3
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1. Warnings/Cautions
Throughout these directions for use, appropriate warnings are given describing potential safety hazards associated
with use of the Ambu AuraOnce.
WARNING
The user should be familiar with the following warnings prior to use of the Ambu AuraOnce.
• The Ambu AuraOnce is delivered sterile.
• Lubricate only the posterior tip of the cuff to avoid blockage of the airway aperture or aspiration of the
lubricant.
• To avoid trauma, do not use force at any time during insertion of the Ambu AuraOnce.
• Adhere strictly to the recommended cuff infl ation volumes as specifi ed in Table 3. Never over-infl ate the cuff
after insertion.
• Ambu AuraOnce is to be used in patients, who have been clinically evaluated by a clinician familiar with
anaesthesia as eligible for a Supraglottic Airway Device.
• In patients with severe oropharyngeal trauma, the Ambu AuraOnce should only be employed when all other
attempts to establish an airway have failed.
• The Ambu AuraOnce is fl ammable in the presence of lasers and electrocautery equipment.
• Use of a nasogastric tube may make regurgitation likely because the tube may interfere with the function of
the lower esophageal sphincter.
• Do not attempt to clean and reuse the Ambu AuraOnce.
CAUTION
• US federal law restricts this device to be sold to or on the order of a physician.
• For use only by clinicians trained in the use of a Ambu AuraOnce.
• Ensure that the device is not in any way damaged before use
• Make a brief functional check as described in section 6 before using the device. Failure of any test indicates
that the device should not be used.
• If airway problems persist or ventilation is inadequate, the Ambu AuraOnce should be removed and
reinserted or a secure airway established by other means.
• Patients should be adequately monitored at all times during use.
• The secure function of all anaesthetic breathing system connectors should be checked before the breathing
circuit is established.
• To minimize contamination, always wear gloves during the preparation and insertion of the Ambu AuraOnce.
• Have a spare Ambu AuraOnce ready and prepared for immediate use.
• When used with MRI, care should be taken to monitor the patient carefully to ensure that correct positioning
of the tube is maintained.
