eMoyo KUDUwave Скачать руководство пользователя страница 13 | Manualshive

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Performance Veriﬁcation of the Kuduwave™

To test the Kuduwave hardware, plug in the device and perform

(built in calibration veriﬁcation

tool). This will also indicate any performance issues. Report any faults found to your distributor.

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.

Ear Inserts

Ear tips must be ﬁrmly attached to the plastic tubes using the stainless steel
couplers or the plastic probe designed for silicone eartips. eMoyo will not be held
liable for any complications if eartips are reused without following the cleaning and
maintenance protocol: After each use, wash and rinse with warm soapy water, then
soak in a 70% alcohol solution for 5 minutes. Once washed, check all water droplets
are dry. If not, take a cotton bud and remove leftover water before use.

USB Patient Response Button

Connect the USB cable of the response button 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 diﬀerent laptops and the
response button may not work when plugged into the ear cup USB port. Use the
response button in the laptop port in these cases.

Positioning the Kuduwave™ Headset

When not in use, place the headset on a stable surface. Cleaning and disinfection
can be done with cleaning wipes which are intended for cleaning plastics that
comply with EN1276.

Although there are a number of ways to position the Kuduwave correctly on the patient’s head, the
following technique is recommended:

Step 1: Initial Position

Gently place the Kuduwave headset on the patient’s head, resting just above
both ears. Ensure the headset is positioned correctly i.e. the left ear cup
(indicated by a Blue LED light) must be on the patient’s left hand side and the
right ear cup (indicated by a Red LED light) must be on the patient’s right hand
side.

Step 2.1: Insert Foam Eartips

Squeeze and roll the foam tip down to its smallest diameter using your thumb
and index ﬁnger. Pull the ear by the pinna up and back for adults (pull the pinna
down for children), and insert the foam tip into the ear canal. Ensure that the

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Содержание KUDUwave

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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