Ambu AuraOnce Disposable Laryngeal Mask, Instructions For Use Manual

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8. Do not perform direct intubation through
AuraOnce as the endotracheal (ET) tube may get
stuck leading to insufficient ventilation.
9. In general, AuraOnce should only be used in
patients who are profoundly unconscious and
will not resist insertion.
10. The overall complication rate for laryngeal mask
is low, but the user must exercise professional
judgement when deciding whether the use of a
laryngeal mask will be appropriate.
The following patients are at higher risk of
serious complications including aspiration and
inadequate ventilation:
• Patients with upper airway obstruction.
• Non-fasted patients (including those cases
where fasting cannot be confirmed).
• Patients suffering from upper gastrointestinal
issues (e.g., esophagectomy, hiatal hernia,
gastroesophageal reflux disease, morbid
obesity, pregnancy > 10 weeks).
• Patients requiring high pressure ventilation.
• Patients who present with pharyngeal/
laryngeal pathology potentially complicating
anatomical fit of the mask (e.g., tumors,
radiotherapy to the neck involving the
hypopharynx, severe oropharyngeal trauma).
• Patients with inadequate mouth opening to
permit insertion.
1.1. Intended use/Indication for 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.
1.2. Intended users and use environment
Medical professionals trained in airway management.
AuraOnce is intended to be used in a hospital setting.
1.3. Intended patient population
Adult and pediatric patients from 2 kg and above
evaluated as eligible for a supraglottic airway.
1.4. Contraindications
None known.
1.5. Clinical benefits
Keeps the upper airway open to allow passage of gases.
1.6. Warnings and cautions
Before insertion, it is essential that all medical
professionals using Ambu AuraOnce are familiar
with the warnings, precautions, indications, and
contraindications found in
Instruction for use.
WARNINGS
1. The product is intended to be used by medical
professionals trained in airway management only.
2. Always visually inspect the product and perform
a functional test after unpacking and prior to
use according to section 3.1 Preparation before
use, as defects and foreign matters can lead to
no or reduced ventilation, mucosal damage, or
infection of the patient. Do not use the product
if any steps in Preparation before use fails.
3. Do not re-use AuraOnce on another patient as it
is a single use device. Re-use of a contaminated
product can lead to infection.
4. AuraOnce does not protect the trachea or lungs
from the risk of aspiration.
5. Do not use excessive force when inserting
and removing AuraOnce as this can lead to
tissue trauma.
6. The cuff volume or pressure may change in
the presence of nitrous oxide, oxygen, or other
medical gases which can lead to tissue trauma.
Ensure to monitor cuff pressure continuously
during the surgical procedure.
7. Do not use AuraOnce in the presence of lasers
and electrocautery equipment as this could lead
to airway fire and tissue burns.