Ambu Disposable Face Mask Mode D'emploi page 5

CAUTIONS
1. Never store the Ambu Disposable Face Mask in a deformed state, otherwise permanent
distortion of the mask could occur, which may reduce the ventilation efficiency.
2. 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.
3. Do not clean the Ambu Disposable Face Mask any other way than described in this IFU.
Other procedures may cause deformation or damage to the device.
4. Only use compatible connections or adapters, as forcing non-compatible connections or
adapters into the connector of the Ambu Disposable Face Mask could damage the device,
rendering it unusable.
5. US Federal law restricts this device to sale by or on the order of a licensed health care
practitioner.
1.7. Potential adverse events
Potential adverse events related to use of face masks (not exhaustive): Pressure wounds, hypoxia
and aggravation of already existing facial and eye injuries.
1.8. 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. Device description
The Ambu Disposable Face Mask is a non-sterile, non-conductive, single patient multiple use
face mask, designed for use with manual and automatic resuscitators and ventilators. The Ambu
Disposable Face Mask is available with or without a check valve and with or without a hook ring.
3. Use of Ambu Disposable Face Mask
3.1. Preparation and inspection of Disposable Face Mask
1. Remove the Ambu Disposable Face Mask from its packaging and inspect for proper inflation
of the cushion.
2. Inspect the cushion for any damage or leakage.
3. Remove and discard the four-prong hook ring if not required.
4. If needed, use a syringe to inflate/remove air to achieve the desired cushion pressure (mask
with check valve only).
3.2. Operating the Disposable Face Mask
1. Apply the mask firmly to the patient's face to achieve a tight seal.
2. Hold the mask tight against the face while securing an open airway through a jaw thrust.
3. If deemed necessary, the surface of the product can be manually cleaned for same patient use
with water and a mild detergent. Rinse thoroughly with clean water. Allow to dry, and check
that the Ambu Disposable Face mask is fully operational before reuse on the same patient. If
not fully operational, the Ambu Disposable Face Mask shall be discarded.
3.3. After use
Used products must be disposed of according to local procedures.
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