51
IMPLANTEO
®
Directives and manufacturer’s declaration – Electromagnetic immunity
The
IMPLANTEO®
is intended to be used in the electromagnetic environment specifi ed below.
The customer or user of the
IMPLANTEO®
must ensure that it is used in such an environment
Immunity test
Test level CEI 60601
Compliance level
Electromagnetic environment - directives
RF disturbances
CEI 61000-4-6
3 Veff
from 150 kHz to 80 MHz
3 V
Portable and mobile RF communications devices must
not be used near any part of the IMPLANTEO®, including
the cables, for the recommended separation distance,
calculated from the equation applicable to the frequency
of the emitter.
Recommended separation distance
d=1,2
√
P
Radiated RF
disturbances
CEI 61000-4-3
3 V/m
from 80 MHz to 2,5 GHz
10 V/m
d=0,4
√
P from 80 MHz to 800 MHz
d=0,7
√
P from 800 MHz to 2,5 GHz
where P is the power characteristic for maximum output
of the emitter in watts (W), according to the manufacturer
of the emitter and d is the recommended separation
distance in metres (m). The strengths of the fi xed RF,
determined by an electromagnetic investigation on site a,
must be less than the compliance level, in each frequency
range b. Interference can occur near the device marked
with the following symbol:
H
NOTE 1 :
to 80 MHz and at 800 MHz, the highest frequency range applies.
NOTE 2 :
these directives do not apply in all situations. Electromagnetic propagation is affected by absorption and by the refl ections
of structures, objects and individuals.
a
The strengths of fi xed emitter fi elds, such as base stations for radiotelephones (cellular/cordless) and terrestrial mobile radios, amateur
radio, AM and FM broadcasting, and TV broadcasting , cannot be theoretically tested with accuracy. To assess the electromagnetic
environment due to fi xed RF emitters, an electromagnetic investigation must be considered on site. If the strength of the fi eld, measured
in the location where the
IMPLANTEO®
is used, exceeds the RF compliance level applicable above, the
IMPLANTEO®
should be observed
to check that it is working normally. If abnormal performance is found, additional steps may be necessary such as redirecting or repositioning
the
IMPLANTEO®
.
b
For the frequency range from 150 kHz to 80 MHz, the strengths of the fi eld must be less than 3 V/m.
Fr
anç
ais
English
Español
Italiano
Deutsch
Português
