User Guide

FCC ID: WTOR200FF

Users Manual

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FCCID_1704615

Nucleus® CR220 Intraoperative Remote Assistant User Guide Professional use only

Symbols Contents Introduction .......................................................................................................X About the intraoperative remote ..................................................................X Note Front view.....................................................................................................X Important information or advice. Can save inconvenience. Back view......................................................................................................X Holding and operating the remote .........................................................X Warning (harmful) Potential safety hazards and serious Navigating through the screens...............................................................X adverse reactions. Initial set-up .......................................................................................................X Could cause harm to person. Charging the remote assistant battery ..................................................X Turning the remote assistant on ..............................................................X Selecting the language ..............................................................................X Practice mode .............................................................................................X Pairing the remote assistant .....................................................................X Setting remote assistant beeps................................................................X Turning the remote assistant off .............................................................X Day before surgery ...........................................................................................X Compatibility Checking remote assistant battery status .............................................X Recharge batteries if required ..................................................................X The Cochlear™ Nucleus® CR220 Intraoperative Remote Assistant is Checking processor status ........................................................................X compatible with the following implants: Resolve processor errors if required ........................................................X • CI512 Immediately before surgery ...........................................................................X • CI513 Repeat battery status checks ...................................................................X • CI522 Locking & unlocking the remote assistant keypad ..............................X • CI24RE (CA) Placing the remote assistant in a sterile bag .........................................X • CI24RE (ST) During surgery ...................................................................................................X • CI24RE H Impedance testing ......................................................................................X • CI422 AutoNRT testing .........................................................................................X After surgery ......................................................................................................X It is not compatible with ABI and double array implants Cleaning the remote assistant .................................................................X Uploading results to fitting software......................................................X Troubleshooting ................................................................................................X

Visual alerts .................................................................................................X Displaying system details ..........................................................................X Introduction Resetting the remote assistant ................................................................X The Cochlear Nucleus CR220 Intraoperative Remote Assistant is a hand- General care and precautions ........................................................................X held remote control that enables a clinician to perform impedance and Technical and legal information ....................................................................X AutoNRT™ tests on a Cochlear implant in the operating theatre. Device specifications ..................................................................................X The intra-operative remote assistant is compatible with the CP810 processor. It does not support bilateral functionality or accessories. Environmental conditions .........................................................................X Certification and applied standards ........................................................X The purpose of this user manual is to guide clinicians through the functions and uses of the CR220 intraoperative remote. Equipment classification ...........................................................................X It is strongly advised that you familiarise yourself with the intraoperative Regulatory authority compliance ............................................................X remote assistant well in advance of your first scheduled surgery. Labelling symbols .......................................................................................X Legal statement ..........................................................................................X The remote assistant is to be used for surgery only. The sound processor and the remote assistant are not sterilised and should be enclosed in sterile plastic bags during surgery. © Cochlear Limited 2012 CR220 User Guide - 5

Features of the remote assistant About the intraoperative remote Back view Front view Not used Not used Lock or unlock slider Personal identification label Remote assistant speaker Not used Remote assistant display Not used Not used Product information label Up arrow Home button Coil guides for pairing Left arrow OK button Down arrow Right arrow Hard reset button USB cable socket Pin for attaching the remote assistant lanyard Note: buttons highlighted in orange do not perform any function. 6 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 7

Getting started How to hold and operate the remote How to navigate through the screens Hold the remote assistant in the palm of your hand. Keep it within 2 metres (about six feet) of the sound processor (about six feet) of each 1. To scroll forward 2. To move back through other. Operating it at a greater distance may cause increased delay through the screens, press the screens, press the between the sound processor and the remote assistant response time or the right arrow button left arrow button loss of communication all together. 3. To select an option on 4. To return to the eprevi- a screen, press the 'OK' ous menu or Home screen, button use the 'Home' button © Cochlear Limited 2012 CR220 User Guide - 9

Initial set-up Charge the remote assistant battery It is recommended to fully charge the remote assistant battery before using the remote assistant for the first time. It may take approximately 2 to 4 hours to fully charge a completely empty battery. A fully charged battery should provide you with enough battery life to last a full surgery. However, battery life varies depending on amount of usage. Ensure that you only use battery charging equipment supplied by Cochlear to charge the remote assistant battery. Tools to charge the remote assistant battery To charge the remote assistant battery, you will need: CP900 series AND charging kit CR220 Series USB cable OR Global power adaptor OR Computer with Computer with a USB port a USB port 10 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 11

Getting started Three options for charging the remote assistant Turning the remote assistant on 1. Charge using the When charging, the To turn the remote assistant on: sound processor battery indicator light will be 1. Press and 2. Start up 3. surgery 4. Press 5. Home charger steady green hold OK screen will warning OK screen will button appear screen will appear Green indicator appear light on battery charger OK OK OR 2. Using the global power adaptor When charging correctly, Selecting the language this screen will appear When using the remote assistant for the first time, it will prompt you to select a language. 1. Selection 2. Press up or down 3. Press screen will arrows to select OK appear preferred language OR 3. Using a computer When the battery is full, Up with a USB port this screen will appear OK Dn Charging with a computer 12 - CR220 User Guide © Cochlear Limited 2012

Practice mode When using practice mode, a small white or black square will appear in Practice mode allows you to familiarise yourself with the remote the top left corner of the screen. assistant before you start using it clinically. No adjustments or changes to settings are saved or sent to the sound processor while in practice mode. If there is no sound processor paired to the remote assistant: 1. Prompt 2. Press right 3. Press 4. Select 'Start' 5. Screen 6. Press screen appears arrow OK and press OK appears OK To cancel practice mode: Up 1. Press & hold 2. Menu 3. Select 'Exit Practice Rt OK OK OK OK button appears Mode' and press OK Dn Up OK OK If you wish to enter practice mode while a sound processor is paired: Dn 1. Press & 2. Menu 3. Select 4. Menu 5. Select 6. Screen 7. Press hold OK appears 'Practice Mode' appears 'Start' and appears OK and press OK press OK Up Up OK OK OK OK Dn Dn

Getting started Getting started Pairing the remote assistant When pairing is complete, the 'Processor Paired' screen will appear, Pairing allows the remote assistant to communicate with the processor. followed by the 'Home' screen Before you start, ensure that both the processor and the remote assistant are switched on. If there is no sound processor currently paired with the remote assistant, the following screen will prompt you to pair a sound processor: Setting remote assistant beeps You can adjust the remote assistant beeps from the Settings screen. If there is already a sound processor paired, you can re-pair with a 1. From the 'Home' screen, use the right arrow key to scroll to different sound processor at any time using the following instructions. the Settings menu To pair the remote assitant with a sound processor: 1. Hold the processor coil on 2. 'Pair processor' 3. Press OK Rt Rt Rt Rt Rt the coil guides at the back of prompt screen and wait during the remote assistant will display initialisation OK 2. Press OK 3. Use up and down arrows to 4. Press OK select 'Soft', 'Loud' or 'Off' Up OK OK Dn 16 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 17

Turning the remote assistant off Day before surgery To turn the remote assistant off: 1. Press and hold the OK button until the menu screen displays. Checking the remote assistant battery status 2. Select Switch Off from the menu selection to turn the remote assistant off. To check the remote assistant battery status, watch for the battery level indicator screen when the remote assitant is switched on. Up OK OK Dn The remote assistant automatically goes into standby mode if it has been inactive for an extended period. Press any button to 'wake' the remote assistant from standby mode. You can also view the battery status by locking the keypad (see p.21). Checking the processor status To check the status of the processor and processor battery: 1. Press the OK button quickly from Home screen. The status screen will display OK OK If the remote assistant receives an error from the processor, or the processor battery is low, a visual alert will display .

Getting started Getting started Recharge batteries and resolve processor errors Immediately before surgery Recharge batteries if they are not fully charged. Refer to pages 9-10 for instructions to recharge the batteries. Repeat battery and processor checks If the remote assistant displays any processor errors, refer to pages 31- 33 to resolve the errors. We recommend repeating the battery and processor checks again on the day of the surgery. (See pages 19-20) Locking & unlocking the remote assistant keypad The remote assistant keypad can be locked to prevent pressing keys accidentally. 1. Slide the lock/unlock slider down 2. The 'Locked' or to lock or up to unlock 'Unlocked' screen will appear The 'Locked' and 'Unlocked' screens also display the remote assistant battery status. The remote assistant cannot be turned off while the keypad is locked. 20 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 21

Getting started Getting started Place the remote assistant in a sterile bag During surgery Before entering the operating theatre, place the remote assistant in a sterile bag and seal the bag. During surgery, the intraoperative remote assistant can be used to perform impedance and AutoNRT tests. When performing intraoperative tests, ensure the processor is placed over the implant to get accurate measurements. Remote assistant in a sterile plastic bag Impedance test The impedance test indicates the electrical status of the intra-cochlear electrodes. It loops continuously through the 22 electrodes, displaying which electrode is being tested, and the status of all electrodes already tested. 1. From the Home 2. Impedance 3. Press OK to start screen, press the screen will continuous impedance right arrow display measurement Rt OK Do not sterilise the remote assistant. 4. When you are satisfied wih 5. 'Stopping' screen will display, the impedance results, press followed by results screen OK to stop the test OK 22 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 23

Using the remote assistant Electrode definitions for impedance test AutoNRT test Neural Response Telemetry (NRT) measures neural activity within Not yet tested/skipped the cochlea in response to electrical stimulation from the implant. An AutoNRT test provides a quick, non-invasive, objective measure of Impedance OK peripheral neural function. 1. Use right 2. AutoNRT 3. Press 4. AutoNRT 5. Press Open circuit arrow to reach screen will OK launch screen OK AutoNRT screen display will display Currently being measured Impedance not found Rt OK OK 6. AutoNRT 7. On successful comple- 8. Number of electrodes will run tion, AutoNRT complete successfully measured screen will display will also display 24 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 25

Using the remote assistant Using the remote assistant Viewing results while AutoNRT is running Viewing final AutoNRT results While the AutoNRT test is running, you can press the right and left The results screen displays the most recent tests for the currently arrow buttons to switch between the following results views: Electrode detected implant. The results are displayed in the following screens: view, graph view and trace view. L R L R L R Electrode view Graph view Trace view Electrode definitions for AutoNRT Pausing AutoNRT You can pause the AutoNRT results while the test is running. Not yet tested/skipped 1. Press any button to pause the process and display the AutoNRT Paused screen. NRT OK Open circuit Currently being measured 2. If you choose to cancel the AutoNRT test prior to successful Neural response not found measurements, the screen displays a cancelled message. 26 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 27

Using the remote assistant Using the remote assistant After surgery Cleaning the remote assistant To keep the remote assistant clean, wipe it with a soft dry cloth. Do not use alcohol, household cleaners or abrasive materials to clean the remote assistant. If the remote assistant gets wet: 1. Turn it off 2. Wipe it with a soft dry cloth 3. Leave out to dry for approximately 12 hours. 4. Turn it on again after it is dry. If the remote assistant no longer functions, return it to your Cochlear representative. Cochlear cannot guarantee that it can repair a water-damaged remote assistant. Do not use an oven or microwave or any other electrical or heating device to dry the remote assistant. Uploading results to fitting software You will need to upload the results from the remote assistant to the cochlear implant fitting software (CustomSound or NFS). Refer to the user guide for your fitting software for full instructions. 28 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 29

Using the remote assistant Using the remote assistant Troubleshooting The remote assistant displays visual alerts when errors occur. Some alerts mean that the testing processes cannot continue (e.g. if the processor coil has moved off the implant). In these cases, the problem will need to be rectified before testing can continue. Visual alerts Error Screen display Troubleshooting information Processor error Text Incorrect coil Text type Coil cable fault Text Can't find Text processor 30 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 31

Using the remote assistant Using the remote assistant Error Screen display Troubleshooting information Error Screen display Troubleshooting information Incorrect Text Remote Text implant assistant battery empty Coil fault Processor and This alert may display during implant error impedance or AutoNRT testing Coil off implant Charge This alert may display during processor error impedance or AutoNRT testing Processor Charge remote This alert may display during battery low error impedance or AutoNRT testing Remote Switch on This alert may display during assistant processor error impedance or AutoNRT testing battery low Processor battery empt 32 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 33

Using the remote assistant Displaying system details Resetting the remote assistant You can view the remote assistant serial and version numbers from the If the Home button does not work or the remote assistant display Settings menu. freezes, you can reset the remote assistant by inserting a pointed object into the reset socket located on the back of the remote. This 1. From the 'Home' screen, use the right arrow key to scroll to will reset the remote to its original settings, including language, pairing the Settings menu information, remote beeps and remote alerts. Rt Rt Rt Rt Rt 2. Press 3. 'Beeps on remote' 4. Press right 5. 'Remote info' OK menu will display arrow screen will display OK Rt 6. Press 7. 'Processor info' 8 Press Home button to return to set- right screen will display tings menu and 'Home' screen arrow Rt Hm Hm 34 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 35

General care and precautions • Only use the intraoperative remote assistant while the recipient is under anaesthetic. • Do not use or store the device in dusty or dirty areas, extreme high or cold temperatures (e.g. Do not store in direct sunlight, behind a window or in a car for extended periods of time) • Take care when placing the remote assistant in a bag or pocket with other objects as the display may scratch. Commercially available protective films may be used to protect the remote assistant display from scratches. • Do not use alcohol, household cleaners or abrasive materials to clean the remote assistant. • Do not use any commercial or household appliance to dry the remote assistant. • Only use the CR200 Series Global Power Adaptor, the CP900 Series Global Power Adaptor (if using the CP900 Series Battery Charger) or the CR200 Series Global charging kit when charging your remote assistant from mains power. • Do not bend or compress the display on the remote assistant. • Do not use excessive force when connecting or disconnecting the USB cable or when using the buttons on the keypad. • Do not disassemble, deform or immerse in water. If the remote assistant is not working, return it to your clinician. Warranty will be void if opened. • Do not use the remote assistant if it becomes unusually warm. Inform your Cochlear representative immediately. • Dispose of electrical components in accordance with your local regulations. • When charging the remote with a computer, ensure the computer conforms to IEC 60950 standards.

Other information Technical and legal information Technical information The remote assistant wireless communication link operates in the 2.4 GHz ISM band using GFSK (Gaussian Frequency Shift Keying) on 10 channels. The link uses a proprietary bi-directional communication protocol and operates over a distance of up to 2m from the CP810 series processor. When interference is present, the wireless communication link switches between the 10 channels to find a channel where the interference least affects the operation of the link. The remote assistant indicates via its display when the processor is not within operating distance, and when the link has been interrupted due to interference. Specifications Physical configuration The remote assistant comprises: • Custom analogue and digital integrated circuits based on a micro- processor design, with bi-directional wireless communication capabilities. • Push-buttons/keys and a slider for control of processor features and its own system features. • A display for indicating system status and activity. • A speaker for sounding an audible alert. • In-built coil sensor to check if the processor’s coil is receiving sound signals from the processor and for pairing. • On-board battery charging circuit. • A temperature sensor for battery safety. • A micro USB connector for charging the remote assistant and updating the firmware. Materials The remote assistant housing, including non-metallic buttons/keys, is made of polycarbonate. 38 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 39

Other information Other information Dimensions Certification and applied standards Length Width Depth The CR220 Remote Assistant fulfils the essential requirements listed in 110 mm 46.1 mm 13.35 mm Annex 1 of the EC directive 90/385/EEC on Active Implantable Medical Devices as last amended by EC Directive 2007/47/EEC. Weight 0197 The remote assistant weighs 65 g. Equipment classification Operating characteristics Your remote assistant is internally powered equipment Type B as Characteristic Range described in the international standard IEC 60601-1:2005, Medical Electrical Equipment - Part 1: Basic Safety and Essential Performance. Wireless technology Proprietary Low Power Bidirectional Wireless Link FCC (Federal Communications Commission) and Canadian IC RF frequency 2.4 GHz compliance Operating battery voltage 3. 7 V This device complies with part 15 of the FCC Rules and with RSS-210 of Battery charging voltage 4.2 V Industry Canada. Operation is subject to the following two conditions: Battery capacity 680 mAh (Internal Lithium-ion • This device may not cause harmful interference. battery) • This device must accept any interference received, including Push-key functions Remote assistant on and off and interference that may cause undesired operation. remote assistant settings change Wireless transmission range Up to 2 m Changes or modifications made to this equipment not expressly approved by Cochlear Limited may void the FCC authorization to Display 128 x 128 pixels, colour LCD operate this equipment. Environmental conditions Condition Minimum Maximum Storage temperature -40 ºC (-40 ºF) +50 ºC (+122 ºF) Storage relative 0% RH 90% RH humidity Operating +5 ºC (+41 ºF) +50 ºC (+122 ºF) temperature Operating relative 0% RH 90% RH humidity 40 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 User Guide - 41

Other information Labelling symbols This equipment has been tested and found to comply with the limits The symbols below are found on your remote assistant components for a Class B digital device, pursuant to Part 15 of the FCC Rules. These and packaging limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses Consult instructions for use 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 Storage temperature limits will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be Relative humidity limits 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 Disposal - do not dispose in fire measures: • Reorient or relocate the receiving antenna. Disposal – dispose of electrical components in accordance with your • Increase the separation between the equipment and receiver. local regulations • Connect the equipment into an outlet on a circuit different from Certification - Japan that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. Certification - Australia FCC ID: WTOR200FF Certification - New Zealand IC ID: 8039A-R200FF Serial number Date of manufacture Type B applied part This device restricted to sale by or on the order of a physician. Recycle CE Registration Mark 0197 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. Nucleus® cochlear implant systems are covered by one or more international patents. © Cochlear Limited 2011 42 - CR220 User Guide © Cochlear Limited 2012

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 AG European Headquarters, Peter Merian-Weg 4, CH - 4052 Basel, Switzerland Tel: 41 61 205 0404 Fax: 41 61 205 0405 Cochlear Deutschland GmbH & Co. KG Karl-Wiechert-Allee 76A, D-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 87 1500 Fax: 44 1932 87 1526 Nihon Cochlear Co Ltd Ochanomizu-Motomachi Bldg, 2-3-7 Hongo, Bunkyo-Ku, Tokyo 113-0033, Japan Tel: 81 3 3817 0241 Fax: 81 3 3817 0245 Cochlear (HK) Ltd Unit 1810, Hopewell Centre, 183 Queens Road East, Wan Chai, Hong Kong SAR Tel: 852 2530 5773 Fax: 852 2530 5183 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 Ltd (Singapore Branch) 6 Sin Ming Road, #01-16 Sin Ming Plaza Tower 2, Singapore 575585 Tel: 65 6553 3814 Fax: 65 6451 4105 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 Benelux NV Schaliënhoevedreef 20i, B - 2800 Mechelen, Belgium Tel: 32 1579 5511 Fax: 32 1579 5500 Cochlear Italia S.r.l. Via Larga 33, 40138 Bologna, Italia Tel: 39 051 601 53 11 Fax: 39 051 39 20 62 Cochlear France S.A.S. Route de l’Orme aux Merisiers, Z.I. Les Algorithmes - Bât. Homère, 91190 Saint Aubin, France Tel: 33 811 111 993 Fax: 33 160 196 499 Cochlear Nordic AB Konstruktionsvägen 14, SE - 435 33 Mölnlycke, Sweden Tel: 46 31 335 14 61 Fax: 46 31 335 14 60 Cochlear Tıbbi Cihazlar ve Sağlık Hizmetleri Ltd. Sti. Cubuklu Mah. Bogazici Cad., Bogazici Plaza No: 6/1, Kavacik TR - 34805 Beykoz-Istanbul, Turkey Tel: 90 216 538 5900 Fax: 90 216 538 5919 Cochlear Canada Inc 2500-120 Adelaide Street West, Toronto, ON M5H 1T1 Canada Tel: 1 416 972 5082 Fax: 1 416 972 5083 Cochlear Medical Device Company India Pvt Ltd Ground floor Platina Bldg, Plot no C 59, G Block, Bandra Kurla Complex, Cochlear implant systems are protected by one or more international patents. The statements made in this guide are believed to be true and correct in every detail as of the date of publication. However, specifications are subject to change without notice. Nucleus is a registered trademark of Cochlear Limited. AutoNRT, Cochlear and the elliptical logo are trademarks of Cochlear Limited. © Cochlear Limited 2012 Printed in Australia 369388 Iss4 APR12


Document Created: 2012-04-24 11:49:18
Document Modified: 2012-04-24 11:49:18
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