ResMed AirSense 11 User Manual page 27

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 static pressure:
For measures of dynamic pressure:
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.
In accordance with ISO 80601-2-74:2017 the measurement uncertainty of the manufacturer's test equipment is
For measures of humidification output
Bluetooth
Technology used:
Connection types:
Frequency:
Max RF power output:
Operation range:
Cellular technology and regulatory compliance
Refer to the Cellular information guide in ResMed.com/downloads/devices.
The device should be installed and operated with minimum distance 15 mm (0.59") between the equipment and the user's body.
Declaration of Conformity (DoC to the Radio Equipment Directive)
ResMed declares that the AirSense 11 device (models 394xx) is in compliance with the essential requirements and other relevant
provisions of Directive 2014/53/EU (RED). A copy of the Declaration of Conformity (DoC) can be found on
ResMed.com/productsupport
The technology, bands and output power information can be found on ResMed.com/downloads/devices.
All ResMed devices are classified as medical devices under the Medical Device Regulation. Any labelling of the product and
printed material showing ,
Humidifier
Maximum heater plate temperature:
Temperature cut-out (heater):
Maximum gas temperature (at mask)
1
The air flow for breathing produced by this therapy device can be higher than the temperature of the room. Under extreme
ambient temperature conditions (104ºF/40ºC) the device remains safe.
Humidifier performance
SlimLine/Standard tubing
Mask Pressure Nominal RH output % at 22ºC ambient
cm H O (hPa) temperature
2
Setting 4
(default setting)
4 80%
10 80%
20 80%
24
± 3.9 L/min
± 0.15 cm H
± 0.04 cm H
± 0.5 mg/L BTPS
Bluetooth Low Energy (BLE)
GATT
2400 to 2483.5 MHz
+4 dBm
10 m (Class 2)
0123, relates to the Medical Device Regulation (EU) 2017/745.
68ºC
74ºC
≤ 41ºC
1 :
Setting 8
(maximum setting)
100%
100%
100%
O (± 0.15hPa)
2
O (± 0.04hPa)
2
Nominal system output mg/L AH
Setting 4
(default setting)
≥6
≥6
≥6
1 2
, BTPS
Setting 8
3
(maximum setting)
>12
>12
>12