9
en
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
Mask size
#1
#1½
#2
#2½
#3
#4
#5
#6
Patient weight
< 5 kg
5 – 10
kg
10 – 20
kg
20 – 30 kg 30 – 50 kg 50 – 70 kg 70 – 100
kg
> 100 kg
Maximum cuff
inflation volume
4 ml
7 ml
10 ml
14 ml
20 ml
30 ml
40 ml
50 ml
Maximum
intracuff
pressure
60 cmH₂O
Airway
connector
15 mm male (ISO 5356-1)
Min. I.D. Tube
5.2 mm 7.3 mm 8.6 mm 8.5 mm 8.5 mm 9.6 mm
10.6
mm
11.3 mm
Max. O.D. Tube
10.5 mm 13 mm
15 mm 17.5 mm 17.5 mm 20 mm
22.5
mm
25 mm
Inflation valve
Luer-connector (ISO 594-1)
Storage
temperature
10 °C to 25 °C
Internal volume
of ventilatory
pathway
5.5 ml
8 ml
11 ml
15 ml
16 ml
21 ml
30 ml
36 ml
Pressure drop
< 1.0
cmH₂O
at 15
l/min
< 0.6
cmH₂O
at 15
l/min
< 0.7
cmH₂O
at 15
l/min
< 0.5
cmH₂O
at 15
l/min
< 1.6
cmH₂O
at 15
l/min
< 0.9
cmH₂O
at 15
l/min
<0.5
cmH₂O
at 15
l/min
< 0.2
cmH₂O
at 15
l/min
Min. interdental
gap
15 mm
17 mm
19 mm
21 mm
25 mm
29 mm
31 mm
33 mm
Internal
pathway
10.3 cm 12.0 cm 13,8 cm 15.9 cm 15.9 cm 17.8 cm 20.0 cm 22.0 cm
Table 1. Specifications for the Ambu® Aura40