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Procleix TIGRIS Operator's Manual

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TIGRIS System
Procleix
Operator's Manual
Volume I: Operating the Instrument
For In Vitro Diagnostic Use
For Use In Taiwan Only

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Summary of Contents for Procleix TIGRIS

  • Page 1 ® TIGRIS System Procleix Operator’s Manual Volume I: Operating the Instrument For In Vitro Diagnostic Use For Use In Taiwan Only...
  • Page 2 ® This manual was produced for use with the PROCLEIX TIGRIS System. Developed and manufactured by: Gen-Probe Incorporated 10210 Genetic Center Drive San Diego, CA 92121 USA (858) 410-8000 EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands Tel: +31 (0)70 345 8570 Fax: +31 (0)70 346 7299 ©...

  • Page 3: Evision Istory

    All sections original issue. 902285 Rev. A 2009-02 All sections revised. 902597 Rev. A 2010-02 All sections revised. 902649EN Rev. A 2010-05 All sections revised. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 4 ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 5: Table Of Contents

    AR Carousel Configuration ................1-13 Sample Bay....................1-14 Vacuum System ..................1-16 Power Switch and Circuit Breaker Switch ..........1-16 ® Overview of the PROCLEIX TIGRIS System Software ........1-17 Main Menu Screen ..................1-17 ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument...

  • Page 6: Contents

    Specifications ...................... 1-21 Physical Specifications ................1-21 Environment....................1-21 ® Water for the PROCLEIX TIGRIS System Specifications ....... 1-22 Power Requirements ................. 1-22 Vacuum Pressure Requirements............... 1-22 Sample Tube Specifications ..............1-22 Sample Requirements ................1-25 System Capacities and Throughput............1-26 Operator Prerequisites ..................
  • Page 7 Creating a New Operator Account ...............5-2 Editing an Operator Account ................5-3 Viewing an Operator Account ..............5-3 Activating or Inactivating an Operator ............5-3 Deleting an Operator Account ..............5-3 ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 8 Instrument Processing Errors................A-1 Results Processing Errors..................A-4 B. S ..........B-1 PPENDIX UPPORT ONTACT NFORMATION Novartis Diagnostics Customer Service ..............B-1 Novartis Diagnostics Technical Service ..............B-1 ® viii PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 9: List Of Figures

    IST OF IGURES ® Figure 1.1 PROCLEIX TIGRIS System ..................1-9 Figure 1.2 Fluids Drawer ......................1-10 Figure 1.3 Waste Drawer (Liquid Waste tube parking slots not shown) ........1-11 Figure 1.4 Assay Reagent (AR) Bay ..................1-12 Figure 1.5 AR Wedge ........................ 1-13 Figure 1.6 Discriminatory Probe Wedge..................
  • Page 10 IST OF IGURES ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 11: List Of Tables

    Table 1.7 Clearance Specifications ...................1-21 Table 1.8 Environmental Requirements ..................1-21 Table 1.9 Environmental Output ....................1-21 ® Table 1.10 Water for the PROCLEIX TIGRIS System Specifications ........1-22 Table 1.11 Power Requirements ....................1-22 Table 1.12 Minimum Vacuum Pressure ..................1-22 Table 1.13 Sample Tube Requirements ..................1-22 Table 1.14 Barcode Requirements ....................1-23...
  • Page 12 IST OF ABLES ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 13: About This Manual

    Provides a description, intended use, and specifications for the PROCLEIX TIGRIS System analyzer and software. ♦ Setting up the Instrument – Provides instructions for setting up the PROCLEIX TIGRIS System for an assay run. ♦ Running Samples – Provides instructions for performing an assay run.

  • Page 14: Formatting Convention For Online Procedures

    2) compromising of sample(s) or pool integrity due to cross contamination or improper volume verification. Note: Indicates additional information applicable to the immediate subject matter. Electric shock warning. Potential biological hazard alert. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 15: Trademarks

    ® PROCLEIX Assay package inserts ® PROCLEIX TIGRIS System Operator’s Manual, Volume II: Maintenance ® PROCLEIX TIGRIS System Operator’s Manual, Volume III: Error Handling ® PROCLEIX Reagent Preparation Incubator Operator’s Manual ® PROCLEIX TIGRIS System Quick Reference Guide ® PROCLEIX TIGRIS System Operator’s Manual...
  • Page 16 BOUT ANUAL ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 17: Section 1. Introduction And Product Description

    The PROCLEIX TIGRIS System is only intended for use with PROCLEIX Assays for in vitro diagnostic use that have package inserts with PROCLEIX TIGRIS System instructions. In the United States, this is limited to licensed PROCLEIX Assays.
  • Page 18 Volume II: Maintenance. Discard any materials that come into contact with waste into biohazard containers. ® Warning: If a biohazardous spill occurs outside the PROCLEIX TIGRIS System analyzer, follow site procedures for decontamination. Warning: If a tip is present following power loss, biohazardous material may remain in the tip.

  • Page 19: Installation Notices

    Warning: Do not move the analyzer. Only Novartis Diagnostics authorized personnel may move the analyzer. ® Caution: Do not install or use non-system software programs on the PROCLEIX TIGRIS System computer workstation without written authorization from Novartis Diagnostics. ®...

  • Page 20: Operational Notices

    Caution: Follow the instructions in the operator's manual, on software screens, and in the ® appropriate PROCLEIX Assay package insert for safe and effective use of the PROCLEIX TIGRIS System. Caution: Do not force a door open. Equipment doors will lock during operation.

  • Page 21: Notices Regarding Samples

    Check the stability time and expiration date of all reagents prior to use. ® Caution: The PROCLEIX TIGRIS System software will not allow the use of any reagent past the expiration date of the Master Lot, even if the individual expiration date has not yet passed.
  • Page 22 Using a clean, disposable wipe, remove any crystallization with water for ® the PROCLEIX TIGRIS System. For water specifications for the PROCLEIX TIGRIS ® System, see “Water for the PROCLEIX TIGRIS System Specifications” on page 1-22 in Volume I: Operating the Instrument.

  • Page 23: Maintenance Notices

    ® PROCLEIX TIGRIS System analyzer, wipe the area with 0.5% sodium hypochlorite in water (diluted bleach) and allow the bleach to contact the area for 15 minutes. Then wipe the area with water. If a large spill occurs, contact Novartis Diagnostics Technical Service for assistance.

  • Page 24: Consumables Notices

    7355 feet (2242 m). ♦ The PROCLEIX TIGRIS System has not been validated to run on a network domain. It must not be configured to log on to a network domain. Contact Novartis Diagnostics Technical Service for more information about network configuration.

  • Page 25: Overview Of The Procleix ® Tigris System

    ® The two main components of the PROCLEIX TIGRIS System are the analyzer and the computer workstation. The system software in the computer workstation directs the analyzer modules to perform each sequential assay step. The analyzer modules contain all of the fluids, reagents, consumables, and mechanical parts that perform the assay.

  • Page 26: Computer Workstation

    RW drive. CD-R media cannot be used. The CD-RW media must be formatted prior to use on ® the PROCLEIX TIGRIS System. Contact Novartis Diagnostics Technical Service for information about formatting CD-RWs. ® Note: CD-RWs containing data from the PROCLEIX TIGRIS System can only be viewed on computers equipped with a software package that can read UDF-formatted disks.

  • Page 27: Waste Drawer

    MTU Waste Cover Prevents splashing or spilling of waste out of the MTU Waste (not shown above) Container. Table 1.2 Waste Drawer Component Functions ® PROCLEIX TIGRIS System Operator’s Manual 1-11 Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 28: Assay Reagent Bay

    Removable bottle holder that makes up one quadrant. AR Carousel Cover Protects opened reagents in the AR Carousel. Table 1.3 Assay Reagent Bay Components ® 1-12 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 29: Ar Carousel Configuration

    Assay and PROCLEIX WNV Assay For the PROCLEIX ULTRIO Assay and PROCLEIX WNV Assay, quadrants 1-3 of the AR Carousel contain wedges that hold the Amplification Reagent, Enzyme Reagent, Probe Reagent, and Selection Reagent. The TCR Carousel in the Sample Bay is also labeled with quadrant numbers to correspond to the AR Carousel.

  • Page 30: Sample Bay

    ECTION ® PROCLEIX ULTRIO Plus Assay For the PROCLEIX ULTRIO Plus Assay, the carousel configuration is altered to accommodate a wedge for Target Enhancer Reagent: ♦ Quadrants 1 and 3 - Assay Reagents (see Figure 1.5) ♦ Quadrant 2 - Target Enhancer Reagent (see Figure 1.7) ♦...

  • Page 31: Figure 1.9 Sample Bay

    ® PROCLEIX The Sample Pipettor performs the following functions in the TIGRIS System assay process: ♦ Senses the liquid level of the wTCR in the TCR bottle, the sample in the sample tube, the wTCR in the MTU, and the combined sample/wTCR in the MTUs.

  • Page 32: Vacuum System

    (in the “up” position) at all times. Caution: The power input panel should only be accessed by Novartis Diagnostics personnel. Figure 1.11 Circuit Breaker Switch ® 1-16 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 33: Overview Of The Procleix ® Tigris System Software

    The PROCLEIX TIGRIS System software is provided for use with the PROCLEIX TIGRIS System. The software cannot be modified by the user. The PROCLEIX TIGRIS System software controls and monitors the assay process. The software starts automatically when the ®...
  • Page 34 ® Overview of the PROCLEIX Assays on the PROCLEIX TIGRIS System ® The PROCLEIX TIGRIS System detects nucleic acid from target organisms in samples using four assay technologies: Step Description Target Capture Isolation and purification of viral RNA/DNA from plasma.

  • Page 35: Target Capture

    (wTCR) in one tube of a Multi-Tube Unit (MTU). The right mixer then mixes the sample ® and wTCR. In the PROCLEIX ULTRIO Plus Assay, the MTU is then moved to the Left Mixer, where Target Enhancer Reagent is added to each reaction tube to enhance the disruption of the HBV viral particles.

  • Page 36: Hybridization Protection Assay (Hpa)

    Internal Control amplicon is detected using a probe with rapid emission of light (flasher signal). Amplicon specific to the analyte is detected using probes with relatively slower ® kinetics of light emission, termed a “glower” signal. The PROCLEIX Assays differentiate between Internal Control and combined analyte signals, but do not discriminate between individual signals.

  • Page 37: Specifications

    (Conversion is 2637 x .293= 773 W) Noise Output Compliant with EN61010-1. Drain Output None—Waste fluids drain to removable containers. Table 1.9 Environmental Output ® PROCLEIX TIGRIS System Operator’s Manual 1-21 Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 38: Water For The Procleix ® Tigris System Specifications

    Total Oxidizable Organic Carbon < 0.05 mg/L * Temperature compensated to 25° C ** CFU = Colony Forming Unit ® Table 1.10 Water for the PROCLEIX TIGRIS System Specifications Power Requirements Electrical Input 200 – 240 VAC, 50-60 Hz Input Current...

  • Page 39: Table 1.14 Barcode Requirements

    ISBT 128 barcodes. Barcode Printer Resolution Minimum 300 dpi, recommended 600 dpi ≥ 0.6 Print Contrast Signal Quality B or higher Table 1.14 Barcode Requirements ® PROCLEIX TIGRIS System Operator’s Manual 1-23 Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 40: Figure 1.13 Barcode Label Requirements

    ECTION Width Skew Height Figure 1.13 Barcode Label Requirements ® 1-24 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 41: Sample Requirements

    The minimum specimen pipetting volume is 500 μL. Up to ten replicates can be tested from ® each sample tube; each replicate is a 500 μL aliquot. Calibrators and PROCLEIX TIGRIS Controls have a fixed number of replicates that is set in the software. Attempts to pipette from the sample tube beyond what is described here can lead to insufficient volume errors.

  • Page 42: System Capacities And Throughput

    ♦ Understanding of the appropriate PROCLEIX Assay package insert included with the reagent kit. ♦ Proper training on the PROCLEIX TIGRIS System by a qualified trainer, including instruction on cleaning and maintaining the analyzer. ® 1-26 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev.

  • Page 43: Glove Changing Recommendations

    Any spill or leakage occurs on the glove. ♦ Preparing Deactivation Fluid. ♦ Performing any maintenance procedures on the PROCLEIX TIGRIS System. ♦ Handling waste on the PROCLEIX TIGRIS System. Table 1.16 Glove Changing Recommendations ® PROCLEIX TIGRIS System Operator’s Manual 1-27 Volume I: Operating the Instrument...
  • Page 44 ECTION ® 1-28 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 45: Section 2. Setting Up The Instrument

    2. Wipe down all work surfaces with diluted bleach. 3. Allow the diluted bleach to remain in contact with the surfaces for at least 15 minutes. 4. Rinse the work surfaces with DI water or water for the PROCLEIX TIGRIS System (see ®...

  • Page 46: Monitoring System Status

    It is recommended that the operator periodically view the messages screen for any informational messages. If there are several repeat informational messages, contact Novartis Diagnostics Technical Service. Table 2.1 System Status Panel Icon Indicators ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 47: Return Times Panel

    Note: If any magnetic wash stations are out of service, the return times will be estimates. See Volume III, Error Handling for more information. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 48: Status Bar

    The system is ready for system and software have been Standby normal operation. initialized or have returned to an idle state. Table 2.4 System Modes ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 49: Table 2.5 System Activities

    The system has or stopped pipetting samples at user direction Restart Analyzer When (Stop All). Complete Unload in Progress The system is unloading all MTUs. Table 2.5 System Activities ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 50: Managing Inventories

    1. From the Tips box of either the Upper Bay panel or the Inventory Status panel, click Load…. A Load Pipette Tips window opens containing instructions for loading the tips onto the ring. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 51: Loading Multi-Tube Units (Mtus)

    Caution: Use the cardboard box to load MTUs. Do not touch individual MTUs or MTU Tiplets or load them individually by hand. a) Remove the plastic shrink wrap from the MTU box. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 52: Figure 2.3 Loading Mtus

    Ensure that there is a gap between the last MTU and the end of the drawer. Do not overload the MTU Drawer. 5. Close the MTU Drawer. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 53: Preparing The Lower Bay

    A Load Fluids window opens, giving basic instructions for the Lower Bay inventory procedure. 2. Open the Fluid and Waste Doors. Rotate the drawer latches and pull out the Fluids Drawer. ® Caution: To prevent waste from contaminating PROCLEIX TIGRIS System fluids, always handle fluids before handling waste. ® PROCLEIX TIGRIS System Operator’s Manual...

  • Page 54: Replacing Depleted Fluids

    ® Caution: Do not load any reagents or other fluids into the PROCLEIX TIGRIS System that are not approved for use by Novartis Diagnostics.
  • Page 55 5. Dispose of any System Fluid left in the container according to the laboratory policies. 6. Fill the System Fluid bottle to the liquid fill line with water for the PROCLEIX TIGRIS System. 7. Pour the entire contents of one bottle of System Fluid Preservative into the System Fluid bottle.
  • Page 56 Remove the cap from the old bottle of Auto Detect 2. Rinse any crystallization off with a squirt bottle containing water for the PROCLEIX TIGRIS System. Ensure that the vent hole is clear of any crystallization.
  • Page 57 ® PROCLEIX TIGRIS System to remove any crystallization, then wrap the cap in a clean absorbent pad and tap it gently to remove any excess water. 2. Add bleach (5% sodium hypochlorite) to the Deactivation Fluid bottle until the liquid level is between the minimum and maximum total fill line on the bottle.

  • Page 58: Scanning Fluid Barcodes

    Fluid Drawer will have to be rescanned. 3. Leaving the Fluid Drawer open, continue on to emptying the Tiplet Waste container. ® 2-14 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 59: Emptying Waste Containers

    4. Fold the top of the bag down around the outside of the Tiplet Waste Container to secure the bag in place. ® PROCLEIX TIGRIS System Operator’s Manual 2-15 Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 60: Figure 2.6 Liquid Waste Container 2 Fitting

    Apply firm pressure to release the hose fitting. 3. Inspect the o-rings on the end of the vacuum hoses to make sure they are present and undamaged. ® 2-16 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 61: Figure 2.8 Liquid Waste Container 1 Fitting

    MTU Waste Deflector and the MTU and tip waste. 3. Remove the MTU Waste Bag and dispose of its contents according to laboratory policies. ® PROCLEIX TIGRIS System Operator’s Manual 2-17 Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 62: Figure 2.9 Mtu Waste Cover

    8. Slide the MTU Waste Container back into its position in the Waste Drawer. 9. Replace Liquid Waste Containers 1 and 2 into the Waste Drawer. Reconnect the correct fittings to the caps. ® 2-18 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 63: Validating The Lower Bay Inventory

    Lower Bay Inventory panel will reduce the Available Tests counts for some Lower Bay Fluids. ® PROCLEIX TIGRIS System Operator’s Manual 2-19 Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 64: Loading Assay Reagents

    Master Lot Sheet. The Lot Number of the new Master Lot populates the Master Lot text box in the New Master Lot window. ® 2-20 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 65 4. Click Inventory in the Load Assay Reagents window to continue with Upper Bay Inventory. Note: For additional information on resolving ambiguous Master Lots, contact Novartis Diagnostics Technical Service. ® PROCLEIX TIGRIS System Operator’s Manual 2-21 Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 66: Loading Ars

    1. Select a new set or previously loaded matched set of ARs. ® ARs that have been previously loaded on the PROCLEIX TIGRIS System must be loaded as part of a “matched set”. The system groups a set of ARs the first time that it scans their barcodes during the inventory process.

  • Page 67: Figure 2.10 Proper Ar Bottle Positioning

    Rotate the bottle in the cup if necessary. d) Close the TCR and Sample Doors. 8. Click Inventory. The system reads the barcodes on the bottles and level-senses the reagents. ® PROCLEIX TIGRIS System Operator’s Manual 2-23 Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 68: Changing The Reagent Quadrant

    3. Select the new quadrant of ARs from the Quadrant drop-down list. 4. Click OK. The Queued Worklists grid updates to show the new AR quadrant. ® 2-24 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 69: Section 3. Running Samples

    Samples cannot be run until a worklist is created for them. The system then automatically populates the worklist when the sample barcodes on its carousel are scanned. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 70: Control Bracketing

    TIGRIS Controls are placed at a configured interval, as well as at the end of the worklist. The set of specimens between sets of PROCLEIX TIGRIS Controls (or, for the first bracket, between the calibrators and the first set of PROCLEIX TIGRIS Controls) are considered a “control bracket.”...

  • Page 71: Creating A Worklist

    4. In the Replicates box, type the number of replicates for each sample to be tested. The Total Tests in the upper right hand corner of the Create Carousel Worklist window reflects the total specimens plus required calibrator and PROCLEIX TIGRIS Control replicates.

  • Page 72: Printing A Worklist

    On the Worklist Details grid, select the specimen to be edited. ® Note: The Edit Tests... button is disabled when a calibrator or PROCLEIX TIGRIS Control is selected. b) Click Edit Tests..An Edit Tests window opens c) Enter the new number of replicates.

  • Page 73: Queuing And De-Queuing Worklists

    Loading Samples into Racks Refer to the appropriate PROCLEIX Assay package insert for information about preparing samples for processing and for recommended sample storage conditions and handling. Load ®...
  • Page 74 1. Load the required calibrators into the first positions in the first sample rack of the worklist and the corresponding PROCLEIX TIGRIS Controls at the end of each bracket and at the end of the worklist, as indicated by the Worklist Report. The instrument will verify correct positioning of the calibrators and PROCLEIX TIGRIS Controls using the tube barcodes, which are different than specimen barcodes.

  • Page 75: Figure 3.3 Sample Pipetting Order

    UNNING AMPLES Table 3.2 shows an example of where calibrators, PROCLEIX TIGRIS Controls, and specimens should be placed for a worklist with 202 specimens, using the default control bracket size of 172 specimens. This example worklist requires 11 sample racks.

  • Page 76: Loading Racks Onto The Sample Carousel

    TIGRIS Controls can be loaded in any order. However, the racks that do contain calibrators or PROCLEIX TIGRIS Controls must be in the order specified by the printed Worklist Report. 4. Load any remaining racks into any available positions on the Sample Carousel.

  • Page 77: Resolving Barcode Scanner Errors

    PROCLEIX TIGRIS System requires the operator to resolve unreadable barcode errors before processing will continue. If this option is not enabled, the PROCLEIX TIGRIS System automatically assigns a Sample ID to all samples with unreadable barcodes. When an unreadable barcode error occurs, follow the prompts in the Fix Racks window to resolve the error.
  • Page 78 If the “Flag Duplicate Samples” option is enabled in the system configuration, the PROCLEIX TIGRIS System identifies a barcode as a “duplicate” if it is run in more than one worklist of the same assay type on the same instrument.

  • Page 79: Processing A Run

    To determine the estimated time that operator action will be required, check the Return Times box in the Status panel. ® PROCLEIX TIGRIS System Operator’s Manual 3-11 Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 80: Monitoring Processing

    3. Remove the completed sample rack from the Sample Carousel, and place it on an absorbent pad on a clean work surface. ® Caution: Always handle specimens, calibrators, and PROCLEIX TIGRIS Controls cautiously and keep sample racks upright to prevent splashing or spilling.

  • Page 81: Stopping A Run

    Data Access Only mode. After the reset has completed, the instrument will perform an unload function to remove all MTUs from the system. This procedure could take up to 2½ hours. ® PROCLEIX TIGRIS System Operator’s Manual 3-13 Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 82 ECTION ® PROCLEIX 3-14 TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 83: Section 4. Managing Results

    To choose which type of worklists to display on the Results screen, select In-Process Worklists or Completed Worklists in the upper left corner of the screen. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 84: Table 4.1 Worklist Detail Grid

    Note: The use of EQCs should be governed by site-specific standard operating procedures. The PROCLEIX TIGRIS System will produce results independent of the EQC results. ® PROCLEIX TIGRIS System Operator’s Manual...

  • Page 85: Status Codes

    Volume verification failure—Sample Testing incomplete because the VVFT Volume verification failure—TCR processing run was stopped Assay processing error Invalid result due to PROCLEIX Sample quantity not sufficient for TIGRIS Control failure processing Table 4.2 Common Status Codes Searching for Worklists To find a worklist or worklists that fit specific criteria, search the worklists in the Worklists grid.

  • Page 86: Assigning Reject Reason Flags

    Specimens with reject reason flags are considered manually invalidated results. When using this feature, refer to the Interpretation of Results ® section and the Quality Control Procedures section of the appropriate PROCLEIX Assay package insert.

  • Page 87: Clearing Reject Reason Flags

    USB flash memory drive. LIS files may be saved to the hard drive or CD-RW only. (Refer to the next page for full USB flash memory drive specifications.) Saving to the Hard Drive or CD-RW ® The following data can be saved to the PROCLEIX TIGRIS System hard drive or CD-RW: ♦ all log files ♦...

  • Page 88: Saving To A Usb Flash Memory Drive

    Minimum capacity of 512 MB. ♦ Dedicated for use with PROCLEIX TIGRIS System files. Do not use this dedicated USB flash memory drive with other file types. Note: LIS files may not be saved to a USB flash memory drive.

  • Page 89: Saving Lis Files

    To print a Results Report, click Print on the Results Report screen. Example Filenames ® The following are examples of files generated for PROCLEIX ULTRIO Assay worklist ID 100013, run on instrument serial number 1035 on January 21, 2004 at 1:52 pm: LIS file: @NA21035-20040121-135234-100013.LIS...

  • Page 90: Saving Logs

    All logs are saved to the archive location set in the system configuration. The name of the saved file follows the naming convention: YYYYMMDD HH.MM[save date] (System Software Version-Serial Number) - YYYYMMDD HH.MM[start date] to YYYYMMDD HH.MM[end date].zip ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 91: Section 5. Supervisor Procedures

    An operator must have the Maintenance–Operators right to make any changes to operator accounts. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 92: Creating A New Operator Account

    Maintenance—Admin Logs Purging, archiving, and sending logs on the Logging tab. Maintenance—Basic Logs Viewing all logs on the ® Maintenance—Database Backing up and restoring the PROCLEIX TIGRIS System database. Maintenance—General Performing the maintenance activities on the Maintenance screen. Maintenance—Operators Adding, editing, and deleting operator accounts on the Operators tab.

  • Page 93: Editing An Operator Account

    ® can log on to and use PROCLEIX TIGRIS System software. An inactive account exists in the TIGRIS System database, but the operator cannot log on until a system administrator PROCLEIX activates the account. To change the status of an account: 1.

  • Page 94: Configuring System Settings

    Figure 5.2 Configuration Screen (Example) Use this screen to do the following: ♦ Manage basic system configuration. ® ♦ Check the PROCLEIX TIGRIS System version being used. ♦ Define custom control samples. ♦ Define site information. ♦ Define tube barcode configuration.

  • Page 95: Software Configuration

    ® Place Controls every __ Sets the number of specimens between PROCLEIX Samples TIGRIS Controls when control bracketing is being requirement used. See “Control Bracketing” on page 3-2 for more information. The default setting is 172 specimens, but this can be changed to any value between 1 and 492 (single analyte assay) or 1 and 487 (triple analyte assay).

  • Page 96: Checking The System Version Information

    In addition to the PROCLEIX TIGRIS Controls provided, users can define up to 20 custom controls. These custom controls do not replace the PROCLEIX TIGRIS Controls and do not affect sample test results or control bracketing. Define the custom controls through the Configuration tab on the Configuration screen: 1.

  • Page 97: Defining Site Information

    ♦ ISBT 128 During initial configuration of the PROCLEIX TIGRIS System, it is necessary to properly set up the sample barcode options for the symbologies that are in use at the testing site. This must be done for both the Sample Carousel Barcode Scanner and the Hand-held Barcode Scanner. The Sample Carousel Barcode Scanner is configured in the PROCLEIX TIGRIS System Software, on the Configuration tab.
  • Page 98 (ampersand) will be interpreted as ISBT 128 barcodes. Note: Regardless of the barcode options selected, Calibrator, EQC, and PROCLEIX TIGRIS Control barcodes are properly interpreted by the system. It is not necessary to enable Allow ISBT 128 Barcodes for these components.
  • Page 99 The following instructions for configuring the hand-held barcode scanner are for use with PROCLEIX TIGRIS System Software version 3.6 or higher. Before starting the procedure, identify the model number of the hand-held barcode scanner to be configured. A metal plate below the hand-held barcode scanner window indicates the model number (LS4208 or LS4000i).
  • Page 100 Note: After scanning this barcode, all parameters are set to their default values (see Table A1 in the Symbol LS4208 Product Reference Guide). b) Scan “Scan Options.” c) Scan “<DATA><SUFFIX>.” d) Scan “Scan Suffix.” ® 5-10 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 101 ROCEDURES e) Scan “1013.” Scan “Enter.” g) Scan “I 2 of 5 - Any Length.” h) To enable Codabar barcodes, scan “Enable Codabar.” ® PROCLEIX TIGRIS System Operator’s Manual 5-11 Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 102 Scan “Disable UPC-A.” Scan “Disable UPC-E.” k) Scan “Disable EAN-13.” Scan “Disable EAN-8.” m) Scan “Disable UCC/EAN-128.” n) Scan “AIM Code ID Character.” ® 5-12 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 103 UPERVISOR ROCEDURES o) Scan “Enable No Read.” p) Scan “Begin New Rule.” q) Scan “Specific String at Start.” Scan “].” s) Scan “A.” ® PROCLEIX TIGRIS System Operator’s Manual 5-13 Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 104 ECTION Scan “0.” u) Scan “N.” v) Scan “R.” w) Scan “End of Message.” x) Scan “Skip Ahead 3 Characters.” ® 5-14 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 105 Note: Contact Novartis Diagnostics Technical Service for more assistance in changing the barcode configuration for the hand-held barcode scanner. ® PROCLEIX TIGRIS System Operator’s Manual 5-15 Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 106 Reference Guide). b) Scan “BEGIN NEW RULE.” c) Scan “SEND ALL DATA THAT REMAINS.” d) Scan “SEND CONTROL M.” This is a carriage return. ® 5-16 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 107 Scan “I 2 of 5 - ANY LENGTH.” Scan “DISABLE UPC-A.” g) Scan “DISABLE UPC-E.” h) Scan “DISABLE EAN-8.” Scan “DISABLE EAN-13.” ® PROCLEIX TIGRIS System Operator’s Manual 5-17 Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 108 Note: Contact Novartis Diagnostics Technical Service for more assistance in changing the barcode configuration for the hand-held barcode scanner. ® 5-18 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 109: Configuring The Lis

    ® Note: The PROCLEIX TIGRIS System workstation will be set up on a local workgroup by a Novartis Diagnostics Service Representative, not on a domain. For information about accessing LIS files from the PROCLEIX TIGRIS System workstation over a network connection, please contact Novartis Diagnostics Technical Service.

  • Page 110: Lis File Export Formats

    Require Results Verification – requires that a worklist be verified before it is transferred to the LIS. ♦ Allow Transmit of Unreadable Barcodes – not applicable to PROCLEIX Assays. ♦ Set LIS Export Delimiter – sets the preferred delimiter format for the export. Once checked, the radio button for either the Comma or Tab delimiter format must be selected in order to override the default delimiter.

  • Page 111: Table 5.3 Lis File Naming Convention

    BracketStartReplicate and BracketEndReplicate will reflect the starting position and ending position of all replicates exported, not just one bracket. ® Examples of output filenames (assuming PROCLEIX ULTRIO Assay on instrument serial number 1023, Run Start Date is October 1, 2005 at 3:24:31 PM, WorklistID is 100000.): @NA21023-20051001-152431-100000.LIS (Re-exportation of bracketed run or no brackets...
  • Page 112 LIS File Data Fields Results have data fields that map to corresponding fields in the LIS file. Note: The PROCLEIX Assays and associated discriminatory assays all use slightly different export formats. Refer to the appropriate section for more detail. ®...
  • Page 113 Serial # of the instrument, with the prefix “HC+”. 254 (15 typical) Firmware Firmware version, with the prefix “HC+”. 254 (20 Revision typical) Site Information Identifying site information. ® PROCLEIX TIGRIS System Operator’s Manual 5-23 Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 114 Assay LIS File (comma delimited): MAS0526,Reactive,HIV-1 HCV HBV,100026,2003-05-21 17:45:51,M,184,Valid,1183,15.51,0.915885,arthurm,105649,76253,3623.33,211299,1.21146e+00 6, 251996,622472,197043,042903,2025-12-31 23:59:59,HC+K12,HC+E5.01 02/20/04, 10120 Genetic Center Drive,Specimen,1.1751e+006,169937,100026-002319-7-0,I030502.001,I030502 All of the information above appears on a single line in the PROCLEIX TIGRIS System LIS file. ® 5-24 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev.
  • Page 115 Max Length Sample ID For specimens, this is the barcode ID. Calibrators, ® PROCLEIX TIGRIS Controls, and EQCs are labeled as follows, where “xxxxxx” is the six-digit lot number included in the barcode ID: ♦ Negative Calibrator: “Negative Calibrator – Lot xxxxxx”...

  • Page 116: Table 5.5 Hiv-1 Discriminatory Lis File Line Content

    Example tube data line for a HIV-1 Discriminatory LIS File (comma delimited): MAS4563,NonReactive,dHIV-1,100376,2005-01-06 21:21:24,IUO,192004,Valid,0,0.00,1.14431,jennifert,93100,57452,326.000,186200.000,1428171. 667,186241.333,,,311348,2025-12-31 23:59:59,HC+1027,HC+E5.11 12/02/04,10120 Genetic Center Dr,Specimen,,,100376-001311-5-0,2.2.18,2.2.18 All of the information above appears on a single line in the PROCLEIX TIGRIS System LIS file. ® 5-26 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev.
  • Page 117 Max Length Sample ID For specimens, this is the barcode ID. Calibrators, ® PROCLEIX TIGRIS Controls, and External Quality Controls (EQCs) are labeled as follows, where “xxxxxx” is the six-digit lot number included in the barcode ID: ♦ Negative Calibrator: “Negative Calibrator –...

  • Page 118: Table 5.6 Hcv Discriminatory Lis File Line Content

    Example tube data line for a HCV Discriminatory LIS File (comma delimited): MAS5632,Reactive,dHCV,100377,2005-01-06 22:08:09,IUO,52177,Valid,1372873,22.64,1.13814,miked,92618,60628,0.000,185237.333,,,1515 702.333,185237.667,311348,2025-12-31 23:59:59,HC+1027,HC+E5.11 12/02/04,10210 Genetic Center Dr,Specimen,,,100377-002575-4-0,2.2.18,2.2.18 All of the information above appears on a single line in the PROCLEIX TIGRIS System LIS file. ® 5-28 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev.
  • Page 119 Max Length Sample ID For specimens, this is the barcode ID. Calibrators, ® PROCLEIX TIGRIS Controls, and External Quality Controls (EQCs) are labeled as follows, where “xxxxxx” is the six-digit lot number included in the barcode ID: ♦ Negative Calibrator: “Negative Calibrator –...

  • Page 120: Table 5.7 Hbv Discriminatory Lis Files

    254 (10 typical) ADM Version Number ADM Version Number. 254 (10 typical) TIGRIS Software PROCLEIX TIGRIS System Software Version Version Number Number. Table 5.7 HBV Discriminatory LIS Files Example tube data line for a HBV Discriminatory LIS File (comma delimited): M A S 1 2 3 5 , N o n R e a c t i v e , d H B V, 1 0 0 3 7 8 , 2 0 0 5 - 0 1 - 0 6 22:46:25,IUO,193674,Valid,0,0.00,1.12447,erinn,93220,52366,824.667,186440.333,,,,,311348,20...
  • Page 121 ROCEDURES ® Line Content for the PROCLEIX WNV Assay LIS Files Each tube data line in the PROCLEIX WNV Assay LIS export contains the following fields, separated by a comma or tab (literal values are given in quotes) Field Contents...

  • Page 122: Configuring The Archive Parameters

    The following data is saved to the location specified by the archive path, which may be the ® PROCLEIX TIGRIS System computer hard drive, a CD-RW, or a USB flash memory drive: ♦ all log files ♦...

  • Page 123: Setting The Date And Time

    3. Enter the archive path where archived information will reside in the Set New Archive Path field. ♦ To archive to the PROCLEIX TIGRIS System computer hard drive, enter “C:\TIGRIS\Archive.” ♦ To archive to the CD-RW drive, insert CD-RW into the appropriate drive, then enter “D:\.”...

  • Page 124: Table 5.9 Time And Date Formats

    5. Click OK in the Set Date and Time window to save all changes. Note: Most laboratories should only have to format the date and time once. ® 5-34 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 125: Managing The Database

    2. Click OK. The system automatically shuts down. The shutdown process can take several minutes. When shutdown is complete, the system creates a copy of the PROCLEIX TIGRIS System database in the configured archive location. When the shutdown/backup process is complete, the software will automatically perform a restart.
  • Page 126 The system automatically shuts down and then restarts. This process can take several minutes. 7. Wait for the system to restart, then log back in. The database is restored to the back-up version. ® 5-36 PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 127: Section 6. Working With Reports

    This section contains descriptions and examples of the reports and logs generated by the ® PROCLEIX TIGRIS System software. The example reports are for informational use only. The data contained in the example reports and logs are not valid test data. Table 6.1 describes the reports available in the PROCLEIX TIGRIS System software:...

  • Page 128: Exporting Reports

    Note: In addition to the reagents shown in the example below, AR reports generated from the PROCLEIX ULTRIO Plus Assay will include Target Enhancer Reagent. Figure 6.1 AR Report Example (Page 1) ®...

  • Page 129: Figure 6.2 Ar Report Example

    The first section of the Assay Reagent Report is information about matched sets of ARs that are currently on-board the PROCLEIX TIGRIS System. This information is organized by quadrant. For each matched set, the report lists the Master Lot barcode, Master Lot expiration date, number of tests remaining, the open/thaw stability expiration date, and the amount of on- board stability remaining.

  • Page 130: Control Report

    2. From the Assay drop-down list, select the applicable assay and click OK. A Select Control window opens. 3. From the Control drop-down list, select the PROCLEIX TIGRIS Control lot number to be viewed. 4. Select the beginning and end date and click OK.

  • Page 131: Sample Results Report

    ORKING WITH EPORTS The bottom portion of the report lists specific information about each instance the specified PROCLEIX TIGRIS Control was used: ♦ Worklist ID ♦ Run Start Date/Time ♦ Reagent Master Lot ♦ Test Number ♦ Analyte RLU ♦...
  • Page 132 Below the list of test results is a legend for the Flags associated with each worklist, and a legend for any tests that were rejected by an operator in each worklist. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 133: Master Lot Report

    The Master Lot Report lists the instrument serial number, Master Lot barcode, expiration date, associated assay, Master Lot number, and the individual Lot Number of each AR and calibrator in the Master Lot. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 134: Operator Rights Report

    The Operator Rights Report is not in an electronic format like the other PROCLEIX TIGRIS System reports. To view the report, print a copy on the system printer from the Operator tab on the Configuration screen.

  • Page 135: Results Report

    The Results Report is a comprehensive report about a worklist. Figure 6.7 Results Report Example (Page 1) Figure 6.8 Results Report Example (Page 2) ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 136: Figure 6.9 Results Report Example

    The Results Report gives four summaries for a specified worklist: ♦ Assay Components ♦ Test Results Report ♦ Reactive Report ♦ Invalid Report ® PROCLEIX 6-10 TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 137 ♦ Assay fluids barcodes and manufacturer’s expiration date ® ♦ PROCLEIX TIGRIS Controls barcodes and manufacturer’s expiration date The Test Results Report includes all of the run information about each sample in the worklist: ♦ Test Number ♦ Rack ID and Position ♦...

  • Page 138: System Performance Report

    Total Tests Run – the total accumulated number of tests that have been run on the system. The final section of the report lists service string information for use by Novartis Diagnostics Technical Service. ® PROCLEIX 6-12 TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 139: Section 7. Shutting Down

    ECTION HUTTING Use the Logoff/Shutdown screen to unload Assay Reagents, empty waste containers independent of ® Lower Bay Inventory, log off the software, and/or shut down the PROCLEIX TIGRIS System. Logging Off ® An operator can log out without shutting down the PROCLEIX TIGRIS System.

  • Page 140: Emptying Waste Containers

    3. Follow the instructions in “Emptying Waste Containers” on page 2-15 to empty the waste containers. 4. Click Done. The system displays the Logoff/Shutdown screen. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 141: Shutting Down

    Turn on the analyzer. c) Turn on the computer workstation. Note: Keep the system on and in Standby mode when not in use. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 142 ECTION ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 143 ARs (except TCR) are loaded and pipetted. Chiller Ramps. Modules within the PROCLEIX p. 1-12 TIGRIS System where the temperature of the AR Carousel. Holds up to four matched sets of MTU is cooled prior to insertion into the ARs. p. 1-12 luminometer.
  • Page 144 L a b o r a t o r y I n f o r m a t i o n S y s t e m . T h e computer system, external to the PROCLEIX TIGRIS System, that is used by the laboratory for reporting, data storage, and other activities.
  • Page 145 Multi-Tube Unit. Group of five disposable chemiluminescent reaction. pp. 1-20, 4-2 polypropylene reaction tubes. All PROCLEIX TIGRIS System reactions take place in an Results Report. Contains comprehensive MTU. p. 2-7 Assay Reagent and sample result information for the specified worklist.
  • Page 146 Specimen. Any test in an assay worklist, Uninterruptible Power Supply (UPS). The excluding calibrators or controls. May include UPS is connected to the PROCLEIX TIGRIS donor samples, proficiency panels, or external System to provide power to the system for a quality controls.

  • Page 147: Appendix A. Status Codes

    The sample ID was manually entered The sample is not marked Invalid. using the keyboard. Sample pipetting error. This is a non-fatal error. The affected samples are marked Invalid. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 148 This is a non-fatal error. The affected samples are marked Invalid. RDV error. This is a non-fatal error. The affected samples are marked Invalid. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 149 “TE” and marked Invalid. The HPA Incubator temperature was out This is a non-fatal error. All samples in of range. the affected MTU are marked invalid. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 150: Results Processing Errors

    Calibrator glower out of range. Test invalid. Glower average out of range. Test invalid. Invalid sample became valid due to a Test invalid. crossover. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 151 “Suspect”. Invalidated or flagged as “Suspect” by Valid “Nonreactive” samples within the ® failed PROCLEIX TIGRIS Controls. bracket are marked “Suspect”. ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 152 PPENDIX ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 153: Appendix B. Support Contact Information

    Asia Pacific Regional Office Unit 1506-7 DCH Commercial Center 25 Westlands Road Quarry Bay, Hong Kong Telephone: +852 2161 3100 Fax: +852 2161 3199 ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...
  • Page 154 PPENDIX ® PROCLEIX TIGRIS System Operator’s Manual Volume I: Operating the Instrument Part # 902649EN Rev. A...

  • Page 155: Tigris System

    ◎ Manufacturing Lot: Please refer to serial number printed on the instrument. ◎ Validity Period: 18 years ® PROCLEIX TIGRIS System Operator’s Manual Volume 1: Operating the Instrument Novartis Vaccines and Diagnostics, Inc. 4560 Horton Street Emeryville, CA 94608-2916 USA +1 (510) 655-8730 Part # 902649EN Rev.

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