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2. Introduction
2.1. Intended use
The Ambu AuraOnce is intended for use as an alternative to a facemask for achieving and maintaining
control of the airway during routine and emergency anaesthetic procedures in fasted patients.
The Ambu AuraOnce may also be used where unexpected difficulties arise in connection with
airway management.
The mask may also be preferred in some critical airway situations.
The Ambu AuraOnce may also be used to establish a clear airway during resuscitation in
profoundly unconscious patients with absent glossopharyngeal and laryngeal reflexes who may
need artificial ventilation.
The device is not intended for use as a replacement of the endotracheal tube, and is best suited for
use in surgical procedures where tracheal intubation is not deemed necessary.
2.2. Contraindications
The Ambu AuraOnce does not protect the patient from the consequences of regurgitation and
aspiration. Ambu AuraOnce should only be used in patients, who have been clinically evaluated by
a clinician familiar with anesthesia, as eligible for a laryngeal mask airway.
When the Ambu AuraOnce is used in profoundly unconscious patients in need of resuscitation or in
an emergency patient with a difficult airway situation (i.e. “cannot intubate, cannot ventilate”), there
is a risk of regurgitation and aspiration. This risk must be carefully balanced against the potential
benefit of establishing an airway (see the guidelines etablished by your own local protocol). The
Ambu AuraOnce should not be used for resuscitation or emergency treatment of patients who are
not profoundly unconscious and who may resist insertion.
3. Specifi cations
The Ambu AuraOnce function is in conformity with Council Directive 93/42/EEC concerning
Medical Devices and ASTM standard no. ASTM F 2560-06 Standard Specification for
Supralaryngeal Airways and Connectors. A summary of the methods, materials, data and
results of clinical studies that validate the requirements of this standard is available on request,
if applicable.
The Ambu AuraOnce is a sterile and single use device.
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