maxium® smart C Electrosurgery Unit with maxium® smart Beam
120
Revision 1
Guidance and manufacturer’s declaration – Electromagnetic immunity
The device is designed for use in the electromagnetic environment specified below. The user of the device must
ensure that it is operated in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment –
Guidelines
Electrostatic discharge
(ESD) according to
IEC 61000-4-2
±6 kV contact discharge
±8 kV air discharge
±6 kV contact
discharge
±8 kV air discharge
Floors should be of wood or
concrete or covered with ceramic
tiles. If the floor is fitted with
synthetic material, relative
humidity must be at least 30%.
Electrical fast
transient/bursts
according to
IEC 61000-4-4
±2 kV for mains power
lines
±1 kV for input and
output lines
±2 kV for mains power
lines
±1 kV for input and
output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surges according to
IEC 61000-4-5
±1 kV symmetrical
voltage
±2 kV asymmetrical
voltage
±1 kV symmetrical
voltage
±2 kV asymmetrical
voltage
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
power interruptions
and supply voltage
fluctuations according
to IEC 61000-4-11
<5% U
T
(>95% drop of U
T
) for ½
period
40% U
T
(60% drop of U
T
) for 5
periods
70% U
T
(30% drop of U
T
) for 25
periods
<5% U
T
(>95% drop of U
T
) for 5
seconds
0% U
T
(100% drop of U
T
) for
½ period
40% U
T
(60% drop of U
T
) for 5
periods
70% U
T
(30% drop of U
T
) for 25
periods
0% U
T
(100% drop of U
T
) for 5
seconds
Mains power quality should be that
of a typical commercial or hospital
environment. If the user requires
continued operation during mains
power interruptions, it is
recommended to power the device
from an uninterruptible power
supply.
Magnetic field at
supply frequency
(50/60 Hz) according to
IEC 61000-4-8
30 A/m
30 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 a. c. mains voltage prior to application of the test level.
