WM 68071 05/2021
MEDUMAT Standard
2
EN 9
2 Safety
2.1.3 Intended application areas
• Primary care at the site of the emergency, e.g., to resuscitate
or induce and maintain anesthesia
• Transport between hospital rooms and departments
• Transport between the hospital and other sites in an
ambulance, ship, airplane or helicopter
• Intra-hospital in the trauma or recovery room
2.1.4 Contraindications
None currently known.
2.1.5 Possible side effects and complications
• Undesirable effects on the cardiovascular system
(e.g., reduction of cardiac output, reduction of venous
return flow)
• Dehydration of the respiratory tract (e.g., mucositis,
sicca syndrome)
• Overinflation of the lung tissue (e.g., lung rupture)
• Gastric insufflation during mask ventilation
(e.g., aspiration of stomach contents)
Risk of injury from misuse due to disregarding the
information in the instructions for use!
Only use the device as defined by the intended purpose
(see "2.1 Intended purpose", page 8).
Note the exclusions and restrictions for intended purpose
(see "2.1.6 Exclusions and restrictions for intended purpose",
page 10).
Observe the safety information in the instructions for use.
Observe all the chapters in the instructions for use.
Intended use includes compliance with all the specifications in
these instructions for use. Any usage which goes beyond or which
is in contradiction to the intended use shall be regarded as misuse.
Failure to observe the information in the instructions for use can
result in incorrect operation of the device and may result in serious
injury or death for the patient, user or bystanders.
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