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CAUTION
1. US federal law restricts this device to be sold to or on the order of a physician.
2. For use only by clinicians trained in the use of an Ambu® Aura40.
3. Ensure that the device is not in any way damaged before use.
4. Make a brief functional check before using the device. Failure of any one test indicates that
the device should not be used.
5. If airway problems persist or ventilation is inadequate, the Ambu® Aura40 should be
removed and reinserted or a secure airway established by other means.
6. Patients should be adequately monitored at all times during use.
7. The secure function of all anaesthetic breathing system connectors should be checked
before the breathing circuit is established.
8. Have a spare Ambu® Aura40 ready and prepared for immediate use.
9. The Ambu® Aura40 has not been tested during MRI.
10. Handle the Ambu® Aura40 carefully as it is made of silicone, which can be torn or punctured.
Avoid contact with sharp or pointed objects.
11. Liquid in the inflation system may cause premature inflation valve failure.
12. All detergents should be used in the recommended dilution/concentration, temperature,
water quality (e.g., ph, hardness), and exposure (soak or contact) time, in accordance with
the detergent manufacturer’s directions.
13. Effective cleaning must be carried out to achieve proper sterilization.
14. Always wear gloves during the preparation and insertion of the Ambu® Aura40 to minimize
contamination.
15. The inflation volumes specified in table 7 are for testing purposes only. These volumes
are not to be used during normal use of the device – the recommended standard inflation
volumes can be found in Table 1.
2. Introduction
2.1. Intended use
The Ambu® Aura40 is intended for use as an alternative to the facemask for achieving and maintaining
control of the airway during routine and emergency anaesthetic procedures in fasted patients.
The Ambu® Aura40 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® Aura40 may also be used to establish a clear airway during resuscitation in the
profoundly unconscious patient with absent glossopharyngeal and laryngeal reflexes who may
need artificial ventilation.
The device is not intended for use as a replacement for the endotracheal tube, and is best suited for
use in surgical procedures where tracheal intubation is not deemed necessary.
2.2. Contraindications
The Ambu® Aura40 does not protect the patient from the consequences of regurgitation and
aspiration. The Ambu® Aura40 should only be used in patients, who have been clinically evaluated
by a clinician familiar with anaesthesia, as eligible for a laryngeal mask airway.
When the Ambu® Aura40 is used in the profoundly unconscious patient 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 established by your own local
protocol). The Ambu® Aura40 should not be used for resuscitation or emergency treatment of
patients who are not profoundly unconscious and who may resist insertion.
