Zimmer Soleo Sono, Инструкция по эксплуатации, Страница: 47 / 52

Manufacturer's EMC Declaration
19
Page 38
Guidelines and manufacturer's declaration - electromagnetic immunity
The Soleo Sono device is intended for use in an electromagnetic environment, as specified below. The customer or the user
of the Soleo Sono 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
Not applicable 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 Sono
requires continued operation, even in the case
of interruptions in the power supply, it is
recommended that the Soleo Sono 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