WTO-CP950SOUND PROCESSOR

Kanso ™ Sound Processor User Guide DRAFT ONLY FOR CLINICAL TESTING ii KANSO ™ SOUND PROCESSOR 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. USER GUiDE 1 DRAFT ONLY FOR CLiNiCAL TESTiNG Microphone ports indicator light ABOUT Front cover Control button Battery cover Kanso ™ Sound Processor Air slots Back Battery cover lock Safety line attachment points Front THIS WAY UP 2 KANSO ™ SOUND PROCESSOR DRAFT ONLY FOR CLiNiCAL TESTiNG Contents Power Batteries . . . . . . . . . . . . . . . . . . . . . . . . . 4 Battery life . . . . . . . . . . . . . . . . . . . . . . . . 4 Lock/unlock the battery cover . . . . . . . . . . . . . 5 Change the batteries . . . . . . . . . . . . . . . . . . 6 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 USER GUiDE 3 DRAFT ONLY FOR CLiNiCAL TESTiNG Care Storage . . . . . . . . . . . . . . . . . . . . . . . . 25 Regular care . . . . . . . . . . . . . . . . . . . . . . 24 Change microphone protectors . . . . . . . . . . . 26 Water, sand and dirt . . . . . . . . . . . . . . . . . 29 Lights and Beeps Lights . . . . . . . . . . . . . . . . . . . . . . . . . 30 Beeps . . . . . . . . . . . . . . . . . . . . . . . . . 32 Troubleshoot . . . . . . . . . . . . . . . 34 Cautions . . . . . . . . . . . . . . . . . . . 39 Warnings For parents and carers . . . . . . . . . . . . . . . . 40 Processors and parts . . . . . . . . . . . . . . . . . 41 Batteries . . . . . . . . . . . . . . . . . . . . . . . . 44 Medical treatments . . . . . . . . . . . . . . . . . 45 Other information . . . . . . . . . 48 4 KANSO ™ SOUND PROCESSOR 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. USER GUiDE 5 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. 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. POWER 6 KANSO ™ SOUND PROCESSOR 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. USER GUiDE 7 DRAFT ONLY FOR CLiNiCAL TESTiNG POWER 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. 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 PROCESSOR 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…

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FCC ID: WTO‐CP950 IC: 8039A‐CP950 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SAMPLE PHOTOGRAPHS EXTERNAL

FCC ID: WTO‐CP950 IC: 8039A‐CP950 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SAMPLE – LABEL DETAILS Please note: Due to size of device, compliance statements are located in the User Manual FCC & IC identification to be laser engraved on back of EUT

FCC ID: WTO‐CP950 IC: 8039A‐CP950 Page 1 of 5 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SAMPLE PHOTOGRAPHS INTERNAL FCC ID: WTO‐CP950 IC: 8039A‐CP950 Page 2 of 5 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SAMPLE PHOTOGRAPHS INTERNAL FCC ID: WTO‐CP950 IC: 8039A‐CP950 Page 3 of 5 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SAMPLE PHOTOGRAPHS INTERNAL FCC ID: WTO‐CP950 IC: 8039A‐CP950 Page 4 of 5 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SAMPLE PHOTOGRAPHS INTERNAL FCC ID: WTO‐CP950 IC: 8039A‐CP950 Page 5 of 5 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SAMPLE PHOTOGRAPHS INTERNAL

Page 1 of 6 EMC Technologies Pty Ltd ABN 82 057 105 549 157 Harrick Road, Keilor Park Victoria 3042, Australia Telephone +61 3 9365 1000 Facsimile +61 3 9331 7455 Email [email protected] Web www.emctech.com.au This document must not be copied or reproduced, except in full without the written permission of the Manager, EMC Technologies Pty Ltd www.emctech.com.au FCC RF Exposure Report Off the ear sound processor Model: CP950 Performed for Cochlear Limited Report Number M150933-3 Issue Date: 11 November 2015 EMC Technologies Report: M150933-3 FCC ID: WTO-CP950 Issue Date: 11/11/2015 Page 2 of 6 This document must not be copied or reproduced, except in full without the written permission of the Manager, EMC Technologies Pty Ltd www.emctech.com.au Table of Contents 1 INTRODUCTION ........................................................................................................................... 4 2 EXPOSURE EVALUATION FOR PORTABLE DEVICE ............................................................... 4 3 GENERAL INFORMATION ........................................................................................................... 4 4 SAR TEST EXCLUSION THRESHOLD FOR 100MHz to 6GHz and 50mm .............................. 5 5 EVALUATION RESULT ................................................................................................................ 6 6 CONCLUSION .............................................................................................................................. 6 EMC Technologies Report: M150933-3 FCC ID: WTO-CP950 Issue Date: 11/11/2015 Page 3 of 6 This document must not be copied or reproduced, except in full without the written permission of the Manager, EMC Technologies Pty Ltd www.emctech.com.au FCC RF Exposure Report , Model: CP950 Report Number: M150933-3 Test Sample: Off the ear sound processor Model Number: CP950 Manufacturer: Cochlear Limited Tested for: Cochlear Limited Address: 1 University Avenue , Macquarie University , NSW, Australia 2109 Phone: +61 (0)2 9428 6555 Contact: Sanjay Boppini Email [email protected] Standard: FCC KDB 447498 D01 General RF Exposure Guidance v06 Mobile and Portable Devices RF Exposure Procedures and Equipment Authorization Policies. FCC Title 47, Part 2.1093 Radiofrequency radiation exposure evaluation: portable devices. Result: The CP950 complied with the exposure limits without SAR measurement based on the procedure in KDB 447498 D01 Clauses 4.3.1 and 4.3.2. Test Date: 12 th October 2015 Test Officer: Mahan Ghassempouri EMC/EMR/SAR/Wireless Engineer M.Sc. in Telecommunication Authorised Signature: Chris Zombolas Technical Director EMC Technologies Pty Ltd EMC Technologies Report: M150933-3 FCC ID: WTO-CP950 Issue Date: 11/11/2015 Page 4 of 6 This document must not be copied or reproduced, except in full without the written permission of the Manager, EMC Technologies Pty Ltd www.emctech.com.au 1 INTRODUCTION This report shows off the ear sound processor CP950 complied with the exposure limits without SAR measurement based on the procedure in KDB 447498 D01 Clauses 4.3.1 and 4.3.2., Model CP950. The test sample and data was provided by the Client. The conclusion herein is based on the information provided by the client. 2 EXPOSURE EVALUATION FOR PORTABLE DEVICE Human exposure to RF emissions from portable devices (47 CFR §2.1093), as defined by the FCC, must be evaluated with respect to the FCC-adopted limits for SAR. 3 GENERAL INFORMATION (Information supplied by the Client) The Equipment Under Test (EUT) was identified as follows: Test sample: Off the ear sound processor Model number: CP950 Radio module: Nordic nRF24L01+ Radio module FCC ID: WTO-CP950 Maximum conducted power: -1 dBm (0.8 mW) Operating frequency 2400– 2483.5 MHz EMC Technologies Report: M150933-3 FCC ID: WTO-CP950 Issue Date: 11/11/2015 Page 5 of 6 This document must not be copied or reproduced, except in full without the written permission of the Manager, EMC Technologies Pty Ltd www.emctech.com.au 4 SAR TEST EXCLUSION THRESHOLD FOR 100MHz to 6GHz and 50mm Frequency (MHz) 5 10 15 20 25 mm 150 39 77 116 155 194 SAR Test Exclusion Threshold (mW) 300 27 55 82 110 137 450 22 45 67 89 112 435 16 33 49 66 82 900 16 32 47 63 79 1500 12 24 37 49 61 1900 11 22 33 44 54 2450 10 19 29 38 48 3600 8 16 24 32 40 5200 7 13 20 26 33 5400 6 13 19 26 32 5800 6 12 19 25 31 The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: max.power of channel,including tuneെup tolerance ሺmWሻ min.test separation distance ሺmmሻ כ ඥ ݂ ሺ ݖܪܩ ሻ ൑3.0 Where  f(GHz) is the RF channel transmit frequency in GHz  Power and distance were rounded to the nearest mW and mm before calculation  The result was rounded to one decimal place for comparison  The test exclusions were applicable only when the minimum test separation distance is ≤ 50 mm and for transmission frequencies between 100 MHz and 6 GHz.  When the minimum test separation distance was < 5 mm, a distance of 5 mm (according to 5) in section 4.1 is applied to determine SAR test EMC Technologies Report: M150933-3 FCC ID: WTO-CP950 Issue Date: 11/11/2015 Page 6 of 6 This document must not be copied or reproduced, except in full without the written permission of the Manager, EMC Technologies Pty Ltd www.emctech.com.au 5 EVALUATION RESULT The standalone transmitter was exempt from SAR if the below condition satisfied in conjunction the with threshold power condition. max.power of channel,including tuneെup tolerance ሺmWሻ min.test separation distance ሺmmሻ כ ඥ ݂ ሺ ݖܪܩ ሻ ൑3.0 Where Minimum test separation distance (݉݉): The minimum test separation distance is determined by the smallest distance from the antenna and radiating structures to the outer surface of the device Maximum power of channel (ܹ݉): Time-averaged maximum conducted output power Frequency (MHz) Maximum Conducted power (mW) Minimum test separation distance (mm) 2483.5 0.8 5 max.power of chan…

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Page 1 of 25 RADIO TEST REPORT FOR CERTIFICATION to FCC PART 15 Subpart C (Section 15.247) Test Sample: Off the ear sound processor Model: CP950 FCC ID: WTO-CP950 Report Number: M150933-1 Rev 1.0 Tested for: Cochlear Limited Issue Date: 23 November 2015 EMC Technologies Pty Ltd reports apply only to the specific samples tested under stated test conditions. It is the manufacturer’s responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. EMC Technologies Pty Ltd shall have no liability for any deductions, inferences or generalisations drawn by the client or others from EMC Technologies Pty Ltd issued reports. This report shall not be used to claim, constitute or imply product endorsement by EMC Technologies Pty Ltd. Accredited for compliance with ISO/IEC 17025. The results of the tests, calibrations and/or measurements included in this document are traceable to Australian/national standards. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration and inspection reports. This document shall only be reproduced in full. EMC Technologies Pty Ltd ABN 82 057 105 549 176 Harrick Road, Keilor Park Victoria 3042, Australia Ph: + 613 9365 1000 Fax: + 613 9331 7455 Email: [email protected] FCC ID: WTO-CP950 Report No.: M150933-1 Rev 1.0 Page 2 of 25 Accredited for compliance with ISO/IEC 17025. The results of the tests, calibrations and/or measurements included in this document are traceable to Australian/national standards. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration and inspection reports. This document shall only be reproduced in full. RADIO TEST REPORT FOR CERTIFICATION to FCC PART 15 Subpart C (Section 15.247) EMC Technologies Report No.: M150933-1 Rev 1.0 Issue Date: 23 November 2015 Contents 1.0 INTRODUCTION _____________________________________________________________ 4 2.0 GENERAL INFORMATION ______________________________________________________ 5 3.0 ANTENNA REQUIREMENT (§15.203) _____________________________________________ 7 4.0 DTS 6 dB BANDWIDTH (§15.247 (a)(2)) ___________________________________________ 7 5.0 PEAK OUTPUT POWER (§15.247 (b)(3)) __________________________________________ 9 6.0 BAND-EDGE EMISSION MEASUREMENTS _______________________________________ 11 7.0 SPURIOUS EMISSION MEASUREMENTS (§15.247 (d)) _____________________________ 13 8.0 POWER SPECTRAL DENSITY (§15.247 (d)) ______________________________________ 22 9.0 RADIO FREQUENCY EXPOSURE (HAZARD) (§15.247 (i)) ___________________________ 24 10.0 COMPLIANCE STATEMENT ___________________________________________________ 24 11.0 MEASUREMENT UNCERTAINTY _______________________________________________ 24 APPENDIX A MEASUREMENT INSTRUMENT DETAILS ___________________________________ 25 FCC ID: WTO-CP950 Report No.: M150933-1 Rev 1.0 Page 3 of 25 Accredited for compliance with ISO/IEC 17025. The results of the tests, calibrations and/or measurements included in this document are traceable to Australian/national standards. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration and inspection reports. This document shall only be reproduced in full. RADIO TEST REPORT FOR CERTIFICATION to FCC PART 15 Subpart C (Section 15.247) Report Number: M150933-1 REV 1.0 Test Sample: Off the ear sound processor Model: CP950 FCC ID: WTO-CP950 Equipment Type: Intentional Radiator (Transceiver) Manufacturer: Cochlear Limited Address: 1 University Avenue , Macquarie University, NSW 2109, Australia Phone: +61 (0)2 9428 6555 Contact: Sanjay Boppini Email: [email protected] Standards: FCC Part 15 – Radio Frequency Devices FCC Part 15 Subpart C – Intentional Radiators Section 15.247 – Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz ANSI C63.10 – 2009 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices KDB 558074 D01 v03r03 Guidance for Performing Compliance Measurements on Digital Transmission Systems (DTS) Operating Under §15.247 Test Date: 12 th and 17 th October 2015 Test Engineer: Mahan Ghassempouri EMC/EMR/SAR/Wireless Engineer M.Sc. in Telecommunication Attestation: I hereby certify that the device(s) described herein were tested as described in this report and that the data included is that which was obtained during such testing. Authorised Signatory: Chris Zombolas Technical Director EMC Technologies Pty Ltd FCC ID: WTO-CP950 Report No.: M150933-1 Rev 1.0 Page 4 of 25 Accredited for compliance with ISO/IEC 17025. The results of the tests, calibrations and/or measurements included in this document are traceable to Australian/national standards. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration and inspection reports. This document shall only be reproduced in full. RADIO TEST REPORT FOR CERTIFICATION to FCC PART 15 Subpart C (Section 15.247) 1.0 INTRODUCTION Radio testing was performed on the Hearing Assistance Device Model: CP950. Test results and procedures were performed in accordance with the following Federal Communications Commission (FCC) standards/regulations: 47 CFR, Part 15, Subpart C Rules for intentional radiators (particularly section 15.247) Section 15.203: Antenna requirements Section 15.205: Restricted bands of operation Section 15.207: Conducted Emission Limits Section 15.209: Radiated Emission Limits (General requirements) Section 15.247: Operation in the bands 902-928 MHz, 2400-2483.5 MHz, 5725-5850 MHz The test sample complied with the requirements of 47 CFR, Part 15 Subpart C - Section 15.247. The measurement procedure used was in accordance with ANSI C63.10-2013. The instrumentation conformed to the requirements of ANSI C63.2-2009. 1.1 Summ…

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FCC ID: WTO‐CP950 IC: 8039A‐CP950 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SETUP PHOTOGRAPHS 0.009 – 30 MHz FCC ID: WTO‐CP950 IC: 8039A‐CP950 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SETUP PHOTOGRAPHS 30 – 1000 MHz FCC ID: WTO‐CP950 IC: 8039A‐CP950 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SETUP PHOTOGRAPHS Above 1 GHz FCC ID: WTO‐CP950 IC: 8039A‐CP950 ______________________________________________________________________ EMC Technologies Pty. Ltd., 176 Harrick Road, Keilor Park, VIC, 3042, Australia. Phone: +61 3 9365 1000 Fax: +61 3 9331 7455 Web: www.emctech.com.au TEST SETUP PHOTOGRAPHS