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Advanced Bionics Neptune Manual

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User Guide for the Neptune™ Sound Processor 47
Electrostatic
discharge (ESD)
IEC 61000-4-2
Power frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
Radiated RF
IEC 61000-4-3
Guidance and manufacturer’s declaration – electromagnetic immunity
The Neptune system is intended for use in the electromagnetic environment
specified below. The customer or the user of the Neptune system
should assure that it is used in such an environment.
Table 8: Guidance and Manufacturer’s Declaration-Electromagnetic immunity
Immunity test IEC 60601 Compliance level
a
Electromagnetic
test level environment - guidance
± 6 kV contact
± 8 kV air
3 A/m
3 V/m
80 MHz to 2.5
GHz
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
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 < 800 MHz
d = 2.3√P ≥ 800 MHz
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 fixed
RF transmitters, as determined by an
electromagnetic site survey,
b
should be
less than the compliance level in each
frequency range.
c
Interference may occur in the vicinity of
equipment marked with the following
symbol:
± 6 kV contact
± 8 kV air
3 A/m
3 V/m
Note 1: These guidelines may not apply in all
situations. Electromagnetic propagation is
affected by absorption and reflection from
structures, objects, and people.
a. Essential performance of the Neptune system per
IEC 60601 requirements is defined as auditory
stimulation within safe amplitudes.
b. Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured
field 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,
field strengths should be less than 3 V/m.
… 48 …


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