Cochlear CP950 SOUND PROCESSOR User Manual

Cochlear Limited SOUND PROCESSOR Users Manual

Users Manual

Kanso™ Sound ProcessorUser GuideDRAFT ONLY FOR CLINICAL TESTING
II KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGThis guide is intended for Cochlear implant recipients and their carers using the Cochlear™ Nucleus® Kanso™ Sound Processor (model number CP950). The processor works with your implant to transfer sound to your ear. It is a self-contained unit that contains the processing unit, microphones, magnet and batteries.You can control your processor by pressing the button, as shown in this guide. You can also use a Cochlear Nucleus CR210 Remote Control or Cochlear Nucleus CR230 Remote Assistant. They also provide extra troubleshooting functions. For more information, please see your remote’s user guide. NOTES • Refer to the Cautions and Warnings sections for safety advice relating to the use of the Kanso Sound Processor, batteries and components.• Please also refer to your Important Information document for essential advice that applies to Cochlear implant systems.Symbols used in this guideNOTEImportant information or advice.TIPTime saving hint.CAUTION (no harm)Special care to be taken to ensure safety and effectiveness. Could cause damage to equipment.WARNING (harmful)Potential safety hazards and serious adverse reactions. Could cause harm to person.
USER GUIDE 1DRAFT ONLY FOR CLINICAL TESTINGMicrophone portsIndicator lightABOUTFront coverControl buttonBattery coverKanso™ Sound ProcessorAir slotsBackBattery cover lockSafety line attachment pointsFrontTHIS WAY UP
2 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGContentsPowerBatteries . . . . . . . . . . . . . . . . . . . . . . . . . 4Battery life . . . . . . . . . . . . . . . . . . . . . . . . 4Lock/unlock the battery cover . . . . . . . . . . . . . 5Change the batteries . . . . . . . . . . . . . . . . . . 6UseTurn on and off . . . . . . . . . . . . . . . . . . . . . 8Pair with remotes . . . . . . . . . . . . . . . . . . . . 9Change program . . . . . . . . . . . . . . . . . . . 10Change volume and sensitivity. . . . . . . . . . . . 11Use audio sources . . . . . . . . . . . . . . . . . . 12Telecoil . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Wireless Accessories. . . . . . . . . . . . . . . . . . . . 12WearWear your processor . . . . . . . . . . . . . . . . . 14For users with two implants . . . . . . . . . . . . . 15Attach a SoftWear pad . . . . . . . . . . . . . . . . 16Change the magnet . . . . . . . . . . . . . . . . . . 18Attach the Safety Line . . . . . . . . . . . . . . . . 20Sport and exercise . . . . . . . . . . . . . . . . . . 22Travel . . . . . . . . . . . . . . . . . . . . . . . . . 23
USER GUIDE 3DRAFT ONLY FOR CLINICAL TESTINGCareStorage . . . . . . . . . . . . . . . . . . . . . . . . 25Regular care . . . . . . . . . . . . . . . . . . . . . . 24Change microphone protectors . . . . . . . . . . . 26Water, sand and dirt . . . . . . . . . . . . . . . . . 29Lights and BeepsLights . . . . . . . . . . . . . . . . . . . . . . . . . 30Beeps . . . . . . . . . . . . . . . . . . . . . . . . . 32Troubleshoot . . . . . . . . . . . . . . . 34Cautions . . . . . . . . . . . . . . . . . . . 39WarningsFor parents and carers . . . . . . . . . . . . . . . . 40Processors and parts . . . . . . . . . . . . . . . . . 41Batteries . . . . . . . . . . . . . . . . . . . . . . . . 44Medical treatments . . . . . . . . . . . . . . . . . 45Other information . . . . . . . . . 48
4 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGBatteriesFor everyday use, the Kanso Sound Processor uses two high power p675 (PR44) zinc air disposable batteries designed for Cochlear implant use NOTE You will need to use other battery types only when you are using the Aqua+ for Kanso accessory. Please see its user guide for details.Battery lifeBatteries 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 and the thickness of skin covering your implant. Your Kanso Sound Processor has been designed to provide the majority of users with a battery life of more than 16 hours for typical use with zinc air batteries. However this will vary depending on your system settings and hearing situations. To help you get the longest life from the batteries, your sound processor will turn off two minutes after you take it off your implant.
USER GUIDE 5DRAFT ONLY FOR CLINICAL TESTINGLock/unlock the battery coverThe battery cover has a tamper resistant lock to help prevent children opening the battery cover. 1. To lock, turn the locking screw clockwise with the battery cover locking tool until it is horizontal.LOCKED2. To unlock, turn the locking screw anticlockwise until it is vertical.UNLOCKEDCAUTION Always check the locking screw is unlocked before attaching or removing the battery cover.POWER
6 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGChange the batteries1. If the battery cover is locked, turn the lock screw anticlockwise to unlock it. 2. Remove the battery cover. Use your fingers on the sides to pull off the cover.3. Push down on each battery with your thumb in the cutout section in the side. The batteries pop up. Pull the batteries out.
USER GUIDE 7DRAFT ONLY FOR CLINICAL TESTINGPOWER4. Remove the new batteries from the packet, and let them stand for a few seconds.See Batteries on page 4.5. Insert the batteries into the battery holder with the side with holes on it (positive terminal) facing out. 6. Replace the battery cover.Lock the cover if required.Your processor will automatically turn on.NOTE If you do not put your sound processor on your implant, it will turn off automatically after two minutes.
8 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGTurn on and off1. Press the button to turn on.2. To turn off, press and hold the button until the light is a steady orange.NOTE Your sound processor will also turn off automatically after being off your implant for two minutes.
USER GUIDE 9DRAFT ONLY FOR CLINICAL TESTINGPair with remotesYou need to pair your sound processor to your CR210 Remote Control or CR230 Remote Assistant to use their control and monitoring functions. Please see your remote’s user guide for details.USEINDICATOR LIGHTS WHAT IT MEANS Green flashesTurning on processor. The number of flashes indicates the number of the current program. Orange flashesProcessor is off the implant. … Quick green flashesProcessor flashes while receiving sound from microphones (Child mode only).
10 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGChange programYou 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. Press the button to switch between programs.INDICATOR LIGHT WHAT IT MEANS Green flashesChanging the program (Child mode only). The number of flashes indicates the number of the current program.NOTE If your clinician has enabled SCAN, your sound processor can automatically select the best program for you.
USER GUIDE 11DRAFT ONLY FOR CLINICAL TESTINGUSEChange volume and sensitivityIf set up by your clinician, you can control the levels of volume or sensitivity (if available) using your CR210 Remote Control or CR230 Remote Assistant. Please see your remote’s user guide for details.NOTE You need to pair your sound processor with your remote first. See your remote’s user guide for details.
12 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGUse audio sourcesYour processor can receive sound from external audio sources.TelecoilTelecoil enables you to listen to room hearing loops.NOTE Telecoil is not recommended for phone use with the Kanso Sound Processor. We recommend you use the Cochlear Wireless Phone Clip.Wireless AccessoriesCochlear Wireless Accessories can wirelessly stream sound to your processor:• Audio sources gives you access to a Mini Microphone or TV Streamer• You use the buttons on the Phone Clip to control phone calls.NOTES• You first need to pair your Wireless Accessories with your sound processor.• For more details, see the Wireless Accessories User Guide.Cycling through audio sourcesAll your available audio sources are accessed by this button-press. Your processor cycles through the audio sources in order, with each button press activating the next available audio source:1. Telecoil2. First paired Wireless Accessory3. Next paired Wireless Accessory...
USER GUIDE 13DRAFT ONLY FOR CLINICAL TESTINGUSE1. Press and hold the button (about 3 seconds) to activate audio sources. 2. Press and hold the button again (about 3 seconds) if you need to cycle to another audio source:FIRST PRESS Telecoil (if enabled)SECOND PRESS First paired Wireless AccessoryTHIRD PRESS... Next paired Wireless Accessory...3. Press the button to turn audio off.NOTE You can also use your remote to control audio sources. See its user guide for details.INDICATOR LIGHTS WHAT IT MEANS … Quick blue flashesProcessor flashes while receiving sound from an audio source (Child mode only).
14 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGWear your processorPlace the processor on your implant with the button/light facing up and battery compartment facing down.CAUTION It is important to position your processor correctly to get the best performance, and so it does not fall off the implant.Button/light facing up Battery compartment facing downINDICATOR LIGHTS WHAT IT MEANS Flash of orange every secondProcessor flashes while coil is off (or connected to the wrong implant).
USER GUIDE 15DRAFT ONLY FOR CLINICAL TESTINGFor users with two implantsAsk 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
16 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGAttach a SoftWear padThe Cochlear SoftWear™ pad is optional. If you experience discomfort when wearing your processor, you can attach this adhesive pad to the back of your processor.NOTE You may need to change to a stronger magnet after attaching a SoftWear pad.1. Peel off the single backing strip on the adhesive side of the pad.2. Attach the pad to the back of the processor – press down firmly.
USER GUIDE 17DRAFT ONLY FOR CLINICAL TESTING3. Peel off the two semicircle backing covers on the cushion side of the pad.4. Wear your processor as usual. NOTE The SoftWear pad may affect your sound processor’s performance. If you notice any change, contact your clinician.WEAR
18 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGChange the magnetIf your sound processor’s magnet is too weak the processor may fall off, or if it is too strong it may cause discomfort. You can adjust the magnet strength by replacing it with a magnet of a different strength from ½ (weakest) to 6 (strongest).1. If the battery cover is locked, turn the lock screw anticlockwise to unlock it.2. Remove the battery cover.Use your fingers on the sides to pull off the cover.3. Use your thumbnail to remove the magnet cover.4. Press down with your finger and turn the magnet anticlockwise until the arrow and side tabs line up with the square notches in the processor case.
USER GUIDE 19DRAFT ONLY FOR CLINICAL TESTINGWEAR5. Use another magnet to pull the magnet from the processor.6. Insert the new magnet in the processor, with the side tabs in the square notches in the processor case.7. Press down with your finger and turn the magnet clockwise to lock the tab on the magnet under the processor’s case.8. Replace the magnet cover. 9. Replace the battery cover and lock it if required.
20 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGAttach the Safety LineTo reduce the risk of losing your processor, you can attach a Cochlear Nucleus Safety Line that clips onto your clothing.WARNING Retention lines longer than the Safety Line (standard length) are not recommended for use by children as they may present a risk of strangulation.1. Pinch the loop on the end of the line between your finger and thumb.2. Pass the loop through the attachment hole in the sound processor from front to back. TIP Use the attachment hole that will be at the rear of the processor when it is on your head.
USER GUIDE 21DRAFT ONLY FOR CLINICAL TESTINGWEAR3. Pass the clip through the loop and pull the line tight. 4. Open the clip by lifting the lever. TIP Make sure you LIFT the tab to OPEN the clip.5. Place the clip on your clothing and press down to close.
22 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGSport and exerciseTIP Always ensure the battery cover is locked when you exercise or play sport.1. Use accessories such as the Safety Line or a headband to help hold your processor in place when you play sport or exercise. 2. After exercise, wipe your processor with a soft cloth to remove sweat or grime. 3. Then check your microphone protectors for dirt.See Change microphone protectors on page 26.Microphone protectors
USER GUIDE 23DRAFT ONLY FOR CLINICAL TESTINGTravelNOTE 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. To avoid any possible buzzing sounds in your ear, turn off the telecoil. • Ask your clinician for a Patient Identification Card. In the unlikely event that your implant sets off a metal detector the ID card will help explain that you have an implanted medical device. • If you need to remove your sound processor as you move through airport security, place it in a case in your hand luggage. • Your sound processor will not interfere with a plane’s navigation system so you won’t need to turn it off during takeoff and landing. If you use a remote control for your processor, switch it off before takeoff as it transmits high frequency radio waves when switched on.WEAR
24 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGRegular careCAUTIONS • 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. SoftWear pad, Safety Line) for dirt and moisture. Wipe the processor with a soft dry cloth. • Keep your processor free from moisture by drying it every night in your dry aid kit. • Check the microphone protectors for signs of dirt or grime and replace if needed. See Change microphone protectors on page 26.Every month• Remove batteries and check for signs of dirt or grime. Wipe the contacts with a soft dry cloth.• Replace a SoftWear pad (if used) if it is worn or damaged, or has accumulated dirt or moisture that cannot be wiped off. If you have any problem with comfort, that is not helped by changing the SoftWear pad, contact your clinician. See Attach a SoftWear pad on page 16.• Check if the Safety Line (if used) is showing signs of wear. Replace as needed. See Attach the Safety Line on page 20.
USER GUIDE 25DRAFT ONLY FOR CLINICAL TESTINGEvery two months• Replace the dry brick in your dry aid kit.Every three months• Replace the microphone protectors – this is very important for the quality of sound. See Change microphone protectors on page 26.StorageDry aid kitStore 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 caseFor long term storage, remove the batteries and store so they do not touch each other. Storage cases are available from Cochlear.CARE
26 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGChange microphone protectorsReplace your microphone protectors every three months, or if they look dirty or you notice any loss in sound quality. Always replace both microphone protectors at the same time.Step 1: Remove microphone protectorsMicrophone protectors1. If the battery cover is locked, turn the lock screw anticlockwise to unlock it.2. Remove the battery cover. Use your fingers on the sides to pull off the cover.3. Use your thumbnail to remove the sound processor’s front cover.
USER GUIDE 27DRAFT ONLY FOR CLINICAL TESTINGCARE4. Firmly push the tip of the removal tool into the middle of the microphone protector.5. Firmly push, and then turn the tool 90° clockwise.6. Lift out the used microphone protector.7. Pull the used microphone protector from the tool and discard.8. Repeat steps 4 to 7 to remove the other microphone protector.
28 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGStep 2: Insert new microphone protectors1. Pull the Kanso Microphone Protector Applicator out of its sleeve. 2. With the microphone protectors facing down, lay the applicator over the processor, with protectors over the microphones. 3. Press the microphone protectors down with your finger. 4. Remove the applicator carefully, peeling it upwards from the side.5. Replace the front cover.6. Replace the battery cover. Lock the cover if required.
USER GUIDE 29DRAFT ONLY FOR CLINICAL TESTINGWater, sand and dirtYour processor is protected against failure from dust penetration or splashing water (IP54 rated). 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 batteries, 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.See Change the batteries on page 6.See Change microphone protectors on page 26.If sand or dirt ever enter the processor, remove it by carefully brushing all indents and holes in the processor’s casing.CARE
30 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGLightsYour clinician can set up your processor to show some or all of the following light indications.Turning on and offLIGHT WHAT IT MEANS …Quick green flashesProcessor flashes while receiving sound from microphones (Child mode only). Quick green flashesTurning on and changing programs. Number of flashes indicates the number of the current program.Long flash of orangeTurning off processor. AlertsLIGHT WHAT IT MEANS …Flash of orange every secondProcessor flashes while it is off your head (or connected to the wrong implant). Orange flashesProcessor batteries are low. Change batteries.Steady orangeFault. Contact your clinician. Stays on until the issue is resolved.
USER GUIDE 31DRAFT ONLY FOR CLINICAL TESTINGAudio sourcesLIGHT WHAT IT MEANS Quick blue flashProcessor flashes when pairing to Wireless Accessory is successful. …Quick blue flashesProcessor flashes while receiving audio from an audio source (Child mode only).LIGHTS AND BEEPS
32 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGBeepsYour clinician can set up your processor so you can hear the following beeps. The beeps are only audible to the recipient.Turning on and offBEEP WHAT IT MEANS Short high beepsChanging the program. The number of beeps indicates the number of the selected program.Short high beepChanging volume or sensitivity level (if available). Short high then short low beepWhen changing volume or sensitivity, indicates upper or lower limit of volume/sensitivity reached.Wireless AccessoriesBEEP WHAT IT MEANS 3-tone chimeConnecting with Wireless Accessory to begin streaming audio.Short beepWhen stopping streaming.TelecoilBEEP WHAT IT MEANSLong high beepSwitching between using the microphones and the telecoil.
USER GUIDE 33DRAFT ONLY FOR CLINICAL TESTINGAlertsBEEP WHAT IT MEANS 2 Short low beepsProcessor batteries are low. Replace batteries. Short low beeps for 4 secondsBatteries are empty and processor is turning off. Replace batteries. 4 long low beeps over 4 secondsGeneral fault. Consult your clinician.Adjusting bass and treble *BEEP WHAT IT MEANSLoud medium beepAdjusting master volume level.Loud long high beepAdjusting treble level. Loud long low beepAdjusting bass level.* If available, Remote Assistant onlyLIGHTS AND BEEPS
34 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGTroubleshootContact your clinician if you have any concerns regarding the operation or safety of your sound processor.PROBLEM RESOLUTIONProcessor will not turn on/button will not respond1. Try turning the processor on again. See Turn on and off on page 8. 2. Replace the batteries. See Change the batteries on page 6.3. If you have two implants, check that you are wearing the correct sound processor on each implant.4. If the problem continues, contact your clinician.The processor switches off1. This is normal operation, as the processor automatically switches off when not connected to the implant for more than two minutes.2. Replace the batteries. See Change the batteries on page 6.The processor will not turn off1. Remove the batteries from the processing unit. See Change the batteries on page 6.You want to perform a regular check on your processorSee Regular care on page 24.
USER GUIDE 35DRAFT ONLY FOR CLINICAL TESTINGPROBLEM RESOLUTIONYou are not sure what processor beeps or light flashes meanSee Lights on page 30 and Beeps on page 32. You want to confirm your processor is receiving sound1. Check the light on the top of the processor (if enabled). See Lights on page 30.2. If you use a CR230 Remote Assistant, check the sound meter on the status screen.3. If the problem continues, contact your clinician.The processor becomes hot1. Remove the processor from your head immediately and contact your clinician.You experience tightness, discomfort or develop a skin irritation at your implant site1. Try using an adhesive SoftWear pad. See Attach a SoftWear pad on page 16. 2. If you are using a retention aid, such as a headband, this may be placing pressure on your processor. Adjust your retention aid, or try a different aid.3. Your processor magnet may be too strong. Ask your clinician to change to a weaker magnet (and use a retention aid such as the Safety Line if required). See Change the magnet on page 18.4. If the problem continues, contact your clinician.TROUBLESHOOT
36 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGPROBLEM RESOLUTIONYou do not hear sound or sound is intermittent1. Try a different program. See Change program on page 10.2. Replace the batteries. See Change the batteries on page 6.3. Make sure the sound processor is properly oriented on your head, see Wear your processor on page 14. 4. If the problem continues, contact your clinician.You do not hear sound from a Wireless Accessory1. Check that the Wireless Accessory is charged and turned on.2. Check that the Wireless Accessory is paired with your processor.3. Check the volume of the Wireless Accessory.4. If you use a CR230 Remote Assistant, use the Streaming menu to check the connection to the accessory.5. If you use a CR230 Remote Assistant, check and adjust the accessory/microphone mixing ratio.6. If available, try a different processor.7. For more troubleshooting, see the Wireless Accessory User Guide.
USER GUIDE 37DRAFT ONLY FOR CLINICAL TESTINGPROBLEM RESOLUTIONYou hear intermittent sound, a buzzing sound or distorted speech1. 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.2. Try moving away from any source of magnetic or electronic interference.3. If the problem continues, contact your clinician.Sound is too loud or uncomfortable1. Try a different program. See Change program on page 10.2. If you use a CR210 Remote Control, turn down the volume. 3. If you have two sound processors (one for each side), ensure you have them on the correct side.4. If the problem continues, Remove your external equipment immediately (sound processor, etc) and contact your clinician.Sound is too quiet or muffled1. Try a different program. See Change program on page 10.2. If you use a CR210 Remote Control, turn up the volume. 3. Try changing the microphone protectors. See Change microphone protectors on page 26.4. If the problem continues, contact your clinician.TROUBLESHOOT
38 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGPROBLEM RESOLUTIONThe processor gets wet1. Dry the processor with a soft cloth, change the microphone protectors and place it in the dry aid kit provided by Cochlear for 8 hours. See Water, sand and dirt on page 29Batteries are not lasting as long as usual1. Clean the battery contacts carefully without bending them. Use the cleaning brush, then wipe the processor with a soft cloth.2. If you are using a non-recommended retention aid that covers your sound processor, replace it with an aid recommended by Cochlear.3. Check that you are using the recommended batteries. See Batteries on page 4.4. Don’t forget to let new batteries stand for a few seconds before putting them in the sound processor. 5. If the problem continues, contact your clinician.
USER GUIDE 39DRAFT ONLY FOR CLINICAL TESTINGCautions 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. The long-term effects of such stimulation in humans are unknown.
40 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGWarnings For parents and carers• Removable parts of the system (e.g. microphone protectors, batteries, magnets, battery cover, Safety Line) can be lost or may be a choking or strangulation hazard. Keep out of reach of children or lock the tamper-proof screw on the processor cover.• Keep the dry brick from the dry aid kit away from small children. Swallowing this material can cause serious internal injuries. • Carers must routinely check the device for signs of overheating and for signs of discomfort or skin irritation at the implant site. Remove the processor immediately if there is any discomfort or pain (e.g. if device becomes hot, or sound is uncomfortably loud) and inform clinician. • 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. Remove the aid immediately if there is any discomfort or pain, and inform clinician.• Dispose of used batteries promptly and carefully, in accordance with local regulations. Keep away from children.• Do not allow children to replace batteries without adult supervision.
USER GUIDE 41DRAFT ONLY FOR CLINICAL TESTINGWARNINGSProcessors 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.• No modification of this equipment is allowed. Warranty will be void if modified. • If you experience tightness or pain at the implant site, or develop significant skin irritation, stop using your sound processor and contact your clinician. • Do not apply continued pressure to the processor when in contact with the skin (e.g. sleeping while lying on processor, or using tight fitting headwear). • Do not push the volume too high for comfort in case a loud noise occurs nearby.
42 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTING• Do not place the processor or parts in any household devices (e.g. microwave oven, dryer). • Do not use a dry aid kit that has an Ultra Violet C (UVC) lamp (e.g. do not use the Freedom™ Dry and Store). • The magnetic attachment of your sound processor to your implant may be affected by other magnetic sources. • Store spare magnets safely and away from cards that may have a magnetic strip (e.g. credit cards, bus tickets). • Your device contains magnets that should be kept away from life supporting devices (e.g. cardiac pacemakers and ICDs (implantable cardioverter defibrillators) and magnetic ventricular shunts), as the magnets may affect the function of these devices. Keep your processor at least 15 cm (6 in) from such devices. Contact the manufacturer of the specific device to find out more.• Your sound processor and remote control radiate electromagnetic energy that may interfere with life supporting devices (e.g. cardiac pacemakers and ICDs). Keep your processor and remote control at least 15 cm (6 in) from such devices. Contact the manufacturer of the specific device to find out more.• Do not place the device or accessories inside any part of your body (e.g. nose, mouth).
USER GUIDE 43DRAFT ONLY FOR CLINICAL TESTINGWARNINGS• 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. Global System for Mobile communications (GSM) as used in some countries), may interfere with the operation of your external equipment. You may hear distorted sound when close, 1-4 m (~3-12 ft), to a digital mobile telephone in use.• For Cochlear Nucleus cochlear implant recipients only, the maximum diving depth is 40 m (~131 ft). Seek medical advice before diving to ensure you do not have any conditions that might make diving contraindicated (e.g. middle ear infection). When wearing a mask, avoid pressure over the implant site.• Before activities that create electrostatic discharge (e.g. playing on plastic slides), remove your processor. In rare cases, discharge of static electricity can damage your Cochlear implant’s electrical components or corrupt the processor’s program. If static electricity is present (e.g. when putting on clothes over your head, or getting out of a car), before the Cochlear implant system touches any object or person, you should touch something conductive such as a metal door handle.
44 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGBatteries• Use only Cochlear supplied or recommended p675 zinc air batteries for everyday use. Other batteries may only be used with the Aqua+ for Kanso accessory. (see its user guide for details).• Insert batteries in the correct orientation. • Do not mix disposable batteries that differ by manufacturer, brand, type, age or previous usage.• Do not short-circuit batteries (e.g. do not let terminals of batteries contact each other, do not place batteries loose in pockets, etc.).• Do not disassemble, deform, immerse in water or dispose of batteries in fire. • 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. • Do not expose batteries to heat (e.g. never leave batteries in sunlight, behind a window or in a car). • 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.• Never put batteries in mouth. If swallowed, contact your physician or local poison information service.
USER GUIDE 45DRAFT ONLY FOR CLINICAL TESTINGWARNINGSMedical 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).If the patient is implanted with other implants, consult the manufacturer’s instructions before performing MRI.
46 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGMedical treatments generating induced currents, heat and vibrationHaving 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.Some medical treatments generate induced currents that may cause tissue damage or permanent damage to the implant. Before initiating any of the following treatments deactivate the device.Warnings for specific treatments are provided below.CONDITION WARNINGDiathermy Do not use therapeutic or medical diathermy (thermopenetration) using electromagnetic radiation (magnetic induction coils or microwave). High currents induced into the electrode lead can cause tissue damage to the cochlea/brainstem or permanent damage to the implant. Medical diathermy using ultrasound may be used below the head and neck.Electroconvulsive therapyDo not use electroconvulsive therapy on an implant patient under any circumstances. Electroconvulsive therapy can cause tissue damage or damage to the implant
USER GUIDE 47DRAFT ONLY FOR CLINICAL TESTINGWARNINGSCONDITION WARNINGElectrosurgery 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.When using bipolar electrosurgical instruments on the head and neck of a patient, the cautery electrodes must not contact the implant and should be kept more than 1 cm (½ in.) from the electrodes.Ionising radiation therapyDo not use ionizing radiation therapy directly over the implant. It may cause damage to the implant.Neurostimulation Do not use neurostimulation directly over the implant. High currents induced into the electrode lead can cause tissue damage to the cochlea/brainstem or permanent damage to the implant.Therapeutic ultrasoundDo not use therapeutic levels of ultrasound energy directly over the implant. It may inadvertently concentrate the ultrasound field and cause tissue damage or damage to the implant.
48 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGPhysical configurationThe processing unit comprises:• Two omni-directional microphones for receiving sound.• An internal telecoil for receiving magnetic fields radiated by room loops.• Custom analogue and digital integrated circuits with digital signal processing (DSP) and bi-directional wireless communication capabilities.• A tri-colour visual indication of processor function or problem.• One button allowing user control of key features.The batteries provide power to the processor, which transfers energy and data to the implant.Materials• Processing unit: polyamide• Magnet casing is made of acrylonitrile butadiene styrene (ABS).Other information
USER GUIDE 49DRAFT ONLY FOR CLINICAL TESTINGBatteriesCheck the battery manufacturer’s recommended operating conditions for disposable batteries used in your processor.Wireless communication linkThe remote control/remote assistant wireless communication link operates in the 2.4 GHz ISM band using GFSK (Gaussian frequency shift keying) on 5 channels. The link uses a proprietary bi-directional communication protocol and operates over a distance of up to 2 metres from the processor. When interference is present, the wireless communication link switches between the 5 channels to find a channel where the interference least affects the operation of the link. The remotes indicate via their displays when the processor is not within operating distance, and when the link has been interrupted due to interference (see the relevant remote user guide for more information).Environmental conditionsCONDITION MINIMUM MAXIMUMStorage & transport temperature -10°C (14°F) +55°C (131°F)Operating temperature +5°C (41°F) +40°C (104°F)Operating relative humidity 0% RH 90% RHOperating pressure 700 hPa 1030 hPaOTHER INFORMATION
50 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGProduct dimensions (Typical values)COMPONENT LENGTH WIDTH DEPTHKanso processing unit 40.9 mm 35.7 mm 11.3 mmProduct weight (Typical values)COMPONENT WEIGHTKanso processing unit (no batteries or magnet) 8.3 gKanso processing unit (including M1 magnet) 11.6 gKanso processing unit (including M1 magnet and two zinc air batteries)13.8 gOperating characteristicsCHARACTERISTIC VALUE/RANGESound input frequency range 100 Hz to 8 kHzWireless technology Proprietary low power bi-directional wireless linkRF frequency 2.4 GHzOperating voltage 2.0 V to 3.1 VPower consumption 20 mW to 60 mWButton functions Turn processor on and off, turn audio sources on and off, change programRemote communication range Up to 2 mBatteries Two PR44 (zinc air) button cell batteries, 1.45V (nominal) eachCochlear recommends p675 zinc air batteries designed for Cochlear implant use
USER GUIDE 51DRAFT ONLY FOR CLINICAL TESTINGOTHER INFORMATIONElectromagnetic compatiblity (EMC)Guidance and manufacturer’s declarationThe Nucleus range of sound processors, remote assistants and remote controls are intended for use in the electromagnetic environments specified in this document.They have been tested and found to be in compliance as shown. You should take care to use your equipment as described. Electromagnetic emissionsEMISSION TEST COMPLIANCE GUIDANCERF emissions CISPR 11Group 1 RF energy is only used for its internal function. The RF emissions are very low and not likely to cause any interference in nearby electronic equipmentRF emissions CISPR 11Class B The device is suitable for use in all establishments, including domestic establishments and those directly connected to public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissions IEC 61000-3-2Not applicableVoltage fluctuations/flicker emissions IEC 61000-3-3
52 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGElectromagnetic immunityIMMUNITY TEST IEC 60601 TEST LEVELCOMPLIANCE LEVEL GUIDANCEElectrostatic discharge IEC 61000-4-2±6 kV contact±8 kV air±6 kV contact±8 kV airSee Warnings and Cautions sectionsElectrical fast transient/burst IEC 61000-4-4Not applicableSurge IEC 61000-4-5Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11Power frequency (50/60 Hz) magnetic field IEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields be at levels characteristic of a typical location in a typical commercial or hospital environmentConducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3Not applicable 3 V/m 80 MHz to 2.5 GHz3 V/m See Warnings and Cautions sections, and “Guidance” below
USER GUIDE 53DRAFT ONLY FOR CLINICAL TESTINGOTHER INFORMATIONGuidancePortable and mobile RF communications equipment should be used no closer to any part of the devices, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance (d): d = 1.2P 80 MHz to 800 MHz d = 2.3P 800 MHz to 2.5 GHzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.Interference may occur in the vicinity of equipment marked with the following symbol:NOTES • At 80 MHz and 800 MHz, the higher frequency range applies.• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
54 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGExplanatory notes:a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the processor is used exceeds the applicable RF compliance level above, the processor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the processor.b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.Recommended separation distancesYour processor is intended for use in an electromagnetic environment where the radiated RF disturbances are controlled.To prevent electromagnetic interference, maintain a minimum distance between the portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
USER GUIDE 55DRAFT ONLY FOR CLINICAL TESTINGOTHER INFORMATIONRATED MAXIMUM OUTPUT POWER OF TRANSMITTER WSEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER M150 KHZ TO 80 MHZ D = 1.2P 80 MHZ TO 800 MHZ D = 1.2P800 MHZ TO 2.5 GHZ D = 2.3P 0.01 Not applicable 0.12 0.230.1 0.38 0.731 1.2 2.310 3.8 7.3100 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
56 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGEquipment classificationYour sound processor is internally powered equipment Type B applied part as described in the international standard IEC 60601-1:2012, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance. FCC (Federal Communications Commission) and Canadian IC complianceThis device complies with part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions:• This device may not cause harmful interference.• This device must accept any interference received, including interference that may cause undesired operation.Changes or modifications made to this equipment not expressly approved by Cochlear Limited may void the FCC authorisation to operate this equipment.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.
USER GUIDE 57DRAFT ONLY FOR CLINICAL TESTINGOTHER INFORMATIONIf 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 or a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help.FCC ID: WTO-CP950IC ID: 8039A-CP950Certification and applied standardsThe Kanso 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.The Kanso Sound Processor also fulfils the essential requirements listed in the EC directive 1999/5/EC on Radio and Terminal Telecommunication Equipment as per the conformity assessment procedure in Annex IV.
58 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGEnvironmental protectionYour sound processor contains electronic components subject to the Directive 2002/96/EC on waste electrical and electronic equipment. Help protect the environment by not disposing of your sound processor or batteries with your unsorted household waste. Please recycle your sound processor according to your local regulations.Privacy and the collection of personal informationDuring 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.
USER GUIDE 59DRAFT ONLY FOR CLINICAL TESTINGOTHER INFORMATIONLabelling symbols The following symbols may appear on your processor or remote components and/or packaging:Refer to instruction manualSpecific warnings or precautions associated with the device, which are not otherwise found on the labelManufacturerAuthorised representative in the European CommunityCatalogue numberSerial numberBatch codeDate of manufactureTemperature limitsCE registration mark with notified body numberRadio compliance certification for Australia and New ZealandR202LSB001Radio compliance certification for JapanKCC-CRM-COH-CP900Radio compliance certification for KoreaBy prescription
60 KANSO™ SOUND PROCESSORDRAFT ONLY FOR CLINICAL TESTINGRecyclable materialDispose of electrical components in accordance with your local regulationsType B applied partIngress Protection Rating• Protected against failure from dust penetration• Protected against failure from splashing with waterLegal statementThe statements made in this guide are believed to be true and correct as of the date of publication. However, specifications are subject to change without notice.© Cochlear Limited 2016
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552811 ISS1 OCT15 ACE, Advance Off-Stylet, AOS, AutoNRT, Autosensitivity, Beam, Button, Carina, Cochlear, コクレア, Codacs, Contour, Contour Advance, Custom Sound, ESPrit, Freedom, Hear now. And always, Hybrid, inHear, Invisible Hearing, MET, MP3000, myCochlear, NRT, Nucleus, 科利耳, Off-Stylet, SmartSound, Softip, SoftWear, SPrint, the elliptical logo and Whisper are either trademarks or registered trademarks of Cochlear Limited. Ardium, Baha, Baha Divino, Baha Intenso, Baha PureSound, Baha SoftWear, BCDrive, DermaLock, Vistafix and WindShield are either trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB. Bluetooth is a registered trademark of Bluetooth SIG.© Cochlear Limited 2016 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 Ltd (ABN 96 002 618 073) 14 Mars Road, Lane Cove, NSW 2066, 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 Canada Inc 2500-120 Adelaide Street West, Toronto, ON M5H 1T1, Canada Tel: +1 416 972 5082 Fax: +1 416 972 5083Cochlear AG EMEA Headquarters, Peter Merian-Weg 4, 4052 Basel, SwitzerlandTel: +41 61 205 8204 Fax: +41 61 205 8205 Cochlear Deutschland GmbH & Co. KG Karl-Wiechert-Allee 76A, 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 KingdomTel: +44 1932 26 3400 Fax: +44 1932 26 3426Cochlear Benelux NV Schaliënhoevedreef 20 i, B-2800 Mechelen, Belgium Tel: +32 15 79 55 11 Fax: +32 15 79 55 70Cochlear France S.A.S. 135 Route de Saint-Simon, 31100 Toulouse, France Tel: +33 5 34 63 85 85 (International) or 0805 200 016 (National) Fax: +33 5 34 63 85 80Cochlear Italia S.r.l. Via Larga 33, 40138 Bologna, Italy Tel: +39 051 601 53 11 Fax: +39 051 39 20 62Cochlear Nordic AB Konstruktionsvägen 14, 435 33 Mölnlycke, Sweden Tel +46 31 335 14 61 Fax +46 31 335 14 60Cochlear Tıbbi Cihazlar ve Sağlık Hizmetleri Ltd. Şti. Çubuklu Mah. Boğaziçi Cad., Boğaziçi Plaza No: 6/1, Kavacık, TR-34805 Beykoz-Istanbul, Turkey Tel: +90 216 538 5900 Fax: +90 216 538 5919Cochlear (HK) Limited Room 1204, 12/F, CRE Building, No 303 Hennessy Road, Wanchai, Hong Kong SARTel: +852 2530 5773 Fax: +852 2530 5183Cochlear Korea Ltd 1st floor, Cheongwon building, 828-5, Yuksam dong, Kangnam gu, Seoul, Korea Tel: +82 2 533 4663 Fax: +82 2 533 8408Cochlear Medical Device (Beijing) Co., Ltd Unit 2208 Gemdale Tower B, 91 Jianguo Road, Chaoyang District, Beijing 100022, P.R. China Tel: +86 10 5909 7800 Fax: +86 10 5909 7900Cochlear Medical Device Company India Pvt. Ltd. Ground Floor, Platina Building, Plot No C-59, G-Block, Bandra Kurla Complex, Bandra (E), Mumbai – 400 051, India Tel: +91 22 6112 1111 Fax: +91 22 6112 1100株式会社日本コクレア（Nihon Cochlear Co Ltd）〒 113-0033 東京都文京区本郷2-3-7 お茶の水元町ビルTel: +81 3 3817 0241 Fax: +81 3 3817 0245Cochlear Middle East FZ-LLC Dubai Healthcare City, Al Razi Building 64, Block A, Ground Floor, Offices IR1 and IR2, Dubai, United Arab Emirates Tel: +971 4 818 4400 Fax: +971 4 361 8925Cochlear Latinoamérica S.A. International Business Park, Building 3835, Office 103, Panama Pacifico, Panama Tel: +507 830 6220 Fax: +507 830 6218Cochlear NZ Limited Level 4, Takapuna Towers, 19-21 Como St, Takapuna, Auckland 0622, New ZealandTel: + 64 9 914 1983 Fax: +61 2 8002 2800www.cochlear.com

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