Advanced Bionics NEPTUNE Manual De Uso página 47

Table 8: Guidance and Manufacturer's Declaration-Electromagnetic immunity
Guidance and manufacturer's declaration – electromagnetic immunity
The Neptune system is intended for use in the electromagnetic environment
specifi ed below. The customer or the user of the Neptune system
should assure that it is used in such an environment.
Immunity test IEC 60601
test level
± 6 kV contact
Electrostatic
± 8 kV air
discharge (ESD)
IEC 61000-4-2
3 A/m
Power frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
3 V/m
Radiated RF
80 MHz to 2.5
IEC 61000-4-3
GHz
Note 1: These guidelines may not apply in all
situations. Electromagnetic propagation is
affected by absorption and refl ection from
structures, objects, and people.
a. Essential performance of the Neptune system per
IEC 60601 requirements is defi ned as auditory
stimulation within safe amplitudes.
b. Field strengths from fi xed transmitters, such
as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio,
AM and FM radio broadcast, and TV broadcast
cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due
to fi xed RF transmitters, an electromagnetic site
survey should be considered. If the measured
fi eld strength in the location in which the
Neptune system is used exceeds the applicable
RF compliance level above, the Neptune systems
should be observed to verify normal operation.
c. Over the frequency range 150 kHz to 80 MHz,
fi eld strengths should be less than 3 V/m.
a
Compliance level
± 6 kV contact Floors should be wood, concrete or
± 8 kV air ceramic tile. If fl oors are covered with
synthetic material, the relative humidity
should be at least 30 %.
3 A/m Power frequency magnetic fi elds should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
3 V/m Portable and mobile RF
communications equipment should
be used no closer to any part of the
Neptune system, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d = 1.2√P
d = 2.3√P
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
metres (m). Field strengths from fi xed
RF transmitters, as determined by an
electromagnetic site survey,
less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
User Guide for the Neptune™ Sound Processor 47
Electromagnetic
environment - guidance
< 800 MHz
≥ 800 MHz
b should be
c