Manufacturer's EMC Declaration
23
Page 80
Guidelines and manufacturer's declaration - electromagnetic immunity
The Soleo SonoStim/Soleo Galva device is designed for operation in the electromagnetic environment specified below. The
customer or the user of the Soleo SonoStim/Soneo Galva device should ensure that it is used in such an environment.
Immunity tests
IEC 60601 - Test
Level
Compliance level
Electromagnetic environment - Guidelines
Electrostatic discharge
(ESD) in accordance with
IEC 61000-4-2
± 6 kV contact
discharge
± 8 kV air discharge
± 6 kV contact
discharge
± 8 kV air discharge
Floors should be made from wood, concrete
or ceramic tiles. If floors are covered with
synthetic material, the relative humidity must
be at least 30%.
Electrical fast transient /
burst in accordance with
IEC 61000-4-4
± 2 kV for mains
cables
± 1 kV for input and
output cables
± 2 kV for mains
cables
Not applicable
The supply voltage quality must correspond to
that of a typical commercial or hospital
environment.
Surges in accordance with
IEC 6100-4-5
± 1 kV differential
mode
± 2 kV common mode
± 1 kV differential
mode
± 2 kV common
mode
The supply voltage quality must correspond to
that of a typical commercial or hospital
environment.
Voltage dips, short-term
interruptions and voltage
variations in accordance
with
< 5% U
T
(> 95% dip in U
T
for ½
period)
40% U
T
(60% dip in U
T
for 5
periods)
70% U
T
(30% dip in U
T
for 25
periods)
< 5% U
T
(> 95% dip in U
T
for 5
seconds)
< 5% U
T
(> 95% dip in U
T
for
½ period)
40% U
T
(60% dip in U
T
for 5
periods)
70% U
T
(30% dip in U
T
for 25
periods)
< 5% U
T
(> 95% dip in U
T
for
5 seconds)
The supply voltage quality must correspond to
that of a typical commercial or hospital
environment. If the user of the Soleo
SonoStim/Soneo Galva requires continued
operation, even in the case of interruptions in
the power supply, it is recommended that the
Soleo SonoStim/Soneo Galva be powered
from an uninterruptible power supply or a
battery.
Magnetic field of the
supply frequency (50/60
Hz) in accordance with
IEC 61000-4-8
3 A/m
3 A/m
Magnetic fields at mains frequency should
have the typical values found in a business or
hospital environment.
Note: U
T
is the mains AC voltage before application of the test level.
Table 202 according to EN 60601-1-2: 2006-10
