4
3. 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.
4. Always ensure to remove all packaging material from the Ambu King Mask prior to use as the pouch could
block the patient’s airway and prevent ventilation.
5. Always visually inspect the product after unpacking and prior to use as defects and foreign matter can lead to
no or reduced ventilation of the patient or reduced delivery of anesthetic and/or medical gases.
6. Do not use the product if inspection fails, as this can lead to no or reduced ventilation or reduced delivery of
anesthetic and/or medical gases.
7. Always ensure correct positioning of the 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
or reduced delivery of anesthetic and/or medical gases.
8. Always inspect the proper inflation of the Ambu King Mask cushion before use, as poor sealing might lead to
insufficient ventilation of the patient or reduced delivery of anesthetic and/or medical gases.
9. Always visually inspect the inflation and sealing properties of the face mask cushion while in use on the patient,
as improper sealing might lead to leakage and reduced or no ventilation of the patient or reduced delivery of
anesthetic and/or medical gases.
10. Always ensure correct positioning and sealing of the Ambu King Mask, as improper sealing can lead to
spreading of airborne infectious diseases to the user.
11. Do not apply excessive force on the Ambu King Mask when keeping it in position, as it might lead to pressure
marks on the patient’s face.
12. Do not use the Ambu King Mask for more than 4 accumulated hours over a maximum time span of 1 week,
in order to avoid the risk of infection.
13. Do not reuse the Ambu King Mask if visible residues are left inside the device in order to avoid the risk of
infection or malfunction.
14. When using supplemental oxygen, do not allow smoking or use of 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. 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.
CAUTION
1. Only use compatible connections or adapters, as forcing non-compatible connections or adapters into the
connector of the Ambu King Mask could damage the device, rendering it unusable.
2. Never store the Ambu King Mask in a deformed state, otherwise permanent distortion of the mask could occur,
which may reduce the ventilation efficiency or delivery of anesthetic and/or medical gases.
3. 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.
4. Do not clean the Ambu King Mask any other way than described in this IFU. Other procedures may cause
deformation or damage to the device.
1.9. Potential adverse events
Potential adverse events related to use of face masks (not exhaustive): Pressure marks, 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 King Mask is a non-sterile, non-conductive, single patient multiple use face mask designed to be handled
with either hand. It functions as a means to connect the breathing equipment or anesthetic circuit to the patient’s upper
airway and allows for direction of anesthetic or medical gases to the patient.
