B Emc Information; Electromagnetic Emissions - For All Equipment And Systems; Electromagnetic Immunity - For All Equipment And Systems - EDAN iM80 User Manual

Patient Monitor User Manual

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
RF emissions
CISPR 11
RF emission
CISPR 11
Harmonic emissions
IEC/EN 61000-3-2
Voltage fluctuations/
flicker emissions
IEC/EN 61000-3-3
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
Electrostatic
discharge (ESD)
IEC/EN 61000-4-2
Electrical fast
transient/burst
Compliance
Group 1
Class A
Class A
Complies
IEC/EN 60601 test level
±6 kV contact
±8 kV air
±2 kV for power supply
lines
Electromagnetic environment – guidance
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.
The monitor is suitable for use in all
establishments,
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
Compliance level
±6 kV contact
±8 kV air
±2kV for power
supply lines
- 167 -
EMC Information
other than domestic
Electromagnetic
environment
guidance
Floors should be wood,
concrete or ceramic tile.
If floor are covered
with synthetic material,
the relative humidity
should be at least 30%.
Mains power quality
should be that of a
-