Ambu 492413031 King Mask Instruction Manual

June 12, 2024
Ambu

Ambu 492413031 King Mask

Ambu-492413031-King-Mask-product

Product Information

The Ambu King Masks are designed to direct anesthesia or medical gases into the patient’s upper airway without inserting any equipment into the trachea. These masks are intended for use in both hospital and pre-hospital environments.

It is important to note that the Ambu King Masks should only be used by CPR- trained personnel. The masks are disposable and are not made with natural rubber latex, making them suitable for individuals with latex allergies. Additionally, they are non-sterile, non-conductive, and equipped with a check valve for optimal functionality.

The Ambu King Masks are MR Safe, meaning they are safe to use in magnetic resonance environments.

Product Usage Instructions

  1. Ensure that you are CPR trained before using the Ambu King Masks.
  2. Before use, inspect the mask for any visible damage or defects. Do not use a mask that appears to be damaged.
  3. Place the mask over the patient’s nose and mouth, ensuring a secure fit.
  4. Connect the mask to the anesthesia or medical gas source using the appropriate connectors.
  5. Administer anesthesia or medical gases according to the prescribed guidelines and procedures.
  6. Monitor the patient’s response and adjust the flow of gases if necessary.
  7. After use, dispose of the mask appropriately as it is intended for single-patient use only.
  8. Follow your facility’s guidelines for waste disposal and ensure proper handling of the used mask.

Note:
The Ambu King Masks are not intended for use in the trachea. If tracheal intubation is required, please consult the appropriate equipment and instructions for that procedure.

Intended use

Ambu King Masks are intended to direct anesthesia or medical gases into the patient’s upper airway without introducing any apparatus into the trachea.

  • The device is for use in hospital and pre-hospital environments.
  • For use by CPR-trained personnel only.
  • Disposable Anesthesia Face Mask.
  • Non-sterile, Non-conductive, with check valve.
  • Single Patient Use Face Mask.
  • Not made with natural rubber latex.
  • Phthalate free.
  • This product is MR Safe.

Instructions for use

  • Remove the mask from the package and inspect the device. In case of damage, dirt or deformation discard the mask and have a replacement mask available.
  • Check the cushion’s inflation for appropriate fit and seal to the patient’s face.
  • The mask collar, if present, may be removed if not needed.
  • To adjust cushion inflation, insert a standard luer tip syringe into the inflation valve. Inflate or deflate as needed.
  • If deemed necessary, the surface of the product can be manually cleaned with water and a mild detergent. Rinse thoroughly with clean water. Allow to dry, and check that the mask is fully operational before re-use on the same patient. If not fully operational, the mask shall be discarded.
  • Discard after single patient use according to hospital protocol.

WARNINGS

  • Avoid contact with sharp objects which could damage the cuff.
  • For single-patient use only.
  • Use on other patients can cause cross-infection.
  • The design and material of the device are not compatible with automatic cleaning or sterilization processes, as it may leave harmful residues or cause malfunction of the device.
  • Scented masks are contraindicated for patients with known allergies to perfumes and plastics.

CAUTIONS

  • Over-inflation or excessive pressure to hold the mask in place may restrict or close the patient’s airway.
  • Under-inflation may result in poor seal and leakage.
  • The mask is designed to connect to a standard fitting. The inside diameter of the mask port of #1-2 is non-standard and must not be attached to another medical device. The outside diameter of the mask port of #3-7 is non-standard and must not be attached to another medical device.
  • US federal law restricts this device to sale by or on the order of a licensed health care practitioner.
Symbol indications Description
MR Safe

Specification

  • Storage temperature range: -40 °C – +60 °C
  • Operation temperature range: -18 °C – +50 °C

Connector size:

  • Ambu King Mask sizes: #1 – #2, 15 mm OD connector
  • Ambu King Mask sizes: #3 – #7, 22 mm ID connector

Ambu® is a registered trademark of Ambu A/S, Denmark Ambu A/S is certified according to ISO 13485.

Ambu A/S
Baltorpbakken 13 2750 Ballerup Denmark
T +45 72 25 20 00
ambu.com.

References

Read User Manual Online (PDF format)

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