23
EN
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The Compex stimulator is intended for use in the electromagnetic environment specied below. The customer or the user of the Compex
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
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood, concrete or ceramic tile.
If oors 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 (power lines)
Not Applicable
(I/O lines)
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1kV Line to Line (or
Neutral)
±2kV line(s) to earth
±1kV Line to Line
Not Applicable
(Line to Earth)
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 a
<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 Compex stimulator requires continued
operation during power mains interruptions, it
is recommended that the Compex stimulator be
powered from an uninterrupted power supply or
a battery.
Power frequency
(50/60Hz) magnetic eld
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic elds should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
a UT is the a.c mains voltage prior to application of the test level.
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