Ambu Disposable Face Mask, Instructions For Use Manual

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3. Explanation of symbols used
Symbol indication Description Symbol indication Description
CN
Country of Manufacturer Single Patient Multiple Use
Medical Device MR Safe
Rx only
Prescription use only
A full list of symbol explanations can be found on ambu.com/symbol-explanation.
4. Product use
4.1. Inspection and preparation
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).
4.2. Operation
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.
4.3. After use
Used products must be disposed of according to local procedures.
5. Technical product specifications
5.1. Specifications
Ambu Disposable Face Mask sizes Neonate, Infant, Toddler, Small/Medium/Large Adult.
Connector size
15 mm OD connector for Neonate and Infant according to
ISO 5356-1.
22 mm ID connector for Toddler, Small/Medium/Large Adult
according to ISO 5356-1.
Check valve Compatible with Luer slip syringe (Mask with check valve only).
Operation temperature limits
-20 °C to +50 °C (-4 °F to +122 °F) according to EN 1789
and ISO 10651-4.
Storage temperature limits
-40 °C to +70 °C (-40 °F to +158 °F) according to EN 1789
and ISO 10651-4.
Recommended long term storage in closed packaging at room temperature, away from sunlight.
5.2. MRI Safety information
The Ambu Disposable Face Mask is MR Safe.