Cochlear Bone Anchored Solutions BAHA5 Sound Processor with wireless communication capabilities User Manual UserMan

Cochlear Bone Anchored Solutions AB Sound Processor with wireless communication capabilities UserMan

UserMan

ZONE 1English Français Deutsch Nederlands ItalianoGB311 19 27 35FR DE NL ITManufacturer:Cochlear Bone Anchored Solutions AB  Konstruktionsvägen 14, SE - 435 33 Mölnlycke, Sweden  Tel: +46 31 792 44 00   Fax: +46 31 792 46 95Regional 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 6352Cochlear Americas  13059 E Peakview Avenue, Centennial, CO 80111, USA  Tel: +1 303 790 9010  Fax: +1 303 792 9025Cochlear AG  EMEA Headquarters, Peter Merian-Weg 4, 4052 Basel, Switzerland  Tel: +41 61 205 0404  Fax: +41 61 205 0405Local offices:Cochlear Deutschland GmbH & Co. KG  Karl-Wiechert-Allee 76A, D-30625 Hannover, Germany  Tel: +49 511 542 770  Fax: +49 511 542 7770Cochlear Europe Ltd  6 Dashwood Lang Road, Bourne Business Park, Addlestone, Surrey  KT15 2HJ, United Kingdom  Tel: +44 1932 87 1500  Fax: +44 1932 87 1526Nihon 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 0245Cochlear (HK) Limited  Unit 1810, Hopewell Centre, 183 Queens Road East, Wan Chai, Hong Kong SAR  Tel: +852 2530 5773  Fax: +852 2530 5183Cochlear Medical Device (Beijing) Co LtdUnit 2208-2212, Tower B, No.9 Gemdale Building, No.91 Jianguo Road, Chaoyang District, Beijing, PR China 100022 P.R. CHINA Tel: +86 10 5909 7800 Fax: (+86 10) 5909 7900Cochlear Limited (Singapore Branch)  6 Sin Ming Road, #01-16 Sin Ming Plaza Tower 2, Singapore 575585  Tel: +65 6553 3814  Fax: +65 6451 4105Cochlear Korea Ltd  1st floor, Cheongwon building, 828-5, Yuksam dong, Kangnam gu, Seoul, Korea  Tel: +82 2 533 4663 Fax: +82 2 533 8408Cochlear Benelux NV  Schaliënhoevedreef 20 1, B - 2800 Mechelen, Belgium  Tel: +32 1579 5511  Fax: +32 1579 5500Cochlear Medical Device Company India (P) Ltd Platina Building, Ground Floor, Plot No. C-59, G-Block, BKC, Bandra (E), Mumbai – 400 0051, IndiaTel: +91 22 6112 1111  Fax: +91 22 61121100Cochlear Italia S.r.l  Via Larga n°33, 40138 Bologna, Italia  Tel: +39 051 601 53 11  Fax: +39 051 39 20 62Cochlear France S.A.S.  Route de l’Orme aux Merisiers, Z.I. Les Algorithmes - Bât. Homère, 91190 Saint Aubin, France  Tel: +33 811 111 993  Fax: +33 160 196 499Cochlear Nordic AB  Konstruktionsvägen 14, SE - 435 33 Mölnlycke, Sweden Tel: +46 31 335 14 61  Fax: +46 31 335 14 60Cochlear Tıbbi Cihazlar ve Sağlık Hizmetleri Ltd. Sti.  Cubuklu Mah. Bogazici Cad., Bogazici Plaza No: 6/1, Kavacik,TR - 34805 Beykoz-Istanbul, Turkey  Tel: +90 216 538 5900  Fax: +90 216 538 5919Cochlear Canada Inc  2500-120 Adelaide Street West, Toronto, ON M5H 1T1  Canada  Tel: +1 416 972 5082  Fax: +1 416 972 5083www.cochlear.comArdium, 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 2014. All rights reserved. SEP14. Printed in Sweden.Baha® 5 Sound ProcessorUser manual part ASound processor type designations for models included in this User Manual are: FCC ID: QZ3BAHA5, IC: 8039C-BAHA5, IC model:  Baha® 5.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 useThe Cochlear™ Baha® 5 Sound Processor 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-BAHA5   and model no.: IC model: Baha® 5.•  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.
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3EnglishWelcomeCongratulations on your choice of the Cochlear™ Baha® 5 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   11.  Microphones2. Battery compartment door3. Program button, Wireless audio streaming button 4. Plastic snap connector5. Attachment point for the safety lineNote 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.IntroductionYou should have received your Baha sound processor from your hearing care professional along with the contents of this kit. To ensure optimal performance, your hearing care professional will fit the processor to suit your needs based on your connection configuration. 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. WarrantyThe 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.
45EnglishUsing your sound processorThe sound processor is equipped with a button to select different listening programs and for enabling/disabling wireless audio streaming. Audio indicators can be activated to alert you to the different settings and processor status. Your sound processor is programmed to be used specifically on either the right or left side of your head. Your audiologist has marked your processor for use on either the left or right side.If you are a bilateral user, changes on one device will automatically apply on the other device. Your hearing care professional can disable this  functionality if you prefer.On/off See figure   21   Turn on your sound processor by closing the  battery compartment.2   Turn off your sound processor by slightly opening the battery compartment until you feel a “click”.When your sound processor is turned off and then back on, it will return to the default setting (program one).Audible status indicators See figure   3Your sound processor is equipped with audible indicators (beeps). Note: Your hearing care professional can disable the beeps if you prefer. Changing the program See figure  4After consulting with you, your hearing care professional has selected up to four programs for your Baha sound processor:Program 1:Program 2:Program 3:Program 4:(These programs are suitable for different listening environments. Ask your audiologist to fill in your specific programs).To switch programs, press and release the button. Audio signals let you know which program you have switched to:Program  1: 1 beep Program  2: 2 beeps Program  3: 3 beeps Program  4: 4 beepsVolume settingsYour hearing care professional has set the volume level for your sound processor. To adjust the level of listening comfort in different listening environments. You can adjust the volume level with the optional Cochlear Baha Remote Control.Using the telephone See figure   5For best results when talking on the telephone, place the receiver near the microphone inlet of the sound processor instead of near your ear canal. Make sure the receiver does not touch the sound processor as this may cause feedback.Baha 5 Sound Processor is a Made for iPhone device and allows direct communication and control with the iPhone, iPad or iPod touch. Alternatively the optional Cochlear Wireless Phone Clip can be used for hands-free calling direct to your Baha 5 Sound Processor.   For assistance in pairing and using these products with your Baha 5 Sound Processor, please contact your hearing care professional or visit our website www.cochlear.com.“Consult instructions for use” or “Operating instructions”“Caution” or “Caution, consult accompanying documents”Audible signalCE-markTemperature limitationInterference riskProduct name, CE mark and ACMA symbolBatch CodeSerial NumberRefer to instructions/bookletACMA (Australian Communications and Media Authority) compliantContacting Customer ServiceWe strive to provide the best possible products and services to our users. 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.Customer Service – Cochlear Americas 13059 E. Peakview Avenue,  Centennial, CO 80111, USAToll free (North America) 1800 523 5798Tel: +1 303 790 9010, Fax: +1 303 792 9025 E-mail: customer@cochlear.comCustomer Service – Cochlear Europe 6 Dashwood Lang Road Bourne Business Park, Addlestone, Surrey KT15 2HJ, United KingdomTel: +44 1932 26 3400, Fax: +44 1932 26 3426 E-mail: info@cochlear.co.ukCustomer Service – Cochlear Asia Pacific 1 University Avenue, Macquarie University NSW 2109, AustraliaToll free (Australia) 1800 620 929 Toll free (New Zealand) 0800 444 819Tel: +61 2 9428 6555, Fax: +61 2 9428 6352 or Toll free Fax 1800 005 215  E-mail: customerservice@cochlear.com.auKey to symbolsThe following symbols will be used throughout these documents. Please refer to the list below for explanations:
67EnglishTo use the test rod:1  Snap the sound processor onto the test rod using the tilt technique. Hold the rod against the skull bone behind an ear. Plug both ears and introduce sound.2  To avoid feedback (whistling), the sound processor should not touch anything other than the test rod.Warnings General adviceA 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 permit 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 training and instructions in lip-reading.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 to extreme temperatures. It is designed to operate within the temperature ranges +5 °C (+41 °F) to +40 °C (+104 °F). In particular, battery performance deteriorates in temperatures under +5 °C. The processor should not be subjected, 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 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.Optional tamper-proof battery door See figure   9To prevent the user from accidentally opening the battery door and exposing the battery, an optional tamper-proof battery door is available. This is particularly useful for children. Contact your hearing care professional for tamper-proof battery doors.To use the tamper-proof battery door: See figure   91.  To unlock the device, carefully insert a pencil in the small hole on the battery door and gently open the battery compartment.2. To lock the device, gently close the battery compartment until it is completely closed and you feel a “click”.Caution: Batteries can be harmful if swallowed. Be sure to keep your batteries out of reach of small children, those with mental challenges, and household pets. In the event a battery is accidentally swallowed, seek immediate medical attention at the nearest emergency center.General processor careYour Baha sound processor is a delicate electrical instrument. 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 the sound processor for a long period, remove the battery.  • During physical activities, secure your sound processor using the safety line. If the physical activity involves contact, Cochlear recommends removing your sound processor and protecting the implant site with a sweat band, etc. • Remove your sound processor before applying hair spray, gel or using hair dye.Using Share the Experience  See figure   10Family members and friends can “share the experience” of bone conduction hearing. The test rod is used by others to simulate hearing with the Baha sound processor. Attaching the safety line See figure   6Before connecting the sound processor, attach the safety line to it and clip the other end of the safety line to your shirt or jacket. Cochlear recommends connecting the safety line when engaging in physical activities. Children should use the safety line at all times.Cochlear wireless accessoriesWith Baha 5 Sound Processor, 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.To activate wireless audio streaming, press and hold the button until an audio melody is heard. See figure   4To end wireless audio streaming, press and release the button. The sound processor will return to the previous program used. Baha 5 Sound Processor is a Made for iPhone device and allows direct communication and control with the iPhone, iPad or iPod touch. Alternatively the optional Cochlear Wireless Phone Clip can be used for hands-free calling direct to your Baha 5 Sound Processor.  Ask your hearing care professional or visit www.cochlear.com to find out more about compatible devices.Note: The Baha 5 Sound Processor has no DAI (Direct Audio Input) port for connecting a cable  directly to external audio sources such as MP3 players or the Cochlear Baha Telecoil.Changing batteriesWhen there is approximately 1 hour of remaining battery power, 4 beeps occur 2 times to let you know that the battery will soon need to be replaced. At this time you may experience low amplification. If the battery runs down completely, the sound processor will beep and then stop working.Use one of the included batteries (zinc-air, non-rechargeable) as a replacement. The batteries included in the sound processor kit reflect Cochlear’s latest recommendations. Contact your hearing care professional for additional batteries.Battery tips • Battery life decreases as soon as the battery is exposed to air (when the plastic strip has been removed).  • Battery life depends on daily use, the volume setting, the use of wireless audio streaming, the sound environment, the program setting, and battery strength. • To maximize battery life, switch off the sound processor when not in use. • If a battery leaks, replace it immediately.To replace the battery:  See figure   71  Hold the sound processor with the back facing upwards.  2  Gently open the battery compartment until it is completely open. Remove the old battery. Dispose of battery according to local regulations. Remove the sticker on the + side of the new battery. Insert the new battery with the + sign facing upwards in the battery compartment.3  Gently close the battery compartment until it is completely closed and you feel a “click”.Flight mode See figure    8When boarding a flight, wireless functionality must be deactivated because radio signals may not be transmitted during flights. To disable wireless operation:1.  Turn off the sound processor by slightly opening the battery compartment until you feel a “click”.2.  Press the button and close the battery compartment at the same time. When in flight mode, wireless operation can be re-enabled by turning the processor off and on normally (i.e., by opening and closing the battery compartment).-20 °C (-4 °F)+50 °C (+122 °F)
89EnglishSound processor type designations for models included in this User Manual are: FCC ID: QZ3BAHA5, IC: 8039C-BAHA5, IC model:  Baha® 5.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  • 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. • Do not dispose of your sound processor in an incinerator or fire. • 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.If the sound processor becomes very wet: 1.  Immediately open the battery door  and remove the battery.2.  Put the sound processor in a container  with drying capsules such as a Dri-Aid Kit, etc. Leave the processor to dry out overnight. Drying kits are available from most hearing  care professionals.Feedback (whistling) problems  See figure   111  Check that items such as hats and glasses do not comes in contact with the sound processor. Also, ensure that neither the head nor the ear come in contact with the sound processor.2  Check that the battery compartment is closed.3  Check that the housing is intact. Functions and audible signalsFunction On the device Audible signalStart up Close battery door 10 beepsShut down Open battery door NoneProgram change Short button press 1 beep for program 12 beeps for program 2 etcLow battery warning 4 beeps 2 timesWhen using Cochlear Wireless AccessoriesVolume change Only on Baha remote control 1 beep indicates volume increase/decreaseVolume limit reached Only on Baha remote control 1 long beepEnable wireless audio streaming Long button press 5 beeps (melody in upward scale)Exit wireless audio streaming Short button press 5 beeps (melody in downward scale)Pairing confirmation None 5 beeps (melody in upward scale)Toggle between wireless accessoriesLong button press NoneFlight mode on Press button and close battery door 10 beeps 2 timesNote: your hearing care professionals may have disabled some of the audible signals.
10is 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 useThe Cochlear™ Baha® 5 Sound Processor 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-BAHA5  and model no.: IC model: Baha® 5.•  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.

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