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Guidance And Manufacturer's Declaration - Advanced Bionics CI-5295 Manual

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Users of the Sky CI M90 sound processor are trained by their cochlear implant professional at the initial
fitting session.
End of Cybersecurity Support
Advanced Bionics products are supported until they no longer have regulatory approval in the country of
use or until the product is obsolesced by Advanced Bionics.

GUIDANCE AND MANUFACTURER'S DECLARATION:

Per IEC 60601-1-2
Electromagnetic Emissions
Emissions Test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Electromagnetic Immunity
The Sky CI M90 sound processor is intended for use in the electromagnetic environment specified below.
The customer or the user of the Sky CI M90 sound processor should assure that it is used in such an
environment.
Immunity
Electrostatic discharge
(ESD) IEC 61000-4-2
Compliance
Group 1
Class B
Not applicable
Not applicable
IEC 60601 Test Level
± 6 kV contact ± 8 kV air
Electromagnetic Environment - Guidance
The Sky CI M90 sound processor 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 Sky CI M90 sound processor 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
Compliance Level
± 6 kV contact ± 8 kV air
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%.
As with the operation of

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