User's Guide

6
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
Compliance
Electromagnetic environment — guidance
RF emissions CISPR 11 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.
RF emissions CISPR 11
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.
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
Complies
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.
Immunity test
IEC60601-1-2 test
level
Compliance level
Electromagnetic environment — guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
±2 kV for power supply
lines
±1 kV for input/output
lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that of a typical
commercial or hospital environment.