Cochlear Baha 5 SuperPower User Manual

SE Cochlear Bone Anchored Solutions AB, Konstruktionsvägen 14, 435 33 Mölnlycke, Sweden. Tel:+46 31 792 44 00
AU Cochlear Ltd, (ABN 96 002 618 073), 1 University Avenue, SE Cochlear Nordic AB, Konstruktionsvägen 14, 435 33 Mölnlycke,
Macquarie University, NSW 2109 Australia. Tel:+61 2 9428 6555 Sweden. Tel:+46 31 335 14 61
US Cochlear Americas, 10350 Park Meadows Drive, Lone Tree, CA Cochlear Canada Inc, 2500-120 Adelaide Street West, Toronto,
CO 80124, USA. Tel:+1 303 790 9010 ON M5H 1T1, Canada. Tel:+1 800 483 3123
Cochlear AG, Peter Merian-Weg 4, 4052 Basel, Nihon Cochlear Co Ltd, Ochanomizu-Motomachi
CH JP
Switzerland. Tel:+41 61 205 8204 Bldg 2-3-7 Hongo, Bunkyo-Ku, Tokyo 113-0033,
Japan. Tel:+81 3 3817 0241
PA Cochlear Latinoamerica, S. A.,
International Business Park Building 3835, Office 403 Panama Pacifico, SG Cochlear Limited (Singapore Branch),
Panama. Tel:+507 830 6220 238A Thomson Road #25-06, Novena Square Office Tower A,
Singapore 307684, Singapore. Phone: +65 65533814
UK Responsible Person: Cochlear Europe Ltd,
GB
Cochlear Medical Device (Beijing) Co Ltd, Unit 2608-2617,
6 Dashwood Lang Road, Bourne Business Park, Addlestone, Surrey, CN
KT15 2HJ, United Kingdom. Tel:+44 1932 26 3400 26th Floor, No.9 Building, No.91 Jianguo Road, Chaoyang District,
Beijing 100022, P.R. China. Tel:+86 10 5909 7800
DE Cochlear Deutschland GmbH & Co. KG, Mailänder Straße 4a,
30539 Hannover, Germany. Tel:+49 511 542 770 HK Cochlear (HK) Ltd, Room 1404-1406, 14/F, Leighton Centre,
77 Leighton Road, Causeway Bay, Hong Kong. Tel:+852 2530 5773
BE Cochlear Benelux NV, Schaliënhoevedreef 20 I,
2800 Mechelen, Belgium. Tel:+32 15 79 55 11 Cochlear Medical Device Company India PVT Ltd,
IN
Platina Bldg, Ground Floor, Plot No. C 59, G Block, BKC, Bandra East,
Cochlear France S.A.S., 135 route de Saint Simon,
FR
Mumbai 400051 India. Tel:+91 22 6112 1111
31035 Toulouse, France. Tel:+33 5 34 63 85 85 (international),
Tel: 0805 200 016 (national) CO Cochlear Colombia,
Avenida Carrera 9 #115-06 Of. 1201 Edificio Tierra Firme,
IT Cochlear Italia s.r.l, Via Trattati Comunitari Europei
Bogota D.C., Colombia. Tel:+57 315 339 7169 / +57 315 332 5483
1957 2007 n.17, 40127 Bologna (BO) Italy. Tel:+39 051 601 53 11
Cochlear México S.A. de C.V, Av. Tamaulipas 150 Torre A piso 9,
MX
Cochlear Tıbbi Cihazlar ve Sağlık
TR
Col. Hipódromo Condesa, 06170 Cuauhtémoc, Ciudad de México,
Hizmetleri Ltd. Sti., Küçükbakkalköy Mah, Defne Sok, Büyükhanlı
México. Tel:+52 0155 5256 2199
Plaza No:3 Kat:3 Daire: 9-10-11-12, 34750, Ataşehir, İstanbul,
Türkiye. Tel:+90 216 538 59 00
www.cochlear.com
Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional
will advise you about the factors which could affect your outcome. Always follow the directions for use. Not all products are available in all
countries. Please contact your local Cochlear representative for product information. In Australia, Baha bone conduction implant systems
are intended for the treatment of moderate to profound hearing loss. For the Cochlear Baha System in Australia: This product is not
available for purchase by the general public. For information on funding and reimbursement please contact your healthcare professional.
Cochlear, Baha, 科利耳, コクレア, 코클리어, Hear now. And always, SmartSound, the elliptical logo, and marks bearing an ® or ™ symbol,
are either trademarks or registered trademarks of the Cochlear group of companies (unless otherwise noted).
Apple, the Apple logo, iPhone, iPad and iPod are trademarks of Apple Inc., registered in the U.S. and other countries.
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.
© Cochlear Bone Anchored Solutions AB 2022. All rights reserved. 2022-12
P2046687 D2046713-V1
Cochlear™
Baha® 5 SuperPower Sound Processor
User manual part A
3
EN-US
ZONE EN-US
English
Sound processor type designations for
The fitting is to be done either at a hospital, by an
audiologist, or in some countries, by a hearing care
models included in this User Manual are:
professional.
FCC ID: QZ3BAHA5SUP, IC: 8039C-BAHA5SUP, IC model:
Baha ® 5 SUP.
List of countries:
Not all products are available in all markets. Product
Statement:
availability is subject to regulatory approval in the
This device complies with Part 15 of the FCC Rules.
respective markets.
Operation is subject to the following two conditions:
The products are in compliance with the following
(1) this device may not cause harmful interference, and
regulatory requirements:
(2) this device must accept any interference received,
• In EU: the device conforms to the Essential Requirements
including interference that may cause undesired operation.
according to Annex I of Council Directive 93/42/EEC for
Note: This equipment has been tested and found to
medical devices (MDD) and essential requirements and
comply with the limits for a Class B digital device, pursuant
other relevant provisions of Directive 2014/53/EU (RED).
to part 15 of the FCC Rules. These limits are designed to
The declaration of conformity may be consulted at www.
provide reasonable protection against harmful interference
cochlear.com.
in a residential installation. This equipment generates, uses
• Other identified applicable international regulatory
and can radiate radio frequency energy and, if not installed
requirements in countries outside the EU and US. Please
and used in accordance with the instructions, may cause
refer to local country requirements for these areas.
harmful interference to radio communications. However,
• In Canada the sound processor is certified under the
there is no guarantee that interference will not occur in
following certification number: IC: 8039C-BAHA5SUP
a particular installation. If this equipment does cause
and model no.: IC model: Baha
harmful interference to radio or television reception, which
• This device complies with Industry Canada licence-
can be determined by turning the equipment off and on,
exempt RSS standard(s).
the user is encouraged to try to correct the interference by
• This Class B digital apparatus complies with Canadian
one or more of the following measures:
ICES-003. Cet appareil numérique de la classe B est
• Reorient or relocate the receiving antenna.
conforme à la norme NMB-003 du Canada.
• Increase the separation between the equipment and
• Operation is subject to the following two conditions:
receiver.
(1) this device may not cause interference, and (2)
• Connect the equipment into an outlet on a circuit
this device must accept any interference, including
different from the one in which the receiver is connected.
interference that may cause undesired operation
• Consult the dealer or an experienced radio/TV technician
of the device. L'exploitation est autorisée aux deux
for help.
conditions suivantes : (1) l'appareil ne doit pas produire
• Changes or modifications can void the user's authority
de brouillage, et (2) l'utilisateur de l'appareil doit
to operate the equipment.
accepter tout brouillage radioélectrique subi, même
si le brouillage est susceptible d'en compromettre le
Intended use
fonctionnement.
The Cochlear Baha 5 SuperPower uses bone conduction
™ ®
to transmit sounds to the cochlea (inner ear). It is
Equipment includes RF transmitter
indicated for people with conductive hearing loss, mixed
Note: The sound processor is suited for use
hearing loss and single sided sensorineural deafness (SSD).
in a home healthcare environment. The home healthcare
Furthermore it is indicated for bilateral and paediatric
environment includes locations such as homes, schools,
recipients. Fitting range up to 65 dB SNHL. It works by
churches, restaurants, hotels, cars, and airplanes, where
combining a sound processor and a small titanium implant
equipment and systems are less likely to be administered
that is placed in the skull behind the ear. The skull bone
by healthcare professionals.
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. The sound processor can be used
together with the Baha Softband.
® 5 SUP.