EDAN SE-12 Series - Electromagnetic immunity

SE-12 Series Electrocardiograph User Manual EMC Information
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Electromagnetic immunity
Guidance and manufacture's declaration – electromagnetic immunity
The 12-channel electrocardiograph is intended for use in the electromagnetic environment
specified below. The customer or the user of 12-channel electrocardiograph 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
8 kV contact
15 kV air
8 kV contact
15 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
IEC/EN 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/EN 61000-4-5
1 kV line to line
2 kV line to
ground
1 kV line to line
2 kV line to ground
Mains power quality should be
that of a typical commercial or
hospital environment.
Power frequency
(50Hz/60Hz)
magnetic field
IEC/EN 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 environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC/EN 61000-4-11
0 % U
T;
0.5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0 % U
T
; 1 cycle
0 % U
T;
0.5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0 % U
T
; 1 cycle
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the 12-channel
electrocardiograph requires
continued operation during