amplex GENIE II - Introduction to Genie II Mk2; Intended Use of the Device; Safety Notices and Precautions

GENIE
®
II Mk2/ eazyReport
TM
software
4
Chapter 1: INTRODUCTION
INTENDED USE
The intended use of the Genie
®
II Mk2 device (with eazyReport™ software) is to perform
isothermal amplification with real-time detection of target nucleic acid. The Genie
®
II
Mk2 device (with eazyReport™ software) is designed for in vitro diagnostic use in
combination with eazyplex
®
kits manufactured by AmplexDiagnostics GmbH. Up to two
eazyplex
®
tests can be performed in parallel.
Additional information concerning the test procedure can be found in the IFU of the
respective eazyplex test.
Only qualified laboratory personnel trained by AmplexDiagnostics GmbH or one of its
distributors should operate this device.
SAFETY NOTICES
Please read the following notices carefully before using the Genie
®
II Mk2 device.
The equipment supplied has been designed to be completely safe to use. However to avoid
any risk to the safety of the equipment, operator, or anybody in the vicinity of the equipment,
please read this chapter carefully before unpacking and using the device. The advice given
in this manual is intended to supplement, not supersede, the normal safety requirements
prevailing in the user’s country. If there is any doubt as to the correct use of the equipment,
contact your local supplier.
Notices
Using the device in a manner not specified by Amplex may result in personal injury or
damage to the device.
Always ensure that the surface on which the device is placed is level and stable and
will not cause the device to topple over. Ensure that the surface is suitable for the
weight and size of the device. If the device is dropped it may be damaged.
The device should never be lifted by its covers. Always ensure that the base or sides
are used as the lifting point.
The device is electrically powered. Please ensure that the correct voltage settings have
been applied before applying power to the device. If in doubt consult a qualified electrician.
The device has a rating label affixed to the rear. Please consult this if needed.
Never try to open the case of the device or to interfere with objects in the device!