Cochlear Bone Anchored Solutions BAHA5SUP Bone anchored sound processor User Manual
Cochlear Bone Anchored Solutions AB Bone anchored sound processor
User Manual
Sound processor type designations for models included in this User Manual are: FCC ID: QZ3BAHA5SUP, IC: 8039C-BAHA5SUP, IC model: Baha®5 SUP. 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 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 2015. All rights reserved. AUG15. Printed in Sweden “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. 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. Baha® 5 SuperPower Sound Processor User manual part A English Français Deutsch Nederlands Italiano ZONE 1 14 25 36 47 GB FR DE NL IT 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 licenceexempt 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 1 12 13 14 15 16 17 11 10 18 English Welcome Congratulations on your choice of the Cochlear™ Baha® 5 SuperPower Sound Processor. You are now ready to use Cochlear’s highly advanced bone conduction sound processor, featuring sophisticated signal processing and wireless technology. This manual is full of tips and advice on how to best use and care for your Baha sound processor. By reading this manual and then keeping it handy for future reference, you will ensure that you get the most benefit out of your Baha sound processor. Key to device See figure 1 Introduction 1. Sound Processing unit 2. Actuator unit 3. Cable 4. Microphones 5. Battery 6. Ear hook 7. Plastic snap connector 8. Buttons 9. Visual indicator To ensure optimal performance, your hearing care professional will fit the processor to suit your needs. Be sure to discuss any questions or concerns that you may have regarding your hearing or use of this system with your hearing care professional. Note on figures: The figures included on the cover correspond to information specific to this model of sound processor. Please reference the appropriate figure when reading. The images shown are not to scale. Warranty The warranty does not cover defects or damage arising from, associated with, or related to the use of this product with any non-Cochlear processing unit and/or any non-Cochlear implant. See the “Cochlear Baha Global Limited Warranty card” for more details. English Key to symbols Contacting Customer Service The following symbols will be used throughout this document. Please refer to the list below for explanations: We strive to provide you with the best possible products and services. Your views and experiences with our products and services are important to us. If you have any comments you would like to share, please contact us. “Consult instructions for use” or “Operating instructions” Bluetooth® Smart “Caution” or “Caution, consult accompanying documents” Manufacturer Audible signal Toll free (North America) 1800 523 5798 Catalogue number Tel: +1 303 790 9010, Fax: +1 303 792 9025 E-mail: customer@cochlear.com CE-mark Date of manufacture Interference risk By prescription Customer Service – Cochlear Europe 6 Dashwood Lang Road Bourne Business Park, Addlestone, Surrey KT15 2HJ, United Kingdom Batch Code Temperature limitation Tel: +44 1932 26 3400, Fax: +44 1932 26 3426 E-mail: info@cochlear.co.uk Serial Number Humidity limitation Customer Service – Cochlear Asia Pacific 1 University Avenue, Macquarie University NSW 2109, Australia Refer to instructions/booklet. Note: Symbol is blue. ACMA (Australian Communications and Media Authority) compliant Made for iPod, iPhone, iPad Model: Baha® 5 SuperPower FCC ID: QZ3BAHA5SUP, IC: 8039C-BAHA5SUP REF Customer Service – Cochlear Americas 13059 E. Peakview Avenue, Centennial, CO 80111, USA Recyclable material Separate disposal of electronic device Do not re-use Toll free (Australia) 1800 620 929 Toll free (New Zealand) 0800 444 819 Tel: +61 2 9428 6555, Fax: +61 2 9428 6352 or Toll free Fax 1800 005 215 E-mail: customerservice@cochlear.com.au Using your sound processor The buttons on your sound processor let you adjust your volume level, choose from your pre-set programs, and enable/disable wireless streaming. You can choose to enable the audible and visual indicators to alert you of changes to the settings and processor status. Your sound processor is programmed to be used as either a left or right-sided device. Your hearing care professional will have marked your processor(s) with a L or R indicator. If you are a bilateral user, changes you make to one device will automatically apply to the second device. On/off See figure 2 Turn on your sound processor by connecting the battery module. T urn off your sound processor by disconnecting the battery. When your sound processor is turned off and then back on again, it will return to the default setting (program one). Audible and visual status indicators See figure 3 Your sound processor is equipped with audible and visual indicators. For an overview of the audible and visual indicators, refer to the table at the back of this section. Your hearing care professional can disable the audible and/or visual indicators if you prefer. Changing the program See figure 4 Together with your hearing care professional you will have selected up to four pre-set programs for your sound processor: Program 1: Program 2: Program 3: Program 4: Product name, CE mark and ACMA symbol English These programs are suitable for different listening environments. Ask your hearing care professional to fill in your specific programs. To switch programs, press and hold the upper button on your sound processor. If enabled, audible and visual indicators will let you know which program you are using: Program 1: 1 beep and 1 flash Program 2: 2 beeps and 2 flashes Program 3: 3 beeps and 3 flashes Program 4: 4 beeps and 4 flashes Changing volume settings See figure 5 1 Press and release the upper button to increase volume. Press and release the lower button to decrease volume. You can also adjust the volume level with the optional Cochlear Baha Remote Control, the Cochlear Wireless Phone Clip or an iOS device (see Made for iPhone section). Using the telephone See figure 6 For best results when talking on the telephone, place the receiver near the microphone inlet of your sound processor instead of near your ear. Make sure the receiver does not touch the sound processor, as this may cause feedback. Your sound processor is a Made for iPhone® hearing device (MFi). This lets you connect your sound processor directly with a compatible iPhone. When connected, you can stream audio directly from your iPhone to your sound processor. To stream wirelessly from other mobile and cordless phones you can use the optional Cochlear Wireless Phone Clip. You will need to check the compatibility of your phone with this product. Made for iPhone (MFI) Batteries Your sound processor is a Made for iPhone (MFi) hearing device. This allows you to control your sound processor and stream audio directly from iPhone, iPad or iPod touch. Ask your hearing care professional or visit: www.cochlear.com for more information. There are two different batteries for the Baha 5 SuperPower: the Standard Rechargeable Battery Module and the Compact Rechargeable Battery Module. Ask your hearing care professional for more information about the choice of battery. Wireless accessories Battery life You can use Cochlear Wireless accessories to enhance your listening experience. Ask your hearing care professional to learn more about your options or visit www.cochlear.com. Batteries should be replaced as needed just as you would with any other electronic device. Battery life varies according to the programs used each day, the sound environment, and the size of battery. To activate wireless audio streaming, press and hold the lower button until you hear a melody. See figure 7 To end wireless audio streaming, press and hold the upper button. The sound processor will return to the previous program. Flight mode See figure 8 When boarding a flight, wireless functionality must be deactivated because radio signals may not be transmitted during flights. To disable wireless operation: T urn off the sound processor by disconnecting the battery. P ress and hold the lower button and connect the battery at the same time. To deactivate flight mode, turn the sound processor off and back on again by disconnecting and connecting the battery. Mains power light Steady green Does not light up Battery socket light Steady orange Steady green Flashing orange Does not light up The rechargeable battery’s lifespan is at least 365 charge cycles. A completely empty rechargeable battery will take approximately four hours to recharge. Rechargeable batteries may take longer to fully recharge with age. To get the longest life from the rechargeable batteries, always recharge before use. When there is approximately one hour of battery power remaining, you will hear an audio indicator comprising of two sets of four short beeps, and the visual indicator will flash repeatedly. At this time you may experience low amplification. If the battery runs down completely, the sound processor will beep and then stop working. What it means Battery charger power is on. Power adaptor is not plugged in or mains power is not available (or, if switched, is not turned on). What it means Battery module is charging. Battery module is fully charged. There is a problem with the battery module. Try a different socket. Replace the rechargeable battery module. Battery module is not properly placed, is over-discharged or there is no power. Check the battery charger is powered on and reconnect the battery charger. If it still does not light up, replace the battery module. English Replace the battery Water, sand and dirt See figure 11 Wear a Snugfit Remove the battery See figure 2 Your sound processor is resistant to water, sand and dust. However, it is still a precision electronic device so the following precautions should be taken. The Snugfit holds your sound processor more securely in place than an earhook alone. It gives carers easy access to controls and accessories and is available in large, medium and tamper resistant (small). Twist the battery module to remove it from the processing unit. Attach the battery See figure 2 Align the battery module to the processor socket to fit the parts together. Twist the battery module as shown to attach the parts. The processor will turn on automatically. Lock/Unlock the battery See figure 9 To increase tamper resistance, push the lock to the far left with your battery cover locking tool to lock the battery module. Push the lock to the far right to unlock the battery module. Charge battery modules See figure 10 Angle and fit the rechargeable battery module into a socket on the Cochlear Nucleus® Battery Charger. Twist clockwise to connect. Connect the battery charger to the power adaptor and plug into mains power. General processor care Your Baha sound processor is a delicate electronic device. Follow these guidelines to keep it in proper working order: • When not in use, turn off your sound processor and store it free from dust and dirt. • If you will not be using your sound processor for a long period, remove the battery. Remove your sound processor before applying hair conditioners, mosquito repellent and or similar products If your processor ever gets wet, dry it with a soft cloth, change the microphone protectors and place it in the dry aid kit provided by Cochlear for 8 hours. If sand or dirt ever enter the processor, shake the components carefully to remove it and change the microphone protectors. Using Share the Experience See figure 12 Family members and friends can “share the experience” of bone conduction hearing. The test rod can be used by others to hear with the sound processor. To use the test rod: Turn on your sound processor and snap the Actuator unit onto the test rod using the tilt technique. Place the Sound Processing unit on the ear. Hold the rod against the skull bone behind an ear. Plug both ears and listen. Note: Your hearing care professional may have disabled some or all of the audible and/or visible indicators. Attach a Snugfit See figure 13 Press firmly on the top of the earhook with your thumb to click it off the sound processor. Click your Snugfit into place Carefully bend the lower part into shape to suit your ear. Attach and remove processor covers See figure 15 To attach, slide the cover onto the processor. To remove, pull the cover away from the processor. Note: Snugfit, Mic Lock, and Processor covers are available as accessories. For more information, ask your hearing care professional or visit www. cochlear.com Replace microphone protectors See figure 16 Wear a Mic Lock See figure 14 Replace your microphone protectors every three months, whenever they look dirty or whenever you notice any loss in sound quality. Always replace both microphone protectors at the same time. The Mic Lock helps hold the processor securely on the ear. Remove microphone protectors Remove a Snugfit Remove your Snugfit by clicking it off the processor. To attach the Mic Lock the first time: 1 Push the Mic Lock band onto the processor with the tubing facing forward. Place the processor on your ear and bring the tubing up to the earhook. Trim the tubing to a length that will hold the processor firmly in place without discomfort. Do not cut it too short. Soften the end of the tubing in warm water and push it onto the tip of your earhook. Let the tubing cool before wearing Remove the protective cap from the Microphone Protector Removal Tool. Push the tip of the tool into the middle of the microphone protector. Turn the tool 90° clockwise Lift out the microphone protector and discard. Repeat steps 2 to 4 to remove the other microphone protector. English Insert new microphone protectors See figure 17 the Microphone Protector Applicator out Pull of its sleeve. With the microphone protectors facing the processor, gently push the slotted end of the applicator under the coil cable plug. the applicator over the processor, Lay aligning the microphone protectors with the microphones. Press the microphone protectors all the way into the microphone holes one at a time. Remove the applicator carefully, peeling it upwards from the earhook end. Care for your battery charger Every day Check that your battery charger is clean. If you notice any dust or dirt: Unplug the power adaptor and remove any battery modules. Hold the battery charger upside down and tap it gently to remove any dirt from the battery charger sockets. Carefully blowing on the battery charger sockets may also help remove dirt. Wipe the battery charger sockets with a soft dry cloth. Cycle batteries in different sockets when recharging to wear the sockets evenly. If it gets wet If the battery charger ever gets splashed with liquid, carefully shake out the liquid and dry the battery charger for 24 hours. Do not use the battery charger until it is dry. 10 Change the earhook See figure 18 Earhooks come in large, medium and small sizes. The smallest earhook can be made tamper resistant. Press firmly on the top of the earhook with your thumb and click it off the sound processor Click the earhook into place Note: Remove your earhook only when necessary – it may become loose if it is removed too often. Warnings General advice A sound processor will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. • Infrequent use of a sound processor may not enable a user to attain full benefit from it. • The use of a sound processor is only part of hearing rehabilitation and may need to be supplemented by auditory and lip reading training. • The patient is an intended operator of the device. • The Model reference is Baha 5 SuperPower Sound Processor. Warnings • The sound processor is a digital, electrical, medical instrument designed for specific use. As such, due care and attention must be exercised by the user at all times. • The sound processor is not waterproof! • Never wear it in heavy rain, in the bath or shower! • Do not expose the sound processor +50 °C (+122 °F) to extreme temperatures. It is designed to operate within the temperature ranges +5 °C (+41 °F) to +40 °C (+104 °F). The processor should not -10 °C be subjected, at any time, (14 °F) to temperatures below -10 °C (14 °F) or above +50 °C (+122 °F). • Contains small parts that may present a choking hazard. • This product is not suitable for use in flammable and/or explosive environments. • If you are to undergo an MRI (Magnetic Resonance Imaging) procedure, refer to the MRI Reference Card included in the document pack. • Portable and mobile RF (radio frequency) communications equipment can affect the performance of your sound processor. • The sound processor is suitable for use in electromagnetic environments with mains power of typical commercial or hospital quality, and power frequency magnetic fields of typical commercial or hospital levels. It is intended for use in an electromagnetic environment in which radiated RF (radio frequency) disturbances are controlled. • Interference may occur in the vicinity of equipment with the symbol to the right. • Dispose of batteries and electronic items in accordance with your local regulations. • Discard your device as electronic waste according to local regulations. • When the wireless function is activated, the sound processor uses low-powered digitally coded transmissions in order to communicate with other wireless devices. Although unlikely, nearby electronic devices may be affected. In that case, move the sound processor away from the affected electronic device. • When using wireless functionality and the sound processor is affected by electromagnetic interference, move away from the source of this interference. • Be sure to deactivate wireless functionality when boarding flights. • Turn off your wireless functionality by using the flight mode in areas where radio frequency emission is prohibited. • Cochlear Baha wireless devices include an RF transmitter that operates in the range of 2.4 GHz–2.48 GHz. • For wireless functionality, only use Cochlear Wireless accessories. For further guidance regarding e.g. pairing, please refer to the user guide of the relevant Cochlear Wireless accessory. • No modification of this equipment is allowed. • Parents and carers are advised that unsupervised use of long cables may present a risk of strangulation. • Do not let your processor or parts entangle with any jewellery (e.g. earhook and earrings) or machinery. • Do not attach or wear a body-worn battery configuration beneath layers of clothing in direct contact with the skin (e.g. in pocket or under a child’s vest). • Make sure all cables used by a child are securely attached to their clothing. • Do not use a dry aid kit that has an Ultra Violet C (UVC) lamp • The microphone protector removal tool is a sharp object. It is not recommended for use by children. • The tamper resistant earhook fitting tool and fitting pin are sharp objects. They are not recommended for use by children • Only use rechargeable batteries and battery chargers supplied or recommended by Cochlear. Use of other batteries or battery chargers may result in harm or injury. • Charge rechargeable batteries before use. • Do not allow children to replace batteries without adult supervision. • Do not touch the battery charger contacts or allow children to use the battery charger without adult supervision. • Do not short-circuit batteries (e.g. do not let terminals of batteries contact each other, do not place batteries loose in pockets, etc.). • Store unused batteries in original packaging, in a clean and dry place. When processor is not in use, remove the batteries and store separately in a clean and dry place. Wipe batteries with a clean dry cloth if they become dirty. 11 English • Battery life means the time a device will run before the rechargeable batteries must be recharged. • Battery charge cycle is a full charge and discharge of the rechargeable battery. • Battery lifespan means the total number of charge cycles a rechargeable battery will last before the battery life degrades to 80% of its original fullycharged capacity. • Use only Baha 5 SuperPower Actuator units. Do not connect the sound processor to any other type of stimulating equipment such as Cochlear Implant coils. Function On the device Audible indicator Visible indicator Turn ON Connect battery 10 beeps 10 flashes Turn OFF Disconnect battery None Change program Press and hold upper button 1 beep for program 1 2 beeps for program 2 etc Change Volume Press and release upper/ lower button to increase/ decrease volume 1 beep indicates volume increase/decrease 1 flash for program 1 2 flashes for program 2 etc 1 flash indicates volume increase/decrease 4 beeps 2 times Rapid flashes When using Cochlear Wireless Accessory or MFi With Cochlear Baha Remote 1 beep indicates volume increase/decrease Control, Cochlear Wireless Phone Clip or with an iPhone 1 long beep 1 short flash indicates volume increase/decrease Enable wireless audio streaming Disable wireless audio streaming Pairing confirmation Press and hold lower button 1 long flash, followed by 1, 2 or 3 short flashes 1,2 or 3 short flashes Toggle between wireless accessories Turn ON flight mode Long press lower button 5 beeps (melody in upward scale) 1 beep for program 1 2 beeps for program 2 etc 5 beeps (melody in upward scale) 5 beeps (melody in upward scale) 10 beeps 2 times 1 long beep 1 long flash Change volume Volume limit reached Mute Press and hold upper button Insert battery and hold lower button Mute button on Wireless Accessory or with an iPhone 1 long flash None Long flash, followed by one short flash 4 double flashes Note: Your hearing care professional may have disabled some or all of the audible and/or visible indicators. 12 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. Functions and audible/visible indicators Low battery warning Sound processor type designations for models included in this User Manual are: 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 licenceexempt 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 13
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