Cochlear R200FF Remote Assistant User Manual 369388 ISS4 01 CR220UG LM
Cochlear Limited Remote Assistant 369388 ISS4 01 CR220UG LM
Cochlear >
User Guide
| Download: |  |
| Mirror Download [FCC.gov] | |
| Document ID | 1704615 |
| Application ID | D5VxslL50R3xTPF8Q3tXtQ== |
| Document Description | User Guide |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 96.81kB (1210089 bits) |
| Date Submitted | 2012-05-23 00:00:00 |
| Date Available | 2012-05-23 00:00:00 |
| Creation Date | 2012-04-24 11:49:18 |
| Producing Software | GPL Ghostscript 8.15 |
| Document Lastmod | 2012-04-24 11:49:18 |
| Document Title | 369388 ISS4-01 CR220UG LM.pdf |
| Document Creator | Adobe Acrobat 10.1.3 |
| Document Author: | WMeskens |
Professional use only User Guide Nucleus® CR220 Intraoperative Remote Assistant Note Important information or advice. Can save inconvenience. Warning (harmful) Potential safety hazards and serious adverse reactions. Could cause harm to person. CI513 CI522 CI24RE (CA) CI24RE (ST) CI24RE H CI422 • • • • • • It is not compatible with ABI and double array implants CI512 • The Cochlear™ Nucleus® CR220 Intraoperative Remote Assistant is compatible with the following implants: Compatibility Symbols Immediately before surgery ...........................................................................X Repeat battery status checks ...................................................................X Locking & unlocking the remote assistant keypad ..............................X Placing the remote assistant in a sterile bag .........................................X During surgery ...................................................................................................X Impedance testing ......................................................................................X AutoNRT testing .........................................................................................X After surgery ......................................................................................................X Cleaning the remote assistant .................................................................X Uploading results to fitting software......................................................X Troubleshooting ................................................................................................X Checking processor status ........................................................................X Resolve processor errors if required ........................................................X 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 Checking remote assistant battery status .............................................X Recharge batteries if required ..................................................................X Front view.....................................................................................................X Back view......................................................................................................X Holding and operating the remote .........................................................X Navigating through the screens...............................................................X Initial set-up .......................................................................................................X Introduction .......................................................................................................X About the intraoperative remote ..................................................................X Contents Visual alerts .................................................................................................X Displaying system details ..........................................................................X Resetting the remote assistant ................................................................X General care and precautions ........................................................................X Technical and legal information ....................................................................X Device specifications ..................................................................................X Environmental conditions .........................................................................X Certification and applied standards ........................................................X Equipment classification ...........................................................................X Regulatory authority compliance ............................................................X Labelling symbols .......................................................................................X Legal statement ..........................................................................................X © Cochlear Limited 2012 CR220 User Guide - 5 The sound processor and the remote assistant are not sterilised and should be enclosed in sterile plastic bags during surgery. The remote assistant is to be used for surgery only. It is strongly advised that you familiarise yourself with the intraoperative remote assistant well in advance of your first scheduled surgery. The purpose of this user manual is to guide clinicians through the functions and uses of the CR220 intraoperative remote. The intra-operative remote assistant is compatible with the CP810 processor. It does not support bilateral functionality or accessories. The Cochlear Nucleus CR220 Intraoperative Remote Assistant is a handheld remote control that enables a clinician to perform impedance and AutoNRT™ tests on a Cochlear implant in the operating theatre. Introduction Not used Pin for attaching the remote assistant lanyard Right arrow OK button Home button Not used Lock or unlock slider 6 - CR220 User Guide © Cochlear Limited 2012 Note: buttons highlighted in orange do not perform any function. Down arrow Left arrow Up arrow Not used Remote assistant display Not used Front view About the intraoperative remote © Cochlear Limited 2012 Hard reset button Coil guides for pairing Remote assistant speaker Personal identification label Back view CR220 User Guide - 7 USB cable socket Product information label Not used Features of the remote assistant 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 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 hold and operate the remote CR220 User Guide - 9 4. To return to the eprevious menu or Home screen, use the 'Home' button 3. To select an option on a screen, press the 'OK' button © Cochlear Limited 2012 2. To move back through the screens, press the left arrow button 1. To scroll forward through the screens, press the right arrow button How to navigate through the screens Getting started 10 - CR220 User Guide © Cochlear Limited 2012 © Cochlear Limited 2012 CR220 Series USB cable AND Global power adaptor CP900 series charging kit CR220 User Guide - 11 Computer with Computer with a USB port a USB port OR OR To charge the remote assistant battery, you will need: Tools to charge the remote assistant battery Ensure that you only use battery charging equipment supplied by Cochlear to 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. Charge the remote assistant battery Initial set-up 12 - CR220 User Guide Charging with a computer OR 3. Using a computer with a USB port OR 2. Using the global power adaptor 1. Charge using the sound processor battery charger © Cochlear Limited 2012 When the battery is full, this screen will appear When charging correctly, this screen will appear Green indicator light on battery charger When charging, the indicator light will be steady green Three options for charging the remote assistant Getting started OK 5. Home screen will appear 1. Selection screen will appear Dn Up 2. Press up or down arrows to select preferred language OK 3. Press OK When using the remote assistant for the first time, it will prompt you to select a language. Selecting the language OK 1. Press and 2. Start up 3. surgery 4. Press hold OK screen will warning OK appear screen will button appear To turn the remote assistant on: Turning the remote assistant on 1. Press & hold OK OK 2. Press right arrow OK 3. Press OK Dn Up OK 4. Select 'Start' and press OK 5. Screen appears 2. Menu appears Dn Up OK 3. Select 'Practice Mode' and press OK 4. Menu appears Dn Up OK 5. Select 'Start' and press OK OK 6. Press OK OK 6. Screen 7. Press appears OK If you wish to enter practice mode while a sound processor is paired: Rt 1. Prompt screen appears If there is no sound processor paired to the remote assistant: No adjustments or changes to settings are saved or sent to the sound processor while in practice mode. Practice mode allows you to familiarise yourself with the remote assistant before you start using it clinically. Practice mode OK 1. Press & hold OK button To cancel practice mode: 2. Menu appears Dn Up OK 3. Select 'Exit Practice Mode' and press OK When using practice mode, a small white or black square will appear in the top left corner of the screen. 16 - CR220 User Guide 1. Hold the processor coil on 2. 'Pair processor' the coil guides at the back of prompt screen the remote assistant will display To pair the remote assitant with a sound processor: © Cochlear Limited 2012 OK 3. Press OK and wait during initialisation If there is already a sound processor paired, you can re-pair with a different sound processor at any time using the following instructions. If there is no sound processor currently paired with the remote assistant, the following screen will prompt you to pair a sound processor: Before you start, ensure that both the processor and the remote assistant are switched on. Pairing allows the remote assistant to communicate with the processor. Pairing the remote assistant Getting started © Cochlear Limited 2012 OK 2. Press OK Rt Rt Rt Rt Dn Up 3. Use up and down arrows to select 'Soft', 'Loud' or 'Off' Rt CR220 User Guide - 17 OK 4. Press OK 1. From the 'Home' screen, use the right arrow key to scroll to the Settings menu You can adjust the remote assistant beeps from the Settings screen. Setting remote assistant beeps When pairing is complete, the 'Processor Paired' screen will appear, followed by the 'Home' screen Getting started Press and hold the OK button until the menu screen displays. Dn OK 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. OK Up 2. Select Switch Off from the menu selection to turn the remote assistant off. 1. To turn the remote assistant off: Turning the remote assistant off OK OK Press the OK button quickly from Home screen. The status screen will display If the remote assistant receives an error from the processor, or the processor battery is low, a visual alert will display . 1. To check the status of the processor and processor battery: Checking the processor status You can also view the battery status by locking the keypad (see p.21). To check the remote assistant battery status, watch for the battery level indicator screen when the remote assitant is switched on. Checking the remote assistant battery status Day before surgery 20 - CR220 User Guide © Cochlear Limited 2012 If the remote assistant displays any processor errors, refer to pages 3133 to resolve the errors. Recharge batteries if they are not fully charged. Refer to pages 9-10 for instructions to recharge the batteries. Recharge batteries and resolve processor errors Getting started 2. The 'Locked' or 'Unlocked' screen will appear © Cochlear Limited 2012 CR220 User Guide - 21 The remote assistant cannot be turned off while the keypad is locked. The 'Locked' and 'Unlocked' screens also display the remote assistant battery status. 1. Slide the lock/unlock slider down to lock or up to unlock The remote assistant keypad can be locked to prevent pressing keys accidentally. Locking & unlocking the remote assistant keypad We recommend repeating the battery and processor checks again on the day of the surgery. (See pages 19-20) Repeat battery and processor checks Immediately before surgery Getting started 22 - CR220 User Guide Do not sterilise the remote assistant. Remote assistant in a sterile plastic bag © Cochlear Limited 2012 Before entering the operating theatre, place the remote assistant in a sterile bag and seal the bag. Place the remote assistant in a sterile bag Getting started Rt © Cochlear Limited 2012 OK OK 3. Press OK to start continuous impedance measurement CR220 User Guide - 23 5. 'Stopping' screen will display, followed by results screen 2. Impedance screen will display 4. When you are satisfied wih the impedance results, press OK to stop the test 1. From the Home screen, press the right arrow 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. Impedance test 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. During surgery Getting started 24 - CR220 User Guide Impedance not found Currently being measured Open circuit Impedance OK Not yet tested/skipped © Cochlear Limited 2012 Electrode definitions for impedance test 2. AutoNRT screen will display OK CR220 User Guide - 25 8. Number of electrodes successfully measured will also display OK 3. Press 4. AutoNRT 5. Press OK launch screen OK will display 7. On successful completion, AutoNRT complete screen will display © Cochlear Limited 2012 6. AutoNRT will run Rt 1. Use right arrow to reach AutoNRT screen Neural 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. AutoNRT test Using the remote assistant Graph view Trace view Press any button to pause the process and display the AutoNRT Paused screen. 26 - CR220 User Guide © Cochlear Limited 2012 2. If you choose to cancel the AutoNRT test prior to successful measurements, the screen displays a cancelled message. 1. You can pause the AutoNRT results while the test is running. Pausing AutoNRT Electrode view © Cochlear Limited 2012 Neural response not found Currently being measured Open circuit NRT OK Not yet tested/skipped Electrode definitions for AutoNRT CR220 User Guide - 27 The results screen displays the most recent tests for the currently detected implant. The results are displayed in the following screens: Viewing final AutoNRT results While 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. Using the remote assistant Viewing results while AutoNRT is running Using the remote assistant 28 - CR220 User Guide Using the remote assistant © Cochlear Limited 2012 Turn it off © Cochlear Limited 2012 CR220 User Guide - 29 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. Uploading results to fitting software Do not use an oven or microwave or any other electrical or heating device to dry the remote assistant. 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. 3. Leave out to dry for approximately 12 hours. 2. Wipe it with a soft dry cloth 1. If the remote assistant gets wet: 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. Cleaning the remote assistant After surgery Using the remote assistant 30 - CR220 User Guide Using the remote assistant © Cochlear Limited 2012 Text Text Coil cable fault Can't find processor © Cochlear Limited 2012 Text Incorrect coil type CR220 User Guide - 31 Troubleshooting information Text Screen display Processor error Error Visual alerts 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. Troubleshooting Using the remote assistant Switch on processor error Remote assistant battery low 32 - CR220 User Guide © Cochlear Limited 2012 Charge remote error Processor battery low Processor battery empt Charge processor error Remote assistant battery empty Error Coil off implant © Cochlear Limited 2012 Troubleshooting information Text Processor and implant error Screen display Coil fault Incorrect implant Error Using the remote assistant Screen display CR220 User Guide - 33 This alert may display during impedance or AutoNRT testing This alert may display during impedance or AutoNRT testing This alert may display during impedance or AutoNRT testing This alert may display during impedance or AutoNRT testing Text Troubleshooting information Using the remote assistant Rt Rt Rt Rt 3. 'Beeps on remote' 4. Press right 5. 'Remote info' menu will display arrow screen will display Rt 34 - CR220 User Guide Rt Hm © Cochlear Limited 2012 Hm 6. Press 7. 'Processor info' 8 Press Home button to return to setright screen will display tings menu and 'Home' screen arrow OK 2. Press OK Rt © Cochlear Limited 2012 CR220 User Guide - 35 If 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. You can view the remote assistant serial and version numbers from the Settings menu. 1. From the 'Home' screen, use the right arrow key to scroll to the Settings menu Resetting the remote assistant Displaying system details Using the remote assistant 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. • • • • • • • • • • • • General care and precautions 38 - CR220 User Guide © Cochlear Limited 2012 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. • • • • • • • © Cochlear Limited 2012 CR220 User Guide - 39 The remote assistant housing, including non-metallic buttons/keys, is made of polycarbonate. Materials Custom analogue and digital integrated circuits based on a microprocessor design, with bi-directional wireless communication capabilities. • The remote assistant comprises: Physical configuration Specifications 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. Technical information Technical and legal information Other information Depth 90% RH 0% RH © Cochlear Limited 2012 +50 ºC (+122 ºF) +5 ºC (+41 ºF) 40 - CR220 User Guide +50 ºC (+122 ºF) 90% RH Minimum -40 ºC (-40 ºF) 0% RH Condition Storage temperature Storage relative humidity Operating temperature Operating relative humidity Environmental conditions Wireless transmission range Display Push-key functions Maximum Proprietary Low Power Bidirectional Wireless Link 2.4 GHz 3. 7 V 4.2 V 680 mAh (Internal Lithium-ion battery) Remote assistant on and off and remote assistant settings change Up to 2 m 128 x 128 pixels, colour LCD Wireless technology RF frequency Operating battery voltage Battery charging voltage Battery capacity Range 13.35 mm Characteristic Operating characteristics The remote assistant weighs 65 g. Weight Width 46.1 mm Length 110 mm Dimensions Other information Other information 0197 This device must accept any interference received, including interference that may cause undesired operation. • © Cochlear Limited 2012 CR220 User Guide - 41 Changes or modifications made to this equipment not expressly approved by Cochlear Limited may void the FCC authorization to operate this equipment. This device may not cause harmful interference. • This device complies with part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions: FCC (Federal Communications Commission) and Canadian IC compliance Your 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. Equipment classification Devices as last amended by EC Directive 2007/47/EEC. The CR220 Remote Assistant fulfils the essential requirements listed in Annex 1 of the EC directive 90/385/EEC on Active Implantable Medical Certification and applied standards 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. • • 42 - CR220 User Guide IC ID: 8039A-R200FF © Cochlear Limited 2012 Increase the separation between the equipment and receiver. • FCC ID: WTOR200FF Reorient or relocate the receiving antenna. • 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: Other information CE Registration Mark © Cochlear Limited 2011 Nucleus® cochlear implant systems are covered by one or more international patents. 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. Legal statement 0197 This device restricted to sale by or on the order of a physician. Recycle Type B applied part Date of manufacture Serial number Certification - New Zealand Certification - Australia Disposal – dispose of electrical components in accordance with your local regulations Certification - Japan Disposal - do not dispose in fire Relative humidity limits Storage temperature limits Consult instructions for use The symbols below are found on your remote assistant components and packaging Labelling symbols Printed in Australia 369388 Iss4 APR12 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 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,
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.4 Linearized : No Page Count : 23 Producer : GPL Ghostscript 8.15 Create Date : 2012:04:24 11:49:18 Modify Date : 2012:04:24 11:49:18 Title : 369388 ISS4-01 CR220UG LM.pdf Creator : Adobe Acrobat 10.1.3 Author : WMeskensEXIF Metadata provided by EXIF.tools