ResMed Lumis Série Mode D'emploi page 23

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 pressure
For measures of time
Pressure accuracy
Maximum static pressure variation at 10 cm H
ISO 80601-2-70:2015
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
25
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
25
Pressure accuracy - bilevel
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
Breath
Inspiratory pressure (cm H
rate
6
10 BPM -0.09, 0.01 / -0.22,
0.01
15 BPM
0.02, 0.08 / -0.22,
0.01
20 BPM
0.17, 0.01 / -0.23,
0.01
22
± 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
± 10 ms
O (10 hPa) according to
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
0.3 / 0.3
10 BPM
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.4 / 0.3
O [hPa]) (Means, Standard Deviations)
2
10
-0.01, 0.07 / -0.22,
0.01
0.12, 0.01 / -0.22,
0.01
0.21, 0.01 / -0.28,
0.01
O (0.15 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
0.5 / 0.4
15 BPM
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.5 / 0.5
0.6 / 0.5
16 21
0.07, 0.05 / -0.24, -0.03, 0.09 / -0.29,
0.01 0.03
0.15, 0.01 / -0.26, 0.15, 0.01 / -0.31,
0.01 0.02
0.25, 0.01 / -0.34, 0.21, 0.17 / -0.38,
0.01 0.02
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
0.7 / 0.7
20 BPM
0.8 / 0.8
0.8 / 0.8
0.8 / 0.8
0.8 / 0.8
0.8 / 0.8
0.8 / 0.8
25
0.12, 0.01 / -0.26,
0.02
0.16, 0.12 / -0.30,
0.02
0.32, 0.02 / -0.40,
0.03