7
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 COMPLIANCE LEVEL ELECTROMAGNETIC
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV ai
±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 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
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)
± 2 kV line(s) to earth
±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% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
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
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.
NOTE: UT is the a.c. mains voltage prior to application of the test level.