ResMed AirCurve 10 CS PaceWave User Manual page 18

Maximum single fault steady pressure
Device will shut down in the presence of a single fault if the steady state pressure exceeds:
30 cm H O (30 hPa) for more than 6 sec or 40 cm H
2
Sound
Pressure level measured according to ISO 80601-2-70:2015 (CPAP mode):
SlimLine:
Standard:
SlimLine or Standard and humidification:
Power level measured according to ISO 80601-2-70:2015 (CPAP mode):
SlimLine:
Standard:
SlimLine or Standard and humidification:
Declared dual-number noise emission values in accordance with ISO 4871:1996.
Physical - device and humidifier
Dimensions (H x W x D):
Air outlet (complies with ISO 5356-1:2015):
Weight (device and cleanable humidifier):
Housing construction:
Water capacity:
Cleanable humidifier - material:
Air filter
Standard:
Hypoallergenic:
Aircraft use
ResMed confirms that device meets the Federal Aviation Administration (FAA) requirements (RTCA/DO-160, section 21,
category M) for all phases of air travel.
Wireless module
Technology used:
It is recommended that the device is a minimum distance of 2 cm from the body during operation. Not applicable to masks,
tubes or accessories. Technology may not be available in all regions.
Declaration of Conformity (DoC to the Radio Equipment Directive)
ResMed declares that the AirCurve 10 device (models 370xx) 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
This radio equipment operates with the following frequency bands and maximum radio-frequency power:
GSM 850/900: 35dBm
GSM 1800/1900: 32dBm
All ResMed devices are classified as medical devices under the Medical Device Directive. Any labelling of the product and
printed material, showing
amendment (2007/47/EC).
O (40 hPa) for more than 1 sec.
2
0123, relates to the Council Directive 93/42/EEC including the Medical Device Directive
25 dBA with uncertainty of 2 dBA
25 dBA with uncertainty of 2 dBA
27 dBA with uncertainty of 2 dBA
33 dBA with uncertainty of 2 dBA
33 dBA with uncertainty of 2 dBA
35 dBA with uncertainty of 2 dBA
116 mm x 255 mm x 150 mm
22 mm
1248 g
Flame retardant engineering thermoplastic
To maximum fill line 380 mL
Injection moulded plastic, stainless steel and silicone seal
Material: Polyester non woven fibre
Average arrestance: >75% for ~7 micron dust
Material: Acrylic and polypropylene fibres in a polypropylene
carrier
Efficiency: >98% for ~7-8 micron dust; >80% for ~0.5 micron
dust
4G, 3G, 2G
English 17