Cochlear R200FF Remote Assistant User Manual 369388 ISS4 01 CR220UG LM

Cochlear Limited Remote Assistant 369388 ISS4 01 CR220UG LM

User Guide

Nucleus® CR220 Intraoperative Remote Assistant User GuideProfessional use only
ContentsIntroduction .......................................................................................................XAbout the intraoperative remote ..................................................................XFront view .....................................................................................................XBack view ......................................................................................................XHolding and operating the remote .........................................................XNavigating through the screens ...............................................................XInitial set-up .......................................................................................................XCharging the remote assistant battery ..................................................XTurning the remote assistant on ..............................................................XSelecting the language ..............................................................................XPractice mode .............................................................................................XPairing the remote assistant .....................................................................XSetting remote assistant beeps ................................................................XTurning the remote assistant off .............................................................XDay before surgery ...........................................................................................XChecking remote assistant battery status .............................................XRecharge batteries if required ..................................................................XChecking processor status ........................................................................XResolve processor errors if required ........................................................XImmediately before surgery ...........................................................................XRepeat battery status checks ...................................................................XLocking & unlocking the remote assistant keypad ..............................XPlacing the remote assistant in a sterile bag .........................................XDuring surgery ...................................................................................................XImpedance testing ......................................................................................XAutoNRT testing .........................................................................................XAfter surgery ......................................................................................................XCleaning the remote assistant .................................................................XUploading results to fi tting software ......................................................XTroubleshooting ................................................................................................XSymbolsNoteImportant information or advice. Can save inconvenience.Warning (harmful)Potential safety hazards and serious adverse reactions.Could cause harm to person.CompatibilityThe Cochlear™ Nucleus® CR220 Intraoperative Remote Assistant is compatible with the following implants:• CI512• CI513• CI522• CI24RE (CA)• CI24RE (ST)• CI24RE H• CI422It is not compatible with ABI and double array implants
Visual alerts .................................................................................................XDisplaying system details ..........................................................................XResetting the remote assistant ................................................................XGeneral care and precautions ........................................................................XTechnical and legal information ....................................................................XDevice specifi cations ..................................................................................XEnvironmental conditions .........................................................................XCertifi cation and applied standards ........................................................XEquipment classifi cation ...........................................................................XRegulatory authority compliance ............................................................XLabelling symbols .......................................................................................XLegal statement ..........................................................................................XIntroductionThe Cochlear Nucleus CR220 Intraoperative Remote Assistant is a hand-held remote control that enables a clinician to perform impedance and AutoNRT™ tests on a Cochlear implant in the operating theatre.The intra-operative remote assistant is compatible with the CP810 processor. It does not support bilateral functionality or accessories. The purpose of this user manual is to guide clinicians through the functions and uses of the CR220 intraoperative remote.It is strongly advised that you familiarise yourself with the intraoperative remote assistant well in advance of your fi rst scheduled surgery. 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
About the intraoperative remoteFront viewNote: buttons highlighted in orange do not perform any function.Not usedNot usedNot usedNot usedHome buttonRight arrowLeft arrowUp arrowDown arrowOK buttonLock or unlock sliderRemote assistant displayBack viewPersonal identifi cation labelRemote assistant speakerHard reset buttonCoil guides for pairing Product information labelUSB cable socketNot usedPin for attaching the remote assistant lanyard© Cochlear Limited 2012 CR220 User Guide - 76 - CR220 User Guide © Cochlear Limited 2012Features of the remote assistant
How to hold and operate the remoteHold 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 other. Operating it at a greater distance may cause increased delay between the sound processor and the remote assistant response time or loss of communication all together. How to navigate through the screens3. To select an option on a screen, press the 'OK' button4. To return to the eprevi-ous menu or Home screen, use the 'Home' button 1. To scroll forward through the screens, press the right arrow button 2. To move back through the screens, press the left arrow button© Cochlear Limited 2012 CR220 User Guide - 9Getting started
Initial set-up Charge the remote assistant batteryIt is recommended to fully charge the remote assistant battery before using the remote assistant for the fi rst 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 batteryTo charge the remote assistant battery, you will need:Computer with a USB port CR220 Series USB cable Computer with a USB port Global power adaptor CP900 seriescharging kit ANDOROR© Cochlear Limited 2012 CR220 User Guide - 1110 - CR220 User Guide © Cochlear Limited 2012
Three options for charging the remote assistant Turning the remote assistant onTo turn the remote assistant on:Selecting the languageWhen using the remote assistant for the fi rst time, it will prompt you to select a language.When charging, the indicator light will be steady green1. Charge using the sound processor battery charger3. Using a computer with a USB port2. Using the global power adaptor When charging correctly, this screen will appearWhen the battery is full, this screen will appear3. surgery warning screen will appear1. Press and hold OK button4. Press OK5. Home screen will appear2. Press up or down arrows to select preferred language1. Selection screen will appear3. Press OK2. Start up screen will appearORORUpDnGreen indicator light on battery chargerCharging with a computerOKOKOK12 - CR220 User Guide © Cochlear Limited 2012Getting started
When using practice mode, a small white or black square will appear in the top left corner of the screen.To cancel practice mode:Practice modePractice mode allows you to familiarise yourself with the remote 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:If you wish to enter practice mode while a sound processor is paired:2. Press right arrow3. Press OK4. Select 'Start' and press OK1. Prompt screen appears2. Menu appears3. Select 'Practice Mode' and press OK1. Press & hold OK4. Menu appears5. Select 'Start' and press OK1. Press & hold OK button2. Menu appears3. Select 'Exit Practice Mode' and press OK6. Press OK7. Press OK5. Screen appears6. Screen appearsUpDnOKUpDnOKUpDnOKUpDnOK OKRt OK OKOKOK
When pairing is complete, the 'Processor Paired' screen will appear, followed by the 'Home' screenSetting remote assistant beepsYou can adjust the remote assistant beeps from the Settings screen.Pairing the remote assistantPairing allows the remote assistant to communicate with the processor. 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: If there is already a sound processor paired, you can re-pair with a different sound processor at any time using the following instructions.To pair the remote assitant with a sound processor:1. Hold the processor coil on the coil guides at the back of the remote assistant3. Press OK and wait during initialisation 1. From the 'Home' screen, use the right arrow key to scroll to the Settings menu2. Press OK 3. Use up and down arrows to select 'Soft', 'Loud' or 'Off'4. Press OK 2. 'Pair processor' prompt screen will displayOKRtRt RtRtUpDnOKOKRt© Cochlear Limited 2012 CR220 User Guide - 1716 - CR220 User Guide © Cochlear Limited 2012Getting started Getting started
Day before surgeryChecking the remote assistant battery statusTo check the remote assistant battery status, watch for the battery level indicator screen when the remote assitant is switched on. You can also view the battery status by locking the keypad (see p.21).Checking the processor statusTo check the status of the processor and processor battery:1. Press the OK button quickly from Home screen. The status screen will displayIf the remote assistant receives an error from the processor, or the processor battery is low, a visual alert will display .Turning the remote assistant offTo turn the remote assistant off:1. Press and hold the OK button until the menu screen displays.2. Select Switch Off from the menu selection to turn the remote assistant off. 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.OKOKUpDnOKOK
Recharge batteries and resolve processor errorsRecharge batteries if they are not fully charged. Refer to pages 9-10 for instructions to recharge the batteries.If the remote assistant displays any processor errors, refer to pages 31-33 to resolve the errors.Immediately before surgeryRepeat battery and processor checksWe recommend repeating the battery and processor checks again on the day of the surgery. (See pages 19-20)Locking & unlocking the remote assistant keypadThe remote assistant keypad can be locked to prevent pressing keys accidentally.The 'Locked' and 'Unlocked' screens also display the remote assistant battery status. The remote assistant cannot be turned off while the keypad is locked.1. Slide the lock/unlock slider down to lock or up to unlock2. The 'Locked' or 'Unlocked' screen will appear© Cochlear Limited 2012 CR220 User Guide - 2120 - CR220 User Guide © Cochlear Limited 2012Getting started Getting started
Remote assistant in a sterile plastic bagDuring surgeryDuring 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. Impedance testThe 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 screen, press the right arrow3. Press OK to start continuous impedance measurement2. Impedance screen will display4. When you are satisfi ed wih the impedance results, press OK to stop the test5. 'Stopping' screen will display, followed by results screenPlace the remote assistant in a sterile bagBefore entering the operating theatre, place the remote assistant in a sterile bag and seal the bag. Do not sterilise the remote assistant.OKRtOK© Cochlear Limited 2012 CR220 User Guide - 2322 - CR220 User Guide © Cochlear Limited 2012Getting started Getting started
AutoNRT testNeural Response Telemetry (NRT) measures neural activity within the cochlea in response to electrical stimulation from the implant. An AutoNRT test provides a quick, non-invasive, objective measure of peripheral neural function.Electrode defi nitions for impedance testNot yet tested/skippedImpedance OKOpen circuitCurrently being measuredImpedance not found1. Use right arrow to reach AutoNRT screen2. AutoNRT screen will display7. On successful comple-tion, AutoNRT complete screen will display8. Number of electrodes successfully measured will also display5. Press OK 4. AutoNRT launch screen will display3. Press OK6. AutoNRT will runOKRt OK© Cochlear Limited 2012 CR220 User Guide - 2524 - CR220 User Guide © Cochlear Limited 2012Using the remote assistant
Viewing fi nal AutoNRT resultsThe results screen displays the most recent tests for the currently detected implant. The results are displayed in the following screens:Electrode defi nitions for AutoNRTNot yet tested/skippedNRT OKOpen circuitCurrently being measuredNeural response not foundViewing results while AutoNRT is runningWhile the AutoNRT test is running, you can press the right and left arrow buttons to switch between the following results views: Electrode view, graph view and trace view. Pausing AutoNRTYou can pause the AutoNRT results while the test is running. 1. Press any button to pause the process and display the AutoNRT Paused screen.2. If you choose to cancel the AutoNRT test prior to successful measurements, the screen displays a cancelled message.Electrode view Graph view Trace viewL RL RL R© Cochlear Limited 2012 CR220 User Guide - 2726 - CR220 User Guide © Cochlear Limited 2012Using the remote assistant Using the remote assistant
After surgeryCleaning the remote assistantTo 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 off2. Wipe it with a soft dry cloth3. 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 fi tting softwareYou will need to upload the results from the remote assistant to the cochlear implant fi tting software (CustomSound or NFS). Refer to the user guide for your fi tting software for full instructions.© Cochlear Limited 2012 CR220 User Guide - 2928 - CR220 User Guide © Cochlear Limited 2012Using the remote assistant Using the remote assistant
TroubleshootingThe 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 rectifi ed before testing can continue. Visual alertsError Screen display Troubleshooting informationProcessor error TextIncorrect coil typeTextCoil cable fault TextCan't fi nd processorText© Cochlear Limited 2012 CR220 User Guide - 3130 - CR220 User Guide © Cochlear Limited 2012Using the remote assistant Using the remote assistant
Error Screen display Troubleshooting informationRemote assistant battery emptyTextProcessor and implant errorThis alert may display during impedance or AutoNRT testingCharge processor errorThis alert may display during impedance or AutoNRT testingCharge remote errorThis alert may display during impedance or AutoNRT testingSwitch on processor errorThis alert may display during impedance or AutoNRT testingError Screen display Troubleshooting informationIncorrect implantTextCoil faultCoil off implantProcessor battery lowRemote assistant battery lowProcessor battery empt© Cochlear Limited 2012 CR220 User Guide - 3332 - CR220 User Guide © Cochlear Limited 2012Using the remote assistant Using the remote assistant
Displaying system detailsYou can view the remote assistant serial and version numbers from the Settings menu.Resetting the remote assistantIf the Home button does not work or the remote assistant display freezes, you can reset the remote assistant by inserting a pointed object into the reset socket located on the back of the remote. This will reset the remote to its original settings, including language, pairing information, remote beeps and remote alerts.2. Press OK 3. 'Beeps on remote' menu will display4. Press right arrowOK1. From the 'Home' screen, use the right arrow key to scroll to the Settings menuRtRt RtRt RtRt5. 'Remote info' screen will display8 Press Home button to return to set-tings menu and 'Home' screen6. Press right arrowRt7. 'Processor info' screen will displayHm Hm© Cochlear Limited 2012 CR220 User Guide - 3534 - CR220 User Guide © Cochlear Limited 2012Using the remote assistant
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 fi lms 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.
Technical and legal informationTechnical informationThe 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 fi nd 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. Specifi cationsPhysical confi gurationThe 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 fi rmware.MaterialsThe remote assistant housing, including non-metallic buttons/keys, is made of polycarbonate. © Cochlear Limited 2012 CR220 User Guide - 3938 - CR220 User Guide © Cochlear Limited 2012Other information
DimensionsLength Width Depth110 mm 46.1 mm 13.35 mmWeightThe remote assistant weighs 65 g.Operating characteristicsCharacteristic RangeWireless technology Proprietary Low Power Bidirectional Wireless LinkRF frequency 2.4 GHzOperating battery voltage 3. 7 VBattery charging voltage 4.2 VBattery capacity 680 mAh (Internal Lithium-ion battery)Push-key functions Remote assistant on and off and remote assistant settings changeWireless transmission range Up to 2 mDisplay 128 x 128 pixels, colour LCDEnvironmental conditionsCondition Minimum MaximumStorage temperature -40 ºC (-40 ºF) +50 ºC (+122 ºF)Storage relative humidity0% RH 90% RHOperating temperature+5 ºC (+41 ºF) +50 ºC (+122 ºF)Operating relative humidity0% RH 90% RHCertifi cation and applied standardsThe CR220 Remote Assistant fulfi ls the essential requirements listed in Annex 1 of the EC directive 90/385/EEC on Active Implantable Medical Devices as last amended by EC Directive 2007/47/EEC. Equipment classifi cationYour remote assistant is internally powered equipment Type B as described in the international standard IEC 60601-1:2005, Medical Electrical Equipment - Part 1: Basic Safety and Essential Performance.FCC (Federal Communications Commission) and Canadian IC complianceThis device complies with part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions:• This device may not cause harmful interference.• This device must accept any interference received, including interference that may cause undesired operation.Changes or modifi cations made to this equipment not expressly approved by Cochlear Limited may void the FCC authorization to operate this equipment.0197© Cochlear Limited 2012 CR220 User Guide - 4140 - CR220 User Guide © Cochlear Limited 2012Other information Other information
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. 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 on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. FCC ID: WTOR200FFIC ID: 8039A-R200FFLabelling symbolsThe symbols below are found on your remote assistant components and packagingConsult instructions for useStorage temperature limitsRelative humidity limitsDisposal - do not dispose in fi reDisposal – dispose of electrical components in accordance with your local regulationsCertifi cation - JapanCertifi cation - AustraliaCertifi cation - New ZealandSerial numberDate of manufactureType B applied partThis device restricted to sale by or on the order of a physician.Recycle0197CE Registration MarkLegal statementThe statements made in this guide are believed to be true and correct as of the date of publication. However, specifi cations are subject to change without notice. Nucleus® cochlear implant systems are covered by one or more international patents.© Cochlear Limited 201142 - CR220 User Guide © Cochlear Limited 2012Other information
Printed in Australia369388 Iss4 APR12Cochlear 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,specifi cations 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 2012Cochlear 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,specifi cations 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 Cochlear Ltd (ABN 96 002 618 073) 14 Mars Road, Lane Cove NSW 2066, Australia Tel: 61 2 9428 6555 Fax: 61 2 9428 6352Cochlear Americas 13059 E Peakview Avenue, Centennial, CO 80111, USA Tel: 1 303 790 9010 Fax: 1 303 792 9025Cochlear 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 HannoverGermany Tel: 49 511 542 770 Fax: 49 511 542 7770Cochlear Europe Ltd 6 Dashwood Lang Road, Bourne Business Park, Addlestone, Surrey KT15 2HJ, United Kingdom Tel: 44 1932 87 1500 Fax: 44 1932 87 1526Nihon 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 0245Cochlear (HK) Ltd Unit 1810, Hopewell Centre, 183 Queens Road East, Wan Chai, Hong Kong SAR Tel: 852 2530 5773 Fax: 852 2530 5183Cochlear Medical Device (Beijing) Co Ltd Unit 2208 Gemdale Tower B, 91 Jianguo Road, Chaoyang District, Beijing 100022P.R. China Tel: 86 10 5909 7800 Fax: 86 10 5909 7900Cochlear Ltd (Singapore Branch) 6 Sin Ming Road, #01-16 Sin Ming Plaza Tower 2, Singapore 575585 Tel: 65 6553 3814 Fax: 65 6451 4105Cochlear Korea Ltd 1st floor, Cheongwon building, 828-5, Yuksam dong, Kangnam gu, Seoul, Korea Tel: 82 2 533 4663 Fax: 82 2 533 8408Cochlear Benelux NV Schaliënhoevedreef 20i, B - 2800 Mechelen, Belgium Tel: 32 1579 5511 Fax: 32 1579 5500Cochlear Italia S.r.l. Via Larga 33, 40138 Bologna, Italia Tel: 39 051 601 53 11 Fax: 39 051 39 20 62Cochlear 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 499Cochlear Nordic AB Konstruktionsvägen 14, SE - 435 33 Mölnlycke, Sweden Tel: 46 31 335 14 61 Fax: 46 31 335 14 60Cochlear Tıbbi Cihazlar ve Sağlık Hizmetleri Ltd. Sti. Cubuklu Mah. Bogazici Cad., Bogazici Plaza No: 6/1, KavacikTR - 34805 Beykoz-Istanbul, Turkey Tel: 90 216 538 5900 Fax: 90 216 538 5919Cochlear Canada Inc 2500-120 Adelaide Street West, Toronto, ON M5H 1T1 Canada Tel: 1 416 972 5082 Fax: 1 416 972 5083Cochlear Medical Device Company India Pvt Ltd Ground floor Platina Bldg, Plot no C 59, G Block, Bandra Kurla Complex,

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