Baha® Attract System User manual part B English Français Deutsch Nederlands Italiano ZONE 1 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 3 10 17 24 31 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 GB FR DE NL IT 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. © Cochlear Bone Anchored Solutions AB 2015. All rights reserved. JAN15. Printed in Sweden. Fold-out only 140 mm width. Use manual cut marks 1 1 2 3 4 2 1 2 3 4 3 4 1 2 English 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. Introduction 3 W ith the button(s) and arrow mark facing upwards, place the sound processor over the This guide includes instructions on: implant behind your ear. It may be easier to • attaching your sound processor to the SP turn the sound processor on before you place it magnet behind you ear. • care, cleaning and maintenance • using accessories 4 R emove the sound processor by grasping the • troubleshooting SP magnet with the sound processor still at- tached. To remove the sound processor from Note on figures: The figures included on the the SP magnet, place one finger under the front and back covers correspond to sections of sound processor and gently tilt until it releases. information in this manual which are common to all Baha sound processors. Please reference Note: the appropriate figure when reading. The sound • During the initial period of use it is processor images shown are representative only recommended to gradually increase the time and not to scale. The appearance of the sound of use of the SP magnet to allow the skin to processor included in your kit may vary. adapt to the pressure from the SP magnet. If any irritation is noted the SP magnet Attaching your sound should be removed in order to let the skin rest for a while. If discomfort and/or skin processor and SP magnet irritation persist, contact your hearing care See figure 1 professional. The SP magnet attaches to your sound processor to keep it in place over the implant magnet and to • To ensure good retention the arrow on the transfer sound from your sound processor to the SP magnet should always face upwards and implant. you should try to limit the amount of hair underneath the SP magnet. Use the tilt technique (described below) to See figure 1 image 3. connect and disconnect your sound processor from the SP magnet. This will ensure it remains in • To avoid feedback (whistling), ensure that the good working order. sound processor is not touching any other items, such as glasses or a hat. 1 P lace the SP magnet on a flat surface. • It is recommended to wear a safety line 2 G ently tilt and snap the sound processor into attached to the sound processor to reduce the the SP magnet coupling. Ensure you align the risk of loss or damage. button(s) on the sound processor with the arrow mark on the SP magnet. 3 Caring for your SP magnet Handling your sound processor Keep your SP magnet clean by wiping it with an alcohol-free wipe. Do not use running water to See figure 3 clean your SP magnet. Once you are familiar with your processor, you can Clean the SP magnet coupling using a soft brush. change the program and the volume level while the sound processor is attached to the SP magnet It is recommended to wear the SP magnet with placed on your head. Make sure you support the the soft pad attached for maximum wearing processor from the bottom with your thumb as comfort. you press the buttons with your index finger. Changing soft pads You should change the SP magnet soft pad Storing your processor regularly. You should replace the soft pad if you Store your sound processor in your storage box observe the following: when it is not in use. The sound processor can be • An accumulation of dirt or moisture on the soft attached to the SP magnet and the safety line can pad that cannot be wiped off be attached to the sound processor. • The soft pad appears worn-out or damaged • You experience a gradual deterioration in Wireless Accessories wearing comfort (if changing the soft pad See figure 4 does not help please contact your hearing care With Baha sound processors you can use the professional) Cochlear Wireless Accessories to enhance your listening experience. Ask your hearing care Contact your hearing care professional to obtain professional to learn more about your options or new soft pads. visit www.cochlear.com. Please note the Cochlear See figure 2 Wireless Accessories are not compatible with all sound processor models. 1 R emove the soft pad from the SP magnet, by lifting and gripping the unglued portion of the Other Audio Accessories soft material, and then slowly release the soft pad from the SP magnet. Connecting accessories via the Direct Audio Input (DAI) Make sure that the adhesive remains are completely removed from the SP magnet. 1 Match the accessory connector with the sound processor DAI connector. 2 S elect a new soft pad and remove the cover sheet to expose the adhesive. 2 H olding the sound processor gently at the corners, carefully push the accessory connector 3 A ttach the soft pad to the SP magnet. Make into the DAI port. sure that the soft pad is centralised and covers the entire SP magnet surface. Note: Not all sound processors have a Direct Audio Input (DAI) access. Consult your user 4 R emove the remaining cover sheet from the manual part A for more information. 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. 4 English Dedicated DAI program and Warnings and precautions microphone mixing Caution: If you are to undergo an MRI An optional DAI program that is set by your (Magnetic Resonance Imaging) procedure, hearing care professional allows you to listen to refer to the MRI Reference Card included in the sounds through the DAI. document pack, or the information below. Using the telecoil MRI Safety Information The telecoil unit improves sound when using some The sound processor and SP Magnet must be landline (fixed) and mobile telephones. It also removed before entering a room where an MRI gives you access to loop facilities in homes and scanner is located. public buildings. Attach the telecoil to the DAI Non-clinical testing has demonstrated that the port. BIM400 Implant Magnet, in combination with Using the Audio adapter a BI300 Implant, is MR Conditional. It can be scanned safely under the following conditions. The Audio adapter allows direct input from Scanning under other conditions may result in computers, personal stereos, TVs, MP3 players and severe patient injury or device malfunction. other external audio equipment. One end of the Audio adapter is connected to the sound processor • Static magnetic field of 1.5 Tesla only at the DAI. The other end is connected to the audio device. • Maximum spatial gradient field of 26600 Gauss/ cm (266 T/m) Caution: Connecting electrical equipment directly to the sound • Maximum switched gradient slew rate per axis of processor is extremely dangerous. Always use 200 mT/m/ms the Audio adapter when connecting an external • Maximum switched gradient amplitude per axis audio source to your sound processor. of 45 mT/m Cochlear is not liable for any damage arising as a result of connecting unsuitable equipment or • Maximum MR System reported whole body incorrect use. averaged specific absorption rate (SAR) of 2.0 W/ kg (Normal Operating Mode) 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. 5 Additional instructions essential to safe Other Safety Information use in the MR environment: • Remove the sound processor and SP Magnet • Under the scan conditions defined above, the for any treatment involving ionizing radiation, BIM400 Implant Magnet is expected to produce such as for example X-ray, CT-scan and radiation a maximum temperature rise of 2.1 ° C after 15 therapy. minutes of continuous scanning. • The implanted magnet may affect diagnostic • In non-clinical testing, the BIM400 Implant information/treatment effectiveness in the area Magnet produced a temperature rise of less than around the magnet during a treatment with 2.1 ° C (extrapolated) at a maximum whole body ionizing radiation (e.g. X-Ray, CTscan, radiation averaged specific absorption rate (SAR) of 2.0 therapy). Consult your treating physician before W/kg (extrapolated) assessed by calorimetry for going through any such treatment. 15 minutes of MR scanning in a 1.5 Tesla Intera, Philips Medical Systems (Software: 12.6.1.3, • The Baha Attract System contains small parts 2010-12-02) MR Scanner. that may be hazardous if swallowed or may cause choking if ingested or inhaled. • In non-clinical gradient-induced heating testing, the BIM400 Implant Magnet produced a • The Baha Attract System contains magnets temperature rise (extrapolated) of less than 4.5 that should be kept away from life supporting ° C at a time rate of change of the theoretical devices, e.g. cardiac pacemakers and ICDs maximum worst-case gradient magnetic field (implantable cardioverter defibrillators) and dB/dt (extrapolated) of 200 T/s during 30 min. magnetic ventricular shunts, as the magnets may of continuous exposure in a test laboratory affect the function of these devices. Contact the system (Pulsed Magnetic Field Generator) manufacturer of the specific device to find out equivalent with a gradient system of a 1.5 Tesla more. MR system. • The Baha Attract System (SP Magnet and • In non-clinical testing with the implant magnet implanted magnet) contains magnets that may in place, the image artefact caused by the device interfere with or damage surrounding electronic extends approximately 11.5 cm (4.5 in.) from devices, for example mobile phones. the BIM400 Implant Magnet when imaged with • If the SP magnet is too weak the sound a gradient echo pulse sequence and a 1.5 Tesla processor may fall off. If it is too strong you MRI system. 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. 6 English • If you experience persistent irritation or soreness • This product is not suitable for use in flammable of the skin, or if the SP magnet gives you any and/or explosive environments. discomfort, remove it and contact your hearing • If the SP magnet and soft material becomes care professional. soaked with water: Put it in a container with • If you wear hats, etc. be sure to avoid pressure drying capsules such as a Dri-aid kit or similar. on your SP magnet as this may cause irritation Leave it to dry out overnight. Drying kits are to the tissue under this magnet. available from most hearing care professionals. • Do not wear your sound processor and SP • For parents or caregivers: regularly check to magnet while sleeping as this may cause see if the user experiences persistent irritation or irritation to the skin under the SP magnet. soreness of the skin, or if the SP magnet causes any discomfort. If so remove it and contact the • The Baha Attract System (SP Magnet and hearing care professional. implanted magnet) contains magnets that may damage magnetic cards (e.g. credit cards, bus Caution: Batteries can be harmful if cards, etc.) and data storage devices. swallowed. Be sure to keep your batteries out of reach of small children and household • Remember that your implant contains a pets. In the event a battery is accidentally magnet, so be aware that it may attract other swallowed, seek immediate medical attention metallic objects that are held in close proximity at the nearest emergency centre. (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). 7 Troubleshooting Battery function can be related to a number of If the possible solutions in this chart do not problems, such as no sound, intermittent sound solve your problem, please see your hearing care and crackling/buzzing. A new battery is often the professional for further assistance. solution. Problem Cause Possible Solution No sound/weak Weak or dead battery. Replace battery. sound Volume too low. Turn up volume. Magnet is too weak. Contact your hearing care professional. Feedback (whistling) Hat, glasses or other object in Relocate or remove the object. contact with sound processor. Battery door in wrong position. Close battery door. Sound is distorted or Too high volume. Decrease volume. intermittent Weak battery. Replace battery. Sound processor Magnet is too weak. Contact your hearing care repeatedly professional. falls off Persistent skin Magnet is too strong. Contact your hearing care irritation professional. Sound processor does Sound processor not turned on. Turn on sound processor. not work Battery door is not completely Gently close the battery door closed. completely. Dead battery. Replace battery. Battery inserted wrong way. Make sure battery is inserted correctly. Key lock is activated. Deactivate key lock. 8 English Additional Information • Federal law restricts the sale of Baha sound processors to those individuals who have Instructions for use in the USA obtained a medical evaluation from a licensed Caution: Federal law (USA) restricts this device physician. Federal law permits a fully informed to sale or by the order of a medical practitioner. adult to sign a waiver statement declining the medical evaluation for religious or personal Warning to hearing aid dispensers beliefs that preclude consultation with a A prospective Baha user must always have physician. The exercise of such a waiver is not in a medical evaluation by a licensed physician your best health interest and its use is strongly (preferably an ear specialist) and have an implant discouraged. placed in the skull bone before a Baha sound processor can be dispensed. The Baha sound A word of caution about batteries processor can be used with a softband which Batteries can be harmful if swallowed. Be sure to does not require an implant. However, a medical always keep your batteries out of reach of small evaluation is still warranted. children, pets, or people of diminished capacity. In the event a battery is accidentally swallowed, Important notice for prospective users of a seek prompt medical attention at the nearest Baha sound processor emergency center, or call the National Button • A prospective Baha user must always have Battery Hotline collect at (202) 625 – 3333. 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. 9 Bienvenue Félicitations pour l'acquisition de votre nouveau processeur Baha®. Ce manuel contient des conseils sur la manière d'utiliser et d'entretenir votre système Cochlear™ Baha® Attract de la meilleure manière. Il doit être considéré comme un complément à la partie A du manuel du processeur et ne la remplace pas. Introduction 3 Orientez le(s) bouton(s) et la flèche vers le haut et placez le processeur sur l'implant, derrière Ce guide fournit des instructions relatives aux votre oreille. Il peut être plus facile d'allumer le procédures suivantes : processeur avant de le placer derrière l'oreille. • fixation du processeur à l'aimant • soins, nettoyage et maintenance 4 P our retirer le processeur, saisissez l'ensemble • utilisation d'accessoires aimant pour processeur et processeur. Pour • recherche de pannes détacher le processeur de l'aimant pour pro- cesseur, glissez un doigt sous le processeur et Remarques concernant les illustrations : faites-le pivoter délicatement jusqu'à ce qu'il se les illustrations présentées sur la première et détache. la quatrième de couverture correspondent à des sections d'informations du présent manuel Remarque : qui s'appliquent de manière générale à tous • pendant la période initiale d'utilisation, il est les processeurs Baha. Veuillez vous reporter à recommandé d'augmenter progressivement la l'illustration adéquate lors de la lecture. Les images durée d'utilisation de l'aimant pour processeur des processeurs ne sont qu'indicatives et ne sont afin de permettre à la peau de s'adapter à la pas à l'échelle. L'aspect du processeur inclus dans pression exercée par l'aimant. Au premier signe votre boîte peut être différent. d'irritation, l'aimant sera enlevé pour laisser la peau se reposer. Si la gêne et/ou l'irritation Fixation du processeur et de cutanée persistent, adressez-vous à votre centre d'implantation. l'aimant pour processeur Voir illustration 1 • Pour assurer une bonne rétention, la flèche L'aimant pour processeur est fixé au processeur pour de l'aimant pour processeur doit toujours être le maintenir en place sur l'aimant pour implant et orientée vers le haut et vous devez essayer de transmettre le son du processeur à l'implant. réduire au minimum la quantité de cheveux sous l'aimant pour processeur. Utilisez la technique préconisée (décrite ci-dessous) Voir illustration 1 image 3. pour mettre en place et retirer votre processeur de l'aimant pour processeur. Cela vous permettra de le • Pour éviter tout larsen (sifflement), veillez à conserver en bon état de fonctionnement. ce que le processeur n'entre en contact avec aucun autre objet tel que des lunettes ou un 1 P lacez l'aimant pour processeur sur une surface chapeau. plane. 2 F aites basculer doucement le processeur et • Il est recommandé de porter un cordon de adaptez-le dans la fixation de l'aimant pour sécurité fixé au processeur pour réduire le processeur. Veillez à aligner le(s) bouton(s) risque de perte ou d'endommagement. du processeur avec la flèche de l'aimant pour processeur. 10