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EMC Guidance
Table 2: Guidance and MANUFACTURER'S declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer's declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should
assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Electrostatic
±6 kV contact
discharge (ESD)
±8 kV air
IEC 61000-4-2
Electrical fast
±2 kV for power
transient / burst
supply lines
IEC 61000-4-4
± 1 kV for input /
output lines
Surge
±1 kV line(s)
IEC 61000-4-5
to line(s)
± 2 kV line(s) to
earth
Voltage dips, short
<5% U
interruptions and
(>95% dip in U
voltage variations on
for 0.5 cycle
power supply input
40% U
lines
(60% dip in U
IEC 61000-4-11
for 5 cycles
70% U
(30% dip in U
for 25 cycles
<5% U
(>95% dip in U
for 5 s
Power frequency
3A / m
(50 / 60 Hz) magnetic
field
IEC 61000-4-8
NOTE U
is the a.c. mains voltage prior to application of the test level.
T
Compliance level
±6 kV contact
±8 kV air
Not applicable
Not applicable
Not applicable
T
)
T
T
)
T
T
)
T
T
)
T
3A / m
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
device requires continued operation during power
mains interruptions, it is recommended that the device
be powered from an uninterruptible power supply or
a battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
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