18
Guidance and manufacture’s declaration – electromagnetic immunity
The device
is intended for use in the electromagnetic environment specified below. The customer or the
user of device
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
±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 61000-4-4
±2 kV for power
supply lines
±2kV for power
supply lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
±1 kV differential
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 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
)
for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
<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
)
for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
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
(50Hz/60Hz)
magnetic field IEC
61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial
or
hospital
environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.