Instructions for Use
Electrosurgical Unit ME 102
V. 3.1
39
Guidance and manufacturer’s declaration according to IEC 60601-1-2,
clause 6.8.3.201 a) 3) Table 201: Electromagnetic emission
The device is intended for use in an electromagnetic environment as specified below. The user should
assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment – Guidance
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 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
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge 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
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% 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
0% U
T
(100% 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
0% U
T
(100% dip in 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.
Power frequency
(50 / 60 Hz)
magnetic field
according to
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 a. c. mains voltage prior to application of the test level.
