Manufacturer:
Cochlear Bone Anchored Solutions AB Konstruktionsvgen 14, SE - 435 33 Mlnlycke, Sweden Tel: +46 31 792 44 00 Fax: +46 31 792 46 95 Regional ofces:
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 ofces:
Cochlear Deutschland GmbH & Co. KG Karl-Wiechert-Allee 76A, D-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 87 1500 Fax: +44 1932 87 1526 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 1810, Hopewell Centre, 183 Queens Road East, Wan Chai, Hong Kong SAR Tel: +852 2530 5773 Fax: +852 2530 5183 Cochlear 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 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 oor, Cheongwon building, 828-5, Yuksam dong, Kangnam gu, Seoul, Korea Tel: +82 2 533 4663 Fax: +82 2 533 8408 Cochlear Benelux NV Schalinhoevedreef 20 1, B - 2800 Mechelen, Belgium Tel: +32 1579 5511 Fax: +32 1579 5500 Cochlear Medical Device Company India (P) Ltd Platina Building, Ground Floor, Plot No. C-59, G-Block, BKC, Bandra (E), Mumbai 400 0051, India Tel: +91 22 6112 1111 Fax: +91 22 61121100 Cochlear Italia S.r.l Via Larga n33, 40138 Bologna, Italia Tel: +39 051 601 53 11 Fax: +39 051 39 20 62 Cochlear France S.A.S. Route de lOrme aux Merisiers, Z.I. Les Algorithmes - Bt. Homre, 91190 Saint Aubin, France Tel: +33 811 111 993 Fax: +33 160 196 499 Cochlear Nordic AB Konstruktionsvgen 14, SE - 435 33 Mlnlycke, Sweden Tel: +46 31 335 14 61 Fax: +46 31 335 14 60 Cochlear Tbbi Cihazlar ve Salk 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 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 Baha 5 Sound Processor User manual part A 3 GB 11 FR 19 DE 27 NL 35 IT English Franais Deutsch Nederlands Italiano ZONE 1 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 2014. All rights reserved. SEP14. Printed in Sweden. 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 numrique de la classe B est conforme 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. Lexploitation est autorise aux deux conditions suivantes : (1) lappareil ne doit pas produire de brouillage, et (2) lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. Equipment includes RF transmitter. Sound 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 users authority to operate the equipment. Intended use The 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. 1 2 5 7 9 1 1 3 1 2 1 4 5 3 4 2 6 2 10 1 8 11 3 2 Welcome Congratulations on your choice of the Cochlear Baha 5 Sound Processor. You are now ready to use Cochlears 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 1. Microphones 2. Battery compartment door 3. Program button, Wireless audio streaming button 4. Plastic snap connector 5. Attachment point for the safety line 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. Introduction You 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. 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. 3 English Contacting Customer Service We 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, USA Toll free (North America) 1800 523 5798 Tel: +1 303 790 9010, Fax: +1 303 792 9025 E-mail: customer@cochlear.com Customer Service Cochlear Europe 6 Dashwood Lang Road Bourne Business Park, Addlestone, Surrey KT15 2HJ, United Kingdom Tel: +44 1932 26 3400, Fax: +44 1932 26 3426 E-mail: info@cochlear.co.uk Customer Service Cochlear Asia Pacific 1 University Avenue, Macquarie University NSW 2109, Australia 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 Key to symbols The following symbols will be used throughout these documents. Please refer to the list below for explanations:
Consult instructions for use or Operating instructions Caution or Caution, consult accompanying documents Audible signal CE-mark Temperature limitation Interference risk Product name, CE mark and ACMA symbol Batch Code Serial Number Refer to instructions/booklet ACMA (Australian Communications and Media Authority) compliant Using your sound processor The 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 2 1 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 3 Your sound processor is equipped with audible indicators (beeps). Note: Your hearing care professional can disable the beeps if you prefer. 4 Changing the program See figure 4 After 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 beeps Volume settings Your 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 5 For 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. 5 English Attaching the safety line See figure 6 Before 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 accessories With 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 4 To 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 batteries When 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 6 included in the sound processor kit reflect Cochlears 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 7 1 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 8 When 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). Optional tamper-proof battery door See figure 9 To 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 9 1. 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 care Your 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 10 Family 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. To 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 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 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
+50 C
(+122 F) 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).
-20 C
(-4 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. 7 English The sound processor is suitable for use in 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 11 1 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. 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 GHz2.48 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 Sound 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 Function Start up Shut down Program change Low battery warning Functions and audible signals On the device Close battery door Open battery door Short button press Audible signal 10 beeps None 1 beep for program 1 2 beeps for program 2 etc 4 beeps 2 times When using Cochlear Wireless Accessories Volume change Only on Baha remote control Volume limit reached Only on Baha remote control 1 beep indicates volume increase/
decrease 1 long beep Enable wireless audio streaming Long button press 5 beeps (melody in upward scale) Exit wireless audio streaming Short button press Pairing confirmation None 5 beeps (melody in downward scale) 5 beeps (melody in upward scale) Toggle between wireless accessories Flight mode on Long button press None Press button and close battery door 10 beeps 2 times Note: your hearing care professionals may have disabled some of the audible signals. 8 9 English ICES-003. Cet appareil numrique de la classe B est conforme 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. Lexploitation est autorise aux deux conditions suivantes : (1) lappareil ne doit pas produire de brouillage, et (2) lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. Equipment includes RF transmitter. 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 users authority to operate the equipment . Intended use The 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 10