Guidance And Manufacturer's Declaration Electromagnetic Emissions And Immunity - ResMed RCM1 User Manual

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.
Guidance and manufacturer's declaration—electromagnetic emissions
These devices are 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
WARNING
• The device should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
• The use of cables other than those specified for the device is not recommended. They may
result in increased emissions or decreased immunity of the device.
Guidance and manufacturer's declaration – electromagnetic immunity
These devices are 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.
IEC60601-1-2 test
Immunity test
level
Electrostatic ±8 kV contact
discharge (ESD) ±15 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
Surge ±1 kV differential
IEC 61000-4-5 mode
±2 kV common mode
6
Compliance
Group 1
Class B
Class A
Complies
Compliance level
±8 kV contact
±15 kV air
±2 kV for power supply
lines
±1 kV for input/output
lines
±1 kV differential
mode
±2 kV common mode
Electromagnetic environment — guidance
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.
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.
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.
Mains power quality should be that of a typical
commercial or hospital environment.