Warnings/Cautions; Introduction; Intended Use; Contraindications - Ambu Aura40 Manual Del Usuario

1. Warnings/Cautions

Throughout these directions for use, appropriate warnings are given describing potential safety
hazards associated with use of the Ambu Aura40.
WARNING
The user should be familiar with the following warnings prior to use of the Ambu Aura40.
• The Ambu Aura40 is delivered non-sterile and must be cleaned and sterilized before initial
use and before each subsequent use.
• Lubricate only the posterior tip of the cuff to avoid blockage of the airway aperture or
aspiration of the lubricant.
• To avoid trauma, do not use force at any time during insertion of the Ambu Aura40.
• Adhere strictly to the recommended cuff inflation volumes as specified in Table 1.
Never over-inflate the cuff after insertion.
• In case the Ambu Aura40 is used in a fasted patient who may have retained gastric
contents, measures should be taken to empty the stomach contents and administer
appropriate antacid therapy. Examples include, but are not limited to, moderate obesity
and hiatal hernia.
• In patients with severe oropharyngeal trauma, the Ambu Aura40 should only be employed
when all other attempts to establish an airway have failed.
• Use of a nasogastric tube may make regurgitation likely because the tube may interfere
with the function of the lower oesophageal sphincter.
• The Ambu Aura40 is flammable in the presence of lasers and electrocautery equipment
CAUTION
• US federal law restricts this device to be sold to or on the order of a physician.
• For use only by clinicians trained in the use of an Ambu Aura40.
• Ensure that the device is not in any way damaged before use.
• Make a brief functional check before using the device. Failure of any one test indicates
that the device should not be used.
• If airway problems persist or ventilation is inadequate, the Ambu Aura40 should be
removed and reinserted or a secure airway established by other means.
• Patients should be adequately monitored at all times during use.
• The secure function of all anaesthetic breathing system connectors should be checked
before the breathing circuit is established.
• To minimize contamination, always wear gloves during the preparation and insertion of
the Ambu Aura40.
• Have a spare Ambu Aura40 ready and prepared for immediate use.
• The Ambu Aura40 has not been tested during MRI.
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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.

3. Specifications

The Ambu Aura40 function is in conformity with Council Directive 93/42/EEC concerning
Medical Devices. 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 Aura40 is a reusable device, delivered non-sterile.
See figure . Ambu Aura40
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