Cochlear Baha Manuel utilisateur

Manufacturer:

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 0404 Fax: +41 61 205 0405

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 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 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.

Route de l’Orme aux Merisiers, ZI les Algorithmes – Bât. Homère, 91190 Saint-Aubin, France Tel: ++33 805 200 016 Fax: +33 160 196 499

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 Latinoamerica, S. A. International Business Park Building 3835, Ofﬁce 103, Panama Paciﬁco, Panama Tel. +507 830 6220 Fax: +507 830 6218

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.

310 17 24 31

PL RU LT ET

ZONE 4

English Polski Русский Lietuviškai Eesti Latviski

Baha®Attract System

User manual part B

Fold-out only 140 mm width. Use manual cut marks

English

Introduction

This guide includes instructions on:

• attaching your sound processor to the SP

magnet

• care, cleaning and maintenance

• using accessories

• troubleshooting

Note on ﬁgures: The ﬁgures included on the

front and back covers correspond to sections of

information in this manual which are common

to all Baha sound processors. Please reference

the appropriate ﬁgure when reading. The sound

processor images shown are representative only

and not to scale. The appearance of the sound

processor included in your kit may vary.

Attaching your sound

processor and SP magnet

See figure 1

The SP magnet attaches to your sound processor

to keep it in place over the implant magnet and to

transfer sound from your sound processor to the

implant.

Use the tilt technique (described below) to

connect and disconnect your sound processor

from the SP magnet. This will ensure it remains in

good working order.

1Place the SP magnet on a ﬂat surface.

2Gently tilt and snap the sound processor into

the SP magnet coupling. Ensure you align the

button(s) on the sound processor with the

arrow mark on the SP magnet.

Welcome

Congratulations on getting your new Baha®sound processor. This manual provides tips

and advice on how to best use and care for your Cochlear™Baha®Attract System. It is a

complement to the sound processor manual part A and does not replace it.

3With the button(s) and arrow mark facing

upwards, place the sound processor over the

implant behind your ear. It may be easier to

turn the sound processor on before you place it

behind you ear.

4Remove the sound processor by grasping the

SP magnet with the sound processor still at-

tached. To remove the sound processor from

the SP magnet, place one ﬁnger under the

sound processor and gently tilt until it releases.

Note:

• During the initial period of use it is

recommended to gradually increase the time

of use of the SP magnet to allow the skin to

adapt to the pressure from the SP magnet.

If any irritation is noted the SP magnet

should be removed in order to let the skin

rest for a while. If discomfort and/or skin

irritation persist, contact your hearing care

professional.

• To ensure good retention the arrow on the

SP magnet should always face upwards and

you should try to limit the amount of hair

underneath the SP magnet.

See figure 1image 3.

• To avoid feedback (whistling), ensure that the

sound processor is not touching any other

items, such as glasses or a hat.

• It is recommended to wear a safety line

attached to the sound processor to reduce the

risk of loss or damage.

Caring for your SP magnet

Keep your SP magnet clean by wiping it with an

alcohol-free wipe. Do not use running water to

clean your SP magnet.

Clean the SP magnet coupling using a soft brush.

It is recommended to wear the SP magnet with

the soft pad attached for maximum wearing

comfort.

Changing soft pads

You should change the SP magnet soft pad

regularly. You should replace the soft pad if you

observe the following:

• An accumulation of dirt or moisture on the soft

pad that cannot be wiped off

• The soft pad appears worn-out or damaged

• You experience a gradual deterioration in

wearing comfort (if changing the soft pad

does not help please contact your hearing care

professional)

Contact your hearing care professional to obtain

new soft pads.

See figure 2

1Remove the soft pad from the SP magnet, by

lifting and gripping the unglued portion of the

soft material, and then slowly release the soft

pad from the SP magnet.

Make sure that the adhesive remains are

completely removed from the SP magnet.

2Select a new soft pad and remove the cover

sheet to expose the adhesive.

3Attach the soft pad to the SP magnet. Make

sure that the soft pad is centralised and covers

the entire SP magnet surface.

4Remove the remaining cover sheet from the

soft pad before you start wearing the SP

magnet.

Note: A small section on the edge of the soft

pad is not covered by adhesive for easier grip

and removal.

Handling your sound

processor

See figure 3

Once you are familiar with your processor, you can

change the program and the volume level while

the sound processor is attached to the SP magnet

placed on your head. Make sure you support the

processor from the bottom with your thumb as

you press the buttons with your index ﬁnger.

Storing your processor

Store your sound processor in your storage box

when it is not in use. The sound processor can be

attached to the SP magnet and the safety line can

be attached to the sound processor.

Wireless Accessories

See figure 4

With Baha sound processors you can use the

Cochlear Wireless Accessories to enhance your

listening experience. Ask your hearing care

professional to learn more about your options or

visit www.cochlear.com. Please note the Cochlear

Wireless Accessories are not compatible with all

sound processor models.

Other Audio Accessories

Connecting accessories via the

Direct Audio Input (DAI)

1Match the accessory connector with the sound

processor DAI connector.

2Holding the sound processor gently at the

corners, carefully push the accessory connector

into the DAI port.

Note: Not all sound processors have a Direct

Audio Input (DAI) access. Consult your user

manual part A for more information.

English

Dedicated DAI program and

microphone mixing

An optional DAI program that is set by your

hearing care professional allows you to listen to

sounds through the DAI.

Using the telecoil

The telecoil unit improves sound when using some

landline (ﬁxed) and mobile telephones. It also

gives you access to loop facilities in homes and

public buildings. Attach the telecoil to the DAI

port.

Using the Audio adapter

The Audio adapter allows direct input from

computers, personal stereos, TVs, MP3 players and

other external audio equipment. One end of the

Audio adapter is connected to the sound processor

at the DAI. The other end is connected to the

audio device.

Caution: Connecting electrical

equipment directly to the sound

processor is extremely dangerous. Always use

the Audio adapter when connecting an external

audio source to your sound processor.

Cochlear is not liable for any damage arising as

a result of connecting unsuitable equipment or

incorrect use.

Using an FM receiver

An FM receiver enables the use of FM systems that

are commonly used in school classrooms.

Your hearing care professional can provide you

with a list of available FM receivers. Attach your

FM receiver to the DAI port. Keep extra batteries

available if using an FM receiver as they have high

energy consumption rates.

Warnings and precautions

Caution: If you are to undergo an MRI

(Magnetic Resonance Imaging) procedure,

refer to the MRI Reference Card included in the

document pack, or the information below.

MRI Safety Information

The sound processor and SP Magnet must be

removed before entering a room where an MRI

scanner is located.

Non-clinical testing has demonstrated that the

BIM400 Implant Magnet, in combination with

a BI300 Implant, is MR Conditional. It can be

scanned safely under the following conditions.

Scanning under other conditions may result in

severe patient injury or device malfunction.

• Static magnetic ﬁeld of 1.5 Tesla only

• Maximum spatial gradient ﬁeld of 26600 Gauss/

cm (266 T/m)

• Maximum switched gradient slew rate per axis of

200 mT/m/ms

• Maximum switched gradient amplitude per axis

of 45 mT/m

• Maximum MR System reported whole body

averaged speciﬁc absorption rate (SAR) of 2.0 W/

kg (Normal Operating Mode)

Additional instructions essential to safe

use in the MR environment:

• Under the scan conditions deﬁned above, the

BIM400 Implant Magnet is expected to produce

a maximum temperature rise of 2.1 ° C after 15

minutes of continuous scanning.

• In non-clinical testing, the BIM400 Implant

Magnet produced a temperature rise of less than

2.1 ° C (extrapolated) at a maximum whole body

averaged speciﬁc absorption rate (SAR) of 2.0

W/kg (extrapolated) assessed by calorimetry for

15 minutes of MR scanning in a 1.5 Tesla Intera,

Philips Medical Systems (Software: 12.6.1.3,

2010-12-02) MR Scanner.

• In non-clinical gradient-induced heating testing,

the BIM400 Implant Magnet produced a

temperature rise (extrapolated) of less than 4.5

° C at a time rate of change of the theoretical

maximum worst-case gradient magnetic ﬁeld

dB/dt (extrapolated) of 200 T/s during 30 min.

of continuous exposure in a test laboratory

system (Pulsed Magnetic Field Generator)

equivalent with a gradient system of a 1.5 Tesla

MR system.

• In non-clinical testing with the implant magnet

in place, the image artefact caused by the device

extends approximately 11.5 cm (4.5 in.) from

the BIM400 Implant Magnet when imaged with

a gradient echo pulse sequence and a 1.5 Tesla

MRI system.

Other Safety Information

• Remove the sound processor and SP Magnet

for any treatment involving ionizing radiation,

such as for example X-ray, CT-scan and radiation

therapy.

• The implanted magnet may affect diagnostic

information/treatment effectiveness in the area

around the magnet during a treatment with

ionizing radiation (e.g. X-Ray, CTscan, radiation

therapy). Consult your treating physician before

going through any such treatment.

• The Baha Attract System contains small parts

that may be hazardous if swallowed or may

cause choking if ingested or inhaled.

• The Baha Attract System contains magnets

that should be kept away from life supporting

devices, e.g. cardiac pacemakers and ICDs

(implantable cardioverter deﬁbrillators) and

magnetic ventricular shunts, as the magnets may

affect the function of these devices. Contact the

manufacturer of the speciﬁc device to ﬁnd out

more.

• The Baha Attract System (SP Magnet and

implanted magnet) contains magnets that may

interfere with or damage surrounding electronic

devices, for example mobile phones.

• If the SP magnet is too weak the sound

processor may fall off. If it is too strong you

may feel discomfort or experience soreness and

irritation of the skin. If you are unsure about

the strength of your SP magnet, contact your

hearing care professional.

English

• If you experience persistent irritation or soreness

of the skin, or if the SP magnet gives you any

discomfort, remove it and contact your hearing

care professional.

• If you wear hats, etc. be sure to avoid pressure

on your SP magnet as this may cause irritation

to the tissue under this magnet.

• Do not wear your sound processor and SP

magnet while sleeping as this may cause

irritation to the skin under the SP magnet.

• The Baha Attract System (SP Magnet and

implanted magnet) contains magnets that may

damage magnetic cards (e.g. credit cards, bus

cards, etc.) and data storage devices.

• Remember that your implant contains a

magnet, so be aware that it may attract other

metallic objects that are held in close proximity

(e.g. hairdresser’s scissors, etc.).

• Do not wear any other magnets (e.g. fridge

magnets) over your implant than SP magnets

from Cochlear supplied to you by your hearing

care professional.

• Do not expose the SP magnet

to extreme temperatures.

The SP magnet is designed

to operate within the

temperature ranges +5° C

(+41°F) to +40° C (+104°F).

The SP magnet should not

be subject, at any time, to

temperatures below -20° C

(-4°F) or above +50° C (+122°F).

• This product is not suitable for use in ﬂammable

and/or explosive environments.

• If the SP magnet and soft material becomes

soaked with water: Put it in a container with

drying capsules such as a Dri-aid kit or similar.

Leave it to dry out overnight. Drying kits are

available from most hearing care professionals.

• For parents or caregivers: regularly check to

see if the user experiences persistent irritation or

soreness of the skin, or if the SP magnet causes

any discomfort. If so remove it and contact the

hearing care professional.

Caution: Batteries can be harmful if

swallowed. Be sure to keep your batteries

out of reach of small children and household

pets. In the event a battery is accidentally

swallowed, seek immediate medical attention

at the nearest emergency centre.

Problem Cause Possible Solution

No sound/weak

sound

Weak or dead battery. Replace battery.

Volume too low. Turn up volume.

Magnet is too weak. Contact your hearing care

professional.

Feedback (whistling) Hat, glasses or other object in

contact with sound processor.

Relocate or remove the object.

Battery door in wrong position. Close battery door.

Sound is distorted or

intermittent

Too high volume. Decrease volume.

Weak battery. Replace battery.

Sound processor

repeatedly

falls off

Magnet is too weak. Contact your hearing care

professional.

Persistent skin

irritation

Magnet is too strong. Contact your hearing care

professional.

Sound processor does

not work

Sound processor not turned on. Turn on sound processor.

Battery door is not completely

closed.

Gently close the battery door

completely.

Dead battery. Replace battery.

Battery inserted wrong way. Make sure battery is inserted

correctly.

Key lock is activated. Deactivate key lock.

Troubleshooting

Battery function can be related to a number of

problems, such as no sound, intermittent sound

and crackling/buzzing. A new battery is often the

solution.

If the possible solutions in this chart do not

solve your problem, please see your hearing care

professional for further assistance.

English

Additional Information

Instructions for use in the USA

Caution: Federal law (USA) restricts this device

to sale or by the order of a medical practitioner.

Warning to hearing aid dispensers

A prospective Baha user must always have

a medical evaluation by a licensed physician

(preferably an ear specialist) and have an implant

placed in the skull bone before a Baha sound

processor can be dispensed. The Baha sound

processor can be used with a softband which

does not require an implant. However, a medical

evaluation is still warranted.

Important notice for prospective users of a

Baha sound processor

• A prospective Baha user must always have

a thorough medical evaluation by a licensed

physician (preferably a physician who specializes

in diseases of the ear, otolaryngologist, otologist,

or otorhinolaryngologist) and have an implant

placed in the skull bone before a Baha sound

processor is purchased.

• The purpose of the medical evaluation is to

ensure that all medically treatable conditions

that may affect hearing are identiﬁed and

treated before the sound processor is purchased.

Following the medical evaluation, the physician

will give you a written statement that states

that your hearing loss has been medically

evaluated and that you may be considered a

Baha candidate. The physician will refer you

to an audiologist or a hearing aid dispenser, as

appropriate, for an audiological evaluation.

• Federal law restricts the sale of Baha sound

processors to those individuals who have

obtained a medical evaluation from a licensed

physician. Federal law permits a fully informed

adult to sign a waiver statement declining the

medical evaluation for religious or personal

beliefs that preclude consultation with a

physician. The exercise of such a waiver is not in

your best health interest and its use is strongly

discouraged.

A word of caution about batteries

Batteries can be harmful if swallowed. Be sure to

always keep your batteries out of reach of small

children, pets, or people of diminished capacity.

In the event a battery is accidentally swallowed,

seek prompt medical attention at the nearest

emergency center, or call the National Button

Battery Hotline collect at (202) 625 – 3333.

Wstęp

Niniejszy przewodnik zawiera informacje na

następujące tematy:

• mocowanie procesora dźwięku do magnesu

• dbanie, czyszczenie i konserwacja

• korzystanie z akcesoriów

• rozwiązywanie problemów

Uwaga do ilustracji: Ilustracje zamieszczone

z przodu i z tyłu okładki odpowiadają sekcjom

informacji dotyczącym wszystkich procesorów

dźwięku Baha. Podczas czytania należy odnosić

się do właściwej ilustracji. Zamieszczone

ilustracje procesorów dźwięku służą wyłącznie

do ilustrowania tekstu i nie przedstawiają

wielkości naturalnych. Wygląd procesora dźwięku

znajdującego się w zestawie może się różnić od

ilustracji.

Zakładanie procesora dźwięku

i magnesu

Patrz ilustracja 1.

Magnes procesora dźwięku łączy się z procesorem

dźwięku w celu utrzymania go na odpowiednim

miejscu względem magnesu implantu znajdującego

się pod skórą oraz do przenoszenia dźwięku z

procesora dźwięku do implantu.

Należy stosować opisaną niżej technikę

przechylania, aby podłączać i odłączać procesor

dźwięku od magnesu. Zapewni to dobre działanie

urządzenia.

1Położyć magnes na płaskiej powierzchni.

2Delikatnie przechylić procesor dźwięku i

zatrzasnąć go na złączu zatrzaskowym magnesu.

Dopilnuj, by przycisk(i) na procesorze dźwięku

skierowane były w tę samą stronę, co strzałka

na magnesie.

Witamy

Gratulujemy nabycia nowego procesora dźwięku Baha®. Niniejsza instrukcja zawiera

wskazówki i porady dotyczące najlepszych sposobów dbania o system Cochlear™Baha®

Attract. Stanowi ona uzupełnienie części A instrukcji obsługi procesora dźwięku.

3Upewnij się, że przycisk(i) i strzałka na

magnesie skierowane są do góry i umieść

procesor dźwięku naprzeciw implantu, za

uchem. Włączenie procesora dźwięku przed

umieszczeniem go za uchem może być

wygodniejsze.

4Aby zdjąć procesor dźwięku z głowy, należy

chwycić magnes z podłączonym procesorem

dźwięku. Aby zdjąć procesor dźwięku z magnesu

zewnętrznego, należy wsunąć jeden palec pod

procesor dźwięku i przechylić delikatnie do zwol-

nienia zatrzasku.

Uwaga:

• W początkowym okresie stosowania zaleca

się stopniowe zwiększanie czasu korzystania

z magnesu, aby pozwolić skórze dostosować

się do nacisku wywieranego przez magnes.

W przypadku zaobserwowania podrażnienia

magnes należy zdjąć, by pozwolić skórze

odpocząć. W przypadku utrzymywania się

dyskomfortu i/lub podrażnienia skóry należy

skontaktować się z lekarzem.

• W celu zapewnienia dobrego utrzymania,

strzałka na magnesie powinna być zawsze

skierowana do góry, należy też ograniczyć

ilość włosów pod magnesem.

Patrz ilustracja 1ilustracja 3.

• Aby uniknąć sprzężenia (gwizdu), należy się

upewnić, że procesor dźwięku nie dotyka

innych przedmiotów, takich jak okulary lub

czapka.

• Zaleca się noszenie linki zabezpieczającej

podłączonej do procesora dźwięku, aby

zmniejszyć ryzyko utraty lub uszkodzenia

procesora.

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