Skull simulator Guide

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1 Because sound matters Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the magical world of sound to people at every stage of life. As a member of one of the world s largest groups of hearing health care companies, we share a close link with Oticon and direct access to the latest advancements in hearing research and technologies. Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology. Skull simulator Guide By working collaboratively with patients, physicians and hearing care professionals, we ensure that every solution we create is designed with user needs in mind. We share an unwavering commitment to providing innovative solutions and support that enhance quality of life for people wherever life may take them. Because we know how much sound matters UK / Manufacturer: Oticon Medical AB Datavägen 37B SE Askim Sweden Phone: info@oticonmedical.com Because sound matters

2 Contents Introduction...5 How does a Skull simulator work?...5 Clinical application...7 Verification... 9 Prepare the sound processor for measurement... 9 Place the sound processor on the Skull simulator Conduct measurement Prepare for comparison of curves in Affinity and Genie Medical Comparison of curves If fine-tuning in Genie Medical is needed Technical measurements...19 Introduction to technical measurements...19 Technical measurement using pure tones...21 Comparison of curves...23 Standardised measurements...25 How to get started...27 Installation...27 Licence Activating the new HIT Licence...31 Setup Affinity...31 Set up Skull simulator...33 Placement of the bone anchored sound processor...35 Set up Genie Medical...37 How to create a protocol in Affinity How to export and import a test protocol in the HIT module CONTENTS CONTENTS 4

3 Introduction This document will assist you with the use of the Interacoustics SKS-10 Skull simulator with Ponto bone anchored sound processors. The Skull simulator can be used for both verification of the fitting and technical measurements to assess the sound processors function. The Skull simulator is used within the Interacoustics Affinity test box, and the Abutment (connection) on the Skull simulator is compatible with both Oticon Medical and Cochlear sound processors. Sound Processor Coupling The performance of the connected sound processor will be shown via the graphical user interface of the Affinity software. Please see chapter How to get started for instructions on installing the Skull simulator. How does a Skull simulator work? The SKS-10 is a coupler designed for objective measurement of bone anchored sound processors. Mass Accelerometer The SKS-10 converts the vibrations from the sound processor into an electrical impulse, which can be seen on the screen in the Affinity Suite software. 5 INTRODUCTION INTRODUCTION 6

4 Clinical application The SKS-10 can be applied at several different points during the patient s rehabilitation process. Pre-operative trial: to assist in the confirmation of the sound processor performance between patients Fitting: to help clinicians verify the fitting Post-fitting: to confirm the correct function of the sound processor and assist in the decision-making process regarding possible repair In each scenario the Skull simulator is used to give an objective, un-opinionated, view of the sound processor s performance and the accuracy of the fitting. Pre-operative trial Fitting Post-fitting 7 INTRODUCTION INTRODUCTION 8

5 Verification Figure 1. Verification tool When fitting the Ponto, use the SKS-10 to verify that the measured output of the sound processor matches the target curve in Genie Medical. The starting point for obtaining an accurate, individual prescribed target is to conduct a BC In-situ measurement in Genie Medical. Importing the predefined protocol for Verification to Affinity will assist and ease the verification procedure; please see chapter How to import a protocol to Affinity for further information. Prepare the sound processor for measurement a. Connect and fit the sound processor in Genie Medical Figure 2. Access the HIT module in the top-right corner b. Go to Fitting step Verification Tool see (Fig. 1) If Genie Medical is run through NOAH when you enter the Verification tool, the Affinity software will launch automatically. c. Affinity will open up in the REM module. Click OK in the Fitting prescription settings dialog click HIT on the upper right (Fig. 2) to access the Hearing Instrument Test (HIT) module The automatic settings should match the test signal. For more information, Click to access the Help files. Automatic settings for: Pure tone Speech signal d. Go to Genie Medical screen e. Turn on/off Automatics see (Fig. 3) All boxes for automatic settings in the Verification tool should be un-checked and thereby deactivated when using pure tones. NM: Noise Management AD: Automatic Directionality DFC: Dynamic Feedback Cancellation VCL: Learning Volume Control Figure 3. Settings for Automatics 9 VERIFICATION VERIFICATION 10

6 Place the sound processor on the Skull simulator Place the sound processor on the SKS-10 abutment. See (section Placement of the Skull simulator for additional information). Note: the connection cord to the sound processor can remain connected when the lid is shut Conduct measurement Go to Affinity screen see (Fig. 4) a. Select Ear (L/R) (1) b. Choose the Verification protocol, or your own protocol (2) c. Choose Signal (Pure Tone or your preferred signal) (3) d. Press Start to run your measurements (4) Before running the measurement, check the positioning of the sound processor on the Skull simulator and close the test box lid see (Fig. 5) 4 Figure 4. Affinity screen Figure 5. Placement of Ponto on the Skull simulator 11 VERIFICATION VERIFICATION 12

7 Prepare for comparison of graphs in Affinity and Genie Medical In Affinity screen see (Fig. 6) a. Click on the curve you want to display in the protocol, e.g. Frequency Response 70 (1) b. Go back to Genie Medical screen Verification tool c. Ensure that the Signal type and Input levels correspond to what you have measured in Affinity d. Click floating graph e. Position the Genie Medical screen and Affinity screen beside each other for easy curve comparison Figure 6. Prepare for curve comparison in Affinity 13 VERIFICATION VERIFICATION 14

8 Comparison of curves a. Go to Genie Medical screen Verification tool see (Fig. 1, page 10) b. Select curve Target 70 see (Fig. 7) c. Compare this curve with Frequency Response 70 in Affinity see (Fig 6, page 14) d. Continue comparing Target 50 in Genie Medical with Frequency Response 50 in Affinity screen and Target 90 with Frequency Response 90 e. Evaluate if the measured curve in Affinity has the same curve configuration as the target curve in Genie Medical f. Evaluate if the measured curve in Affinity reaches the same output level as the target curve in Genie Medical, ideally within ±3-5 db Figure 7. Output curves in Verification tool The default settings in Verification tool are: Curve type; Output, Skull Signal type; Pure/Warble Tone Input levels; 50, 70- and 90 db µn Tips box for default settings The following speech-shaped signals are comparable: Genie Medical Affinity ANSI S3.42 Pseudo Random Noise ICRA stationary (ANSI S3.5) ICRA: Urgnmn Tips box for comparable speech-shaped signals 15 VERIFICATION VERIFICATION 16

9 If fine-tuning in Genie Medical is needed: a. Go to Verification tool see (Fig 1., page 10) b. Adjust controls to fine-tune c. Go back to Affinity d. Perform a new measurement see Section Conduct measurement e. The second measured curve (2) will now appear in the same graph as the first measured curve (1) see (Fig. 8) f. All fine-tuning is retained when you close the verification tool, and can then be saved to the sound processor in the end fitting step 2 1 Figure 8. Measured curves in Affinity It is possible to compare your current measurement with a previous one: 1. Click on the list Current session to open a previous session Click to lock the sessions to the screen 2. Perform your measurement or compare to a previous measured curve 3. Click to unlock the session 4. Click to go back to current session Tips box for comparison of curves between current and previous measurements 17 VERIFICATION VERIFICATION 18

10 Technical measurement Introduction to technical measurements Technical measurement helps you evaluate the technical performance of the Ponto sound processor. This can be helpful at listed fittings steps: Before the next potential patients gets it During the fitting, to get a reference curve to compare later on After the fitting, if the patient complains about the Ponto sound processor s performance 19 TECHNICAL MEASUREMENTS TECHNICAL MEASUREMENTS 20

11 Technical Measurement using pure tones 1 When performing technical Measurement, make sure the client does not wear the sound processor during the test. 2 Importing the predefined protocol for Technical Measurement to Affinity will assist and ease the Technical Measurement procedure; please see chapter How to Export and Import a test protocol in the HIT module. Figure 9. Access Technical tool via End Fitting Tools Technical Measurements 1. Connect the sound processor in Genie Medical. 2. Go to End Fitting Tools see 1 (Fig. 9) Technical Measurements See 2 (Fig. 9) 3. Choose the desired standard technical settings. See 1a (Fig. 10) 4. Program the desired standard technical setting to the sound processor. See 1b (Fig. 10) 5. Click on Open HIT Module to launch the Affinity HIT software. See 2 (Fig. 10) Go back to Affinity screen See (Fig. 4, page 12) a. Select Ear (L/R) b. Choose the Technical protocol c. Choose Signal (pure tone or speech signal) d. Control positioning of the sound processor on the Skull simulator See (Fig. 5, page 12) e. Press Start to run your measurements 1a 1b Figure 10. Technical tool 3 21 TECHNICAL MEASUREMENTS TECHNICAL MEASUREMENTS 22

12 Comparison of curves Measured curves can be compared to graphs in Genie Medical. See (Fig. 11) a. For comparison with graphs in Genie Medical, follow the steps in sections Prepare for comparison of curves in Affinity and Genie Medical and Comparison of curves b. Make sure the measured curves are measured with the same signal type and output level as the one with which it is compared If the sound processor is disconnected while in the Technical tool, Technical settings are stored in the local memory of the sound processor. Do not allow the client to listen to sound processors with technical settings. The user settings must be restored to the sound processor If the tool was accidently closed before user settings were programmed into the sound processor, attach the cable and click Connect in Genie Medical. If the sound processor contains technical settings, Genie Medical automatically restores the user settings Figure 11. Output curves in Technical Tool The default settings in Technical tool are: Curve type; Gain, Skull Signal type; Pure/Warble Tone Input levels; 50, 65- and 80 db µn Tips box default setting in Technical Tool 23 TECHNICAL MEASUREMENTS TECHNICAL MEASUREMENTS 24

13 Standardised measurements The standardised measurements Battery Current Drain (1), Harmonic Distortion (2), Equivalent input noise (3) and Processing delay (4) are included in the Technical measurement protocol. 5 a. Go back to Affinity screen b. Click on the measurement you would like to evaluate, i.e. Harmonic Distortion (2) c. The technical information on harmonic distortion will then show on the right side of the screen d. Compare those values to values in the product information Figure 12. Standardised measurement, in this example harmonic distortion 25 TECHNICAL MEASUREMENTS TECHNICAL MEASUREMENTS 26

14 How to get started Installation To prepare the Affinity for use with the SKS-10, you will require the following items: The Affinity 2.0 hardware The Interacoustics SKS10 Skull simulator and its power supply The HIT440 software licence The SKS10 Skull simulator licence This section of the guide will take you through how to correctly licence and begin using the Skull simulator within the Affinity Suite. 27 HOW TO GET STARTED HOW TO GET STARTED 28

15 Licence If you have purchased an Affinity that has already got the functionality for the Skull simulator pre-configured then you can skip this step. If you have owned your Affinity for a while and wish to add the Skull simulator functionality then please follow these instructions. a. After purchasing a Skull simulator and a Skull simulator licence, please send Interacoustics (service@interacoustics.com) the serial number To copy the serial number, go to Menu/Help/About, click on Licence and select Copy s/n ; this will copy the serial number to the Clipboard See (Fig. 13) b. Paste the serial number in the body of an and mail it to Interacoustics c. Interacoustics will then a new HIT licence Figure 13. Copy licence 29 HOW TO GET STARTED HOW TO GET STARTED 30

16 Activating the new HIT licence a. Go to HIT module/menu/help/about b. Click on Licence c. Paste the new licence number under HIT/New licence see (Fig. 14) Setup Affinity When starting your Affinity for the first time, you will need to enable the Skull simulator; please follow the instructions below to enable this. a. Go to HIT/Menu/Setup/HIT440 setup see (Fig. 14) b. Choose Skull simulator or your preferred protocol under Selected Protocols c. Under General Settings, ensure that Skull simulator is chosen under Coupler see (Fig. 15) Figure 14. Paste licence Figure 15. General settings 31 HOW TO GET STARTED HOW TO GET STARTED 32

17 Set up Skull simulator The SKS-10 requires an external power supply for it to operate correctly. Ensure that this is connected to the sound processor ahead of performing any measurements. Once connected, the SKS-10 should be positioned in the test box see (Fig. 15). This ensures that the abutment is at the reference point marked by a cross in the floor of the Affinity test box. In this position, it is easier to align the Affinity reference microphone closer to your Sound Processor s microphones once it has been connected to the Skull simulator. All of this information is given in the software on loading the Skull simulator protocol. It can be seen in the form of a pop-up see (Fig. 15). Figure 15. Set up Skull simulator This pop-up can be deactivated by inserting a checkmark in the Do not show this setup guide again box. To re-initiate the Skull Coupler Setup Guide startup window, go to Menu/ Setup/General Setup and insert a checkmark in the Show setup guide box. 33 HOW TO GET STARTED HOW TO GET STARTED 34

18 Placement of bone anchored sound processor It may be required that you leave the test box lid open approximately 1 centimetre when performing certain measurements. The protocol should alert you of when to open this. Leaving the box ajar improves the quality of the measurement. Skull simulator placement and reference point (marked by the cross) Bone anchored hearing sound processor connected to the Skull simulator at reference point 35 HOW TO GET STARTED HOW TO GET STARTED 36

19 Setup Genie Medical In Genie Medical, use the Verification tool and the Technical tool when you perform your measurements. The Verification tool can be launched from the fitting step see (Fig. 18) and the Technical tool can be launched from the end fitting step see (Fig. 19). Hence, while using the Verification tool, one cannot go directly to the Technical tool. Use the verification tool when performing verification measurements and the technical tool when performing technical measurements. Figure 18. Access the Verification tool from the Fitting step Figure 19. Access the Technical measurement tool from the end fitting step 37 HOW TO GET STARTED HOW TO GET STARTED 38

20 How to create a protocol in Affinity Please see the Quick Guide HIT440 Protocol Setup found on the Interacoustics homepage. Please scan the QR Code to acces the Quick Guide on the Interacoustics homepage Quick guide on how to create or edit protocols in the Affinity software 39 HOW TO CREATE A PROTOCOL IN AFFINITY HOW TO CREATE A PROTOCOL IN AFFINITY 40

21 How to export and import a test protocol in the HIT module Export a protocol 1. Launch your Interacoustics Software suite as usual 2. Go into the HIT module 3. Go into Menu > Setup > HIT440 Setup 4. The screen will then be shown (Fig. 20) 5. Use the Selected Protocol drop-down menu to select the protocol you wish to export. Note: a pop-up will appear on doing this, asking if you want to save as read only. If yes is selected then the protocol cannot to be edited or modified when imported into the software 6. Next, click on the Export button and specify the location where you wish to save it. This file can then be copied to a USB thumb drive or ed to allow sharing between systems. Figure HOW TO EXPORT AND IMPORT A TEST PROTOCOL IN THE HIT MODULE HOW TO EXPORT AND IMPORT A TEST PROTOCOL IN THE HIT MODULE 42

22 How to export and import a test protocol in the HIT module Import a protocol Repeat steps until you are back to the screen (Fig. 21) 1. Click on the Import button 2. Select the protocol you have previously exported 3. This will then add itself to your list of protocols within your system 4. Note: if importing a protocol with the same name as another protocol already in the software, then the newest version imported will have a plus sign (+) at the end of the protocol name. Figure HOW TO EXPORT AND IMPORT A TEST PROTOCOL IN THE HIT MODULE HOW TO EXPORT AND IMPORT A TEST PROTOCOL IN THE HIT MODULE 44

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