Guidance And Manufacturer's Declaration; Electromagnetic Emissions; Electromagnetic Immunity; Separation Distances Between Rf Communications Equipment And Naída Ci - Advanced Bionics Naida Cl Q70 Manual De Instrucciones

Guidance and Manufacturer's Declaration

Per IEC 60601-1-2

Electromagnetic Emissions

The Naída CI is intended for use in the electromagnetic environment specified below. The customer or
the user of the Naída CI should ensure that it is used in such an environment.
Emissions Test Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Not applicable
IEC 61000-3-2
Voltage fluctuations/ flicker emissions
Not applicable
IEC 61000-3-3

Electromagnetic Immunity

The Naída CI is intended for use in the electromagnetic environment specified below. The customer or
the user of the Naída CI should ensure that it is used in such an environment.
IEC 60601
Immunity Test
Compliance level
Test level
Electrostatic
± 6 kV
± 6 kV contact
discharge (ESD)
contact
± 8 kV air
IEC 61000-4-2 ± 8 kV air
Power frequency
(50/60 Hz)
3 A/m 3 A/m
magnetic field
IEC 61000-4-8
3 V/m
Radiated RF
80 MHz to 3 V/m
IEC 61000-4-3
2.5 GHz
58
Naída CI Sound Processor User Guide
Electromagnetic Environment-Guidance
The Naída CI uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
The Naída CI is suitable for use in all
establishments, including domestic establishments
and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes.
a Electromagnetic Environment-Guidance
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 Naída CI,
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
P
where 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, should be less than the compliance level
b
in each frequency range. c
Interference may occur in the vicinity of
equipment marked with the following symbol:
These guidelines may not apply in all situations. Electromagnetic propagation
NOTE:
is affected by absorption and reflection from structures, objects and people.
a Essential performance of the Naída CI 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 Naída CI is used exceeds the applicable RF compliance level above, the Naída CI 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.
Separation Distances between RF Communications Equipment and Naída CI
Recommended separation distances between portable and mobile
RF communications equipment and the Naída CI
The Naída CI is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the Naída CI can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Naída CI as recommended below, according to the maximum output power of
the communications equipment.
Rated Maximum Output
Power of Transmitter
(w)
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
These guidelines may not apply in all situations. Electromagnetic propagation
NOTE:
is affected by absorption and reflection from structures, objects and people.
Separation distance according to frequency of transmitter
(m)
d d
= 1.2√P < 800 MHz = 1.2√P < 800 MHz
0.12 0.23
0.38 0.73
1.2 2.3
3.8 7.3
12
Naída CI Sound Processor User Guide
23
59