1 Introduction
1.1.1 Exclusions and limitations of the intended
1.2 Owner/operator and user
8
EN
MEDUVENT Standard
purpose
The device has not been approved for the following applications:
•
Operation in hyperbaric chambers
•
Operation in conjunction with magnetic resonance imaging
machines
•
Use in sustained ventilation for longer than 24 hours
qualification
The device must only be used by persons with medical training
who have received instruction in ventilation technique.
As the operator or user, you must familiarize yourself with the
method of operation and use of this medical device by reference
to the instructions for use before using it for the first time.
You should also get yourself trained in the operation and use of
this medical device. Follow the statutory requirements for
operation and use (in Germany, particularly the Medizinprodukte-
Betreiberverordnung [German regulation concerning the operators
of medical devices]).