Creo Medical CROMA Instrucciones De Uso página 46

Specifications
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Electrosurgical Generator is intended for use in the electromagnetic environment specified below. The customer or the user
of the Electrosurgical Generator should ensure that it is used in such an environment.
Immunity Test IEC 60601-1-2 Test Level
6Vrms in ISM bands
between 0.15MHz and
80MHz.
The ISM (industrial, scientific
and medical) bands between
-
0.15 MHz 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.
Conducted RF
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3 80 MHz to 2.7 GHz
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
a
amateur radio, AM and FM radio broadcast and TV broadcast 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 Electrosurgical Generator is used exceeds the applicable RF compliance level above, the
Electrosurgical Generator should be observed to verify normal operation. If abnormal performance is observed, additional mea-
sures may be necessary, such as reorienting or relocating the Electrosurgical Generator.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
Electromagnetic Immunity Notes:
A = Performance of the generator remains unaffected.
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Compliance
Level
3 Vrms
A
3 V/m
A
Electromagnetic Environment – Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Electrosurgical
Generator, including cables, than the recommended
separation distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended Separation Distance
-
d = [1.17]√P
d = [1.17]√P 80 MHz to 800 MHz
d = [2.33]√P 800 MHz to 2.7 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
compliance level in each frequency range
Interference may occur in the vicinity of equipment marked
with the following symbol:
should be less than the
a
.
b