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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.
1.2. Indications for use
The Ambu Disposable Face Mask is used for respiratory care and support.
1.3. 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
1.4. Intended user
The Ambu Disposable Face Mask is for use by medical professionals, rescue- and emergency personnel
trained in airway management.
1.5. Intended use environment
The Ambu Disposable Face Mask is intended to be used in pre-hospital (EMS) and hospital environments
including MR system rooms.
1.6. Contra indications
None known.
1.7. Clinical benefits
The Ambu Disposable Face Mask will allow for passage of air to the patient and visualization through the dome.
1.8. Warnings and cautions
Failure to observe these precautions may result in inefficient ventilation of the patient, cross-infection or
damage to the equipment.
WARNINGS
1. For single patient multiple use only. Use on other patients can cause cross infection.
2. Only to be used by intended users who are familiar with the content of this manual, as incorrect use
may harm the patient.
3. Always ensure to remove all packaging material from the Ambu Disposable Face Mask prior to use as
the pouch could block the patient’s airways and prevent ventilation.
Summary of Contents for Disposable Face Mask
Page 1: ...Ambu Disposable Face Mask INSTRUCTIONS FOR USE...
Page 8: ...8 1 2 3 Ambu 4 5 6 7 Ambu 8 Ambu 9 Ambu 4 1 10 Ambu 11 Ambu 12 13 14 15 16...
Page 22: ...22 1 2 3 M Ambu 4 5 6 7 M Ambu 8 M Ambu 9 M Ambu 4 1 10 M Ambu 11 M Ambu 12 13 14 15 16...
Page 50: ...50 1 1 1 CPR 1 2 1 3 6 1 4 1 5 EMS MR 1 6 1 7 1 8 1 2 3...
Page 51: ...51 ja 4 PEEP 5 6 7 8 9 1 4 10 11 12 13 14 15 16 1 2 3 4 5 1 9 1 10 2...
Page 80: ...80 1 2 3 Ambu 4 5 6 7 Ambu 8 Ambu 9 Ambu 4 1 10 Ambu 11 Ambu 12 13 14 15 16...
