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.
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 1
DRAFT ONLY FOR CLINICAL TESTING Contents Power Batteries . . . . . . . . . . . . . . . . . . . . . . . . Battery life . . . . . . . . . . . . . . . . . . . . . . . Lock/unlock the battery cover . . . . . . . . . . . . Change the batteries . . . . . . . . . . . . . . . . . 4 4 5 6 Use Turn on and off . . . . . . . . . . . . . . . . . . . . . 8 Pair with remotes . . . . . . . . . . . . .
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 . . . . . . . . . . . . . . . . . . . .
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
DRAFT ONLY FOR CLINICAL TESTING Travel NOTE Visit www.cochlear.com/clinic-finder to find the nearest clinic in places you are travelling. • Take a printout from your clinician of your most recent program in case you need help with your processor. • If you have a backup sound processor, check that it is programmed correctly and take it with you. • It’s okay to move through metal detectors and full body scanners with your sound processor on.
DRAFT ONLY FOR CLINICAL TESTING 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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
DRAFT ONLY FOR CLINICAL TESTING Cautions • Young children who are developing motor skills are at greater risk of an impact to the head from a hard object (e.g. table or chair). Impact to the sound processor may cause damage to the processor or its parts. Impact to the head in the area of the Cochlear implant could damage it and result in its failure. • Most patients can benefit from electrical stimulation levels that are considered safe, based on animal experimental data.
DRAFT ONLY FOR CLINICAL TESTING Warnings For parents and carers • Removable parts of the system (e.g. microphone 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.
DRAFT ONLY FOR CLINICAL TESTING Processors and parts • Each processor is programmed specifically for each implant. Never wear another person’s processor or lend yours to another person. • Use your Cochlear implant system only with approved devices and accessories. • If you experience a significant change in performance, remove your processor and contact your clinician. • Your processor and other parts of the system contain complex electronic parts. These parts are durable but must be treated with care.
DRAFT ONLY FOR CLINICAL TESTING • 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).
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.
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.
DRAFT ONLY FOR CLINICAL TESTING Medical treatments Magnetic resonance imaging (MRI) MRI is contraindicated except under special circumstances. Do not allow a patient with an implant to be in a room where an MRI scanner is located except under special circumstances. Full MRI safety information is available at www.cochlear.com/warnings or by calling your regional Cochlear office (contact numbers available at the end of this document).
DRAFT ONLY FOR CLINICAL TESTING Medical treatments generating induced currents, heat and vibration Having a cochlear implant means extra care must be taken when receiving some medical treatments. Before starting medical treatment, the information in this section should be discussed with the recipient’s physician. The sound processor must be removed before starting any of the medical treatments listed in this section.
DRAFT ONLY FOR CLINICAL TESTING WARNING Electrosurgery Electrosurgical instruments can induce radio frequency currents that could flow through the electrode. Monopolar electrosurgical instruments must not be used on the head or neck of an implant patient as induced currents could cause damage to cochlear/neural tissues or permanent damage to the implant.
DRAFT ONLY FOR CLINICAL TESTING Other information Physical configuration The processing unit comprises: • Two omni-directional microphones for receiving sound. • An internal telecoil for receiving magnetic fields radiated by 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.
DRAFT ONLY FOR CLINICAL TESTING Batteries Check the battery manufacturer’s recommended operating conditions for disposable batteries used in your processor.
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.
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.
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
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.
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.
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 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.
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.
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.
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.
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 cert
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.
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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 Hea
