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Appendix E EMC information
EMC guidance and manufacturer’s declarations - Electromagnetic emissions -For all the
equipments and systems
EMC guidance and manufacturer’s declarations - Electromagnetic emissions
EM-301 electrocardiograph is intended for use in the electromagnetic environment specified below. The
customer or user of EM-301electrocardiograph should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment guidance
RF emissions
CISPR 11
Group 1
EM-301 electrocardiograph 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
Harmonic emissions
IEC 61000-3-2
Class B
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
EM-301electrocardiograph is suitable for use in all
establishments other than domestic and those directly
connected to the public low voltage power supply
network that supplies buildings used for domestic
purposes.
EMC guidance and manufacturer’s declarations - Electromagnetic emissions - For all the equipments and systems
EMC guidance and manufacturer’s declarations –Electromagnetic immunity
EM-301
、
EM-601 electrocardiograph is intended for use in the electromagnetic environment specified
below.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 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
±2 kV for power
supply
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
