Gazelle GZ100, User Manual, Page: 7 / 124

7
GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual
1 Introduction
Your Gazelle Reader is enabled with one or more of the following test capabilities:
•
Hb Variant
• COVID-19
•
Malaria
The enabled tests will be shown on the HOME page.
The Gazelle Test System is comprised of the following components:
•
Gazelle Reader, and
•
Gazelle Malaria test or
•
Gazelle Hb Variant test, or
• COVID-19 test
The Gazelle Reader is a small, table-top, in vitro diagnostic instrument that works with Gazelle proprietary, single-use
disposable cartridges to perform a test. The Reader uses magnetic field technology in conjunction with a photodetector to
perform and read results from the Gazelle Malaria test; cellulose acetate electrophoresis technology to perform and read
results from the Gazelle Hb Variant test; or fluorescence detection to perform and read results from the Gazelle COVID-19
test.
See the applicable Cartridge Package Insert for the Intended Use for the test.
1.1 About this User Manual
This Gazelle™ Diagnostic Device User Manual is intended to be a comprehensive source of information for setup, settings, error
messages, maintenance tips and troubleshooting tips. The Reader also comes with a Gazelle™ Setup Guide sheet for
instructions on setting up the Reader upon unboxing. The instructions for use inserts included with the Hb Variant Test