8 EN MEDUVENT Standard
WM 67851 01/2021
2 Safety
2.1.1 Intended areas of application
• Mobile use in emergency medicine or primary care at the site
of the emergency, e.g. for resuscitation or to initiate and
execute anesthesia (including TIVA: total intravenous
anesthesia)
• During transport between hospital rooms and departments
• During transport between the hospital and other premises by
ambulance, aircraft, helicopter or ship
• In hospital in the shock room or recovery room
2.1.2 Possible side effects and complications
• Undesired effect on the cardiovascular system (e.g. reduced
cardiac output, reduced venous return)
• Drying of the airways
• Hyperinflation of lung tissue (e.g. lung rupture)
• Gastric insufflation during mask ventilation (e.g. aspiration of
stomach contents)
2.1.3 Exclusions and limitations of the intended use
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
2.2 Clinical benefit of the product
The medical benefit of ventilation therapy is the sustained
oxygenation and ventilation (CO
2
evacuation) of the lungs in the
event that spontaneous breathing fails. A mechanical ventilator
also offers the following benefits relative to a bag-valve mask:
• More constant tidal volume and lower peak pressures
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