Contents Introduction Operator Training Requirements Getting Started Remote Testing Getting Started with the KUDUwave™ Software Working with Folders Working with Patients Working with Clinical Tests KUDUwave™ Tympanometer KUDUwave™ Integrations Settings X-check (Cross Check) Assistance from the Manufacturer Cleaning and Maintenance...
An operator may not act as a professional unless qualified to do so. Medical Purpose The medical purpose of the KUDUwave is to assist in testing the behavioral auditory responses of a patient and to determine hearing thresholds which will assist in diagnosis of hearing impairments.
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12. Where the audiometer needs to travel regularly from one test site to the next. Contra-Indications The KUDUwave cannot be used to do behavioural testing in subjects that cannot clearly indicate when they heard the sounds presented, for example younger children (less than 12 months of age) and mentally compromised test subjects.
Mark the package as FRAGILE when it is in transit. Frequent Usage The KUDUwave is suitable for continuous, regular use. Analysis of all its functions confirms that there is no risk to either the operator or patient. These functions are detailed within this document and include measures to minimise any potential risk.
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Additional technical support is also available via our ticket based system, online chat, email and telephone with the KUDUwave support team. Additional group or one-one training may be provided at a cost, to be determined at such time as it is necessary.
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Description of Symbols The following important symbols are used on the KUDUwave and its components.: Symbol Description Manufacturer, eMoyoDotNetza (Pty) Ltd, 179 Beyers Naude Drive, Johannesburg, South Africa EC Authorised Representative, PSF Medical BV, Marten Messweg 8, 3068AV Rotterdam, The Netherlands Symbol for CE Mark with Notified Body Number.
● Patient Management and Medical Record Suite - eMoyo EMR ● Telemedicine Enabled Your KUDUwave can be one of the following configurations, which determines what tests it can perform and extra features it may have. KUDUwave™ OH KUDUwave™ Prime KUDUwave™ Pro KUDUwave™...
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Three meter long twisted KUDUwave dual USB cable ● USB patient response button ● Radio Ear Bone vibrator with metal headband attached to the KUDUwave black headband with a screw (Pro and Pro TMP configurations only) ● Calibration certificate ●...
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3 ports available for the KUDUwave connections (Left cup, Right cup and Response Button) ● A USB Hub cannot be used with the KUDUwave Pro TMP. Consult support if you require one. Software Installation If your KUDUwave controller PC was professionally configured by eMoyo, all the necessary software will already be installed.
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The KUDUwave will indicate the right side with a red light (Note this is not a warning light) and the left side with a blue light when powered. You will now be able to begin testing. If the device is not plugged in, it will not be possible to proceed to testing until the device is properly connected.
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Disconnecting the KUDUwave™ If it is required that the KUDUwave be disconnected, ensure all test data is saved and close the software. The USB cables can then be unplugged. For safe storage and to extend the lifespan, please wind the USB cables in large loops when returning to the case for storage.
KUDUwaves. Swapping of bone vibrators between devices may result in inaccurate testing. If you are unsure about which bone vibrator should be used with your KUDUwave please check its calibration certificate or alternatively contact eMoyo support.
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To test remotely: ● The trained operator positions the KUDUwave on the patient or the patient is instructed to position the KUDUwave on themselves. ● The trained facilitator can login to the patient’s PC to control the test through a remote connection (like TeamViewer), or the test can be conducted on the patient’s PC and the...
Getting Started with the KUDUwave™ Software Practitioner Details Run the eMoyoEMR application by double clicking on the icon on your desktop, and enter your details (not mandatory). These details will appear on all reports and audiograms. You can also select your language of choice.
Give us your feedback Help us improve the KUDUwave by giving us your feedback. In the software is a link to a short 5 min survey, where you can let us know how you are experiencing your mobile audiometer and its accompanying software.
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Selecting a folder or subfolder will display its contents in the right hand pane. Smart Folders The KUDUwave uses multiple criteria (OSHA, SANS, WHO etc.) to develop testing protocols and assistive interpretations of results. The KUDUwave also uses these criteria to separate which test protocols are most needed and used by a particular industry.
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(i.e. PLH test significances are required for the software to do test comparisons and identify between baseline, screening and exit tests) Under “Users and security”, you can set up folder security restricting access to particular folders. Contact eMoyo by completing the online form. eMKW-TD0054-21- Page 17...
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Click the save icon to save changes. The folder type will be displayed at the top right hand corner of your screen. Listed below are the different types of smart folders and how you can use them. Hearing Conservation Screening Program for South Africa (PLH and Milestone/STS) Using this smart folder type simplifies the method of testing to identify early hearing loss and to calculate measures for compensation.
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Complete two baseline tests, or even a third if you suspect the patient is malingering. ● Manually enter the baseline results of the patient if they were tested before, but are new in the KUDUwave database. ● Adjust the dB level to limit the test. By default this is set to 10dB Follow Up Tests ●...
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This folder specifically caters for the MDR-TB program set-up in South Africa, but can be applied to other projects across the world. Which tests can I perform in this folder type? ● Extended high frequencies with the KUDUwave Pro™. ● Incorporates questionnaires for the patient, including records of which medication the patient is currently receiving.
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● If the patient has already completed their baseline test (for example he was first tested a year ago), manually enter these results into the KUDUwave database by clicking: Enter baseline / initial test. NOTE: You cannot perform a Monitoring or Exit test until the patient’s full history is manually entered into the system.
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8kHz. ● Manually enter the baseline results of the patient if they were tested before, but are new in the KUDUwave database. Follow Up Tests ● If the patient already has a baseline result in the database, and you want to collect a follow up result, select the type of test from the bottom section, either including or excluding 8kHz.
Working with Patients Add and manage your patient data within the Patient Interface. The patient interface will appear when a new patient is created or by double clicking on the patient file in the data view pane of the home page. Adding a New Patient To create a new patient, first select or create the folder under which the patient should be stored, then click...
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Notes tab. Notes regarding tests are discussed later. Notes and Tests KUDUwave™ software bundles notes and tests within a single function. To add a new note or test click to get access to the following options: eMKW-TD0054-21- Page 24...
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All audiometry listed items are discussed in the “Working with clinical tests” section. Request the Orca or Keystone User Manual to find out more about this added feature of the eMoyoEMR software. File upload To upload additional digital documents to your patients records such as; clinical notes or old audiograms, select “File upload”...
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GUIDs that are linked to the respective tests or patients. eMoyo does not take responsibility for the transmission of data off the PC, if the end user requires any backup solutions (cloud or hardware) it is done at their own risk. If third party integrations are utilised then it is the responsibility of the third party application to handle the data.
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In the folder view, click “Export”, select a date range and then click “Export all KUDUwave Pure Tone results in this folder for this date range” to only include patients in this folder. Click “Export all KUDUwave Pure Tone results for all folders for this date range”.
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You can import a patient file which was exported from the KUDUwave software in a “.moyo” format. Click on “Import a patient and clinical data from an eMoyo EMR software file that was exported on a patient”. Find and select the “.moyo” file, then click “Open” to import it.
Working with Clinical Tests Create a New Test Ensure that your KUDUwave™ is plugged in before attempting to initiate a test. To add a new test click on to get access to the following options: To do pure tone audiometry select : “Audiometry: KUDUwave...
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Select a patient in this default folder and click on Select “Audiometry: KUDUwave Pure-tone test” and you will then see the test protocol menu as on the previous page. Note: You can copy the preset settings of the default macros in this menu to your new test macro. This is an easier way to make minor adjustments to the already existing test protocols.
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The second option relates to the type of audiometer required for the testing. This only limits the area which will be tested. For example the Diagnostic audiometer settings has a higher dB range than the screening audiometer. This must be noted carefully, as not all audiometer simulations allow you to test all frequencies.
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Workflow and pages to view settings, seen below, includes a variety of options which can be viewed by the operator or patient before the test begins. Check the box for any option which is required. To view details regarding your KUDUwave audiometer, check the box below: eMKW-TD0054-21- Page 32...
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Click , to move on to the “Setup for automatic testing page”, or if you have chosen the manual method of threshold seeking, you will move onto the “Masking and Occlusion Effect Rules” page. Select frequencies to be tested for each ear for air conduction and edit further settings to design your custom macro.
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Under “more settings” you can edit whether tones must be blocked if noise levels are detected to be too loud, minimum and maximum test thresholds and what dB level you want each frequency to begin testing from. eMKW-TD0054-21- Page 34...
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Lastly, you can edit the time frame before tones are presented, either increasing or decreasing delays and the randomized delays. Click , to move on to the “Masking and Occlusion effect rules” page. Deselect these check boxes if you want to mask manually during the test. Click , to move on to the “Conditioning page”.
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Conditioning Your Patient Below is the conditioning page. First select the correct eartip which is currently being used (foam or rubber). If silicone (rubber) eartips are being used, you will need to do a Seal Check before presenting a tone. Present a tone to the patient on this page at either, 40, 60, 80 or 100 dBHL at 1kHz, and assess if they respond by pressing the response button well within the waiting time.
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Conditioning can be done manually, using the talk forward feature to explain the test procedure to the patient. Alternatively revert to an automatic conditioning method, where a pre-recorded message will be read to the patient explaining the test procedure. To switch between these modes click on the button at the top of the screen that says: Auto Conditioning or Manual Conditioning.
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Automatic Test The automated test will start running immediately after conditioning is completed. Wait for the test to complete and select “Save”. Manual Test After conditioning the patient, click . Now manual testing can be performed. Alternatively, create a custom test macro, and choose the manual option for tone threshold seeking. On the right hand side of the test screen, you will see the Test Controls Panel.
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Blue icons mask the left ear, while the pure tone is presented to the right ear. The KUDUwave will automatically mask the ears when performing bone conduction tests, unless this is removed for manual tests macros.
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Marking the Threshold The KUDUwave uses markers stipulated in ISO standards and which are relevant for air conduction using insert earphones and forehead placement for bone conduction. The blue crosses/red circles on the side bar are to mark the minimum plateau threshold...
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To utilize the Stenger test, click on the Stenger button. For more information on how to use this test please read our blog found here: https://emoyo.net/post-kudu/stenger-test-and-patient-response- monitoring-with-kuduwave/ Notes and Interpretations Under this side panel, any notes regarding the audiometry test or patient notes can be made and saved to the audiogram report.
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Speech Reception Threshold (SRT) Testing To conduct a SRT test, select the “Audiometry: KUDUwave General Speech Word Lists Test” option from the New Test Menu. Then select the list of words read in the specified language you wish to use. More languages are available from the emoyo website.
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The assessment of speech in noise provides important diagnostic information which the pure tone audiogram cannot reliably predict. The KUDUwave provides speech in noise testing through its integration with QuickSIN. Once purchased online, access QuickSIN by adding a patient or select an already existing patient.
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Select QuickSIN from the next test menu. To begin, select the ear you wish to start with and set the appropriate intensity level. Then click Next. Click on List 1 to view the first list of sentences which will be tested. How Speech in Noise works A list of 6 sentences with 5 keywords per sentence, is presented within a babble noise.
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The KUDUwave has two different scoring pads which you can choose from. The scoring section above allows you to click on the number (score from 0 to 5) and the KUDUwave will immediately begin playing the next sentence.
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The testing page will open and each word will be presented at the selected dB level. Mark each word correct or incorrect with the thumbs up and down buttons. To capture the words incorrectly iterated, select “Capture”. Once a word is marked as incorrect, you can capture the word and save it to the report.
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Change the dB level and click the “Next” arrow again. Continue testing at the new dB level. Click the “Next” arrow again and select the right ear to continue testing the right ear. Click “Save"at the end of the test. Viewing Notes and Tests Selecting a record in the history panel will open the file in the Test Data Pane (5).
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OSHA (must be used with OH Baseline, Screening and Exit test significances) Copy the audiogram from the eMoyo software to your PC clipboard with this button. You can paste it into another document by pressing Ctrl + V. Show Hearing loss Bands on the audiogram by choosing one of the options from the drop down menu.
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Click on , and select an option from the menu for Assistive Interpretation. Select the type of interpretation wanted: The interpretations can then be viewed and saved. eMKW-TD0054-21- Page 49...
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Ototoxicity Monitoring with Assistive Interpretation For ototoxicity monitoring, select the first baseline test as a “Ototoxicity Baseline” and the following test as “Ototoxicity Monitoring”. Click on and select the option for assistive interpretation. Select “Ototoxicity interpretation”. You can now view the interpretation notes and calculations for both the Baseline test, the Follow up tests and comparisons of the two.
KUDUwave™ Tympanometer Begin a Tympanometry Test Click on the + Note / Test button and select Tympanometry from the list. This opens up the homepage of the tympanometry software Check the Device Status The Device Status indicates whether each side of the device is connected and ready to perform tests.
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A green light indicates that the specific side of the device is connected and ready A red light indicates that the specific side of the device is not connected. Unplug and reconnect this side. A test cannot be conducted until the green light is on. Select Test Protocols and Parameters Under Test Protocols, select one of the pre-set protocols.
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If no lights appear, a stable reading cannot be obtained. Check that the correct side is inserted into the calpods or if there is excessive ambient noise, try shielding the device from it. Select User Preferences Various user preferences can be selected. These will be saved for next time you open the software. Compensates for the admittance of the air in the ear canal ●...
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Select an Appropriate Ear-tip Choose an ear-tip that is big enough to seal the ear canal but not too big that it hurts the patient when inserted. Note: foam ear-tips tympanometry tests! The foam ear-tips do not provide an adequate seal. Only the silicone eartips are to be used.
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Insert the ear-tips into the ear canal and ensure it makes a good seal. If the Seal Checker user preference is on, the status of the seal will be indicated. A black light indicates that the probe is out of the ear or Seal Checker is off. This will show after a successful sweep.
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respectively. To the left and right of the test buttons are indicator lights. A purple light indicates that a sweep is underway. An orange light indicates that audio is being played but the sweep is not underway yet. A white light indicates that the pump is initialising or resetting itself. The pressure in the ear canal is updated in real time and is displayed on the pressure bars on each side.
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the equivalent volume of the ear canal ● Vea (cm³) TW (daPa) the tympanogram width ● the pressure at which the peak occurred ● Peak (daPa) (also called tympanometric peak pressure) Peak (mmho) the peak compliance ● the suggested classification of the tympanogram as ●...
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This is so that you can see in advance that reflexes will need calibration so that you do not arrive at the reflex test with the KUDUwave on the patient's head before realising that reflexes need calibration.
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The reflex threshold used by the automatic test protocols is selectable at the “Reflex Threshold” control. The reflex history records all reflex segments which will go into the report data saved for the test. You can select a history threshold for reflex segments to save to avoid saving a large amount of segments that do not contain reflex responses.
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The lower right part of the reflex test page shows the reflex history. It contains all reflex tests which had a measured reflex deflection greater than the history threshold selected at the Reflex Start page. In this case note that only the 90 dBHL reflex measurement has gone into the reflex history since the others are below the reflex history threshold.
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Manual Reflex Test In manual mode you need to manually present each stimulus by clicking the stimulate left/right buttons or by pressing the “L” keyboard key for left and the “R” keyboard key for right. Select the reflex type (probe ear and stimulus ear) by clicking the corresponding radio button at the “Refex History Viewer”...
KUDUwave™ Integrations Noah Integration If the end user intends to use the KUDUwave device with Noah, the user needs to have a valid Noah license. Ensure that you have the latest version of KUDUwave 5 (version 5.2 or above) and Noah (version 4.8 or above) to avoid incompatible versions.
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Select the language you would like the program to operate in. Finally, click Finish to save the setup. Noah will automatically open. Click OK to begin registering your license. eMKW-TD0054-21- Page 63...
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KUDUwave and another which is the Noah plugin). If chosen to test with Noah, do not use the eMoyo shortcut, only this one is linked to Noah. Alternatively, launch Noah and select KUDUwave from the integrations menu.
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You will be able to access all patients which are created in Noah from this portal. Once a patient is selected, begin the audiometry test with the KUDUwave by clicking “Start”. Click on the top half of the screen to begin the Pure Tone Threshold Audiometry test.
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The bottom left hand corner, begins the Word The bottom right hand corner, begins the Recognition KUDUwave test. Speech Reception Threshold test. eMKW-TD0054-21- Page 66...
Settings Find the settings button in the bottom left side of the home screen. Installation ID Your Unique Installation ID can be found in the top right hand corner. Language You can change the software language from the drop down menu in the top right hand corner. Upload a Letterhead eMKW-TD0054-21- Page 67...
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This option will open the Microsoft Paint program, automatically sized in the correct ratio for the KUDUwave letterhead. Design your letterhead in this space and save it in the bitmap (bmp) format. Later on upload the letterhead as explained above.
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All data previously captured in earlier versions (before 5.2) of KUDUwave 5 software, will not be flagged for syncing to the eMoyo server. Click this option to process all existing data for syncing. This is only necessary once, all tests done thereafter will be automatically flagged. To upload data to the eMoyo server, click on the cloud button on the left hand side of the screen.
Follow the instructions and then click the Start button to run the X-check. Note: that the X-check can only run if your KUDUwave is equipped with the cross check hardware. If this is not the case you will see the following screen:...
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After clicking the “Start” button the X-check will run automatically and the following test page will be shown: The X-check should take about 30 seconds to complete. A message will then be shown to tell you if your device calibration verification has passed: Clicking the “Finish”...
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This report page shows the test frequencies as well as the Amplitude Error. The Amplitude Error is the discrepancy or difference between the calibrated level of the KUDUwave’s air conduction output and the actual air conduction output, which has just been measured by the X- check.
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If the test fails, a message will list common reasons which cause X-check to fail alternatively to your KUDUwave being out of calibration. As an example, bumping or moving the KUDUwave while the X-check is running will prevent it from accurately measuring the air conduction output and cause the test to fail. Follow the instructions and click the “Retest”...
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If the test still fails after you have followed the instructions then your KUDUwave could be out of calibration. Contact eMoyo to book a calibration. Troubleshooting Computer is not able to connect to the KUDUwave If the computer is not able to connect to the KUDUwave, the following message will pop up.
Assistance from the Manufacturer Contacting eMoyo Any serious incident that has occurred in relation to the KUDUwave should be reported to eMoyo Head Office and the competent authority of the Member State in which the user and/or patient is established.
KUDUwave pure tone threshold test of all the octave frequencies. Save the test results. Remove the KUDUwave, turn it around so that the left side is on the right ear and the right side is on the left ear and redo the automatic KUDUwave pure tone threshold test. Compare the left and right thresholds of the two tests with each other.
Daily Calibration Verification It is advisable to perform a biological test at the start of each day that the KUDUwave will be used. Annual Calibration Annual calibration is required. eMoyo will calibrate and return your KUDUwave to you in accordance with your maintenance contract.
User Manual. Disposal and Recycling It is advisable that the unit is returned to eMoyo for disposal and recycling. Please call +27 87 231 0132, or email support@emoyo.net, for instructions. Alternatively contact your international distributor or EU representative for disposal and recycling instructions.
If you experience problems, kindly send an email with as much information as possible (including the specific error message(s) and under which circumstances they occurred) to support@emoyo.net or contact your local sales representative. Additional support information can also be accessed at https://emoyo.net/category/helpdesk/.
WARNING: No modification of this equipment is allowed. Standards The KUDUwave has been independently examined, tested and certified by a registered Notified Body in order to ensure Safety and Design Standards detailed in the General and Audiometry Specifications. Audiometry Standards...
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2x standard laptop USB ports (5 V, 900 mA max per port) Unplug laptop from mains while testing Data transfer Twisted KUDUwave™ dual USB cable 2x standard 3 meter A Male to Mini B Male USB cables Environmental Operational temperature 15 - 35 °C...
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Maintenance: Probes, Eartips and Associated Tubing The probe can be cleared of any debris using only the cleaning kit provided by eMoyo. Special care should be taken not to push any debris further into the tubes. Eartips are SINGLE-USE ONLY.
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*The default extended high frequency (9 kHz - 16 kHz) reference equivalent threshold sound pressure levels (RETSPL) are different to those of ISO 389-5 for insert earphones. Speech Testing Specifications Transducer KUDUwave ™ built-in insert earphone Masking Speech weighted random noise Spectrum constant from 125 Hz to 1000 Hz, then -12 dB/oct...
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< 59 dB SPL at 8000 Hz conduction system sound attenuation 9.0 dB at 125 Hz characteristics using Ambi-dome™ technology 10.0 dB at 250 Hz Combined ear-cup and immittance silicone insert 30.0 dB at 500 Hz eartip 33.3 dB at 750 Hz 29.7 dB at 1000 Hz 33.0 dB at 1500 Hz 38.0 dB at 2000 Hz...
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Maximum Permissible Ambient Noise Levels for the KUDUwave™ According to BS EN ISO 8253-1:2010 Difference MPANL in one-third-octave Difference in attenuation + Average between the bands, for air conduction MPANL for typical supra- attenuation Average average audiometry for hearing aural earphones for hearing...
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Replacement Item Specification Item Specification Comment/Warning Eartip Foam, manufactured to eMoyo Do not replace it with any other than eMoyo supplied specification items. Ear Cup Acoustic Foam, manufactured to Do not replace it with any other than eMoyo supplied Cushions eMoyo specification items.
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Tympanometer transducer KUDUwave™ built-in transducer Influence of ambient pressure and The KUDUwave™ Pro TMP contains an environmental sensor which measures temperature on calibration atmospheric pressure, temperature and relative humidity. Conversion between volume and admittance is handled automatically. The unit will ask for recalibration with the calibration cavities if the environment changes significantly.
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Analysis performed Compliance peak level; compliance peak pressure level; ear canal volume; peak width; tympanogram type Reflex Measurements Reflex test types Ipsilateral, contralateral and bilateral (simultaneous ipsi- and contralateral) Reflex stimuli 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz and broadband noise Frequency: ±1 % THD: <...
KUDUwave). In order to ensure correct operation the following precautions must be adhered to: The use of components and cables other than those specified or sold by eMoyo may result in increased emission or decreased immunity of the KUDUwave. The list of cables and components below must be adhered to in order to ensure compliance.
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The KUDUwave™ is intended for use in the electromagnetic environment specified below. The customer or operator of the KUDUwave™ must ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The KUDUwave™...
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NOTE 1 - UT is the a.c. mains voltage prior to application of the test level. NOTE 2 - Power supply line electrical fast transient is not applicable because the KUDUwave is powered from the USB port of a laptop running on its battery.
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RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the KUDUwave™ is used exceeds the applicable RF compliance level above, the KUDUwave™ should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re- orienting or relocating the KUDUwave™.
The software can be operated over a network by any number of people from any number of computers. When it is plugged in, the KUDUwave will check that the Personal Computer Software is suitable to control it. Additional software functionality purchased will be associated with a single device and such software will only work for devices that have the license to use the new software.
If the KUDUwave, which is the subject of this Limited Warranty, fails during the warranty period for reasons covered by this Limited Warranty, eMoyo will retain the option to repair or replace the KUDUwave.
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