Cochlear Baha 4 User Manual

Manufacturer:
Cochlear Bone Anchored Solutions AB Konstruktionsvägen 14, SE - 435 33 Mölnlycke, Sweden Tel: +46 31 792 44 00 Fax: +46 31 792 46 95
Regional offices:
Cochlear Ltd (ABN 96 002 618 073) 1 University Avenue, Macquarie University NSW 2109, Australia Tel: +61 2 9428 6555 Fax: +61 2 9428 6352
Cochlear Americas 13059 E Peakview Avenue, Centennial, CO 80111, USA Tel: +1 303 790 9010 Fax: +1 303 792 9025
Cochlear AG EMEA Headquarters, Peter Merian-Weg 4, 4052 Basel, Switzerland Tel: +41 61 205 0404 Fax: +41 61 205 0405
Local offices:
Cochlear Deutschland GmbH & Co. KG Karl-Wiechert-Allee 76A, D-30625 Hannover, Germany Tel: +49 511 542 770 Fax: +49 511 542 7770
Cochlear Europe Ltd 6 Dashwood Lang Road, Bourne Business Park, Addlestone, Surrey KT15 2HJ, United Kingdom Tel: +44 1932 87 1500 Fax: +44 1932 87 1526
Nihon Cochlear Co Ltd Ochanomizu-Motomachi Bldg, 2-3-7 Hongo, Bunkyo-Ku, Tokyo 113-0033, Japan Tel: +81 3 3817 0241 Fax: +81 3 3817 0245
Cochlear (HK) Limited Unit 1810, Hopewell Centre, 183 Queens Road East, Wan Chai, Hong Kong SAR Tel: +852 2530 5773 Fax: +852 2530 5183
Cochlear Medical Device (Beijing) Co LtdUnit 2208-2212, Tower B, No.9 Gemdale Building, No.91 Jianguo Road, Chaoyang District, Beijing, PR China 100022
P.R. CHINA Tel: +86 10 5909 7800 Fax: (+86 10) 5909 7900
Cochlear Limited (Singapore Branch) 6 Sin Ming Road, #01-16 Sin Ming Plaza Tower 2, Singapore 575585 Tel: +65 6553 3814 Fax: +65 6451 4105
Cochlear Korea Ltd 1st floor, Cheongwon building, 828-5, Yuksam dong, Kangnam gu, Seoul, Korea Tel: +82 2 533 4663 Fax: +82 2 533 8408
Cochlear Benelux NV Schaliënhoevedreef 20 1, B - 2800 Mechelen, Belgium Tel: +32 1579 5511 Fax: +32 1579 5500
Cochlear Medical Device Company India (P) Ltd Platina Building, Ground Floor, Plot No. C-59, G-Block, BKC, Bandra (E), Mumbai – 400 0051, India
Tel: +91 22 6112 1111 Fax: +91 22 61121100
Cochlear Italia S.r.l Via Larga n°33, 40138 Bologna, Italia Tel: +39 051 601 53 11 Fax: +39 051 39 20 62
Cochlear France S.A.S. Route de l'Orme aux Merisiers, Z.I. Les Algorithmes - Bât. Homère, 91190 Saint Aubin, France Tel: +33 811 111 993 Fax: +33 160 196 499
Cochlear Nordic AB Konstruktionsvägen 14, SE - 435 33 Mölnlycke, Sweden Tel: +46 31 335 14 61 Fax: +46 31 335 14 60
Cochlear Tıbbi Cihazlar ve Sa‹lık Hizmetleri Ltd. Sti. Cubuklu Mah. Bogazici Cad., Bogazici Plaza No: 6/1, Kavacik,TR - 34805 Beykoz-Istanbul, Turkey
Tel: +90 216 538 5900 Fax: +90 216 538 5919
Cochlear Canada Inc 2500-120 Adelaide Street West, Toronto, ON M5H 1T1 Canada Tel: +1 416 972 5082 Fax: +1 416 972 5083
www.cochlear.com
Ardium, Baha, Baha Divino, Baha Intenso, Baha PureSound, Baha SoftWear, DermaLock, Vistafix and
WindShield are either trademarks or registered trademarks of Cochlear Bone Anchored Solutions
AB. Cochlear, Hear Now. And always and the elliptical logo are either trademarks or registered
trademarks of Cochlear Limited.
© Cochlear Bone Anchored Solutions AB 2013. All rights reserved. OCT13.
Baha 4 Sound Processor
®
User manual part A
3 11 19 27 35
GB SV DA FI NO
English Svenska Dansk Suomi Norsk ZONE 3
Sound processor type designations for
List of countries:
Not all products are available in all markets. Product
models included in this User Manual are:
availability is subject to regulatory approval in the
FCC ID QZ3BAHA4, IC: 8039C-BAHA4, IC model: Baha4.
respective markets.
Statement:
Specification of restrictions: You are not allowed to
This device complies with Part 15 of the FCC Rules. Op-
operate the equipment within 20 km of the center of Ny
eration is subject to the following two conditions: (1) this
Ålesund, Norway.
device may not cause harmful interference, and (2) this
The products are in compliance with the following
device must accept any interference received, including
regulatory requirements:
interference that may cause undesired operation.
• In EU: the device conforms to the Essential
Requirements according to Annex I of Council Directive
Note: This equipment has been tested and found to
93/42/EEC for medical devices (MDD) and essential
comply with the limits for a Class B digital device,
requirements and other relevant provisions of Directive
pursuant to part 15 of the FCC Rules. These limits are
1999/5/EC (R&TTE). The declaration of conformity may
designed to provide reasonable protection against
be consulted at www.cochlear.com
harmful interference in a residential installation.
• In US: FCC CFR 47 Part 15, subpart C, section 15.249.
This equipment generates, uses and can radiate radio
• Other identified applicable international egulatory
frequency energy and, if not installed and used in
requirements in countries outside the EU and US. Please
accordance with the instructions, may cause harmful
refer to local country requirements for these areas.
interference to radio communications. However, there
• In Canada the Sound Processor is certified under the
is no guarantee that interference will not occur in a
following certification number: IC: 8093 -BAHA4.
particular installation. If this equipment does cause
• This device complies with Industry Canada licence-
harmful interference to radio or television reception,
exempt RSS standard(s).
which can be determined by turning the equipment
• This Class B digital apparatus complies with Canadian
off and on, the user is encouraged to try to correct the
ICES-003. Cet appareil numérique de la classe B est
interference by one or more of the following measures:
conforme à la norme NMB-003 du Canada.
• Reorient or relocate the receiving antenna.
• Operation is subject to the following two conditions:
• Increase the separation between the equipment and
(1) this device may not cause interference, and (2)
receiver.
this device must accept any interference, including
• Connect the equipment into an outlet on a circuit differ-
interference that may cause undesired operation
ent from the one in which the receiver is connected.
of the device. L'exploitation est autorisée aux deux
• Consult the dealer or an experienced radio/TV technician
conditions suivantes : (1) l'appareil ne doit pas produire
for help.
de brouillage, et (2) l'utilisateur de l'appareil doit
Changes or modifications can void the user´s authority to
accepter tout brouillage radioélectrique subi, même
operate the equipment .
si le brouillage est susceptible d'en compromettre le
Intended use fonctionnement.
The Cochlear ™ Baha ® 4 Sound Processor uses direct bone
conduction to transmit sounds to the cochlea (inner ear). Equipment includes RF transmitter.
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.