Ambu PEEP 20, Instructions For Use Manual

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1.8. Potential adverse events
Potential adverse events related to the use
of the Ambu Disposable PEEP 20 Valve
(not exhaustive): Hypoxia, barotrauma including
pneumothorax, volutrauma, reduced cardiac
output and systemic perfusion.
1.9. General notes
If, during the use of this device or as a result
of its use, a serious incident has occurred,
please report it to the manufacturer and to
your national authority.
2.0. Device description
The Ambu Disposable PEEP 20 Valve is a
positive end-expiratory pressure valve with
an Ø 30 mm connector and is compatible
with breathing equipment conforming
with EN ISO 5356-1. The Ambu Disposable
PEEP 20 Valve is for single patient use. The
product can be supplied with an adaptor
for Ø 22 mm connectors.
3.0. Explanation of symbols used
Symbol
indication
Description
MR Conditional
CN
Country of manufacturer
Medical Device
Single Patient Multiple Use
Rx Only
US federal law restricts this device
to sale by or on the order of a
licensed health care practitioner
A full list of symbol explanations can be found
on ambu.com/symbol-explanation.
4. Product use
4.1. Operating the PEEP valve
Operating instruction
1. Inspect the Ambu Disposable PEEP 20 Valve
to make sure it is free of obstructions.
2. Firmly attach the inlet connector of the
Ambu Disposable PEEP 20 Valve to the
resuscitator, portable ventilator,