Apex iX Sense CPAP System Manuel D'instructions page 31

iX Sense / English
8.3 Noise Emissions Values
The A-weighted sound pressure level is:
Device: 28 dB(A) with and uncertainty of 3 dB(A).
Device with Humidifier: 29.5 dB(A) with and uncertainty of 3 dB(A).
The A-weighted sound power level is:
Device: 36.5 dB(A) with an uncertainty of 3 dB(A).
Device with Humidifier: 38.0 dB(A) with an uncertainty of 3 dB(A).
Note: Values determined according to noise test code given in ISO 80601-2-70:2015, using the basic
standards ISO 3744 and ISO 7779.
8.4 Pressure Accuracy
Maximum static pressure variation at 10 cmH
Without Humidification
With Humidification
Static pressure accuracy has a measurement uncertainty of ± 0.15 cm H
Maximum dynamic pressure variation according to ISO 80601-2-70:2015
Device without/with Humidification and 15mm Light grey tubing
Pressure(cmH2O)
< 10 cmH O
2
≥ 10.0 to 20 cm H O
Dynamic pressure accuracy has a measurement uncertainty of ± 1.27 cm H
Results are expressed as STPD (Standard Temperature and Pressure, Dry).
8.5 Maximum Flow Rate
Pressure (cm H
15 mm Flow (LPM)
tubing
Results are expressed as STPD (Standard Temperature and Pressure, Dry).
8.6 Maximum Single Fault pressure
When assessing the relative risks of using this equipment, the Physician should understand that this device
can deliver pressures up to 20 cmH
Results are expressed as STPD (Standard Temperature and Pressure, Dry).
O (10 hPa) according to ISO 80601-2-70:2015
2
15mm Light grey tubing
±0.5 cmH O (±0.5 hPa)
W
2
±0.5 cmH O (±0.5 hPa)
2
10 BPM
1 / 1
1.5 / 2
O)
2
4
>30
O. In the event of certain fault conditions, a maximum pressure is 40 cmH2O.
2
O
2
15 BPM
1.5 / 1.5
2 / 2.5
O
2
Test pressures (cm H
8 12
>30 >30
20 BPM
2 / 2
2.5 / 3
O )
2
16 20
>30 >30
28