Ambu Disposable Face Mask Mode D'emploi page 3

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1. Important information – Read before use

Read these safety instructions carefully before using the Ambu® Disposable Face Mask.

The instructions for use may be updated without further notice. Copies of the current version are

available upon request. Please be aware that these instructions do not explain or discuss clinical

procedures. They describe only the basic operation and precautions related to the operation of

the Ambu Disposable Face Mask.

Before initial use of the Ambu Disposable Face Mask, it is essential for operators to have received

sufficient training in using the product and to be familiar with the intended use, warnings,

cautions, and indications mentioned in these instructions.

There is no warranty on the Ambu Disposable Face Mask.

1.1. Intended use

The Ambu Disposable Face Mask is a disposable face mask intended for oxygenating and

ventilating the airways.

The device is for use in hospital and pre-hospital (EMS) environments.

For use by CPR trained personnel only.

1.1.1. Intended patient population

The Ambu Disposable Face Mask product is intended to be used on patients of all ages and

comes in 6 sizes to ensure that the inner shape of the dome is spacious enough for the mouth

and nose.

• Ambu Disposable Face Mask, Large Adult

• Ambu Disposable Face Mask, Medium Adult

• Ambu Disposable Face Mask, Small Adult

• Ambu Disposable Face Mask, Toddler

• Ambu Disposable Face Mask, Infant

• Ambu Disposable Face Mask, Neonate

1.1.2. Intended use environment

The Ambu Disposable Face Mask is intended to be used in pre-hospital (EMS) and hospital

environments including MR system rooms.

1.2. Indications for use

The Ambu Disposable Face Mask is used for respiratory care and support.

1.3. Intended user

The Ambu Disposable Face Mask is for use by medical professionals, rescue- and emergency

personnel trained in airway management.

1.4. Contraindications

None known.

1.5. Clinical benefits

The Ambu Disposable Face Mask will allow for passage of air to the patient and visualization

through the dome.