Ambu AuraOnce Disposable Laryngeal Mask, Instructions For Use Manual

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CAUTIONS
1. 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.
2. Before use, always check for compatibility
between AuraOnce and the external device to
avoid the use of devices not being able to pass
through lumen of AuraOnce.
3. The cuff pressure should be kept as low as
possible while still providing sufficient seal and
should not exceed 60 cmH
2
O.
4. Any signs of airway problems or inadequate
ventilation must be monitored regularly and
AuraOnce must be repositioned, reinserted or
replaced as required to maintain a patent airway.
5. Always reconfirm the patency of the airway after
any change in the patient's head or neck position.
1.7. Potential adverse events
The use of laryngeal masks is associated with
minor adverse effects (e.g., sore throat, bleeding,
dysphonia, dysphagia) and major adverse effects
(e.g., regurgitation/aspiration, laryngospasm,
nerve injury).
1.8. General notes
If, during the use of this device or as a result of its use,
a serious incident has occurred, please report it to the
manufacturer and to your national authority.
2.0. Device description
AuraOnce is a sterile, single-use laryngeal mask
consisting of a curved patient tube with an inflatable
cuff at the distal end. The cuff can be inflated through
the check valve allowing the pilot balloon to indicate
the inflation/deflation status. The cuff conforms to
the contours of the hypopharynx and with its lumen
facing the laryngeal opening of the patient. The tip
of the cuff presses against the upper oesophageal
sphincter and the proximal end of the cuff rests
against the base of the tongue.
AuraOnce comes in 8 different sizes. The main
components of AuraOnce are seen in figure
1
.
Figure 1 (page 4) : Overview of AuraOnce parts:
1. Connector; 2. Patient tube; 3. Cuff; 4. Check
valve; 5. Pilot balloon; 6. Pilot tube; 7. Nominal
length of internal ventilatory pathway*.
*See Table 1 for the nominal length provided
in centimeters.
Figure 2 (page 4) : Correct position of
AuraOnce in relation to AuraOnce parts
and anatomical landmarks
AuraOnce parts: 1. Inflatable cuff; 2. Size marking;
3. Ventilatory opening; 4. Ventilatory pathway;
5. Normal depth of insertion marks; 6. Machine end.
Anatomical landmarks: A. Esophagus; B. Trachea;
C. Cricoid ring; D. Thyroid cartilage; E. Vocal cords;
F. Laryngeal inlet; G. Epiglottis; H. Hyoid bone;
I. Tongue; J. Buccal cavity; K. Nasopharynx;
L. Incisors.
COMPATIBILITY WITH OTHER DEVICES/EQUIPMENT
AuraOnce can be used in conjunction with:
• Ventilation equipment; 15 mm conical connectors
in compliance with ISO 5356-1
• Airway management devices; Bronchoscopes and
exchange catheters*
• Other accessories; Standard 6 % conical Luer
syringe, Manometer with standard 6 % conical Luer
connector, Water-based lubrication, Suction catheter
When using instruments through the mask ensure
that the instrument is compatible and well lubricated
before insertion.
* See Table 1 for information on maximum instrument size.