Ambu Disposable Face Mask, Instructions For Use Manual

Page: 5 / 100

en
5
4. Always visually inspect the product after unpacking, assembly and prior to use as defects and foreign
matter can lead to no or reduced ventilation of the patient.
5. Do not use the product if inspection fails, as this can lead to no or reduced ventilation.
6. Do not use the product if contaminated by external sources, as this can cause infection.
7. Always inspect the proper inflation of the Ambu Disposable Face Mask cushion before use, as poor
sealing might lead to insufficient ventilation of the patient.
8. Always ensure correct positioning and sealing of the Ambu Disposable Face Mask, as improper
sealing can lead to spreading of airborne infectious disease to the user.
9. Do not use the Ambu Disposable Face Mask for more than 4 accumulated hours over a maximum
time span of 1 week, in order to avoid the risk of infection.
10. Do not reuse the Ambu Disposable Face Mask if visible residues are left inside the device in order to
avoid the risk of infection or malfunction.
11. Always ensure correct positioning of the Ambu Disposable Face Mask on the patient by performing,
with either hand, an appropriate jaw thrust through relevant hand grip strategy, or by head straps
connected to the hook rings. Reposition if applicable, as improper sealing of the face mask could lead
to insufficient ventilation of the patient.
12. Do not apply excessive force on the face mask when keeping it in position, as it might lead to
pressure marks on the patient’s face.
13. Always visually inspect the inflation and sealing properties of the disposable face mask cushion
while in use on the patient, as improper sealing might lead to leakage and reduced or no ventilation
of the patient.
14. When using supplemental oxygen, do not allow smoking or use the device near an open flame, oil,
grease, other flammable chemicals or equipment and tools, which cause sparks, due to the risk of fire
and/or explosion.
15. Professionals performing the procedure should assess the choice of face mask size and compatible
devices (e.g. resuscitator, etc.) in accordance with the patient’s specific condition(s), as incorrect use
may harm the patient.
16. Do not use the product when ventilating patients with severe facial trauma and/or eye injury due
to the risk of improper sealing and aggravation of injury unless a medical assessment indicates the
necessity. Switch to an alternative method for directing air to the patient, if available.
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.
1.9. 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.
1.10. 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.