact the kit provider directly Luminex Technical 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 Canada Europe can contact us at 1 512 381 4397 between the hours of 7 00 a m to 7 00 p m Central Time Monday through Friday Inquiries may also be sent by email to support luminexcorp com Luminex Technical Support is also available to users in Europe by calling 31 162408333 between the hours of 8 30 and 5 30 Central European Time Monday through Friday Email inquiries in Europe can be sent to supporteurope Juminexcorp com Additional information is available on the Luminex website Search on the desired topic or navigate through menus Also review the website s FAQ section To access Luminex website FAQ section In your browser s address field enter http luminexcorp custhelp com This address takes you directly to the FAQ
103. atch Summary Report prints batch information in a sample versus test grid format useful for an assay developer to quickly reference a test result for a particular sample Calibration Trend Report provides information about all instrument calibration operations that occurred during the date range entered by the operator System Control Trend Report provides information about all verification operations that were performed during the date range entered by the operator Data Analysis Report displays all the information available in the Data Analysis window You access this report through the Analysis Window For more information on printing this report see page 5 89 To print a report from a batch or a specific time frame Install the printer before initiating the print command 1 Click Print Report The Report Selection dialog box opens igi xi m Select a report Analyte Report C Maintenance Report C Clinical Patient Report C Batch Summary Report C Patient Summary Report C Calibration Trend Report C Quality Control Report C System Control Trend Report E Cancel Figure 5 57 Report Selection Dialog Box 2 Select the type of report that you want to print and click Next For the Analyte Clinical Patient and Batch Summary Reports the Batch Selection dialog box opens Select the batch to print See Figure 5 58 For the Quality Control Maintenance Calibration Trend and System Control Trend Reports
104. ate sample lines and cuvette after biohazard contact using 1096 to 2096 household bleach daily if working with biohazards monthly if not working with biohazards Wash As needed using distilled water Four times after system calibration Twice after sanitize Drain e For troubleshooting and preventative maintenance purposes only drain the cuvette and refill in preparation for running Draining the system removes debris from the bottom of the cuvette when draining you do not supply solution Draining takes approximately two minutes and should be followed by an alcohol flush using 70 isopropanol or 70 ethanol 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 uL of distilled water Self To verify system operation Diagnostics 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 or 70 ethanol Any fluid that drains from the system drains to the Luminex XYP reservoir as the default However you can set the system to drain to any unused well on the microtiter plate The drain function normally expels 125 uL of fluid Ensure that the location you select to expel fluid has the reserve capacity to hold the volume expelle
105. ature PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software The DD temperature measures the doublet discriminator temperature DD temperature shifting indicates a need for system recalibration If you have not calibrated the arrows showing the temperature range for the DD temperature both appear at the bottom of the thermometer and the thermometer appears in red An out of range temperature logs an error but does not halt the acquisition For information on setting the XYP instrument heater temperature see page 5 45 The Command List displays commands associated with batches new advanced batches or multi batches loaded for processing on the system The Command List shows the status of each command as the system processes it and whether the command completes successfully or fails Figure 5 5 shows that the first two commands were successful the third command is running and the rest of the commands are pending Figure 5 6 shows that the third command failed CmdNo Command Plate Loc Cmd Status 1 XY Heater On none Plate1 Succeeded 0 sec 2 Reservoir Wash Reservoir Plate1 Succeeded 23 sec 4 Acquire B1 Plate Pending 5 Acquire C1 Plate1 Pending 6 XY Heater Off lt none gt Plate Pending Figure 5 5 Command List Section of the Run Batch Tab CmdNo Command Plate Loc Cmd Status 1 XY Heater On none Plate1 Succeeded 0 sec 2 Reservoir Wash
106. available the appropriate Upgrade buttons will be upgra de toa speci fic 1 enabled To load an older firmware version select the Browse button z r Lar Version 2 0 582 firmware version then click iac the Browse button and select PEELE i No device detected Detecting the desired firmware version 2 POSSEM from the Open dialog box BEES Movement Device To enable a connection to the SD device connect the SD device to G the host PC using the serial cable from the XYP and select the SD f Movement 5 device radio button C SD Device 3 c XYP E f 21 15 Fmwaeisuptodte Ius I Browse Status 4 _ 1 LXR Runtime Version 4 Status of Upgrade 2 Luminex 100 analyzer firmware version 5 Movement Device SD Device selection button 3 Luminex XYP SD instrument firmware version Note If you are upgrading the Luminex XYP instrument firmware consider doing it at this time then verify the Luminex 100 analyzer and the Luminex XYP instrument at the same time Verify Successful Firmware Upgrade Update Interface Cable PN 89 00002 00 071 Rev C Figure B 19 LXFirmware Update Tool Dialog Box 4 Click Upgrade adjacent to the Detector Device text box The Confirm LX100 Firmware Download dialog box opens Click Yes to continue with the upgrade Click No to return to the previous dialog box 5 The Download In Progress dialog box opens displaying the progress Read the information presented on the dialog box W
107. board then connect the Y cable to the PC See Figure B 5 1 Keyboard 3 Y Cable 2 Barcode Reader 4 Mouse Figure B 5 Connecting the PC Mouse Barcode Header and Keyboard PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 Note The sheath and waste containers must be placed on the same surface as the Luminex XYP instrument Do not place the containers on top of the Luminex 100 analyzer Install the Luminex XYP Instrument Sample Probe 12 13 14 xMAP Technology Connect the color coded tubing connectors to the Luminex 100 analyzer Blue sheath green air orange waste Fill the sheath bottle with sheath fluid to just below the air intake fitting Place the sheath and waste containers to the left side of the analyzer Connect the blue connector to the sheath fitting bottom fitting on the sheath bottle Connect the green connector to the air fitting top fitting on the sheath bottle Connect the orange connector to the waste fitting on the waste bottle Plug the Luminex XYP instrument Luminex 100 analyzer PC and monitor power cords into approved outlets We strongly recommend using an uninterruptible power supply to protect the system from power variations Refer to Recommended Additional Equipment page 3 7 for additional information To install the Luminex XYP instrument sample probe Verify that the Luminex 100 analyzer and Luminex XYP instrument power switches are off Un
108. calibrator and control containers to ensure homogeneity Do not dilute xMAP calibrator or control reagents 2 Load a microtiter plate with at least five drops of each CALI in well Al CAL2 in well B1 CONI in well C1 CON2 in well D1 and distilled water in well E1 through H1 to wash a total of four times Use different wells as necessary To select different well locations in the software click on the drop down arrow next to the entry cell for the calibrator or control then click in the well location on the microtiter plate image 3 Click Eject Retract then place the plate on the plate holder 4 Fillthe Luminex XYP reservoir with a solution of 7096 isopropanol or 7046 ethanol 5 Click Eject Retract 6 Onthe Maintenance tab click Prime Click OK and wait for the Prime to finish about 1 minutes 7 Click Alcohol Flush Click OK and wait until the alcohol flush completes The Device Status section in the status bar changes from yellow to green and displays Standby 8 Click New CAL Targ to enter or confirm calibration lot numbers in the Update CAL Targets dialog box See Figure 5 25 9 Enter the CALI lot number and expiration date as printed on the bottle Enter the values listed on the Certificates of Quality COQ included with your calibrators into the CALI boxes If you are using a previously entered lot select it from the drop down menu in the Current CALI group box or click Import to import the information See
109. ch uses a covalently linked fluorochrome antibody complex to detect or quantify a particular antigen PN 89 00002 00 071 Rev C xMAP Technology Luminex xMAP microsphere set laser microparticle microspheres multi analyte multi batch photobleaching PMT qualitative quantitative reporter reporter channel RP or RP1 RP1 RP PN 89 00002 00 071 Rev C Luminex xMAP microsphere set Luminex multi analyte microspheres containing a unique mixture of two distinctly colored fluorochromes to distinguish them from other multi analyte microspheres Light Amplification by Stimulated Emission of Radiation laser This highly purified source of light is an efficient way to excite fluorochrome electrons A solid substance with a diameter in the micrometer range Often used as a synonym for a microsphere Polystyrene spheres with a diameter in the micrometer range Also called beads Several assays or tests performed simultaneously in the same reaction container A set of batches to be processed consecutively The process in which light absorption converts the fluorochromes inside the beads into different fluorescent or nonfluorescent compounds Photobleaching prevents beads from being properly classified Photomultiplier tube measures the excitation emission intensity of the reporter dye bound to the surface of the xMAP microspheres Pertaining to calculations that determine the absence or presence of
110. commands see Validating or Invalidating Standards and Controls on page 5 83 and Change Lot on page 5 85 In addition to the function buttons you can choose to sort data sequentially by order acquired or alphabetically by Sample ID These options are available in the Sort group box next to the function buttons These sorting functions are helpful in viewing batches containing replicate samples Replicate samples are defined as samples with identical sample identifications Replicate standards PN 89 00002 00 071 Rev C xMAP Technology Errors Tab Using Luminex 100 IS 2 3 Software controls and unknown samples are not always acquired in sequential wells and thus make sample viewing difficult When viewing samples alphabetically all replicate samples are displayed together with the replicate sample s average AVG then individual samples If you view replicate batches sequentially each sample displays in the order it was acquired followed by a replicate average summary section The Errors tab displays a list of errors that occurred during acquisition It organizes the errors in two categories System and assay errors top section of tab and Sample errors bottom section of tab Table 5 5 lists the errors in each category irai Estan Quantitative Batch Test 1 Failed Control in Batch Test 4 Sample Errors A2 Sample HighiLow H1 Sample High Low Hex
111. continue in full force and effect EULA PN 89 30000 00 070 Contents Introduction 1 1 About This Manual 0 0 0 0 eee eee eee eee 1 1 The Luminex 100 IS 2 3 System 0 0 0 0 00 00 0000 1 1 Intended Use uela e bee ida ahaa yee aaa 1 1 Technical Support 0 0 0 cece eee 1 2 Luminex Website 0 0 0 0 eiee i Aea eens 1 2 Safety 2 1 Symbols 22s li ead head eR BERNER BERI RT UE et 2 1 Warnings and Notes 20 cece eee 2 2 Safety Precautions llle 2 2 ECC Label eder duode eut e d tud the 2 4 PIUIGICS EP eis aven wi sateedd andes tages 2 4 Luminex 100 Analyzer Laser 00000005 2 5 Barcode Reader Laser cece eee eee eee 2 7 Mechanical i645 bec olus e ede ne A 2 7 Biological 45 e dane ee COON ex dae ae awn 2 7 Heat mm 2 8 Blue Indicator Light 0 0 0 0 eee eee eee ee 2 8 Decontaminating the Luminex 100 Analyzer for Return Shipment 0 0 0 cece eee eee ee eee 2 9 The System 3 1 Theory of Operation 0 0 0 0 eee eee ee eee 3 1 Hardware 1212 eid h ea E laca Le eas 3 2 xMAP Technology Reagents l leeeeeeees 3 3 Required Laboratory Reagents 0 0 0 ce eee eee 3 3 Luminex 100 IS 2 3 Software 0 0 0 cece eee eee 3 3 Luminex 100 IS Performance Specification 3 3 Noc PM 3 3 Accuracy and Precision lslee eee ee eee eee 3 4 Se sl vity ro rrer du dddowsd ta d ueexe D e ee R DIE ee dede 3 4 Capac
112. cording to function The Daily Startup group contains the Warmup Prime Alcohol Flush and Wash Commands For more information on daily startup see page 5 43 For more information on the commands see the Commands section on page 5 31 The Instrument Calibration group contains the CAL CAL2 CONI and CON2 buttons For more information on calibrating the system see page 5 46 For more information about these commands see the Commands section on page 5 31 The Batch Setup group contains the New Batch New Multibatch and New Lot buttons For more information on creating and running batches and multibatches see page 5 51 For more information about these commands see the Commands section on page 5 31 The Reports and Analysis group contains the Analysis and Print buttons For more information on running reports and analyses see page 5 86 For more information about the Analyses and Print commands see the Commands section on page 5 31 The Daily Shutdown group contains command buttons that you can use when shutting down the system For more information on performing a daily shutdown see page 5 96 For more information on the Sanitize and Soak commands see the Commands section starting on page 5 31 The Run Batch tab contains a microtiter plate and reservoir image XYP and DD temperature readbacks a sheath pressure gauge print button command list displaying batch commands and their status and plate and XYP command buttons
113. ction rate 1 uL second Sample uptake volume 20 200 pL Reporter channel detection A D resolution 14 bits Communications interface USB Luminex XYP instrument communications interface RS 232 Luminex 100 IS User Manual Version 2 3 Luminex XYP Instrument General Luminex SD System General PC Specifications xMAP Technology 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 Ibs UL installation category UL Installation Category II as defined in Annex J of UL 61010A 1 Pollution degree UL Pollution Degree 2 as defined in Section 3 7 3 2 of UL 61010A 1 Heater operating range 35 C to 55 C 95 F to 131 F with tolerance 0 C to 2 C Input voltage range 100 240 V 10 1 8 Amps 47 63 Hz AC inlet fuse 3 A 250 V fast acting Ambient temperature 15 C to 30 C 59 to 86 F Humidity 20 to 80 noncondensing Altitude designed to operate at up to 2400m 7874 feet above mean sea level Physical dimensions 20 cm 8 inches W x 30 cm 11 75 inches D x 24 75 cm 9 75 inches H Weight 9 kg 20 Ibs UL installation category UL Installation Category II as defined in Annex J of UL 61010A 1 Pollution degree UL Pollution Degree 2 as defined in Section 3 7 3 2 of UL 61010A 1 Input voltag
114. d Luminex 100 IS User Manual Version 2 3 Run Self Diagnostics Using the Cleanup Utility xMAP Technology To drain the system 1 On the Maintenance tab click Eject Retract Ensure that the reservoir is empty or insert a plate onto the plate holder 2 Make sure that the correct location is selected next to the Drain button Click Drain A confirmation dialog box opens 3 Click OK The Device Activity box on the Status Bar indicates that the system is draining To run self diagnostics Onthe Maintenance tab click Self Diag 2 Click OK The system processes the various self diagnostic tests When tests are complete the Status Bar changes from a Processing command state to an Idle command state The self diagnostic tests should take less than one minute to complete If the self diagnosis fails you can obtain detailed information regarding the results of the self diagnostic test See the following View Self Diagnostic Details section To view details of the self diagnostics test that passed or failed 1 Click on the Diagnostics tab and view the Message log If a diagnostics test failed an error message displays with a yellow background 2 Double click the yellow row to see a detailed description An Errors dialog box opens showing a list of passed and failed self diagnostic tests Click OK to close this dialog box Use the Cleanup Utility to e Perform a disk cleanup e Delete the
115. d Table Background This is the color used in filling the table s rectangle Currently this feature is not used Table Foreground This is the color used in bounding the table s rectangle and for the text inside the table Currently this feature is not used PN 89 00002 00 071 Rev C xMAP Technology Using Luminex 100 IS 2 3 Software Test 36 Customization 3 xj General Axis Font Color Style Grapl Desk Background a a si O B E E LJ n LIMEN TCI C Graph Foreground C Graph Background Table Foreground Table Background Cancel Original Export Maximize Figure 5 50 Customization Dialog Box Color Tab Style Tab use the Style tab for control of subset color subset line type and subset point type Subset 1 line type and Subset 2 data point See Figure 5 51 Test 36 Customization X General Anis Font Color Style Subset 2 ee om Point Type e Solid Circle Line Type Lass Cancel Apply Original Export Maximize Figure 5 51 Customization Dialog Box Style Tab To modify features using the Graph Menu Most of these menu items provide a shortcut for many of the features provided in the Customization dialog box Refer to page 5 77 for details 1 Right click anywhere in the graph on the Standards tab The graph menu opens See Figure 5 52 2 Select the desired menu item from the list and it
116. d well or reservoir on the plate Click OK Perform this step twice 6 Check that the Luminex XYP instrument sample probe has been vertically aligned for the plate used in the kit After Running Samples After running samples Refer to Maintenance Procedures on page 5 92 for detailed Sanitize and Soak command operation 1 Sanitize with a 10 to 20 household bleach solution 2 Run two Wash cycles with distilled water 3 Soak with distilled water Wait until the soak completes 4 If desired turn off the Luminex 100 analyzer Routine Tasks Sheath and Waste Fluids Replace the sheath fluid and empty the waste container as required You must manually monitor waste container levels The Run Batch tab displays a warning when you need to refill or replace the sheath fluid container See Figure 6 1 File Toole Help JmxQ4NI 549 Home Run Batch Maintenance Tm Luminex100 Integrated System 2 3 No Batch Loaded N v 10 11 12 XYP Htr Temp DD Temp OOC 65 5 3 60 55 we 45 0 000001000E OOOOOOQC OOOOOOQC 00000000C OOOCOOOOCB OOCOOCOQCs OOCOCOOCs OOCOOOOQOQ Cmd No command Plate Loc Cmd Status h A1 Flatel Succeeded 23 sec Toti EvenisiSee Sheath Empty Standby idina Wemed p o Figure 6 1 Refill Sheath Fluid Warning Circled in Photo 6 2 PN 89 00002 00 071 Rev C xMAP Technology Refill the Sheath Fluid Container Empty the Waste Container Note There
117. d Patient List The Open Patient List File dialog box opens 4 Double click on a patient list text file to append to the batch The patients from that list append to the first unassigned available well If all patient IDs in the batch or multi batch are identified the system appends the patient list to the first empty location after the batch s or multi batch s last command list activity If any of the acquire sample commands within the template of the batch has an unassigned value the system applies the first 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 5 Choose whether to save the batch or multi batch for later use Click Save only to save the batch or multi batch To run it after you finish creating it click Save and Load 6 Click Finish The system saves the batch or multi batch for later use or it loads it for immediate use according to the decision you made when creating it Use this procedure to open a previously processed batch and correct the batch s sample names and dilution factors You can delete a sample from a batch If you change the patient information in a batch including those imported from a patient list the system automatically notes the change in the comments box of the sample table within the database While editing the database the system marks the changes you make in r
118. d instructions on using a feature in the Luminex IS 2 3 software Opens a dialog box in which you select a calibration file that contains calibration lot information to import to use for calibrating the analyzer Opens a dialog box in which you select a control file that contains control lot information to import for use when verifying calibration Opens up the Import Template dialog box from which you select a template to import for use in a batch This combination menu command on the Batch Setup window allows you to add a user defined number of patients to the command list or skip a defined number of wells on the microtiter plate The two options on the menu are Acquire Patient and Skip Invalidates or removes a control from the data analysis Luminex does not recommend invalidating controls Removes a standard from the data curve Use this command if doing so improves the curve fit Use caution when doing so because invalidating a standard will greatly affect the curve fit and subsequently the sample results Opens the Open Patient List File dialog box from which you select a patient list text file to append to a batch Toggles the x axis scale on the histogram or dot plot between logarithmic and linear modes Toggles between maximum and minimum histogram and dot plot views This command is found in the Analysis window Use this command to view the next test in the batch Luminex 100 IS User Manual Version 2 3 New Adva
119. d or control you want to validate or invalidate See Figure 5 54 Select the desired menu item to apply When invalidating the Name box turns red with an asterisk proceeding it When validating the Name box reverts to black text Invalidate Control Invalidate Control All Tests Invalidate Standard 1 Invalidate Standard All Tests Validate Control Validate Control All Tests Validate Standard Validate Standard All Tests Invalidate Standard Invalidate Control Validate Control Validate Standard 1 Menu for multiple tests 2 Menu for single test Figure 5 54 Invalidate and Validate Shortcut Menus 2 Click Recalc to recalculate the results if the Auto option was not selected To validate or invalidate a standard or control entry using the Invalidate and Validate Buttons 1 Select the desired standard or control name in the Standards or Controls grid 2 Click the appropriate buttons at the bottom of the Analysis window Invalidate Standard F4 Validate Standard F5 Invalidate Control F6 or Validate Control F7 PN 89 00002 00 071 Rev C xMAP Technology Using Luminex 100 IS 2 3 Software 3 The appropriate Standard or Control dialog box opens To invalidate or validate all tests click Yes For only the single test click No When invalidating the Name box turns red with an asterisk proceeding it When validating the Name box reverts to black text 4 Click Recalc to recalculate th
120. dard StdL 1 Finish Description 4 01 Plate Acquire Standard StdL L 1 None 3 5 E1 Platel Acquire Standard Std XL 1 X ij GIF1 Plate1 Acquire Standard Saxl 1 Conca A a 7 G1 Plae1 Acquire Control ConL 1 3 8H1 Plate1 Acquire Control Con 1 Created By 9 A2 Platel Acquire Patient 2 L Name 1062 Plate1 Acquire Patient 2 Load Pa List 11 C2 Plate1_ Acquire Patient 2 Template Info 12 D2 Plate1 Acquire Patient 1 13 E2 Plate Acquire Patient 1 e Name 14 F2 Plate1 Acquire Patient 1 Help B3 Repatassay 15 G2 Plate1 Acquire Patent 1 lel Description 1 2 2 4 8 6 7 0 9 10 10 12 Save and Load Raplicate Simplax Quant r 22 5 rem UE New Lot 9 0 0 0 09 0 0 9 4 r Standard Info F AOCGCOCOCOCOCOCOC Product No 3000 Product Name 36 RepOt Kit Version No Lot Name 36Repotsed SERRE Expiration Date 06 10 2005 Control Info Developing Co Product No 3000 Product Name 36 Repat Kit mny Lot Name 38RepQtcon Expiration Date 08 10 2005 Figure 5 27 Luminex Batch Setup Window Enter the batch name if different from the default name a description optional and the creator s name optional Luminex 100 IS User Manual Version 2 3 Note If any of the acquire sam ple commands within the tem plate of the batch has an unassigned Sample ID the sys tem applies the first patient ID in the list to the unassigned sample acquisition command The sys tem appends an
121. dialog box opens See Figure 5 28 If you do not want to add a patient list to the batch skip to step 11 pen Patient List File Look in a Common e Ex E3 ExportedT emplates s BrowseDB ocx s cbMsgbox ocx E crviewer dll s Datalnterpretation2 ocx E GenFormulaDisplayLib ocx x GraphObjects dll E Graph bjectsInterface dil My Documents E IVD_CalReport ocx E My Network P 21x E IVD ConReport ocx E IVDImplements dll E IVD CPReport ocx E IVDInterfaces ll E IVD L VJTReport oc E IVDinterpGraph o El I D_MainReport ocx El IVDinterpGraphD E IVD PSReport ocx E IVDMachineCalib E IVDBackup ocx E IVDMath dli E IVDBeadSelect ocx E IVDMathCommon E IVDDevice dll E IVDMathE sp dll is IvDGraphwWrapper oc E IVDMathlnterface i ion Flenm rz Open as read only Figure 5 28 Open Patient List File Dialog Box 11 Select a patient file to append to the batch and click Open The system appends the patients to the batch PN 89 00002 00 071 Rev C xMAP Technology Open a Batch Copying and Exporting Batch Data Clear a Batch from the System PN 89 00002 00 071 Rev C 12 13 14 15 Using Luminex 100 IS 2 3 Software If all patient IDs in the batch are identified the system appends the patient list items to the first empty location following the batch s last command list activity See Add a Patient List on page 5 62 for information re
122. e Also see classification channel Refers to dyes embedded in the microsphere Also see 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 Used to verify standards within the kit Tells you that the curve or thresholds are correct xMAP microspheres used to verify the calibration and optical integrity for the Luminex 100 analyzer Principal fluid pathway within the optics component of the system through which the sample is read The analysis of acquired batch data The difference between the current temperature of the Doublet Discriminator APD and its temperature at your last calibration The system displays this value on the Diagnostics tab within the software The current temperature of the doublet discriminator avalanche photo diode Wavelength range that an excited fluorochrome emits when its electrons fall from a higher to a lower energy state Expressed in nanometers nm Occurs when the signal processor determines that a particle is being observed Referred to as one bead as it passes through the laser Wavelength range that excites a molecule s electrons to a higher energy state Expressed in nanometers nm Light emission that occurs when the electrons of a fluorochrome drop to a lower energy state A fluorescent molecule See fluorochrome A technique whi
123. e cleared batch if it has not been run by clicking Open Batch l To clear a batch from the system Right click on the area to clear Luminex 100 IS User Manual Version 2 3 Replay a Batch xMAP Technology 2 Click Clear in the dialog box 3 Click Yes to confirm that you want to clear the batch You can reprocess batches through the system multiple times using Replay Batch Replay Batch uses the data stored in the run files from the initial acquisition to reprocess a batch creating a new batch output file Each time you reprocess a batch using Replay Batch the system handles it as if it is a new batch thus creating a separate processed batch entry and output file The initial batch data and output file always remain intact and unchanged You reprocess a batch using Replay Batch to e Run as demonstrations to see how the system processes samples and analyzes the results e Testa batch using different parameters such as setting a different number of events to be collected or using a different bead map or new formula for analysis also using a different template The number of beads for collection must be less than or equal to the number of previously collected in the original sample If you reprocess a batch with the same template parameters in a different template the system obtains results identical to the original batch If you reprocess a batch using changed parameters the system may obtain different results W
124. e range 100 240 V 10 0 4 Amps 47 63 Hz AC inlet fuse 2 Amp 250 V time lag For systems using a PC A Dell OptiPlex GX280 or Dell Optiplex GX520 or newer PC is shipped with the Luminex 200 system For systems using a laptop a Dell D610 Notebook is shipped with the system Microsoft Windows XP is pre installed on the computers The power requirements are 115 230 V 6 Amps 50 60 Hz For updated information regarding the PC notebook or operating system go to http www luminexcorp com then click on the Support link to open the FAQ list PN 89 00002 00 071 Rev C xMAP Technology Recommended Additional Equipment Uninterruptible Power Supply UPS Surge Protector Printer Barcode Labels Vortex Bath Sonicator System Overview Electronics Power Input Module Communications Ports SB9 PIN Luminex 100 Analyzer Ventilation Filter PN 89 00002 00 071 Rev C The System Luminex highly recommends using an uninterruptible power supply UPS to protect your system from power outages Choose one that can provide 1050 Watts for at least 45 minutes The UPS should be UL listed CSA certified and CE marked when used internationally If you do not use a UPS use a surge protector Choose a protector that meets your needs Factors to consider include electrical environment endurance suppressed voltage rating and method of protection It should have six outlets rated at least 1500 Watts and be UL li
125. e results if the Auto option was not selected Change Lot Use the Change Lot command to edit the lot that is applied to the batch currently opened in data analysis To change the lot to another available lot 1 Click Change Lot Alt F8 located at the bottom of Analysis window to display the Choose Lot dialog box See Figure 5 55 2 The dialog box displays a list of available standard and control lots that you can apply to a batch Highlight the desired lot and click OK to apply the selected lot to the batch opened in data analysis Figure 5 55 shows standard and control Figure 5 56 shows standard only Choose Lot The following is a list of lots that are available to apply to this batch Please choose the lot that you wish to apply Standard Lots for Product Control Lots for Product B3638 Qt Kit B3638 Qt Kit ud zi on Edited ID 16 fghfgfghf ID 9 B3538Con ID 8 B3638Std ID 7 Note indicates the lot that is set as the current lot for new batches OK Cancel Figure 5 55 Choose Lot Dialog Box Standard and Control PN 89 00002 00 071 Rev C 5 85 Luminex 100 IS User Manual Version 2 3 xMAP Technology Choose Lot The following is a list of lots that are available to apply to this batch Please choose the lot that you wish to apply Standard Lots for Product B21Lum Qual B21LQStd ID 6 Note indicates the lot that is set as the current lot for new batches Cancel
126. e the old PC and set aside Place the new PC in place Connect the monitor power and Com cables to the new PC Install the keyboard into a USB port Connect the barcode reader to the back of the PC Connect the mouse to the mouse port Continue with the Install Luminex 100 IS 2 3 Software section To install the Luminex 100 IS 2 3 software Turn on power to only the PC and monitor switches are on the front The system starts up Windows Log into Windows as local Administrator a In the Welcome to Windows dialog box press Ctrl Alt Delete b In the Log On to Windows dialog box enter Administrator in the User Name box In the Password box enter the Administrator password If you do not know it see your IT representative or contact Luminex Technical Support In the Log on to box select the name of your local machine from the scroll list c Click OK to complete the log on procedure d Verify that all applications are closed Insert the Luminex 100 IS 2 3 software CD into the drive The CD autoplays and in a few moments displays the Luminex 100 IS 2 3 splash screen See Figure B 15 Luminex 100 IS User Manual Version 2 3 Note If the system displays a blank screen after it has rebooted press Alt Tab on the keyboard to display the software on the monitor Verify Successful Upgrade xMAP Technology Luminex100 IS 2 3 Luminex 1996 2004 Luminex Corporation All rights reserved Figure B 15
127. e using an SD see Appendix D of this manual Fluid leaks can result in poor pressurization and failed sample acquisition Symptom Possible problem Solution Pressure too low The sample probe is clogged The syringe seal leaks The syringe valve leaks Clean the sample probe See page 6 4 Replace the syringe seal See page 6 8 Hand tighten the syringe connection silver knob on the syringe valve Run a Prime command If leaks continue call Technical Support Large amount of fluid pooled around instrument Fittings or fluid lines are damaged Call Technical Support Fluid dripping from the sample probe The sample probe is clogged The sample three way valve is faulty Clean the sample probe See page 6 4 Contact Technical Support PN 89 00002 00 071 Rev C xMAP Technology Fluid is leaking from the front of the analyzer The syringe seal leaks The syringe valve leaks Troubleshooting Replace the syringe seal See page 6 8 Hand tighten the syringe connection silver knob to the white syringe valve Run a Prime If leaks continue contact Technical Support Sample Probe Problems with the sample probe can lead to fluid leaks and pressurization problems as well as inhibit sample acquisition Symptom Possible problem Solution Sample probe leak Sample arm is stuck in the up position The sample probe is clogged The system is
128. e wrong Verify that you are using the template correct template See Importing Templates on page 5 52 You are using incorrect lot Verify that you have entered the information correct lot information See page 5 46 There is a problem with the kit Run system controls If they pass contact the kit manufacturer Luminex SD Problems Filter Malfunction Draining the Reservoir If the empty sheath fluid container is not replaced and the system continues to operate the Luminex SD system eventually vents pressure to prevent air from being introduced into the Luminex 100 analyzer This may interrupt a sample and prevent further samples from being collected If the filter attached to the sheath intake line becomes clogged from extended use an alarm will sound even though the bulk sheath container is not empty If this happens contact Luminex Technical Support for a replacement filter If the alarm sounds even though the bulk sheath container has fluid and the sheath filter is in good condition the system is reporting a malfunction If this happens contact Luminex Technical Support If you need to ship the Luminex SD system back to Luminex Corporation drain the reservoir before you pack the system Call Technical Support for additional information PN 89 00002 00 071 Rev C xMAP Technology Verification PN 89 00002 00 071 Rev C Troubleshooting To verify your system from the Maintenance tab 1 2
129. eak Make sure the lines between the sheath and waste bottles and the analyzer are fully connected Remove and retighten the sheath bottle cap Inspect the fittings to be sure they form a tight seal Check for system leaks Run a Prime command If you do not hear the compressor turn on call Technical Support Ensure that the fitting connects tightly above the sample probe below the blue light See Fluid Leaks on page 7 4 Disconnect the sheath and waste bottle connections from the analyzer Run a Prime Command If pressure builds remove and retighten the sheath fluid bottle cap then reconnect fluid lines to the analyzer If pressurization fails again replace the sheath bottle PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 Pressure too High Fluid Leaks Problem internal to the instrument The sheath bottle 1s overfilled Regulator not adjusted properly xMAP Technology Determine if the problem is with the analyzer or the SD or bottles by disconnecting the sheath line from the analyzer and running a prime Check the air pressure on the Diagnostic tab If air pressure builds the problem is with the SD or sheath fluid bottle Ensure that the sheath bottle is not filled above the fill line If using bottles open the center door on the Luminex analyzer Use a screwdriver to adjust the regulator to fit in the center of the green region on the Run Batch tab If you ar
130. ed Field Name Field Value Description Results This field has no associated value It is used to indicate the beginning of the statistical results section of the OUTPUT CSY file DataType type This field is the name of the statistic represented in the Sample versus the Test data block immediately below this field Possible values for DataType include Median Result Count Mean CV Peak Std Dev Trimmed Count Trimmed Mean Trimmed CV Trimmed Peak Trimmed Std Dev and Avg Result See Table 2 Statistics Definitions CRC Entry Optional CRC indicator for the file data Used to detect external changes to the file Statistics Definitions Statistical calculations are performed for each test in each sample The number of events to collect for each test in a sample is defined in the template from which the batch was created In any equations listed below N indicates the number of events that were collected for an individual test in a single sample The trimmed distribution represents the events that were collected for an individual test in a single sample with the lowest 5 and highest 5 of the data points removed to help eliminate outliers Table D 2 Statistics Definitions Statistic Description Median The middle value in the distribution of data Result The final test result based on a qualitative or quantitative analysis This value could have units associated with
131. ed Developing Co C Product No 1 P g m Product Name Productt uminex 9 Lot Name A123457 Expiration Date 05 30 2002 Create a New Advanced Batch PN 89 00002 00 071 Rev C Figure 5 34 Luminex Batch Setup for Dilution 4 To change the dilution factor click the Dil Factor field The white background indicates that you can enter text Enter each dilution factor as a decimal not as a ratio 5 Click Finish The system saves the information you entered Use New Advanced Batch to acquire data without creating a template It writes raw data results to a simple csv file format You can define parameters for samples gates regions events on plate and off plate commands This feature does not store the results in the Luminex System database or allow you to perform data analysis on acquired batches The Luminex analyzer uses only the 100 region bead map However in the Acquisition Detail tab you can view the data for 25 50 64 and 100 regions and save the data to a csv file Use plates with wells that will hold at least 185 uL the extra 25 uL from the sample plus an extra 160 uL that is dispensed back into the well following acquisition Luminex 100 IS User Manual Version 2 3 xMAP Technology Tocreate a New Advanced Batch 1 Open the Acq Detail tab 2 On the Acquisition Detail toolbar click New Advanced Batch The Options Dialog Box opens with the General tab displayed See Figure 5 35
132. ed text This distinguishes the change from the patient information entered into the original batch Patient list entries are case sensitive Figure 5 33 shows an edited patient list Luminex 100 IS User Manual Version 2 3 xMAP Technology To edit a patient list 1 On the File menu select Edit Patient List The Open Batch dialog box opens 2 Select the desired batch containing the patient list that you want to edit and click Select The Edit Patient List dialog box opens similar to Figure 5 33 3 Edit the desired patient and associated dilution factor information Click Finish to accept your edits and close the dialog box A Edit Patient List Batch 4 5 02 12 09 ID 6 gi Location Sample ID Dil Factor C1 1 v D1 Finish E1 1 F1 X Cancel LJ Load Pa List Figure 5 33 Edit Patient List Dialog Box Assign Sample Indicate the sample dilution factor so the sample analysis in Dilution Factors quantitative tests is accurate The system multiplies the result by the dilution factor for reporting Do not use dilution factors for qualitative testing You define the dilution factors on a sample by sample or patient by patient basis The list displays each sample s accession number and dilution factor in relation to its well position To assign sample dilution factors 1 On the File menu click New Batch The Open Template dialog box opens 2 Select the desired template and click
133. een acquired you must rename the lot To create a new lot 1 On the Home tab click New Lot The Open Template dialog box opens See Figure 5 41 Open Template Version ID Template Name Description 3 Template 1 28 02 9 32 bwh vbby h 4 Template 1 28 02 10 22 21h 5 Template 1 29 02 12 2 2 90 B Template 1 29 02 12 25 123 7 Template 2 5 02 15 42 2 2 100 8 Template 2 5 02 10 04 2 2 101 9 Template 2 6 02 10 55 2 2 101 10 Template 2 6 02 10 58 2 2 101 11 Template 2 6 02 11 00 2 2 101 12 Template 2 5 02 11 01 2 2 101 ate 2 6 02 11 02 2 2 101 13 Temp Select Cancel Figure 5 41 Open Template Dialog Box 2 Highlight the template that will use the new lot information and 6699 click Select Then continue with substep a or b a If this is a new template with no associated lot information a New Standard Lot or New Control Lot dialog box opens as appropriate Enter the standard and control numbers to con Luminex 100 IS User Manual Version 2 3 Note Depending on the types of products associ ated with the template that you select the screen may vary from the example in Figure 5 43 That is if you are creating only standard lots then only the upper xMAP Technology tinue Once you enter the numbers the Update Lot Informa tion dialog box opens See Figure 5 42 and Figure 5 43 b If the template has associated lot information the Update Lot Information dialog box
134. en click Select The most recent Replay Batch is the last or has the highest ID number See Figure 5 29 Open Batch E ID Batch Name Description Multi Batch ID Name 2 B3554 Quant Testing Mean SD Trimmed Mean 4 3654 Rep Quant Batch Mean SD Trimmed Mean 5 Batch 5 1 12 16 10 FILEMODE None 6 Batch 6 102 16 11 FILEMODE None 7 Batch 6 3402 1349 FILEMODE None B Batch 5 342 13 51 FILEMODE None 9 Batch 5 3 12 113 52 FILEMODE None 10 Batch 5 3402 13 53 FILEMODE None 11 Batch 5 342 13 54 FILEMODE None 12 Batch 5 3402 14 13 FILEMODE None 13 Batch 5 3 02 14 17 FILEMODE None 14 Batch 6 302 14 17_FILEMODE None 16 Ratch RAM 14 10 Ell EMODE chon zj Cancel Figure 5 29 Analyze Open Batch The Analysis window opens showing the Batch info in the Standards tab To close the Analysis window click Close See Analyzing Batches and Multi Batches on page 76 Delete a Batch You can only delete unprocessed batches Batches are deleted from the Open Batch list and moved to the Open Incomplete Batch list To delete an unprocessed batch 1 PN 89 00002 00 071 Rev C On the File menu click Delete Batch A dialog box opens listing the unprocessed batches in the database Luminex 100 IS User Manual Version 2 3 Create a Multi Batch xMAP Technology 2 Select the unprocessed batch that you want to delete 3 Click Select to delete the batc
135. end at the left side of the tab No Cmd Name and Symbol columns shows available commands and their colored coded sym bols Symbol appears in the Table 5 9 Symbol Color Codes Symbol Color A Blue Cl Red C2 Green NI Teal N2 Purple W Olive D Black S Fuchsia PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software 6 Click the Bead Set tab Select the checkboxes next to each desired bead set for this batch Click Select All to select all the listed bead sets or Deselect All to deselect all selected bead sets General Plate Layout Selected Events Caption Select All i 100 001 m 100 002 Deselect AIl oO 100 003 L1 100 D04 Default Events cr D TE oO 100 006 100 m 100 007 o 100 008 Apply to All O 100 D09 o 100 010 oO 100 011 O 00 D12 zl 100 regions Y OK Cancel Figure 5 36 Options Dialog Box Bead Set Tab 7 Editthe Events and Caption information for each bead set Edit the Default Events box to change the default value Click Apply to All to apply the default value to all bead sets Table 5 8 lists selection shortcuts Table 5 8 Bead Set Tab Selection Shortcuts Selected Column Select by clicking in the box Events Column Select desired field and right click The value displayed in the Default Events box updates the selected field when you click Apply Default If names are defined under this column you can right click
136. eplace the sample probe and adjust the vertical height You should adjust the vertical height anytime the probe is removed 4 Alcohol Flush the system with 70 isopropanol or 70 ethanol Clean Exterior Surfaces To clean exterior surfaces follow these steps 1 Disconnect the system from ac power by turning off the power switches and unplugging the Luminex 100 analyzer the Luminex XYP instrument and the Luminex SD system 2 Wipe all exterior surfaces with mild detergent then a 10 to 20 bleach solution and finally with plain distilled water 6 4 PN 89 00002 00 071 Rev C xMAP Technology Calibration and System Controls Every Six Months Luminex 100 Analyzer Air Intake Filter Note Hold on to the tubing Do not allow the tubing to fall inside the the analyzer PN 89 00002 00 071 Rev C Maintenance and Cleaning Open both doors of the analyzer and clean all accessible surfaces with detergent followed by a 10 to 20 bleach solution and then plain distilled water Dry the sheet metal surfaces to prevent corrosion Plug in and power on the Luminex 100 analyzer the Luminex XYP instrument and the Luminex SD system Calibrate the system as outlined in Calibration Procedures on page 5 46 Run calibration and system controls at least once a month during routine use and following installation if the system is moved if a part is replaced if the delta calibration temperature shown on the system monitor
137. er Home Run Batch Maintenance Diagnostics L Luminex100 Integrated System 2 3 Batch Hame Batch 4 26 2005 10 42 Batch Description Autosize Statistic Median gt jm Mb xoa Sample TestA 39 Te ire Mstand B 56 Test C 36 E3 Platel F3 Platel Show Bead alb PEE fe 8 i 7500 15000 PN 89 00002 00 071 Rev C 1 Luminex IS 2 3 Toolbar 5 Status Bar 2 Batch Name and Description 6 Histogram 3 Batch Data Area 7 Dot Plot 4 Acquisition Detail Toolbar Figure 5 11 Acquisition Detail Tab Luminex 100 IS User Manual Version 2 3 xMAP Technology The Batch Name and Description section displays the name of the batch as well as its description The Batch Data area displays sample results The left column shows plate location and Sample ID description The remaining columns display selected bead sets for the assay Each row represents the data for each bead set from one well The Acquisition Detail Toolbar shown in Figure 5 12 provides functions to acquire raw data without using templates The toolbar has additional buttons if you have Developer s Workbench installed For more information about the commands on the Acquisition Detail Toolbar see the Command section beginning on page 5 31 diae b xo lll 1 2 3 4 35 6 7 1 Replay Batch 6 Cancel All 2 New Advanced Batch 7 Eject Retract 3 View Batch Data 8 Pause 4 Start Plate 9
138. er there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and the receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help This system contains fluidics In the event of a fluid leak turn off all power to the system and disconnect all power cords Remember that the on off switch is not a disconnect means the power cord must be removed from the outlet Contact Luminex Corporation for further information PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 Analyzer Laser PN 89 00002 00 071 Rev C Safety You must monitor waste levels manually Do not allow the waste container to overflow Empty the waste container each time the sheath fluid container is filled Do not place the waste container on top of the instrument Warning If biological samples have been tested with the system use your standard laboratory safety practices when handling system waste The Luminex 100 IS system classifies per FDA 21 CFR 1040 10 and 1040 11 as
139. era opc eb atia ders 3 10 sheath Filter dece eer eR ep ERR s 3 11 Air Waste and Sheath Fluid Connectors 3 11 Luminex Sheath Delivery System 3 12 Waste Fluid Container 0 0 20 ee ee eee 3 12 Optical nation eae So Foe cola N dard ack 3 12 xMAP Technology Reagents 0 000008 3 12 Basic Concepts 4 1 Background Information lllslleeeeeeeeeeeA 4 1 a e uice re e ob eR ERST ef CERT a ERST 4 Excitation ea eaa loli e RA ERR IRE sab bene ERE RE E 4 1 xMAP Microspheres 0 000 cece ee 4 2 Software Overview 0 0 cece een eee 4 2 Using Luminex 100 IS 2 3 Software 5 1 Main WindOW i5 eq ee C RO Res adios wa ae alas 5 1 Menu Bat eo err Gee IRR RCM AGRO RSV e 5 3 Toolbar 55 3 e repe ee eye Re gr este Wo este e p R6 5 4 Tabs 4E bEbeGenBUdesephb bee xS d bre d bre td 5 4 Home tab seus REV RV ER DET ES 5 4 Run Batch Tab 0 0 0 eee 5 5 Maintenance Tab 0 0 c eee eee eee eee 5 8 Diagnostics tab 1 0 eee ies 5 9 Acquisition Detail Tab 0000000008 5 12 ii PN 89 00002 00 071 Rev C xMAP Technology Contents Status Bar oclo e lA e ERAI REVELA YS penes 5 17 Secondary Windows 0 eee eee cece eee 5 20 Batch Setup Window 0 0 cee eee eee eee 5 20 Analysis Window 0 0 0 e eee eee eee eens 5 22 Errors Tab ius et bes Dee beat OU RP Tea 5 23 Standards Tab uu esee eee eme RR UR gs 5 24 Sam
140. ersion 2 3 Selecting Existing CAL or CON Lots Importing CAL or CON Lots xMAP Technology 4 Ensure that the analyzer is set to draw CONI and CON2 beads from the wells you loaded in step 2 of Run System xMAP Calibrators on page 5 47 5 Inthe Maintenance tab click CONI then click OK Wait until CONI completes The Device Status section in the status bar changes from Running to Standby 6 Click CON2 then click OK Wait until CON2 completes The Device Status section in the status bar changes from Running to Standby The System Monitor on the Diagnostics tab displays date and time in green if both CONI and CON2 are successful 7 Ensure the analyzer is set to the draw distilled water from the well you loaded it in step 2 of Run System xMAP Calibrators on page 5 47 8 Click Wash to wash the system after running the system calibrators Wash a total of four times You will need to change the well location Click on the dropdown menu located to the right of the Wash button 9 Click OK and wait until the wash completes The device status section in the status bar changes from Running to Standby If an error occurs during system calibration or verification an X appears in front of the Diagnostics tab title and the title text turns red To select an existing lot 1 On the Maintenance tab click New CAL Targ or New CON Targ 2 Selecta lot using the arrows located to the right of the I
141. escence intensity values Detect 1000 fluorochromes phycoerythrin PE per xMAP microsphere Reporter channel dynamic range 3 5 decades of detection The specifications below reflect minimum capacity values 10 GB hard drive 100 MB read write CD ROM Analyze multiple 96 well plates per batch Analyze multiple assay templates per plate Distinguish a minimum of 1 to a maximum of 100 unique xMAP microsphere sets in a single sample Detect and distinguish surface reporter fluorescence emissions at 575 nm on the surface of 1 100 unique xMAP microspheres sets in a single sample Sample core 15 20 um core at 1 uL sec sample inject rate Maintain samples at a constant temperature from 35 C to 55 C 95 F to 131 F Automatic sampling from a 96 well plate Start sampling from any well position Sheath container and waste container hold enough volume to run up to two 96 well plates between refills Microtiter plates with 96 wells must be compatible with the Luminex XYP instrument plate holder The following microtiter plate types are compatible with the Luminex XYP instrument plate holder flatbottom conical round filter bottom half plates overall height no more than 0 75 19 mm any color Microtiter plates with 96 wells must be compatible with Luminex XYP instrument heater block temperature from 35 C to PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 Analyzer General Optics Fluidics Electronics PN 89 00002
142. esults Notice that the well G3 location test result is lt 10 and the associated Comments column for the third sample indicates a sample out of range error Sample High Low because this sample has an MFI less than the lowest standard in the standard curve for this non competitive batch The first sample is within the standard curve range and thus displays an unflagged test result The system does not flag results as normal or abnormal according to a defined range Error flags only note samples that fall below or above the standard curve The Comments column cells are editable and the information is displayed in reports 5 28 PN 89 00002 00 071 Rev C xMAP Technology Using Luminex 100 IS 2 3 Software ES Analysis lal x Protein Batch Errors F9 Standards F11 S System Comments Open Batch Export Data Close IL 4 R 2 0 9995 Sample High Low Background R 2 0 9999 Sample High Low Background R 2 0 9994 Sample High Low Next Test F2 Invalidate Standard FA Invalidate Control F6 Change Formula F8 ee Mn Ue orien menial Recac F ato Previous Test F3 Validate Standard F5 Validate Control FT Change Lot Alt F8 C Alphabetically by Sample ID Background Unknown 1 Unknown 1 Unknown 2 Sys Sample High Low Unknown 2 Sys Sample High Low Unknown 3 Sys Sample High Low Unknown 3 Sys Sample High Low Unknown 4
143. ete batch 1 On the File Menu click Open Incomplete Batch The Open Run dialog box opens Select the batch you wish to recover from the list 2 Click Start to continue where the batch left off Note that a comment is added to the batch to indicate that the batch is being rerun The barcode reader lets you quickly enter sample identification numbers or accession numbers Use the Code 128 barcode label type when scanning barcode labels into the system as patient identities Warning Laser light Do not stare into the beam Class II laser product To scan samples into the system using the barcode reader 1 Aim the barcode reader s beam to read the middle of the barcode series horizontally The beam must encompass the entire set of bars See the shaded area in Figure 5 32 Figure 5 32 Barcode Reader Beam Aimed Across Code Luminex 100 IS User Manual Version 2 3 xMAP Technology Squeeze the barcode reader s trigger The beam activates and reads the barcode The barcode information appears in the appropriate row Visually verify that the barcode data scanned correctly It is critical that you scan or enter the correct identification number Add a Patient List You can apply a Patient List to any batch or multi batch only during batch setup in the Luminex Batch Setup dialog box You can create a Patient List text file using Windows Notepad or a text editor The text file must meet the following req
144. etween 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 The SOFTWARE PRODUCT is protected by copyright laws and international copyright treaties as well as other intellectual property laws and treaties The SOFTWARE PRODUCT is licensed not sold 1 GRANT OF LICENSE Subject to the terms and conditions of this EULA Luminex hereby grants to you a nonexclusive nontransferable nonassignable license without right to sublicense under Luminex s copyrights and trade secrets to use the SOFTWARE PRODUCT on a hardware platform purchased from Luminex pursuant to Luminex s terms and conditions of sale You may make one 1 copy of the SOFTWARE PRODUCT for backup or archival purposes only Although no rights or licenses under any of Luminex s patents are granted by or shall be implied from the license of the SOFTWARE or the sale of Luminex instrumentation to you the purchaser you may obtain a license under Luminex s patents if any to use this unit of Luminex instrumentation with fluorescently labeled microsphere beads authorized by Luminex by purchasing such beads from Luminex or an authorized Luminex reseller 2 RESTRICTIONS e You must mai
145. ev C xMAP Technology Open a Multi Batch PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Create a New Batch The procedure is shown on page 5 53 Click Save and Load instead of Save Only when you are finished setting up the New Batch To reassign the positions of the batches within the multi batch use the mouse to drag the highlighted well to the location on the microtiter plate where you want to begin acquiring data Make sure that each additional batch is in its desired location Enter the Multi Batch name and Created By then click Finish The Run Batch tab opens representing the batches you selected or created on the microtiter plate Click Eject and load the first plate of the multi batch Click Start Plate to being acquiring data from the multiple batches in the sequence that you set up To create a multi batch with existing batches Click New Multi Batch In the Luminex Multi Batch dialog box click Add Batch to add an existing batch to the multi batch See Figure 5 30 Select the first batch to add and click Select The batch appears beginning in well A1 of the microtiter plate on the Luminex Multi Batch Setup dialog box Red lines separate this batch from subsequent batches Repeat steps 2 and 3 to add additional batches Enter the Multi Batch name and Created By then click Finish The Run Batch tab opens representing the batches you selected or created on the microtiter plate Click Eject
146. ex or pipette your samples up and down to ensure that the beads are present in the solution Replace photobleached microspheres with a fresh lot of microspheres There is an insufficient number of beads in the sample Ensure that there are 2000 5000 beads per set per well Bead Detail Irregularities Use these tools to assist in diagnosing system and kit related problems system calibrators system controls assay standards assay controls PN 89 00002 00 071 Rev C xMAP Technology Troubleshooting error messages Review reports routinely to detect trends Use system xMAP control microspheres to check the success of the system calibration and for troubleshooting purposes If there is a problem with your kit results xMAP controls can help determine if the problem is analyzer related If Calibration and Controls are successful contact the kit manufacturer A normal bead detail display is shown below It depicts a tight bead population within a white region Bead Details Figure 7 1 Normal Bead Detail The histogram for the bead detail above looks like this Figure 7 2 Normal Histogram PN 89 00002 00 071 Rev C 7 11 Luminex 100 IS User Manual Version 2 3 xMAP Technology Symptom Possible problem Solution Calibration microspheres classify too high amp You may be using photobleached calibration microspheres Replace the microspheres with a fresh batch
147. fluid pressure is too high Ensure that the sheath fluid container is at the same level as the analyzer On systems with a Luminex Sheath Delivery system ensure that the sheath fluid pressure reading is equal to the original ready by adjusting the regulator as outlined in Install the SD System on page B 10 Calibrate and verify the system Runtime Sheath Pressure Out of Limits Too Low There is a pressurization problem with the sheath fluid See Pressurization on page 7 3 Low Laser Power Detected The system isn t sufficiently warmed up Possible Laser Failure Warm up the system This takes approximately 30 minutes Calibrate and verify the system Open the calibration trend report for LIOOCAL2 and record the last three reporter voltages Contact Luminex Technical Support with this information PN 89 00002 00 071 Rev C xMAP Technology Command Encountered Time Out Error The current command failed Troubleshooting Check the system to verify that itis warmed up and that there are no pressurization problems Repeat the command If the command continues to time out contact Technical Support Instrument Not Calibrated The instrument is out of calibration Calibrate the instrument Sample Error Sample error messages occur when there is a problem with sample Mess ag es acquisition These errors can display on the Diagnostics tab in the Message Log in Reports or on the
148. for acquisition 2 The Open Batch command on the Analysis window allows you to view data from a different batch Opens the online help file Opens the Open Run dialog box in which you select a batch to recover Opens the Open Multi Batch dialog box in which you select a multi batch to use for acquisition Pauses the command that the system is currently processing PN 89 00002 00 071 Rev C xMAP Technology Previous Test Prime Print Batch Worklist Print Report Recalc Replay Batch Report Raw Fluorescence Resume Sample Probe Down Sanitize PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software This command is found in the Analysis window Use this command to view the previously run test in the batch Removes air from the system s fluidic pathways by drawing Luminex xMAP Sheath Fluid from the sheath fluid container You do not need to supply solution in a plate Priming takes approximately one minute This command should also be used as part of the daily startup routine Prints the status of each of the commands in the command list as well as the microtiter plate graphic Prints the data interpretation report including the standards controls graph of standards and Samples data Recalculates an affected test after a change is made to lot information There are two options Manual recalculate and auto If the auto checkbox is selected the Recalc button manually recalculate is grayed o
149. garding the patient file format Verify the dilution factor settings and adjust as necessary See page 5 64 for more information Select Save and Load default or Save Only Click Finish If you selected Save and Load the Run Batch tab opens displaying the batch including the samples you added If you selected Save Only the system becomes idle as it waits for you to initiate a command If you selected Save and Load load the plate using the Eject Retract button then click Start Plate Use this procedure to open an existing batch The batch name and description appear on the Run Batch tab when you load the batch You can open Saved Only batches with this procedure 1 2 To open a saved batch for an acquisition Click Open Batch The Open Batch dialog box opens Double click on the desired batch The system loads the batch as you created it in the Run Batch tab Click Start Plate to initiate batch acquisition To export Batch Data Right click in the Batch Data area of the Acquisition Detail tab In the right click menu click Copy to copy the currently displayed data to the clipboard Click Export to manually export the currently loaded batch to the appropriate Output csv file The Clear Batch command clears the entire batch from the Run Batch tab or the Message Log on the Diagnostic tab Once you choose to clear the batch and verify that you want to continue with the command you can recover th
150. gins warming up when you turn power on however you will need to use the Warmup command if the system is idle for four hours or longer Washes fluidics line Sends fluid distilled water through the fluidic lines in the system Pulls the fluid from a well or the reservoir and runs it completely through the system to the waste receptacle Zooms or enlarges a specific area on the histogram or dot plot display Click and drag right to left to adjust the graph s range Luminex 100 IS User Manual Version 2 3 Procedures Using the Online Help xMAP Technology This section explains how to perform functions in the software Help files describe Luminex System features and capabilities You may find these topics by searching the contents of books and topics or by searching an alphabetic listing of the topics and books Topics provide information and details regarding software features system capabilities and any number of related material Books usually contain a group of topics These topics are grouped together because they discuss similar or related topics Hyperlinks provide instant access to another topic or subtopic with related information to the linked subject or term To open the system s online help 1 On the Help menu click Contents 2 Inthe Help dialog box scroll through the contents and select the desired topic Also consider the index to locate information 3 Double click the help topic that you want to v
151. h If you need to recover a deleted batch select Open Incomplete Batch from the File menu A multi batch is a set of batches that you want to process consecutively You can add batches to the multi batch from existing batches in your database or you can create new batches to add to the multi batch You can include as many batches as you need The software does not limit you to a certain number of batches per multi batch Different batches within the multibatch are separated by thick red lines above the first well and below the last well of each batch Multi batches may span more than one plate A blue line separates the graphical representation of the plates A scroll bar appears along the bottom of the microtiter plate image so you can view additional plates To create a multi batch with new batches 1 Click New Multi Batch The Luminex Multi Batch Setup dialog box opens shown in Figure 5 30 u Luminex Multi Batch Setup Please enter the required information and add batches to the Multi Batch list You may double click a batch for detailed information Note indicates a required field EIA X Add Batch New Batch Finish Cancel m Multi Batch Name By z le 7 mlelolse QOOOOO0O0O0O0000 No ID Batch Name Batch Description No Cmds Figure 5 30 Luminex Multi Batch Setup Dialog Box 2 Inthe Luminex Multi Batch dialog box click New Batch PN 89 00002 00 071 R
152. he Instrument 3 Open Batch 10 Disconnect from the Instrument 4 Create New Multi Batch 11 Eject Retract 5 Open Multi Batch 12 Open Help File 6 Start Analysis 13 Single Step 7 Export Batch Data Figure 5 2 Luminex IS 2 3 Toolbar Tabs This section describes the tabs in the Main window Home tab This is the default tab It is organized by the order of system use It contains a Favorites list and five button groups representing data acquisition and maintenance categories Luminex100 IS Software Eile Tools Help m Re z IRA Q Single Step Home Run Batch Maintenance Diagnostics Acq Detail Luminex Luminex100 Integrated System 2 3 Favorites Daily Startup Add Add Tempiatil a pex il E r i Eo H E E BackFlust ly A oM le Step 4 1 2 Template ui Pfeil Aicohol Fi ashi Instrument Calibration d od ed ad Batch Setup 2 mm K Reports and Analysis LIE Analys Print Daily Shutdown KT eel 1 Favorites List 2 Button Groups Figure 5 3 Home Tab PN 89 00002 00 071 Rev C xMAP Technology Run Batch Tab PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Favorites You can use the Favorites list to create a customized list of often used commands and templates Items appear in alphabetical order for easy locating For more information on setting up the Favorites list see page 5 42 Button Groups Button groups are grouped ac
153. he base of the cuvette The sample then passes through with sheath fluid at a reduced rate resulting in a narrow sample core to ensure that each microsphere is illuminated individually The sample injection rate is such that the xMAP microspheres are introduced to the optics path as a series of single events The Luminex SD system lets you run samples continuously without refilling sheath bottles It automatically draws sheath from a non pressurized bulk sheath container to constantly maintain a reservoir Luminex 100 IS User Manual Version 2 3 Hardware xMAP Technology of pressurized sheath fluid A single 20 liter sheath container provides enough fluid for 48 hours or more of normal operation The optics assembly consists of two lasers One laser excites the dye mixture inside the xMAP microspheres and the second laser excites the fluorosphere bound to the surface of the xMAP microspheres Avalanche photo diode detectors measure the excitation emission intensities of the color coding classification dye mixtures inside the xMAP microspheres and a photomultiplier tube detects the excitation emission intensity of the reporter molecule bound to the surface of the xMAP 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 Results of the analyses are processed and provided in a report format The Luminex 100 IS system i
154. he cable that connects the analyzer to the PC is 5 feet long the cable that connects the SD to the analyzer is 2 5 feet long 10 xMAP Technology Luminex19 Figure B 3 Install Alignment Guide Ensure that the power switches on the analyzer and XYP instrument are in the off position Attach the power cord to the power input module of the Luminex XYP instrument and attach the serial cable to the Luminex X YP instrument Do not plug the Luminex XYP instrument into the power outlet Attach the power cord to the input module of the Luminex 100 analyzer then attach the USB cable PN 85 10011 00 046 to P1 on the analyzer Do not plug the power cord into the power outlet See Figure B 4 Connect the Luminex 100 analyzer USB cable and the Luminex XYP instrument serial cable to the PC See items 12 and 14 in Figure B 4 PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 IS System Setup 4 1 USB Communication Cable P1 9 Y Cable Port 2 Luminex XYP Instrument 10 Mouse Cable port 3 Luminex XYP Instrument to PC Serial Cable 11 PC Power Cable 4 Power Cords 12 Luminex 100 port USB 5 Luminex XYP Instrument Power Switch 13 Monitor cable port 6 Luminex 100 Analyzer Power Switch 14 Luminex XYP port 7 Luminex 100 analyzer 15 Printer cable port 8 SD Cable P2 Figure B 4 Luminex 100 IS Connections Luminex 100 analyzer Luminex XYP Instrument and PC 11 Connect the Y cable to the barcode reader and key
155. he database is backed up and the Backup Database To dialog box closes Close the IS Software You remove the Luminex 100 IS Version 2 1 or 2 2 software through the Windows Control Panel 1 On the PC desktop select Start gt Settings gt Control Panel The Control Panel dialog box opens on the desktop Double click the Add Remove Programs icon The Add Remove Programs dialog box opens Under the Currently installed programs list select the Luminex 100 IS entry The entry expands to include the Change Remove button Click Change Remove The InstallShield Wizard dialog box opens similar to Figure B 17 Select Remove and click Next The Confirmation File Deletion dialog box opens Click OK If a Shared File Detected dialog box opens select the Don t display this message again checkbox then click Yes If a Self registration error dialog box opens Click OK When the InstallShield Wizard Maintenance Complete dialog box opens click Finish In the Add Remove Programs dialog box click Close Click the X on the Control Panel to close it If the Luminex 100 IS icon is still present on the desktop select the icon and drag it to the Recycle Bin To install the Luminex 100 IS 2 3 software continue with Install Luminex 100 IS 2 3 Software page B 15 PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 IS 2 3 Firmware Installation Firmware Upgrade Cable Configurations PN 89 00002 00 071 Rev C Luminex 1
156. he lot concentration values Click Save A dialog box opens alerting you that this lot has been used to set up a batch and that you must create a new lot to continue Respond to the Create New Standard Lot or Create New Control Lot with Yes Rename it in the New Lot Number dialog box Import Lot to an Use this procedure to import a lot to an existing template from Existing Template another computer from a diskette or from a CD ROM To import a lot to an existing template 1 On the Home tab click New Lot The Open Template dialog box opens Select the template to receive the imported lot and click Select The Update Lot Information dialog box opens See Figure 5 45 Click Import Lot The Open dialog box opens Navigate to the desired drive s folder and select the lot that you want to import and click Open The lot imports into your template PN 89 00002 00 071 Rev C xMAP Technology Export a Lot from an Existing Template PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Update Lot Information Import Export amp 2 Cal x i uer Revert Save Cancel Change the current lot by saving selected lot r Test Standards 2000 Current Lot B3654QtStd Current Lot REEE NewLot Delete Lot Exp Date 06 05 2003 7 r Test Controls 2000 Current Lot B3654QtCon Current Lot B36540Con NewLot DeleteLot Exp Datefo3 07 2003 LowLimit Expected Values
157. hen the download is finished the Status text box displays Download Complete Click OK 6 Turn off the power for 5 seconds then turn the power to the Luminex 100 back on 7 Next verify the upgrade See note 1 Start up the Luminex 100 IS software 2 On the Help menu click About the Device The About the Luminex 100 amp Luminex XYP Devices dialog box opens 3 Verify that the Controller Version entry for the Luminex 100 Device Information section on the dialog box displays the upgrade version If you are upgrading from Luminex 100 Version 1 7 replace the serial interface cable with USB cable supplied in the upgrade Luminex 100 IS User Manual Version 2 3 Luminex XYP Instrument Firmware Update Update Firmware Note If you are directed by Technical Support or by upgrade kit instructions to upgrade to a specific firmware version then click the Browse button and select the desired firmware version from the Open dialog box Note If you are upgrading the Luminex 100 firmware consider doing it at this time then verify the Luminex 100 analyzer and the Luminex XYP instrument at the same time Verify Successful Firmware Upgrade xMAP Technology If you are upgrading from Luminex 100 IS Version 2 1 or 2 2 continue to use the USB cable Follow the steps in this section to update and verify the Luminex XYP instrument firmware To update the Luminex XYP instrument firmware 1 2 Close any open appl
158. hen you replay a batch it labels unknown samples as Pal Pa2 Pa3 and so on If you replay a batch containing replicates replicate averaging will not be calculated in data analysis A number of variables can affect the final test results You may also change the standards or controls processed with the batch or multi batch These variables may effect your test results minimum number of events for acquisition formula used to analyze the MFI values e standards or controls validation or invalidation type of analysis qualitative quantitative acquisition only or maintenance To reprocess samples using Replay Batch 1 On the Acq Detail tab click Replay Batch The Browse for Folder dialog box opens displaying the My Batches folder PN 89 00002 00 071 Rev C xMAP Technology 2 Using Luminex 100 IS 2 3 Software Select the desired batch under the My Batches folder and click OK The Open Template dialog box opens Click on the desired template and click Select The Run Batch tab becomes the active tab You can monitor the commands as they process Click on the Acq Detail tab and monitor the data histogram and dot plot After replaying a batch you can analyze the data To analyze Replay Batch data 1 Note The Open Batch 2 dialog box does not list or show the templates asso ciated to the batches Click Start Analysis In the Open Batch dialog box select the batch you want to analyze th
159. hway 4 1 patient summary reports 4 3 5 86 PC specifications 3 6 performance specifications 3 3 Index 3 Luminex 100 IS User Manual Version 2 3 photodiode 4 1 photomultiplier 4 1 plate 4 1 plate holder ejecting tray B 10 polystyrene 4 2 power down 6 4 Practical Flow Cytometry 3rd edition by Howard M Shapiro M D New York Wiley Liss Inc 1995 4 1 Preliminary Off plate commands clear 5 69 preventing corrosion 6 4 prime remove air in waste line 6 2 printer 3 7 printing 4 3 probe 4 1 B 8 probe removal B 7 processed batches analyze 5 83 product numbers 8 1 protect 4 2 protection provided 2 2 protective housing 2 6 Q Quality Control Report 5 86 R radiation exposure 2 6 rate 4 1 raw fluorescence 5 39 reaction 4 1 reagent specifications 3 3 reagents 3 3 8 3 specifications 3 3 refill sheath warning 6 2 release system pressure 6 2 remove controls 5 84 probe B 7 shield B 8 standards 5 83 replace fuses 6 11 replace syringe plunger 6 8 report raw fluorescnce 5 39 reporter 4 1 reporter channel 3 5 Index 4 xMAP Technology reporter laser 4 1 specifications 3 5 reports 4 3 reprocess batches 5 56 reservoir B 9 responsibility 2 9 restoring the database reload database previously saved 5 91 results reports 4 2 return shipment 2 9 running samples after 6 1 before 6 1 once a day 6 1 sheath container cap 6 1 verify 6 1 S safety advisories 2 2 safety information B 1 safety precautions 2 1 2 2
160. iate biosafety procedures and use personal protective equipment such as gloves gowns laboratory coats face shields or mask and eye protection and ventilation devices Observe all local state and federal biohazard handling regulations when disposing of biohazardous waste material PN 89 00002 00 071 Rev C 2 7 Luminex 100 IS User Manual Version 2 3 xMAP Technology Heat Warning The heater plate of the Luminex XYP instrument may be hot and could cause personal injury if touched Do not touch the heater plate A Blue Indicator Light The blue light above the Luminex 100 analyzer sample arm indicates the on off status of the Luminex 100 analyzer and is harmless The blue light emitting diode LED does not emit light in the UV spectrum 2 8 PN 89 00002 00 07 1 Rev C xMAP Technology Decontaminating the Luminex 100 Analyzer for Return Shipment Note It is the user s responsibility to decontaminate the analyzer before shipment PN 89 00002 00 071 Rev C Safety Luminex Technical Support will give you a Return Material Authorization RMA number if they direct you to return the system They will explain how to return the system according to Luminex procedures The accessible surfaces and the internal fluidics system must be sanitized and decontaminated before returning the analyzer This is particularly important when biohazardous sa
161. ication between the PC and the analyzer Used during troubleshooting to help remove debris from the bottom of the cuvette 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 or 70 ethanol Any fluid that drains from the system drains to the Luminex XYP reservoir as the default However you can set the system to drain to any unused well on the microtiter plate The drain function normally expels 125 uL of fluid If the XYP plate is retracted this command ejects the microtiter plate If the XYP plate is already ejected this command retracts the plate Saves bead event data to the database Opens the Open Batch dialog box from which you choose a batch to export to an output csv file Opens a dialog box in which you choose the calibration file to export to an output file Opens a dialog box in which you choose a control validation file to export to an output file PN 89 00002 00 071 Rev C xMAP Technology Export Data Help Import Calibration Import Control Import Template Insert Invalidate Control Invalidate Standard Load Patient List Log Linear Maximize Minimize Next Test PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Exports data to a csv file in the batch folder There is no dialog box to confirm that the data was exported Opens the help file Use this command if you nee
162. ications On the PC desktop click Start gt Programs gt Luminex gt LXR gt LX Firmware The LX Firmware Update Tool dialog box opens See Figure B 19 Notice in the Movement Device text box item 3 in Figure B 19 that the top line displays the current version of the Luminex X YP analyzer firmware and that the second line displays its status If the second line indicates that the firmware is up to date then click Close No further action is required If an update version is available then continue with step 4 Click Upgrade adjacent to the Movement Device text box The Confirm XYP Firmware Download dialog box opens Click Yes to continue with the upgrade Click No to return to the previous dialog box The Download In Progress dialog box opens displaying the progress Read the information presented on the dialog box When the download is finished the Status text box displays Download Complete Turn the power off for 5 seconds then turn the power to the XYP back on Click OK Next verify the upgrade Start up the Luminex 100 IS software On the Help menu click About the Device The About the Luminex100 amp Luminex XYP Devices dialog box opens Verify that the Controller Version entry for the Luminex 100 Device Information section on the dialog box displays the version listed in the upgrade document Your upgrade kit instructions list the correct version number PN 89 00002 00 071 Rev C xMAP Technology Luminex SD Sys
163. iew A topical dialog box opens with information on that topic To display device information about the Luminex analyzer Luminex XYP instrument and the Luminex LXR SDK On the Help menu click About the Device The resulting dialog box shows information that may be helpful when contacting Luminex Technical Support Click OK to close the dialog box To display information about the system software On the Help menu click About the Software The resulting dia log box shows information about the system software This includes software version build number and the system copy right information Click OK to close the dialog box To display system information 1 Onthe Help menu click About the Software The resulting dialog box opens that displays software information 2 Click System Info The System Information dialog box opens Click X in the top right corner to close the dialog box 3 Click OK to close the dialog box PN 89 00002 00 071 Rev C xMAP Technology Setting Software Options Define General Tab Information PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Set up and customize the system software and enter your company information in the Options dialog box The Software Options dialog box has three tabs the General tab the Company Information tab and the Data Export tab To configure software options Onthe Tools menu click Options 2 Click on the tab in which you
164. ings defined by the kit manufacturer The process using system controls to ensure the analyzer is functioning properly with current calibration settings See Luminex xMAP microsphere set PN 89 00002 00 071 Rev C Luminex 100 IS System Installation Overview Luminex 100 IS System Setup PN 89 00002 00 071 Rev C This appendix provides hardware firmware and software installation procedures as required for new or system updates On new systems the factory preinstalls the latest versions of the firmware and software you perform only the hardware installation Upgrades become available for enhancements or to repair a corrupted file Upgrade instructions or Luminex Technical Support may direct you to sections in this appendix to perform a software or firmware procedure If this is a new Luminex 100 IS 2 3 system installation then only perform the procedure in the following Luminex 100 IS System Setup section Otherwise perform any of the following procedures as required Q Luminex 100 IS System Hardware Setup lIf you are install ing the Luminex 100 IS 2 3 system hardware continue with Luminex 100 IS System Setup page B 1 Q Luminex 100 IS Software Installation If you need to upgrade or reinstall your Luminex 100 IS 2 3 system software refer to Luminex 100 IS 2 3 Software Installation page B 14 Q Luminex Firmware Installation If you need to perform a firmware upgrade in your Luminex 100 analyzer Luminex XYP in
165. inless steel filter end of the sheath fluid line to the bottom of a full 20 liter box of sheath fluid Secure the cap on the sheath fluid box Place the sheath fluid container so that the cap is on the top e Attach the power cord to the input module on the back of the Luminex SD system Connect the P1 cable PN 85 10011 00 068 to the back of the SD and to P2 on the back of the analyzer Plug the power cord into the power outlet See Figure B 12 Figure B 12 Back of SD System P1 Port Turn on the power to the Luminex SD system the Luminex SD system automatically primes itself You hear the Luminex SD system pump turn on When the Luminex SD reservoir is about 2 3 full it automatically stops priming Open the center access door on the Luminex 100 analyzer Use a screwdriver to turn the regulator fully clockwise This typically takes three to six full turns Regulator is under arrow as Figure B 13 shows PN 89 00002 00 071 Rev C xMAP Technology Install the Luminex XYP Instrument Heater Block PN 89 00002 00 071 Rev C Luminex 100 IS System Setup EH EH EH F ss lt ss w lt i oe Figure B 13 Luminex 100 Analyzer Regulator Adjustment 6 From the Home or Maintenance tab select Prime During this prime cycle use a screwdriver to adjust the regulator on the front of the Luminex SD system See Figure B 13 Adjust it until the sheath pressure displayed on the Diagnostic tab System Monitor sectio
166. ion within the distribution Std Dev NZX x N N 1 1 Trimmed Count Trimmed Mean Optional The number of data points in the trimmed distribution Nj Optional The sum of the data points in the trimmed distribution divided by the number of data points Trimmed Mean 2x Ni Trimmed CV Optional The measure of relative dispersion within the trimmed distribution Trimmed CV 100 x Trimmed Std Dev Trimmed Mean Trimmed Peak Optional The value that is equal to the largest number of data points within the trimmed distribution Trimmed Std Dev Optional The measure of dispersion within the trimmed distribution Trimmed Std Dev N x Ex Ny N 1 Avg Result Statistics Column Definitions Optional The average of any replicate samples final test results based on a qualitative or quantitative analysis The blocks of statistical data are displayed such that the first row of data represents the column headers and the following rows represent the samples that were acquired for the batch Table D 3 Statistic Column Definitions Column Name Description Location The location of the sample in terms of the command list sequence 1 2 3 the well placement A1 B1 C1 or both 1 A1 2 B1 3 C1 Sample The name of the sample as defined in the batch setup Limited to 30 characters Test Test2 TestN The nu
167. irmware is up to date then click Close No further action is required If an update version is available then continue with step 8 8 Click Upgrade adjacent to the Movement Device text box The Confirm SD Firmware Download dialog box opens Click Yes to continue with the upgrade Click No to return to the previous dialog box 9 The Download In Progress dialog box opens displaying the progress Read the information presented on the dialog box When the download is finished the Status text box displays Download Complete Click OK 10 Turn off the power for 5 seconds then turn it back on 1 On the PC desktop click Start gt Programs gt Luminex gt LXR gt LX Firmware The LX Firmware Update Tool dialog box opens See Figure B 19 2 Anentry in the Movement Device text box should read Firmware up to date Luminex 100 IS User Manual Version 2 3 xMAP Technology Turn the power off to the SD XYP and LX100 Reconnect the serial cable to the X YP Connect the SD interface cable to the SD and LX100 Turn on the power to the SD The XYP and the LX100 Netwo rk Installation This section is intended for your network IT representative regarding Advisory computer name changes Luminex does not support network installations However if your installation requires that you change the computer name perform these steps Note The Windows XP security settings Virus Protection and e Automatic Updates alerts have been turned off
168. is NO warning of a high waste volume Empty the waste container each time you fill the sheath container Weekly Visual Inspection Run Self Diagnostics Clean Sample Probe PN 89 00002 00 071 Rev C Maintenance and Cleaning To refill the sheath fluid container 1 Release system pressure by removing the lid from the sheath fluid container 2 Replace the sheath fluid box with a new box or refill the sheath fluid container To empty the waste container 1 Disconnect the waste container from the Luminex 100 analyzer 2 Discard the waste from the waste container by appropriate means 3 Reconnect the waste container to the Luminex 100 analyzer and replace the cap Any time the sheath container is disconnected from the Luminex 100 analyzer you must remove air from the sample lines by priming If the sheath container ever runs dry prime the system at least twice until the air is removed from the system Open all of the Luminex 100 analyzer doors and visually inspect for leaks corrosion and other signs of improper function Check all visible tubing connections Check the Luminex XYP instrument air intake filter for buildup of dust Check the SD system and its connection for leaks If you see a leak turn off the power to the Luminex SD system and contact Luminex Corporation Run Self Diagnostics on a weekly basis to check system integrity On the Maintenance tab click Self Diag The system performs self
169. is immediately applied PN 89 00002 00 071 Rev C 5 81 Luminex 100 IS User Manual Version 2 3 Enable Automatic Analysis xMAP Technology Viewing Style Font Size Numeric Precision Plotting Method Data Shadows Grid Lines Grid in Front Include Data Labels Comparison Subsets as Normal Mark Data Points LL rh XE ML S a Maximize Customization Dialog Export Dialog Figure 5 52 Graph Menu Items You can configure the system to automatically start analysis data reduction immediately following batch acquisition If you disable the Auto start Analysis feature you must select Analysis from the Home tab or toolbar to analyze a batch Note that the Auto start Analysis feature is disabled when processing a multi batch To ensure that calculated data is exported to the output csv file you should not select both Auto Start Analysis and the Auto Export Batches checkbox on the Data Export tab of the Options dialog box Also note that Analysis and data reduction are synonymous terms To enable automatic analysis 1 Onthe Tools menu click Options then click on the General tab See Figure 5 53 Luminex100 IS Software Options sli xj General Company Information Data Export Default Batch Directory c My Batches Fal Current User A Analysis Display Digits 2 Iv Display Confirmation Screens r Enable Raw Data Storage F Report Raw Fluorescence s Auto start Analysis 9 OK ij
170. it as defined in the template It may also indicate some error condition in the analysis such as the sample was beyond the range of the curve fit a divide by zero error occurred etc Some example include Invalid the user invalidated this sample or a single test within a sample lt 10 pg mL the result could not be calculated because it fell outside the valid range of the curve fit 210000 pg mL the result could not be calculated because it fell outside the valid range of the curve fit ERROR some mathematical error occurred such as an MFI value that does not intersect the concentration curve N A a result is not applicable for this sample i e a background sample Count The number of data points in the distribution N The number of gated events that fell within the test s specified region Mean Optional The sum of the data points in the distribution divided by the number of data points Mean 2x N PN 89 00002 00 071 Rev C xMAP Technology Table D 2 Statistics Definitions Statistic Description CV Optional The measure of relative dispersion within the distribution CV 100 x Std Dev Mean Peak Optional The value that is equal to the largest number of data points within the distribution For example in data set 1 2 2 3 3 3 4 5 3 is the peak because it occurs the most number of times in the distribution list Std Dev Optional The measure of dispers
171. itative and Quantitative algorithms The algorithm is determined by the kit manufacturer during template creation A Qualitative analysis determines results as either positive or negative reactive or non reactive and so on The system is flexible in defining custom result ranges such as negative low positive high positive and so on Refer to the Luminex Developer Workbench Guide Version 2 3 for additional information All determinations are based on a single standard A Quantitative analysis determines the sample concentrations from standard curves using regression methods such as 4P or 5P logistic curve fitting There are two main assay types non competitive such as a capture sandwich and competitive In a non competitive assay the slope of a concentration versus Mean Fluorescent Intensity MFI standard curve is a positive number That is low concentrations result in low MFIs and high concentrations result in high MFIs Conversely competitive assays generate a standard curve with a negative slope the endpoints of which are high MFI low concentration on the left and low MFI high concentrations on the right You may direct the system to acquire samples in replicate regardless of batch type For qualitative batches replicate values are averaged and the reported interpretation is determined from this replicate average Replicates in quantitative batches are based on a standard curve that is generated by either the Fit of al
172. ity eos tae e Read su dede i ex gra 3 4 Luminex 100 Analyzer General 0 000000 3 5 OPUS soon eneilkks peed AER beads ad Edu Eder iad uds 3 5 PIUIAICS M 3 5 PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 xMAP Technology Blectr ties is ci ies lA Re er esI LEE RISE 3 5 Luminex XYP Instrument General 0 0 0005 3 6 Luminex SD System General 0 000002 eee eee 3 6 PC Specifications iua aa eoe wc P el eae eed 3 6 Recommended Additional Equipment 3 7 Uninterruptible Power Supply UPS 3 7 Surge Protector n d cia hanes ei AG 3 7 Printer occ os ead ne eae bad ee ERR os 3 7 Barcode Labels oes ee Ron wae wares ae 3 7 0 gt Care ran cie itrr tiri thr oiri eNe eii 3 7 Bath Sonicator crase sce eee rh hes 3 7 System Overview lesse 3 7 EleCtFODIOS iz ee ure me eoe mech o Re UR RR Ae 3 7 Power Input Module 0 0 0 00 eee 3 7 Communications Ports SB9 PIN 000 3 7 Luminex 100 Analyzer Ventilation Filter 3 7 Luminex XYP Instrument Ventilation Filter 3 8 FluidiCS ser RR che eee Re pir eee oie es as 3 8 sample Arm ide oe duce de ee rye won legis 3 8 Luminex XYP Instrument Sample Probe 3 8 Cheminert Fitting 0 0 2 eee eee ee eee 3 8 ACCESS DOOIS s eta epeece eb ae epe Bh Ea es 3 9 Air Intake Filter lees 3 10 SYMNGSC cds tanita eerie p
173. k Warmup then click OK The command list on the Run Batch tab indicates that the system lasers are running The Device Activity box on the Status Bar indicates that the system is warming The Laser Status section on the Status Bar is yellow as it counts down from 1800 seconds Upon completion the Laser Status bar turns green and displays Warmed Up Prime your system as part of the daily startup routine and as necessary to remove air from the system s fluidic pathways after e refilling the sheath container removing and replacing the sheath container e observing air in the tubing changing the sheath fluid filter changing the syringe seal PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 Backflush the System Run an Alcohol Flush Run a Wash Cycle xMAP Technology When priming the system draws Luminex xMAP sheath fluid from the sheath fluid container and sends it directly out to waste and takes approximately one minute You do not supply solution in a plate To prime the system Click Prime then click OK to confirm that you want to prime the system The status bar indicates that the prime command is processing Backflush the system to remove obstructions from the cuvette e if fluid does not flow through the waste tubing during prime cycles or during sample acquisition e if fluid drips from the sample probe during priming and forms puddles of fluid on the plate During a backflush the sy
174. k the Add Remove Programs icon The Add Remove Programs dialog box opens 3 Inthe Currently installed programs list select LMAT entry The entry expands to include the Change Remove button Click Change Remove Luminex 100 IS User Manual Version 2 3 Remove Luminex 100 Version 1 7 Software Note During the Luminex 100 Version 1 7 software removal error dialog boxes may open They are of no consequence to the uninstall Just click OK or Yes in response and continue with the uninstall xMAP Technology The InstallShield Wizard Welcome dialog box opens See Figure B 17 InstallShield wizard gt XI Welcome Madify repair or remove the program amp e Welcome to the LMAT Setup Maintenance program This program lets you modify the current installation Click one of the options below C Modify l Select new program components to add or select currently installed components to remove Cc D Ep Reinstall all program components installed by the previous setup gh ge Remove all installed components Back Cancel Figure B 17 InstallShield Wizard Dialog Box Remove Select Remove and click Next The Confirmation File Deletion dialog box opens Click OK If the Shared File Detected dialog box opens select Don t display this message again then click Yes If the Registry Editor dialog box opens click OK When the InstallShield Wizard Maintenance Complete dialog box opens click
175. ker to the right of the power input module 6 Replace the module door 7 Plugin and power on the analyzer or instrument PN 89 00002 00 071 Rev C 6 11 Luminex 100 IS User Manual Version 2 3 xMAP Technology PN 89 00002 00 071 Rev C Luminex 100 IS Maintenance Log Month s Year Procedure Use this form to record information over a four week period Fill in the month s and year above Fill in the dates in the first line of the table For each item listed at the left enter your initials under each date that you perform the item Note Follow your standard laboratory safety practices when cleaning or maintaining the system Do not remove the instrument cover under any circumstances Dates Daily maintenance Startup Initials for each item listed at the left fill in your initials under each date that you perform the item Laser warmup Check sheath fluid Check waste level Tighten sheath cap Alcohol Flush 7096 isopropanol or 7096 ethanol Wash twice sheath fluid or distilled water Shut down Initials for each item listed at the left fill in your initials under each date that you perform the item Sanitize 1096 to 2096 household bleach solution Wash twice water Loosen sheath cap Tum system off optional Weekly Visual inspection Date nitia
176. l standards or Mean of replicates The chosen curve fit is defined by the assay developer when defining an assay template The default is Fit of all standards Unknown samples are calculated from the standard PN 89 00002 00 071 Rev C xMAP Technology Note Luminex does not rec ommend performing Data Analysis while the Luminex System is performing data acquisition on another batch Customize Data Analysis Settings PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software curve Replicate samples are averaged to determine the reported quantitative result denoted as AVG The system can analyze only batches that it acquires using qualitative or quantitative templates It does not analyze acquisitions using Data Collection Only or Maintenance templates For an overview of the Analysis window see page 5 22 You can customize how the sample data results are displayed in the analysis graph on the Standards tab There are two options that allow you to customize the display Use the Customization dialog box and the Graph Menu right click menu some items are available on both You can define the general features of the graph axis settings and increments fonts colors and styles presented in the graph representing the sample data results You also can export the analysis to a graphic file clipboard and so on To modify the general features of the Standards tab graph 1 Click Data Analysis 2 Double c
177. lick OK Wait until CON2 completes Verify that the system controls completed successfully from the Diagnostics tab System Monitor If controls are successful the date and time appear as green text If controls fail the date and time are appear as red text On the Maintenance tab click the well where you placed the sheath fluid Click Wash A confirmation dialog box opens Luminex 100 IS User Manual Version 2 3 xMAP Technology 15 Click OK and wait until the Wash completes The Device Status section on the Status Bar changes to standby when the Wash cycle is complete The Run Batch tab indicates if the command succeeded or failed upon completion 16 Run four WASH commands 7 20 PN 89 00002 00 071 Rev C Product Numbers Hardware Note These part numbers are subject to change without notice Note Common description of product is enclosed in brackets PN 89 00002 00 071 Rev C Product Description Customer Number Rear Air Filter CN 0001 01 Bottom Air Filter CN 0002 01 Air Filter Intake CN 0027 01 Alignment guide XYP instrument CN 0016 01 Bar Code Scanner CN PCO03 01 Serial Cable 5 feet CN 0005 01 PC Luminex 100 IS CN PC04 01 2 Amp 250 Volts Fast Acting Fuse Qty 10 CN 0019 01 3 Amp 250 Volts Fast Acting Fuse CN 0051 01 Heater Block XYP CN 0017 01 Wrench Hexdrive Ball Driver CN 0025 01 3 32 Luminex 100 IS Version 2 3 complete CN L005 01 system Luminex
178. lick the desired batch The Analysis window opens displaying the Standards tab 3 Double click anywhere within the graph to display the Customization dialog box See Figure 5 46 Notice across the dialog box are five tabs General Axis Font Color and Style Also notice that there are six buttons along the bottom of the dialog box They are the OK Cancel Apply Original Export and Maximize buttons x General Avis Font Color Style Main Title r Test 36 A ae Numeric Precision Sub Title es amp Qo Viewing Style Gnd Lines G Coke Boh C Y C X C None Grid in front of data Monochrome C Monochrome Symbols Font Size C Lage Med Small Figure 5 46 Customization Dialog Box General Tab Luminex 100 IS User Manual Version 2 3 xMAP Technology Customization Dialog Box Buttons OK click to update the graph s parameters with the new infor mation and exit the Customization dialog box Cancel click to abort selections and exit Apply Apply is similar to the OK button but does not close the Customization dialog box It updates graph parameter with new information Original click this button to restore the edited information to the previous or original values Export click this button to export data from a Metafile or BMP graphic to a csv output file in the batch folder file or to the clip board You can also export to a printer and specify the object size Select the desired fea
179. ls Date I nitials Date nitials Date nitials Monthly Clean sample probe Date nitials Wipe exterior surfaces Date I nitials Calibrate and verify Date I nitials Every six months Replace air intake filter Date I nitials analyzer Replace air intake filter XYP Date nitials Replace syringe plunger seal or Date I nitials syringe Check analyzer ventilation filter Date I nitials Yearly Replace sheath filter Date nitials As required Replace fuses Date nitials Comments PN 89 00002 00 071 Rev C Troubleshooting Troubleshooting the Luminex 100 IS System PN 89 00002 00 071 Rev C Troubleshooting procedures help users isolate identify and remedy problems with the Luminex 100 analyzer and Luminex XYP This chapter does not troubleshoot problems with the PC For help with PC problems please call Dell Technical Support at 800 624 9896 To troubleshoot a problem select a general symptom Next identify the possible problem and remedy it with one of the solutions listed This troubleshooting chapter supplies information for the following topics Power Supply Problems Communication Pressurization Fluid Leaks e Sample Probe Calibration Problems Acquisition Problems Bead Detail Irregularities Error Messages Printing Errors Verification You can find answers to frequently asked questions FAQs on our website http luminexcorp
180. lush the System 2 0 0 0 0c eee eee ee 5 44 Run an Alcohol Flush 0 00000005 5 44 Run a Wash Cycle 0 0 0 cece eee ee eee 5 44 Set Luminex XYP Instrument Heater Temperature 5 45 Calibration Procedures 0 0 0 cece eee ee eee 5 46 Run System xMAP Calibrators 5 47 Run System xMAP Controls 20005 5 49 Selecting Existing CAL or CON Lots 5 50 Importing CAL or CON Lots 00 0 5 50 Exporting CAL or CON lots 000 5 51 Batch Setup Procedures 00 0 0 eee eee eee ee 5 51 Importing Templates 0000000005 5 52 Create a New Batch 0 0 0 e eee eee 5 53 Open Batch ste ea iee enni eR eR ees 5 55 Copying and Exporting Batch Data 5 55 Clear a Batch from the System 5 55 Replay a Batch 0 0 0 eee eee eee 5 56 Delete a Batch 4 i212 assay vind Re gard aude es eed 5 57 Create a Multi Batch 0000000 5 58 Open a Multi Batch 00 2c eee eee eee 5 59 Process Multiple Plates 0000 5 60 Re Run or Recover Incomplete Batch 5 61 Scan in Samples With a Barcode Reader 5 61 Add a Patient List eese eee eee ee 5 62 Edit a Patient List 0 0 0 eee ee eee eee 5 63 Assign Sample Dilution Factors 5 64 Create a New Advanced Batch
181. ly stored in the Downloaded Program Files folder on your hard disk View Files Cancel Figure 5 63 Disk Cleanup for Selected Drive To delete the Message Log directory 1 2 PN 89 00002 00 071 Rev C In the Cleanup Utility dialog box click Delete MsgLog Directory In the Cleanup Utility confirmation dialog box click Yes Luminex 100 IS User Manual Version 2 3 xMAP Technology To delete the batch folders 1 Inthe Cleanup Utility dialog box click Delete Batch Directory 2 Inthe Cleanup Utility confirmation box click Yes to delete all the batch folders All the folders under C My Batches are deleted The C My Batches folder remains Daily Shutdown Procedures Sanitize the Sanitize the system with 10 to 20 household bleach to System decontaminate the sample lines and the cuvette after biohazard contact You should sanitize as part of your daily shutdown routine after biohazard contact Sanitizing uses the Luminex XYP reservoir location because only the reservoir can accommodate the amount of fluid necessary to sanitize the instrument To sanitize the fluidics in the analyzer Onthe Maintenance tab click Eject Retract 2 Putthe bleach solution in the reservoir 3 Click OK The plate holder retracts and the system performs the Sanitize command 4 Runtwo Wash commands Run a Wash Use the wash command as part of shutdown procedure and as Command needed especiall
182. lyte you want to view The system displays this analyte in detail Switch between tabs to observe the tests errors under the Errors tab and unknown results under the Samples tab To view the next test in the batch click Next Test F2 To view the previous test click Previous Test F3 You may also click on the test name in the left grid control You can invalidate or validate a standard or control in either of two ways In the Analysis window use the associated buttons on the bottom of the window or right click in the row containing the standard or control you want to validate or invalidate Invalidating standards You can invalidate or remove a standard if doing so improves the curve fit Observe caution when doing so Luminex 100 IS User Manual Version 2 3 xMAP Technology Invalidating standards greatly affects the curve fit and subsequently the sample results For further instruction on assay standard curves and the appropriateness of invalidating or removing standards contact the assay kit manufacturer Invalidating controls You can invalidate or remove a control in data analysis However Luminex does not recommend invalidating controls For further instruction on assay controls and guidelines regarding accepting or rejecting control values contact the assay kit manufacturer To validate or invalidate a standard or control entry using the right mouse click procedure 1 Right click in the row containing the standar
183. m or Small is suggested On occasion the graph may automatically reduce the size of the font to produce a higher quality image Show Annotations Currently this feature is not used This check box allows you to remove or add the annotations from the image Numeric Precision When exporting text and data from the Export Dialog you can define the number of decimal posi tions at 0 1 2 or 3 Grid Lines The Graph can contain vertical grid lines horizon tal grid lines both vertical and horizontal grid lines or no grid lines Select the appropriate radio button Grid in front of data Check this option to place the grid in front of the data graphics Otherwise the data graphics are drawn on top of the grid Axis Tab Use the Axis tab to change your X axis and Y axis values and specify whether to display them as linear or log If you select Log use Auto or ensure that the Min value is greater than zero See Figure 5 48 Test 36 Customization x General Axis Font Color Style Min 304 078 Max 12506 6 A Axis Linear Log C Auto C Min C Max Min Max Min 6 77 Max 420 Cancel Original Esport Maximize Figure 5 48 Customization Dialog Box Axis Tab Font Tab Use the Font tab to change the appearance of the fonts that appear in the Main Title Sub Title and Subset Point Axis Label boxes The bottom of the dialog box displays a sample of
184. mber of test columns following the Sample column will depend on the number of tests defined in the Template used to create the batch Each of the test columns will contain the test name for any given test Therefore if the Template has 3 tests named Protein A Protein B and Protein C then these names will appear in the 3 test column headers in the OUTPUT CSV file Limited to 30 characters PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 xMAP Technology Table D 3 Statistic Column Definitions Column Name Description Total Events one of the defined regions The number of events that fell with in the defined DD gate and into one of the defined regions for a test in the batch For example if a template had 3 tests defined and the batch had counts of 100 102 and 105 for the tests then the total count would be 307 even though more events may have been detected that did not fall within the DD gate or Notes Sample notes PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 IS OUTPUT CSV file with no additional features enabled Program Luminex 100 IS 409 Build 2 3 BETA Date 7 28 2004 2 12 01 PM SN LX10001298011BE Session Bead 22 Quant Batch Operator Joe User Samples 8 Min Events 0 Results DataType Median Location Sample Test 22 Total Events Notes
185. minex XYP to the PC 0 0 0 0 0 eee B 3 Install the Luminex XYP Instrument Sample Probe B 6 Power On System Components 0 000 B 8 Accept the Luminex 100 IS 2 3 Software License Agreement 00 cece eee B 8 Adjust the Sample Probe Vertical Height B 8 Install the Luminex X YP Instrument Reservoir B 9 Calibrate and Verify the System B 10 Install the SD System 0 0 0 0 eee eee eee B 10 Install the Luminex XYP Instrument Heater Block B 13 Luminex 100 IS 2 3 Software Installation B 14 Luminex 100 Version 1 7 with Windows 98 to Luminex 100 IS Version 2 3 0 00002 cee eee B 15 Install NeW BC eue ede Somes med B 15 Install Luminex 100 IS 2 3 Software B 15 Verify Successful Upgrade 0 B 16 Luminex 100 Version 1 7 with Windows 2000 to Luminex 100 IS Version 2 3 00 000 eee eee B 17 PN 89 00002 00 071 Rev C Contents vil Luminex 100 IS User Manual Version 2 3 xMAP Technology Archive My Sessions folder 4 B 17 Remove Luminex LMAT Software B 17 Remove Luminex 100 Version 1 7 Software B 18 Install Luminex 100 IS 2 3 Software B 19 Luminex 100 IS Version 2 1 2 2 to Luminex 100 IS Version 2 3 o epe om HA E on dee e oe B 19 Backup Luminex 100 IS 2 1 or 2 2 Database B 19 Remove Luminex 100 IS 2 1 or 2 2
186. mmands right click on the corner marker or plate layout and select Clear Off Plate Cmd s See Figure 5 39 Luminex 100 IS User Manual Version 2 3 xMAP Technology General Bead Set Plate Layout Right click the grid to display the popup command menu Establish the offplate commands to run before the plate begins Acquire Data Cmd Name No Cmd Name Warmup 1 Reservoir Wash Prime Backflush Sanitize Cancel Clear All Reservoir Soak Self Test OK Cancel Figure 5 40 Plate Layout Tab Off Plate Commands 12 Insert off plate commands You can insert off plate commands 13 that run after a single well after a range of wells or after rows or columns of wells The prompt sentence displayed should be appropriate for your selection For example if you select row B the prompt Establish the off plate commands to run after wells B1 through B12 appears To establish insert off plate commands select the desired wells then right click over the plate layout Select Insert Off Plate Cmd s from the menu Select the desired commands and click OK The background of the established wells turn green To clear insert off plate commands select the wells to clear right click on the plate layout and select Clear Selection from the menu After you define the information on the General Bead Set and Plate Layout tabs click OK Click Cancel to abort Table
187. mple probe is not properly aligned There is a clog in the fluid line Delta Cal temp out of range There is a problem with the kit Verify that you properly mixed the samples before dispensing into the wells Verify that you loaded the sample to the correct well on the plate Verify that the sample volume added to the well is correct Clean the sample probe See Clean the Sample Probe on page 6 4 Align the sample probe See page B 8 Run the following commands Backflush Drain Alcohol Flush Wash Verify that the delta cal temperature is within 3 0 degrees Recalibrate if outside these limits and retry Verify that the system is functioning properly by running the system controls Run system controls If they pass contact the kit manufacturer PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 Cannot calculate inverse function xMAP Technology This error message encompasses a range of mathematical errors often indicating that the sample result was negative or invalid This is according to the parameters defined by the formula used to analyze the sample results Standards assay controls and unknowns may all be flagged with Unknown Formula Failure A standard curve is plotted using the MFI and expected concentration value An Unknown Formula Failure message may occur when the system is unable to calculate a standard concentration from the standard curve You are using th
188. mples have been run Make a copy of this page to fill out and return with the system Complete the following checklist signed and dated and return it with the Luminex 100 analyzer 1 Remove all specimens disposables and reagents from the system 2 Disconnect the sheath line going from the SD system to the analyzer 3 Connecta sheath bottle filled with a solution of 1096 to 2096 household bleach and water to the analyzer 4 Sanitize the system using the Sanitize command on the main screen of the system Follow this by washing twice with distilled water 5 Disconnect the system from AC power by turning off the power switch on the rear of the system then unplugging the analyzer power cord from the wall source 6 Disconnect the SD system and waste and sheath containers 7 Rinse the waste container with 10 to 20 household bleach solution and drain 8 Wash all exterior surfaces with a mild detergent followed by a 10 to 20 bleach solution 9 Open both front doors of the analyzer and clean all accessible surfaces with mild detergent followed by a 1096 to 20 bleach solution 10 Pack the system within a biohazard bag place it in the corrugated box then insert it in its original packaging or an approved shipping container Attach this checklist to the top of the corrugated box prior to packaging in the crate Was there an internal leak in the system Yes No Print Name Signature Date
189. mpleted Time 5 25 2001 11 10 05 AM CommandName Acquire Patient 4 CommandNo 15 of 15 51 Command Started Time 5 25 2001 11 09 50 AM CommandName Acquire Patient 4 CommandNo 15 of 15 50 Command Completed Time 5 25 2001 11 09 50 AM CommandName Acquire Patient 3 CommandNo 14 of 15 49 Command Started Time 5 25 2001 11 09 34 AM CommandName Acquire Patient 3 CommandNo 14 of 15 48 Command Completed Time 5 25 2001 11 09 33 AM CommandName Acquire Patient 2 CommandNo 13 of 15 47 Command Started Time 5 25 2001 11 09 18 AM CommandName Acquire Patient 2 CommandNo 13 of 15 46 Command Completed Time 5 25 2001 11 09 17 AM CommandName Acquire Patient 1 CommandNo 12 of 15 AR Cammand Ctartad Tima BINEINNNA ALASAN ANA Carnamandlama Acauira Datiant 4 Carnamandila 19 af 146 j Figure 5 10 Message Log The log displays actions in color coded text and shading Items in the Message Log appear in the following color codes Green text represents a successful system calibration verification command acquisition or maintenance functions e Red text represents failed commands errors or warnings e Black text represents normal processes and actions e Yellow shading indicates that a detailed description about the processes or actions is available This color may vary depending on your tool tip color system settings To view details of a message double click the shaded row A dialog box opens providing details To clear the Mes
190. mport and Export buttons in the Update CAL Targets and Update CON Targets dialog boxes Review the lot information and press OK to select the calibration lot To import system CAL or CON lots 1 Onthe Maintenance tab click New CAL Targets or New CON Targets as appropriate An Update CAL Targets or Update CON Targets dialog box opens PN 89 00002 00 071 Rev C xMAP Technology Exporting CAL or CON lots Batch Setup Procedures PN 89 00002 00 071 Rev C 4 1 Using Luminex 100 IS 2 3 Software Click Import CAL or Import CON as appropriate The Open dialog box opens To select the calibration lot or control lot to import click the drop down arrow for the Look in box Browse for the appropriate folder diskette or CD location The file type is a lif file After you select the location the available lots display in the selection list Click the name of the lot to import and click Open The lot name appears in the product information box The lot and target information is displayed on the Update dialog box Click OK to complete the operation To export system CAL or CON lots On the Maintenance tab click New CAL Targets or New CON Targets An Update CAL Targets or Update CON Targets dialog box opens Ensure you have the desired lot to export displayed or selected Click Export CAL or Export CON as appropriate In the Save As dialog box select the folder directory where you want to export the lot a
191. must be monitored manually Check the sheath fluid level before starting a run or procedure Waste Fluid Container Optical xMAP Technology Reagents xMAP Technology For proper operation place the Luminex SD system at the same level as the base of the Luminex XYP instrument Do not put it on top of the Luminex 100 analyzer Warning If biological samples have been tested with the system use your standard laboratory safety practices The waste fluid container receives waste from the system The waste container should not be placed on top of the instrument Caution Waste levels must be manually monitored Do not allow the waste container to overflow The optical system consists of the optical assembly and the excitation lasers The optical assemblies do not require manual adjustment by the user The xMAP technology reagent system consists of classification calibration microspheres reporter calibration microspheres classification control microspheres and reporter control microspheres PN 89 00002 00 071 Rev C Background Information Fluidics Excitation PN 89 00002 00 071 Rev C Basic Concepts xMAP technology is a versatile system that measures soluble analytes The Luminex 100 IS system 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
192. n reads the same as the sheath pressure you recorded in step 4 The system should stabilize at this sheath pressure The air pressure should be the same as you recorded in step 4 within 0 1 psi If the Prime cycle ends before you have completed the adjustment select Prime again and continue to adjust the regulator 7 Calibrate the system again Observe the sheath pressure displayed on the Diagnostic tab System Monitor section during the calibration cycle The pressure should be within 0 1 psi of the pressure recorded in Step 4 Follow up with installing the heater block below if necessary Use the Luminex X YP instrument heater block as required by your assay kit instructions This is an optional step When not in use store the heater block in the bracket inside the left access door of the Luminex 100 analyzer Luminex 100 IS User Manual Version 2 3 Luminex 100 IS 2 3 Software Installation xMAP Technology To install the Luminex XYP instrument heater block 1 Onthe Maintenance tab click Eject Retract to eject the plate holder 2 Insert the Luminex XYP instrument heater block on the plate holder See Figure B 14 Figure B 14 The Luminex XYP Instrument Heater Block 3 Click Eject Retract to retract the plate holder 4 Turn the heater on and set the temperature Refer to Set Luminex XYP Instrument Heater Temperature page 5 45 For new system installations perform the preliminary commands listed in
193. n 3 3 insert off plate commands establish 5 70 installing XYP heater block B 13 XYP reservoir B 9 XYP sample probe B 6 instrument operation 2 1 status 2 8 instrument operation 2 7 integrity 4 2 intended use general system 1 1 K kit manufacturer 4 2 L label type specifications 3 7 labels 2 3 2 7 laboratory reagents 3 3 laboratory testing 1 1 laser 4 1 analyzer 2 6 apertures 2 6 bar code reader 2 7 information 2 5 location 2 6 radiation 2 6 warnings 2 5 leaks 2 4 light protect from 4 2 light emission 2 8 location 2 8 Luminex 7 1 Luminex 100 analyzer maintenance functions B 9 Luminex 100 IS 4 1 general laboratory use 1 1 specifications 3 7 Luminex 100 IS analyzer and XYP 2 3 Luminex 100 IS software 1 1 PN 89 00002 00 071 Rev C Index Luminex xMAP microspheres 4 2 Luminex xMAP technology 4 1 Luminex XYP specifications 3 6 M maintenance reports 4 3 5 87 tab B 9 maintenance schedule annual 6 10 as required 6 11 daily 6 1 monthly 6 4 routine tasks 6 2 semi annual 6 5 weekly 6 3 manual adjustment 3 12 marketing 2 3 mechanical 2 2 2 7 message log 4 2 MFI 5 76 microsphere 4 1 4 2 microtiter plate 4 1 monitor the system 4 2 monitor waste fluid refill sheath container 6 2 multi analyte 4 1 N needle 4 1 0 off plate commands 5 69 operation of instrument 2 1 optical 3 12 optical assembly 3 12 optical integrity 4 2 optics 3 5 specifications 3 5 options 4 2 P paths 4 1 pat
194. n t properly pressurized Clean the sample probe See page 6 4 Ensure that the sample probe is not clogged and there are no leaks in the syringe seal or syringe valve PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 IS User Manual Version 2 3 Sample arm stuck in the down position The sample probe height is too low or the path to the well is blocked DO NOT turn off the Luminex XYP instrument 1 Remove the blue light housing from the Luminex 100 2 Unscrew the tubing connector that connects the sample tube to the top of the sample arm The system monitor changes from Busy to Running and sample acquisition continues Click Cancel to make adjustments before continuing with the rest of the samples 3 Ifthe sample arm still does not raise save all the data that has been collected to this point Turn off the analyzer but keep the XYP instrument on 4 Exit the Luminex IS Software 5 Turn the analyzer back on and restart the software 6 Replace the sample tubing and blue light Adjust the sample arm 7 Runacalibration with DI water to reset the sample probe optical switch Sample arm does not go down smoothly The 96 well plate is incorrectly seated in the XYP instrument The 96 well plate is warped The sample arm is misaligned Adjust the 96 well plate Inspect the 96 well plate Replace it if it is warped Readjust the sample arm horizontal alignment
195. nced Batch New Batch New CAL Targ New CON Targ New Lot Open Batch Open Help Open Incomplete Batch Open Multi Batch Pause xMAP Technology Assay developers use New Advanced Batch to acquire data without having to build templates This provides the developer with a faster and more convenient tool to develop assays It does not store the results in the Luminex IS 2 3 database It writes raw data to the output csv file if Auto Export is selected and writes run files if Enable Raw Storage is selected This feature is the primary use of the Acquisition Detail tab When you click on the New Advanced Batch button the Options dialog box opens where you enter information about the batch define bead events for the session and define commands for plate layout Opens a dialog box in which you select a template to create a new batch in the Luminex Batch Setup window Opens the Update CAL Targets dialog box in which you enter information about the calibration microspheres you are using to calibrate the system Opens the Update CON Targets dialog box in which you enter information about the control microspheres you are using to verify system calibration Opens the Open Template dialog box from which you select a template to which you want to add a lot or edit lot information 1 The Open Batch command selected from the file menu or toolbar opens the Open Batch Dialog box from which you choose an existing batch to use
196. ncludes the following hardware e Luminex 100 analyzer e Computer PC monitor and accessories e Luminex XYP instrument e Luminex Sheath Delivery System Luminex SD Power cables e Alignment guide Two long sample probes e Luminex XYP instrument sample probe e Reservoir Shield e Heater block e Sheath fluid container e Waste container e Sheath fluid line e Air line e Sheath fluid intake line e Communications 1 serial communication cable Communications 1 USB communication cable Communications 1 CANBUS communication cable short cable e Barcode reader e Sample probe height alignment kit 3 32 Hexdrive Balldriver wrench PN 89 00002 00 071 Rev C xMAP Technology xMAP Technology Reagents Required Laboratory Reagents Luminex 100 IS 2 3 Software Luminex 100 IS Performance Specification Speed PN 89 00002 00 071 Rev C The System e Classification calibration microspheres CAL1 e Reporter calibration microspheres CAL2 e Classification control microspheres CON1 e Reporter control microspheres CON2 e Sheath fluid e Household bleach e 70 isopropanol or 70 ethanol Mild detergent Luminex 100 IS 2 3 software provides complete control of the system and performs data analysis Your Luminex 100 IS 2 3 system is preloaded with the Luminex software However we supply a software CD should you need to reinstall the software This software requires a dedicated system
197. nex 100 IS 2 3 Software The menu bar contains the following menus File Menu Tools Menu and Help Menu File menu contains the following commands Import Template New Batch Open Batch Delete Batch Edit Patient List Open Incomplete Batch Batch Comment New Multi Batch Open Multi Batch Data Analysis Export Batch Data Print Report Exit Tools menu contains the following commands Connect Disconnect Database Backup Database Restore Erase Database Update CAL Targets Update CON Targets New Assay Lot Options Cleanup For information on each of these commands see the Commands section beginning on page 5 31 Help menu this contains menu selections that open the online help and describe the software and hardware Contents opens the online help About the Device opens a dialog box that shows the version and serial numbers of the Luminex instruments you are using About the Software opens a dialog box that shows the version of the Luminex Software you are using Luminex 100 IS User Manual Version 2 3 xMAP Technology Toolbar The shortcut buttons on the toolbar can be found in other locations in the software The Help button opens the online help The Single Step option on the toolbar allows you to pause the system in between each command or sample acquisition within a batch mE gy H 25 QA o sse ud 1 2 34 5 6 7 8 9 10 11 12 13 1 Import Template 8 Print Report 2 New Batch 9 Connect to t
198. nly the 100 most recent acquired events The Density Dot Plot displays a constant accumulation of events Increasing density is indicated by contrasting colors See Table 5 2 for the density dot plot color legend Table 5 2 Dot Plot Color Legend Layer Color 0 none 1 dark blue 2 pink 3 dark green 4 cyan 5 light blue 6 light green T orange 8 dark red The density dot plot allows visual elimination of data values determined to be insignificant to the display Luminex recommends you collect your data in density dot plot mode to observe all 5 16 PN 89 00002 00 07 1 Rev C xMAP Technology Using Luminex 100 IS 2 3 Software collected events Post acquisition does not display decaying dot plot it s only a real time function Status Bar The Status Bar displays information about the Command State Device Status Device Activity Laser Status Total Events per Second and Region Events per Second Color coding indicates the urgency of each item s status Device Activity uses no color coding Command State Device Statue Device Activity Laser Status Total vente Sec Region tente see Idling A e Figure 5 15 System Status Bar Table 5 3 describes the types of status bar messages in relation to the message color coding Table 5 3 Status Bar Color Coding Device Status Category Color Indicates Command Indicates communication status of the Luminex analyzer or State operations being pr
199. ntain all proprietary notices on all copies of the SOFTWARE PRODUCT e You may not distribute copies of the SOFTWARE PRODUCT to third parties You may not reverse engineer decompile disassemble or otherwise attempt to derive source code from the SOFTWARE PRODUCT You may not copy other than one backup or archival copy distribute sublicense rent lease transfer or grant any rights in or to all or any portion of the SOFTWARE PRODUCT e You must comply with all applicable laws regarding the use of the SOFTWARE PRODUCT e You may not modify or prepare derivative works of the SOFTWARE PRODUCT e You may not use the SOFTWARE PRODUCT in a computer based service business or publicly display visual output of the SOFTWARE PRODUCT You may not transmit the SOFTWARE PRODUCT over a network by telephone or electronically by any means 3 TERM AND TERMINATION Your rights under this EULA are effective until termination You may terminate this EULA at any time by destroying the SOFTWARE PRODUCT including all computer programs and documentation and erasing any copies residing on your computer equipment Luminex may terminate this EULA upon thirty 30 days written notice to you Your rights under this EULA automatically terminate without further action on the part of Luminex if you do not comply with any of the terms or conditions of this EULA Upon any termination of this EULA you agree to destroy the SOFTWARE PRODUCT and erase any copies residing
200. ntrol ConL 1 amp 8 H1 Plate1 Acquire Control ConL 1 Created By 9 A2 Plate1 Acquire Patient 2 Lg lt Name gt 10 B2 Plate1 Acquire Patient 2 Load Pa List 11 C2 Plate1 Acquire Patient 2 Template Info 12 D2 Plate1 Acquire Patient 1 13 E2 Plate1 Acquire Patient 1 9 Name 14 F2 Plate1 Acquire Patient 1 Help B36 RepQt Assay 15 G2 Plate1 Acquire Patient 1 ley ADILA Mlata A Am Manti annt A Description Replicate Simplex Quant New Lot C Save only Standard Info bd Product No 3000 C 9 C 9C IC 9 C 96 9C 9 Product Name 36 Repat Kit Version No PYIYYYYY 9 Lot Name 36Repatstd 2227 DODD ODD 0 Expiration Date 06 10 2005 Control Info Product No 3000 Product Name 36 RepOt Kit Lot Name 36Repe tCon Expiration Date 06 10 2005 Developing Co The following features are part of the Batch Setup Window Batch Info group box Template Info group box nsert command Command list 5 20 PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Microtiter Plate image Command button group box Save group box e Standard Info group box Control Info group box New Lot button The Batch Info group box has text boxes in which you can input the name description and creator name of a new batch The Template Info group box shows the name description version
201. nts detected per second that are Events Second classified in a region The Status Bar displays status information as the software processes commands Table 5 4 shows the typical messages that appear in the status bar Additionally information displays as text on the Diagnostics tab 5 18 PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Table 5 4 Status Bar Communication Message Details Status Bar Color Message Indicates Green Idle Waiting to process the next command Standby The Luminex analyzer is ready and waiting to perform a command Yellow Connecting The software is attempting to connect to the instrument Processing The instrument is communicating with the software as it processes commands Pausing The instrument has stopped processing the list of commands but finishing the active command Paused The software stopped processing the list of commands A resume function becomes available to change the state back to processing Busy The instrument is processing a maintenance command Red Disconnected The software has not yet attempted to connect or fails to connect to the instrument Locked Out Another application currently has control of the instrument The software locks out as long as the other application runs To remove the locked out stat
202. ocessed Green Idle or processing Yellow Connecting pausing or paused Red Disconnected or locked out Indicates the current process of or warning about the Luminex analyzer Green Running or standby Yellow Busy pressurizing sheath is empty or warming up Red Not ready or disconnected Device Activity Indicates the activity that the Luminex analyzer is performing Note The device activity has no color code PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 xMAP Technology Table 5 3 Status Bar Color Coding Continued Category Color Indicates e Idling waiting for a command Aspirating drawing in sample e Collecting Data collecting data Sanitizing sanitizing the instrument Washing washing the sample line Priming priming the instrument Calibrating calibrating the instrument Canceling canceling a command e Backflushing backflushing the instrument e Draining draining the instrument Warming Up warming up the instrument e Verifying verifying calibration e Soaking soaking the probe e Adjusting sample probe e Self Diagnosing performing self diagnostic routine Laser Status Laser temperature and readiness status Green Lasers warmed up Yellow Warmup timer countdown in seconds from 1800 Red Lasers off Total Events Number of total bead events detected per second Second Region Number of bead eve
203. on Click Save The system applies the lot you just created to the template To edit information for an existing lot On the Home tab click New Lot The Open Template dialog box opens Highlight the template that you want to edit and click Select The Update Lot Information dialog box opens See Figure 5 44 Import Export amp w2 x tot tet Revert Save Cancel Change the current lot by saving selected lot r Test Standards 2000 Current Lot B3654QtStd Current Lot z Newiot Delete Lot Exp Date 06 05 2008 7 Update Lot Information Test 54 r Test Controls 2000 Current Lot B3654QtCon Current Lot B36540tCon NewLot DeleteLot Exp Datefo3 07 2003 gt Low Limit Expected Values High Limit Test 36 Test 54 mg dL mg dL 150 405 Figure 5 44 Update Lot Information Dialog Box 3 Change or edit the expiration date and the lot concentration values Luminex 100 IS User Manual Version 2 3 4 xMAP Technology Click Save The system updates the lot changes and applies them to the template Edit Lot 4 To edit lots on a used template may have new lot number of Information on a reagents but are using same template Used Template 1 On the Home tab click New Lot The Open Template dialog box opens Double click the template that you want to edit An Update Lot Information dialog box opens See Figure 5 44 Change or edit t
204. on the system monitor on the Diagnostics tab is more than 3 degrees e if sample acquisition is problematic Each step in the calibration procedure usually takes less than one minute You must run xMAP controls after each calibration Once calibrated the calibration values remain until you calibrate again You can track system calibration and verification results through the Calibration Trend Report and the System Control Trend report If you need target value information for Calibration or Control microspheres you can find the information on the Luminex website at http Avww luminexcorp com Click on the Support link then navigate to the FAQ page on the Support page PN 89 00002 00 071 Rev C xMAP Technology Run System xMAP Calibrators Note When dispensing calibra tion and control microspheres hold the bottle upside down at a 90 degree angle to the micro titer plate to ensure that you are getting accurate drop volume PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Ensure that the Luminex analyzer lasers are warmed up and the probe height is set correctly before calibrating the system Do not move the system waste line while calibrating You can run calibration and verification commands from the Maintenance tab You can import and export calibration and control lots and reuse existing lot information for calibration and controls To calibrate your system with xMAP calibrators 1 Vortex the xMAP
205. on to the exported batch file output csv Luminex 100 IS User Manual Version 2 3 xMAP Technology Export Location Label Style Choose one of these options to define the label data style exported to the Output csv file You can select sequential numbering by plate location or both default 2151 x General Company Information Data Export Iv Auto Export Batches Additional Batch Information iv Copy Output csv to Common Output Dir I Prompt for Batch Comment I Write Sample Comments Additional Export Stats Template Version Template Desc l Mean I Trimmed CV gt F CV Trimmed Peak Template Dev Co o F Peak Trimmed Std Dev Template Author z Std Dev Avg Results Sample Volume I Trimmed Count I Trimmed Mean Test Sort Order Export Location Label Style Alphabetical by Test Name Sequential 1 2 3 C Sequential by Region ID C Plate Location A1 B1 C1 C Template Setup Order C Both 1 A1 2 B1 3 C1 p OK 4 Feri Figure 5 23 Options Dialog Box Data Export Tab Setting up the Favorites To add templates to the Favorites list List On the Favorites list click Add Template 2 Inthe Open Template dialog box double click the template to add to your Favorites list To add commands to the Favorites list 1 Click Add Commands from the Favorites list
206. opens To create a new lot when there is an existing lot click New Lot on the Standard or Control section of the dialog box A New Standard Lot or New Control Lot dialog box opens Enter the standard or control lot number See Figure 5 42 and Figure 5 43 3 Click OK New Standard Lot Number New Control Lot Number Td OK Cancel Figure 5 42 Add Lot Standard and Control Dialog Boxes Import Expot amp we3 x Lot Lot Revert Save Cancel Change the current lot by saving selected lot Test Standards 2000 Current Lot B3654QtStd Current Lot B36540tSta v NewLot Delete Lot Exp Date 06 05 2003 F Update Lot Information Test Controls 2000 Current Lot B3654QtCon Current Lot B36540tCon NewLot DeleteLot Exp Datefos 07 2003 Low Limit Expected Values High Limit Test 36 Test 54 imgidL mg dL Con Normal 150 405 Figure 5 43 Update Lot Information Dialog Box PN 89 00002 00 071 Rev C xMAP Technology Edit Lot Information on an Unused Template PN 89 00002 00 071 Rev C 1 Using Luminex 100 IS 2 3 Software Enter the expiration date in the Exp Date field Enter the standard concentration values provided in the kit manufacturer s instructions See Figure 5 43 Enter the control reagent values The controls are divided into 3 separate tabs Low Limit Expected Value or High Limit All information must be defined to enable the Save butt
207. ot button is visible only if the template you are using requires the use of standards or controls The button opens the Update Lot Information dialog box in which you can manage lot information When the system analyzes batches it displays the data in a three tab format within the Analysis window The following three tabs present the batch information in greater detail e Errors tab lists errors that occur during batch acquisition such as controls that failed e Standards tab lists all tests in the batch a regression chart for each test and the standards or controls associated with the batch e Samples tab lists background samples and all samples or unknowns acquired in the batch with either a qualitative or quantitative result Nine function buttons are available on the lower portion of the Analysis window These buttons perform tasks or functions that are relevant to the Standards tab although they appear on all three tabs of the Analysis window The buttons are e Next Test F2 e Previous Test F3 e nvalidate Standard F4 e Validate Standard F5 e nvalidate Control F6 e Validate Control F7 e Change Standard only if Developer s Workbench is installed e Change Lot Alt F8 e Recalc Standards tab only only available on the Standards tab and only if the Auto checkbox is not selected For a description of these commands see Commands on page 5 31 For information on procedures using these
208. ottom wells stack two of the smaller 3 35 mm diameter alignment discs together and place them into the selected well For a round bottom U bottom plate stack two of the smaller 3 35 mm diameter alignment discs and place them into well A1 For a plate with conical wells place one alignment sphere into the selected well Select the Maintenance tab then click Eject Retract to eject the plate holder Place the 96 well microtiter plate on the Luminex XYP instrument plate holder with position A1 in the top left corner Click Eject Retract to retract the plate Use the 3 32 inch hex wrench to loosen the height adjustment locking screw See Figure B 9 Verify that the correct location is selected with the appropriate number of discs The location must be the same as indicated in the software or the location you choose Click Sample Probe Down to lower the sample probe Using the thumb wheel lower the probe until it just touches the top of the alignment discs or sphere Use a 3 32 inch hex wrench to tighten the height adjustment locking screw Click Sample Probe Up to raise the sample probe Replace the plastic shield that covers the sample probe area Install the Luminex XYP Use the Luminex XYP instrument reservoir for the Luminex 100 Instrument Reservoir analyzer maintenance functions PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 xMAP Technology To install the Luminex XYP instrument reservoir
209. page 5 50 for more details on importing a Calibration lot Luminex 100 IS User Manual Version 2 3 5 48 xMAP Technology Update CAL Targets A3735 05 19 2002 Figure 5 25 Update CAL Targets Dialog Box 10 Repeat step 9 for the CAL2 lot 11 In the Maintenance tab click CALI then click OK The device status section in the status bar changes from Running to Standby 12 Click CAL2 then click OK Wait until CAL2 completes The Device Status section in the status bar changes from Running to Standby and the Diagnostics tab turns red The System Monitor on the Diagnostics tab displays the date and time in green if CAL1 and CAL2 are successful The Diagnostics tab turns red if all substances CAL or CON have not been run and under the following conditions the first time the software is opened the first time a system is calibrated a new database is installed an old database is restored a CAL or CON fails PN 89 00002 00 07 1 Rev C xMAP Technology Run System xMAP Controls PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software You must run system controls following calibration Continue with the following Run System xMAP Controls section Run System xMAP controls to verify calibration Dispense the Control microspheres into the microtiter plate at the same time that you dispense the Calibration microspheres See Run System xMAP Calibrators on page 5
210. ples Tab s esee DIRE PURERS KU XN OD 5 28 Replicate Averaging 0 ee eee eee eee 5 29 Commands ice eta ete Mee Seed CUP DOR Ue x RR 5 31 Acquire Patient 1 0 0 0 eee eee res 5 31 Add Baths ies ber eng eae a ain old ok cm ER og 5 31 Alcohol Flush lssleleeeeeeeeeeee eee 5 31 AUtOSCale 5 Ese eae Restos a e aia dae g 5 31 AULOSIZE cos ease p d eR UR Rue RR CDS C RU C SRI e 5 31 Backfl sh z us oen tee ee ate doe Cae oven os 5 31 CALI 2 atta cae eem tob ente dao dotato sos 5 31 CAL csl dee dI a dee dU recen 5 31 Cancel Command 0 0 00 e cece eens 5 31 CanceLAIlL 21 cese e ce ER beds beg aida Gade 5 31 Change Lot icr er enmt eee eeu 5 31 COND iacu ies ins Bases Blah aaa td 5 31 CON Z esis ead behead A ERI eee nea 5 31 Connect to Instrument 0 00 cece ee eee 5 32 Create New Multi Batch 0 0 0 eee eee eee 5 32 Delete Bat h isas esos ee ae Lae e SR t cs 5 32 Density Decaying lees 5 32 Display Confirmation Screens 0000005 5 32 Disconnect from the Instrument 005 5 32 Drain 3 iat a hase ds ead RI ce gd ew LASS 5 32 EjecURetract eoe o chi ane EE uper i dE 5 32 Enable Raw Data Storage 0 0 0 ce eee eee 5 32 Export Batch Data 5 32 Bxpott CAL stow pcg trang genes e hte ibd edad 684 5 32 Export CON accu ki e ee ea ee E d 5 32 Export Data isn cet Pic iach tinny e ette ara es 5 33 Help sco isa bth wk ba a
211. plug them from the electrical outlet Remove the light housing directly above the sample arm by grasping and firmly pulling out It remains attached by a wire harness Place it on top of the analyzer See Figure B 6 1 Light Housing 2 Cheminert fitting with cap Figure B 6 Light Housing Removed PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 IS System Setup 3 Unscrew the cap from the Cheminert fitting 4 Insert the sample probe into the sample probe holder Insert the Cheminert fitting into the sample probe holder turning it clockwise Be careful that the threads are correctly aligned Hand tighten only See Figure B 7 1 Cheminert Fitting 3 Sample Probe 2 Sample Probe Holder Figure B 7 Insert Sample Probe and Cheminert Fitting 5 Push the light housing back into place 6 Install the clear plastic shield that covers the sample probe area See Figure B 8 Luminex19 Figure B 8 Sample Probe Area with Clear Plastic Shield in Place PN 89 00002 00 071 Rev C Luminex 100 IS User Manual Version 2 3 Power On System Components Accept the Luminex 100 IS 2 3 Software License Agreement Adjust the Sample Probe Vertical Height xMAP Technology 7 Plug the Luminex XYP instrument and the Luminex 100 analyzer into an approved outlet Power on the system components e The Luminex 100 analyzer switch on back The Luminex XYP instrument switch on back e The PC and monitor switches on front
212. r access to service panel 2 Center door access to syringe Figure 3 3 Luminex 100 Analyzer Access Doors PN 89 00002 00 071 Rev C 3 9 Luminex 100 IS User Manual Version 2 3 xMAP Technology Air Intake Filler A replaceable air intake filter cleans the air used to pressurize sheath fluid This filter is enclosed behind an access door located on the back of the Luminex 100 analyzer See Figure 3 4 Figure 3 4 Air Intake Filter Syringe The syringe delivers a sample from the 96 well microtiter plate to the cuvette See Figure 3 5 1 Syringe Seal 2 Syringe Figure 3 5 Syringe and Syringe Seal 3 10 PN 89 00002 00 071 Rev C xMAP Technology The System Sheath Filter The sheath filter removes particles greater than ten microns in diameter from the sheath fluid See Figure 3 6 Figure 3 6 Sheath Filter Air Waste and The air waste and sheath connectors located on the left side of the Sheath Fluid analyzer connect to the SD system and waste fluid containers using Connectors clear tubing The air connector is green the sheath fluid connector is blue and the waste fluid connector is orange See Figure 3 7 1 Sheath fluid connector blue 2 Air connector green 3 Waste connector orange Figure 3 7 Air Waste and Sheath Fluid Connectors PN 89 00002 00 071 Rev C 3 11 Luminex 100 IS User Manual Version 2 3 Luminex Sheath Delivery System Note If you are not using the SD System sheath fluid levels
213. rawing sheath fluid from the sheath fluid container You do not need to supply solution in a plate A backflush command takes about seven seconds Runs the Classification portion of the Luminex System calibration Runs the Reporter portion of the Luminex System calibration Cancels the process for the last command initiated Cancels all the commands in progress Opens the Change Lot dialog box from which you select a lot to apply to a batch Runs the verification for the Classification calibration Runs the verification for the Reporter calibration Luminex 100 IS User Manual Version 2 3 Connectto Instrument Create New Multi Batch Delete Batch Density Decaying Display Confirmation Screens Disconnect from the Instrument Drain Eject Retract Enable Raw Data Storage Export Batch Data Export CAL Export CON 5 32 xMAP Technology Establishes a connection between the PC and the analyzer This command opens the Luminex Multi Batch dialog box in which you add or create new batches to add to a multi batch Opens the Delete Batch dialog box which shows a listing of the unprocessed batches in the database When you highlight a batch and click Select in this dialog box the system deletes the selected batch Toggles between the default density dot plot and the decaying dot plot views Enables confirmation dialog boxes to display when you initiate many of the maintenance commands Disconnects commun
214. rs 1 2 7 1 outside U S 1 2 phone numbers 7 1 U S A 1 2 templates 4 2 5 52 test analysis view 5 83 test rate 4 1 testing clinical samples 3 2 tests 4 1 thumb wheel B 8 troubleshooting 7 1 types B 8 microspheres 4 2 types of microtiter plate B 8 U UL mark 2 3 unauthorized additional software 3 3 Underwriter Laboratories Incorporated 2 3 uptake 4 1 user manual conventions 1 1 user accessible components 3 7 V ventilation filter XYP 3 8 verification command 5 47 setting well location 5 47 trend report 4 3 updating lots 5 47 View detailed test analysis 5 83 visual inspection 6 3 volume 4 1 vortex 3 7 W warmup 6 1 warnings 2 1 2 7 2 8 5 46 6 8 biological 2 7 laser 2 5 Index 5 Luminex 100 IS User Manual Version 2 3 warranty 2 2 waste connector 3 11 container 3 12 6 2 high volume 6 3 wipe exterior surfaces 6 4 X xMAP 3 4 reagents 3 3 4 1 technology 1 1 XYP 2 3 air intake filter 6 6 heater block B 13 heater temperature 5 46 ventilation filter 3 8 Index 6 xMAP Technology PN 89 00002 00 071 Rev C
215. s xen otf H oz UNDC E AH sneux3 julog JsMeyxXy josoJey e qeqoJd Joso1oy sonsouBeiq pue uomnel eisu 104 Y e gissoqd eqolg uous fuisN ueuM enea Buiooo eoeuns fumnoddng SISEM WO1 SheUxoe JosoJee e qeqoig 6 jsneuxe osojoe A ejqeqoud eouejeej uoisuejxe Aes lt 8 eoueJegp qep 7 y SNUILUJ9 eui ejsew Jo 11 deo Moq 01 0 eo ep 1 euuoosip eui ejeJedo oi jnoyiip s 1 JEU uons seorep eseui uonisod jou oq sp109 Jewod eui ase GS xeuiun eui pue JAX xeutuim 004 xeutun y 10 Sjoeuuoosip eoi eq sseooe eoueuejureui esn YAMS Jewog lt 9 RA uj 0 ejdoed z sesinbes 00X7 rTenueui Jasn perjddns jo suoyonysu uonejeisui pue BurBexoed uo suononursur Burppueu pue Buiddius wojo J S RA yenuew Jesn e2u919j9J Ajuo Buiuuee eAnoe1oJd ui sjeprno ojur pebBnjd eq pjnous sp109 eur p 64 9726 Al Z iste 106186 was elo p BY LLZ dl Sp 97 UMOYs JOU 100 j uo xog piny ujeeus x 29 92 a 79891 1uBiem uiejs s douejunoo elo E SS999 uolIMs Jamod JO e2uejeo o ejqeo pue jsneuxe exejui pue Duyooo 104 eoueJeo 5 E By 688 qi SS 6L QS xeuiun By ot v2 GI 26 S OO xeutiuun1 Auejo 10 Buimesp siu WO1 peniuo ueeg eA eu JepeeJ epooJeq pue Od aul 4epeeJ epooJeq Jeus eui o Od Jjeus eur o GS xeutum dAX xeuiuum 00L xeumum Sjueuoduuoo 1ofeuu G JO sjsisuoo ulejs S S OO xeurum eu Lr S910N B 27 PN 89 00002 00 071 Rev
216. s label appears on the back panel of the Luminex 100 analyzer and on the back panel of the Luminex XYP instrument Ce 1 a MCS 800 748 0241 CE D Figure 2 2 CE Label The Luminex 100 analyzer and the Luminex XYP instrument comply with European Union EU safety requirements and therefore may be marketed in the Europe Single Market This voltage label appears on the back of the Luminex 100 analyzer Model No o Luminex 09 S N LX10003101301 Luminex Corporation Laboratory 12212 Technology Blvd Austin Texas 78727 Manufactured in USA e US LISTED April 2003 69uF 100 120V 200 240 1 4A 47 63 Hz Figure 2 3 Luminex 100 Serial Number Label The Luminex 100 analyzer has been tested by Underwriter Laboratories Inc UL Luminex 100 IS User Manual Version 2 3 FCC Label Fluidics xMAP Technology The following label appears on the back of the Luminex XYP instrument Figure 2 4 Luminex XYP Serial Number Label The Luminex XYP instrument has been tested by UL This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications Howev
217. s of calibration commands performed over a specified time period e System Control Trend Reports provide results of system controls performed over a specified time period e Batch Summary Reports provide batch information in a sample versus test grid format Quality Control Reports track the trends of assay controls over a period of time These reports let you look at specific details regarding the samples you process through the Luminex 100 IS 2 3 software and system operation System tools help you monitor the system including a display showing real time system property values and a message log Errors are shown in the message log and also on your reports You can even add comments to specific results in some of these reports To keep track of your reagents the Luminex 100 IS 2 3 software stores lot numbers expected values and expiration information A comprehensive set of self diagnostic tests ensure that your system is working correctly These tests are performed at startup and can be performed at any time If any problem is detected an error message appears in the message log to inform you Luminex 100 IS User Manual Version 2 3 xMAP Technology PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Main Window PN 89 00002 00 071 Rev C This manual describes how to use the Luminex IS 2 3 software It includes a glossary and information regarding the CSV file setup The software user should have a basic famili
218. s the Save in location The default is the Backup folder directory found in C Program Files Luminex Luminex 100 IS Backup Enter the lot name for the exported lot into the File Name box Click Save then click OK The dialog box closes After you click OK you can use the lot target values with the next calibration or verification The system saves the lot to the existing software as a lot accessible for the next calibration and or verification Once you export the desired calibration or control lot you can save it to disk to import to another computer A batch consists of a group of samples processed under control of a template Batches are set up using templates defined by assay kit manufacturers Batches consist of templates and samples for acquisition and can span more than one plate Templates contain predefined commands that must be included in every batch acquisition Luminex 100 IS User Manual Version 2 3 Importing Templates xMAP Technology You can group batches together as a multi batch Multi batches can consist of any number of batches that have been setup from different assay templates and are processed consecutively The assay kit manufacturer may provide templates in the kits which they distribute on diskette or CD Templates typically include assay standards controls and maintenance commands such as washes or primes to acquire along with samples OEM manufacturers may provide templates pre ins
219. sad hoo eed gee ais 5 33 Import Calibration lesse 5 33 Import Control sss nc solace clan tia wk evade 5 33 Import Template 5 33 lI 5 33 Invalidate Control 0 0 2 0 0 eee 5 33 Invalidate Standard 1 2 0 cee eee 5 33 Load Patient List 0 0 2 0 cee eee 5 33 I og Lin ar oce ee ort Ree der ce el e 5 33 PN 89 00002 00 071 Rev C iii Luminex 100 IS User Manual Version 2 3 xMAP Technology Maximize Minimize 0 0 00 ees 5 33 Next Test ros oce esce wae irs ioe RC ent NH owe ES 5 33 New Advanced Batch 0 0 0 0 ccc eee ee ee 5 34 New Batch oett eU eb WR ede era tob 5 34 New CAL larg dudes b edonne Hieteagddewsadai lt 5 34 New CON Targ sc oos eR eR ee eee 5 34 New Lot 55 ure tete oto OR WA ss Noe Do D bw 5 34 Open Batch cca jes sea nee ea rii eR A sees 5 34 Open Help oreste ete de Mee Hae wate sta 5 34 Open Incomplete Batch 0 0 0 00 00008 5 34 Open Multi Batch 0 0 5 34 hour qe 5 34 Previous Test epe eene qun d e y 5 35 Prime oes oett oa Re RARE SUCK ack hers CR ode dy 5 35 Print Batch Worklist 0 0 00 5 35 Print Report ode Leah Pad aa eia eoe ae 5 35 ler H 5 35 Replay Batch lsssleeelee eh 5 35 Report Raw Fluorescence eleleleee ees 5 35 Resume Seek 4 Xpacevwuew3ge te Se V Rie 5 35 Sample Probe Down 0 0 0c eee eee eee 5 35 SaliliZe 15kebesa eia
220. sage log right click in the Message Log area and click Clear on the menu Acquisition Detail The Acquisition Detail tab offers advanced batch sample monitoring Tab and on the fly data acquisition without templates The primary function is real time monitoring of batch sampling during acquisition through a display of sample bead statistics histogram and dot plot data During batch acquisition bead statistics can be useful if batch errors occur For example if samples are constantly failing due to insufficient bead count you can monitor whether the failure is due to low bead concentration or if other assay problems are present The Acquisition Detail tab provides access to the Developer Workbench DWB software features Details about these features are provided in the Luminex Developer Workbench Guide Version 2 3 documentation You must have the DWB software installed to enable these features Caution Do not alter kit manufacturer s predefined templates or create alternative templates for off the shelf kits unless instructed by the kit manufacturer 5 12 PN 89 00002 00 071 Rev C xMAP Technology Using Luminex 100 IS 2 3 Software Acquisition Detail tab features Batch Name and Description Batch Data Area Acquisition Detail Toolbar Histogram Dot Plot Figure 5 11 identifies the major features of the Acquisition Detail tab Sh Luminex100 IS Software Els loos Hope Luminex am me gt we EE B4 0 pes
221. sample arm 3 8 adjusting vertical height 6 11 sample data entering 4 2 sample details 4 3 Sample Errors 5 24 sample probe B 7 adjust B 8 clean 6 4 sample progress 5 11 samples tab 5 22 sanitize 5 45 5 96 6 1 remove air bubbles 5 44 with 70 isopropanol 5 44 sensitivity 3 4 4 1 setting 5 46 sheath filter 3 11 8 2 sheath flow rate 3 5 sheath fluid connector 3 11 container 3 11 filling 6 2 filter 6 10 levels 6 1 product number 8 3 PN 89 00002 00 071 Rev C xMAP Technology sheath fluid container 3 11 software 3 3 8 3 software overview Luminex 100 IS software 4 2 software specifications 3 3 dedicated system 3 3 soluble analytes 4 1 specifications 3 5 accuracy precision 3 4 capacity 3 4 classification laser 3 5 electronics 3 5 fluidics 3 5 hardware 3 2 Luminex 100 analyzer 3 5 Luminex 100 IS 3 3 3 5 3 7 Luminex XYP 3 6 PC 3 6 reporter laser 3 5 sensitivity 3 4 speed 3 3 vortex 3 7 speed specifications 3 3 stability 4 2 standards tab 5 22 start up procedure 6 1 status of instrument 2 8 storage raw data 5 39 subsystems 3 7 surge protector 3 7 surge protector specifications 3 7 symbols 2 1 syringe 3 10 4 1 syringe seal 6 8 8 2 system drain 5 94 errors 5 24 integrity 4 2 overview 3 7 trend report 5 87 system setup communication cables B 4 PC B 4 XYP B 4 PN 89 00002 00 071 Rev C Index T tabs samples 5 22 standards 5 22 technical support 1 2 7 1 Canada 1 2 email address 1 2 7 1 hou
222. selected rows and Reset back to normal defaults Caption Column Entire Column Select an entire column by clicking the column heading Selected Events or Caption 8 Click the Plate Layout tab See Figure 5 37 On this tab you define commands for the desired wells on the plate You can Luminex 100 IS User Manual Version 2 3 xMAP Technology define commands that apply to one or more wells one or more rows of wells or one or more columns of wells You can define on plate or off plate commands Right click the grid to display the popup command menu 1 12 3 4 5 6 7 8 9 10 11 12 OOOQOOOQOQQO SD0DOOOOOOOOOO goOoOOOOOOOOOO 8a 0D0O0OOOOOOOQO goOOOOOOOOOOQO goOOoQOooooooQO FOOOCOOOOO0O00O HOOQOOOOOOOO0OO OK Cancel Note Wells are always read in rows letters A to H and col umns numbers 1 to 12 start ing with A1 If partial columns are selected they are still read in the same order 10 Figure 5 37 Plate Layout Tab Select wells To select a single well click the well To select multiple wells in a group click and hold the mouse button with the cursor over the first well then drag the cursor around the desired wells To select a row or column click the letter or number of the row or column Select plate commands Right click over the selected wells to display the Command menu See Figure 5 38 Select the desired command The associated command symbol appears in
223. sted CSA certified CE marked for nondomestic use when used internationally Printer HP LaserJet 2300 or available equivalent Use the Code 128 barcode label type when scanning barcode labels into the system as patient identities VWR product number 58816 121 Speed range 0 3200 rpm or equivalent Cole Parmer product number 08849 00 Operating frequency 55 kHz or equivalent The system consists of three subsystems electronic fluidic and optical The following section describes the user accessible components of each subsystem The power input modules contain the on off switch and fuses The communications port connects the Luminex 100 analyzer or the Luminex XYP instrument to the computer and the Luminex SD system to the Luminex 100 analyzer Located on the bottom of the Luminex 100 analyzer the filter must be checked and cleaned as necessary For proper ventilation do not obstruct the area below and allow at least two inches 5 cm of clearance around the Luminex 100 analyzer Luminex 100 IS User Manual Version 2 3 xMAP Technology Luminex XYP The XYP instrument ventilation filter cleans the air that cools the Instrument internal parts of the Luminex XYP instrument See Figure 3 1 Ventilation Filter 1 1 Air intake filter access door 5 Communication Ports DB9 2 Power Switch 6 XYP Communication Port DB9 3 Power Input Module 7 Analyzer ventilation filter on bottom of analyzer 4 XYP ventilation Filter
224. stem draws sheath fluid from the sheath fluid container and sends it directly to waste You do not need to supply solution in a plate A backflush takes between 10 and 30 seconds To clear obstructions from the cuvette Click Backflush then click OK to verify that you want to back flush the system The status bar shows that the backflush command is processing Alcohol flush the system to remove air bubbles from the sample tubing and the cuvette using 70 isopropanol or 70 ethanol The cuvette is the principal fluid pathway within the optics component of the system where the system reads the sample To remove air bubbles from the sample tubing and cuvette 1 On the Maintenance tab click Eject Retract 2 A confirmation dialog box opens telling you to place solution in the reservoir 3 Put 70 isopropanol or 70 ethanol in the reservoir 4 Click OK The plate holder retracts and the system performs the Wash command Use the wash cycle after an alcohol flush or as needed For example wash four times with distilled water after calibration and twice with PN 89 00002 00 071 Rev C xMAP Technology Set Luminex XYP Instrument Heater Temperature PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software distilled water after Sanitize Place at least 200 uL in a microtiter well or fill the Luminex XYP reservoir with distilled water Washing takes about 30 seconds You should wash after calibration and verification
225. strument or Luminex SD system refer to Luminex 100 IS 2 3 Firmware Installation page B 21 Before connecting the system components ensure that the facility complies with all system and safety requirements Read the safety information that begins in Warnings and Notes page 2 2 Position the instrument to minimize temperature fluctuations Luminex 100 IS User Manual Version 2 3 xMAP Technology The following sections describe how to connect the Luminex 100 IS system components An Installation Drawing page B 27 provides clearances and other related information Figure B 1 shows the components of the system and how they should be placed Perform the following procedures to set up the system Each of these steps can be found on the page number shown in parentheses 1 Connect the Luminex 100 analyzer and Luminex XYP to the PC page B 3 2 Install the Luminex XYP Instrument Sample Probe page B 6 3 Power On System Components page B 8 4 Accept the Luminex 100 IS 2 3 Software License Agreement page B 8 5 Adjust the Sample Probe Vertical Height page B 8 6 Install the Luminex XYP Instrument Reservoir page B 9 7 Calibrate and Verify the System page B 10 8 Install the SD System page B 10 9 Install the Luminex XYP Instrument Heater Block page B 13 1 Monitor 4 Barcode Scanner 2 PC 5 Luminex SD system 3 Luminex XYP Instrument 6 Luminex 100 Analyzer Figure B 1 Luminex 100 IS System Setup PN 89 0
226. system PC and Luminex Data Collector software and the Luminex 100 analyzer and XYP instrument This section does not address communication issues with other peripheral devices The term Communication refers to The transfer of data between the PC and the analyzer The current status of the analyzer and XYP instrument nstrument readbacks nstrument control sample acquisition session uploading and start stop and pause features Symptom Possible problem Solution PC cannot initialize communication with analyzer The communication cable is Check the communications unplugged or plugged into the cable connections wrong port PN 89 00002 00 071 Rev C xMAP Technology The XYP or the LX 100 power Is not turned on Troubleshooting Turn off the PC and then turn on the LX100 XYP and then the PC Pressurization Normal air and sheath pressure readings vary between 6 9 psi while the compressor runs If the system pressure is out of range your sample acquisition will fail or return poor results Symptom Possible problem Solution Pressurization fails or pressure is too low The sheath and waste lines are not fully connected An air leak is present in the sheath bottle The sheath or waste bottle fittings are cracked There is a leak in the system The compressor does not engage The Cheminert Fitting is loose Fluid leaks in the system The sheath bottle has an air l
227. t up the system The dialog box prompts you to verify that the lot information for CAL 1 CAL2 CONI and CON reagents are correct 5 Click OK to verify that the lot information is accurate Table 5 11 shows a recommended schedule for maintenance operations Table 5 11 Maintenance Operations Recommended Use Schedule Operation Recommended Use Schedule Warmup Daily After four hours of system inactivity Prime Daily To remove air from sheath fluid tubing After performing these actions refilling the sheath container removing and replacing sheath container changing the sheath fluid filter changing the syringe seal Backflush Troubleshooting and preventative maintenance purposes only to remove obstructions from the cuvette if fluid does not flow through the waste tub ing during prime cycles or during sample acquisition if fluid drips from the sample probe during priming and forms puddles of fluid on the plate Alcohol Flush Daily Before system calibration After changing the sample probe To remove air bubbles from the cuvette using 7096 isopropanol or 7096 ethanol PN 89 00002 00 071 Rev C xMAP Technology Drain the Analyzer PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Table 5 11 Maintenance Operations Recommended Use Schedule Continued Operation Recommended Use Schedule Sanitize To decontamin
228. t Test F2 Invalidate Standard F4 invalidate Control F6 Change Formula F8 ipid PUER Previous Testis Validate Standard FS _ Validate Control F7 Change Lot AIt F8 PN 89 00002 00 071 Rev C 0o fv Auto Alphabetically by Sample ID Figure 5 16 Analysis Window Errors Tab Open Luminex 100 IS User Manual Version 2 3 xMAP Technology Table 5 5 Error Categories System and Assay Errors Sample Errors Instrument Not Calibrated Failed Verification system lists each failed control Failed Control verifier failed Temperature Divergence from Insufficient Bead Count Sample High Low Analyzer Error High Sheath Pressure Low Sheath Pressure Calibration Temperature Sample Timeout Failed Curve Fit Sample Empty Analysis Error Cannot Calculate Inverse e APD Temp Range Exceeded Function XYP Temp Unstable Different Qualitative Results Low Voltage High Sheath Pressure e Low Sheath Pressure Command Timeout Low Laser Power e Cannot Calculate Inverse Function Failed Std in Batch Standards Tab The Standards tab lists all the batch tests with system comments specific to each test The detailed test information that is displayed on the three tabs of the Analysis window is determined by the test selected under the Standards tab The Standards tab displays the quantitative batch s standard curve It displays qualitative batches as a graph plot
229. t side of the Luminex 100 analyzer Make the following connections refer to Figure B 11 as needed e Connect the sheath fluid line blue fitting to the Sheath Out connector on the front of the Luminex SD system e Connect the air line green fitting to the Air In connector on the front of the Luminex SD system e If you are using the Luminex SD system waste line connect the waste line tubing to the waste connector on the left side of the Luminex 100 analyzer orange fitting Place the other end of the waste line into a large waste receptacle Cut off excess tubing Ensure the waste receptacle is level with the Luminex 100 analyzer or no more than three feet below it e Connect the sheath fluid intake line white fitting to the Sheath In connector on the front of the Luminex SD system ooo ON Luminex sp SAR EEHHNEMN EN SHEATH OUT E SHEATH IN NE 7 1 Power and Fault indicators 5 Sheath Out connector blue 2 Prime button 6 Sheath In connector white 3 Regulator adjust 7 Reservoir window 4 Air In connector green Figure B 11 Luminex Sheath Delivery Device B 11 Luminex 100 IS User Manual Version 2 3 Note Ensure that the sheath fluid box is at least three feet below the system otherwise the Luminex SD system will overfill Note The regulator must be fully opened to work properly It is important to make sure that you turn it as far as it will go 3 xMAP Technology e Lower the sta
230. talled with your system The kit manufacturer includes assay reagents in the assay kit You must provide information about these reagents such as lot numbers and concentration values for the standards and assay controls A batch can include samples across more than one plate When setting up a batch if the number of samples exceeds the wells in one microtiter plate another plate appears 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 During acquisition the Run Batch tab displays the wells containing the samples in the microtiter plate Colors indicate the progress in analyzing the samples The following well colors indicate well acquisition states e Green well with command number sample not acquired e Yellow well sample currently in acquisition e Red well sample failed Check the system monitor for more information e Green background with check mark successfully completed Common sample errors are due to lower number of events acquired than established in the template You need to import new templates to the system only once You must enter lot information for the standard and control reagents as specified in the template This lot information is used for every batch setup using the template until it is changed Templates include standards controls both standards and controls maintenance
231. tch Sample input can be done quickly with either the keyboard or a barcode scanner A batch can include as many samples as you have for the assay and can include multiple microtiter plates You can even group multiple batches together into a multi batch for efficient processing You can process a batch immediately or choose to archive the batch for testing later As testing proceeds through the plate you will see the display update to show the wells that have been processed Progress is shown in both graphic and tabular form PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Basic Concepts System calibrators and controls are provided as part of the system Calibrate at least once monthly when the delta calibration dCAL temperature changes by 3 degrees or if the system is powered off or moved 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 e Analyte Reports provide batch results grouped by the test in a batch e Patient Summary reports provide batch results grouped by each patient or unknown in a batch Clinical Patient reports provide a breakdown of samples according to the test analysis with that sample Maintenance Reports provide a history of all maintenance operations performed during a specified period of time Calibration Trend reports provide result
232. te or local regulatory agencies and have not been tested by Seller or Luminex for safety or efficacy in food drug medical device cosmetic commercial or any other use unless otherwise stated in Seller s technical specifications or material data sheets furnished to Buyer Buyer expressly represents and warrants to Seller that Buyer will properly test and use any Product in accordance with the practices of a reasonable person who is an expert in the field and in strict compliance with the United States Food and Drug Administration and all applicable domestic and international laws and regulations now and hereinafter enacted BUYER HEREBY GRANTS TO LUMINEX A NONEXCLUSIVE WORLDWIDE UNRE STRICTED ROYALTY FREE FULLY PAID UP LICENSE WITH THE RIGHT TO GRANT AND AUTHORIZE SUBLICENSES UNDER ANY AND ALL PATENT RIGHTS IN INVENTIONS COMPRISING MODIFICATIONS EXTENSIONS OR ENHANCEMENTS MADE BY BUYER TO THE PRODUCT OR TO THE MANUFACTURE OR USE OF THE PRODUCT IMPROVE MENT PATENTS TO MAKE HAVE MADE USE IMPORT OFFER FOR SALE OR SELL ANY AND ALL PRODUCT EXPLOIT ANY AND ALL METHODS OR PROCESSES AND OTHERWISE EXPLOIT IMPROVEMENT PATENTS FOR ALL PURPOSES NOTWITHSTAND ING THE FOREGOING IMPROVEMENT PATENTS SPECIFICALLY EXCLUDES PATENT CLAIMS CONCEIVED AND REDUCED TO PRACTICE BY BUYER CONSISTING OF METH ODS OF SAMPLE PREPARATION METHODS OF CONJUGATING PRODUCT TO ANALYTES THE COMPOSITION OF MATTER OF THE SPECIFIC CHE
233. tem Firmware Update Update Firmware Note If you are directed by Technical Support or by upgrade kit instructions to upgrade to a specific firmware version then click the Browse button and select the desired firmware version from the Open dialog box Note If you are upgrading the Luminex XYP instrument firmware consider doing it at this time then verify the Luminex 100 analyzer and the Luminex XYP instrument at the same time Verify Successful Firmware Upgrade PN 89 00002 00 071 Rev C Luminex 100 IS 2 3 Firmware Installation If you are upgrading the firmware for more than one component for instance the SD and the XYP you must upgrade the SD system first Follow the steps in this section to update and verify the Luminex SD system firmware To update the Luminex SD system firmware 1 Close any open applications 2 Turn off the power to the SD XYP and LX100 3 Remove the serial cable from the Luminex XYP instrument and plug it into P2 on the back of the SD system 4 Turn power back on to the SD system 5 Onthe PC desktop click Start Programs Luminex LXR LX Firmware The LX Firmware Update Tool dialog box opens See Figure B 19 6 Select the SD Device option button Notice in the Movement Device text box item 3 in Figure B 19 that the top line displays the current version of the Luminex SD system firmware and that the second line displays its status 7 If the second line indicates that the f
234. the Prepare System for First Use page B 26 before running samples New Luminex 100 IS 2 3 systems arrive with the Luminex 100 IS 2 3 software installed Upgrading existing systems to Luminex 100 IS Version 2 3 requires that you upgrade your software through an upgrade kit The upgrade kits include necessary components such as software CDs manuals cables and instructions Select the upgrade kit that applies to your current version or is called out in your upgrade kit procedure If your current software version is e Luminex 100 Version 1 7 with Windows 98 you need Upgrade Kit CN U010 01 Follow the procedure on page B 15 e Luminex 100 Version 1 7 with Windows 2000 you need Upgrade Kit CN U010 06 Follow the procedure on page B 17 e Luminex 100 IS Version 2 1 or 2 2 you need Upgrade Kit U010 07 Follow the instructions on page B 19 PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 Version 1 7 with Windows 98 to Luminex 100 IS Version 2 3 Install New PC Install Luminex 100 IS 2 3 Software PN 89 00002 00 071 Rev C Luminex 100 IS 2 3 Software Installation Overview of upgrade to Luminex IS 2 3 software procedure 1 Install new PC Install Luminex IS 2 3 software Verify successful upgrade To install the new PC Close all applications Perform a complete system shutdown Turn the power off and unplug the Luminex 100 analyzer Luminex XYP and PC Remove all connections from the old PC Remov
235. the font as you select it See Figure 5 49 Luminex 100 IS User Manual Version 2 3 xMAP Technology Test 36 Customization x General Axis Font Color Style Main Title Arial I bold italic underline Sub Title Times New Roman v bold italic underline Subset Point Axis Labels Aral v bold italic underline sample AaBbCc DdEeFfGg Cancel Apply Original Export Maximize Figure 5 49 Customization Dialog Box Font Tab Color Tab Use the Color tab to define the various color parameters on the analysis graph See Figure 5 50 Desk Foreground this is the color that is used when placing text onto the Desk Background It includes the main title sub title subset point labels grid numbers Desk Background this is the color that surrounds the bound ing rectangle of the graph s grid That is the color of the bor der that appears behind the text labeling Shadow Color the rectangles that make up the graph s grid and table are bounded at the bottom right edges with shadows To remove the shadows choose the same color as the Desk Background Graph Foreground this is the color used for the bounding rectangles of the grid the grid lines of the graph and lines that are used to bound some of the plotting methods like the bounding line around bars of the Bar Plotting Method Graph Background this is the color that is used as the back ground color of the graph s gri
236. ting the assay standard Above the graphical information the tab displays the formula that it used to calculate batch data Below the graphical information the tab displays the Standards and Controls values for the selected test 5 24 PN 89 00002 00 071 Rev C xMAP Technology Using Luminex 100 IS 2 3 Software E Analysis inl xl Open Batch Export Data Cos Protein Batch IL 4 Errors F9 Standards F11 Samples F12 Toana S Y 1 48E 02 2 85E 04 1 x A85E 03 1 26E00 6 69E 01 ILA E IL 6 R 2 0 9999 Sample HighiLow Logistis 5p yza b H c PAYS EIL 8 R 2 0 9994 Sample High Low Next Test F2 Invalidate Standard F4 invalidate Control F6 a F Previous Test F3 Validate Standard F5 V alidate Control F7 chano Change Lot Alt F8 Alphabetically by Sample ID o 1000 2000 3000 4000 5000 6000 7000 8000 9000 10000 pgtL Loc Standard Expected Conc MFI TestResult CV Unit a ct 10 10 82 14 66 pgimL D1 10 10 68 1511 paml E1 315 31 6 212 27 70 pgimL F1 316 316 208 2730 pgimL G1 100 100 853 93 05 pain Ht 100 100 833 90 84 pgimL A2 316 316 2824 344 57 poimL E Loc Control Expected Cone MFI Low Limit High Limit Test Result CV Unit a A3 Coni 00 100 797 75 125 86 89 pgimL B3 Con100 100 815 75 125 88 86 pgimL
237. tion wait for the status to change The communication cables are Remove and reconnect the cable not connected connections Close the software application and reopen it Close the software application then turn off the Luminex system Power on the system and check the status Refill Sheath Sheath fluid is low Refill the sheath container then click Resume Running Sheath Empty Sheath fluid is empty Replace or fill the sheath fluid System Error Messages PN 89 00002 00 071 Rev C container with sheath fluid Run two Prime commands There are two types of error messages system error messages and sample error messages System error messages are displayed in three places the Message Log on the Diagnostics Tab the message log located in the Windows message log folder the Errors tab Luminex 100 IS User Manual Version 2 3 xMAP Technology Error Message Possible problem Solution Unknown Diagnostic Error Unknown varied Record the error code number and message Contact Luminex Technical Support XYP Instrument Heater Stability Range Exceeded The heater block temperature is not hitting the target value Low Voltage Detected Possible laser failure Turn off the analyzer XYP and PC then turn them back on Calibrate and verify the system If the error message occurs again contact Luminex Technical Support Runtime Sheath Pressure out of Limits Too High The sheath
238. tion in whole or in part is strictly prohibited Standard Terms and Conditions For Use of Product By opening the packaging containing this product Product or by using such Product in any manner you are consenting and agreeing to be bound by the following terms and conditions You are also agree ing that the following terms and conditions constitute a legally valid and binding contract that 1s enforce able against you If you do not agree to all of the terms and conditions set forth below you must promptly return the Product for a full refund prior to using them in any manner l Acceptance ALL SALES ARE SUBJECT TO AND EXPRESSLY CONDITIONED UPON THE TERMS AND CONDITIONS CONTAINED HEREIN AND UPON BUYER S ASSENT THERETO NO VARIATION OF THESE TERMS AND CONDITIONS SHALL BE BINDING UPON LUMINEX CORPORATION LUMINEX UNLESS AGREED TO IN WRITING AND SIGNED BY AN AUTHORIZED REPRESENTATIVE OF LUMINEX For purposes of this agree ment Seller shall mean the Luminex authorized reseller that sells the Product to Buyer Buyer by accepting the Product shall be deemed to have assented to the terms and conditions set forth herein notwithstanding any terms contained in any prior or later communications from Buyer and whether or not Seller shall specifically or expressly object to any such terms Warranties Any warranty obligations for the Product shall be exclusively provided in writing to Buyer directly by Seller LUMINEX MAKES NO W
239. ttle of calibrator beads Adjust the sample probe height See page B 8 Clean the sample probe See page 6 4 Luminex 100 IS User Manual Version 2 3 There is a partial clog in the system There is air in the system Possible problem with the laser xMAP Technology Clean the sample probe See page 6 4 Run 3 backflushes 3 drains 2 alcohol flushes and 3 washes with distilled water Run a prime and alcohol flush View the calibration trend report Check for dramatic changes in temperature sheath pressure or voltages If any of these situations are evident on the report Contact Technical Support Zero events collected during calibration There is a problem with fluid levels Check the fluid levels in the sheath and waste containers Verify that both bottles are tightly connected to the instrument Check that the waste bottle cap is vented Laser related issue Verify fluid is moving through the system by performing a wash A wash function will cause fluid to go out to waste in five distinctive spurts If there s not fluid going to waste clean the sample probe see page 6 4 Run 3 backflushes 3 drains 2 alcohol flushes and 3 washes with distilled water If the issue does not resolve contact Technical Support Analyzer fails Controls The control microspheres are not fully suspended Wrong control lot number or target values are entered in Update CON Targets dialog box
240. tures and click Export See Figure 5 47 x m Esport MetaFile C BMP C Test Data Only Esport Destination ClipBoard C File Browse C Printer Object Size C No Specific Size Milimeters inches Points EE ancel Width 5 177083 384375 Inches Figure 5 47 Exporting Dialog Box Maximize Click to maximize the graph to full screen Restore to original size by pressing Escape on the keyboard or by click ing in the title bar Customization dialog box tabs e General Tab Use this tab to define general parameters See Figure 5 46 Main and Sub Titles These edit boxes allow you to add edit or delete these titles If no title is present you can enter one Delete all characters from a title to remove it Viewing Style The Graph supports three viewing styles Color Monochrome Monochrome with Symbols This customization allows you to quickly adjust the image to best suit printing on a monochrome printer If you include fewer than four subsets in a graph then the Monochrome set ting will probably be the best choice If four or more subsets 5 78 PN 89 00002 00 071 Rev C xMAP Technology PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software are included in the graph then Monochrome with Symbols will help distinguish the different subsets Font Size The Graph supports three font sizes Large Medium and Small When printing the graph a font size of Mediu
241. turning off the power switch on the rear of the analyzer then unplugging the analyzer power cord from the wall source Disconnect the sheath fluid tubing before changing the filter Open the left door on the Luminex 100 analyzer Disconnect the filter by pushing down on the metal clamps on each connection See Figure 6 7 Figure 6 7 Sheath Filter Connect the new sheath filter matching up the color coded fittings The arrow on the sheath filter should be pointing up Reconnect the sheath fluid tubing Plug in and power on the Luminex 100 analyzer Close the left analyzer door Prime twice PN 89 00002 00 071 Rev C xMAP Technology Maintenance and Cleaning As required Fuses Danger To avoid serious injury or death by electric shock you must turn off the system and unplug it from the wall outlet To replace the fuses in either the Luminex 100 analyzer or the Luminex XYP instrument 1 Turn off the power switch on the rear of the analyzer or instrument then unplug the instrument power cord from the wall source Remove the power cord from the analyzer or instrument 2 With a small flathead screwdriver open the module door on the lower left corner of the back of the analyzer or instrument See Figure 6 8 P Figure 6 8 Opening the Module Door 3 Remove the red cartridge use a flathead screwdriver 4 Check both fuses for damage 5 Replace damaged fuses with the type specified on the stic
242. uirements The first line of text in the file must be L X100IS Patient List The second line of text in the file must be Accession Dilution Factor Any following lines of text should be only in the format x y Where x accession ID number for the patient patient identifier string and y dilution factor The dilution factor is optional but if entered must be a numeric value If the dilution factor is omitted the system defaults to one Patient list entries are case sensitive This applies to entries made through the graphical user interface or in a file The format must be like the following example or it will not load properly Double check all Sample IDs before you save the newly created batch An example of a typical patient list file LX100IS Patient List Accession Dilution Factor a001 1 a002 2 a003 1 b001 4 b002 0 6 c917 4 cee4gf 1 PN 89 00002 00 071 Rev C xMAP Technology Edit a Patient List PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software To add a Patient List file while creating a batch or multi batch 1 On the toolbar click Create New Batch or Create New Multi Batch The Open Template dialog box opens 2 Selectatemplate to create a new batch and click Select The Luminex Batch Setup dialog box opens showing the template commands and the microtiter plate representation For multi batches the Luminex Multi Batch Setup dialog box opens 3 Click Loa
243. us close the other application or wait until the application completes Luminex 100 IS User Manual Version 2 3 xMAP Technology S econdary In addition to the main window there are other windows that are Windows displayed when you select certain commands These are the Batch Setup Window and Analysis Window Additional windows display in the Developer s Workbench software if you have it installed on your system For more information about the Developer s Workbench see the Luminex Developer Workbench Guide for Version 2 3 Batch Setup Window In the Batch Setup window you define information used to create batches All of the commands are on the same page there are no tabs The window opens when you click New Batch and select a template Luminex Batch Setup P Please establish the starting location for the batch and enter the appropriate patient information Note indicates a required field Insert Acquire Patient x fi Apply Batch Info gt No Location Command Sample ID Dil Factor Name B 1 A1 Plate1 Acquire Standard Std M 1 v Batch erai 16 38 A 2 B1 Plate1 Acquire Standard Std M 1 i m 8 3 C1 Plate1 Acquire Standard Std L 1 Finish Description Bj 4 D1 Plate1 Acquire Standard StdL 1 None amp 5 E1 Plate1 Acquire Standard Std XL 1 X amp 6 F1 Plate1 Acquire Standard Std XL 1 Cancel 5 amp 7 G1 Plate1 Acquire Co
244. ut In the auto selection mode changes automatically trigger the system to reanalyze the affected test If you are not using the auto mode the ReCalc button is available after you make a change such as changing a formula or lot or invalidating or validating a standard or control Replays batch sample acquisition All batch commands are replayed allowing for batch acquisition viewing exactly as in real time You cannot replay New Advanced Batches When running a Replay Batch command the original acquisition data is not altered A new file is created The most common use is for system demonstration and training Enables the median fluorescence intensity MFI to appear on the Analyte Report Resumes the process that was paused Raises and lowers the sample probe to adjust the probe height This adjustment is recommended when using different microtiter plates or when changing sample probes Uses the Luminex XYP reservoir due to volume requirement The sanitize command performs a similar function as the alcohol flush Luminex 100 IS User Manual Version 2 3 Save and Load Save Only Self Diagnostics Show Bead Single Step Skip wells Soak xMAP Technology command However the sanitize command uses 10 to 20 household bleach to decontaminate sample lines and the cuvette after biohazard contact If selected displays the run batch tab immediately after you set up batch information and click Finish Allows you to sa
245. ve the batch information User can open the batch later to acquire data Performs a self diagnostics to see if the Luminex analyzer and all system operations are functioning correctly Self Diagnostics tests these functions 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 Debubbler valve test After selecting an entry from the drop down list sets the histogram to show events for only one beadset bead set number all gated events within the gate or all events inside and outside the gate Select all default before setting the gate Selecting this option on the toolbar pauses the system in between each command or sample acquisition within a batch Enables you to deliberately bypass specific wells during batch acquisition Prevents salt crystals from forming in the probe due to air exposure Soaking the probe replaces sheath fluid in the probe with water You should perform the soak function at the end of each day The system uses at least 250 uL of distilled water PN 89 00002 00 071 Rev C xMAP Technology Start Analysis Start Plate Statistics Test Sort Orders Validate Control Validate Standard View Batch Data Warmup Wash Zoom PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3
246. x 100 IS Version 2 3 software update before installing firmware upgrade tools and firmware files See Luminex 100 IS 2 3 Software Installation page B 14 for the procedure There are two types of interface cable that connect between the Luminex 100 analyzer and the PC one is a serial cable and the other is a USB cable To upgrade from Luminex 100 Version 1 7 use the existing serial interface cable Then replace with USB cable after the upgrade To upgrade from Luminex 100 IS Version 2 1 or 2 2 use the existing USB cable To upgrade the Luminex 100 analyzer firmware 1 2 Close any open applications On the PC desktop click Start Programs Luminex LXR LX Firmware The LX Firmware Update Tool dialog box opens See Figure B 19 Notice in the Detector Device text box item 2 in Figure B 19 that the top line displays the current firmware version and the second line displays the firmware status That is either an update is available or the firmware is up to date See note If the second line indicates that the firmware is up to date then click Close No further action is required If an update version is available then continue with step 4 PN 89 00002 00 071 Rev C xMAP Technology Luminex 100 IS 2 3 Firmware Installation Note If you are directed by LxFirmware Update Tool x Technical Support or by Welcome to the LxFirmware update tool upg rade kit instr uctions to If any upgrades are
247. y after calibration and after sanitizing Place at least 200 mL in a microtiter well or fill the Luminex XYP reservoir with distilled water To perform a Wash command Onthe Maintenance tab click Eject Retract 2 Click Wash A confirmation dialog box opens telling you to place solution in the reservoir 3 Putdistilled water in the reservoir 4 Click OK The plate holder retracts and the system performs the Wash command 5 96 PN 89 00002 00 071 Rev C xMAP Technology Perform a Soak Command Exit Luminex IS 2 3 Software PN 89 00002 00 071 Rev C Using Luminex 100 IS 2 3 Software Soak the sample probe to prevent the sheath fluid crystals from forming in the sample probe To perform a soak command 1 On the Maintenance tab click Eject Retract 2 Select Reservoir from the dropdown menu next to the Soak button then click Soak A confirmation dialog box opens telling you to place solution in the reservoir 3 Putdistilled water in the reservoir 4 Click OK The plate holder retracts and the system performs the Soak command When you exit the system a confirmation dialog box prompts you to verify that you really want to exit the system To exit the system On the File menu click Exit then click Yes Luminex 100 IS User Manual Version 2 3 xMAP Technology PN 89 00002 00 071 Rev C Maintenance and Cleaning Daily Maintenance Before Running Samples PN 89 00002 00 071 Rev C
248. y remaining patient IDs to the end of the command list in the order as they appear in the patient list xMAP Technology 5 If you want to insert an Acquire Patient or Skip command select the command from the Insert menu In the multiplier box enter the number of patients that you want to add to the list or the number of wells that you want to skip and click Apply Skipped wells and patient wells added to the batch are shown as green wells on the microtiter plate image 6 If you are running a maintenance template add any samples for processing Then click Save and Load default or Save Only Otherwise continue with step 7 7 Ifyou want to change the well location where you begin acquiring samples drag the highlighted starting well default is A1 to the desired location on the microtiter plate 8 Click the field in the Sample ID row that represents the last empty well on the microtiter plate 9 Enter the sample ID for the sample to add Repeat this step to add all of the additional samples to the batch You can enter the sample manually through a patient list or using the system barcode reader Batches may span more than one plate When the first plate is full a blue line separates the columns of the first plate with those of a second plate To add a sample ID to the end of the list press the Enter key or double click in the last line 10 To add a patient file to the batch click Load Pa List An Open Patient List File

Luminex 100 IS User Manual. To be used only by Scott Placke.

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