Cochlear 8039C-BAHA5SUP User Manual Download

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Cochlear Bone Anchored Solutions AB

Konstruktionsvägen 14, 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 8204 Fax: +41 61 205 0405

Cochlear Latinoamerica, S. A.

International Business Park Building 3835, Office 403, Panama Pacifico, Panama Tel. +507 830 6220 Fax: +507 830 6218

Local offices:

Cochlear Deutschland GmbH & Co. KG

Karl-Wiechert-Allee 76A, 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 26 3400 Fax: +44 1932 26 3426

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 1204, 12/F, 297-307 Hennessy Road, Wan Chai, Hong Kong Tel: +852 2530 5773 Fax: +852 2530 5183

Cochlear Medical Device (Beijing) Co Ltd

Unit

2208-2212, Gemdale Tower B, 91 Jianguo Road, Chaoyang District, Beijing 100022, PR China

Tel: +86 10 5909 7800 Fax: +86 10 5909 7900

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 I, 2800 Mechelen, Belgium Tel: +32 1579 5511 Fax: +32 1579 5500

Cochlear Medical Device Company India PVT Ltd

Platina Bldg, Ground Floor, Plot No. C 59, G Block, BKC, Bandra East, Mumbai 400051, India

Tel: +91 22 6112 1111 Fax: +91 22 61121100

Cochlear Italia

SRL

Via Larga 33, 40138 Bologna, Italy Tel: +39 051 601 53 11 Fax: +39 051 39 20 62

Cochlear France S.A.S.

135 route de Saint Simon, 31100 Toulouse, France Tel: +33 5 34 63 85 85 (international) Tel: 0805 200 016 (national)

Fax: +33 5 34 63 85 80

Cochlear Nordic AB

Konstruktionsvägen 14, 435 33 Mölnlycke, Sweden Tel: +46 31 335 14 61 Fax: +46 31 335 14 60

Cochlear Tıbbi Cihazlar ve Sağlık Hizmetleri Ltd. Sti.

Cubuklu Mah. Bogazici Cad. Bogazici Plaza No: 6/1 Kavacik, 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

The Cochlear Baha 5 SuperPower Sound Processor is compatible with iPhone 6 Plus, iPhone 6, iPhone 5s,
iPhone 5c, iPhone 5, iPad Air 2, iPad Air, iPad (4th generation), iPad mini 3, iPad mini 2, iPad mini and iPod
touch (5th generation) using iOS 7.* or later.

Ardium, Baha, Baha SoftWear, BCDrive, DermaLock, Vistafix and Windshield are either trademarks or registered
trademarks of Cochlear Bone Anchored Solutions AB. Cochlear, Nucleus, SmartSound, SnugFit, Hear now. And
always and the elliptical logo are either trademarks or registered trademarks of Cochlear Limited. The Bluetooth
word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by
Cochlear Limited is under license. Apple, iPhone, iPad and iPod touch are trademarks of Apple Inc., registered in
the U.S. and other countries. © Cochlear Bone Anchored Solutions AB 2016. All rights reserved. MAY16.

“Made for iPhone” means that an electronic accessory has been designed to connect specifically to iPhone
and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the
operation of this device or its compliance with safety and regulatory standards. Please note that the use of this
accessory with iPhone may affect wireless performance.

Translations of 631286-3.

Sound processor type designations for
models included in this User Manual are:

FCC ID: QZ3BAHA5SUP, IC: 8039C-BAHA5SUP, IC model:
Baha

5 SUP.

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

5 SuperPower Sound Processor

(Baha 5 SUP) uses 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.

List of countries:
Not all products are available in all markets. Product
availability is subject to regulatory approval in the
respective markets.
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.

• 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: 8039C-BAHA5SUP
and model no.: IC model: Baha

5 SUP.

• 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