Procleix TIGRIS Operator's Manual

®

Procleix TIGRIS System

Operator’s Manual

Volume I: Operating the Instrument

For In Vitro Diagnostic Use

For Use In Taiwan Only

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
[phone]

EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Tel: [phone]
Fax: [phone]

© 2004–2010 Gen-Probe Incorporated.
QCS 902653

ii PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

REVISION HISTORY

PART NUMBER REVISION DATE SECTION(S) REVISED
901456 Rev. A 2007-03 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.

REVISION HISTORY

PROCLEIX® TIGRIS System Operator’s Manual iii
Volume I: Operating the Instrument

Part # 902649EN Rev. A

iv PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

CONTENTS

REVISION HISTORY .................................................................................................. iii

CONTENTS ............................................................................................................... v

LIST OF FIGURES ..................................................................................................... ix

LIST OF TABLES ...................................................................................................... xi

ABOUT THIS MANUAL ............................................................................................ xiii

How This Manual Is Organized ..................................................................................xiii

Highlighting and Quotation Conventions....................................................................xiii

Formatting Convention for Online Procedures ............................................. xiv

Special Symbols........................................................................................... xiv

Trademarks ................................................................................................................ xv

Related Documentation.............................................................................................. xv

CONTENTS

SECTION 1. INTRODUCTION AND PRODUCT DESCRIPTION ...................................... 1-1

Description and Intended Use ...............................................................................1-1

Warnings and Cautions .........................................................................................1-1

Health and Safety Notices............................................................................1-1

Installation Notices .......................................................................................1-3

Operational Notices......................................................................................1-4

Notices Regarding Samples.........................................................................1-5

Reagent Notices...........................................................................................1-5

Maintenance Notices....................................................................................1-7

Data Management Notices...........................................................................1-7

Consumables Notices ..................................................................................1-8

Limitations..............................................................................................................1-8

Overview of the PROCLEIX

Computer Workstation ...............................................................................1-10

Fluids Drawer .............................................................................................1-10

Waste Drawer ............................................................................................1-11

Assay Reagent Bay....................................................................................1-12

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

Main Menu Screen .....................................................................................1-17

®

TIGRIS System.......................................................1-9

®

TIGRIS System Software .....................................1-17

PROCLEIX® TIGRIS System Operator’s Manual v
Volume I: Operating the Instrument

Part # 902649EN Rev. A

CONTENTS

Overview of the PROCLEIX® Assays on the PROCLEIX® TIGRIS System ....... 1-18

Target Capture........................................................................................... 1-19

Transcription-Mediated Amplification (TMA).............................................. 1-19

Hybridization Protection Assay (HPA) ....................................................... 1-20

Dual Kinetic Assay (DKA) .......................................................................... 1-20

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 ........................................................................................ 1-26

Glove Changing Recommendations.................................................................... 1-27

SECTION 2. SETTING UP THE INSTRUMENT ............................................................2-1

Preparing the Workspace...................................................................................... 2-1

Starting the System ............................................................................................... 2-1

Monitoring System Status ..................................................................................... 2-2

System Status and Inventory Status Panels................................................ 2-2

Return Times Panel ..................................................................................... 2-3

Status Bar .................................................................................................... 2-4

Managing Inventories ............................................................................................ 2-6

Loading Consumables........................................................................................... 2-6

Loading Pipette Tips .................................................................................... 2-6

Loading Multi-Tube Units (MTUs)................................................................ 2-7

Preparing the Lower Bay....................................................................................... 2-9

Replacing Depleted Fluids......................................................................... 2-10

Scanning Fluid Barcodes........................................................................... 2-14

Emptying Waste Containers ...................................................................... 2-15

Validating the Lower Bay Inventory ........................................................... 2-19

Priming the System.................................................................................... 2-19

Loading Assay Reagents .................................................................................... 2-20

Working with Master Lots .......................................................................... 2-20

Loading ARs .............................................................................................. 2-22

Changing the Reagent Quadrant............................................................... 2-24

vi PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

CONTENTS

SECTION 3. RUNNING SAMPLES............................................................................ 3-1

Using A Worklist ....................................................................................................3-1

Control Bracketing........................................................................................3-2

Creating a Worklist.......................................................................................3-3

Editing a Worklist .........................................................................................3-3

Printing a Worklist ........................................................................................3-4

Deleting a Worklist .......................................................................................3-4

Queuing and De-Queuing Worklists.............................................................3-5

Loading Sample Racks..........................................................................................3-5

Loading Samples into Racks........................................................................3-5

Loading Racks onto the Sample Carousel ...................................................3-8

Resolving Barcode Scanner Errors ..............................................................3-9

Processing a Run ................................................................................................3-11

Initiating Processing ...................................................................................3-11

Monitoring Processing................................................................................3-12

Unloading Sample Racks ....................................................................................3-12

Stopping a Run ....................................................................................................3-13

SECTION 4. MANAGING RESULTS ......................................................................... 4-1

Viewing Results .....................................................................................................4-1

Status Codes................................................................................................4-3

Searching for Worklists ................................................................................4-3

Assigning Reject Reason Flags .............................................................................4-4

Clearing Reject Reason Flags ...............................................................................4-5

Verifying Worklists .................................................................................................4-5

Saving Data Files and Logs...................................................................................4-5

Saving to the Hard Drive or CD-RW ............................................................4-5

Saving to a USB Flash Memory Drive..........................................................4-6

Saving LIS Files ...........................................................................................4-7

Saving Kinetic Files ......................................................................................4-7

Saving/Printing Results Report ....................................................................4-7

Example Filenames......................................................................................4-7

Saving Logs .................................................................................................4-8

SECTION 5. SUPERVISOR PROCEDURES................................................................ 5-1

Managing Operators ..............................................................................................5-1

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 vii
Volume I: Operating the Instrument

Part # 902649EN Rev. A

CONTENTS

SECTION 6. WORKING WITH REPORTS...................................................................6-1

Configuring System Settings ................................................................................. 5-4

Software Configuration ................................................................................ 5-5

Checking the System Version Information................................................... 5-6

Creating Custom User-Defined Controls ..................................................... 5-6

Defining Site Information ............................................................................. 5-7

Barcode Scanner Configuration................................................................... 5-7

Configuring the LIS .................................................................................... 5-19

LIS File Export Formats ............................................................................. 5-20

Configuring the Archive Parameters.......................................................... 5-32

Setting the Date and Time ......................................................................... 5-33

Managing the Database ...................................................................................... 5-35

Archiving and Purging Worklists ................................................................ 5-35

Archiving and Purging Logs....................................................................... 5-35

Backing Up and Restoring the Database................................................... 5-35

Searching Reports................................................................................................. 6-1

Printing Reports..................................................................................................... 6-1

Exporting Reports.................................................................................................. 6-2

Assay Reagent Status Report ............................................................................... 6-2

Control Report ....................................................................................................... 6-4

Sample Results Report ......................................................................................... 6-5

Master Lot Report.................................................................................................. 6-7

Operator Rights Report ......................................................................................... 6-8

Results Report....................................................................................................... 6-9

System Performance Report ............................................................................... 6-12

SECTION 7. SHUTTING DOWN ............................................................................... 7-1

Logging Off............................................................................................................ 7-1

Unloading ARs ...................................................................................................... 7-1

Emptying Waste Containers.................................................................................. 7-2

Shutting Down ....................................................................................................... 7-3

INDEX OF TERMS .................................................................................................. I-1

APPENDIX A. STATUS CODES .............................................................................. A-1

Instrument Processing Errors................................................................................A-1

Results Processing Errors.....................................................................................A-4

APPENDIX B. SUPPORT CONTACT INFORMATION .................................................. B-1

Novartis Diagnostics Customer Service ................................................................B-1

Novartis Diagnostics Technical Service ................................................................ B-1

viii PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

LIST OF FIGURES

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.................................................................................... 1-13

Figure 1.7 Target Enhancer Reagent Wedge............................................................................ 1-14

Figure 1.8 Sample and TCR Doors ........................................................................................... 1-14

Figure 1.9 Sample Bay .............................................................................................................. 1-15

Figure 1.10 Analyzer Power Switch........................................................................................... 1-16

Figure 1.11 Circuit Breaker Switch ............................................................................................ 1-16

Figure 1.12 Main Menu Screen ................................................................................................. 1-17

Figure 1.13 Barcode Label Requirements................................................................................. 1-24

Figure 2.1 Status Bar................................................................................................................... 2-2

Figure 2.2 Inventory Status Screen ............................................................................................. 2-6

Figure 2.3 Loading MTUs ............................................................................................................ 2-8

Figure 2.4 Removing the MTU Box ............................................................................................. 2-8

Figure 2.5 Fluid Details Window ................................................................................................ 2-10

Figure 2.6 Liquid Waste Container 2 Fitting .............................................................................. 2-16

Figure 2.7 Liquid Waste Container 1 Fittings ............................................................................ 2-16

Figure 2.8 Liquid Waste Container 1 Fitting .............................................................................. 2-17

Figure 2.9 MTU Waste Cover .................................................................................................... 2-18

Figure 2.10 Proper AR Bottle Positioning.................................................................................. 2-23

Figure 3.1 Worklist Manager Screen ........................................................................................... 3-1

Figure 3.2 Control Bracket........................................................................................................... 3-2

Figure 3.3 Sample Pipetting Order .............................................................................................. 3-7

Figure 3.4 Run Manager Screen (Example).............................................................................. 3-11

Figure 4.1 Results Screen (Example).......................................................................................... 4-1

Figure 4.2 Example of Two USB Ports ........................................................................................ 4-6

Figure 5.1 Operators Tab ............................................................................................................ 5-1

Figure 5.2 Configuration Screen (Example) ................................................................................ 5-4

Figure 6.1 AR Report Example (Page 1)..................................................................................... 6-2

Figure 6.2 AR Report Example (Page 2)..................................................................................... 6-3

Figure 6.3 Control Report Example ............................................................................................. 6-4

Figure 6.4 Sample Results Report Example ............................................................................... 6-5

Figure 6.5 Master Lot Report Example........................................................................................ 6-7

Figure 6.6 Operator Rights Report Example ............................................................................... 6-8

Figure 6.7 Results Report Example (Page 1).............................................................................. 6-9

Figure 6.8 Results Report Example (Page 2).............................................................................. 6-9

Figure 6.9 Results Report Example (Page 3)............................................................................ 6-10

Figure 6.10 Results Report Example (Page 4) .......................................................................... 6-10

Figure 6.11 System Performance Report .................................................................................. 6-12

LIST OF FIGURES

PROCLEIX® TIGRIS System Operator’s Manual ix
Volume I: Operating the Instrument

Part # 902649EN Rev. A

LIST OF FIGURES

x PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

LIST OF TABLES

Table 1.1 PROCLEIX® TIGRIS System Components .................................................................1-9

Table 1.2 Waste Drawer Component Functions ........................................................................1-11

Table 1.3 Assay Reagent Bay Components ..............................................................................1-12

Table 1.4 Sample Bay Components ..........................................................................................1-15

Table 1.5 Main Screens .............................................................................................................1-18

Table 1.6 Size and Weight Specifications .................................................................................1-21

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

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

Table 1.15 System Capacities and Throughout ........................................................................1-26

Table 1.16 Glove Changing Recommendations ........................................................................1-27

Table 2.1 System Status Panel Icon Indicators ...........................................................................2-2

Table 2.2 Inventory Status Panel Icon Indicators ........................................................................2-3

Table 2.3 Return Times Panel .....................................................................................................2-3

Table 2.4 System Modes .............................................................................................................2-4

Table 2.5 System Activities .........................................................................................................2-5

Table 2.6 AR Barcode Information ............................................................................................2-20

Table 3.1 Worklist Conditions ......................................................................................................3-2

Table 3.2 Example Tube Placement ...........................................................................................3-7

Table 3.3 Rack Status Symbols and Colors ..............................................................................3-12

Table 4.1 Worklist Detail Grid ......................................................................................................4-2

Table 4.2 Common Status Codes ...............................................................................................4-3

Table 4.3 Reject Reason Flags ...................................................................................................4-4

Table 5.1 Additional Operator Rights ..........................................................................................5-2

Table 5.2 Configuration Options ..................................................................................................5-5

Table 5.3 LIS File Naming Convention ......................................................................................5-21

Table 5.4 PROCLEIX

LIS File Line Content .................................................................................................5-24

Table 5.5 HIV-1 Discriminatory LIS File Line Content ...............................................................5-26

Table 5.6 HCV Discriminatory LIS File Line Content .................................................................5-28

Table 5.7 HBV Discriminatory LIS Files ....................................................................................5-30

Table 5.8 PROCLEIX

Table 5.9 Time and Date Formats .............................................................................................5-34

Table 6.1 Reports ........................................................................................................................6-1

LIST OF TABLES

®

TIGRIS System Specifications ......................................1-22

ULTRIO® and PROCLEIX ULTRIO Plus® Assay

®

WNV Assay LIS Files ...........................................................................5-32

PROCLEIX® TIGRIS System Operator’s Manual xi
Volume I: Operating the Instrument

Part # 902649EN Rev. A

LIST OF TABLES

xii PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

ABOUT THIS MANUAL

ABOUT THIS MANUAL

This operator’s manual provides procedures related to operation of the PROCLEIX® TIGRIS System.

How This Manual Is Organized

This manual is divided into the following sections:

♦ About This Manual – Describes the purpose and organization of the manual, special

symbols, and highlighting and quotation conventions used in the manual.

♦ Introduction and Product Description – Lists the warnings and cautions related to operator

safety. Provides a description, intended use, and specifications for the PROCLEIX
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.

♦ Managing Results – Provides instructions for viewing, printing, rejecting, verifying, and

saving assay results.

♦ Supervisor Procedures – Provides instructions for managing operator accounts, configuring

the software, and maintaining the PROCLEIX TIGRIS System database.

♦ Working with Reports – Provides descriptions of reports available in the PROCLEIX TIGRIS

System software and instructions for generating these reports.

♦ Shutting Down – Provides instructions for logging off the software and shutting down the

system.

♦ Index of Terms – Provides definitions of key terms and abbreviations used in this manual.

♦ Status Codes – Provides descriptions of status codes appended to assay results.

♦ Support Contact Information – Provides contact information for Novartis Diagnostics

Technical Service and Novartis Diagnostics Customer Service.

®

TIGRIS

Highlighting and Quotation Conventions

Highlighting and quotation marks are used to convey specific meaning within the context in which
they are used. The context and meaning of the highlighting and quotation marks are defined below.

All uppercase letters are used for:

♦ Acronyms.

♦ Copyrighted and trademarked terms where uppercase is the expected form.

Italics are used for:

♦ Titles of other documents.

♦ Minor emphasis within normal text.

Underline Italics are used for:

♦ References to screen names.

PROCLEIX® TIGRIS System Operator’s Manual xiii
Volume I: Operating the Instrument

Part # 902649EN Rev. A

ABOUT THIS MANUAL

Bold is used for:

♦ Headings.

♦ Table headers.

♦ Captions.

♦ Text that needs to be delineated from surrounding text.

♦ Program interface buttons, fields, and selections (see "Formatting Convention for Online

Procedures" on page xiv).

Bold Italics: Bold Italics are only used to call attention to especially important information such
as warnings, cautions, and notes. See “Special Symbols” for additional information.

Quotation Marks: Single quotation marks are not used in this manual. Double quotation marks
are used to:

♦ Define chapter and section names in cross-references.

♦ Indicate words that are not formally a part of the Novartis Diagnostics or blood testing industry

lexicons, but have a generally understood meaning.

Formatting Convention for Online Procedures

The command convention used to convey a sequence of one-step PC tasks is First level •
Second level • Third level • etc., with each level shown in bold and separated from the

preceding level by a bullet (•). To indicate selections from a dialog box, the selection names are
shown in bold, but without bullets.

For example:

1. From the Windows desktop, select Start • Settings • Control Panel • System.

2. Click the Environment tab.

3. Under User Variables, select Path.

Keys are shown in bold, such as in “Press the Enter key.”

Special Symbols

The symbols below are used to warn of potentially dangerous situations and draw attention to
other particularly important information.

Warning: Indicates the possibility of severe personal injury or loss of life if the
instructions are not followed.

,

Caution: Indicates a possibility of 1) instrument damage or data loss if instructions are
not followed or 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.

xiv PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

Corrosive liquid or substance warning.

This symbol represents a possible pinch-point hazard.

This symbol represents a possible hot surface hazard.

Trademarks

The following terms are trademarks:

These terms… Are trademarks of…

PROCLEIX, ULTRIO

TIGRIS Gen-Probe Incorporated

Any other brand names in this manual are trademarks of their respective companies.

Novartis Vaccines and Diagnostics, Inc.

ABOUT THIS MANUAL

Related Documentation

The documents listed below contain additional information related to or referenced by topics
described in this manual:

Title

PROCLEIX

PROCLEIX

PROCLEIX

PROCLEIX

PROCLEIX

®

Assay package inserts

®

TIGRIS System Operator’s Manual, Volume II: Maintenance

®

TIGRIS System Operator’s Manual, Volume III: Error Handling

®

Reagent Preparation Incubator Operator’s Manual

®

TIGRIS System Quick Reference Guide

PROCLEIX® TIGRIS System Operator’s Manual xv
Volume I: Operating the Instrument

Part # 902649EN Rev. A

ABOUT THIS MANUAL

xvi PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

SECTION 1. INTRODUCTION AND PRODUCT DESCRIPTION

Description and Intended Use

The PROCLEIX® TIGRIS System is an integrated nucleic acid testing system which fully
automates all steps necessary to perform the PROCLEIX
through amplification, detection, and data reduction. The PROCLEIX Assays are qualitative in
vitro nucleic acid amplification tests for the detection of pathogenic viruses in human specimens,
as defined in the assay package insert.

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.

®

Assays from sample processing

Warnings and Cautions

Novartis Vaccines and Diagnostics, Inc. does not take any responsibility for unauthorized
modifications of the instrument or for failure of operating personnel to heed the warnings and
cautions. Any equipment used in a manner not specified by Novartis Vaccines and Diagnostics,
Inc. may become unsafe. Follow the standard laboratory precautions when operating the
PROCLEIX
TIGRIS System and its related components. Review all the Warnings in this section before
operating the PROCLEIX TIGRIS System.

Health and Safety Notices

®

TIGRIS System. The warnings in this section apply specifically to the PROCLEIX

Biological and Chemical Hazards

Warning: Follow Universal Precautions when working with potentially hazardous materials,
including the following circumstances:

®

♦ When handling specimens, calibrators, and PROCLEIX

these as potentially infectious material.

♦ When working with liquids in and around the equipment.

♦ When handling waste and waste containers. They may contain biohazardous

waste.

♦ When performing maintenance activities.

Always wear proper protective equipment, including a laboratory coat, gloves, and
eye protection, when working with hazardous materials.

Warning: Handle and dispose of solid and liquid waste and all unused reagents and
materials that have come in contact with specimens and reagents according to local, state,
and federal regulations.

Warning: Leaks, splashes, and drips from the Sample Pipettor may contain biohazardous
materials.

Warning: Do not heat any substance above a temperature that will cause it to emit toxic
fumes; death or severe injury may result.

PROCLEIX® TIGRIS System Operator’s Manual 1-1
Volume I: Operating the Instrument

TIGRIS Controls. Treat

Part # 902649EN Rev. A

SECTION 1

,

,

Warning: Clean spilled waste immediately by wiping the surface with 0.5% sodium
hypochlorite in water (diluted bleach). Allow the diluted bleach to contact surfaces for 15
minutes, and then rinse with water. See Table 1.2, “Recommended Cleaning Agents,” in
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. Following Universal Precautions, use a damp paper towel to carefully remove the tip
and appropriately dispose of the tip according to local, state, and federal regulations.

Caution: Wait 30 minutes after receiving the last “Standby-Deactivation of MTUs started”
message before beginning the Lower Bay inventory process in order to ensure that
remaining MTUs are properly deposited in the MTU Waste Container.

Caution: Thoroughly clean and disinfect all work surfaces.

.

Auto Detect 2 contains 1.6 N sodium hydroxide. Sodium hydroxide is corrosive and
causes burns. In case of contact with eyes, rinse immediately with plenty of water and
seek medical advice.

Target Enhancer Reagent contains lithium hydroxide. Lithium hydroxide is corrosive and
causes burns. In case of contact with eyes, rinse immediately with plenty of water and
seek medical advice.

System Fluid, Deactivation Fluid, and Liquid Waste Containers 1 and 2 contain sodium
hypochlorite. Avoid contact with skin, eyes, and mucous membranes. Wash affected area
with water if contact with this fluid occurs. If this fluid spills, dilute with water before wiping
dry. Follow laboratory procedures for working with bleach. Do not autoclave the liquid
waste containers.

1-2 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

Electrical and Mechanical Hazards

Warning: Only Novartis Diagnostics authorized personnel should perform electrical
servicing.

Warning: Never touch any switches or outlets with wet hands.

Warning: Turn off the analyzer before disconnecting the AC power cord.

Warning: Keep clothing and hair away from the Sample Carousel and pipette tip ring when

loading sample racks and pipette tip trays.

Warning: Do not operate the analyzer if it is suspected or found that liquid has leaked,
spilled, or overflowed onto electrical components. Contact Novartis Diagnostics Technical
Service.

Caution: Make sure that motorized equipment parts are not blocked by sample tubes,

,

racks, reagent bottles, or other equipment.

Caution: Improperly seated racks can cause a system failure.

,

®

Do not attempt to gain access to the PROCLEIX
Sample Carousel Door) while the analyzer is in operation.

Avoid touching surfaces marked with a hot surface symbol.

TIGRIS System (except through the

Installation Notices

Warning: The PROCLEIX
authorized personnel only.

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.

Caution: Connect only approved components to the PROCLEIX® TIGRIS System analyzer

,

and computer workstation.

Caution: Do not expose the PROCLEIX® TIGRIS System to direct sunlight or extreme

,

temperatures.

®

TIGRIS System must be installed by Novartis Diagnostics

PROCLEIX® TIGRIS System Operator’s Manual 1-3
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 1

Operational Notices

,

,

,

,

,
,
,

Warning: Only properly trained personnel should operate the PROCLEIX® TIGRIS
System.

Caution: Do not remove the covers. Only Novartis Diagnostics authorized personnel may
remove the covers of the PROCLEIX

Caution: Do not modify the PROCLEIX® TIGRIS System hardware or software. Only
Novartis Diagnostics authorized personnel may change the system. Do not add
accessories, or use supplies, including MTU Waste bags, or reagents that are not
authorized by Novartis Diagnostics.

Caution: To ensure accurate test results, follow all instructions in the appropriate
PROCLEIX assay package insert for use on the PROCLEIX

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.

Caution: Open the Waste Door fully before opening the Waste Drawer.

Caution: Do not shut off power to the CPU while the system is restarting or running.

®

TIGRIS System.

®

TIGRIS System.

®

Caution: Do not handle fluids over keyboard and related computer equipment as spills

,

may damage the system, thereby preventing operation and causing malfunction.

Caution: The operator must visually check the vacuum level of the PROCLEIX® TIGRIS

,

System when loading the Target Capture Reagent to ensure that the system is operating
with a vacuum level that meets the requirements in “Vacuum Pressure Requirements” on
page 1-22. Contact a Novartis Diagnostics Technical Service Representative for assistance
if it does not.

Caution: Two primes are required if the instrument has not been used for three or more

,

days.

Caution: To prevent contamination or misalignment, avoid touching the Amplification and

,

HPA Pipettors when removing the AR Carousel and/or Cover.

Caution: The interpretation on the run report will not change for a specimen flagged with a

,

reject reason code. The Flags column must be carefully reviewed to identify specimens
with reject reason codes.

Caution: Do not include the Start/Stop characters (if present) when manually entering a

,

Sample ID – doing so will create a mismatch between the actual Sample ID and the ID on
the printed report.

Caution: DO NOT shut down the system using the computer power button—doing so may

,

cause unnecessary errors and possible database corruption.

Caution: Before closing the MTU Drawer, ensure that there is a gap between the last MTU

,

and the end of the drawer. Do not overload the MTU Drawer.

1-4 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

Notices Regarding Samples

Caution: Mishandling samples may compromise assay results.

,

Caution: Do not run unapproved assay sample types on the PROCLEIX® TIGRIS System.

,

See the appropriate PROCLEIX

Caution: Always handle specimens, calibrators, and PROCLEIX® TIGRIS Controls

,

cautiously and keep sample racks upright to prevent splashing or spilling.

Caution: Avoid touching the tops of specimens, calibrators, and PROCLEIX® TIGRIS

,

Controls during preparation and loading.

Caution: Processing a sample with less than the minimum sample volume can result in

,

errors (e.g., a Quantity Not Sufficient (QNS) error). The minimum sample volume includes
both the sample pipetting volume and the dead volume. For gel plasma separator tubes,
the minimum sample volume includes the sample pipetting volume and the buffer zone
volume.

Caution: Inspect all specimens, calibrators, and PROCLEIX® TIGRIS Controls for

,

undissolved particles, clots, foam, bubbles, or film. Do not attempt to use samples with
undissolved particles, clots, or foam on the system. Clots and foam may result in false level
sensing of liquid. An error message may not be generated. These conditions could
potentially cause an invalid run or a suspect bracket.

®

Assay package insert for allowable sample types.

Caution: Use only the sample racks and sample tubes that are designed for use on the

,

PROCLEIX

Caution: Ensure that all tubes are loaded straight and seated firmly in the sample rack.

,

Improperly loaded tubes may become unseated and pop out of the rack.

Caution: Do not place External Quality Controls (EQCs) in PROCLEIX® TIGRIS Control

,

positions.

Caution: Using sample barcodes with check digits is recommended to reduce the risk of

,

barcode misreads.

Caution: A misaligned or damaged barcode may cause system errors.

,

®

TIGRIS System.

Reagent Notices

Caution: Handle all reagents, fluids, and solutions according to the instructions outlined in

,

this manual. Open reagents, fluids, and solutions carefully.

Caution: Do not use reagents or fluids that have exceeded their stability times or

,

expiration dates. 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.

Caution: Inspect all packaged reagents, fluids, and consumables for damage before use.

,

Inspect Assay Reagents (ARs) for precipitate or foam. Avoid creating foam when handling
reagents. Do not use reagents with precipitate or foam.

Caution: Probe Reagents are photosensitive. Do not store Probe Reagents where they

,

could be exposed to direct light.

Caution: Do not load any reagents or other fluids into the PROCLEIX® TIGRIS System

,

that are not approved for use by Novartis Diagnostics.

PROCLEIX® TIGRIS System Operator’s Manual 1-5
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 1

,

,

,
,

,
,

Caution: Do not combine any assay reagents or fluids without specific instruction. Never
top off AR or fluid bottles. The PROCLEIX
the reagent fluid level and reject bottles that have been topped off.

Caution: Do not spill reagents. If reagents spill, contact Novartis Diagnostics Technical
Service.

Caution: To prevent contamination, always use a new cap when recapping an AR bottle.

Caution: To prevent waste from contaminating PROCLEIX® TIGRIS System fluids, always

handle fluids before handling waste.

Caution: Avoid contaminating the assay reagents with samples.

Caution: Observe the following advisories when preparing ARs:

♦ Perform reagent preparation in a template free area.

♦ Reagents should be prepared in a separate work space, away from the

sample preparation area.

♦ Keep specimens, calibrators, and PROCLEIX

the reagent preparation area.

♦ Avoid touching the tops of open reagents during preparation and loading.

®

TIGRIS System will recognize the changes in

®

TIGRIS Controls away from

Caution: Use aseptic techniques when preparing System Fluid.

,

Caution: Do not uncap the System Fluid bottle before moving it for fluid disposal and

,

refilling.

Caution: When replacing the Oil, confirm that the volume of the previous bottle has

,

diminished. If there is an indication that the Oil has not been consumed, please call
Novartis Diagnostics Technical Service for troubleshooting instructions.

Caution: Before replacing the Auto Detect 2 Bottles, check the vent holes on the bottle

,

caps for crystals. Using a clean, disposable wipe, remove any crystallization with water for
the PROCLEIX
System, see “Water for the PROCLEIX
Volume I: Operating the Instrument.

Caution: Do not put the barcode label over the vent hole on the Deactivation Fluid or

,

System Fluid bottle cap. The bottle will collapse under vacuum if the vent hole is covered.

Caution: To avoid false errors when replacing the Deactivation Fluid bottle, align the

,

handle indentations so that they face the rear left corner.

Caution: If bottles are not scanned in the correct order, two possible scenarios can occur:

,

®

TIGRIS System. For water specifications for the PROCLEIX TIGRIS

♦ If one fluid type, for example, Wash Solution, is scanned into the field of

another fluid type, for example Auto Detect 1, the barcode will not be
accepted.

♦ If bottle B of a specific fluid is scanned into a bottle A barcode field, the wrong

information will be in the database which could result in a bottle running dry
unexpectedly, causing a system failure.

®

TIGRIS System Specifications” on page 1-22 in

1-6 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

Maintenance Notices

Caution: Excluding maintenance procedures specifically illustrated in this manual, which

,

are performed by trained PROCLEIX
technicians should perform maintenance on the system.

Caution: Treat the waste in the liquid waste containers as a potential source of assay

,

contamination. When handling liquid waste, be careful to not contaminate the work
surfaces.

Caution: If a small sample or reagent spill occurs inside an easily accessed area of the

,

PROCLEIX
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.

Caution: If a spill occurs in an inaccessible area inside the analyzer, contact Novartis

,

Diagnostics Technical Service. Do not try to clean the inaccessible parts of the analyzer
without proper assistance.

Caution: For routine surface contamination, do not spray bleach or water directly on the

,

PROCLEIX

Caution: Follow the laboratory guidelines to clean up any bleach spills that occur while

,

performing system maintenance.

®

TIGRIS System analyzer, wipe the area with 0.5% sodium hypochlorite in

®

TIGRIS System surfaces.

®

TIGRIS System operators, only trained authorized

Caution: Prepare a clean work surface before operating the system.

,

Caution: The work area must have adequate sink facilities to accommodate the

,

procedures described in this manual. Sink facilities for waste disposing should be separate
from sink facilities for filling with clean water. Waste and reagent disposal facilities should
meet all applicable local, state, and federal guidelines.

Caution: The rear access panel should only be opened by Novartis Diagnostics personnel.

,

Caution: The power input panel should only be accessed by Novartis Diagnostics

,

personnel.

Data Management Notices

Caution: Archiving before purging must be enabled. If archiving before purging is not

,

enabled, the logs will be permanently deleted from the PROCLEIX
database.

Caution: After changing the date and time formats, the system software must be restarted

,

for the changes to apply to the reports formats.

Caution: DO NOT restore the database unless directed to by Novartis Diagnostics

,

Technical Service.

®

TIGRIS System

PROCLEIX® TIGRIS System Operator’s Manual 1-7
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 1

Consumables Notices

,

,

,

,

,
,

,

Caution: Do not apply excessive force to the MTU waste bag while handling. If
mishandling occurs, inspect the waste bag for puncturing, remove any protruding tips while
following Universal Precautions, and place the entire bag and contents into a new bag.

Caution: Press bag down firmly against sides of the MTU Waste Container to ensure that
there are not wrinkles or air pockets that might catch an MTU as it is discarded.

Caution: Make sure that the Tiplet Waste Bag is flat against the sides of the container so
that the sensors will recognize the presence of the bag when the door is closed.

Caution: Do not re-use pipette tips, Multi-Tube Units (MTUs), or MTU Tiplets. Use only
tips, MTUs, MTU Waste Covers and MTU Waste Deflectors that are supplied by Novartis
Diagnostics. Use of unapproved consumables may compromise assay or analyzer
performance.

Caution: Avoid touching the tops or bottoms of pipette tips.

Caution: Load only full pipette tip trays. Do not insert individual pipette tips into the trays.

The system tracks which tip positions it has used and will not use individually inserted tips.

Caution: Use the cardboard box to load MTUs. Do not touch individual MTUs or MTU
Tiplets or load them individually by hand.

Caution: Do not switch the caps or bottle positions of the two liquid waste containers.

,

Replace each container in the proper position with its appropriate cap.

Limitations

♦ The sample barcodes are not tracked between multiple PROCLEIX® TIGRIS Systems.

♦ The positive specimen test algorithm is not performed automatically at the PROCLEIX TIGRIS

System level. See the appropriate PROCLEIX Assay package insert for further instructions.

♦ The positive pool resolution is not automatically performed at the PROCLEIX TIGRIS System

level. See the appropriate PROCLEIX Assay package insert for further instructions.

♦ It is the responsibility of each user to assure that the LIS data transfer is properly validated

with the LIS system at each site.

♦ The last line of the LIS export file contains a Cyclic Redundancy Checksum (CRC) tag that can

be used in a computer program to verify the file contents. Novartis Diagnostics Technical
Service can provide instructions to LIS programmers on verification of the CRC tag.

♦ Results verification subsequent to LIS transmission is the responsibility of each user to

properly validate.

♦ The performance of the PROCLEIX TIGRIS System has not been determined for altitudes

above 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.

1-8 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

Upper Bay

Lower Bay

Sample Bay

Waste Drawer

Fluids Drawer

Assay Reagent Bay

MTU Drawer

Drip Pan

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.

The analyzer is divided into a Lower Bay and an Upper Bay.

PROCLEIX® TIGRIS System Operator’s Manual 1-9
Volume I: Operating the Instrument

Figure 1.1 PROCLEIX

®

TIGRIS System

Table 1.1 describes the functions of the major components of the analyzer.

Component Function

Fluids Drawer

Contains the assay-generic fluids, tiplet waste container, and a hand­held barcode scanner.

Waste Drawer Collects the solid and liquid waste.

Assay Reagent (AR)
Bay

Contains the assay-specific reagents, except Target Capture Reagent
(TCR).

Sample Bay Contains the TCR, disposable pipette tips, and sample racks.

MTU Drawer Contains the multi-tube units (MTUs) in which the assay takes place.

Drip Pan Collects internal leaks and spills from the instrument.

Table 1.1 PROCLEIX

®

TIGRIS System Components

Part # 902649EN Rev. A

SECTION 1

Deactivation Fluid

System Fluid

Oil (A and B)

Auto Detect 2 (A and B)

Auto Detect 1 (A and B)

Tiplet Waste Container

Hand-held barcode scanner

Wash Solution (A and B)

Computer Workstation

The workstation (including the computer, monitor, keyboard, mouse, printer, cart, UPS, hand­held barcode scanner, and all associated cables) is provided and installed by Novartis
Diagnostics.

The workstation is equipped with a CD-RW drive that can be used for archiving and/or backing
up log files and database information. This CD-RW drive allows repeated cycles of recording
onto a single compact disk. Only media designated as CD-RW media is supported by the CD­RW drive. CD-R media cannot be used. The CD-RW media must be formatted prior to use on
the PROCLEIX
about formatting CD-RWs.

®

TIGRIS System. Contact Novartis Diagnostics Technical Service for information

Note: CD-RWs containing data from the PROCLEIX
on computers equipped with a software package that can read UDF-formatted disks.

®

TIGRIS System can only be viewed

Fluids Drawer

The Fluids Drawer, located in the middle of the Lower Bay, contains six fluids that are used
as part of the assay process, as well as a system fluid with an anti-microbial agent, which is
used as the hydraulic force to aspirate and dispense reagents and samples and rinse the
reagent pipettor arms. It also contains the tiplet waste container and a hand-held barcode
scanner.

Figure 1.2 Fluids Drawer

1-10 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

MTU Waste DeflectorMTU Waste Container

Liquid Waste Container 2

Liquid Waste Container 1

Waste Drawer

The Waste Drawer, located on the right side of the Lower Bay, collects solid and liquid
waste.

Figure 1.3 Waste Drawer (Liquid Waste tube parking slots not shown)

Component Function

♦ Collects the Wash Solution and wTCR/Sample waste from the

Liquid Waste
Container 1

Liquid Waste
Container 2

MTU Waste
Container

(+ bag)

MTU Waste
Deflector

MTU Waste Cover
(not shown above)

Magnetic Wash Station cycle during Target Capture.

♦ Collects the reaction waste aspirated from MTUs after Deactivation

Fluid is dispensed in the deactivation queue.

♦ Collects waste from the System Fluid used to rinse the pipettors

throughout the assay process.

♦ Collects the used MTUs after reaction waste is aspirated and

discarded.

♦ Collects disposable pipette tips used to transfer the sample and

wTCR to the MTU.

♦ Guides MTUs and pipette tips into the MTU Waste Container to

prevent waste accumulation in one area.

♦ Prevents splashing or spilling of waste out of the MTU Waste

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

SECTION 1

AR Cover

AR Carousel

AR Barcode Scanner

AR Carousel Wedge

Assay Reagent Bay

The Assay Reagent (AR) Bay, located on the left side of the analyzer, holds all assay­specific reagents (ARs) except TCR.

Figure 1.4 Assay Reagent (AR) Bay

Component Function

AR Barcode Scanner

AR Carousel

AR Carousel Wedge Removable bottle holder that makes up one quadrant.

AR Carousel Cover Protects opened reagents in the AR Carousel.

Reads the barcode on each Assay Reagent during AR
inventory validation.

Divided into 4 quadrants. A quadrant holds one set of ARs
(except TCR).

Table 1.3 Assay Reagent Bay Components

1-12 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

Selection Reagent

Probe Reagent

Enzyme Reagent

Amplification Reagent

Position 4

Position 3

Position 2

Position 1

AR Carousel Configuration

PROCLEIX ULTRIO® 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. Figure 1.5 shows an AR Wedge.

Figure 1.5 AR Wedge

Quadrant 4 of the AR Carousel contains a wedge that holds the Discriminatory Probe Reagents.
For Discriminatory Assays, the Discriminatory Probe Reagent in quadrant 4 will be run with the
AR set in quadrant 3. Even though the Probe Reagent in quadrant 3 will not be used for the
discriminatory assay, it still must be loaded in quadrant 3 with the rest of the AR set.

Figure 1.6 Discriminatory Probe Wedge

The Discriminatory Wedge in quadrant 4 can be replaced with one that is not specific to
Discriminatory Assays.

PROCLEIX® TIGRIS System Operator’s Manual 1-13
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 1

Position 2

Position 1

Sample Door

TCR Door

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)

♦ Quadrant 4 - Discriminatory Probe Reagents (see Figure 1.6)

Figure 1.7 Target Enhancer Reagent Wedge

Note: Target Enhancer Reagent loaded into Position 1 is used with ARs loaded in
quadrant 1; Target Enhancer Reagent loaded into Position 2 is used with ARs loaded in
quadrant 3.

Sample Bay

The Sample Bay, located on the right side of the analyzer, contains the sample racks,
disposable pipette tips, and TCR. It is covered by a two-part door.

1-14 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

Figure 1.8 Sample and TCR Doors

INTRODUCTION AND PRODUCT DESCRIPTION

TCR Carousel

Pipette Tip Ring

Sample Carousel

The Sample Door provides access to the Sample Carousel and Pipette Tip Ring, while the TCR
Door provides access to the entire Sample Bay, including the TCR Carousel.

Figure 1.9 Sample Bay

Component Function

The Sample Pipettor performs the following functions in the

PROCLEIX

®

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.

Sample Pipettor

♦ Aspirates and dispenses sample and wTCR into the MTUs.

♦ Detects clots in the samples.

The Sample Pipettor uses one tip to dispense wTCR to an entire MTU, but
uses a new tip for each sample dispensed. A filter barrier ensures that
fluids do not enter the pipettor assembly. The disposable pipette tips are
ejected down the Tip Strip Chute and into the MTU waste container after
each use.

DiTi Cone Located on the Sample Pipettor; holds and ejects disposable pipette tips.

Pipette Tip Ring Holds up to 5 trays of disposable pipette tips, each containing 96 tips.

Reads the barcode from the sample racks and sample tubes prior to assay
processing. The system uses this information to create worklists and verify
samples and racks have been loaded properly.

Sample Barcode
Scanner

Reading the sample barcode is the first step in the positive identification
process in which all activities for a sample are traced from the time its
barcode is initially scanned through assay processing until results are
reported. Note: The system software will only accept symbologies that
have been enabled in the Barcode Configuration

screen See “Configuring

the Sample Carousel Barcode Scanner” on page 5-7.

Sample Carousel Holds up to 9 sample racks, each with space for 20 sample tubes.

TCR Carousel Holds up to 4 bottles of TCR.

TCR Barcode
Scanner

Reads the barcode on each bottle of TCR.

Specimen Deck Platform for the Sample Carousel and the TCR Carousel.

Table 1.4 Sample Bay Components

PROCLEIX® TIGRIS System Operator’s Manual 1-15
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 1

Analyzer Power Switch

Vacuum System

The vacuum pump is responsible for the aspiration of liquid from MTUs in the magnetic wash
station and deactivation queue. The aspirated waste is deposited in Liquid Waste Container 1.
The vacuum gauge is located behind the TCR Door in the upper left corner above the Sample
Carousel. Under normal operating conditions, the vacuum level should meet the pressure
requirements listed in “Vacuum Pressure Requirements” on page 1-22.

The vacuum system contains a filter which prevents aerosols from being released into the
laboratory. The filter will be replaced by Novartis Diagnostics authorized personnel during
periodic maintenance. For more information about vacuum maintenance or filter replacement,
contact Novartis Diagnostics Technical Service.

Power Switch and Circuit Breaker Switch

The analyzer power switch is located to the right of the Sample Bay.

Figure 1.10 Analyzer Power Switch

The circuit breaker is located above the main power cord at the rear of the analyzer. Leave the
main circuit breaker power on (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

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

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
PROCLEIX

This section provides an overview of the information and functions available on the main
screens.

Main Menu Screen

After an operator logs in to the system, the Main Menu screen opens.

®

TIGRIS System computer workstation is started.

Figure 1.12 Main Menu Screen

PROCLEIX® TIGRIS System Operator’s Manual 1-17
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 1

From the Main Menu screen, the operator can access the following screens:

Screen Tasks To get there

Inventory
Status

Messages Troubleshoot system errors and view informational

Worklists Create, edit, view, print, and delete worklists Worklists tab (right)

Run Create, queue, and dequeue worklists, load and unload

Results View, search for, reject, print, verify, and export sample

Maintenance Perform maintenance tasks and performance checks,

Configuration Create, edit, or delete operator accounts, manage the

Logoff/
Shutdown

Manage reagent, fluid, and consumable inventories and
waste capacity, monitor the status of doors and covers,
view and print AR, Controls, and Master Lot reports

messages.

sample racks, start, manage, and stop assay
processing, change AR quadrants

results

view and print activity, maintenance, and message logs,
archive and restore the database

system configuration

Log off the software, shut down the system, unload
assay reagents, empty waste independent of Lower Bay
inventory

Inventory Status
panel (bottom)

Messages icon of
the System Status
panel (bottom)

Run tab (right)

Results tab (right)

Maintenance tab
(right)

Configuration tab
(right)

Logoff/Shutdown
tab (right)

Table 1.5 Main Screens

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.

Transcription-Mediated Amplification (TMA) Amplification of target RNA/DNA produces

multiple copies of RNA for easier detection.

Hybridization Protection Assay (HPA) Detection of the amplified RNA/DNA using

light-emitting nucleic acid probes.

Dual Kinetic Assay (DKA) Analysis of kinetic chemiluminescent data to

determine the validity and reactivity status of a
sample.

1-18 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

Target Capture

The Target Capture process isolates the viral RNA and DNA from plasma specimens and
purifies it for amplification.

1. The Sample Pipettor combines each sample with working Target Capture Reagent
(wTCR) in one tube of a Multi-Tube Unit (MTU). The right mixer then mixes the sample

and wTCR. In the PROCLEIX
Mixer, where Target Enhancer Reagent is added to each reaction tube to enhance the
disruption of the HBV viral particles. Finally, the MTU is moved to the Anneal Incubator for
the Target Capture reaction.

a) TCR solubilizes the viral envelope, denatures proteins, and releases viral genomic

RNA/DNA.

b) Oligonucleotides called “capture oligonucleotides” hybridize to the target RNA/DNA

sequences from the lysed virus.

c) The capture oligonucleotide and target RNA/DNA complexes attach to magnetic

particles by their tail sequence.

2. The MTU enters a Magnetic Wash Station (MWS):

a) In the MWS, magnets pull the magnetic particles, bound to target RNA/DNA

complexes, to the sides of the tubes.

ULTRIO Plus® Assay, the MTU is then moved to the Left

b) Aspirators in the MWS aspirate denatured plasma components. Removal of this

debris purifies the target RNA/DNA for amplification.

c) The MWS adds Wash Solution to each tube of the MTU, mixes the contents,

reapplies the magnet, and aspirates the contents. This wash step and magnetic
binding step is repeated for each reaction tube.

d) Liquid Level Sensing (LLS) verifies Wash Solution dispense and aspiration via

conductive tiplets.

3. When the magnetic wash cycle is complete, the target RNA/DNA is pure enough to be
amplified by Transcription-Mediated Amplification.

Transcription-Mediated Amplification (TMA)

Transcription-Mediated Amplification (TMA) uses two enzymes (Reverse Transcriptase and RNA
Polymerase) to produce billions of copies of RNA amplified product from the purified target.

The TMA process takes approximately one hour.

1. Oil is dispensed into the MTU, then the Amplification Pipettor dispenses Amplification
Reagent. The left mixer mixes the reagents.

a) Oil helps to prevent evaporation and the generation of aerosols, which can

contaminate other samples.

b) Amplification Reagent contains dNTPs, NTPs and oligonucleotide primers. These

primers help the two enzymes create copies of the target RNA/DNA.

2. The MTU moves to the Anneal Incubator. Incubation promotes the binding of the primers
to the target RNA/DNA.

3. The MTU moves to the Transition Incubator, then to the Amplification Incubator, where the
Amplification Pipettor dispenses Enzyme Reagent into the MTU.

PROCLEIX® TIGRIS System Operator’s Manual 1-19
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 1

Hybridization Protection Assay (HPA)

The Hybridization Protection Assay (HPA) process hybridizes the amplicon to single-stranded
nucleic acid probes that are labeled with an Acridinium Ester (AE) molecule, and then it selects
and detects the hybridized probes.

The Enzyme Reagent contains Reverse Transcriptase and RNA Polymerase enzymes.

a) Reverse Transcriptase uses the promoter/primer to create a DNA copy of the target

RNA. If the target is DNA, the process skips to step d.

b) The RNAse H activities of the Reverse Transcriptase degrades the original target

RNA.

c) The second primer binds to the new DNA copy and Reverse Transcriptase creates

a double stranded DNA duplex.

d) RNA polymerase uses transcription to make multiple RNA copies of the DNA

template.

e) The process repeats until the reagent supply is exhausted.

4. The amplified RNA, called “amplicon,” is ready to be hybridized with the labeled nucleic
acid probe in the Hybridization Protection Assay.

1. The system moves the MTU into the HPA Incubator, where the HPA Pipettor dispenses
Probe Reagent into it.

The Probe Reagent contains AE labeled oligonucleotides. The sequence of the probes
specifically complements the target amplicon.

2. If amplicon is present, it hybridizes to the probes.

3. The HPA Pipettor dispenses Selection Reagent into the MTU, then moves the MTU to the
Transition Incubator.

4. During the Selection phase, the hybridized and unhybridized probes are differentiated by
inactivating the AE label on the unhybridized probes.

Dual Kinetic Assay (DKA)

During DKA (detection), the chemiluminescent signal produced by the hybridized probe is
measured in a luminometer and is reported as relative light units (RLUs). Inactive AE will not
emit light in the detection process.

1. The system dispenses Auto Detect 1 and Auto Detect 2 into the MTU.

2. Auto Detect 1 and 2 react with the AE molecule, emitting photons (particles of light).

3. A luminometer reads the light signal, if present.

Internal Control is added to each reaction tube as part of the wTCR. The Internal
Control in this reagent confirms that the specimen processing, amplification, and
detection steps have been performed properly. The Internal Control signal in each tube
is differentiated from the analyte signal by the different kinetics of the AE labels. The
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
differentiate between Internal Control and combined analyte signals, but do not
discriminate between individual signals.

®

Assays

1-20 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

If applicable, specimens found reactive in the primary assay may be run in individual
Discriminatory Assays to determine if they are reactive for one of the viruses being
assayed or any combination of viruses.

4. After the luminometer reads the amplicon signal, the system dispenses Deactivation Fluid

to destroy any amplicon present in the MTU, aspirates the liquid, and discards the MTU.

The Discriminatory Assay steps are identical to the primary assay steps except that
Discriminatory Probe Reagents specific to a single virus are used in place of the primary assay
Probe Reagent.

Specifications

Physical Specifications

Component Dimensions (W x D x H) Weight

PROCLEIX

System Analyzer

Vacu um Pump

®

TIGRIS

69 x 36 x 72 in
(175.3 x 91.4 x 183 cm)

17 x 11.8 x 17.4 in
(43 x 30 x 44 cm)

1291 pounds (581 kg)

55 pounds (25 kg)

Table 1.6 Size and Weight Specifications

Component Minimum clearance required

PROCLEIX TIGRIS System

Analyzer (Overall space required
is: 117 x 60 x 96 in (297 x 152 x
244 cm, W x D x H)

Computer Workstation 24 in (61 cm) clearance in front

Table 1.7 Clearance Specifications

24 in (61 cm) vertical clearance
24 in (61 cm) around left side and back
24 in (61 cm) accessible on the right side
36 in (91.4 cm) at front of analyzer

Environment

Ambient Temperature 15 to 25° C

Humidity 20-85%

Shock and Vibration Compliance with IEC 68-2-6, 7.

Table 1.8 Environmental Requirements

Heat Dissipation

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

773 W (2637 BTU/Hour) during steady operation
(Conversion is 2637 x .293= 773 W)

Part # 902649EN Rev. A

SECTION 1

Water for the PROCLEIX® TIGRIS System Specifications

Electrical resistivity* >

Bacteria <

Particulate matter 0.22 micron filter

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

10 ΩM-cm

10 CFU/mL**

Power Requirements

Electrical Input 200 – 240 VAC, 50-60 Hz

Input Current 16 A

Electrical Connector L6-30R (USA)

Table 1.11 Power Requirements

Vacuum Pressure Requirements

The maximum vacuum pressure is 12 inches Hg.

Local Altitude Minimum Pressure

1 to 2000 feet (0 to 610 m) 6.5 inches Hg

2001 to 4000 feet (611 to 1219 m) 6.0 inches Hg

4001 to 5000 feet (1220 to 1524 m) 5.5 inches Hg

5001 to 7355 feet (1525 to 2242 m) 5.0 inches Hg

Table 1.12 Minimum Vacuum Pressure

Sample Tube Specifications

Type Size Material

12 x 75mm to 16 x 100mm (including

Specimen

Calibrators,

®

PROCLEIX
Controls

Refer to the appropriate PROCLEIX
specimen collection tubes.

TIGRIS

13 x 75mm, 13 x 100mm, and 16 x
75mm, 13 x 82 mm)

13mm x 82mm Polypropylene plastic

Table 1.13 Sample Tube Requirements

®

Assay package insert for more information about

Polypropylene plastic or
siliconized glass

1-22 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

Sample Tube Barcodes

Note: A sample barcode ID cannot have a space character as the prefix or suffix.

Note: If your sample barcodes do not meet these specifications, contact Novartis

Diagnostics Technical Service.

Size (Vertical) 61 mm

Skew < 10° from vertical

Minimum Height 0.6 in (16 mm)

Minimum Width 0.5 in (13 mm)

Placement

Top of label must be 2.2-2.9 inches (56-73 mm)
from bottom of tube.

Bottom of label must be 0.4-1.6 inches (10-40 mm)
from bottom of tube.

Code 39 (checksum optional), Code 128

Format

(non-ISBT), ISBT 128, Codabar (checksum
optional)

Number of Characters 2 to 20

Feature Size 6.5 mil (0.16 mm) to 10 mil (0.245 mm)

Quiet Zone ≥ 1.6 mm

Any except a comma or sequences encoding 1-20.

Allowed Characters

In addition to these exceptions, space characters
may not be used in ISBT 128 barcodes.

Barcode Printer Resolution Minimum 300 dpi, recommended 600 dpi

Print Contrast Signal ≥ 0.6

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

SECTION 1

Width

Height

Skew

Figure 1.13 Barcode Label Requirements

1-24 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

Sample Requirements

Sample Quality

All sample tubes must contain sufficient liquid for processing, and must be free of undissolved
particles, clots, and foam. Specimens with visible precipitates or fibrinous material should be
clarified according to instructions in the appropriate PROCLEIX

Volume 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
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.

Processing a sample with less than the minimum sample volume may result in errors. The
minimum sample volume includes both the sample pipetting volume and the dead volume.

Dead Space Volume Requirement

For samples in tubes that do not contain red cells or a gel separator, the dead space volume
requirements must be taken into account. Dead space volume is defined as the volume of
sample in a tube that must be present in order for the system to initiate pipetting.

For example, the dead space volume for a 12 mm or 13 mm diameter round-bottom tube is
500 µL. Each sample of this type must have at least the required specimen pipetting volume of
500 µL, plus the dead space volume of 500 µL of plasma. Refer to the table below for minimum
specimen volume requirements.

®

Assay package insert.

®

TIGRIS

Tube Diameter Dead Space Volume Total Volume Requirement

12 mm - 13 mm 500 µL 1000 µL

16 mm 1000 µL 1500 µL

Buffer Zone Requirement

For samples in tubes that contain cells, a layer of debris after centrifugation, or a gel separator,
a minimum volume of plasma defined as a buffer zone volume must exist between the cell,
debris, or gel interface and the PROCLEIX TIGRIS System’s pipette tip.

For example, the buffer zone required for a 12 mm or 13 mm diameter round-bottom tube is
200 µL. Each sample of this type must have at least the required specimen volume of 500 µL
plus the buffer zone volume of 200 µL of plasma. Refer to the table below for minimum
specimen volume requirements.

Tube Diameter Buffer Zone Volume Total Volume Requirement

12 mm - 13 mm 200 µL 700 µL

16 mm 400 µL 900 µL

PROCLEIX® TIGRIS System Operator’s Manual 1-25
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 1

System Capacities and Throughput

AR Sets (PROCLEIX
ULTRIO and WNV Assays)

AR Sets (PROCLEIX
ULTRIO Plus Assay)

Sample Racks Up to 20 tubes per rack, up to nine racks (180 tubes).

MTU Drawer Five reaction tubes per MTU, up to 20 MTUs (100 tests).

Pipette Tips 96 tips per rack, up to five racks (480 tips).

Liquid Waste Containers 2 x 10 L (2.6 US gal), up to 1,000 tests per container.

Solid Waste Containers Up to 1,000 tests.

Throughput (PROCLEIX
ULTRIO and WNV Assays)

Throughput (PROCLEIX
ULTRIO Plus Assay)

*Results are reported after controls are processed.

Table 1.15 System Capacities and Throughout

Operator Prerequisites

Up to four AR sets at a time or three AR sets and four
Discriminatory Probe bottles.

Up to two AR sets at a time, four Discriminatory Probe bottles,
and two bottles of Target Enhancer Reagent.

3.5 hours for first results; 109 results per hour thereafter*

3 hours and 56 minutes for first results; 84 results per hour
thereafter*

A qualified operator has the following:

♦ Proficiency in laboratory practices, including training in handling hazardous material.

♦ Familiarity with the PROCLEIX

♦ Understanding of the appropriate PROCLEIX

reagent kit.

♦ Proper training on the PROCLEIX TIGRIS System by a qualified trainer, including

instruction on cleaning and maintaining the analyzer.

®

TIGRIS System Operator’s Manual.

®

Assay package insert included with the

1-26 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

INTRODUCTION AND PRODUCT DESCRIPTION

Glove Changing Recommendations

Establishing good laboratory techniques is key to minimizing contamination associated with
amplification assays. One of the most effective methods to minimize contamination risk is
through frequent glove changing. See Table 1.16 for glove-changing recommendations for
operators of the PROCLEIX

Change Gloves Condition

Change gloves before... ♦ Preparing reagents or fluids.

Change gloves after... ♦ Cleaning work surfaces or handling bleach.

®

TIGRIS System.

♦ Handling samples.

♦ Loading reagents or fluids.

♦ Loading pipette tips or MTUs.

♦ Unloading reagents or fluids.

♦ Unloading sample racks.

♦ Performing any maintenance procedures on the PROCLEIX

TIGRIS System.

♦ Touching other lab equipment, including refrigerators and

freezers.

♦ Cleaning sample racks.

♦ Handling samples.

♦ 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

Part # 902649EN Rev. A

SECTION 1

1-28 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SECTION 2. SETTING UP THE INSTRUMENT

Preparing the Workspace

SETTING UP THE INSTRUMENT

Prepare a clean work surface in the laboratory before working with Assay Reagents (ARs) or
operating the PROCLEIX

1. Prepare a solution of 0.5% sodium hypochlorite in DI water or water for the PROCLEIX

TIGRIS System (diluted bleach) daily. (See “Water for the PROCLEIX
Specifications” on page 1-22)

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

“Water for the PROCLEIX

5. Dry the surfaces with a clean wipe.

6. Cover the bench with clean, plastic-backed absorbent laboratory bench covers. (optional)

®

TIGRIS System:

®

TIGRIS System Specifications” on page 1-22).

®

TIGRIS System

Starting the System

Follow the instructions in the operator's manual, on software screens, and in the appropriate
PROCLEIX
System.

The PROCLEIX TIGRIS System has been designed to remain in standby mode during routine
use. However, in some instances, the operator must start the system and log on to the
PROCLEIX

®

Assay package insert for safe and effective use of the PROCLEIX® TIGRIS

®

TIGRIS System software.

Review the Warnings and Cautions in Section 1 before operating the PROCLEIX TIGRIS
System.

1. Make sure that all system doors, covers, and drawers are closed.

2. Turn the analyzer on using the power switch on the front of the analyzer (LED will be

green).

Note: Always start the analyzer before the computer workstation.

Note: Take care to avoid bumping the power switch while the PROCLEIX TIGRIS

System is operating—doing so may result in accidental system shutdown and
premature termination of assay processing.

3. Turn on the computer workstation.

Note: Leave the monitor and printer on at all times, even when the analyzer and
PC are off.

The instrument initializes, resets the hardware, and unloads any MTUs left on the
system. The PROCLEIX TIGRIS System software starts automatically and displays the
login screen unless there are Warning Messages or Operator Intervention Messages
directing the operator to the Messages

4. Log on to the PROCLEIX TIGRIS System software.

a) Enter a username and password.

tab. The Auto Archiving process is initiated.

PROCLEIX® TIGRIS System Operator’s Manual 2-1
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 2

Status Bar

Return Times

Inventory Status

System Status

b) Click Logon.

The Main Menu
up process. The current activity field on the Status Bar displays the start up activity
being performed and the estimated time of completion.

When the start up process is complete, the Status Bar reads “Standby.”

screen opens. The system takes several minutes to complete the start-

Monitoring System Status

The bottom of the screen has four status panels that monitor the system as follows:

♦ The System Status

♦ The Inventory Status

statuses, as well as door and covers statuses.

♦ The Return Times

during sample processing.

♦ The Status Bar displays the system mode, current user, current system action, and the

current date and time.

panel monitors system conditions.

panel monitors reagents, fluids, waste, and consumables inventory

panel estimates the times that the system will require user interaction

Figure 2.1 Status Bar

System Status and Inventory Status Panels

The System Status and Inventory Status panels contain color-coded icons that alert the operator
to certain conditions. Red flashing icons indicate that an action is required. Green flashing icons
indicate that a task has been completed or valid inventory is on-board and therefore no action is
required.

Icon Meaning of Flashing Red Icon

Messages

Maintenance Maintenance items are overdue. See Volume II, Maintenance.

Temperature

Printer The printer is turned off, has malfunctioned, or is out of paper.

Note: Information messages will display in the Messages
red. 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.

Error or warning messages are waiting in the Messages
screen. See Volume III, Error Handling.

One or more internal modules is not at the temperature required for processing.
No action is required. The system will not start assay processing until all
system component temperatures are within the expected ranges.

tab, but the icon will not flash

tab of the Inventory

2-2 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

Table 2.1 System Status Panel Icon Indicators

SETTING UP THE INSTRUMENT

Icon Meaning of Flashing Red Icon

Reagents No ARs are loaded.

Fluids

Waste Fluid inventory is needed or invalid.

Doors One or more doors is unlocked or open.

Tips (count)

MTUs
(count)

The Lower Bay fluids inventory is invalid, the system needs to be primed, or
there is no current fluid inventory.

The number of available pipette tips is less than 97 or the Tips count is not
displayed.

The number of available MTUs is less than six.

Table 2.2 Inventory Status Panel Icon Indicators

Return Times Panel

The Return Times panel estimates when the operator should return to the system to perform an
action for the current worklist. If the operator does not perform the action at that time, a time-out
period begins, and processing pauses. The operator must take care to complete the action
before the maximum time-out period is exceeded (about three hours under normal conditions).

Field Meaning/Action Required

Load MTUs at the estimated time displayed. This return time is dashed out

Load MTUs

Load Tips

Load Racks

Next Results Set

Auto Logoff

Note: If any magnetic wash stations are out of service, the return times will be estimates.
See Volume III, Error Handling for more information.

if there are enough MTUs to complete the in-process worklist or if the MTU
queue is empty.

Load pipette tips at the estimated time displayed. This return time is dashed
out if there are enough tips to complete the in-process worklist.

Load additional sample racks at the estimated time displayed. This return
time is dashed out if all racks on the in-process worklist are currently
loaded.

A new set of completed worklist results will be available at the estimated
time displayed.

Unless the operator performs an action by the specified time, the system
will automatically log the operator off. If this occurs, the operator must log
back on before performing additional activities. A system administrator must
adjust or turn off the Auto Logoff setting. See “Configuring System Settings”
on page 5-4.

Table 2.3 Return Times Panel

PROCLEIX® TIGRIS System Operator’s Manual 2-3
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 2

Status Bar

The Status Bar displays the system mode, current user, current system action, and the date/
time. Use the system mode to determine the availability of the system for certain activities.
Table 2.4 describes possible system modes.

Mode Meaning Occurrence

The system is in this mode as worklists
are queued for processing. This mode
continues through specimen pipetting,
assay processing, and results
processing.

The system is in this state during system
initialization, hardware reset, and during
unload and priming operations.

A progress bar is displayed during this
state and no program features or
functions are available.

The system is in this state if an error
occurs while the system is connecting to
the system, performing a hardware reset
or performing an unload operation.

The system is in this state if an error
occurs for any other reason than the
system connecting to the system,
performing a hardware reset or
performing an unload operation.

The system is in this state after the
system and software have been
initialized or have returned to an idle
state.

Assay Processing

Data Access Only

Data Initialization

Error—Data
Access Only

Error—No Data
Access

Standby

The system is processing a
worklist.

The system is busy, but some
software functions are
available.

The system and software are
initializing. The system is in
this state at start-up.

A system error has occurred.
The operator can manipulate
worklists and data in the
system.

A system error has occurred.
The operator cannot perform
any data access activities
except Send Logs.

The system is ready for
normal operation.

Table 2.4 System Modes

2-4 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SETTING UP THE INSTRUMENT

The Current Activity displays which processing step the system is performing. The activities are
listed below in Table 2.5:

Activity Meaning

Correcting Racks

The system is verifying that the operator has resolved all Sample
ID or sample rack barcode errors.

Doing Maintenance The system is performing a maintenance activity.

Error Processing
Complete. OK to
Shutdown

Hardware Reset in
Progress

Initializing the Procleix
TIGRIS System

The system has completed error processing, and the system can
now be shut down.

A system hardware reset is in progress.

The system is initializing.

Loading MTUs The system is loading MTUs.

Loading Racks The system is loading sample racks.

Performing AR Inventory The system is validating the AR inventory.

Performing Fluid
Inventory

The system is performing an inventory of the Lower Bay fluids.

Pipetting The Sample Pipettor is pipetting wTCR or sample.

Priming Fluids The system is priming the fluid lines in the Lower Bay.

Processing Error. Please
Wait

Processing Results for
Worklist xxx

Scanning Racks

An error has stopped all system activity.

The system is finalizing results.

The system is scanning and verifying sample racks and sample
tubes.

Starting the Analyzer The system is initializing the analyzer.

Stopping Operations Will
Restart Analyzer When
Complete

The system has or stopped pipetting samples at user direction
(Stop All).

Unload in Progress The system is unloading all MTUs.

Table 2.5 System Activities

PROCLEIX® TIGRIS System Operator’s Manual 2-5
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 2

Managing Inventories

Use the Inventory Status screen to manage reagents, fluids, consumables, and waste.

Figure 2.2 Inventory Status Screen

Loading Consumables

Pipette tips and Multi-Tube Units (MTUs) can be loaded at any time except for when the Status
Bar indicates that the system is in Data Access Only mode or during maintenance procedures.

Do not re-use pipette tips, MTUs, or MTU Tiplets. Use only tips, MTUs, MTU Waste Covers and
MTU Waste Deflectors that are supplied by Novartis Diagnostics. Use of unapproved
consumables may compromise assay or analyzer performance.

Loading Pipette Tips

The Pipette Tip Ring can hold up to 5 trays of 96 tips, for a total of 480 tips. The indicator on
the Load... button changes from green to red if there are 96 tips (one tray) or fewer remaining.

Note: If the Tips Count does not display the number of tips on the system, load tips as
described below to update the tip count. If there are no empty tip trays on board, click
Done in the Load Pipette Tips
the database.

To l o ad t i ps:

1. From the Tips
Load….

A Load Pipette Tips
ring.

box of either the Upper Bay panel or the Inventory Status panel, click

window to set the tips count equal to the last known count in

window opens containing instructions for loading the tips onto the

2-6 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SETTING UP THE INSTRUMENT

2. Click Move Tip Ring.

The Pipette Tip Ring rotates one position clockwise to expose the next tip tray position
on the carousel.

3. Open the Sample Door.

Note: If a worklist is pipetting, the system will not unlock the Sample Door until the
current MTU is finished pipetting.

4. Replace the first empty tip tray.

a) Remove the existing tray.

b) Holding a full pipette tip tray by the edges, load it into the Pipette Tip Ring. Avoid

touching the edges of the ring with the tips. Avoid touching the tops or bottoms of
pipette tips. Make sure that the tabs of the pipette tip tray fit firmly into the

slots of the Pipette Tip Ring.

Load only full pipette tip trays. Do not insert individual pipette tips into the trays. The
system tracks which tip positions it has used and will not use individually inserted tips.

5. Close the Sample Door.

6. Repeat steps 2–5, replacing all empty tip trays with full trays.

7. Click Done.

The tips count updates with the assumption that all empty trays have been replaced.

8. If any partial trays have been replaced, click Reset in the Tips

to reset the tips count to 480.

box of the Upper Bay panel

Loading Multi-Tube Units (MTUs)

The indicator on the Load button changes from green to red if there are five or fewer MTUs
remaining in the MTU drawer. The MTU Drawer holds up to 20 MTUs (enough for up to 100
tests).

To load MTUs:

1. From the MTUs

Inventory Status

The System unlocks the MTU Drawer and displays a Load MTUs

2. When prompted by the system, pull out the MTU Drawer.

Note: Do not try to force the drawer open before the Load MTUs

3. Load a box, or a partial box, of 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.

box in either the Upper Bay panel of the Inventory Status screen or the
panel, click Load….

window.

window displays.

PROCLEIX® TIGRIS System Operator’s Manual 2-7
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 2

b) Hold the box of MTUs by the side, with the moveable flap at the top of the box

facing in towards the analyzer.

Figure 2.3 Loading MTUs

c) Slide the box down into the guides in the MTU drawer. Make sure that the MTUs

are securely in the guides. MTUs fit into the guides in only one direction.

If the entire box is not loaded, some MTUs will hang off the back of the drawer.
These extra MTUs remain in the box and can be loaded later.

d) Slide the MTU box backward, away from the analyzer.

Figure 2.4 Removing the MTU Box

The MTUs in the guides remain in the drawer.

4. Visually inspect MTUs:

♦ Check that the barcodes on the MTUs are present, properly aligned, and are not

damaged.

Caution: A misaligned or damaged MTU barcode may cause system errors.

,

♦ Check that the distributor foot (handle) on each MTU is intact and undamaged. The

distributor foot is opposite the barcode handle.

♦ Check that all MTU tiplets are in place. Do not replace dropped tiplets into MTUs.

♦ Check for any extra MTU tiplets inside the MTU tubes. Remove any defective MTUs

or MTUs with extra tiplets.

♦ 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.

2-8 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SETTING UP THE INSTRUMENT

If the MTU Drawer does not close properly, check to make sure that the MTUs all fit
into the drawer guides.

The System updates the MTU count.

Preparing the Lower Bay

The operator must manage the Lower Bay inventory any time the computer workstation is
started or restarted, one of the fluids becomes depleted or expires, or one of the waste
containers is filled.

The System monitors every component in the Lower Bay and displays the number of tests
remaining for each component in the Lower Bay

Note: The number of available tests that is displayed for Auto Detect 1, Auto Detect 2, Oil
and Wash Solution is the total combined number of tests remaining in both the A and B
bottles of each fluid.

Note: If system is shut down, on-board stability is not tracked for the following fluids: Auto
Detect 1 & 2, Oil, and Wash Solution.

Managing the Lower Bay inventory involves four tasks:

1. Replacing depleted or expired fluids

panel of the Inventory screen.

2. Scanning the barcodes of the fluids into the system

3. Emptying the solid and liquid waste containers

4. Priming the fluid lines in the system

Warning: Always wear proper protective equipment, including a laboratory coat, gloves,
and eye protection, when working with hazardous materials.

To begin the Lower Bay inventory process:

1. Click Load... in the Lower Bay

A Load Fluids
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.

window opens, giving basic instructions for the Lower Bay inventory

panel of the Inventory Status screen.

PROCLEIX® TIGRIS System Operator’s Manual 2-9
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 2

Replacing Depleted Fluids

In order to properly manage the Lower Bay fluids, the operator must take into account the
number of tests remaining for each fluid versus the total number of tests that will be run before
Lower Bay inventory is performed again. If not enough tests remain, the depleted fluid must be
replaced.

To verify the number of tests remaining for each fluid:

1. Click the View Fluid Details button in the Load Fluids

The Fluid Details
each individual fluid bottle within the Fluids Drawer.

window opens, displaying the current number of tests remaining in

window.

Figure 2.5 Fluid Details

2. Determine which bottle (A or B) to replace for each, then click OK to close the window.

Note: Take into account the number of tests that are consumed by a system prime. A
system prime may consume up to 80 tests per bottle. If the number of tests that will be
run plus 80 exceeds the number of tests remaining for any Lower Bay fluid bottle,
replace that fluid.

Note: When replacing fluid bottles, ensure that bottles A and B of the same fluid are
from the same lot.

Warning: Handle and dispose of solid and liquid waste and all unused reagents and
materials that have come in contact with specimens and reagents according to local,
state, and federal regulations.

Caution: Do not load any reagents or other fluids into the PROCLEIX® TIGRIS System

,

that are not approved for use by Novartis Diagnostics.

2-10 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

Window

SETTING UP THE INSTRUMENT

Caution: Do not combine any assay reagents or fluids without specific instruction.

,

Never top off AR or fluid bottles. The PROCLEIX
changes in the reagent fluid level and reject bottles that have been topped off.

Note: When replacing fluid bottles, align the bottle seams away from the sensors.
Failure to do so can cause false “bottle empty” errors.

If replacing multiple fluids, start with those that are most susceptible to contamination:

1. System Fluid

2. Wash Solution (A & B)

3. Auto Detect 1 (A & B)

4. Auto Detect 2 (A & B)

5. Oil (A & B)

6. Deactivation Fluid

®

TIGRIS System will recognize the

Replacing System Fluid

Caution: Use aseptic techniques when preparing System Fluid.

,

Caution: System Fluid Preservative contains sodium hypochlorite solution. Avoid contact

,

with skin, eyes, and mucous membranes. Wash affected area with water if contact with this
fluid occurs. If this fluid spills, dilute with water before wiping dry.

To replace the System Fluid:

1. Disconnect the quick-connect fitting from the cap of the System Fluid bottle.

2. Connect the System Fluid tubing to the quick-connect Parking Slot located next to the

barcode scanner.

3. Remove the System Fluid bottle and place it on an absorbent pad on a clean work

surface.

4. Remove the System Fluid cap and wrap it in a clean absorbent pad.

Caution: Do not uncap the System Fluid bottle before moving it for fluid disposal

,

and refilling.

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.

8. Remove the old barcode label on the System Fluid bottle and dispose of it.

9. Place the new System Fluid Preservative bottle label on the top of the System Fluid bottle.

Write the fluid preparation date on the label.

Caution: Do not place the barcode label over the vent hole on the System Fluid

,

bottle cap. The bottle will collapse under vacuum if the vent hole is covered.

10. Replace the cap on the System Fluid bottle and place the System Fluid bottle back in its

position in the Fluid Drawer.

PROCLEIX® TIGRIS System Operator’s Manual 2-11
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 2

Replacing Wash Solution, Auto Detect Reagents and Oil

,

11. When replacing the bottle, make sure that its seam is not aligned with the sensor to the
right of the bottle, otherwise the sensor might not detect the bottle correctly. Make sure
that the bottle is firmly seated in the drawer.

12. Remove the System Fluid line from the Parking Slot, and re-connect it to the quick­connect fitting on the System Fluid bottle cap. When re-connecting, check that the correct
fluid line tags are matched to the correct container.

Note: System Fluid can be prepared ahead of time in the extra System Fluid
bottle. System Fluid expires 30 days after preparation. See Volume II, Maintenance
for instructions on cleaning and filling the System Fluid bottle.

Caution: When replacing the Oil, confirm that the volume of the previous bottle has
diminished. If there is an indication that the Oil has not been consumed, call Novartis
Diagnostics Technical Service for troubleshooting instructions.

Note: Replace Auto Detect 2 before replacing Oil.

1. Disconnect the quick-connect fitting from the bottle cap.

2. Remove the bottle from the drawer.

3. For Auto Detect 2:

a) Using water for the PROCLEIX

connector on the bottle cap.

b) 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.

c) Cover the cap with a dry wipe, and tap it gently to remove water clinging to the cap.

4. Remove the cap from the new bottle, and replace it with the one from the old bottle with
the quick-connect fitting.

5. Re-seal the old fluid bottle with the cap from the new bottle, and set it aside.

6. Write the current date on the “Open Date” line on the bottle’s label to indicate the date on
which the fluid was opened and loaded onto the system.

7. Place the new bottle in the appropriate position in the Fluid Drawer.

8. Align barcodes on the Auto Detect 1 and Oil bottles so that they are visible through the slot
at the front of the drawer. Align the Wash Solution barcode on the bottle so that it is visible
through the slot in the Plexiglas cover.

9. Re-connect the appropriate fluid line to the quick-connect fitting on the bottle cap. Check
the fluid line tags to make sure that the correct fluid line is connected to each bottle.

10. Discard the capped used bottle according to the laboratory policies.

®

TIGRIS System, dampen a wipe and wipe the

2-12 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SETTING UP THE INSTRUMENT

Replacing the Deactivation Fluid

Caution: Deactivation Fluid contains sodium hypochlorite (bleach). When working with

,

Deactivation Fluid or bleach, follow laboratory policies for handling bleach.

To replace the Deactivation Fluid:

1. Remove and empty the Deactivation Fluid bottle:

a) Disconnect the quick-connect fitting from the cap of the Deactivation Fluid bottle.

b) Remove the Deactivation Fluid bottle from the Fluid Drawer and place it on an

absorbent pad on a clean work surface.

c) Remove the cap from the bottle and wrap it in a clean absorbent pad.

d) Dispose of any liquid remaining in the bottle according to the laboratory policies.

e) Rinse the inside of the cap, including cap threads and vent holes, with water for the

PROCLEIX
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.

3. Open a new bottle of Buffer for Deactivation Fluid.

4. Pour the Buffer for Deactivation Fluid into the Deactivation Fluid bottle.

5. Make sure that the bleach/Buffer for Deactivation Fluid mixture level is above the

minimum total fill line on the bottle.

6. Replace the cap on the Deactivation Fluid bottle.

7. Remove the old barcode label from the Deactivation Fluid bottle cap, and replace it with

the barcode label from the Buffer for Deactivation Fluid bottle.

Caution: Do not put the barcode label over the vent hole on the Deactivation Fluid

,

bottle cap. The bottle will collapse under vacuum if the vent hole is covered.

8. Write the current date on the “Open Date” line on the bottle’s label to indicate the date on

which the fluid was prepared and loaded onto the system.

9. Place the Deactivation Fluid bottle back in its position in the Fluid Drawer.

Caution: To avoid false errors when replacing the Deactivation Fluid bottle, align

,

the handle indentations so that they face the rear left corner.

®

TIGRIS System to remove any crystallization, then wrap the cap in a

10. Reconnect the fluid line to the quick-connect fitting on the Deactivation Fluid bottle cap.

Check the fluid line tags to make sure that the correct fluid line is connected to each bottle.

PROCLEIX® TIGRIS System Operator’s Manual 2-13
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 2

Scanning Fluid Barcodes

After replacing any depleted fluid bottles in the Fluids Drawer, scan all of the bottles in the
drawer into the Lower Bay inventory. The barcode for each label codes the fluid type, lot
number, expiration date, and bottle-specific identifier.

To scan fluid barcodes into the system:

Note: If all of the Lower Bay inventory procedures are not completed correctly, the system
will force the operator to re-scan all of the Lower Bay fluid barcodes before continuing.

1. Using the hand-held barcode scanner in the Fluid Drawer, scan each bottle into inventory
in the following order:

a) Wash Solution B

b) Wash Solution A

c) Auto Detect 1 A

d) Auto Detect 1 B

e) Auto Detect 2 A

f) Auto Detect 2 B

g) Oil A

h) Oil B

i) System Fluid Preservative

j) Buffer for Deactivation Fluid

As each fluid is scanned into inventory, the field next to the fluid name is populated with
the barcode.

Caution: If bottles are not scanned in the correct order, two possible scenarios

,

may occur:

♦ If one fluid type, for example Wash Solution, is scanned into the field of

another fluid type, for example Auto Detect 1, the barcode will not be
accepted.

♦ If bottle B of a specific fluid is scanned into a bottle A barcode field, the wrong

information will be in the database which could result in a bottle running dry
unexpectedly, causing a system failure.

2. After scanning, make sure bottle placement is still correct (barcode alignment, seams,
etc.) and that all 12 fluid lines are securely connected.

Note: Do not click Inventory on the Load Fluids
have been emptied. If the inventory validation is attempted before emptying the
waste, all of the fluids in the Fluid Drawer will have to be rescanned.

window until the waste containers

3. Leaving the Fluid Drawer open, continue on to emptying the Tiplet Waste container.

2-14 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SETTING UP THE INSTRUMENT

Emptying Waste Containers

To prevent contamination, always handle fluids before handling waste. After scanning the fluids
in the Fluid Drawer into inventory, empty the four waste containers in the following order:

♦ Tiplet Waste Container

♦ Liquid Waste Container 1

♦ Liquid Waste Container 2

♦ MTU Waste Container

The System will not continue with the Lower Bay inventory procedures until the waste
containers are empty.

The Load Fluids

Warning: Use Universal Precautions when handling waste and waste containers. Handle
and dispose of liquid and solid waste and all unused reagents and materials that have
come in contact with specimens and reagents according to local, state, and federal
regulations.

Warning: Clean spilled waste immediately by wiping the surface with 0.5% sodium
hypochlorite in water (diluted bleach). Allow the diluted bleach to contact surfaces for
15 minutes, and then rinse with water. See Table 1.2, “Recommended Cleaning Agents,” in
Volume II: Maintenance. Discard any materials that come into contact with waste into
biohazard containers.

Caution: Do not apply excessive force to the MTU waste bag while handling. If

,

mishandling occurs, inspect the waste bag for puncturing, remove any protruding tips while
following Universal Precautions, and place the entire bag and contents into a new bag.

Caution: Treat the waste in the liquid waste containers as a potential source of assay

,

contamination. When handling liquid waste, be careful to not contaminate the work
surfaces.

Caution: Use only MTU Waste Bags, MTU Waste Deflectors, and MTU Waste Covers that

,

are supplied by Novartis Diagnostics. Do not reuse these consumables.

Caution: Do not switch the caps or bottle positions of the two liquid waste containers.

,

Replace each container in the proper position with its appropriate cap.

window should still be open from replacing and scanning fluids.

Caution: Liquid Waste Container 1 and Liquid Waste Container 2 fluids contain sodium

,

hypochlorite (bleach). Do not autoclave.

Emptying the Tiplet Waste Container

The Tiplet Waste Container is located behind the bottles of fluid in the Fluid Drawer. To empty
the tiplet waste:

1. Remove the red Tiplet Waste Bag from the Tiplet Waste Container and dispose of it

according to the laboratory policies.

2. Fit a new Tiplet Waste Bag into the Tiplet Waste Container.

3. Press the bag down into the four corners of the Tiplet Waste Container.

Caution: Make sure that the Tiplet Waste Bag is flat against the sides of the

,

container so that the sensors will recognize the presence of the bag when the door
is closed.

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

SECTION 2

Left line

Right line

Emptying the Liquid Waste

To empty the Liquid Waste containers, first open the waste drawer:

5. Close the Fluids Drawer and secure it in place by rotating the latch.

1. Rotate the latch and pull out the drawer.

2. Disconnect the quick-connect fitting on the Liquid Waste Container 2 bottle cap.

3. Park the quick-connect fitting into the slot above the container on the door frame (Figure

2.6) where it will not interfere with Lower Bay maintenance.

Figure 2.6 Liquid Waste Container 2 Fitting

4. After the hose is secured, pull the drawer out farther to facilitate access to the Liquid
Waste Containers and MTU Waste Container.

To empty Liquid Waste Container 1:

1. Firmly press the gray plastic vacuum fitting of the left line (leading to the vacuum manifold)
on the bottle cap of Liquid Waste Container 1. When the vacuum releases, pull the hose to
disconnect it from the bottle cap. Apply firm pressure to release the hose fitting.

Figure 2.7 Liquid Waste Container 1 Fittings

2. Firmly press the gray plastic vacuum fitting of the right line (leading to the vacuum trap) on
the bottle cap of Liquid Waste Container 1. When the vacuum releases, pull the hose to
disconnect it from the bottle cap. 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

Part # 902649EN Rev. A Volume I: Operating the Instrument

SETTING UP THE INSTRUMENT

4. Park the hose fittings in the slots located on the left side of the drawer (Figure 2.8) to

securely hold the hoses during Lower Bay Maintenance.

Figure 2.8 Liquid Waste Container 1 Fitting

5. Remove Liquid Waste Container 1 from the drawer and transfer it to the disposal location.

6. Remove the bottle cap from Liquid Waste Container 1 and place it on an absorbent pad.

7. Dispose of the contents according to the laboratory policy.

8. Add 200 mL of bleach (5% sodium hypochlorite) to Liquid Waste Container 1.

Note: Do not add more than 200 mL of bleach (5% sodium hypochlorite) to Liquid
Waste Container 1, or the system will display a “Liquid Waste Container 1 not
empty” error.

9. Replace the cap to Liquid Waste Container 1 and set the sealed container aside while the

MTU waste container is emptied. See “Emptying the MTU Waste Container” on page 2-17.

To empty Liquid Waste Container 2:

1. Remove Liquid Waste Container 2 and place it near the drain in the laboratory.

2. Unscrew the cap, and place it on an absorbent pad on a clean work surface.

3. Empty the contents according to the laboratory procedure.

4. Re-cap Liquid Waste Container 2 and set the sealed container aside while the MTU Waste

Container is emptied.

Emptying the MTU Waste Container

The MTU Waste Container is located behind the two Liquid Waste Containers in the Waste
Drawer. To empty the MTU Waste Container:

1. Pull the MTU Waste Container forward in the drawer.

Note: The MTU Waste Drawer must be pulled forward completely, or else the
sensor will not change status.

2. Carefully lift the MTU Waste Cover off the MTU Waste Container, handling it only by the

outside (top side with graphic) surface, as the inside (bottom) has been exposed to MTU
waste. Fold the MTU Waste Cover and place it inside the MTU Waste Bag along with the
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

SECTION 2

4. Fit a new MTU Waste Bag into the MTU Waste Container.

5. Fold the top of the bag down around the outside of the MTU Waste Container.

Note: Press bag down firmly against sides of the MTU Waste Container to ensure
that there are no wrinkles or air pockets that might catch an MTU as it is
discarded.

6. Slide a new MTU Waste Deflector over the rear-right corner of the MTU Waste Bag and
Container.

The Waste Deflector helps to hold the MTU Waste Bag in place and keeps MTUs from
accumulating on one side of the container.

7. Fold the edges of the MTU Waste Cover down at the perforations and place it over the top
of the MTU Waste Container. Align the cover opening with the MTU Waste Deflector at the
rear of the MTU Waste Container. Ensure that the MTU Waste Cover graphic is visible
(facing up) when installing the MTU Waste Cover.

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

Part # 902649EN Rev. A Volume I: Operating the Instrument

SETTING UP THE INSTRUMENT

Validating the Lower Bay Inventory

After replacing any depleted fluids, scanning in all fluids, and emptying all waste containers,
complete the Lower Bay inventory:

1. Verify that all 15 fluid and waste lines have been reconnected. Connections that are not

well secured could adversely affect assay results.

2. Close and lock the drawers. Close the doors.

3. Click Inventory on the Load Fluids

The System verifies that all of the Lower Bay inventory procedures have been
completed successfully. If any of the Lower Bay inventory procedures were not
completed, the system alerts the operator to the procedures that need to be completed
to successfully validate the inventory.

Note: If an error message appears, correct the problem(s) that it lists, re-scan the
fluid bottles, empty all waste containers, and click Inventory again. If the listed
problem cannot be corrected, see Volume III, Error Handling or call Novartis
Diagnostics Technical Service.

When all of the procedures have been successfully completed, the system validates the
inventory and updates the Lower Bay Inventory
number of remaining tests and the expiration date of the on-board stability for each
Lower Bay fluid.

4. Click Done.

window.

panel on the Inventory screen with the

Priming the System

After Lower Bay inventory, or if four hours have elapsed without processing samples, the fluid
lines must be primed to eliminate bubbles. A red Prime button on the Lower Bay Inventory
panel indicates that priming is needed.

Caution: Two primes are required if the instrument has not been used for three or more

,

days.

Note: The Lower Bay inventory must be valid before the system can be primed.

To prime the system:

1. Verify that the MTU count is at least seven.

2. Verify that all fluids have enough tests remaining for priming.

Each prime consumes up to 80 tests from each bottle of fluid. If fluid volume is
insufficient, an error will be generated.

3. Click Prime in the Lower Bay Inventory

The priming process takes about 20 minutes. An estimated time of completion displays
in the Status Bar. During the priming process, the system goes into Data - Access Only
mode, which only allows the operator to view and print results and/or reports.

Note: Priming the system consumes Lower Bay fluids. If the system is primed
more than once from the same set of bottles, the Lower Bay Inventory
reduce the Available Tests counts for some Lower Bay Fluids.

PROCLEIX® TIGRIS System Operator’s Manual 2-19
Volume I: Operating the Instrument

panel.

panel will

Part # 902649EN Rev. A

SECTION 2

Loading Assay Reagents

Load Assay Reagents (ARs) onto the system after managing the Lower Bay inventory, priming
the system, and completing Daily Maintenance.

See the appropriate PROCLEIX

Working with Master Lots

The Master Lot barcode can be found on the Master Lot Sheet that is included in each AR kit.
The Master Lot ensures that only the reagents belonging to a specific Master Lot can be run
together on the PROCLEIX

Each Master Lot need only be entered once into the system. Use the Master Lot report to verify
that the barcodes on each new set of ARs matches the Master Lot information already entered.

Using the Master Lot Report

To view the Master Lot report:

®

TIGRIS System.

®

Assay package insert for reagent preparation instructions.

1. Click inside the Inventory Status

The Inventory Status

2. On the right side of the Inventory Status

A Select Master Lot Barcode

3. Select the Master Lot number from the Master Lot

A Master Lot Report

4. Verify that the individual lot numbers of each reagent on the Master Lot Report match the
lot numbers for the set.

The barcode on each AR bottle contains 21 digits. Table 2.6 describes the information
coded by the sets of digits that make up the barcode.

Information Type

Assay Type 2 1-2

Reagent Type 2 3-4 02 = Enzyme Reagent

Lot # 6 5-10 123456

Expiration date 6 11-16 300606 = June 30, 2006

Bottle ID 5 17-21 54321

screen displays.

window opens.

# of
Digits

Table 2.6 AR Barcode Information

panel.

screen, click View Master Lot Report....

window opens.

Digit Position Example

drop-down list.

03 = PROCLEIX ULTRIO

®

Assay

Adding a Master Lot

If a set of ARs belongs to a Master Lot that is not yet in the system database, the operator
must add the new Master Lot to the database before the set can be loaded.

1. In the Upper Bay Inventory
Master Lot window opens.

2. Using the barcode scanner on the computer workstation, scan in the Master Lot barcode
on the 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

Part # 902649EN Rev. A Volume I: Operating the Instrument

panel on the Inventory Status screen, click New Lot. A New

SETTING UP THE INSTRUMENT

3. Click OK.

A New Master Lot Components

window opens.

4. Scan the remaining barcodes on the Master Lot card for each AR belonging to the Master

Lot. The AR barcodes can be scanned in any order.

5. As each AR barcode is scanned, the barcode populates the appropriate text boxes in the

New Master Lot Components

window.

6. Click OK.

Unregistering a Master Lot

Unregistered Master Lots remain in the database, but cannot be used to run assays. To
unregister a Master Lot:

1. Click Unregister Lot... on the Inventory Status

The Unregister Master Lot

window opens.

screen.

2. Scan the Master Lot barcode on the Master Lot Sheet to enter it into the Barcode field.

3. Click OK.

If the barcode passes the necessary checks, it is unregistered and an Unregister Master
Lot confirmation window opens.

4. Click OK.

Re-registering a Master Lot

To re-register a Master Lot:

1. Click New Lot. A New Master Lot

window opens.

2. Using the hand-held barcode scanner on the computer workstation, scan the Master Lot

barcode from the Master Lot Barcode Sheet. A Confirmation

window opens, indicating the

Master Lot barcode has been previously unregistered.

3. Click OK to re-register. A final New Master Lot

window opens.

4. Click OK to exit.

Resolving an Ambiguous Master Lot

When validating Upper Bay Inventory, “Master Lot is Ambiguous” messages may appear in the

Load Assay Reagents

and therefore the system does not know which Master Lot to track the reagent with. The
operator must identify the correct Master Lot in order to accurately track on-board reagent
stability.

window. This occurs when a reagent is part of more than one Master Lot,

To resolve an ambiguous Master Lot:

1. Click the message line to resolve the Master Lot. A “Resolve Ambiguous Master Lot”

message appears.

2. Scan in the correct Master Lot for that quadrant, then click OK.

3. Repeat for any other quadrants that the system identified as having an ambiguous Master

Lot.

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

SECTION 2

Loading ARs

1. Select a new set or previously loaded matched set of ARs.

ARs that have been previously loaded on the PROCLEIX
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. They are then required to be run as
a set in all subsequent worklists. Bottles belonging to a matched set cannot be
swapped with bottles in other sets of ARs. The System will not validate AR inventory if
the bottles in a previously used matched set were not kept together. Use the AR Report
to identify bottle IDs belonging to a matched set (see “Assay Reagent Status Report” on
page 6-2).

A worklist can only use one set of ARs. In other words, the AR quadrant cannot be
switched in the middle of assay processing.

Label the reagent bottles (Target Capture Reagent, Probe Reagent, Amplification
Reagent, Enzyme Reagent, Selection Reagent and Target Enhancer Reagent [if
applicable—PROCLEIX
bottles belonging to a set.

Discriminatory Probe Reagents can be run with any “matched set” of ARs (Amplification
Reagent, Enzyme Reagent, Probe Reagent, Selection Reagent, TCR and Target
Enhancer Reagent [PROCLEIX

2. Verify that all ARs are free of precipitates.

ULTRIO Plus® Assay only]) with the date and initials to identify

ULTRIO Plus® Assay only]) within each master lot.

®

TIGRIS System must be

3. On the Upper Bay Inventory

The AR Door unlocks, and a Load Assay Reagents

4. Remove and discard the caps from the AR bottles.

5. Load the prepared Amplification Reagent, Enzyme Reagent, Probe Reagent, and
Selection Reagent into the AR Carousel:

a) Open the AR Door and remove the AR Carousel Cover. While holding the AR

Carousel Cover in one hand, remove the AR Carousel. Place the AR Carousel on
an absorbent pad on a clean work surface, and replace the AR Carousel Cover
back into the AR Bay for storage.

Caution: To prevent contamination or misalignment, avoid touching the

,

Amplification and HPA Pipettors when removing the AR Carousel and/or Cover.

b) Visually inspect each reagent for foam and/or bubbles.

Caution: Inspect all packaged reagents, fluids, and consumables for damage

,

before use. Inspect Assay Reagents for precipitate or foam. Avoid creating foam
when handling reagents. Do not use reagents with precipitate or foam.

c) The AR Carousel quadrants are numbered 1–4. Each position within the quadrant is

labeled with the first letter of each reagent type and the quadrant number. Slide
each AR bottle into its appropriate position in the first available quadrant of the AR
Carousel.

panel of the Inventory Status screen, click Load.

window opens.

6. If running the PROCLEIX
quadrant 2. Load into Position 1 (left position) for use with ARs loaded in quadrant 1;
Position 2 (right position) for use with ARs loaded in quadrant 3. (See Figure 1.7 on
page 1-14.)

2-22 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

ULTRIO Plus® Assay, load Target Enhancer Reagent into

SETTING UP THE INSTRUMENT

d) Verify that the barcode for each bottle is visible through the slot in the carousel.

Figure 2.10 Proper AR Bottle Positioning

e) Lift the carousel by the knob at the top, supporting the carousel with the other hand.

With the support hand, remove the AR Carousel Cover and place the AR Carousel
gently into the slot in the AR Bay.

f) Gently rotate the carousel until it locks into place.

The carousel is locked when a “click” is heard and a slight bit of resistance is felt as it
is rotated. The AR Carousel indicator on the Inventory Status

screen should be green,

indicating that the carousel is seated properly.

g) Replace the AR Carousel Cover over the AR Carousel.

The notches on the AR Carousel Cover should fit snugly into the openings on the AR
Bay. Press down on one side of the AR Carousel Cover to verify that it is firmly seated
in the AR Bay and does not wobble back and forth.

h) Close the AR Door.

7. Load the Target Capture Reagent (TCR) into the TCR Carousel:

a) Lift open the Sample Door and TCR Door.

b) Slide the TCR bottle into the cup of the TCR Carousel that matches the number of

the quadrant of the AR Carousel where the other ARs were loaded.

c) Verify that the barcode of the bottle of TCR is visible through the slot in the TCR

cup. 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

SECTION 2

9. If the system displays an error screen, wait for the inventory process to finish, fix the
error(s) and click Inventory again.

When the system finishes validating the AR inventory, the Load Assay Reagents
window confirms that the barcodes are valid.

10. If the matched set has been used before, the system recognizes them and does not ask
for a TCR/IC reconstitution date. Skip to step 13.

11. If the ARs have never been loaded on the system, it groups them into a matched set. It
then prompts the operator to scan the Internal Control barcode and enter the
reconstitution date for the Internal Control.

12. By default, the screen displays the current date as the reconstitution date when the box is
checked. If the TCR has been reconstituted with Internal Control on a prior date, enter that
date as the reconstitution date by clicking the arrow to the right of the date box and
selecting the correct date.

13. Click Continue.

The system performs level-sensing on each reagent. If the pipettor senses a level other
than what is expected, the system displays an error message.

When the system confirms that the ARs are valid, it displays a confirmation window.

14. Click Done.

The System updates the Upper Bay Inventory
tests and the on-board expiration date for each quadrant of ARs in the AR Carousel.

Because the system consumes pipette tips and System Fluid during AR inventory, the
Tips count and test capacity for the System Fluid inventory are also updated after AR
inventory.

panel to show the available number of

Changing the Reagent Quadrant

If multiple quadrants of ARs are loaded, the system automatically chooses a quadrant of ARs
that contains enough tests for the worklist and has the earliest expiration date. The default
choice can be overridden after the worklist is queued, but before sample pipetting begins.

Note: A worklist can only use one set of ARs. In other words, the AR quadrant cannot be
switched in the middle of assay processing.

1. On the Queued Worklists
changed.

2. Click Change Reagent Quadrant….

A Change Reagent Quadrant
assay being run, the number of samples on the worklist, the worklist type (always
“Carousel”), and a drop-down list of all AR quadrants with enough reagents to run the
specified worklist.

3. Select the new quadrant of ARs from the Quadrant drop-down list.

4. Click OK.

The Queued Worklists

grid, select the worklist that contains AR quadrants to be

window opens. This window displays the worklist’s ID, the

grid updates to show the new AR quadrant.

2-24 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SECTION 3. RUNNING SAMPLES

Using A Worklist

The System uses worklists to manage its processing runs. Use the Worklist Manager screen to
create and manage the worklists.

RUNNING SAMPLES

Figure 3.1 Worklist Manager Screen

To access the Worklist Manager
screen.

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

Volume I: Operating the Instrument Part # 902649EN Rev. A

®

TIGRIS System Operator’s Manual 3-1

, select the Worklists tab on the right side of the Main Menu

SECTION 3

Possible worklist conditions, their descriptions, and helpful notes for use are described in Table

3.1.

Worklist
Condition

Stored

Queued

In-process

Completed

Stopped

Invalid

Description Notes

♦ Can be modified.

A created worklist that has not been
placed in the queue for processing.

♦ Can be deleted.

♦ De-queued worklists return to

“stored” state.

A worklist that has been selected for
processing in the next run.

A worklist that is currently being
pipetted.

A worklist that has finished processing;
results have been reported.

A worklist that was “in-process” and
cancelled due to instrument error or
user action.

A completed worklist that has

♦ Can be de-queued and returned to

a “stored” state.

♦ Cannot be de-queued.

♦ Can be aborted.

♦ Can be verified.

♦ Results can be transmitted to LIS.

♦ Worklist samples that did not

complete processing and do not
have results must be re-run.

♦ All samples must be re-run.
calibrators that failed run validity
criteria.

Table 3.1 Worklist Conditions

Control Bracketing

Control bracketing is a process that allows worklist results to be released in smaller subsets.
With control bracketing, PROCLEIX
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.”

The default bracket size is 172 specimens, but this can be changed to any value between 1
and 492 for a single analyte assay or between 1 and 487 for a triple analyte assay.

®

TIGRIS Controls are placed at a configured interval, as

Figure 3.2 Control Bracket

If other criteria described in the appropriate assay package insert are met, such as calibrators
being valid, the validity of specimens is evaluated by brackets. Results for in-process worklists

3-2 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

RUNNING SAMPLES

appear on the Results screen as each bracket finishes processing. The software can also be
configured to automatically release results to the LIS as each bracket finishes processing. See
“Configuring System Settings” on page 5-4 for more information about configuration. See the
appropriate PROCLEIX
based on control bracketing.

Note: When the control bracket size is changed in the software configuration, the new
bracket size does not apply retroactively to existing worklists.

®

Assay package insert for more information about results interpretation

Creating a Worklist

To create a Carousel Worklist:

1. From either the Worklist Manager

Worklist….

A Create Carousel Worklist

2. Select the assay to be run from the Assay drop-down list.

The Analyte drop-down list defaults to the appropriate analyte.

3. In the Total Specimens text box, enter the total number of specimens that are to be
included in the worklist. Include custom user-defined controls in the total specimen count,
but do not include the required PROCLEIX

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
reflects the total specimens plus required calibrator and PROCLEIX TIGRIS Control
replicates.

5. Click OK.

The system adds the worklist to the Stored Worklists

A Carousel Worklist does not have any Sample IDs associated with it until the racks are
loaded and scanned.

window opens.

or Run Manager screen, click Create Carousel

®

TIGRIS Controls or calibrators.

window

grid.

Editing a Worklist

If a worklist has not yet been queued and scanned, the Worklist Manager screen can be used
to edit it:

1. Select the worklist to be edited from the Stored Worklists

2. Click Edit Carousel Worklist....

Note: The Edit Carousel Worklist button is grayed out until a Carousel Worklist is
selected.

An Edit Carousel Worklist

3. Use the Edit Specimen Count... button to change the number of specimens in the
worklist:

a) Click Edit Specimen Count....

An Edit Specimen Count

b) In the New Specimen Count text box, type the new number of specimens for the

worklist.

c) Click OK.

PROCLEIX

Volume I: Operating the Instrument Part # 902649EN Rev. A

®

TIGRIS System Operator’s Manual 3-3

window opens.

window opens.

grid.

SECTION 3

If specimens are being deleted, a confirmation dialog box opens. Click OK to
confirm.

The Worklist Details

grid in the Edit Carousel Worklist window updates to display

the new specimen count.

4. Use the Edit Tests... button to change the number of replicates for an individual specimen

in the worklist:

a) 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.

d) Click OK.

5. Click OK to confirm.

6. When all of the changes in the Edit Carousel Worklist

The Worklist Details

grid on the Worklist Manager updates to display the new

window are completed, click Done.

information for the worklist and its samples.

Printing a Worklist

Use the Worklist Manager to print a worklist of tests. Use the printed worklist as a guide for
correct placement of calibrators, PROCLEIX

1. In the Stored Worklists

grid, select the worklist to be printed.

2. At the bottom of the Worklist Detail

A print dialog box opens.

®

TIGRIS Controls, and specimens.

box, click Print Worklist….

®

3. Make any necessary changes to the printer set-up.

4. Click OK.

Deleting a Worklist

Use the Worklist Manager to delete a stored worklist.

Note: A worklist must be de-queued before it can be deleted.

1. In the Stored Worklists

2. Click Delete Worklist.

A confirmation dialog box opens.

3. Click OK.

The system deletes the worklist from the PROCLEIX
removes it from the Stored Worklists

Note: The ID number of the deleted worklist is not used again.

3-4 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

grid, select the worklist to be deleted.

®

TIGRIS System database and

grid.

RUNNING SAMPLES

Queuing and De-Queuing Worklists

To add a worklist to the queue:

Note: If the “Require Operator Logon When Worklist Queued” configuration option is
enabled, the operator is prompted to re-logon to complete the queuing process. This
ensures that the username that is recorded on the Worklist Report accurately reflects the
operator that queued the worklist.

Note: Worklists cannot be queued if an automated maintenance task is queued.

1. From the Stored Worklists
queued.

2. Click Add.

The system adds the worklist to the Queued Worklists
of available tests for both the Lower Bay Inventory and Upper Bay Inventory in
anticipation of the volume of reagent and fluid that will be used for the queued worklist.

To remove a worklist from the queue:

1. On the Queued Worklists

2. Click Remove.

The system de-queues the worklist and moves it to the stored worklists. The inventory
that was reduced in anticipation of the worklist is restored.

grid of the Run Manager screen, select the worklist to be

grid. It also updates the number

grid, select the worklist to be removed.

Loading Sample Racks

Samples can be loaded and run after one or more worklists have been created and queued for
the samples.

Note: Make sure that the samples meet the appropriate sample volume requirements
before loading them into sample racks. See “Sample Requirements” on page 1-25.

Note: Improperly prepared samples may cause errors on the PROCLEIX
Refer to the appropriate PROCLEIX
preparation instructions.

®

Assay package insert for important sample

®

TIGRIS System.

Caution: Processing a sample with less than the minimum sample volume can result in

,

errors (e.g., a Quantity Not Sufficient (QNS) error). The minimum sample volume includes
both the sample pipetting volume and the dead volume. For gel plasma separator tubes,
the minimum sample volume includes the sample pipetting volume and the buffer zone
volume.

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
calibrators, PROCLEIX
racks onto the system.

Caution: Avoid touching the tops of specimens, calibrators, and PROCLEIX® TIGRIS

,

Controls during preparation and loading.

Caution: Use only the sample racks and sample tubes that are designed for use on the

,

PROCLEIX

PROCLEIX

Volume I: Operating the Instrument Part # 902649EN Rev. A

®

TIGRIS System Operator’s Manual 3-5

®

®

TIGRIS Controls, and specimens into sample racks before loading the

TIGRIS System.

SECTION 3

,

,

,

The number of sample tubes loaded must match the number of samples associated with the
worklist. Load sample tubes into clean sample racks on a clean work surface.

Using a printed worklist as a guide (see “Printing a Worklist” on page 3-4), load samples into
the sample racks:

Caution: Always handle specimens, calibrators, and PROCLEIX® TIGRIS Controls
cautiously and keep sample racks upright to prevent splashing or spilling.

Caution: Ensure that all tubes are loaded straight and seated firmly in the sample rack.
Improperly loaded tubes may become unseated and pop out of the rack.

Caution: Do not place External Quality Controls (EQCs) in PROCLEIX® TIGRIS Control
positions.

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.

Caution: Inspect all specimens, calibrators, and PROCLEIX® TIGRIS Controls for

,

undissolved particles, clots, foam, bubbles, or film. Do not attempt to use samples
with undissolved particles, clots, or foam on the system. Clots and foam may result
in false level sensing of liquid. An error message may not be generated. These
conditions could potentially cause an invalid run or a suspect bracket.

2. Load the specimens and user-defined controls (if applicable) in any order between the
calibrators and the PROCLEIX TIGRIS Controls. Make sure that tube barcodes are visible
through the slots in the sample rack.

3-6 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

RUNNING SAMPLES

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.

Rack #

Rack
Position

Sample Tube Replicates Tube Barcode

1 1 Negative Calibrator 3 0425…

1 2 Positive Calibrator 3 0427…

1 3-20 Specimens 1-18 1 TBD

2 1-20 Specimens 19-38 1 TBD

3 1-20 Specimens 39-58 1 TBD

4 1-20 Specimens 59-78 1 TBD

5 1-20 Specimens 79-98 1 TBD

6 1-20 Specimens 99-118 1 TBD

7 1-20 Specimens 119-138 1 TBD

8 1-20 Specimens 139-158 1 TBD

9 1-14 Specimens 159-172 1 TBD

9 15 Negative Control 1 0406...

9 16 Positive Control 1 0410...

9 17-20 Specimens 173-176 1 TBD

10 1-20 Specimens 177-196 1 TBD

11 1-6 Specimens 197-202 1 TBD

11 7 Negative Control 1 0406…

11 8 Positive Control 1 0410…

Table 3.2 Example Tube Placement

Note: This example is for a single analyte assay run. Other assays may have different
calibrators, controls, replicates, and tube barcodes. See the appropriate PROCLEIX Assay
package insert for further instructions.

Figure 3.3 Sample Pipetting Order

PROCLEIX

Volume I: Operating the Instrument Part # 902649EN Rev. A

®

TIGRIS System Operator’s Manual 3-7

SECTION 3

Loading Racks onto the Sample Carousel

Racks can be loaded whenever the Load Racks… button is enabled, indicating an available
spot on the Sample Carousel, including while previous worklists are processing. This method
should be used when replacing completed racks with new racks within a single worklist or when
starting a new set of worklists.

Note: Sample racks cannot be loaded until a worklist has been created for them and
queued.

1. In the Sample Pipetting Status

box of the Run Manager screen, click Load Racks….

The Sample Carousel rotates so that open rack positions are directly behind the
Sample Door. The Sample Door unlocks, and a Load Racks

window opens.

2. Lift open the Sample Door.

3. Load the first rack into the first open position in the Sample Carousel. To minimize spills,
hold the sample rack with one hand at each end of the rack.

Note: The racks that do not contain calibrators or PROCLEIX

®

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.

5. Verify that the rack is firmly seated in the Sample Carousel.

Note: Improperly seated racks may cause a system failure.

6. Check Rack Loaded for each position with a rack loaded.

7. Close the Sample Door.

8. If more than three racks are being loaded, click Next in the Load Racks

window to rotate

the Sample Carousel to the next set of open rack positions. Repeat steps 2–8 as
necessary for the worklist, to a maximum of 9 racks. Additional use of the Load Racks...
function is necessary for worklists that require more than 9 racks.

Note: Do not use the same sample rack more than once per worklist. If the system
detects a duplicate sample rack within a single worklist, it generates an error.

Note: A rack cannot be moved to another location on the Sample Carousel after it
has been scanned.

9. In the Load Racks

window, click Done.

The Sample Barcode Scanner scans in the individual sample barcodes on each sample
rack to complete the sample loading process. When all barcodes have been
successfully read, the sample ring in the Run Manager

screen displays a blue wedge
for each rack. If the Sample Barcode Scanner cannot read a barcode or identifies a
duplicate barcode (only if configured to detect them), the sample ring in the Run
Manager displays a red wedge for each rack with errors. After scanning is complete, the
user is prompted to resolve the error(s).

3-8 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

RUNNING SAMPLES

Resolving Barcode Scanner Errors

Unreadable Barcodes

If the “Fix unreadable barcodes before process” option is enabled in the system configuration,
the PROCLEIX
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.

®

TIGRIS System requires the operator to resolve unreadable barcode errors

When an unreadable barcode error occurs, follow the prompts in the Fix Racks
resolve the error. Use the handheld barcode scanner or the keyboard pad to manually enter an
unreadable barcode.

Note: Clicking Cancel in the Fix Racks
process worklist.

1. From the Fix Racks

resolved.

2. If the source of the error is due to a barcode that is turned away from the barcode scanner,

re-position the tube in the sample rack.

3. If the error is not resolved by repositioning the tube, click on the error message for that

particular tube in the Fix Racks
hand-held barcode scanner to scan the barcode into the Manual Sample ID

For an ISBT 128 barcode, the check character is read by the scanner and does not
need to be typed into the Check Character field. The field remains empty.

4. If the handheld barcode scanner cannot read the barcode, use the workstation keyboard

to enter the barcode.

Caution: Do not include Start/Stop characters (if present) when manually entering

,

a Sample ID—doing so will create a mismatch between the actual Sample ID and
the ID in the printed Report.

window, determine which tubes in the appropriate rack need to be

window dequeues a queued worklist or stops an in-

window. Take the tube out of the sample rack and use the

window to

window.

For a barcode that is not ISBT 128

a) If the check box for ISBT 128 Barcode is selected, clear it.

b) For Sample ID, type the barcode ID.

c) Click OK.

A new Manual Sample ID

d) To complete double entry, type the barcode ID in the Sample ID field again.

e) Click OK.

For an ISBT 128 barcode

a) For Sample ID, type all 16 characters of the barcode including the prefix.

b) For Check Character, type the check character located in the small box to the right

of the barcode

c) Click OK.

Note: Double entry should not be required for ISBT 128 barcodes. However, if
the system is not configured for ISBT 128 barcode use, the Check Character
and ISBT 128 Barcode fields are not available in the Manual Sample ID
window and double entry must be performed. For configuration instructions,
see “Barcode Scanner Configuration” on page 5-7.

:

:

window appears.

PROCLEIX

Volume I: Operating the Instrument Part # 902649EN Rev. A

®

TIGRIS System Operator’s Manual 3-9

SECTION 3

Duplicate Barcodes

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.

5. Repeat steps 1–4 for all unreadable barcodes.

6. After resolving all unreadable barcode errors, click Rescan.

®

Note: Sample barcodes are not tracked between multiple PROCLEIX

®

TIGRIS Systems.

Note: Scans of the same ISBT 128 barcode are not flagged as duplicates if the ISBT 128
Special Characters setting on the Barcode Configuration

screen is different for each scan.

To avoid having to modify the ISBT 128 Special Characters setting, ensure that it is
configured appropriately from the beginning.

Note: If a manually entered (typed) ISBT 128 barcode is not identical to what is stored in
the system from a previous scan of that barcode, they are not flagged as duplicates. When
manually entering a previously scanned ISBT 128 barcode, enter the exact barcode as it is
stored in the system, based on the required barcode configuration settings of the testing
site.

When a duplicate barcode error is identified, follow the prompts in the Fix Racks

window to

resolve the error.

1. From the Fix Racks

window, determine which tube in the appropriate rack is a duplicate.

The error message indicates the barcode number, worklist ID, rack number, test
number, and date and time that the barcode had previously been processed.

Refer to the Quality Control Procedures and Interpretation of Results sections of the
appropriate PROCLEIX

®

Assay package insert for more information about when a

specimen may be retested.

2. To resolve the error, either replace the tube with another one or click on the error message
to allow the test to process.

3. After resolving all duplicate barcode errors, click Rescan.

3-10 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

Processing a Run

Use the Run Manager screen to manage run processing.

RUNNING SAMPLES

Figure 3.4 Run Manager Screen (Example)

To access the Run Manager
screen.

screen, click the Run tab on the right side of the Main Menu

Initiating Processing

If the System is configured to automatically start pipetting (see “Configuring System Settings” on
page 5-4), the system automatically starts pipetting samples as soon as it scans and validates
the sample racks in the worklist.

Note: In order to change the Auto Start Pipetting after Rack Validation setting, the system
must be in Standby mode.

If the System is not configured to automatically start pipetting, click Start Pipetting in the

Sample Pipetting Status

Note: Wait for confirmation of sample pipetting – the on-screen rack turns yellow – before
walking away from the system.

Once pipetting starts, the system requires no further operator action until it runs out of sample
racks or consumables or finishes processing all worklists. To determine the estimated time that
operator action will be required, check the Return Times

box.

box in the Status panel.

PROCLEIX

Volume I: Operating the Instrument Part # 902649EN Rev. A

®

TIGRIS System Operator’s Manual 3-11

SECTION 3

Monitoring Processing

The operator can use two windows to monitor the progress of assay processing.

The Assay Processing Status
estimated completion time for each worklist in the queue.

The Sample Pipetting Status
in the carousel is represented by a color-code and a symbol, signifying the status of the sample
rack.

Color Symbol Status

Gray None Rack not loaded

Blue Rack loaded

Yellow Pipetting in-process

Green Pipetting complete

Red Error or Cancellation

Table 3.3 Rack Status Symbols and Colors

box of the Run Manager screen lists the current status and

box displays an image of the Sample Carousel. Each rack position

Unloading Sample Racks

When a rack turns green in the Sample Pipetting Status window, it has completed pipetting and
can be unloaded. Racks can be unloaded any time the Unload Racks button is enabled.

Note: To save time, processed sample racks may also be unloaded at the same time as
new racks are being loaded using the Load Racks... button (see “Loading Sample Racks”
on page 3-5).

1. To unload completed racks, click Unload Racks in the Sample Pipetting Status

The Sample Carousel rotates so that the completed racks are directly behind the
Sample Door. The Sample Door unlocks, and an Unload Racks

2. Lift open the Sample Door.

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.

4. Close the Sample Door.

5. To unload more than three completed sample racks, click Next and repeat steps 2–5.

6. Click Done.

The Sample Carousel rotates, and the Sample Barcode Scanner scans the rack
positions to verify that the racks have been unloaded.

Note: After unloading racks, store specimens as specified in the appropriate
PROCLEIX Assay package insert.

window opens.

box.

7. Clean sample racks before re-using them. See Volume II, Maintenance.

3-12 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

RUNNING SAMPLES

Further specimen manipulation should be performed according to laboratory SOPs (Standard
Operating Procedures).

Stopping a Run

Use the Assay Processing Status box in the Run Manager screen to stop an in-process worklist
one of two ways:

♦ Stop Current - Click this button to stop sample pipetting in the current worklist highlighted

in the In-Process Worklists
remaining unpipetted samples are marked CAN for Cancel. Any samples that have
already been pipetted continue processing. The system then begins processing the next
worklist scheduled to be pipetted.

♦ Stop All - Click this button to stop all processing for all worklists in the In-Process

Worklists grid and Queued Worklist grid. All the results that were not released at the time

Stop All was clicked are marked NTA and are lost. Any samples that were not pipetted
are marked with both NTA and CAN.

All queued worklists that have not started pipetting are dequeued. Sample racks must be
unloaded.

Note: Clicking Stop All will result with a hardware reset of the analyzer. At this time, the
software will go to 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.

grid. The system stops pipetting that worklist and the

PROCLEIX

Volume I: Operating the Instrument Part # 902649EN Rev. A

®

TIGRIS System Operator’s Manual 3-13

SECTION 3

3-14 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

MANAGING RESULTS

SECTION 4. MANAGING RESULTS

Use the Results screen to view test results. Results can be viewed either after the worklist has
finished or as brackets of in-process worklists are released.

Figure 4.1 Results Screen (Example)

To access the Results

screen, select the Results tab on the right side of the Main Menu screen.

Viewing Results

The Results screen displays two types of worklists:

♦ In-process worklists – Worklists that are currently processing. Results are displayed for

any control brackets that have completed processing. See “Control Bracketing” on
page 3-2 for more information about control brackets.

♦ Completed worklists – Worklists that have completed processing. All results are

available.

To choose which type of worklists to display on the Results
Worklists or Completed Worklists in the upper left corner of the screen.

screen, select In-Process

PROCLEIX® TIGRIS System Operator’s Manual 4-1
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 4

The Worklists grid on the upper right side of the Results screen displays the following
information about each worklist of the selected type:

♦ ID – Worklist ID

♦ Assay – Assay that was run

♦ Specimens – Number of specimens in the worklist

♦ Verified – Whether or not the worklist has been verified

♦ LIS State – Whether or not the worklist results have been saved to a Laboratory

Information System (LIS).

♦ Start Time – The starting date and time that the worklist was run.

The Worklist Details
results for each sample in the worklist selected in the Worklists

grid at the bottom of the screen displays the following information about

grid:

Field Description

Test No. Sample position in the worklist.

RackID-position Sample rack barcode and sample tube position in the rack.

Sample ID Scanned or manually entered sample barcode.

IC RLU Relative Light Units detected during DKA for Internal Control.

IC Interpretation Valid or Invalid result for Internal Control.

Analyte RLU Relative Light Units detected during DKA for the specific analyte detected.

Analyte S/CO The signal to cut off ratio for the specific analyte detected.

Overall
Interpretation

Reactive, NonReactive, Valid, Invalid or Suspect results for the specific
analyte detected.

Status System-generated codes applied to tests.

Rejected Whether or not the test result was rejected by an operator.

Reasons If applicable, operator reasons for rejecting the test result.

Type

Sample type (e.g., calibrator, PROCLEIX TIGRIS Control, specimen, or
user control).

Table 4.1 Worklist Detail Grid

Refer to the “Quality Control Procedures” and “Interpretation of Results” sections in the
appropriate assay package insert for information on results interpretation and the criteria used
to process results.

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.

4-2 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

MANAGING RESULTS

Status Codes

The system automatically assigns status codes to a sample result to signify why it has marked
a test as invalid or to relay other information related to that test. Table 4.2 displays some of the
more common Status codes that might occur. See “Appendix A. Status Codes” for a
comprehensive list of Instrument and Results processing codes.

Code Description Code Description

M Manually entered barcode ID S

ML

MT Magnetic wash tip not picked up VVFS Volume verification failure—Sample

NTI

P Assay processing error

QNS

Magnetic wash station level-sense
failure

Testing incomplete because the
processing run was stopped

Sample quantity not sufficient for
processing

Table 4.2 Common Status Codes

SPA

VVFT Volume verification failure—TCR

x

Sample ID barcode manually
scanned

Sample processing aborted: sample
pipetting failure

Invalid result due to PROCLEIX
TIGRIS Control failure

Searching for Worklists

To find a worklist or worklists that fit specific criteria, search the worklists in the Worklists grid.

1. In the Worklists

A Results Search

2. Choose search criteria as follows:

Note: All of the search fields are optional.

grid, click Search….

window opens.

Note: To clear the secondary sort field, highlight the field and press Delete on the
keyboard.

♦ Run Date – the date range during which the worklists completed processing

♦ Assay – the assay performed on the worklist

♦ Sample ID – the barcode ID of a sample in the worklist

♦ Verification Status – whether the worklist was verified

♦ Transmission Status – whether the worklist results have been saved to a Laboratory

Information System (LIS)

3. Click OK.

The Worklists

4. To return to the full list of completed worklists, click Show All.

grid on the Results screen displays all worklists that fit the search criteria.

PROCLEIX® TIGRIS System Operator’s Manual 4-3
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 4

Assigning Reject Reason Flags

A reject reason flag can be assigned to a specimen after a worklist has completed processing if
an issue with the specimen is discovered. 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
package insert.

®

Assay

Note: Calibrators and PROCLEIX

®

TIGRIS Controls cannot be manually invalidated by the

operator.

To manually invalidate a result:

1. In the Worklists

2. In the Worklist Detail

grid, select the worklist with the specimen to be manually invalidated.

grid, select the specimen.

3. Click Reject Result….

A Reject Result Reason

window opens.

4. From the Reject Reason drop-down list, select the reason for manually invalidating the
test result.

Note: Reject reason flags are used in the event that specimen acceptability was
not properly assessed prior to testing or specimen acceptability limits were not met
during testing.

Flag Description Flag Description

RO Other—specify reason RSH Sample hemolyzed

RSA

Sample* age beyond package
insert limits

RSI Incorrect sample used

RSB Sample icteric RSM Sample mucoid**

RSBE Sample barcode entry incorrect RSS Sample storage error

RSC Sample collection error

* All references to “samples” in this table indicate specimens.

** Not applicable to PROCLEIX

®

Assays.

Table 4.3 Reject Reason Flags

5. If RO – Other is selected, enter the reason for manually invalidating the specimen. Up to
47 characters can be entered.

Note: Only one reject reason flag is allowed per specimen. To assign more than
one reject reason flag, select RO - Other and enter the multiple reasons.

6. Click OK.

The System updates the specimen results in the database; the reject reason flag
appears in both the Worklist Detail

Caution: The interpretation on the run report will not change for a specimen

,

grid and the Results Report.

flagged with a reject reason flag. The Flags column must be carefully reviewed to
identify specimens with reject reason flags.

4-4 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

MANAGING RESULTS

Clearing Reject Reason Flags

A reject reason flag can be removed from a test result as long as the worklist to which the
specimen belongs has not been verified. To clear a reject reason flag:

1. In the Worklists

2. In the Worklist Detail

3. Click Clear Rejection Flag.

The system updates the specimen results in the database; the reject reason flag no
longer appears on the Worklist Detail

4. When the Confirmation

grid, select the worklist with the flag to be cleared.

grid, select the specimen.

grid or the Results Report.

window opens, click OK.

Verifying Worklists

Once a worklist has finished processing, it can be verified. After a worklist has been verified, its
rejection status can no longer be changed. To verify a worklist:

1. Select the worklist from the Completed Worklists

2. Click Verify Worklist.

A dialog box opens, prompting verification of the worklist.

3. Verify the worklist is correct, then click OK.

The system assigns the status “Verified” to the worklist and does not allow future
changes, such as rejecting results or clearing rejection flags.

grid.

Saving Data Files and Logs

With the exception of LIS files, all data files and logs can be saved to the hard drive, CD-RW,
or 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

♦ kinetic data (.csv files)

♦ results reports (.pdf files)

♦ worklists (.pdf files)

♦ database archive

♦ LIS files (.LIS files)

However, before files can be saved, the system must be configured with the appropriate
pathways. See “Configuring System Settings” on page 5-4 for more information on configuring
pathways.

Note: The system must be in Standby or Data Access Only state to save to CD-RW. The
system cannot be in Assay Processing mode.

PROCLEIX® TIGRIS System Operator’s Manual 4-5
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 4

Saving to a USB Flash Memory Drive

Log files, kinetic data, results reports, worklists, and the database archive can be saved to a
USB flash memory drive with the following specifications:

Note: When the system indicates that a write operation has been completed, wait at least
7 minutes before attempting to eject the CD-RW disk. After 7 minutes, check to see if the
LED light on the CD-RW drive is blinking. If the light is blinking, the system is still writing
data to the disk and the operator must wait another 7 minutes before attempting to eject
the CD-RW disk. If the light is not blinking, eject the CD-RW disk.

♦ SuperTalent Flash Inc. SUPERFLASH 512 MB USB 2.0 Flash Memory Drive Model

STF_UT_USB20, or equivalent.

♦ No pre-loaded software (e.g. U3).

♦ 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.

To save data to a USB flash memory drive:

1. Confirm that the system is in Standby mode.

2. Locate a free USB port on the PROCLEIX

®

TIGRIS System workstation.

A port may be located on the front or back of the workstation, and there may be
multiple ports. An example of two ports is shown in Figure 4.2. Do not unplug existing
hardware from a port to accommodate the USB flash memory drive.

Figure 4.2 Example of Two USB Ports

3. Firmly insert the USB flash memory drive into the USB port.

Note: If a “Found New Hardware Wizard” message appears on the screen, remove
the USB flash memory drive from the USB port and contact Novartis Diagnostics
Technical Service for further instructions.

4. From the Configuration

tab on the Configuration screen, confirm that the archive path is

set to the E:\ drive.

5. Save the data (refer to appropriate heading later in this section according to the type of
data being saved).

Note: Do not remove the USB flash memory drive until file saving is complete.
Premature removal may lead to corruption of the memory drive or system
shutdown.

4-6 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

MANAGING RESULTS

6. If the USB flash memory drive will not be used routinely for saving files, change the

archive path back to the original setting after the files have been saved.

If the files are not successfully saved to the USB flash memory drive, check for the following:

♦ The USB flash memory drive is firmly inserted into the correct USB port

♦ There is enough space on the USB flash memory drive to store the files

♦ The system is in Standby mode

♦ The archive path is properly configured

If these conditions are met but the problem persists, contact Novartis Diagnostics Technical
Service for further instructions.

Saving LIS Files

To save LIS files:

1. Select the worklist to be saved from the Completed Worklist

screen.

2. If saving to a CD-RW, insert the appropriately formatted disc into the disc drive.

3. Click Transmit to LIS.

4. Check the status of the transmitted files from the LIS State

grid view to ensure that they are transmitted successfully.

grid view of the Results

box in the Completed Worklist

Saving Kinetic Files

To save kinetic files:

1. Select the worklist to be saved from the Completed Worklist

screen.

2. Click Save Kinetic Data.

The status bar indicates when the kinetic data file has been saved. For example, when
worklist ID 100011 run is saved on March 18, 2004 on instrument serial number 1234,
the status bar will display: Exported Kinetic Data: d:\KIN1234-20040318-112450-

100011.csv.

grid view of the Results

Saving/Printing Results Report

To save the results report:

1. Click View Results Report on the Worklist Detail

2. Click Export.

An Exporting Records

window appears. When exporting is complete, it disappears.

grid to view the Results Reports.

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

Kinetic file: KIN1035-20040121-135234-100013.csv

Result Report: 1035-20040121-135234-100013.pdf

PROCLEIX® TIGRIS System Operator’s Manual 4-7
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 4

Saving Logs

System logs may need to be saved for troubleshooting purposes. To do so:

Note: To access this function, the operator must have “Maintenance-Admin Logs” rights. In
addition, “Allow Send Logs” must be enabled in the system configuration.

1. Do one of the following:

♦ In the Logging tab of the Maintenance

♦ If the system is in the “Error - No Data Access” mode, on the Messages

Send Logs.

A Send Logs

2. Select the date range of interest as specified by Novartis Diagnostics Technical Service.

3. Click Send to save the logs.

A second Send 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

window opens.

window appears and gives the status of the logs being archived.

screen, under All Logs, click Send Logs.

screen click

4-8 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SUPERVISOR PROCEDURES

SECTION 5. SUPERVISOR PROCEDURES

Use the Configuration screen to manage operator accounts, configure system settings, and manage
the database. To access the Configuration

Main Menu

screen.

Managing Operators

Use the Operators tab on the Configuration screen to add, edit, and delete operator accounts.

screen, select the Configuration tab on the right side of the

Figure 5.1 Operators Tab

The Operators
operator account in the

Every operator account has a set of “rights” assigned to it. Rights indicate the tasks that an
operator has permission to perform within the system, such as performing maintenance and
rejecting test results.

An operator must have the Maintenance–Operators right to make any changes to operator
accounts.

PROCLEIX® TIGRIS System Operator’s Manual 5-1
Volume I: Operating the Instrument

grid shows the username, operator name, and status (active or inactive) for each

PROCLEIX

®

TIGRIS System database.

Part # 902649EN Rev. A

SECTION 5

Creating a New Operator Account

To create a new operator account:

1. Click Add… on the Operators

An Add Operator

window opens.

tab.

2. Enter the full name of the operator in the Operator Name field.

3. Enter a username that is six to eight characters long in the Username field. This is the
username that the operator will use to log on to the system.

Note: The username and password are not case-sensitive.

4. Enter a six- to eight- character password for the account in the Password field.

5. Re-enter the password in the Verify Password field.

6. Select the rights to be assigned to this operator account in the Available Rights

box.

All operator accounts are automatically assigned rights that allow them to perform basic
system operation (the “Operator” right). Additional rights to an operator account can be
assigned as described in Table 5.1.

Right Description

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

System database.

Maintenance—General Performing the maintenance activities on the

Logging tab.

®

TIGRIS

Maintenance screen.

Maintenance—Operators Adding, editing, and deleting operator accounts on the

Operators tab.

Maintenance—Results Archiving and purging results from the database.

Maintenance—Setup Setting the time and date, adding new Master Lots, and

unregistering Master Lots from the system.

Maintenance—Software Setup Changing system settings on the

Results Rejection Assigning rejection flags to specimens.

Results Verification Verifying the results of a completed worklist.

Configuration tab.

Table 5.1 Additional Operator Rights

7. Click > to move the selected rights to the Assigned Rights

box.

Note: To assign all available rights to an operator account, click >>. To remove
rights, select the rights and click <.

8. Click OK.

The system creates and activates the account.

5-2 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

Editing an Operator Account

To edit an existing operator account:

SUPERVISOR PROCEDURES

1. Select the operator account on the Operators

2. Click Edit….

An Edit Operator

3. Make changes to the operator name, password, and/or rights as needed.

Note: Usernames cannot be changed.

4. Click OK to save the changes.

5. Changes take effect immediately.

window opens, showing the current properties of the account.

grid.

Viewing an Operator Account

To see the rights assigned to an account without editing the account:

1. Select the account to be viewed on the Operators

2. Click View Rights….

A View Operator Rights
rights assigned to the account.

3. Click OK to exit.

To view a list of all operator accounts and the rights assigned to them, print the Operator Rights
Report (see “Operator Rights Report” on page 6-8).

window opens, which lists the operator name, username, and

grid.

Activating or Inactivating an Operator

All operator accounts have a status of “Active” or “Inactive.” An operator with an active account
can log on to and use PROCLEIX

PROCLEIX TIGRIS System database, but the operator cannot log on until a system administrator

activates the account.

To change the status of an account:

1. Select the account whose status is to be changed on the Operators

2. Click Change Status.

The Active/Inactive status for the operator changes on the grid on the Operators

®

TIGRIS System software. An inactive account exists in the

grid.

tab.

Deleting an Operator Account

To remove an existing operator account:

1. Select the account to be deleted on the Operators

2. Click Delete.

A Delete Operators

3. Click OK to confirm the deletion of the operator account.

The selected operator account is deleted from the Operators

dialog box opens.

grid.

grid.

PROCLEIX® TIGRIS System Operator’s Manual 5-3
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 5

Configuring System Settings

Use the Configuration tab on the Configuration screen to change the options for the system.

Figure 5.2 Configuration Screen (Example)

Use this screen to do the following:

♦ Manage basic system configuration.

♦ Check the PROCLEIX

♦ Define custom control samples.

♦ Define site information.

♦ Define tube barcode configuration.

♦ Set the export location for results and logs.

♦ Set the system’s date and time.

♦ Start and stop LIS Control (transmission).

♦ Monitor the UPS connection status – Green indicates the UPS is connected and Red

indicates the UPS is not connected.

The system must be in Standby mode to access the system settings on the Configuration tab.

Note: An operator must have “Maintenance – Software Setup” rights to configure the
software.

®

TIGRIS System version being used.

5-4 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SUPERVISOR PROCEDURES

Software Configuration

System configuration parameters are grouped together in the Options box on the Configuration
tab.

To enable an option, check the box next to it. The system automatically saves the changes.
Table 5.2 describes available options.

Option Description

Auto Logoff after no
activity for:__ minutes

Require Double Entry of
Sample IDs for Test
Requests

Scanning Barcode
Confirms Sample ID

Fix Unreadable Barcodes
before Processing*

Auto Start Pipetting after
Rack Validation

Display Tip Count Displays the pipette tip count on the

Place Controls every __
Samples

Require Operator Logon
When Worklist Queued

Flag Duplicate Samples Flags sample barcodes that have been run on a

Enable Manually Created
Worklists

Automatically logs off the current operator after the
specified amount of time without activity.

Requires double entry for manual keyboard entry. Enabled

Not applicable to PROCLEIX Assays. Disabled

Allows the operator to fix unreadable barcodes before
processing. Prevents the system from automatically
assigning a Sample ID; all barcodes must be
successfully scanned or manually entered. If this
option is not enabled, the system automatically
assigns a Sample ID in the case of an unreadable
barcode.

The system automatically starts pipetting after racks
have been validated.

Inventory screen. Enabled

Sets the number of specimens between PROCLEIX
TIGRIS Controls when control bracketing is being
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).

Requires the operator to re-enter a user ID and
password to queue a worklist.

previous or in-process worklist.

Not applicable to PROCLEIX Assays. Disabled

®

Required
Setting

No
requirement

Enabled

Enabled

No
requirement

No
requirement

Enabled

*If this option is not enabled, the instrument will not allow “Flag Duplicate Samples” to be enabled.

Table 5.2 Configuration Options

PROCLEIX® TIGRIS System Operator’s Manual 5-5
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 5

Checking the System Version Information

Check version information for the PROCLEIX® TIGRIS System by clicking Version
Information… on the Configuration

tab of the Configuration screen.

The Version Information

♦ Master Controller version

♦ Embedded controller version

♦ Analyzer serial number

♦ Assay protocols installed on the system

screen displays the following information about the system setup:

Creating Custom User-Defined Controls

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

1. Click Define User Controls….

A Define User Controls

2. In the Prefix field, type the barcode prefix for each control.

The barcode can be any kind of Sample ID desired with a prefix of up to 19 characters
long as long as it meets the following criteria:

♦ The prefix must start and end with the letter “C” (the user need not enter the beginning

“C” in the Prefix field).

window opens.

tab on the Configuration screen:

♦ The barcode label on the control tube must begin with the prefix, including a “C” at

both the start and end of the barcode.

♦ The entire barcode cannot be longer than 20 characters.

3. In the Control Name field, enter a descriptive name for each control.

The Control Name should be something meaningful to all PROCLEIX TIGRIS System
operators in the laboratory. The Control Name can be up to 50 characters long; it will be
displayed on Results reports and on the Results

Note: For control names longer than 18 characters, the entire name may not be
displayed on the report. The number of characters depends on the type and size of
the characters.

4. Click OK to save the changes.

The system will now recognize samples with the defined prefixes as user-defined
controls when they are run as part of a worklist.

grid.

5-6 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SUPERVISOR PROCEDURES

Defining Site Information

The site-specific information displayed on all PROCLEIX® TIGRIS System reports is
configurable:

1. On the Configuration

A Site Information

2. Enter up to eight lines of site-specific information to be printed on reports, such as the

laboratory name and address.

Note: Each line of text is limited to 60 characters.

3. Click OK to save the changes.

This information will now appear on all future reports.

tab of the Configuration screen, click Define Site Info….

window opens.

Barcode Scanner Configuration

The PROCLEIX® TIGRIS System supports the following barcode symbologies for sample tube
barcodes:

♦ Code39

♦ Codabar

♦ Code 128

♦ 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. The Hand-held Barcode Scanner is configured using the scanner
itself. The latter step is performed by a Novartis Diagnostics Technical Service representative
upon installation. Any time that an update to the barcode configuration is desired, the
configuration changes must be made for both the Sample Carousel Barcode Scanner and the
Hand-held Barcode Scanner. Otherwise, a configuration mismatch will occur and barcodes may
be interpreted differently using the Sample Carousel Barcode Scanner and Hand-held Barcode
Scanner. Use the instructions below to change the barcode configuration settings.

Caution: Using sample barcodes with check digits is recommended to reduce the risk of

,

barcode misreads.

Configuring the Sample Carousel Barcode Scanner

To configure barcodes:

1. Click Barcode Configuration....

A Barcode Configuration

2. Select configuration options to enable interpretation of the barcode symbologies that are

in use at the testing site. Barcode symbologies that are not enabled are reported as
unreadable during sample rack scanning. Do not enable barcode symbologies that are not
in use at the site.

a)

Codabar

♦ Allow Codabar Barcodes - Enables interpretation of Codabar barcodes.

PROCLEIX® TIGRIS System Operator’s Manual 5-7
Volume I: Operating the Instrument

window opens.

Part # 902649EN Rev. A

SECTION 5

♦ Enable Check Digit - Enables verification of sample barcodes using a Check

Digit character. If this option is not selected, the scanner will assume that a Check
Digit is not present. If a barcode containing a Check Digit is scanned by the
system with this option disabled, the Check Digit will become part of the scanned
Sample ID. It will not be used to verify the scanned barcode.

Note: This option is NOT available on the Handheld Barcode Scanner. If
the Sample Carousel Barcode Scanner cannot read the barcode and
Enable Check Digit is required, the barcode must be manually entered
using the keyboard.

♦ Check Digit Type (NW-7, Modulo 16, or ISO 11-2) - Select the Check Digit type

being used at the testing site.

♦ Transmit Check Digit - Enables the check digit to be transmitted with the

barcode ID; it will be displayed in the Results Report.

♦ Enable Large Intercharacter Gap - Controls the configuration frames. By default

this option is disabled, as it should only be enabled if Novartis Diagnostics
personnel determine that the barcodes being used have a large intercharacter
gap.

b)

ISBT 128

♦ Allow ISBT 128 Barcodes - Enables interpretation of ISBT 128 barcodes.

16-character Code 128 barcodes beginning with “=” (equal sign) or “&”
(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.

♦ Allow ONLY ISBT 128 Barcodes - If enabled, all sample tube barcodes must be

in ISBT 128 format.

Note: Because Master Pool Tube (MPT) barcodes are not in ISBT 128
format, do not enable Allow ONLY ISBT 128 Barcodes if samples will be
tested in pools.

♦ ISBT 128 Special Characters

- one of the following barcode stripping options

may be enabled:

• Do not strip characters from barcodes - Barcodes are reported with all 16

characters including prefix and suffix characters.

• Strip prefix character from barcodes - Barcodes are reported without the

first character, which must be “=” (equal sign) or “&” (ampersand).

• Strip prefix and suffix characters from barcodes - Barcodes are reported

without the first character or the last two characters (i.e., flag or checksum
characters).

Note: The barcode stripping option only applies to ISBT 128 barcodes
even if the system is configured to allow both ISBT 128 and non-ISBT
Code 128 barcodes.

Note: If the two-digit suffix flag characters printed vertically to the right of the
barcode are greater than or equal to 60 and less than or equal to 96, they are
used as the checksum during barcode scanning.

5-8 PROCLEIX® TIGRIS System Operator’s Manual

Part # 902649EN Rev. A Volume I: Operating the Instrument

SUPERVISOR PROCEDURES

c) Code 39

♦ Allow Code 39 Barcodes - Enables interpretation of Code 39 barcodes.

♦ Enable Check Digit - Enables verification of sample barcodes using a Modulo 43

Check Digit character. If this option is not selected, the scanner will assume that a
Check Digit is not present. If a barcode containing a Check Digit is scanned by the
system with this option disabled, the Check Digit will become part of the scanned
Sample ID. It will not be used to verify the scanned barcode.

♦ Transmit Check Digit - Enables the check digit to be transmitted with the

barcode ID; it will be displayed in the Results Report.

♦ Enable Large Intercharacter Gap - Controls the configuration frames. By default

this option is disabled, as it should only be enabled if Novartis Diagnostics
personnel determine that the barcodes being used have a large intercharacter
gap.

d)

Interleaved 2 of 5 (Do NOT enable—this barcode symbology has not been

validated for samples on the PROCLEIX® TIGRIS System.)

e) Code 128

♦ Allow Code 128 - Enables interpretation of non-ISBT Code 128 barcodes.

f) AGC Sampling Mode - Controls the Automatic Gain Control (AGC). Unless

otherwise instructed by Novartis Diagnostics personnel, leave this setting as
Continuous.

g) Good Decode Reads - Specifies the number of identical reads that the scanner

must obtain from a barcode before reporting the sample barcode ID. The number of
reads can be set from 6 to 31, and the default is 6.

Note: It is recommended that the user contact Novartis Diagnostics Technical
Service to obtain further information before changing the Good Decode Reads
value.

Configuring the Hand-held Barcode Scanner

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).

Configuring the Symbol LS4208 Hand-held Barcode Scanner

Refer to the following instructions to configure the Symbol LS4208 hand-held barcode scanner.

Note: Code 128, Code 39 (no check digit), and Interleaved 2 of 5 limited to 14
characters (I 2 of 5) are enabled by factory default.

1. Power on the system and computer workstation with the hand-held barcode scanner

installed.

2. Scan the following barcodes in this order, unless instructed otherwise:

PROCLEIX® TIGRIS System Operator’s Manual 5-9
Volume I: Operating the Instrument

Part # 902649EN Rev. A

SECTION 5

a) Scan “*Restore Defaults.”

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

Part # 902649EN Rev. A Volume I: Operating the Instrument