DRAFT ONLY FOR CLINICAL TESTING Nucleus® 7 Sound Processor User Guide CP1000 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING This guide is intended for Cochlear implant recipients and their carers using the Cochlear™ Nucleus® 7 Sound Processor (model number: CP1000). The processor works with your implant to transfer sound to your ear, and is made up of a processing unit, earhook, coil and cable, and a battery module. You can power your processor with disposable or rechargeable batteries.
DRAFT ONLY FOR CLINICAL TESTING Nucleus 7 Sound Processor Coil Microphones and microphone protectors Indicator light Earhook Serial number Coil cable Nucleus 7 processing unit ABOUT Control button Coil magnet Battery module Made for iPhone (MFi) Your sound processor is a Made for iPhone (MFi) hearing device. This allows you to control your sound processor with some iPhone® and iPod touch® devices using the Cochlear Nucleus Smart app. Please see the app’s user guide for details.
DRAFT ONLY FOR CLINICAL TESTING Contents Power Batteries . . . . . . . . . . . . . . . . . . . Battery life . . . . . . . . . . . . . . . . . . Lock the battery module to the processor Lock the disposable battery module cover Replace the battery module . . . . . . . . Change disposable batteries . . . . . . . . Charge rechargeable batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 .5 .6 .7 .8 10 12 Use Turn on and off . . .
DRAFT ONLY FOR CLINICAL TESTING Care Regular care . . . . . . . . Battery charger care . . . Storage . . . . . . . . . . Water, sand and dirt . . . Change microphone cover Change the coil and cable Change the coil magnet . . . . . . . . . . . . . . . Lights and Beeps Troubleshoot Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DRAFT ONLY FOR CLINICAL TESTING Batteries You have a choice of three battery types for the Nucleus 7 Sound Processor: The disposable battery module consists of: • Cochlear Nucleus 7 Battery Cover • Cochlear Nucleus 7 Battery Holder It uses two disposable batteries and has a tamper-resistant lock. The Cochlear Nucleus 7 Standard Rechargeable Battery Module The Cochlear Nucleus 7 Compact Rechargeable Battery Module 4 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Battery life 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, your implant type, the thickness of skin covering your implant, and the size and type of battery. The rechargeable battery’s lifespan is at least 400 charge cycles. A completely empty rechargeable battery will take approximately four hours to recharge.
DRAFT ONLY FOR CLINICAL TESTING Lock the battery module to the processor To increase tamper resistance, the battery module can be locked to the sound processor. 1. Use your battery cover locking tool to push the lock to the far left to lock the battery module. 2. Push the lock to the far right to unlock the battery module. CAUTION Always check this lock is unlocked before attaching or removing the battery module. 6 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Lock the disposable battery module cover The disposable battery module has a tamper-resistant lock to help prevent children opening the battery cover. POWER LOCK Turn the locking screw clockwise with the battery cover locking tool until it is in a horizontal position. UNLOCK Turn the locking screw anticlockwise until it is in a vertical position. CAUTION Always check the locking screw is unlocked before attaching or removing the battery cover.
DRAFT ONLY FOR CLINICAL TESTING Replace the battery module Remove the battery module 1. Twist the battery module as shown to release it from the processing unit. 2. Pull the battery module from the processing unit. 8 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Attach the battery module 1. Align the battery module to the processor socket to fit the parts together. Rechargeable battery modules— align raised marker on battery module with back of processing unit Disposable battery module— align indents and lock on battery module with back of processing unit POWER 2. Twist the battery module as shown to attach the parts. Your processor will turn on automatically.
DRAFT ONLY FOR CLINICAL TESTING Change disposable batteries The disposable battery module uses two high power zinc air batteries. Cochlear recommends 675 (PR44) zinc air batteries designed for cochlear implant use. Do not use silver oxide or alkaline batteries. 1. Press and hold the button for 5 seconds, then release to turn off your processor. 2. Pull the unlocked battery cover away from the battery holder. 3. Remove the batteries from the battery holder. 10 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING 4. Remove the new batteries from the packet, and let them stand for a few seconds. 5. Insert the batteries into the battery holder with the flat side (positive terminal) facing up. POWER 6. Replace the battery cover by sliding it up towards the processing unit. Lock the cover if required Your processor will automatically turn on. NOTE If you do not put your processor on your implant, it will turn off automatically after two minutes, if enabled by your clinician.
DRAFT ONLY FOR CLINICAL TESTING Charge rechargeable batteries There are two chargers that can be used with the rechargeable battery modules: • Cochlear Nucleus 7 Y Battery Charger (see page 14) • Cochlear Nucleus 7 USB Battery Charger (see page 16). Before you start Your Nucleus 7 rechargeable battery module has built-in safety and monitoring features. Read this section before using your battery charger.
DRAFT ONLY FOR CLINICAL TESTING FLAT BATTERIES Even if your rechargeable battery module goes flat while being used with your Nucleus 7, it should hold some battery life. This means you can recharge a flat battery module up to 1 year after running it flat. WHAT DO I DO? Charge your flat battery module after use. NOTE If a rechargeable battery module is too flat to charge, the LED will flash orange (error). BATTERY HEALTH CHECK POWER Rechargeable battery modules have a built-in “health check”.
DRAFT ONLY FOR CLINICAL TESTING Use the Y Battery Charger The Y Battery Charger can charge two rechargeable battery modules at once. It uses the supplied USB cable to plug into: • a wall power outlet using the supplied power adaptor plug, or • a USB port (e.g. computer). 1 3 2 3 2 1 2 3 Power cable Rechargeable battery module connector LED indicator 14 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING 1. Connect the rechargeable battery module to the charger. 2. Twist to lock. 3. Plug the charger into a power outlet or USB port. The LED flashes green while charging. POWER USB 4. The LED changes to steady green when the module is fully charged. NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Use the USB Battery Charger The USB Battery Charger can charge one rechargeable battery module at a time. It uses a USB connector to plug into: • a wall power outlet using the supplied cable and power adaptor plug, or • a USB port (e.g. computer). 2 3 1 1 2 3 USB connector Rechargeable battery module connector LED indicator 16 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING 1. Remove the covers from the charger. 2. Connect the rechargeable battery module to the charger. POWER 3. Plug the charger into a power outlet or USB port. The LED flashes green while charging. USB 4. The LED changes to steady green when the module is fully charged. NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Turn on and off 1. To turn on either: • Connect the battery (see page 9), or • If the battery is already connected, short press the button. 2. To turn off, either: • Disconnect the battery (see page 8), or • Press and hold the button for 5 seconds, then release. The light will change to steady orange as the processor turns off. NOTE Your processor will also turn off automatically after being off your implant for two minutes, if enabled by your clinician.
DRAFT ONLY FOR CLINICAL TESTING INDICATOR LIGHTS WHAT IT MEANS Turning on processor. The number of flashes indicates the number of the current program. Green flashes … Quick green flashes Processor flashes while receiving sound from microphones (Child mode only). ... Orange flashes Processor is off the implant. Processor is turning off.
DRAFT ONLY FOR CLINICAL TESTING Change program You can choose between programs to change the way your sound processor deals with sound (e.g. in noisy or quiet places). Usually two programs are all you need, but your clinician can give you up to four programs. 1. Short press the button to switch between programs. NOTE If your clinician has enabled SCAN, your sound processor can automatically select the best program for you.
DRAFT ONLY FOR CLINICAL TESTING Telecoil Your clinician can enable telecoil if you want to listen to room hearing loops. NOTE Telecoil is not recommended for phone use with the Nucleus 7 Sound Processor. We recommend you use the Cochlear Wireless Phone Clip. See Wireless accessories on page 22. TIP You can also use your remote or the Nucleus Smart app to control telecoil. See their user guides for details. 1. Press and hold the button for 2 seconds then release to turn on telecoil.
DRAFT ONLY FOR CLINICAL TESTING Wireless accessories Cochlear True Wireless™ Accessories can wirelessly stream sound to your processor: • The Mini Microphone or TV Streamer are controlled from your processor. • You use the Phone Clip controls for phone calls. NOTE You first need to pair your wireless accessories with your sound processor. See their user guide for details. TIP You can also use your remote or the Nucleus Smart app to control wireless accessories. See their user guides for details.
DRAFT ONLY FOR CLINICAL TESTING 1. Press and hold the button for 2 seconds then release to stream audio. Press and release again if you need to cycle to the next audio source. Blue: streaming audio. 2. Short press the button to stop streaming. USE NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Use monitor earphones Carers can use monitor earphones to check that a Cochlear implant recipient is receiving sound, and that functions like telecoil or wireless accessories are working. NOTES • Only use approved earphones/headphones with the monitor earphone adaptor (ones with a 3- or 4-pin audio jack that fits the adaptor). You CAN use earbuds. You CANNOT use noise-cancelling headphones. • Don’t connect multiple monitor earphone adaptors in series.
DRAFT ONLY FOR CLINICAL TESTING 3. Insert the battery module, then twist to connect. 4. Plug the monitor earphones into the adaptor. USE NOTE Use only Cochlearapproved earphones. Ask your clinician for guidance 5. Use the earphones to check that the recipient is hearing sound. NOTE Do not put the sound processor on the recipient’s implant. NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Wear your processor 1. Place the processor on your ear, letting the coil dangle. 2. Move the coil sideways and onto your implant. INDICATOR LIGHTS WHAT IT MEANS Processor flashes while coil is off Flash of orange every second (or connected to the wrong implant). 26 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING For users with two implants Ask your clinician to give you coloured stickers (red for right, blue for left) to make identifying left and right processors easier. CAUTION If you have two implants, you must use the correct sound processor for each implant. NOTE Your sound processor will recognise the implant’s ID, so it will not work on the wrong implant. WEAR NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Change earhooks The Cochlear Nucleus 7 Earhook comes in small, medium and large sizes. For extra help wearing your processor securely and safely, see Retention accessories on page 29. NOTE Remove your earhook only when necessary–it may become loose if it is removed too often. 1. Pull up on the earhook to remove it. 2. Click the new earhook into place. 28 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Retention accessories A range of optional Cochlear Nucleus 7 accessories are available to help you wear your sound processor securely and safely. NOTE Hybrid mode cannot be used with retention accessories. They either position the sound processor off the ear, or use a custom earhook which means the acoustic component cannot be fitted. Nucleus 7 Tamper Resistant Earhook A small earhook for young children.
DRAFT ONLY FOR CLINICAL TESTING Nucleus 7 Earmould Adaptor Allows you to attach a custom earmould to hold your sound processor in place more securely than an earhook alone. NOTE The custom earmould is not supplied by Cochlear. Nucleus 7 Koala Clip Holds your sound processor so you can clip it onto your clothing. Great for chidren. NOTE You will need to use a coil with a longer cable. Nucleus 7 Headworn Adaptor Holds your sound processor and coil, so you can wear them on your head.
DRAFT ONLY FOR CLINICAL TESTING Cochlear™ Safety Cord Clips to clothing so active people are less likely to lose their sound processor. Available in single or double (for users with two processors). Nucleus 7 Headband Holds your sound processor and coil in place. Great for active adults and children. Has pockets for left and right side sound processors. WEAR NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Wear the Headband The Cochlear Headband is an optional accessory that holds the processor in place on your implant. This is useful for children or for physical activities. Headband sizing To choose a headband, measure your head circumference: SIZE CIRCUMFERENCE SIZE CIRCUMFERENCE XXS 41-47 cm M 52-58 cm XS 47-53 cm L 54-62 cm S 49-55 cm NOTE The headband may affect your sound processor’s performance. If you notice any change, contact your clinician.
DRAFT ONLY FOR CLINICAL TESTING 2. Insert your processor(s) in the correct pocket(s): • the left processor in the left-side pocket, the right processor in the right-side pocket • the side of the coil that fits onto your implant is facing up towards you. 3. Push the coil through the slit in the headband. WEAR 4. Pick up the ends of the headband, and place the anti-slip section against your forehead. 5. Join the ends behind your head.
DRAFT ONLY FOR CLINICAL TESTING Sport and exercise TIP Always ensure the battery cover and battery modules are locked when you exercise or play sport. NOTE If you want to use your processor around water, ask your clinician about the Cochlear Nucleus 7 Aqua+. 1. Use retention accessories such as the Snugfit, Safety Cord or Headband to help hold your processor in place when you play sport or exercise. 34 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING 2. After exercise, wipe your processor with a soft cloth to remove sweat or grime. WEAR 3. Then check your microphone protectors for dirt. See Change microphone cover on page 44. NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Travel NOTE Visit www.cochlear.com/clinic-finder to find the nearest clinic in places you are travelling. • Take a printout from your clinician of your most recent program in case you need help with your processor. • If you have a backup sound processor, check that it is programmed correctly and take it with you. • It’s okay to move through metal detectors and full body scanners with your sound processor on.
DRAFT ONLY FOR CLINICAL TESTING Flight mode NOTE In flight mode, you can change programs as normal using the processor button. You can only use telecoil to stream audio, as True Wireless Accessories will not be available. To enter flight mode: 1. Disconnect the battery. WEAR 2. Press and hold the button (1) while reconnecting the battery (2). Release the button when the green light comes on. To exit flight mode: 1. Disconnect and reconnect the battery.
DRAFT ONLY FOR CLINICAL TESTING Regular care CAUTIONS • Do not use cleaning agents or alcohol to clean your processor. • Turn your processor off before cleaning or performing maintenance. Every day • Check all parts and any accessories you use (e.g. Snugfit) for dirt or moisture. Wipe the processor, coil, cable, earhook and accessories with a soft dry cloth. (You can leave accessories on the processor while cleaning.) • Keep your processor free from moisture by drying it every night in your dry aid kit.
DRAFT ONLY FOR CLINICAL TESTING Every month Check if earhooks or retention accessories are becoming loose or showing signs of wear. Replace as needed. See Change earhooks on page 28, or your retention accessory’s instructions. Every two months • Replace the dry brick in your dry aid kit. Every three months • Replace the microphone cover–this is very important for the quality of sound. See Change microphone cover on page 44. CARE NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Battery charger care Every day • Check your battery charger is clean. If you notice any dust or dirt: 1. Disconnect the battery charger from the power source and remove any battery modules. 2. Hold the battery charger upside down and tap it gently to remove any dirt from the battery charger sockets. Carefully blowing on the sockets may also help remove dirt. 3. Wipe the battery charger sockets with a soft dry cloth.
DRAFT ONLY FOR CLINICAL TESTING Storage Dry aid kit Store your processor at night in the dry aid kit provided by Cochlear. Store the processor fully assembled for 8 hours for optimal drying effect. Storage case CARE For long term storage: • remove disposable batteries and store so they do not touch each other • remove rechargeable battery modules and store fully charged. Storage cases are available from Cochlear. NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Water, sand and dirt Your processor is resistant to water, sand and dust. However, it is still a precision electronic device so you should take the following precautions. If your processor ever gets wet, dry it with a soft cloth. Then remove the battery module (and disposable batteries if used), dry them and the contacts with a soft cloth, and replace them. Replace the microphone protectors and place your processor in the dry aid kit provided by Cochlear for 8 hours.
DRAFT ONLY FOR CLINICAL TESTING Your processor is protected against failure from dust and temporary immersion in water (IP57 rated) when you wear it with: • a rechargeable battery module • a coil and coil cable • no acoustic component. • a disposable battery module • a coil and coil cable • an acoustic component worn in the ear. NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Change microphone cover Replace your microphone protectors every three months, or if they look dirty or you notice any loss in sound quality. They are built into the Cochlear Nucleus 7 Microphone Cover, which is completely replaced. Microphone protectors Microphone cover Step 1: Remove old microphone cover 1. Hold the coil cable grip and firmly pull it straight out of the processor. Do not tug on the flexible part of the coil cable.
DRAFT ONLY FOR CLINICAL TESTING Step 2: Insert new microphone cover 1. Fit the replacement microphone cover onto the processor. 2. Press down firmly with a finger on each end of the microphone cover until you hear a click. CARE 3. Push your coil cable into the processor until it clicks. Do not twist. NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Change the coil and cable The Cochlear Nucleus 7 Slimline™ Coil comes in four cable lengths (6, 8, 11 and 25 cm) so you can choose the most comfortable fit. You might also need to change to a different length cable to use some retention accessories (e.g. Headworn). NOTE Only remove the coil from your sound processor when necessary. 1. Hold the coil cable grip and firmly pull it straight out of the processor. Do not pull on the flexible part of the coil cable.
DRAFT ONLY FOR CLINICAL TESTING Change the coil magnet You need to choose a Cochlear Nucleus 7 Magnet that is the correct strength–if it is too weak the coil may fall off, and if it is too strong it may cause discomfort. Magnet strength ranges from ½ (weakest) to 6 (strongest). You might also need to change to a stronger magnet to use some retention accessories (e.g. Headworn). NOTE If your clinician has provided you with a Nucleus 7 Magnet Reverse Polarity, use it as described here for a normal magnet.
DRAFT ONLY FOR CLINICAL TESTING Lights Your clinician can set up your processor to show some or all of the following light indications. Turning on and off LIGHT WHAT IT MEANS … Quick green flashes Processor flashes while receiving sound from microphones (Child mode only). Turning on and changing programs. Number of flashes indicates the number of the current program. Quick green flashes Turning off processor. Long flash of orange Locking button LIGHT WHAT IT MEANS Locking processor button.
DRAFT ONLY FOR CLINICAL TESTING Streaming audio LIGHT Quick blue flash … Quick blue flashes WHAT IT MEANS Processor flashes when pairing to wireless accessory is successful. Processor flashes while receiving audio from an audio source (Child mode only). Alerts WHAT IT MEANS … Flash of orange every second Processor flashes while it is off your head (or connected to the wrong implant). Orange flashes Steady orange Processor batteries are low. Change batteries. Fault. Contact your clinician.
DRAFT ONLY FOR CLINICAL TESTING Battery charging LIGHT WHAT IT MEANS … Battery module is charging. Battery module is fully charged. … Error. Try a different rechargeable battery module. If you are using the Y Battery Charger, try the rechargeable battery module on the other connector on the charger. Does not light up 50 592753_1-06_EN_CP1000_UG_EMEA.indd 50 Battery module is not properly connected, is over-discharged, or there is no power.
DRAFT ONLY FOR CLINICAL TESTING Beeps Your clinician can set up your processor so you can hear the following beeps (they are only audible to you). Turning on and off BEEP WHAT IT MEANS Changing the program. The number of beeps indicates the number of the selected program. Short high beeps Short high beep When changing volume or sensitivity, indicates upper or lower limit of volume/ sensitivity reached.
DRAFT ONLY FOR CLINICAL TESTING Telecoil BEEP WHAT IT MEANS Switching between using the microphones and the telecoil. Long high beep Wireless accessories BEEP 3-tone chime WHAT IT MEANS Connecting with wireless accessory to begin streaming audio. When stopping streaming. Short beep Alerts BEEP WHAT IT MEANS Processor batteries are low. Change batteries. 2 Short low beeps Short low beeps for 4 seconds 4 long low beeps over 4 seconds 52 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Adjusting master volume, bass and treble * BEEP Loud medium beep WHAT IT MEANS Adjusting master volume level. Adjusting treble level. Loud long high beep Adjusting bass level. Loud long low beep LIGHTS AND BEEPS * If available, Nucleus Smart app only NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.
DRAFT ONLY FOR CLINICAL TESTING Troubleshoot Contact your clinician if you have any concerns regarding the operation or safety of your sound processor. PROBLEM RESOLUTION Processor will not 1. turn on/button will not respond 2. 3. 4. 5. 6. The processor switches off 1. 2. The processor will not turn off 1. 2. 54 592753_1-06_EN_CP1000_UG_EMEA.indd 54 Try turning the processor on again. See Turn on and off on page 18. Try unlocking the button. See Lock the control button on page 19.
DRAFT ONLY FOR CLINICAL TESTING PROBLEM RESOLUTION You are not sure what processor beeps or light flashes mean See Lights on page 48 and Beeps on page 51. You do not hear sound or sound is intermittent 1. 2. 3. 4. 5. You hear 1. intermittent sound, a buzzing sound or distorted speech 2. 3. Check for sources of interference such as radio and TV transmission towers (within approximately 1.6 km or 1 mile), shopping centres, airport security systems and mobile phones.
DRAFT ONLY FOR CLINICAL TESTING PROBLEM RESOLUTION Sound is too loud or uncomfortable 1. 2. 3. 4. 5. Sound is too quiet or muffled 1. 2. 3. 4. 5. 56 592753_1-06_EN_CP1000_UG_EMEA.indd 56 If you use a Nucleus 7 Remote Control, turn down the volume. If you use the Nucleus Smart app, turn down the volume or sensitivity. Try a different program. See Change program on page 20. If you have two sound processors (one for each side), ensure you have them on the correct side.
DRAFT ONLY FOR CLINICAL TESTING PROBLEM RESOLUTION You want to confirm your processor is receiving sound 1. 2. 3. 4. Check the light on the top of the processor (if enabled). See Lights on page 48. If you have monitor earphones, a hearing person can listen to the sound received by the processor. See Use monitor earphones on page 24. If you use the Nucleus Smart app, use the sound meter to check the processor is receiving sound ????. If the problem continues, contact your clinician. 1.
DRAFT ONLY FOR CLINICAL TESTING PROBLEM RESOLUTION You do not hear 1. sound from a wireless accessory 2. 3. 4. 5. 6. 7. You do not hear sound from a monitor earphone 1. 2. 3. 4. 58 592753_1-06_EN_CP1000_UG_EMEA.indd 58 Check that the wireless accessory is charged and turned on. Check that the wireless accessory is paired with your processor. Check the volume of the wireless accessory.
DRAFT ONLY FOR CLINICAL TESTING PROBLEM RESOLUTION You hear loud or distorted sound from a monitor earphone 1. The processor gets 1. wet You want to perform a regular check on your processor Remove the monitor earphone and consult your clinician. Dry the processor with a soft cloth, change the microphone protectors and place the processor in the dry aid kit provided by Cochlear for 8 hours. See Water, sand and dirt on page 42. See Regular care on page 38.
DRAFT ONLY FOR CLINICAL TESTING PROBLEM RESOLUTION Batteries are not lasting as long as usual 1. 2. 3. 4. 5. 6. Clean all connections and parts of the battery module. Clean all connections on the processing unit. Try replacing the coil with a new coil. If you are using disposable batteries, check that you are using the recommended batteries. See Change disposable batteries on page 10. Don’t forget to let new disposable batteries stand for a few seconds before you put them in the sound processor.
DRAFT ONLY FOR CLINICAL TESTING Cautions • Young children who are developing motor skills are at greater risk of an impact to the head from a hard object (e.g. table or chair). Impact to the sound processor may cause damage to the processor or its parts. Impact to the head in the area of the Cochlear implant could damage it and result in its failure. • Most patients can benefit from electrical stimulation levels that are considered safe, based on animal experimental data.
DRAFT ONLY FOR CLINICAL TESTING Warnings For parents and carers • Removable parts of the system (e.g. microphone cover, magnets, batteries, battery cover, retention aids) can be lost or may be a choking or strangulation hazard. Keep out of reach of children or lock the tamper-resistant screw on the battery module and/or cover. • Parents and carers are advised that unsupervised use of long cables (e.g. coil or accessory cables) may present a risk of strangulation.
DRAFT ONLY FOR CLINICAL TESTING • Carers must monitor for signs of discomfort or skin irritation if a retention aid (e.g. headband) is used that applies pressure to the sound processor or coil. Remove the aid immediately if there is any discomfort or pain, and contact your clinician. • Keep the dry brick from the dry aid kit away from small children. Swallowing this material can cause serious internal injuries. • Do not allow children to replace batteries without adult supervision.
DRAFT ONLY FOR CLINICAL TESTING Processors and parts • Each processor is programmed specifically for each implant. Never wear another person’s processor or lend yours to another person. • Use your Cochlear implant system only with approved devices and accessories. • If you experience a significant change in performance, remove your processor and contact your clinician. • Your processor and other parts of the system contain complex electronic parts. These parts are durable but must be treated with care.
DRAFT ONLY FOR CLINICAL TESTING NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.indd 65 WARNINGS • If you need to adjust the volume often, or if adjusting volume ever causes discomfort, contact your clinician. • Do not let your processor or parts entangle with any jewellery (e.g. earhook and earrings) or machinery. • Do not place the processor or parts in any household devices (e.g. microwave oven, dryer). • Do not expose the processor or parts to heat (e.g.
DRAFT ONLY FOR CLINICAL TESTING • Do not place the device or accessories inside any part of your body (e.g. nose, mouth). • Seek medical advice before entering any environment that may adversely affect the operation of your Cochlear implant, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. • Some types of digital mobile telephones (e.g.
DRAFT ONLY FOR CLINICAL TESTING Batteries NUCLEUS 7 SOUND PROCESSOR USER GUIDE 592753_1-06_EN_CP1000_UG_EMEA.indd 67 WARNINGS • Use only Cochlear supplied or recommended 675 (PR44) zinc air batteries designed for cochlear implant use. We do not recommend using silver oxide or alkaline batteries. • Insert disposable batteries in the correct orientation. • If disposable batteries are short-circuited the processor will not work and its temperature can reach 42° C (107° F).
DRAFT ONLY FOR CLINICAL TESTING • Wipe batteries with a clean dry cloth if they become dirty. • Store unused batteries in original packaging, in a clean and dry place. • Do not use damaged or deformed batteries. If skin or eyes come into contact with battery fluid or liquid, wash out with water and seek medical attention immediately. • Do not expose batteries to heat (e.g. never leave batteries in sunlight, behind a window or in a car). • Never put batteries in your mouth.
DRAFT ONLY FOR CLINICAL TESTING Medical treatments Magnetic resonance imaging (MRI) MRI is contraindicated except under special circumstances. Do not allow a patient with an implant to be in a room where an MRI scanner is located except under special circumstances. Full MRI safety information is available at www.cochlear.com/warnings or by calling your regional Cochlear office (contact numbers available at the end of this document).
DRAFT ONLY FOR CLINICAL TESTING Medical treatments generating induced currents, heat and vibration Having a cochlear implant means extra care must be taken when receiving some medical treatments. Before starting medical treatment, the information in this section should be discussed with the recipient’s physician. The sound processor must be removed before starting any of the medical treatments listed in this section.
DRAFT ONLY FOR CLINICAL TESTING CONDITION WARNING Electrosurgery Electrosurgical instruments can induce radio frequency currents that could flow through the electrode. Monopolar electrosurgical instruments must not be used on the head or neck of an implant patient as induced currents could cause damage to cochlear/ neural tissues or permanent damage to the implant.
DRAFT ONLY FOR CLINICAL TESTING Other information Physical configuration The processing unit comprises: • Two omni-directional microphones for receiving sound. • An internal telecoil for receiving magnetic fields radiated by phones, neckloops and roomloops. • Custom analogue and digital integrated circuits with digital signal processing (DSP) and bidirectional wireless communication capabilities. • A tri-colour visual indication of processor function or problem.
DRAFT ONLY FOR CLINICAL TESTING Materials Battery life, charge cycles and lifespan • Battery life means the time a device will run before the disposable batteries must be replaced, or the rechargeable batteries 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 fully-charged capacity.
DRAFT ONLY FOR CLINICAL TESTING Operating characteristics Processing unit CHARACTERISTIC VALUE/RANGE Sound input frequency range 100 Hz to 8 kHz Wireless technology Proprietary low power bidirectional wireless link RF frequency 2.4 GHz Operating voltage 2.00 V to 4.
DRAFT ONLY FOR CLINICAL TESTING Product component dimensions (Typical values) ITEM LENGTH WIDTH DEPTH DIAMETER Nucleus 7 processing unit with medium earhook and standard rechargeable battery module 36.5 mm 9.0 mm 45.0 mm N/A 9.0 mm 17.3 mm N/A 17.8 mm N/A Disposable battery module 29.4 mm Compact rechargeable battery module 18.0 mm 9.0 mm Standard rechargeable battery module 9.0 mm 17.8 mm N/A N/A N/A 5.8 mm 30.3 mm OTHER INFORMATION Coil 24.8 mm Product weight (Typical values.
DRAFT ONLY FOR CLINICAL TESTING Environmental conditions CONDITION MINIMUM MAXIMUM Storage & transport temperature -10° C (14° F) +55° C (131° F) Storage & transport humidity 0% RH 90% RH Operating temperature (sound processor)+5° C (41° F) +40° C (104° F) Operating temperature (battery charger) +0° C (32° F) +40° C (104° F) Operating relative humidity 0% RH 90% RH Operating pressure 700 hPa 1060 hPa Environmental protection Your sound processor contains electronic components subject to the D
DRAFT ONLY FOR CLINICAL TESTING Disposable batteries Check the battery manufacturer’s recommended operating conditions for disposable batteries used in your processor. Wireless communication link The wireless communication link operates in the 2.4 GHz ISM band using GFSK (Gaussian frequency-shift keying), and a proprietary bidirectional communication protocol. It continuously switches between channels to avoid interference on any specific channel.
DRAFT ONLY FOR CLINICAL TESTING Electromagnetic compatiblity (EMC) WARNING Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in.) to any part of your Nuclues 7 Sound Processor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
DRAFT ONLY FOR CLINICAL TESTING 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.
DRAFT ONLY FOR CLINICAL TESTING Radio compliance for Japan This device is granted pursuant to the Japanese Radio Law ( ) and its relevant law. This device should not be modified (otherwise the granted designation number will become invalid). R 202-L SD 08 8 Radio compliance for Korea 1. Equipment name/model name: 2. Registration number: MSIP-CRM-COH-CP1000 3. Company name: Cochlear Limited 4. Manufactured date: 2016 5.
DRAFT ONLY FOR CLINICAL TESTING Certification and applied standards The Nucleus 7 Sound Processor fulfils the essential requirements listed in Annex 1 of the EC directive 90/385/EEC on Active Implantable Medical Devices as per the conformity assessment procedure in Annex 2. The year in which authorisation to affix the CE mark was granted was 2016.
DRAFT ONLY FOR CLINICAL TESTING Labelling symbols The following symbols may appear on your processor or remote components and/or packaging: Refer to instruction manual Specific warnings or precautions associated with the device, which are not otherwise found on the label Manufacturer M/N Model number Authorised representative in the European Community Catalogue number Serial number Batch code Date of manufacture Temperature limits CE registration mark with notified body number Radio compliance cert
DRAFT ONLY FOR CLINICAL TESTING R 202-L SD0 8 8 Radio compliance certification for Japan Radio compliance certification for Korea By prescription Recyclable material OTHER INFORMATION Dispose of electrical components in accordance with your local regulations Type B applied part Ingress Protection Rating • Protected against access of solid foreign objects greater than or equal to 1.0mm diameter. • Protected against failure from splashing water.
DRAFT ONLY FOR CLINICAL TESTING Privacy and the collection of personal information During the process of receiving a Cochlear device, personal information about the user/recipient or their parent, guardian, carer and hearing health professional will be collected for use by Cochlear and others involved in care with regard to the device. For more information please read Cochlear’s Privacy Policy on www.cochlear.com or request a copy from Cochlear at the address nearest you.
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DRAFT ONLY FOR CLINICAL TESTING 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 Ltd (ABN 96 002 618 073) 14 Mars Road, Lane Cove, NSW 2066, 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 Canada Inc 2500-120 Adelaide Street West, Toronto, ON M5H 1T1, Canada Tel: +1 416 972 5082 Fax: +1
