EDAN iM80 - B EMC Information; Electromagnetic Emissions - for All EQUIPMENT and SYSTEMS; Electromagnetic Immunity - for All EQUIPMENT and SYSTEMS

Patient Monitor User Manual EMC Information
- 167 -
B EMC Information
- Guidance and Manufacture’s Declaration
B.1 Electromagnetic Emissions - for all EQUIPMENT and
SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitor should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The monitor 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 emission
CISPR 11
Class A
The monitor is suitable for use in all
establishments, other than domestic
establishments and those directly connected to
the public low-
voltage power supply network
that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC/EN 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC/EN 61000-3-3
Complies
B.2 Electromagnetic Immunity - for all EQUIPMENT and
SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitor should assure that it is used in such an environment.
Immunity test IEC/EN 60601 test level Compliance level
Electromagnetic
environment -
guidance
Electrostatic
discharge (ESD)
IEC/EN 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile.
If floor are covered
with synthetic material,
the relative humidity
should be at least 30%.
Electrical fast
transient/burst
±2 kV for power supply
lines
±2kV for power
supply lines
Mains power quality
should be that of a