12
EN
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of the stimulator
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
±8kV contact
±15kV air
±8kV contact
±15kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst IEC
61000-4-4
±2kV for power supply lines
±1kV 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
±1kV Line to Line
±2kV line(s) to earth
±1kV 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
stimulator requires continued operation
during power mains interruptions, it is
recommended that the stimulator be
powered from an uninterrupted power
supply or a battery.
Power frequency
(50/60Hz) 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.
SAFETY WARNING
UT is the a.c mains voltage prior to application of the test level.
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