Users Manual
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| Document ID | 2820382 |
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| Document Description | Users Manual |
| Short Term Confidential | No |
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| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 252.13kB (3151587 bits) |
| Date Submitted | 2015-11-24 00:00:00 |
| Date Available | 2015-11-24 00:00:00 |
| Creation Date | 2015-10-23 09:48:50 |
| Producing Software | Adobe PDF Library 10.0.1 |
| Document Lastmod | 2015-10-23 09:49:05 |
| Document Title | Users Manual |
| Document Creator | Adobe InDesign CS6 (Windows) |
DRAFT ONLY FOR CLINICAL TESTING Kanso™ Sound Processor User Guide DRAFT ONLY FOR CLINICAL TESTING This 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 guide NOTE Important information or advice. TIP Time 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. ii KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Kanso™ Sound Processor Front THIS WAY UP Indicator light Microphone ports Control button Front cover Battery cover ABOUT Air slots Back Safety line attachment points Battery cover lock USER GUIDE DRAFT ONLY FOR CLINICAL TESTING Contents Power Batteries . . . . . . . . . . . . . . . . . . . . . . . . Battery life . . . . . . . . . . . . . . . . . . . . . . . Lock/unlock the battery cover . . . . . . . . . . . . Change the batteries . . . . . . . . . . . . . . . . . Use Turn on and off . . . . . . . . . . . . . . . . . . . . . 8 Pair with remotes . . . . . . . . . . . . . . . . . . . . 9 Change program . . . . . . . . . . . . . . . . . . . 10 Change volume and sensitivity . . . . . . . . . . . . 11 Use audio sources . . . . . . . . . . . . . . . . . . . 12 Telecoil . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Wireless Accessories . . . . . . . . . . . . . . . . . . . 12 Wear Wear your processor . . . . . . . . . . . . . . . . . 14 For users with two implants . . . . . . . . . . . . . . 15 Attach a SoftWear pad . . . . . . . . . . . . . . . . 16 Change the magnet . . . . . . . . . . . . . . . . . . 18 Attach the Safety Line . . . . . . . . . . . . . . . . 20 Sport and exercise . . . . . . . . . . . . . . . . . . . 22 Travel . . . . . . . . . . . . . . . . . . . . . . . . . 23 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Care Storage . . . . . . . . . . . . . . . . . . . . . . . . Regular care . . . . . . . . . . . . . . . . . . . . . Change microphone protectors . . . . . . . . . . Water, sand and dirt . . . . . . . . . . . . . . . . . 25 24 26 29 Lights and Beeps Lights . . . . . . . . . . . . . . . . . . . . . . . . . 30 Beeps . . . . . . . . . . . . . . . . . . . . . . . . . 32 Troubleshoot Cautions . . . . . . . . . . . . . . 34 . . . . . . . . . . . . . . . . . . 39 Warnings For parents and carers . . . . . . . . . . . . . . . . .40 Processors and parts . . . . . . . . . . . . . . . . . 41 Batteries . . . . . . . . . . . . . . . . . . . . . . . 44 Medical treatments . . . . . . . . . . . . . . . . . 45 Other information USER GUIDE . . . . . . . . 48 DRAFT ONLY FOR CLINICAL TESTING Batteries For 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 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 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. KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Lock/unlock the battery cover The 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. POWER LOCKED 2. To unlock, turn the locking screw anticlockwise until it is vertical. UNLOCKED CAUTION Always check the locking screw is unlocked before attaching or removing the battery cover. USER GUIDE DRAFT ONLY FOR CLINICAL TESTING Change the batteries 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. Push down on each battery with your thumb in the cutout section in the side. The batteries pop up. Pull the batteries out. KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING 4. 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. POWER 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. USER GUIDE DRAFT ONLY FOR CLINICAL TESTING Turn on and off 1. 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. KANSO™ SOUND PROCESSOR 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 Processor is off the implant. Orange flashes … Quick green flashes Processor flashes while receiving sound from microphones (Child mode only). USE Pair with remotes You 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. USER GUIDE 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. Press the button to switch between programs. INDICATOR LIGHT Green flashes WHAT IT MEANS Changing 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. 10 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Change volume and sensitivity If 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. USE USER GUIDE 11 DRAFT ONLY FOR CLINICAL TESTING Use audio sources Your processor can receive sound from external audio sources. Telecoil Telecoil 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 Accessories Cochlear 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 sources All 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. Telecoil 2. First paired Wireless Accessory 3. Next paired Wireless Accessory... 12 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING 1. 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 SECOND PRESS THIRD PRESS... Telecoil (if enabled) First paired Wireless Accessory Next paired Wireless Accessory... USE 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 flashes Processor flashes while receiving sound from an audio source (Child mode only). USER GUIDE 13 DRAFT ONLY FOR CLINICAL TESTING Wear your processor Place 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 down INDICATOR LIGHTS WHAT IT MEANS Processor flashes while coil is off Flash of orange every second (or connected to the wrong implant). 14 KANSO™ SOUND PROCESSOR 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 USER GUIDE 15 DRAFT ONLY FOR CLINICAL TESTING Attach a SoftWear pad The 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 2. Attach the pad to the backing strip on the back of the processor – adhesive side of the pad. press down firmly. 16 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING 3. Peel off the two semicircle backing covers on the cushion side of the pad. WEAR 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. USER GUIDE 17 DRAFT ONLY FOR CLINICAL TESTING Change the magnet If 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. 18 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING 5. 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. 8. Replace the magnet cover. 9. Replace the battery cover and lock it if required. USER GUIDE 19 WEAR 7. Press down with your finger and turn the magnet clockwise to lock the tab on the magnet under the processor’s case. DRAFT ONLY FOR CLINICAL TESTING Attach the Safety Line To 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. 20 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING 3. Pass the clip through the loop and pull the line tight. 4. Open the clip by lifting the lever. 5. Place the clip on your clothing and press down to close. USER GUIDE 21 WEAR TIP Make sure you LIFT the tab to OPEN the clip. DRAFT ONLY FOR CLINICAL TESTING Sport and exercise TIP 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 22 KANSO™ SOUND PROCESSOR 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. 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. • 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. USER GUIDE 23 WEAR • If you need to remove your sound processor as you move through airport security, place it in a case in your hand luggage. 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. 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. 24 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Every 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. Storage Dry aid kit CARE 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 For long term storage, remove the batteries and store so they do not touch each other. Storage cases are available from Cochlear. USER GUIDE 25 DRAFT ONLY FOR CLINICAL TESTING Change microphone protectors Replace 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 protectors Microphone protectors 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 sound processor’s front cover. 26 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING 4. 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. CARE 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. USER GUIDE 27 DRAFT ONLY FOR CLINICAL TESTING Step 2: Insert new microphone protectors 1. 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. 28 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Water, sand and dirt Your 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. CARE 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. USER GUIDE 29 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 Alerts LIGHT 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 30 Processor batteries are low. Change batteries. Fault. Contact your clinician. Stays on until the issue is resolved. KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Audio sources 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). LIGHTS AND BEEPS USER GUIDE 31 DRAFT ONLY FOR CLINICAL TESTING Beeps Your clinician can set up your processor so you can hear the following beeps. The beeps are only audible to the recipient. 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 Short high then short low beep Changing volume or sensitivity level (if available). When changing volume or sensitivity, indicates upper or lower limit of volume/ sensitivity reached. Wireless Accessories BEEP 3-tone chime WHAT IT MEANS Connecting with Wireless Accessory to begin streaming audio. When stopping streaming. Short beep Telecoil BEEP Long high beep 32 WHAT IT MEANS Switching between using the microphones and the telecoil. KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Alerts BEEP 2 Short low beeps Short low beeps for 4 seconds Processor batteries are low. Replace batteries. Batteries are empty and processor is turning off. Replace batteries. General fault. Consult your clinician. LIGHTS AND BEEPS 4 long low beeps over 4 seconds WHAT IT MEANS Adjusting 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 * If available, Remote Assistant only USER GUIDE 33 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 turn on/button will not respond 1. 2. 3. 4. The processor switches off 1. 2. Try turning the processor on again. See Turn on and off on page 8. Replace the batteries. See Change the batteries on page 6. If you have two implants, check that you are wearing the correct sound processor on each implant. If the problem continues, contact your clinician. This is normal operation, as the processor automatically switches off when not connected to the implant for more than two minutes. Replace the batteries. See Change the batteries on page 6. The processor will not turn off 1. You want to perform a regular check on your processor See Regular care on page 24. 34 Remove the batteries from the processing unit. See Change the batteries on page 6. KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING PROBLEM RESOLUTION You are not sure what processor beeps or light flashes mean See Lights on page 30 and Beeps on page 32. You want to confirm your processor is receiving sound 1. 2. 3. Check the light on the top of the processor (if enabled). See Lights on page 30. If you use a CR230 Remote Assistant, check the sound meter on the status screen. If the problem continues, contact your clinician. 1. Remove the processor from your head immediately and contact your clinician. You experience tightness, discomfort or develop a skin irritation at your implant site 1. Try using an adhesive SoftWear pad. See Attach a SoftWear pad on page 16. 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. 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. If the problem continues, contact your clinician. 2. 3. 4. USER GUIDE 35 TROUBLESHOOT The processor becomes hot DRAFT ONLY FOR CLINICAL TESTING PROBLEM RESOLUTION You do not hear sound or sound is intermittent 1. 2. 3. 4. You do not hear sound from a Wireless Accessory 1. 2. 3. 4. 5. 6. 7. 36 Try a different program. See Change program on page 10. Replace the batteries. See Change the batteries on page 6. Make sure the sound processor is properly oriented on your head, see Wear your processor on page 14. If the problem continues, contact your clinician. 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. If you use a CR230 Remote Assistant, use the Streaming menu to check the connection to the accessory. If you use a CR230 Remote Assistant, check and adjust the accessory/ microphone mixing ratio. If available, try a different processor. For more troubleshooting, see the Wireless Accessory User Guide. KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING PROBLEM RESOLUTION You hear 1. intermittent sound, a buzzing sound or distorted speech 2. 3. Sound is too loud or uncomfortable 1. 2. 3. Sound is too quiet or muffled 1. 2. 3. 4. USER GUIDE Try a different program. See Change program on page 10. If you use a CR210 Remote Control, turn down the volume. If you have two sound processors (one for each side), ensure you have them on the correct side. If the problem continues, Remove your external equipment immediately (sound processor, etc) and contact your clinician. Try a different program. See Change program on page 10. If you use a CR210 Remote Control, turn up the volume. Try changing the microphone protectors. See Change microphone protectors on page 26. If the problem continues, contact your clinician. 37 TROUBLESHOOT 4. 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. Try moving away from any source of magnetic or electronic interference. If the problem continues, contact your clinician. DRAFT ONLY FOR CLINICAL TESTING PROBLEM RESOLUTION The processor gets wet 1. 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 29 Batteries are not lasting as long as usual 1. Clean the battery contacts carefully without bending them. Use the cleaning brush, then wipe the processor with a soft cloth. If you are using a non-recommended retention aid that covers your sound processor, replace it with an aid recommended by Cochlear. Check that you are using the recommended batteries. See Batteries on page 4. Don’t forget to let new batteries stand for a few seconds before putting them in the sound processor. If the problem continues, contact your clinician. 2. 3. 4. 5. 38 KANSO™ 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. The long-term effects of such stimulation in humans are unknown. CAUTIONS USER GUIDE 39 DRAFT ONLY FOR CLINICAL TESTING Warnings 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. 40 KANSO™ SOUND PROCESSOR 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. • 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. USER GUIDE 41 WARNINGS • No modification of this equipment is allowed. Warranty will be void if modified. DRAFT 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). 42 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING • 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. USER GUIDE 43 WARNINGS • 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. DRAFT ONLY FOR CLINICAL TESTING Batteries • 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. 44 KANSO™ SOUND PROCESSOR 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). If the patient is implanted with other implants, consult the manufacturer’s instructions before performing MRI. WARNINGS USER GUIDE 45 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. 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 WARNING Diathermy 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 therapy Do not use electroconvulsive therapy on an implant patient under any circumstances. Electroconvulsive therapy can cause tissue damage or damage to the implant 46 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING 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. 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 therapy Do 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 ultrasound Do 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. USER GUIDE 47 WARNINGS CONDITION 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 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). 48 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Batteries Check the battery manufacturer’s recommended operating conditions for disposable batteries used in your processor. Wireless communication link Environmental conditions CONDITION MINIMUM MAXIMUM Storage & 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% RH Operating pressure 700 hPa 1030 hPa USER GUIDE 49 OTHER INFORMATION The 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). DRAFT ONLY FOR CLINICAL TESTING Product dimensions (Typical values) COMPONENT LENGTH WIDTH DEPTH Kanso processing unit 40.9 mm 35.7 mm 11.3 mm Product weight (Typical values) COMPONENT WEIGHT Kanso processing unit (no batteries or magnet) 8.3 g Kanso processing unit (including M1 magnet) 11.6 g Kanso processing unit (including M1 magnet and two zinc air batteries) 13.8 g Operating characteristics CHARACTERISTIC VALUE/RANGE Sound input frequency range 100 Hz to 8 kHz Wireless technology Proprietary low power bi-directional wireless link RF frequency 2.4 GHz Operating voltage 2.0 V to 3.1 V Power consumption 20 mW to 60 mW Button functions Turn processor on and off, turn audio sources on and off, change program Remote communication range Up to 2 m Batteries Two PR44 (zinc air) button cell batteries, 1.45V (nominal) each Cochlear recommends p675 zinc air batteries designed for Cochlear implant use 50 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Electromagnetic compatiblity (EMC) Guidance and manufacturer’s declaration The 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 emissions EMISSION TEST COMPLIANCE GUIDANCE Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 USER GUIDE 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 equipment The device is suitable for use in all establishments, including domestic establishments and those directly connected to public low-voltage power Not applicable supply network that supplies buildings used for domestic purposes. 51 OTHER INFORMATION RF emissions CISPR 11 DRAFT ONLY FOR CLINICAL TESTING Electromagnetic immunity IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE GUIDANCE LEVEL Electrostatic discharge IEC 61000-4-2 ±6 kV contact ±6 kV contact ±8 kV air ±8 kV air See Warnings and Cautions sections Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Not applicable Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 52 3 A/m 3 A/m Power frequency magnetic fields be at levels characteristic of a typical location in a typical commercial or hospital environment Not applicable 3 V/m 80 MHz to 2.5 GHz 3 V/m See Warnings and Cautions sections, and “Guidance” below KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING Guidance Portable 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 = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz 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. USER GUIDE 53 OTHER INFORMATION where 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. DRAFT ONLY FOR CLINICAL TESTING Explanatory 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 distances Your 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. 54 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING RATED MAXIMUM OUTPUT POWER OF TRANSMITTER (W) SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER (M) 150 KHZ TO 80 MHZ D = 1.2 P 80 MHZ TO 800 MHZ D = 1.2 P 800 MHZ TO 2.5 GHZ D = 2.3 P 0.01 Not applicable 0.12 0.23 0.1 0.38 0.73 1.2 2.3 10 3.8 7.3 100 12 23 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. USER GUIDE 55 OTHER INFORMATION For 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. DRAFT ONLY FOR CLINICAL TESTING Equipment classification Your 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 compliance This 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. 56 KANSO™ SOUND PROCESSOR DRAFT ONLY FOR CLINICAL TESTING 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 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-CP950 Certification and applied standards The 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. USER GUIDE 57 OTHER INFORMATION IC ID: 8039A-CP950 DRAFT ONLY FOR CLINICAL TESTING Environmental protection Your 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 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. 58 KANSO™ SOUND PROCESSOR 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 Authorised representative in the European Community Catalogue number OTHER INFORMATION Serial number Batch code Date of manufacture Temperature limits CE registration mark with notified body number Radio compliance certification for Australia and New Zealand 202 LSB001 KCC-CRMCOH-CP900 Radio compliance certification for Japan Radio compliance certification for Korea By prescription USER GUIDE 59 DRAFT ONLY FOR CLINICAL TESTING Recyclable material Dispose of electrical components in accordance with your local regulations Type B applied part Ingress Protection Rating • • Protected against failure from dust penetration Protected against failure from splashing with water Legal statement The 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 60 KANSO™ SOUND PROCESSOR Notes ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... ........................................................................................... 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: +1 416 972 5083 Cochlear AG EMEA Headquarters, Peter Merian-Weg 4, 4052 Basel, Switzerland Tel: +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 7770 Cochlear Europe Ltd 6 Dashwood Lang Road, Bourne Business Park, Addlestone, Surrey KT15 2HJ, United Kingdom Tel: +44 1932 26 3400 Fax: +44 1932 26 3426 Cochlear Benelux NV Schaliënhoevedreef 20 i, B-2800 Mechelen, Belgium Tel: +32 15 79 55 11 Fax: +32 15 79 55 70 Cochlear 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 80 Cochlear Italia S.r.l. Via Larga 33, 40138 Bologna, Italy Tel: +39 051 601 53 11 Fax: +39 051 39 20 62 Cochlear Nordic AB Konstruktionsvägen 14, 435 33 Mölnlycke, Sweden Tel +46 31 335 14 61 Fax +46 31 335 14 60 Cochlear Tıbbi Cihazlar ve Sağlık Hizmetleri Ltd. 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 5919 Cochlear (HK) Limited Room 1204, 12/F, CRE Building, No 303 Hennessy Road, Wanchai, Hong Kong SAR Tel: +852 2530 5773 Fax: +852 2530 5183 Cochlear Korea Ltd 1st floor, Cheongwon building, 828-5, Yuksam dong, Kangnam gu, Seoul, Korea Tel: +82 2 533 4663 Fax: +82 2 533 8408 Cochlear 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 7900 Cochlear 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 0245 Cochlear 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 8925 Cochlear Latinoamérica S.A. International Business Park, Building 3835, Office 103, Panama Pacifico, Panama Tel: +507 830 6220 Fax: +507 830 6218 Cochlear NZ Limited Level 4, Takapuna Towers, 19-21 Como St, Takapuna, Auckland 0622, New Zealand Tel: + 64 9 914 1983 Fax: +61 2 8002 2800 www.cochlear.com 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 552811 ISS1 OCT15
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