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1. Intended use
The Ambu AuraGain is intended for use as an alternative to a face mask for achieving and
maintaining control of the airway during routine and emergency anaesthetic procedures.
Intended users: "Professionals trained in airway management”.
Have a spare AuraGain ready and prepared for immediate use.
Contents sterile unless packaging is damaged or opened.
WARNINGS
The user should be familiar with the following warnings prior to use of the Ambu AuraGain.
• Do not use the AuraGain before Pre check: Visual inspection, air leak test of the device and
compatibility with ET tubes and gastric tubes. Failure of any test indicates that the device
should not be used.
• All Ambu AuraGain masks must, prior to use, be investigated and inspected for any
potential foreign body. The cuff-protector only serves as protecting the AuraGain
during storage and transportation and must be removed prior to use.
• Do not use the Ambu AuraGain if there are any bulges on the cuff or if there are any
signs of leakage.
• To avoid trauma, do not use excessive force.
• The Ambu AuraGain is flammable in the presence of lasers and electrocautery equipment.
• For single use only. Use on other patients can cause cross infection. Do not soak, rinse,
or sterilize this device as these procedures may leave harmful residues or cause
malfunction of the device. The design and material used are not compatible with
conventional cleaning and sterilization procedures.
• The presence of a gastric channel does not rule out the possibility of aspiration even if
the device is correctly located and fixed in place.
• Do not attempt to pass a gastric tube into the stomach via the gastric channel in the
presence of known suspected oesophageal pathology.
• The cuff volume or pressure may change in the presence of nitrous oxide, oxygen,
or other medical gases.
• The AuraGain does not protect the trachea or lungs from the risk of aspiration.
CAUTION
• US federal law restricts this device to be sold to or on the order of a physician.
• Ensure that the device is not in any way damaged before use.
• The patency of the AuraGain should be reconfirmed after any change in the patient's
head or neck position.
For further product information see
www.ambu.com
Summary of Contents for AuraGain
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