Cochlear Baha 4 Manual Del Usuario página 10

Sound processor type designations for
models included in this User Manual are:
FCC ID QZ3BAHA4, IC: 8039C-BAHA4, IC model: Baha4.
Statement:
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired
operation.
Note: This equipment has been tested and found to
comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against
harmful interference in a residential installation.
This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful
interference to radio communications. However, there
is no guarantee that interference will not occur in a
particular installation. If this equipment does cause
harmful interference to radio or television reception,
which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and
receiver.
• Connect the equipment into an outlet on a circuit
different from the one in which the receiver is
connected.
• Consult the dealer or an experienced radio/TV
technician for help.
Changes or modifications can void the user´s authority to
operate the equipment .
Intended use
The Cochlear Baha 4 Sound Processor uses direct bone
™ ®
conduction to transmit sounds to the cochlea (inner ear).
It works by combining a sound processor and a small
titanium implant that is placed in the skull behind the
ear. The skull bone integrates with the titanium implant
through a process called osseointegration. This allows
sound to be conducted via the skull bone directly to the
cochlea, which improves hearing performance.
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List of countries:
Not all products are available in all markets. Product
availability is subject to regulatory approval in the
respective markets.
Specification of restrictions: You are not allowed to
operate the equipment within 20 km of the center of Ny
Ålesund, Norway.
The products are in compliance with the following
regulatory requirements:
• In EU: the device conforms to the Essential
Requirements according to Annex I of Council Directive
93/42/EEC for medical devices (MDD) and essential
requirements and other relevant provisions of Directive
1999/5/EC (R&TTE). The declaration of conformity may
be consulted at www.cochlear.com
• In US: FCC CFR 47 Part 15, subpart C, section 15.249.
• Other identified applicable international regulatory
requirements in countries outside the EU and US. Please
refer to local country requirements for these areas.
• In Canada the Sound Processor is certified under the
following certification number: IC: 8093C-BAHA4.
• This device complies with Industry Canada licence-
exempt RSS standard(s).
• This Class B digital apparatus complies with Canadian
ICES-003. Cet appareil numérique de la classe B est
conforme à la norme NMB-003 du Canada.
• Operation is subject to the following two conditions:
(1) this device may not cause interference, and (2)
this device must accept any interference, including
interference that may cause undesired operation
of the device. L'exploitation est autorisée aux deux
conditions suivantes : (1) l'appareil ne doit pas produire
de brouillage, et (2) l'utilisateur de l'appareil doit
accepter tout brouillage radioélectrique subi, même
si le brouillage est susceptible d'en compromettre le
fonctionnement.
Equipment includes RF transmitter.