Table 2 : Manufacturer's directives and declaration – Electromagnetic immunity
IMMUNITY TESTS
± 8 kV on contact
Electrostatic
± 2, 4, 6, 8 and
discharges (DES)
15 kV in the air
IEC 61000-4-2
± 2 kV for
electricity power
lines
Repeated fast
transients
± 1 kV for input/
IEC 61000-4-4
output lines
Repetition
frequency 100 kHz
± 0.5, ± 1 kV
Transitory over-
between phases
voltage
± 0.5, ± 1, ± 2kV
IEC 61000-4.-5
between phase
and earth
0% Ut for a
duration of 0.5
cycles at 0°, 45°,
90°, 135°, 180°,
225°, 270°, 315°
Voltage dips,
brief cut-offs and
0% Ut for a
voltage variations
duration of 1 cycle,
on electrical
70% for a duration
power input lines
of 25/30 cycles,
IEC 61000-4-11
both at 0°
0% for a duration
of 250/300 cycles
at 0°
TEST LEVEL
IEC 60601-1-2
± 8 kV on contact
± 2, 4, 6, 8 and
15 kV in the air
± 2 kV for
electricity power
lines
± 1 kV for input/
output lines
Repetition
frequency 100 kHz
± 0.5, ± 1 kV
between phases
± 0.5, ± 1, ± 2 kV
between phase and
earth
0% Ut for a duration
of 0.5 cycles at
0°, 45°, 90°, 135°,
180°, 225°, 270°,
315°
0% Ut for a duration
of 1 cycle,
70% for a duration
of 25/30 cycles,
both at 0°
0% for a duration
of 250/300 cycles
at 0°
LEVEL OF
COMPLIANCE
ENVIRONMENT - DIRECTIVES
Stimulation should not be
launched until the appliance has
been set up according to the
procedure described in §11.
Floors should be of wood,
concrete or ceramic tiles.
If floors are covered with
synthetic material, the relative
humidity of the floor should be
at least 30%.
The quality of the mains power
supply should be that of a
typical commercial or hospital
environment.
The quality of the mains power
supply should be that of a
typical commercial or hospital
environment.
The quality of the mains power
supply should be that of a
typical commercial or hospital
environment. If the
user requires continuous
running during power cuts,
they are recommended to
power the
uninterruptible power supply or
a battery.
ELECTROMAGNETIC
actiTENS
with an
actiTENS
95