STANDARDS AND GENERAL WARNINGS
8
Note
: All relevant data referring to these products can be found on the data label visible on the
rear part of the cabinet. Here is an example of the label:
1.1 TESTING AND INTENDED USE
This equipment is tested in compliance with established regulations and then shipped ready for
use.
•
This product is intended for use:
•
As a rapid freezer in research use.
•
As a medical device for freezing samples for diagnostic use (storage of samples not
intended to be re-introduced to the human body).
•
As a medical device for freezing blood components for storage and eventual re-introduction
to the human body.
This Product is not intended for long-term storage.
Registration: This medical application is considered a Class II medical device by the FDA.
“If the equipment is used in a manner not specified by the manufacturer, the protection
provided by the equipment may be impaired.”
1.2 INTRODUCTION
This manual provides all instructions required for the correct use of the equipment and to keep it
in optimal condition. It also contains important user safety information. The following professional
roles are explained in order to define individual responsibilities:
Installer
: a qualified technician who installs the equipment in accordance with these instructions.
User
: the person who, after having read this manual carefully, uses the equipment in
accordance
with the intended specification of use described in this manual. User’s
