Electrosurgical Unit Minicutter
Revision 08
47
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
HF conducted
disturbances
according to
IEC 61000-4-6
3 V
eff
150 kHz to
80 MHz
6 V
eff
a
in ISM
frequency
bands
150 kHz to
80 MHz
3 V
eff
150 kHz to
80 MHz
6 V
eff
a
in ISM
frequency
bands
150 kHz to
80 MHz
Portable or mobile radio equipment should be used no
closer to the device (including cables) than the
recommended separation distance of 30 cm (12″).
Field strengths from stationary radio emitters, as
determined by an electromagnetic site survey
b
, 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.
HF radiated
disturbances
according to
IEC 61000-4-3
3 V/m
80 MHz to
2.7 GHz
3 V/m
80 MHz to
2.7 GHz
Note
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
The ISM bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957
MHz to 27.283 MHz, and 40.66 MHz to 40.70 MHz.
b
Field strengths from stationary transmitters, such as base
stations for radio (cellular/cordless) telephones and mobile land radio units, amateur radio stations and AM and
FM radio and TV stations, cannot be predicted precisely by theory. 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.
