Specifications - Philips Respironics EE Leak 1 AF541 Instructions For Use Manual

Symbol Title and Meaning
Reorder number
Indicates the manufacturer's catalogue number so
the medical device can be identified.
Mask leak symbol and value
Indicates the intentional leak of the mask.
ISO 7000:2014, Graphical symbols for use on equipment - Registered symbols
ISO 15223-1:2012, Medical devices - Symbols to be used with medical devices labels - General
requirements
IEC/TR 60878:2015, Graphical symbols for electrical equipment in medical practice

Specifications

The technical specifications of the mask are provided to determine if it is compatible with your
therapy device, and that alerts and alarms function properly.
Warning: Use outside of these specifications may result in ineffective therapy. The
pressure flow curve shown below is an approximation of expected performance. Exact
measurements may vary.
Pressure Flow Curve
70
60
50
40
30
20
10
0
0 5
Resistance with Anti-Asphyxia Valve Closed to Atmosphere
Drop in Pressure at
All sizes
Closed to Atmosphere: A minimum of 3 cm H
anti-asphyxia valve closes.
Open to Atmosphere: In the absence of positive airway pressure (0 cm H
valve will open.
Inspiratory and Expiratory Resistance with Anti-Asphyxia Valve Open to Atmosphere at
50 SLPM
Inspiratory Resistance
Expiratory Resistance
AF541 EE Leak 1
AF541 EE Leak 1 with Disposable Circuit (DEP)
10 15 20
Pressure cm H
50 SLPM
0.3 cm H O
2
1.6 cm H
1.0 cm H
25 30
O
2
100 SLPM
0.6 cm H O
2
O must be maintained to ensure that the
2
O
2
O
2
8
Reference
ISO 7000-2493
Symbol 5.1.6,
ISO 15223-1
-
35 40
O), the anti-asphyxia
2