Instructions for Use
Electrosurgical Unit ME 102
40
V. 3.1
Guidance and manufacturer’s declaration according to IEC 60601-1-2,
clause 6.8.3.201 b) Table 204: Electromagnetic immunity
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
Conducted RF
according to
IEC 61000-4-6
Radiated RF
according to
IEC 61000-4-3
3 V
eff
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V
eff
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Portable and mobile RF communications equip-
ment should be used no closer to any part of
the device (including cables) than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance:
P
d
17
.
1
=
P
d
17
.
1
=
for 80 MHz to 800 MHz
P
d
33
.
2
=
for 800 MHz to 2.5 GHz
where
P
is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and
d
is the
recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a
,
should be less than the compliance level in
each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following symbol.
Note 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2:
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio stations and AM and FM radio and TV stations, cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the device is used exceeds the applicable RF compliance level specified above, the
device should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the device.
b
Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
