10 EN MEDUMAT Standard
2
WM 68071 05/2021
2 Safety
2.1.6 Exclusions and restrictions for intended
purpose
The device is not approved for the following applications:
• Operation in hyperbaric chambers
• Operation in combination with magnetic resonance scanners
(MRT, NMR, NMI)
• Ventilation of premature babies (born before the end of
the 36th week of pregnancy)
• Use for long-term ventilation in excess of 24 hours
2.2 Requirements for the user
MEDUMAT Standard
2
must only be used by persons who possess
a medical qualification and have received training in ventilation
techniques.
All operators/users must familiarize themselves with the operation
and use of this medical device as described in the instructions for
use before using the device for the first time.
They should also receive formal instruction on the operation and
use of this medical device.
Always ensure adherence to the statutory requirements for
operation and use of the device (in Germany, the Medical Device
Directive (MPBetreibV) in particular).
2.3 Safety information
2.3.1 How to use the device
Warning Risk of poisoning if the device is used in a toxic atmosphere!
If the device is used in a toxic atmosphere, it can suck in toxic
gases from the ambient air. These toxic gases may reach the lungs
of the patient and poison them.
Do not use the device in a toxic atmosphere.
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