GUIDANCE AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC IMMUNITY
The Compex stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of
the Compex stimulator should assure that it is used in such an environment.
IMMUNITY TEST
Electrostatic discharge
(ESD) IEC 61000-4-2
±2kV for power supply
Electrical fast
transient/burst
IEC 61000-4-4
±1kV for input/output
±1kV Line to Line (or
Surge
IEC 61000-4-5
±2kV line(s) to earth
(>95% dip in UT) for
Voltage dips, short
(60% dip in UT) for 5
interruptions and
voltage variations on
power supply
input lines
(30% dip in UT) for 25
IEC 61000-4-11 a
(>95% dip in UT) for
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
IEC 60601
COMPLIANCE LEVEL
TEST LEVEL
±6kV contact
±6kV contact
±8kV air
±2kV (power lines)
lines
Not Applicable
lines
±1kV Line to Line
Neutral)
Not Applicable
(Line to Earth)
<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)
5 sec
3 A/m
a UT is the a.c mains voltage prior to application of the test level.
ELECTROMAGNETIC ENVIRONMENT -
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
±8kV air
Mains power quality should be that of a
typical commercial or hospital environment.
(I/O lines)
Mains power quality should be that of a
typical commercial or hospital environment.
<5% UT
0,5 cycle
40% UT
Mains power quality should be that of a
typical commercial or hospital environment.
cycles
If the user of the Compex stimulator requires
continued operation during power mains
70% UT
interruptions, it is recommended that the
Compex stimulator be powered from an
cycles
uninterrupted power supply or a battery.
<5% UT
for 5 sec
Power frequency magnetic fields should be at
3 A/m
levels characteristic of a typical location in a
typical commercial or hospital environment.
EN
GUIDANCE
least 30%.
20