General Notes; Device Description; Potential Adverse Events - Ambu Aura-i Bedienungsanleitung

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
Aura-i and the external device to avoid the use of
devices not being able to pass through lumen of Aura-i.
3. The cuff pressure should be kept as low as possible
while still providing sufficient seal and should not
exceed 60 cmH O.
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4. Any signs of airway problems or inadequate
ventilation must be monitored regularly, and Aura-i
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.
6. For pediatric patients, if removal of Aura-i is planned
after an ET-tube is placed through the mask, an
ET-tube without cuff must be used to ensure the
pilot balloon of the ET-tube does not block
the removal of Aura-i.

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

Aura-i 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.
The design of the connector and patient tube allow
intubation with ET-tubes.
Aura-i comes in 8 different sizes. The main components of
Aura-i are seen in figure 1 .
Figure 1 (page 4): Overview of Aura-i parts:
1. Connector; 2. Connector Shell; 3. Patient tube;
4. Cuff; 5. Check valve; 6. Pilot balloon; 7. Pilot tube;
8. Nominal length of internal ventilatory pathway*
* See Table 1 for the nominal length provided in centimeters.
Figure 2 (page 4): Correct position of Aura-i in
relation to Aura-i parts and anatomical landmarks
Aura-i parts: 1. Inflatable cuff; 2. Size marking;
3. Ventilatory opening; 4. Ventilatory pathway;
5. Normal depth of insertion marks; 6. Machine end;
7. Max. ET-tube size indication; 8. Navigation marks
for flexible scope.
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
Aura-i can be used in conjunction with:
• Ventilation equipment; 15 mm conical connectors in
compliance with ISO 5356-1.
• Airway management devices; Bronchoscopes*,
ET-tubes*, Intubation 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
and the maximum ET-tube size that can be used with each
Aura-i mask size.
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