8
Symbol Title and Meaning Reference
Reorder number
Indicates the manufacturer’s catalogue number so
the medical device can be identified.
ISO 7000-2493
Symbol 5.1.6,
ISO 15223-1
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
Specications
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
Flow Rate (SLPM)
0
10
20
30
40
50
60
70
AF541 EE Leak 1
AF541 EE Leak 1 with Disposable Circuit (DEP)
Pressure cm H
2
O
Resistance with Anti-Asphyxia Valve Closed to Atmosphere
Drop in Pressure at
50 SLPM 100 SLPM
All sizes 0.3 cm H
2
O 0.6 cm H
2
O
Closed to Atmosphere: A minimum of 3 cm H
2
O must be maintained to ensure that the
anti-asphyxia valve closes.
Open to Atmosphere: In the absence of positive airway pressure (0 cm H
2
O), the anti-asphyxia
valve will open.
Inspiratory and Expiratory Resistance with Anti-Asphyxia Valve Open to Atmosphere at
50SLPM
Inspiratory Resistance 1.6 cm H
2
O
Expiratory Resistance 1.0 cm H
2
O