Procleix TIGRIS - SECTION 1. INTRODUCTION AND PRODUCT DESCRIPTION; Description and Intended Use; Warnings and Cautions

INTRODUCTION AND PRODUCT DESCRIPTION
PROCLEIX
®
TIGRIS System Operator’s Manual 1-1
Volume I: Operating the Instrument
Part # 902649EN Rev. A
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
®
Assays from sample processing
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.
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. The warnings in this section apply specifically to 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
SECTION 1. INTRODUCTION AND PRODUCT DESCRIPTION
Biological and Chemical Hazards
Warning: Follow Universal Precautions when working with potentially hazardous materials,
including the following circumstances:
♦ When handling specimens, calibrators, and PROCLEIX
®
TIGRIS Controls. Treat
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.