Value
Pressure measurement
1
:
Mask pressure
2
Flow and flow derived values
Flow
Leak
2
1
Results are expressed as STPD (Standard Temperature and Pressure, Dry).
2
Accuracy may be reduced by the presence of leaks, supplemental oxygen, tidal volumes <100 mL or minute ventilation <3 L/min.
3
Measurement accuracy verified as per EN ISO 10651-6:2009 for Home Care Ventilatory Support Devices (Figure 101 and Table 101) using
nominal ResMed mask vent flows.
Measurement system uncertainties
In accordance with ISO 80601-2-70:2015 the measurement uncertainty of the manufacturer's test equipment is:
For measures of flow
For measures of volume (< 100 mL)
For measures of volume (≥ 100 mL)
For measures of static pressure
For measures of dynamic pressure
For measures of time
Note: ISO 80601-2-70:2015 stated accuracies and test results provided in this manual for these items already include the
relevant measurement uncertainty from the table above.
Pressure accuracy
Maximum static pressure variation at 10 cm H
Without humidification
With humidification
Maximum dynamic pressure variation according to ISO 80601-2-70:2015
Device without humidification and Standard air tubing / Device with humidification and Standard air tubing
Pressure [cm H
O (hPa)]
2
4
8
12
16
20
Device without humidification and SlimLine air tubing / Device with humidification and SlimLine air tubing
Pressure [cm H
O (hPa)]
2
4
8
12
16
20
20
Accuracy
±[0.5 cm H
0 (0.5 hPa) + 4% of measured value]
2
1
:
±6 L/min or 10% of reading, whichever is greater, at 0 to 150 L/min positive flow
±12 L/min or 20% of reading, whichever is greater, 0 to 60 L/min
± 1.5 L/min or ± 2.7% of reading (whichever is greater)
± 5 mL or 6% of reading (whichever is greater)
± 20 mL or 3% of reading (whichever is greater)
± 0.15 cm H
± 0.27 cm H
± 10 ms
O (10 hPa) according to ISO 80601-2-70:2015
2
Standard air tubing
± 0.5 cm H
O (± 0.5 hPa)
2
± 0.5 cm H
O (± 0.5 hPa)
2
10 BPM
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
10 BPM
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
O (hPa)
2
O (hPa)
2
SlimLine air tubing
± 0.5 cm H
± 0.5 cm H
15 BPM
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
15 BPM
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
O (± 0.5 hPa)
2
O (± 0.5 hPa)
2
20 BPM
0.8 / 0.8
0.8 / 0.8
0.8 / 0.8
0.8 / 0.8
0.8 / 0.8
20 BPM
0.8 / 0.8
0.8 / 0.8
0.8 / 0.8
0.8 / 0.8
0.8 / 0.8