Electrosurgical Unit Minicutter
46
Revision 08
Guidance and manufacturer’s declaration – Electromagnetic immunity
The device is intended for use in an electromagnetic environment as specified below. The user of the device must
ensure that it is used in such an environment.
Immunity tests
IEC 60601 test level
Compliance level
Electromagnetic environment
– Guidance
Electrostatic discharge
(ESD) according to
IEC 61000-4-2
±8 kV contact discharge
±15 kV air discharge
±8 kV contact discharge
±15 kV air discharge
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Fast electrical
transients/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
The quality of the supply
voltage should be that of a
typical commercial or hospital
environment.
Surges according to
IEC 61000-4-5
±1 kV differential-mode
voltage
±2 kV common-mode
voltage
±1 kV differential-mode
voltage
±2 kV common-mode
voltage
The quality of the supply
voltage 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
0% U
T
(100% dip in U
T
) for
½ period at 0.45, 90,
135, 180, 225, 270 and
315 degrees
0% U
T
(100% dip in U
T
) for
1 period
70% U
T
(30% dip in U
T
) for
25/30 periods, single-
phase at 0 degrees
0% U
T
(100% dip in U
T
) for
250/300 periods
0% U
T
(100% dip in U
T
) for
½ period at 0.45, 90,
135, 180, 225, 270 and
315 degrees
0% U
T
(100% dip in U
T
) for
1 period
70% U
T
(30% dip in U
T
) for
25/30 periods, single-
phase at 0 degrees
0% U
T
(100% dip in U
T
) for
250/300 periods
The quality of the supply
voltage should be that of a
typical commercial or hospital
environment. If during
activation of HF output power
any perceptible problems with
the power supply should occur,
it is recommended to feed the
device from an uninterruptible
power supply.
Supply-frequency
(50/60 Hz) magnetic field
according to IEC 61000-4-8
30 A/m
30 A/m
Magnetic fields at mains
frequency should conform to
the typical values as found in
industrial or hospital
environments.
Note
U
T
is the AC mains voltage prior to application of the test levels.
