The instructions for use is valid for Genie 2 | 2019.2 and Genie | 2017.1. Genie 2 is a fitting software used for the Oticon Opn™, Oticon Opn S™,. Oticon Xceed ...
Instructions for use Genie 2 and Genie 1 Table of contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Use environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Getting ready . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 System requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Optional tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Stand-alone Genie 2 or Genie and database . . . . . . . . . . . . . . . . . . 5 Genie 2 overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Tinnitus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Oticon RemoteCare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Genie overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Definition of product symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 2 Introduction The instructions for use is valid for Genie 2 | 2019.2 and Genie | 2017.1. Genie 2 is a fitting software used for the Oticon OpnTM, Oticon Opn STM, Oticon Xceed, Oticon Opn PlayTM, Oticon Xceed Play and Oticon Siya hearing instrument families and models. Genie is a fitting software used for all other Oticon hearing instrument families and models. A printed version of the IFU can be obtained through your local distributor. | Intended use The fitting software is intended for fitting and updating of hearing solutions. The fitting software can facilitate access to real-ear measurement equipment. Intended use of Tinnitus SoundSupport Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief for patients suffering from tinnitus as part of a tinnitus management program. Tinnitus SoundSupport is not intended for clients below 18 years of age. Tinnitus SoundSupport is targeted to licensed hearing care professionals (audiologists, hearing instrument specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing loss. Fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program. | Use environment Used by hearing care professionals in a clinical setting. 3 Getting ready | Installation Installation of the software will install Genie 2 and/or Genie. If you already have a previous version of Genie 2 and/or Genie installed, it will automatically be updated and client sessions will be visible in both Genie 2 and Genie. The installation program will start automatically when you insert the Genie 2 DVD/USB in the drive/port. Otherwise open Windows Explorer, browse to the drive and double-click "Setup.exe". Follow the instructions on the screen. | System requirements The system requirements to install and use Genie 2 & Genie are listed below: Hardware requirements · CPU: Intel Core i5, 4 cores, 2 GHz or faster · 4 GB RAM or higher · 8 GB free space on the hard disk · Screen resolution: minimum 1280 x 1024 pixels · DVD drive for DVD installation · USB 2.0 port for USB installation and programming devices · Keyboard and mouse · Stereo or 5.1 surround sound card (recommended) Operating System requirements · Windows 7 SP1 (32/64 bit) · Windows 8 (all editions except RT) · Windows 10 (32/64 bit) | Optional tools · Noah 4 (if not running Genie 2 or Genie stand-alone)*. It is recommended to use the latest version of Noah to get the most out of Genie 2. · A browser for access to Oticon web pages · A PDF reader to read PDF documents · We recommend that you protect your system by installing anti-virus protection software | Stand-alone Genie 2 or Genie and Database When Genie 2 or Genie is running without Noah, i.e. in stand-alone mode, a Client module is automatically installed. An additional Client organiser step will appear. In the Client module, you can enter demographic data, such as client name, date of birth, address and the audiogram. Client data is automatically saved in the Genie 2 or Genie database and used for the subsequent fittings. To start Genie 2 or Genie in stand-alone mode, click the Windows Start button, Programs, Oticon folder, and then Genie 2 or Genie. *Do not install Genie 2 or Genie on a Noah 2 or 3 system. Your Oticon fitting data in the Noah 2 or 3 database will then no longer be accessible. 4 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings 5 Genie 2 overview This is an overview of the functionality, main features, and tools in Genie 2. You can use it to learn about the typical steps and tools used for fitting in Genie 2. | Genie 2 organiser steps horizontal navigation | The task pane vertical navigation In each organiser step there is a task pane on the left side of the screen. The task pane gives you access to tools and links which are related to where you are in the fitting process. 1 23 45 6 1.Client: Appears only when running Genie 2 outside NOAH 2.Counselling: Appears only if Oticon Counselling Tools have been installed. 3.Family: Choose Simulate or Connect. 4.Selection: Selection of hearing instrument style and features. 5.Fitting: Fine-tuning and verification of gain and settings. 6.End Fitting: Verify and set individual client operational settings for buttons, indicators and accessories. Save and Exit. 6 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings 7 Genie 2 overview | Family step Once you have chosen your client in Noah or under Client in the Genie 2 stand-alone software, you will enter the Family step. From there choose one of the following options. 2 1 1.Connect hearing instruments: Restart the hearing instruments for detection with FittingLINK 3.0 or Noahlink Wireless and click the Connect button, or attach hearing instruments with cables and click the Connect button. In follow-up sessions you can choose to proceed with instrument settings, do a new fitting, or transfer settings when connecting different hearing instruments. 2.Simulate connection: Click the Simulate button to simulate connection of hearing instruments. | Transfer Settings in Genie 2 This tool lets you transfer settings from a fitting session to a new selection of hearing instruments. The tool automatically starts when new hearing instruments, that differ from the present session, are connected or selected or it is opened from the Tools menu. Before transfering the settings, Genie 2 will inform you about which settings can or can not be transferred. 8 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings | Selection step In this step, you specify your choices further by selecting the options shown below. 1 2 a b c 3 5 4 1.Status field: View of selected style, power level, indicators, and acoustics as well as connection status. 2.Tools in Task Pane (optional) e.g. a.Personalisation: Customise the fitting for your client's specific listening needs. Oticon recommends to use it in the first fitting session or when experience level changes. b.Acoustics: Select acoustic coupling to the ear, e.g. ear piece, tubing, and vent. c.Audiometric Data: Verify and update audiometric parameters to ensure correct gain prescription. In particular, this is relevant when fitting hearing instruments for infants and children. 3.Selection of hearing instrument family, if in simulation mode. 4.Selection of hearinginstrument style, if in simulation mode. 5.Selection of power level of receiver. 9 Genie 2 overview | Fitting step In this step, you can fine-tune the gain using a broad range of fitting tools including classic gain trimmers, meta-trimmers, REM tool and Feedback Analyser. If gain adjustments are required, consider using the Adaptation Manager before fine-tuning individual frequency bands. 1 2 11 10 9 7 a b c 6 8 3 4 5 h d e f g 1.Connection Bar: Connection status of the hearing instruments · Grey: Not connected. · Green: Connected and settings are programmed and saved in the hearing instruments. 2.Select active program and link programs to P1 (program 1). 3.Set the Adaptation Manager. A three step transition to prescribed gain. 4. The arrow expands the number of fitting bands. 5. The arrow gives access to MPO controls. 6.Sound Controls meta-trimmers: · Brightness Perception trimmer: Changes brightness of sound (for the VAC+ prescriptive rationale only). · Soft Sound Perception trimmer: Changes audibility of soft sound (for VAC+ prescriptive rationale only). · Bass Sound Perception trimmer: Changes the fullness of sound (for VAC+, DSE SP and DSE lin). 10 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings 7. Graphs and graph views: · Curve type · Signal type · Input levels · Target view · Predicted feedback margin · Compression ratios 8.Oticon SoundStudio: Demonstration of various sound environments to to simulate real-life sounds and situations in your clinic. 9.Paediatric Panel: Only available in paediatric fitting mode, which is enabled for children younger than 18 years. 10.Tools in Task Pane (optional) e.g.: a. OpenSound NavigatorTM: Adjust how Oticon hearing instruments process sound in simple to complex listening environments (see separate section). OR Support in Noise: Adjust noise reduction and directionality in Oticon hearing instruments. b.Program Manager: Add and name programs, activate Auto Phone program and select prescriptive rationale. c.Feedback Analyser: Analyse the feedback risk (see separate section). d. Tinnitus: Enable and adjust Tinnitus SoundSupportTM (see separate section). e.Speech RescueTM LX: Enable and adjusts frequency lowering. f.In-situ Audiometry: Measure the client's hearing by using the hearing instruments as transducers (see separate section). g.REM: Run REM AutoFit or set the hearing instruments to measurement mode for use with your real-ear measurement equipment. h. Bimodal: Only available in monaural fittings. Provides specific fine-tuning controls that help you adjust the instrument setting for clients with a cochlear implant on one side and a instrument on the other. 11.CROS: The tool lets you adjust the CROS level when fitting a hearing instrument with a CROS transmitter. Only available when CROS transmitter is selected. 11 Genie 2 overview | OpenSound NavigatorTM tool The tool is specifically used to adjust how the client's hearing instruments process sound in simple and complex environments. OpenSound Navigator prescription is also adjusted based on the answers provided by your client in the Personalisation tool. 1 2 a d b c 1.OpenSound Navigator response: Graphical view of changes made in YouMaticTM LX tool below, pertaining to directionality and noise reduction settings in simple to complex environments 2.YouMatic LX: a.Noise Reduction Simple: Noise reduction settings for simple listening environments. b.Open Sound - Transition: Adjust the amount of help (Low, Medium, High or Very High) your client needs in order to focus on speech in noisy environments. The Transition Bar right above it reflects your choices graphically by showing you at what point help will kick in for your client. Alternatively, you can choose a non-adaptive directionality, Pinna Omni, or the Full Directionality option in the Directionality settings in the lower right corner. c.Noise Reduction Complex: Adjust noise reduction settings for complex environments. d.Noise Reduction: Deactivate noise reduction. 12 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings 13 Genie 2 overview | Feedback analyser tool Feedback analysis is recommended for new fittings and whenever fitting parameters change. 1 2 3 1.Start: Run a feedback analysis with the selected hearing instrument and acoustic coupling to the ear. 2.Clear: Delete the analysed feedback margin. 3.Background Noise Level: Indicates noise level in room and allows you to monitor when the environment is too loud for valid feedback analysis. 14 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings | Tinnitus 9 3 6 4 7 1 2 5 8 1.Tinnitus SoundSupport on/off: Activate or deactivate Tinnitus SoundSupport. 2.Binaural linking: Default is off. 3.Tinnitus relief sound selection: Four Broadband Sounds and three Nature Sounds. Default is "Shaped" (to audiogram). 4.Signal Level: Adjust one or both ears. Initial level is based on the client's audiogram. 5.Modulation: Broadband sounds can be personalised by adding one of four modulation types: Tranquil, Mild, Spirited, and Bustling. 6.Trimmer table: Broadband Sounds can be shaped in 16 frequency bands. 7.Automatic Level Steering: On/off option. Automatically lowers tinnitus relief sounds when environmental sounds become louder. 8.Microphone Hearing Instrument: On/off option to turn hearing instrument microphone off. 9.Max wearing: A Max wearing time table will appear if tinnitus relief sound levels exceed a level that could lead to permanent hearing damage and exposure should therefore be limited. 15 Genie 2 overview | In-situ Audiometry tool In-situ Audiometry allows you to find the client's hearing thresholds using the hearing instruments as transducers. This means the fitting can be fine-tuned to be specific for the ear, the instrument and the acoustic coupling. 1 1. Tone type. 2. Talk over. 3. Play tone. 4. Audiogram use. 2 3 4 16 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings | End Fitting step The End Fitting step is the final step in the fitting process. Here you can verify correct programs, rationales and settings. The following end-of-fitting functions are also available. 2 1 a b c 3 1.Overview of final hearing instrument settings and functionality 2. Use End Fitting Task Pane to: a.Define Buttons and Indicators: Button operation, volume control, beep setting and LED patterns. b.Manage Accessories: Volume level and balance of paired: smartphone, ConnectClip and TV adapter. Also manage autophone and DAI/FM programs. c.Generate report: Print, save or email a selection of reports according to your needs and your client's needs. d.Rechargeable Batteries: Only available when connected to miniRITE R. Shows current battery level, battery health and instruction on how to replace the battery. 3.Save And Exit/Save And Go To Client Step: Saves and programs final settings and adjustments into your client's hearing instruments. Settings and adjustments have also been saved continuously throughout the fitting so it is always safe to disconnect the hearing instruments without losing important data. 17 Genie 2 overview | Oticon RemoteCare Oticon RemoteCare enables you to communicate with your client and to make real-time adjustments to your client's hearing instruments remotely. If you cannot upload your changes remotely, a physical visit is necessary. See Genie 2 help file for fitting tools that are not available with Oticon RemoteCare. Additional system requirements · PC camera OR external camera. · Microphone and speakers OR headset. · RemoteCare account. To sign up, contact your local Oticon representative. · A stable internet connection: recommended minimum speed 1/1 Mbit/s (check with your provider) Client system requirements Oticon Opn (FW 6.0 or later), Oticon Opn S, Oticon Xceed, Oticon Opn Play, Oticon Xceed Play and Oticon Siya hearing instruments paired to your client's phone · An iPhone, iPad or Android phone. See compatible models and software here: www.oticon.global/hearing-aid-users/support/ faq/compatibility · A stable internet connection: recommended minimum speed 1/1 Mbit/s (check with your provider). · An e-mail account. IMPORTANT NOTICE The hearing care professional is responsible to obtain the license needed to use Oticon RemoteCare with the clients. Oticon does not take any responsibility. | Enable Oticon RemoteCare Create account Open the Oticon RemoteCare invitation email sent by your local representative and follow the instructions. 18 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings | Oticon RemoteCare fitting 2 1 1.Toggle to turn on RemoteCare. 2.Sign in. 3.Enter client account details 3 and press 'Continue'. 4 4.Click 'Start an appointment' to establish communication with client. Note: It is only possible to start an appointment when the client is already present/has started an appointment. 19 Genie 2 overview 5 a c b 5.Click 'Connect' to detect and connect to the client's hearing instrument(s). The status indicators turn green when the hearing instruments are connected. The connection status of the hearing instruments is indicated three places: a) Connection Bar. b) R emoteCare connection overview. c) Hearing instrument status indicators in RemoteCare communicator. A 8 9 b c d a 6 7 RemoteCare communicator (A) a) Enables text messaging and communication via audio and video between you and your client. b) H earing instrument status indicators. c) Enable/disable your camera. d) M ute/unmute your microphone. 6.Fit hearing instrumentss as you would do normally, if needed. 7.Click 'Upload' to upload the new settings to the hearing instrument(s). 8. Click 'Disconnect'. The hearing instrument(s) will be disconnected from Genie 2 and will restart. Note: You can also disconnect the hearing instruments from the End Fitting screen. 9.Go to the End Fitting step and click 'Save and exit'/'Save and go to client step' to save and end the session with the client. 20 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings 21 Genie overview This is an overview of the functionality and main features and tools in Genie. You can use it to learn about the typical steps and tools used for fitting in Genie. | Family step 2 1 1. Attach hearing aid and click Detect OR 2. To simulate, select a family button. | The Organiser steps horizontal navigation 1 2 3 4 5 6 1. Client: Appears only when running Genie outside Noah. 2. Counselling: Appears only if eCaps has been installed. 3. Family: Selection of all hearing instrument families. 4. Selection: Select instrument styles and features. 5. Fitting: Verifying and fine tuning of settings. 6.End Fitting: Verify and set client operations buttons. Save, Program and Exit. 22 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings 23 Genie overview | The Task Pane Vertical navigation In each Organiser step there is a Task Pane that gives access to tools and links related to where you are in the fitting process. | Selection step 1 2 a b c 1. View style and prescribed vent in the status field. 2. Optional tools in the Task Pane: a. Personal Profile. b. Program Manager. c. Acoustics. 24 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings 25 Genie overview | Fitting step Verify the prescribed setting, for example by using the various built-in sound environments. If adjustments are required, consider using the Adaptation Manager before adjusting individual controls. 6 1 7 8 3 2 4 5 1. The Connection Bar indicates whether the instrument is · Not connected (grey) · Connected (yellow) · Connected and settings are programmed and stored in the instruments (green) 2.Sets the Adaptation Manager. A three step transition to Prescribed gain. 3. Sets the detail and comfort level of soft sounds. 4. The arrow expands the number of controls. 5. The arrow gives access to MPO controls. 6.To program instruments during the fitting, press Program Instrument button. 7. Select Active Program and link programs to P1. 8. Tools in Task Pane (optional) e.g. · Automatics Manager (Automatics & YouMatic) · Program Manager (see below) · Feedback Manager · Speech RescueTM (frequency lowering available in Oticon Dynamo and Oticon Sensei SP hearing aids) · Tinnitus (See Tinnitus Fitting Guide) · Live Demonstration · Memory (and Life Learning) · Fitting Assistant (see below) 26 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings 27 Genie overview | Program Manager Use this tool to add or change the content of programs. 5 6 4 1 2 3 1. Add a new program. 2. Select content of program. 3. Activate Auto Phone. 4. Change the order of the programs. 5. Select the program (P1, P2...) you want to change. 6. Select Controls in the Task Pane to return to Fitting view. | Fitting Assistant A fine-tuning tool to handle the most common client complaints. 5 1 3 2 4 1. Select a tab: General Perception, Speech Perception or Own Voice 2. Select a control and direction for the desired result (left or right the initial setting is in the middle). 3.Hold the cursor over the desired step and a tool tip will pop-up with a suggestion. 4. Use the sound environment buttons to verify the adjustment. 5. Select Controls in the Task Pane to return to Fitting view. 28 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings 29 Genie overview | End Fitting step c 2 a b 3 1 1. Link Streamer to instruments: · Fitting Link: Click 'Read' serial' no. or enter Streamer serial number · NOAHlink: Click 'Read' serial no. or enter Streamer serial number · HI-PRO: Enter Streamer serial number 2. Use End Fitting Task Pane to; a. Define button operation and activate VC function b. Define Phone programs and activate Auto Phone options c. Open and print customised User Instructions 3. Click Save, Program and Exit. 30 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings Warnings You should familiarise yourself with the following general warnings and the entire contents of this booklet before using the fitting software to avoid possible client injury or hearing instrument failure. | General safety precautions For safety reasons, always read the Intended Use of the fitting software, the risks related to the fitting level of the Tinnitus SoundSupport feature and the recommended wearing times. | Connection Take care not to lose the wired or wireless connection to the hearing aid or let communication errors interrupt the fitting flow. | Choking hazards For safety reasons, caution must be taken when fitting children younger than 36 months. Children younger than 36 months must always use a tamper-resistant battery drawer. For safety reasons, always use ear moulds when fitting children younger than 36 months. | Firmware For safety reasons, always ensure that the client is not wearing the hearing aid during a firmware update, as the updated hearing aid will be reset to factory settings after the update. Moreover, do not give the hearing aid to the client before restoring user settings. Ensure that the serial number of the connected hearing aid corresponds to the serial number registered in the office automation system for the relevant client. Always note the firmware version of the hearing aid before and after a firmware update. Ensure that the firmware version of the programming device is compatible with the firmware version of the fitting software. Avoid interruptions or connection failure to the hearing aid or connectivity device during a firmware update. | REM System Pay attention to any error messages from the REM system caused by incorrect or unintended data sent to the REM system. | Tinnitus For safety reasons, always caution the client about limiting the use of the Tinnitus SoundSupport feature to ensure safe listening levels. Be aware of the high sound-pressure level generated by the Tinnitus SoundSupport feature. Note the recommended limits to the wearing time of the Tinnitus SoundSupport feature as shown in the fitting software. In the print report and the Instruction for Use for the hearing aid, always enter the maximum wearing time per day. Tinnitus SoundSupport is not intended for clients below 18 years of age. 32 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings 33 Warnings | Power instruments For safety reason, caution should be taken when selecting, fitting and using a hearing aid where the maximum sound pressure capability exceeds 132 dB SPL (IEC 711) as there may be a risk of damaging residual hearing of the hearing aid client. | Transfer Settings Your client must not wear the instruments while transferring settings. | In-situ Audiometry In-situ Audiometry should not be used for diagnostic purposes. Make sure that you add an audiogram in Noah or the Client step before you conduct In-situ Audiometry in Genie or Genie 2. Remove any REM AutoFit results before you conduct In-situ Audiometry. Make sure you carry out In-situ Audiometry in a quiet area. | Tone Burst ABR in Genie 2017.1 In Genie 2017.1, please enter ABR values as eHL. This ensures the correct prescription gain is applied for the audiogram. Only applies for Genie 2017.1. | Disclaimer The manufacturer does not take responsibility for the consequences of using this fitting software outside intended use or warnings. 34 Introduction | Getting ready | Genie 2 overview | Genie overview | Warnings Definition of product symbols The following are descriptions of symbols that may appear in the instruction for use and/or on the regulatory packaging label: Symbol 0543 USB Description Warnings Text marked with a warning symbol must be read before using the product. Manufacturer The device is produced by the manufacturer whose name and address are stated next to the symbol. Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. CE mark The device complies with Medical Device Directive 93/42/EEC. The four digits number indicates the identification of the notified body. Electronic waste (WEEE) Recycle hearing aids, accessories or batteries according to local regulations. Hearing aid users can also return electronic waste to their hearing care professional for disposal. Electronic equipment covered by Directive 2012/19/ EU on waste and electrical equipment (WEEE). Consult electronic instructions for use Indicates the need for the user to consult an electronic instructions for use. Consult instructions for use Indicates the need for the user to consult an instructions for use. Manufactured by: Oticon A/S Kongebakken 9 2765 Smørum Denmark +45 3917 7100 Australian Sponsor Oticon Australia a division of Audmet Australia Suite 4, Level 4, Building B 11 Talavera Road North Ryde NSW 211 0543 35 www.oticon.global 209337AU / 2019.04.10Adobe PDF Library 15.0 Adobe InDesign CC 14.0 (Windows)