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test selected.

Alongside these options, is the layout choice for the audiogram. From the drop down menu select one
of the below options:

1.

Standard

Standard audiogram with test notes included

2.

PLH/ STS

Occupational /Industrial Health Audiogram layout with test comparisons
(must be used with OH Baseline, Screening and Exit test significances)

3.

HSE

Patient Categorization from 1 to 4

4.

OSHA

STS test comparisons
(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.

Click on the icon beside the drop down menu, to illustrate consonants and sounds
mapped across the audiogram for counseling purposes.

Check the boxes for Left or Right to view the corresponding threshold on the
audiogram. You can also compare the currently selected audiogram with a
previous test, listed in the drop down menu “Compare with”.

Test Significances

You can change the Significance of a test or note by clicking on the
highlighter, or right clicking on the test in the History Pane, and
selecting the appropriate label from the drop down menu.

By selecting To Interpret, you can use the Assistive Interpretation feature
found in the New Test menu.

Digital Signatures

To sign off a test record or report click on the
pen icon. The patient must sign in the block
with the red cross and the clinician / tester in
the other block.

Assistive Interpretation

To use the assistive interpretation feature, change the
significance of the saved test to: “To interpret” or mark it
as a Baseline test for PLH, Milestone or Ototoxicity.

Page 49

Summary of Contents for KUDUwave

Page 1: ...eMKW TD0054 Rev25 Date of Issue 14 09 2022...

Page 2: ...e Tympanometer 52 Kuduwave Integrations 63 Settings 68 X check Cross Check 71 Assistance from the Manufacturer 75 Cleaning and Maintenance 76 Storage and Shipping 77 Expected Service Life 78 Disposal...

Page 3: ...iagnostic clinical Tympanometer as detailed in BS EN 60645 5 Clinical Benefits Serving and accessing more patients as a result of the Kuduwave portability Boothless assessments allowing for diagnostic...

Page 4: ...bjects have otorrhea otitis externa or the presence of a foreign body in the ear canal Residual Risk Cross infection between patients when eartips are re used Please do not re use eartips on various p...

Page 5: ...ry of sound energy to the patient s ears Bone Vibrator The bone vibrator is positioned against the patient s forehead by the operator From this position it can be used to deliver sound energy to the p...

Page 6: ...r use for important cautionary information such as warnings and precautions that cannot for a variety of reasons be presented on the medical device itself Consult instructions for use Indicates the ne...

Page 7: ...reening Screening Diagnostic Bone VIbrator Included Diagnostic Bone VIbrator Included Monitoring of Ototoxicity Monitoring of Ototoxicity Extended High Frequency up to 16kHz Extended High Frequency up...

Page 8: ...rtificate Two sound tubes with stainless steel ear tip couplers or silicone ear tip coupler TMP probes attached to the Kuduwave dependent on the Kuduwave configuration Spares Prime and Pro configurati...

Page 9: ...ase or upgrade your current OS to the Google Chrome OS If a USB hub is required please ensure it adheres to the following specifications Self powered it must have its own power supply from an electric...

Page 10: ...sktop Alternatively you can find eMoyo EMR under programs in your start menu Launch immediately after installation or click the icon to launch Please follow these five steps to run eMoyo EMR as admini...

Page 11: ...The software is currently available in English Spanish French Portuguese Bahasa and Dutch Page 10...

Page 12: ...Kuduwave Equipment Connecting the Kuduwave Plug the larger USB plugs into the USB ports of the PC Plug the smaller plugs into the corresponding ports of the Kuduwave headset Ensure these are secure a...

Page 13: ...n to either one of the ear cup USB ports or into a third USB port in the PC A light will pulse come on and switch off again if connected correctly Note Not all Kuduwaves are powered the same by differ...

Page 14: ...rubber Kudutip into the patient s ear canal To do so wiggle and twist the eartips slightly as you push it into the ear canal To ensure that low frequency tones do not leak out and to ensure effective...

Page 15: ...st keep their finger on the button and be ready to press it when a sound is played The patient must be told to press the button as quickly as possible and then let go of the button Remote Testing The...

Page 16: ...m Menu Here you have access to Home return to the home page Records return back to the folder you were busy with Plugins additional features which can be added to your software Support contact support...

Page 17: ...h your patients using the search tool 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...

Page 18: ...retations of results The Kuduwave also uses these criteria to separate which test protocols are most needed and used by a particular industry To streamline the process of choosing which tests need to...

Page 19: ...lder Note Some of these test significances are relevant for particular audiogram layouts which pertain to your industry i e PLH test significances are required for the software to do test comparisons...

Page 20: ...Milestone Baseline STS Screening Standard Threshold Shift PLH Baseline Screening Entry Follow up Periodic and Exit Percentage Loss of Hearing How do I start testing 1 After adding a patient to the sma...

Page 21: ...ning for Children and Adults WHO This folder is designed to screen masses efficiently and effectively using World Health Organization guidelines Which tests can I perform in this folder type Pure tone...

Page 22: ...any indication of ototoxicity is highlighted in a report How do I start testing 1 After adding a patient to the smart folder click on to open a new test 2 This next menu will appear for you to select...

Page 23: ...p visit complete the monitoring form test and interpretation Once the patient is ready to exit the program complete the exit form test and interpretation Hearing Screening for Humanitarian Outreach Pr...

Page 24: ...start testing 1 After adding a patient to the smart folder click on Note Test to open a new test 2 The menu below will appear for you to start the automatic test You can return to the normal interfac...

Page 25: ...ata Pane 4 Any test data can be previewed in the Test Data Pane 5 To edit patient details select the field by clicking in the field and enter the new information All tests thereafter will have the upd...

Page 26: ...the country code Email Email addresses linked to your patient can be stored here Select the Email tab to add email addresses Select Add another to add additional email addresses and Delete to delete...

Page 27: ...nal digital documents to your patients records such as clinical notes or old audiograms select File upload from Browse to the file you would like to upload to the patient profile select it name it and...

Page 28: ...elect Text notes from the Note Test menu Enter the name of the note and enter the note text Select to save or to cancel the note The note is saved in the patient history Patient History The Patient Da...

Page 29: ...y mitigated Exporting Patient Data Exporting a Single Patient s Data From within a patient profile click on export all data of this patient at the top right corner of the patient management screen Thi...

Page 30: ...Kuduwave Software File 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...

Page 31: ...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 Pure tone test From this nex...

Page 32: ...nor adjustments to the already existing test protocols Just click on one of the pre existing test macros and then click on the button at the bottom of the screen Create a new Test setup Macro To start...

Page 33: ...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 The table below...

Page 34: ...section is the option of tones which can be presented the duration of the tone and the randomisation interval between presentations The parameters of the stenger test can be set here To use the stenge...

Page 35: ...Kuduwave audiometer check the box below 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 Occlus...

Page 36: ...frequencies to be tested for each ear for air conduction and edit further settings to design your custom macro Scroll down to then select all the bone conduction frequencies which should be tested Pa...

Page 37: ...oud minimum and maximum test thresholds and what dB level you want each frequency to begin testing from Lastly you can edit the time frame before tones are presented either increasing or decreasing de...

Page 38: ...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 Automatically the wait time is set to 2 5 seconds 2500 milliseconds...

Page 39: ...d 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 T...

Page 40: ...ning 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...

Page 41: ...it louder click To decrease intensity to make it softer click To increase frequency click to decrease frequency click To switch between left blue screen and right red screen click on the blue L or red...

Page 42: ...ed in order for the tester to establish a threshold in the test ear by masking the non test ear Marking the Threshold The Kuduwave uses markers stipulated in ISO standards and which are relevant for a...

Page 43: ...is automatically set to view all thresholds Edit this by selecting which thresholds you would like to view on the screen from the drop down menu provided To extend the testing screen to view the exte...

Page 44: ...st Menu Then select the list of words read in the specified language you wish to use More languages are available from the emoyo website Select which ear you want to begin testing at the specified int...

Page 45: ...patient and the loudness of the word can be changed by clicking the Softer or Louder buttons Click the Next button to continue once testing of the left ear is complete Select the Right ear option and...

Page 46: ...ywords per sentence is presented within a babble noise The sentences are presented at a signal to noise ratio which decreases in increments of 5dB s from 25 which is very easy to 0 which is very diffi...

Page 47: ...press play for the next sentence or to save the test result There are a total of 12 lists each with 6 sentences Word Recognition WR Testing To conduct a word recognition test select the Audiometry Ku...

Page 48: ...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 t...

Page 49: ...w 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...

Page 50: ...e consonants and sounds mapped across the audiogram for counseling purposes Check the boxes for Left or Right to view the corresponding threshold on the audiogram You can also compare the currently se...

Page 51: ...Click on and select an option from the menu for Assistive Interpretation Select the type of interpretation wanted Page 50...

Page 52: ...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 ca...

Page 53: ...ns 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 The left light will indicate...

Page 54: ...y volume to be checked make sure the probe is inserted into the same cavity volume in the calpod All three cavity volumes must be processed for the check to pass and to conduct a test Insert the probe...

Page 55: ...a seal is obtained Norm Highlighting Highlights the metrics that fall outside general norms Hold Plots Superimposes the current and previous tympanograms Compliance units Selects units of mmho Acousti...

Page 56: ...when inserted Note Do not use the foam ear tips for tympanometry tests The foam ear tips do not provide an adequate seal Only the silicone eartips are to be used Insert the Eartip Into the Ear Canal a...

Page 57: ...ed Try re inserting the ear tip A green light indicates that there is a good seal and a sweep can be started The Seal Checker can be temporarily stopped by clicking on the light indicator If the Auto...

Page 58: ...e tympanogram is updated in real time and is displayed on the graph in the center The blue line is for the left ear tympanogram The red line is for the right ear tympanogram The ear canal volume is in...

Page 59: ...page or by pressing the hot key H This can be used for Eustachian Tube Function or for checking test retest reliability Increasingly fainter shades of blue or red are used to differentiate between th...

Page 60: ...calibration has changed significantly If reflex calibration is needed it will be indicated by a gray cross and purple message next to the calibrate button These calibration messages could also indicat...

Page 61: ...reflex test page click on the Next button from the tympanogram page This opens the reflex test page where the acoustic reflexes are tested Reflex Test Page Layout The top part of the reflex test page...

Page 62: ...s select the radio button for that stimulus at the stimulus parameters When an automatic test mode has been selected the reflex types that will be tested are shown by the check boxes In this example L...

Page 63: ...s F to change the stimulus or to increase or decrease the HL use the num pad keys Automatic Reflex Test 1 Select one of the automatic test protocols at the reflex start page 2 Select the stimuli to be...

Page 64: ...h 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 You can download the latest Kuduwave software from htt...

Page 65: ...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 Page 64...

Page 66: ...o EMR 2 Kuduwave Noah Module Please refer to our website to download each file or contact support to assist you Getting Started with the Kuduwave Noah Module Once both files have been installed you wi...

Page 67: ...om 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 Once the te...

Page 68: ...The bottom left hand corner begins the Word Recognition Kuduwave test The bottom right hand corner begins the Speech Reception Threshold test Page 67...

Page 69: ...r 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 To include you...

Page 70: ...end the backup data to and click Save Import and Merge Data from a Backup To import a previously backed up version of all patient data select Import a backup and merge it with this database Note A war...

Page 71: ...The eMoyo server is reserved for contracted cloud storage solutions Re index the database for fast searching To enhance the speed of the search tool on your home screen click this option and the datab...

Page 72: ...ote This does not replace the need for calibrations as per local standards To cross check your Kuduwave click the button either on the homepage or under Plugins on the left hand side If your Kuduwave...

Page 73: ...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 button will exit the...

Page 74: ...e Depending on the version of X Check you are running The PDF report is automatically saved in the C Program Files x86 eMoyoDotNet Pdf folder on your computer or C Program Files x86 eMoyoDotNet eMOYO...

Page 75: ...puter 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 This means that the Kuduwave audiometer was not plugged in correct...

Page 76: ...2 27 082 440 0826 Website emoyo tech Remote Assistance We offer to help you remotely by taking control of your laptop with the TeamViewer plugin To download the TeamViewer remote assistance plugin ple...

Page 77: ...obstructed over time Warning Never use acetone based cleaning products when cleaning the Kuduwave Note Ear wax and debris can collect in the ear probe Make sure that there is no debris on the ear prob...

Page 78: ...mmended conditions are not exceeded Namely for combinations of temperature within the range of 15 C to 35 C relative humidity within the range of 30 to 90 and ambient pressure within the range of 98 k...

Page 79: ...e When traveling or shipping the Kuduwave it is important to use its original case This casing is specifically designed for traveling and to absorb shock Please make sure to perform the following task...

Page 80: ...he specific error message s and under which circumstances they occurred to support emoyo tech or contact your local sales representative Additional support information can also be accessed at https em...

Page 81: ...ted even at high intensities Inspect the ear probes and eartips for debris that may be blocking the sounds I have run out of ear foam eartips Contact your sales representative to obtain new eartips Do...

Page 82: ...15223 1 EN 1041 FDA Establishment No 3011545613 FDA Owner Operator No 10048069 Product Code Device Class Regulation Number EWO 2 874 1020 Calibration Laboratory calibrated in accordance with BS EN 606...

Page 83: ...tenance 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 t...

Page 84: ...cy deviation 5 25 Default 10 Masking Narrow band noise automatically centered at the test frequency The default extended high frequency 9 kHz 16 kHz reference equivalent threshold sound pressure level...

Page 85: ...NSI S3 1 ISO 8253 1 SANS 10182 70 dB SPL at 125 Hz 69 dB SPL at 250 Hz 58 dB SPL at 500 Hz 53 dB SPL at 1000 Hz 50 dB SPL at 2000 Hz 59 dB SPL at 4000 Hz 59 dB SPL at 8000 Hz Air conduction system sou...

Page 86: ...5 1500 9 5 11 5 120 2000 11 5 16 5 120 3000 13 0 17 0 110 4000 15 0 14 0 105 6000 16 0 15 0 100 8000 15 5 19 5 90 9000 13 5 85 10000 12 5 95 11200 21 5 85 12500 25 5 80 14000 32 5 70 16000 41 55 Teste...

Page 87: ...According to ANSI S3 1 1999 Hz Average attenuatio n provided by industry standards headsets Average attenuatio n provided by Kuduwave Difference between the average attenuation provided by the two ea...

Page 88: ...ms Detachable Sound Tubes Medical grade PVC Do not replace it with any other than eMoyo supplied items Tympanometry Specifications Tympanometry General Tympanometer transducer Kuduwave built in transd...

Page 89: ...aphical display on PC Admittance Measurement Units cm3 or acoustic mmho 1 acoustic mmho 10 8 m3 Pa s Range 0 2 cm to 5 cm measurement plane Accuracy 5 or 0 1 cm of the equivalent volume or 0 1 acousti...

Page 90: ...ted below relative to a 2 cm3 cavity in which the stimulus is calibrated Stimulus frequency Hz Ear canal SPL for different ear canal volumes relative to 2 cm3 dB 0 5 cm3 1 0 cm3 500 14 8 1000 11 6 200...

Page 91: ...st of cables and components below must be adhered to in order to ensure compliance The Kuduwave should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary t...

Page 92: ...supply lines not applicable see note 2 1 kV for input output lines 100 kHz repetition frequency SIP SOP port See note 2 Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Not applicable see...

Page 93: ...an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IE...

Page 94: ...ration distance according to frequency of transmitter m 150 kHz to 80 MHz 1 2 80 MHz to 800 MHz 1 2 800 MHz to 2 5 GHz 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12...

Page 95: ...inued development and enhancement of the Kuduwave eMoyo reserves all rights not expressly granted Warranty and Disclaimer Limited Warranty eMoyoDotNetza Pty Ltd t a eMoyo warrants that the Kuduwave if...

Page 96: ...buse of the goods The Customer does hereby indemnify and hold eMoyo harmless against any claim by any third person arising directly or indirectly out of any defect s in the goods or equipment supplied...

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