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Manufacturer's EMC declaration
29
Guidance and manufacturer's declaration – electromagnetic immunity
The Soleo SonoStim / Soleo Stim is intended for use in one of the electromagnetic environments specified below. The
customer or the user of the Soleo SonoStim / Soleo Stim device should ensure that the device is used in such an
environment.
Immunity tests
IEC 60601 test level
Compliance level
Electromagnetic environment - Guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV 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
± 2 kV for mains power
lines
± 1 kV for input/output
lines
± 2 kV for mains
power lines
Not applicable
The quality of the supply voltage should
correspond to a typical business or hospital
environment.
Surge
IEC 6100-4-5
± 1 kV differential
mode
± 2 kV common mode
± 1 kV differential
mode
± 2 kV common
mode
The quality of the supply voltage should
correspond to a typical business or hospital
environment.
The quality of the supply
voltage should correspond
to a typical business or
hospital environment.
<5% U
T
(>95% dip in U
T
for 0.5
cycle)
40% U
T
(>60% dip in U
T
for 5
cycles)
70% U
T
(>30% dip in U
T
for 25
cycles)
<5% U
T
(>95% dip in U
T
for 5
sec)
<5% U
T
(>95% dip in U
T
for
0.5 cycle)
40% U
T
(>60% dip in U
T
for 5
cycles)
70% U
T
(>30% dip in U
T
for
25 cycles)
<5% U
T
(>95% dip in U
T
for 5
sec)
Mains power quality should be that of a typical
commercial or hospital environment. If the
user of the Soleo SonoStim / Soleo Stim
requires continued operation during power
mains interruptions, it is recommended that
the Soleo SonoStim / Soleo Stim be powered
from an uninterruptible power source.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Note: U
T
is the AC mains voltage prior to application of the test level.
Table 202 as per EN 60601-1-2:2006-10
