Guidance And Manufacturer's Declaration Electromagnetic Emissions And Immunity; Guidance And Manufacturer's Declaration-Electromagnetic Emissions; Guidance And Manufacturer's Declaration - Electromagnetic Immunity - ResMed AirCurve 10 ST-A Clinical Manual

Flow (maximum) at set pressures
The following are measured accordingly to ISO 80601-2-70:2015 at the end of the specified air tubing:
Pressure
cm H O (hPa)
2
4
8
12
16
20
25
Guidance and manufacturer's declaration electromagnetic emissions and
immunity
Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to EMC information provided in this document.
The AirCurve 10 ST-A device has been designed to meet EMC standards. However, should you
suspect that the device performance (eg, pressure or flow) is affected by other equipment, move
the device away from the possible cause of interference.
Guidance and manufacturer's declaration—electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that the device is used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that the device is used in such an environment.
Immunity test IEC60601-1-2 test
level
Electrostatic ±6 kV contact
discharge (ESD) ±8 kV air
IEC 61000-4-2
Electrical fast ±2 kV for power
transient/burst supply lines
IEC 61000-4-4 ±1 kV for input/output
lines
52
AirCurve 10 and AirCurve 10,
Standard humidification and
L/min Standard
L/min
180 143
168 135
157 136
144 134
131 123
120 115
Compliance level
±8 kV contact
±15 kV air
±2 kV
±1 kV for input/output
lines
AirCurve 10 and
SlimLine
L/min
162
151
140
128
117
96
Compliance Electromagnetic environment — guidance
Group 1 The device uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
Class B The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage network that
supplies buildings used for domestic purposes.
Class A
Complies
Electromagnetic environment — guidance
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
AirCurve 10,
humidification and
ClimateLineAir
L/min
151
142
135
121
109
84