Gazelle GZ100, User Manual, Page: 8 / 124

8
GZL-LBL-0004 r15 Gazelle Diagnostic Device User Manual
Multipack, Gazelle PathoCatch™ COVID -19 Test FIA Kit, Malaria Test Multipack, and Malaria Controls Test Kit contain
instructions for running each test.
This Gazelle™ Diagnostic Device User Manua l can also be downloaded from the customer resources page at:
http://www.hemexhealth.com/crc (Password=GZLC).
1.2 Intended Use
The Gazelle ™ Reader is an in vitro diagnostic device intended for the qualitative or quantitative detection of components
indicative of infectious disease, metabolic, or physiologic conditions. It uses miniaturized electrophoresis, fluorescent and
visual lateral flow, and magneto-optical detection methods, depending on the test cartridge used. The device is intended for
professional use in a healthcare point-of-care or laboratory setting.
1.3 Device Description
The Gazelle Reader is a small, table-top device that reads test results from proprietary, single-use test kits cartridges that
use one of 3 technologies : miniaturized electrophoresis, fluorescent or visual lateral flow, and magneto-optical detection.
For some tests, the Reader provides a quantitative test result, while other test results are qualitative.
The Reader can be used in challenging environments that may be warm (operating temperature range 5°C to 45°C) or high in
humidity (operating relative humidity range 5% to 95%) and operates on a built-in lithium-ion battery. The Reader can be
charged using the standard micro-USB wall adapter provided.
The Reader has internal data storage to keep a record of test results. From the Reader, Users can print test results to a Wi-Fi
connected printer or to a printer connected to a Wi-Fi accessible computer.
The Gazelle Reader allows remote software updates to ensure operation with the latest testing algorithms. Administrators
are automatically notified about software updates when the Reader is connected to the internet via Wi-Fi and can choose to
upgrade the software if desired.