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Procleix TIGRIS User Manual

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

Table of Contents

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Procleix TIGRIS Specifications

General IconGeneral
Assay TechnologyTranscription-Mediated Amplification (TMA)
Dimensions213 cm (H) x 183 cm (W) x 86 cm (D)
Sample TypesSerum, plasma
TargetsHIV-1, HCV, HBV
Detection MethodChemiluminescence
WeightApproximately 1200 lbs
Throughput per dayUp to 1000 samples
ThroughputUp to 1000 tests in 24 hours

Summary

SECTION 1. INTRODUCTION AND PRODUCT DESCRIPTION

Description and Intended Use

Details the PROCLEIX TIGRIS System's purpose and intended use.

Warnings and Cautions

Lists critical safety warnings and cautions for operating the system.

Installation Notices

Provides essential notices and warnings regarding the installation process.

Operational Notices

Outlines important cautions and recommendations for system operation.

Notices Regarding Samples

Specifies cautions and guidelines for handling and processing samples.

Reagent Notices

Details important notices and cautions for handling and using reagents.

Maintenance Notices

Provides cautions and guidelines related to system maintenance procedures.

Data Management Notices

Outlines cautions and recommendations for managing system data.

Consumables Notices

Lists cautions and recommendations for using system consumables.

Limitations

Describes known limitations of the PROCLEIX TIGRIS System's functionality.

Overview of the PROCLEIX® TIGRIS System

Describes the system's main components and bays.

Overview of the PROCLEIX® Assays on the PROCLEIX® TIGRIS System

Explains the four assay technologies used by the system.

Specifications

Details physical, environmental, and performance specifications of the system.

SECTION 2. SETTING UP THE INSTRUMENT

Preparing the Workspace

Instructions for preparing a clean work surface before operation.

Starting the System

Step-by-step guide for starting the analyzer and software.

Monitoring System Status

Explains how to monitor system status using panels and status bar.

Managing Inventories

Procedures for managing reagents, fluids, consumables, and waste.

Preparing the Lower Bay

Tasks involved in managing the Lower Bay inventory, including fluids and waste.

Loading Assay Reagents

Instructions for loading assay reagents onto the system.

Loading ARs

Detailed steps for loading Assay Reagents (ARs) into the carousel.

Changing the Reagent Quadrant

How to select or change the reagent quadrant for a worklist.

SECTION 3. RUNNING SAMPLES

Using A Worklist

Introduction to worklist management for processing runs.

Control Bracketing

Explains the process of using controls to bracket worklist results.

Creating a Worklist

Step-by-step guide for creating a carousel worklist.

Editing a Worklist

Instructions on how to modify an existing worklist.

Printing a Worklist

Procedure for printing a worklist for reference.

Deleting a Worklist

How to remove a stored worklist from the system.

Queuing and De-Queuing Worklists

Steps for adding and removing worklists from the processing queue.

Loading Sample Racks

Guidance on loading sample racks onto the carousel.

Resolving Barcode Scanner Errors

Procedures for resolving unreadable and duplicate barcodes.

Processing a Run

Overview of managing the run processing.

Monitoring Processing

How to monitor the progress of assay processing.

Unloading Sample Racks

Instructions for unloading completed sample racks.

Stopping a Run

Methods for stopping current or all assay processing.

SECTION 4. MANAGING RESULTS

Viewing Results

How to access and view test results on the system.

Status Codes

Explains system-assigned codes for sample results and errors.

Searching for Worklists

How to search for worklists based on specific criteria.

Assigning Reject Reason Flags

Procedure for manually invalidating results with reason flags.

Clearing Reject Reason Flags

Steps to remove reject reason flags from results.

Verifying Worklists

Process for verifying that a worklist's results are correct.

Saving Data Files and Logs

Instructions for saving various system data files and logs.

Saving Logs

Detailed steps for saving system logs for troubleshooting.

SECTION 5. SUPERVISOR PROCEDURES

Managing Operators

Overview of managing operator accounts and rights.

Creating a New Operator Account

Step-by-step guide for creating new operator accounts.

Editing an Operator Account

Instructions for modifying existing operator account details.

Viewing an Operator Account

How to view assigned rights for an operator account.

Activating or Inactivating an Operator

Procedure for changing operator account status (Active/Inactive).

Deleting an Operator Account

Steps to remove an operator account from the system.

Configuring System Settings

How to manage and configure system settings and options.

Configuring the LIS

Steps to configure the Laboratory Information System interface.

Configuring the Archive Parameters

How to set up parameters for archiving system data.

Setting the Date and Time

Procedure for setting the system's date and time.

SECTION 6. WORKING WITH REPORTS

Searching Reports

How to search for specific content within reports.

Printing Reports

Instructions on how to print system reports.

Exporting Reports

Process for saving reports electronically to various media.

Assay Reagent Status Report

Details on generating and understanding the AR status report.

Control Report

How to generate and interpret the PROCLEIX TIGRIS Control report.

Sample Results Report

Instructions for generating and understanding sample results.

Master Lot Report

How to view lot information for Assay Reagents.

Operator Rights Report

Information on generating and viewing operator rights.

Results Report

How to generate comprehensive reports for worklists and results.

System Performance Report

Details on generating a report about instrument run time.

SECTION 7. SHUTTING DOWN

Logging Off

Procedures for logging out of the system software.

Unloading ARs

Steps for unloading Assay Reagents before shutdown.

Emptying Waste Containers

How to empty waste containers before system shutdown.

Shutting Down

Instructions for safely shutting down the system and workstation.

APPENDIX A. STATUS CODES

Instrument Processing Errors

Lists and explains error codes related to instrument processing.

Results Processing Errors

Lists and explains error codes related to results processing.

APPENDIX B. SUPPORT CONTACT INFORMATION