KUDUwave 5000 Operation & User’s Manual

Tel: +27 11 782 1154 | Fax: +27 11 86 542 0142 | Email: [email protected] Address: 179 Beyers Naude Drive, Northcliff, Johannesburg, 2195, South Africa eMoyoDotNet (Pty) Ltd | Reg No: 2005/032169/07 | www.emoyo.net

Medical Purpose Patient Populations Device Description Device Placement Application Frequently Used Functions Details of Applied Parts Description of Symbols and Markings 2. Operator Training Requirements Basic Requirements Training and Certification Requirements 3. Getting Started Unpacking the KUDUwave™ Hardware KUDUwave™ Configurations Packaging Checklist Serial Number Software Installation Device Drivers Software Launch Software Language Preparing the Test Environment Preparing and Positioning the Patient Checking Device Connectivity 4. Preparing the KUDUwave™ Equipment Twisted KUDUwave™ Dual USB Cable KUDUwave™ Headset Ear Inserts USB Patient Response Button 5. Positioning the KUDUwave™ Headset Step 1: KUDUwave™ – Initial Position Step 2: Insert Eartips Step 3: KUDUwave™ – Final Position Step 4: Patient Response Button Step 5: Bone Vibrator Positioning (Optional) 6 6 6 7 7 7 7 8 8 9 10 10 10 10 11 12 12 13 13 13 14 14 14 15 15 15 15 16 16 16 17 17 17 18 18 19

Remote Testing 7. Cleaning and Maintenance General Care Cleaning Procedure When Cleaning the KUDUwave™ Calibration Daily Calibration Annual Calibration Ad Hoc Calibrations Calibrations by Other Organisations 8. Storage and Shipping 9. Expected Service Life 10. Disposal and Recycling 11. Traveling with Your KUDUwave™ 12. Upgrades, Maintenance and Support Upgrades and New Features Frequently Asked Questions (FAQs) 13. Support Service Loan Devices Personal Computer Problems Online Virtual Support Service, Support and Maintenance Contract 14. Troubleshooting Troubleshooting Checklist In Need of Assistance 15. Technical Specifications Standards Instrument Specifications Audiometry Specifications Air Conduction Frequency Specifications Bone Conduction Frequency Specifications Narrowband Masking Replacement Item Specification 19 20 20 20 20 21 22 22 22 23 23 23 23 24 24 24 24 24 25 25 25 25 25 26 26 27 27 27 28 29 31 32 32 33

17. End User License Agreement (EULA) 18. Warranty and Disclaimer Limited Warranty Disclaimer 33 39 40 40 40

The intention of this manual is to provide you with a good understanding of the KUDUwave 5000 (from hereon referred to as KUDUwave™) operations, and to understand how its different technologies work together. The manual contains technical specifications and also details potential hazards, usage methodologies and other information related to the purchasing, maintenance and safe usage of the device. Please note that this manual’s purpose is not to train KUDUwave™ operators to be healthcare professionals or to act as such. If you would like to attain a hard copy of this manual, please contact eMoyo and one will be delivered to you free of charge. Note: In tele-audiology, a subsection of telemedicine, a facilitator that might not be trained to perform the professional tests and interpret the results may fit the KUDUwave™ on the patient for an operator. This facilitator cannot act as an operator or a professional. The role of the facilitator is to assist an operator or professional to complete the process of remote tele-audiology tests. The following sections providing a broad overview of the KUDUwave™ from a user’s perspective. Medical Purpose The KUDUwave™ is a mobile audiometer featuring Ambi-Dome™ technology, which provides compliant testing outside a certified sound room using its built-in sound proofing, while including the functions found in a typical audiometer. This is achieved through a combination of sound damping and real time monitoring of ambient noise. The KUDUwave™’s medical purpose is to assist in testing a patient’s behavioural auditory responses in order to determine their hearing thresholds, and as such assist in diagnosing any hearing impediments.

for using the KUDUwave™. However, the KUDUwave™ cannot be used to test very young children, or people with physical or mental disabilities that prevent them from clearly signaling that they have heard a test audio tone presented to them. During testing the patient should be calm and comfortable and should not be distracted. Device Description The KUDUwave™ looks like a normal circumaural earphone headset typically used to listen to music. However, the KUDUwave™’s circumaural cups also help to attenuate environmental ambient noise. The KUDUwave™ electronics are all built into the headset, meaning the headset and the control are combined into a single, compact device and not separate physical modules (i.e. there is no separate box to drive the audiometer). Device Placement Place the KUDUwave™ headset on the patient’s head, above the ears and carefully insert the foam eartips into the each of the patient’s ears. Carefully place each Ambi- Dome™ over one ear at a time, and once placement is secure, ensure that the sound tubes are still connected before starting with a test. If needed, the KUDUwave™’s bone vibrator can be attached and positioned on the patient’s forehead. When not in use there are no specific requirements, beyond those outlined in this document, for its placement and storage. Application The KUDUwave™ is designed to be completely portable and should be operated and maintained by a trained operator. It may be used for testing as often as required (potentially more than 100 times a day), typically indoors in an area free from noise and distractions. The KUDUwave™ should not be used in an excessively wet, hot or dusty environment. The KUDUwave™ can be used in an open air testing that adheres to the above requirements.

As the KUDUwave™ is designed for continuous, regular usage. An analysis of all its frequently used functions has been performed in order to ensure that none constitute as an unacceptable risk to either the operator or patient. These functions are detailed in the relevant sections of this User Manual, with guidance describing how to minimise any potential risks. Details of Applied Parts The following parts are defined as “applied parts” in accordance with BS EN 60601-1: Ear Inserts: The Left and Right Ear Inserts will be positioned in the outer ear by the operator. They do not carry any electrical, chemical or mechanical energy and contain no metallic parts, and facilitate the delivery 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 patient’s cochlea. The KUDUwave™ uses a certified bone vibrator from Radioear.

The following important symbols are used on the KUDUwave™ and its accessories: Symbol Description Manufacturer, eMoyoDotNet (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. Conforms to Medical Device Directive 93/42/EEC. Symbol designating Type B Applied Parts according BS EN 60601-1. or Caution. Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. or Consult instructions for use. Indicates the need for the user to consult the instructions for use. Single use only. Serial number. Batch code. Indicates the manufacturer's batch code so that the batch or lot can be identified. Ingress protection. Keep Dry. Indicates that the medical device needs to be protected from moisture Temperature limit. Indicates the temperature limits to which the medical device can be exposed safely. Humidity limit. Indicates the range of humidity to which the medical device can be safely exposed. Fragile, handle with care. Indicates a medical device that can be broken or damaged if not handled carefully.

Basic Requirements The operator must be a trained healthcare professional (typically an audiologist, hearing aid acoustician, general practitioner, ENT, nurse or audiometrist) or a practitioner who has been trained in audiometry. The operator must be able to read and communicate fluently in English, and as needed, in the primary language of the patient. Training and Certification Requirements eMoyo provides structured training for both facilitators and operators of the KUDUwave™. The operator will receive a certificate of completion after successfully completing his/her training. 3. Getting Started This section outlines the installation and setup procedures of the KUDUwave™. Warning: The KUDUwave™ is highly sensitive and technically complex and should be treated with care. The ear cups of the KUDUwave™ block out the ambient noise as a first attenuation barrier. Tubes which fit eartips can be found at the bottom of each ear cup. Eartips are inserted into the patient’s ear, and act as a second sound attenuation barrier. The ear cups are fitted over the insert eartips. The KUDUwave™ is controlled via standard USB cables that connect each earcup of the The KUDUwave™ to a personal computer. The USB cables also provide the requisite power to the KUDUwave™.

directly to the KUDUwave™ headset. The bone vibrator can be kept in position on the KUDUwave™ using the headband screw. Unpacking the KUDUwave™ Hardware The KUDUwave™ is packaged in a robust shock absorbing case designed to protect it during transportation. Inspect the case for signs of any damage and notify your supplier immediately if any signs of mechanical or physical damage are found. Warning: eMoyo recommends that you use the robust shock absorbing carry case to ship your KUDUwave™. Please mark the package as FRAGILE. Circumaural Ear Seal (ear comfort cushion) Circumaural ear cushion for secure and comfortable fit and the second noise blocking stage Bone Vibrator For diagnostic pure tone bone conduction testing Bone Vibrator Spring & Swivel Adjustable Headband & Swivel link Allows for secure and adjusts to fit all head sizes KUDUwaveTM Memory Foam Eartip The third stage of noise blocking with a noise reduction rating (NRR) of 34 dB (disposable) Sound Reflective Ear Cup Each cup houses an individual audiometer as well as functioning as the first stage of noise blocking

Pure Tone Air Conduction Pure Tone Air and Bone Conduction Pure Tone Air and Bone Conduction Active Noise Monitoring Active Noise Monitoring Active Noise Monitoring Automated and Manual Testing Protocols Automated and Manual Testing Protocols Automated and Manual Testing Protocols Patient Management and Medical Record Suite Patient Management and Medical Record Suite Patient Management and Medical Record Suite Telemedicine Enabled Telemedicine Enabled Telemedicine Enabled - - Extended High Frequency (up to 16kHz) PC Based Software PC Based Software PC Based Software Packaging Checklist Please check that all items listed below are received in good condition. If any items are missing or damaged, immediately notify your KUDUwave™ distributor. • The KUDUwave™ headset • Three meter long twisted KUDUwave™ dual USB cable • USB patient response button • Radio Ear Bone vibrator with headband attached to the KUDUwave™ headband with a headband screw (Plus and Pro configurations only) • Calibration certificate • Two sound tubes with eartip couplers attached to the KUDUwave™ • Spares (6 sound tubes and 1 brass connector) • Starter pack of eartips

headset. Serial number information is required when contacting customer support. Software Installation If your KUDUwave™ contoller PC was professionally configured by eMoyo, all the necessary software will already be installed, optimised and initialised. Should this not be the case, or should you wish to install the software on more than one computer, please contact eMoyo and on of our friendly technicians will be assigned to assist you. Device Drivers Drivers will automatically begin installing as the KUDUwave™’s USB cables have been plugged into a personal computer. The KUDUwave™ is a plug and play device and all drivers will be installed automatically. If the device is plugged into a new USB port on the same computer for the first time, then some drivers will be installed again. Please wait until Windows notifies you that the drivers have been installed successfully. Warning: If you launch the KUDUwave™ software before the drivers were installed, the KUDUwave™ software will prompt you that it could not find the device, even though the device is plugged in. This can happen if you launch the KUDUwave™ software shortly after plugging the KUDUwave™ into the USB ports for the first time.

find emoyo4.0 under programs in your start menu. Launch the software by clicking the emoyo4.0 icon. Warning: The emoyo4.0 software must be launched with Administrator rights in Windows 7, 8 and 10 in order to ensure that it functions correctly. To do this right click on the emoyo4.0 icon and select “Run as administrator”. Software Language The software is currently only available in English. Preparing the Test Environment It is essential that the test environment is as quiet as possible in order to ensure test compliance and that the patient is not disturbed. The KUDUwave™ monitors the ambient noise in real time and will indicate if ambient noise is sufficiently loud to disrupt the test. The test environment should be free from any distractions that may disturb either

Preparing and Positioning the Patient The patient should be seated in the test environment at least 1.5 meters from the test computer. It is important that the patient cannot see the screen of the test computer. Care should be taken to ensure the patient is as comfortable as is possible to minimise distractions. Should the patient be unable to sit, care must be taken to ensure they are positioned in as comfortable and relaxed a position as is possible. Patients who are notably anxious should be reassured and made as comfortable as possible. Checking Device Connectivity Make sure the KUDUwave™ is plugged into the personal computer before you select any of the KUDUwave™ tests in the eMoyo software. If the KUDUwave™ is plugged into the personal computer both the Red and Blue LED will light up and you will be able to press the “Next >>” button to continue performing the test. If the device is not plugged in it will not be possible to proceed. 4. Preparing the KUDUwave™ Equipment Twisted KUDUwave™ Dual USB Cable Plug the larger USB plugs of the twisted KUDUwave™ USB cable into the USB ports of the test personal computer. Plug the smaller plugs of the twisted KUDUwave™ USB cable directly into the bottom of the KUDUwave™ headset. The KUDUwave™ will indicate the right side with a red light, and will indicate the left side with a blue light when powered. Ensure that both USB cables are securely connected from the left and right KUDUwave™ ear cups to two USB ports on the test personal computer. The USB cables must not be tangled or left in a position where they may cause someone to trip over or become entangled in them.

unnecessary damage before storing it away in the KUDUwave™ case. KUDUwave™ Headset The headset must be placed on a stable surface. It must be cleaned and disinfected after each use with a cleaning wipe in compliance with EN1276 that are intended for use on plastic items. Ear Inserts A new set of foam eartips must be firmly attached to the plastic tubes. Used eartips must be disposed of as medical waste after testing. Warning: The foam eartips are disposable and for single use only to prevent hazardous cross contamination. eMoyo will not be held liable for any complications if eartips are reused. USB Patient Response Button The USB cable from the Patient Response Button must be firmly attached to the USB connector on the left ear-cup of the KUDUwave™. Attaching it to the right ear-cup

computer. 5. Positioning the KUDUwave™ Headset Although there are a number of ways to position the KUDUwave™ correctly on the patient’s head, the following technique is recommended: Step 1: KUDUwave™ – Initial Position The KUDUwave™ headset should first be gently placed on the patient’s head, resting just above their ears. Care must be taken to ensure that the headset is the correct way around (i.e. the left ear cup must be on the patient’s left hand side and vice versa). Step 2: Insert Eartips Insert the foam eartip onto the tubing, and make sure that the eartip is inserted up to the end of the brass ridge. Squeeze the foam tip between thumb and index finger. Pull the ear by the pinna (up and back in adults and down in children) and insert the squeezed foam tip into the canal. Make sure the tip is inserted deep enough into the ear canal. The eartip must be held in the ear canal until the foam has expanded sufficiently so that it is securely in place. If the eartip is fit loosely in the ear canal then a larger size foam eartip should be used. Sound leakage around a loosely fitted eartip will result in testing inaccuracy.

Step 3: KUDUwave™ – Final Position The headset can now be lifted up to, and simultaneously placed over, the patient’s ears. Ensure the ear cups are supported by the headband and do not hang on the ears. Care must be taken not to dislodge the ear inserts from the patient’s ear canal. It is important to lift the left and right ear cups slightly in turn to visually confirm the ear inserts are still correctly positioned. Make sure that the tubing is not tangled under the cups. The tubing should loop out under the cups towards the front of the ear to avoid tangling and or bending. Step 4: Patient Response Button The Patient Response Button must be placed in the patient’s hands. Ensure that the cable does not become tangled or damaged. The patient must keep his 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.

If the bone vibrator is to be used, the metal headband must be adjusted and placed over the patient’s head in such a way as to ensure that it is positioned carefully in line with the middle partition between eyebrows/middle of the eyes of the patient’s forehead. Warning: Bone vibrators are calibrated to a specific KUDUwave™. They are not interchangeable between 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. 6. Performing a Test Please see the emoyo4.0 User Manual for full details on how to perform KUDUwave™ tone threshold test (manual or automatic), bisyllabic speech test (speech reception threshold) and monosyllabic speech test (speech discrimination), using the KUDUwave™. For a quick reference, please see the emoyo4.0 Quick Start Guide included with your device or use the help included in the eMoyo software package (this can be accessed by pressing the “?” button in the eMoyo application whilst performing a KUDUwave™ test.

internet connections. To test remotely 1. The trained operator starts the eMoyo software application on his or her local personal computer. 2. A connection is made to a KUDUwave™ headset connected to a remote personal computer. 3. The remote personal computer is specified using its unique IP address. 4. A trained facilitator can then fit the KUDUwave™ headset on the patient. The operator can proceed with the test. Both the operator and facilitator need to complete the required eMoyo KUDUwave™ training. 7. Cleaning and Maintenance General Care The KUDUwave™ is a highly sensitive, state of the art device that must be treated with care. It must be cleaned and disinfected regularly and care should be taken not to damage any of the sensitive microphones or speakers when cleaning or handling the device. Cleaning Procedure The KUDUwave™ must be thoroughly cleaned and disinfected after each and every use (i.e. before each new patient is tested) with a cleaning and disinfection wipes complying with EN1276 that are intended for use on plastic items.

1. Disconnect all USB cables and use an antibacterial wipe to clean the KUDUwave™ headset, ear cups, sound tubes, response button and the bone vibrator (if it was used). 2. It is important to ensure that during cleaning no liquid enters any holes in the ear cups. 3. Used foam eartips must be disposed of after each test as medical waste. 4. When cleaning the device, avoid bending or twisting any of the cables or sound tubes. 5. If any permanent sharp bends, cracks or holes in the sound tubes are visible, replace them with spares provided. Calibration can be verified using the standard daily biological calibration check routine. 6. Check that the sound tube or brass eartip coupler has not become blocked or 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 probe or inside the disposable eartip before placing an eartip. Once debris or any foreign material has lodged into the little holes of the ear probe, it may be possible to remove the debris from the holes. If debris enters the holes, then the debris must be removed, cleaned and disinfected and the calibration should be verified using the standard biological calibration verification routines. Warning! Make sure that there is no debris on the ear probe or inside the disposable eartip before placing an eartip onto the ear probe. Note: The recommended daily biological calibration routine is as follows: Put the KUDUwave™ on your head and do an automatic KUDUwave™ 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™ tone threshold test. Compare the left and right thresholds of the two tests with each other. None of the thresholds of the compared sides may differ with more than 10 dB.

and the patient. Never reuse disposable eartips because old ear wax and cleaning solutions can damage the ear probe permanently. Cleaning solutions also damages the foam of the eartips and can lead to incorrect readings. It is an irresponsible risk to clean eartips for re-use, as cleaning solution or wax can end up inside the ear probe and give incorrect results. Warning! Never reuse disposable eartips. Eartips are cheap and any perceived cost saving will not outweigh the risks to the device and more importantly, the patient. Calibration In order for the KUDUwave™ to operate correctly it is vital that it is calibrated correctly. eMoyo has the equipment and necessary expertise to calibrate your KUDUwave™. Please contact eMoyo to schedule your next calibration. Daily Calibration Although there is no need for daily biological testing, 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. Note: The KUDUwave™ software has been designed to automatically warn you when the minimum calibration is due. Your device will be assessed annually to determine its serviceability before it is calibrated. The KUDUwave™ users can expect a minimum service life of 5 years.

Some states or countries require audiometers to be calibrated more than once a year, especially when audiometers are used for mobile testing. Please make sure of what the legislatory requirements are for your state or country. If you are ever in doubt whether the KUDUwave™ is in calibration it is recommended to verify the calibration biologically. If you are still in doubt it is essential to do an electro- acoustic calibration check. Calibrations by Other Organisations Due to the digital, robust and integrated design of the KUDUwave™, chances of it going out of calibration are very slim. If another organisation wants to calibrate a KUDUwave™, they may perform a typical calibration process to verify that the thresholds and frequencies of the unit are correct. After completing the calibration routine the calibration organisation will not need to adjust any thresholds or frequencies. A calibration certificate must be issued to show that the KUDUwave™ is within calibration limits. In the unlikely event where the calibration shows limits outside acceptable limits, please contact eMoyo immediately. 8. Storage and Shipping Warning! When shipping the KUDUwave™ please use the robust shock absorbing carry case to reduce the risk of damage to the device during transit. Remember to seal the shipping container securely and to mark the container FRAGILE. Always store the KUDUwave™ out of direct sunlight in a clean and dry environment within the temperature and humidity limits detailed in the Technical Specifications. 9. Expected Service Life The KUDUwave™ has an expected service life of at least five years of continuous use. Regular maintenance and general care will prolong the service life considerably. The KUDUwave™ can be used any number of times without restriction as long as it is both calibrated, and cleaned in accordance with the instructions in this User Manual.

There are no specific disposal requirements for the KUDUwave™. However, it is advisable that the unit is returned to eMoyo for disposal and recycling. 11. Traveling with Your KUDUwave™ 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 tasks: • Always unplug all USB cables before placing the KUDUwave™ into the case. • Also make sure the bone vibrator is attached to the headband to ensure it does not move while being shipped. • Keep a foam eartip on each sound tube tip to prevent dirt from entering the sound tubes. • Make sure no cables or sound tubes are caught up between the lid and the case before closing it. • Always perform a biological test after traveling with your KUDUwave™. 12. Upgrades, Maintenance and Support Upgrades and New Features eMoyo often provides software and hardware upgrades for existing products. Please contact eMoyo at [email protected] for the latest information on upgrades and new features. You can also visit our website at www.kuduwave.com. Frequently Asked Questions (FAQs) Please refer to websites for more information

At eMoyo we are confident that we can deliver a unique support service specifically designed for clients in remote areas. Loan Devices In the unlikely event that one of our devices has a problem, we will express courier a loan device to you at your cost (if available). Personal Computer Problems If your personal computer was purchased with your KUDUwave™ from a distributor, please contact your distributor for repair and servicing. For problems with personal computers that were not purchased from an eMoyo distributor, please contact the appropriate dealer or a local IT specialist. Online Virtual Support You can obtain online training using video conferencing software on your laptop. The video conferencing software comes pre-installed on the distributor supplied laptops. If you are using a non-distributor supplied laptop, eMoyo will supply you with the video conferencing software. To receive online training, you will need to be located in an area with a good broadband internet connection. You will be issued a certificate of competency to operate our devices after training and a short practical evaluation. Service, Support and Maintenance Contract The latest service, support and maintenance contract can be obtained from your local sales representative.

possible (including the specific error message(s) and under which circumstances they occurred) to [email protected] or contact your local sales representative. Additional support information can also be accessed at http://support.emoyo.net/ support/home. Troubleshooting Checklist Problem Possible Solution eMoyo software does not recognise that the KUDUwave™ is connected. Check that the USB cables have been firmly connected from both ear cups to the USB ports on the personal computer. The left and right LED’s will indicate if power is being received from the USB port. Try the second set of two new USB cables in case the original pair have become damaged. Ensure the Patient Response Handset has been connected to a USB port. Restart the computer and try to launch the software again. Responses from the Patient Response button are not being recorded by the eMoyo software. Ensure the Patient Response Handset has been firmly connected to the left ear cup. If another Patient Response Handset is available try it instead to ascertain if the response button is broken. Ensure that the patient environment is not too noisy so non-compliant results are not being recorded. Confirm that the operator can hear sounds being presented using the same headset. The patient cannot hear sounds being presented even at high intensities. Inspect the ear probes and eartips for debris that may be blocking the sounds.

Contact your sales representative to obtain new eartips. Do not continue using the existing ones or attempt to clean and reuse them. The eMoyo software keeps telling me I have X days until the device needs calibration. Ensure that you send your KUDUwave™ to eMoyo to be calibrated whenever prompted. Contact your local sales representative for more details. In Need of Assistance? Please contact your local IT consultant if you need assistance with confirming your personal computer’s specifications, or need an upgrade to meet the minimum requirements. 15. Technical Specifications 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 Pure tone: BS EN 60645-1 (Type 3) Speech: BS EN 60645-2 (Type B) Other Standards BS EN 60601-1, BS EN 60601-1-2, BS EN 60601-1-6, BS EN ISO 13485, BS EN ISO 14971, BS EN 62304, BS EN ISO 14155, BS EN ISO 15223-1, EN 1041 Medical CE mark European Council Directive 93/42/EEC Medical device class IIa Calibration Laboratory calibrated in accordance with: BS EN 60645-1, EN 60645-2, SANS 10154-1 and SANS 10154-2

Shipping dimensions 410 x 320 x 190 mm Net weight 250 g Shipping weight 1627 g Power supply 2x standard laptop USB ports (5 V, 500 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 conditions Indoor use only Operational temperature 15 - 35 °C Operational humidity (non-condensing) 30 - 90 % Operational ambient pressure 98 - 104 kPa Shipping and storage temperature 10 - 40 °C Shipping and storage humidity (non-condensing) 30 - 75 % Shipping and storage ambient pressure 70 - 106 kPa Warm-up time 10 - 20 sec Patient response system Handheld tactile push button (USB) Sound tube Medical grade PVC 80 shore, Clear with white x-ray line, L 180 mm, ID 1.7 mm, OD 2.9 mm

bone vibrator frequency specification and narrow band frequency specification. Pure Tone Testing Specifications Air conduction transducer KUDUwave™ 5000 built-in insert earphone Bone vibrator transducer Radio Ear B71, B71W or B81 Bone vibrator placement Forehead Air conduction frequency range 125 Hz - 8 kHz standard 8 kHz - 16 kHz extended Bone vibrator frequency range 250 Hz - 4 kHz Frequency accuracy < 0.05 % Air conduction total harmonic distortion < 3 % Bone vibrator total harmonic distortion < 6 % Bone vibrator headband static force 5.4 N ±0.5 N Air conduction calibration coupler IEC 60318-4 (IEC 711) Ear Simulator RETSPL as per ISO 389-2, ISO 389-4* Bone vibrator calibration coupler IEC 60318-1 Ear Simulator with IEC 60318-6 Artificial Mastoid RETSPL as per ISO 389-3 Tone presentation Pure tone or warble tone Warble tone waveform Sinusoidal Warble tone repetition rate 4 - 20 Hz Default = 5 Hz

5 - 25 % Default = 10 % Masking Narrow band noise automatically centered at the test frequency Speech Testing Specifications Transducer KUDUwave 5000 built-in insert earphone Masking Speech weighted random noise Spectrum constant from 125 Hz to 1000 Hz, then -12 dB/oct from 1 kHz to 6 kHz ±5 dB Calibration All pre-recorded words in word lists calibrated against 1 kHz calibration signal Additional Audiometry Specifications Talk forward 40 - 100 dBHL adjustable Modes of operation Manual Automatic shortened ascending (Hughson and Westlake method - ISO 8253-1) Automatic standard ascending Shortened and standard bracketing Fixed frequency Békésy sweep (optional) Pure tone Stenger (optional) Air conduction system sound attenuation characteristics using Ambi-dome™ technology Combined ear-cup and ear-insert attenuation 31.0 dB at 125 Hz 37.7 dB at 250 Hz 43.8 dB at 500 Hz 40.8 dB at 1000 Hz 38.1 dB at 2000 Hz 52.3 dB at 4000 Hz 45.8 dB at 8000 Hz 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. Refer to table X for the RETSPL values used. *

pressure levels to test down to 0dBHL EN 26819 < 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 Frequency Specifications Freq (Hz) RETSPLs (dB) Max Output (dBHL) 125 28.0 80 250 17.5 90 500 9.5 105 750 6.0 110 1000 5.5 110 1500 9.5 110 2000 11.5 110 3000 13.0 105 4000 15.0 100 6000 16.0 90 8000 15.5 85 9000 13.5 85 11200 21.5 75 12500 25.5 80 14000 32.5 65 16000 41 50

Freq (Hz) RETFLs (dB) Maximum Mastoid Hearing Levels (dBHL) Maximum Forehead Hearing Levels (dBHL) Maximum Mastoid Hearing Levels (Occluded ear) (dBHL) 250 67.0 35 25 45 500 58.0 60 45 60 750 48.5 65 50 60 1000 42.5 70 60 65 1500 36.5 80 70 70 2000 31.0 80 70 70 3000 30.0 80 70 70 4000 35.5 65 60 60 Occluded ear (bilateral eartips in sito) Narrowband Masking Specifications Freq (Hz) Max Output (dBHL) Lower Cut-Off Frequency (Hz) Upper Cut-Off Frequency (Hz) 125 80 110 145 250 90 215 290 500 105 435 575 750 110 650 890 1000 110 865 1150 1500 110 1295 1770 2000 110 1730 2310 3000 105 2600 3560 4000 100 3475 4700 6000 90 5100 7120 8000 85 6770 9380

Item Specification Comment/Warning Eartip Foam, manufactured to eMoyo specification Do not replace with any other than eMoyo supplied items. Ear Cup Cushions Acoustic Foam, manufactured to eMoyo specification Do not replace with any other than eMoyo supplied items. Detachable Sound Tubes Medical grade PVC Do not replace with any other than eMoyo supplied items. 16. Electromagnetic Compatibility (EMC) Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this section. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. Following the guidelines in this section will help prevent this. Warning! The KUDUwave™ has been tested to the BS EN 60601-1- 2:2007 for both immunity (susceptibility to interference from external sources) and emissions (interference generated by the KUDUwave™). In order to ensure correct operation the following precautions must be adhered to: • The use of accessories 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 accessories 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 then the KUDUwave™ should be observed to verify normal operation in the configuration in which it will be used. List of cables and accessories that affect compliance 1. USB Cable, Type A to mini-B, maximum length 3.0 metres.

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 CISPR 11 Group 1 The KUDUwave™ uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class A (within measurement uncertainty) The KUDUwave™ is suitable for use in all establishments other than domestic and those directly connected to the public low- voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations / flicker emissions IEC 61000-3-3 Not applicable Guidance and Manufacturer’s Declaration - Electromagnetic Immunity 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

supply lines ±1 kV for input/ output lines Power supply lines: not applicable, see note 2 ±1 kV for input/ output lines See note 2 Surge IEC 61000-4-5 ±1 kV differential mode ±2 kV common mode Not applicable, see note 2 See note 2 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000- 4-11 <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec Not applicable, see note 2 See note 2 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 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.

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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be no closer to any part of the KUDUwave™, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms 80 MHz to 800 MHz 800 MHz to 2.5 MHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by 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 IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m

NOTE 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed 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™. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

communications equipment and the KUDUwave™ The KUDUwave™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the operator of the KUDUwave™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the KUDUwave™ as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 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 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 - At 80 MHz and 800 MHz, the separation distance for the higher frequency applies. NOTE 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

The eMoyoDotNet (Pty) Ltd. End-User License Agreement (EULA) is a legal agreement between you, either an individual or a single entity and eMoyo, for the KUDUwave™ device and software. Software includes the personal computer software and the KUDUwave™ device firmware. Software may be installed and used by any number of people (either an individual or a single entity). The software may be installed on any number of computers. 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. The hardware may be used by any number of people (either an individual or a single entity). The hardware may be used on any number of Personal Computers and can be operated over a network by any number of people. eMoyo took all reasonable care to ensure a safe and compliant device, but there is always the slightest possibility for error. eMoyo and its employees and consultants do not take responsibly for any complications that may be the result of errors in the device or software. Specifications are subject to change without notice due to the continued development and enhancement of the KUDUwave™. eMoyo reserves all rights not expressly granted.

Limited Warranty eMoyoDotNet (Pty) Ltd. t/a eMoyo warrants that the KUDUwave™, if properly used and installed as per eMoyo’s instructions, will be free from defects in material and workmanship. The KUDUwave™ will conform to eMoyo’s high quality specifications for the period of three years, as stipulated on the Terms and Conditions found on the invoice. This warranty • begins on the date of purchase, (for your convenience, please keep the dated tax invoice as evidence of this date) • is extended through distributors, • covers defect(s); • and does not cover tamper, drop, misuse or modifications. 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™. All shipping costs required to repair or replace the device remain the responsibility of the purchaser. Disclaimer The Purchaser shall have no claim against eMoyo whatsoever, notwithstanding the termination or lapse of any contract. eMoyo will not be held responsible for loss or damage of any nature whatsoever, whether direct or indirect, consequential or otherwise, sustained as a result of any goods or equipment supplied or any advice given or any installation effected or any maintenance undertaken by eMoyo being in any way defective or absent or not conforming to the description thereof as a result of any other cause whatsoever. Under no circumstances will eMoyo be liable for damage arising from misuse or abuse 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 and or advice given to the Customer.