Materials; Principles Of Operation; Preparation For Use; Cleaning And Sterilization - Ambu Aura40 Manual Del Usuario

#1 # 1 ½
Patient weight <5 kg 5-10 kg
Maximum cuff
4 ml 7 ml
inflation volume
Maximum intracuff
pressure
 Airway connector
Min� I�D� Tube 5,2 mm 7,3 mm
Max� O�D� Tube 10,5 mm 13 mm
Inflation valve
Storage temperature
Internal volume of
5,5 ml 8 ml
ventilatory pathway
<1�0 cm H O <0�6 cm H O
Pressure drop 2 2
at 15 l/min at 15 l/min
Min� interdental gap 15 mm 17 mm
Internal pathway 10,3 cm 12,0 cm
Table 1. Specifications for the Ambu Aura40

3.1. Materials

The Ambu Aura40 is 100% latex free. The materials used for the product and packaging are:
Part
Airway connector

/ Tube/Cuff
 
Inflation Valve

/ Pilot balloon/Manual vent
 
Pilot tube

Packaging - Pouch
Table 2. Material used for the Ambu Aura40
See figure Ambu Aura40

6
492 4610 40 Aura40_V03_0810.indd 6-7
Mask size
# 2 # 2 ½ #3 # 4 # 5
10-20 kg 20-30 kg 30-50 kg 50-70 kg 70-100 kg
10 ml 14 ml 20 ml 30 ml 40 ml
60 cm H O
2
15 mm male (ISO 5356-1)
8,6 mm 8,5 mm 8,5 mm 9,6 mm 10,6 mm
15 mm 17,5 mm 17,5 mm 20 mm 22,5 mm
Luer-connector (ISO 594-1)
10 °C to 25 °C
11 ml 15 ml 16 ml 21 ml 30 ml
<0�7 cm H O <0�5 cm H O <1�6 cm H O <0�9 cm H O <0�5 cm H O
2 2 2 2 2
at 15 l/min at 15 l/min at 15 l/min at 15 l/min at 15 l/min
19 mm 21 mm 25 mm 29 mm 31 mm
13,8 cm 15,9 cm 15,9 cm 17,8 cm 20,0 cm
Material
Polysulphone
Silicone
Polyester/Polypropylene/Nitrile/Stainless steel
Silicone
Silicone
Tyvek/PET/PE

4. Principles of operation

The mask is designed to conform to the contours of the hypopharynx with its lumen facing
# 6
the laryngeal opening. When correctly inserted, the distal tip of the cuff rests against the
>100 kg
upper oesophageal sphincter.
50 ml The Ambu Aura40 comes in eight different sizes for use in patients of different weight. See
table 1 for selection guidelines and max. inflation volumes. Please note that the cuff inflation
volumes shown in table 1 are maximum volumes. Applying the stated maximum inflation
volume may respond to a cuff pressure above the maximum of 60 cm H
to continuously monitor the cuff pressure.
11,3 mm
25 mm
WARNING
Make sure the manual vent is closed during clinical use
36 ml
See figure . Correct position of the Ambu Aura40 in relation to anatomical landmarks.
Anatomical Landmarks
<0�2 cm H O
2
at 15 l/min
A – Esophagus
B – Trachea
33 mm
22,0 cm C – Cricoid ring
D – Thyroid cartilage
E – Laryngeal inlet
F – Epiglottis
Table 3. Description of anatomical landmarks and Ambu Aura40 parts

5. Preparation for use

5.1 Cleaning and sterilization

Cleaning and sterilization as described below must be carried out before initial use and before
each subsequent use as the Ambu Aura40 is delivered non-sterile.
The Ambu Aura40 can be used a maximum of 40 times provided the recommended cleaning,
sterilization and handling procedures are followed. Proper cleaning and sterilization of the
device is essential to ensure continued safe usage up to 40 times.
A record card for sterilization of the Ambu Aura40 accompanies every device from delivery.
To ensure a proper documentation of the sterilization cycles, the record card should be
completed each time the Ambu Aura40 is sterilized.
Ambu A/S has validated the instructions provided in 5.1.1. and 5.1.2. as being capable of
preparing an Ambu Aura40 for re-use. Any deviation from the instruction provided should be
properly evaluated for effectiveness and potential adverse consequences. The cleaning and
sterilization instructions in 5.1.1. and 5.1.2 have been validated in accordance with EN ISO 17664
and AAMI TIR 12.
O. It is recommended
2
Aura40
G – Hyoid Bone 1 – Patient end
H – Tongue 2 – Size marking
I – Buccal cavity 3 – Ventilatory opening
J – Nasopharynx 4 – Ventilatory pathway
K – Incisors 5 – Normal depth of insertion marks
6 – Machine end
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