6
13. Do not use the product in patients suffering from conditions such as cardiogenic
shock, myocardial infarction, left heart failure, hypovolaermia or a combination
of these conditions resulting in haemodynamic instability unless a medical
assessment indicates the necessity, as high PEEP can lead to reduced cardiac
output and systemic perfusion.
14. Do not use a product with decreased performance unless a medical assessment
indicates the necessity as decreased performance can lead to hypoxia.
15. Do not use the product in patients with unilateral (one-sided) lung disease,
bronchopleural fistulae or similar conditions unless a medical assessment
indicates the necessity, as this can lead to hyperinflation of the lung tissue
reducing healing of injured site.
16. When using supplemental oxygen, do not allow smoking or use of device near
open flame, oil, grease, other flammable chemicals or equipment and tools,
which cause sparks, due to the risk of fire and/or explosion.
CAUTIONS
1. Please see packaging for more specific information about the expiration date, as
the use of an expired device might lead to decreased performance or malfunction
of the product.
2. Always keep components from same device together during reprocessing to
avoid reassembly of components with different durability leading to the risk of
product failure.
3. Be careful not to unscrew the adjustment cap as it can detach. If this happens the
cap can be reattached again.
4. U.S. federal law restricts this device to sale by or on the order of a licensed health
care practitioner.
1.8. Potential Adverse events
Potential adverse events related to the use of the Ambu Reusable PEEP 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.
