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Digital Color Doppler Palm Ultrasound System
70
2. Guidance and manufacturer’s declaration – electromagnetic immunity
The SonoEye is intended for use in the electromagnetic environment the SonoEye should
assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment –
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Power
frequency
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical
commercial or hospital
Radiated RF EM
fields IEC61000-4-3
3V/M
80MHz-2.7GHz
80%AM at 1KHz
3V/M
80MHz-2.7GHz
80%AM at 1KHz
Radiated RF EM fields
should be at levels
characteristic of a
typical location in a
typical
commercial or hospital
environment.
Proximity fields from
RF wireless
communications
equipment
IEC 61000-4-3
See teble 9
See table 9
Proximity fields from RF
wireless
communications
equipment should be at
levels characteristic of a
typical location in a
typical
commercial or hospital
environment.
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