SE-1201 Electrocardiograph User Manual EMC Information
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Guidance and manufacture’s declaration - electromagnetic immunity -
for all EQUIPMENT and SYSTEMS
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
±
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
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
3A/m 3A/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
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
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 power
mains interruptions, it is
recommended that the
12-channel
electrocardiograph be
