maxium® smart C Electrosurgery Unit with maxium® smart Beam
Revision 1
121
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
Conducted RF
according to
IEC 61000-4-6
Radiated RF
according to
IEC 61000-4-3
6 V
eff
150 kHz to
80 MHz
10 V/m
80 MHz to
2.5 GHz
6 V
eff
150 kHz to
80 MHz
10 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
6
,
0
=
P
d
4
,
0
=
for 80 MHz to 800 MHz
P
d
7
,
0
=
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 10 V/m.
