KUDUwave 5000 User Manual
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KUDUwave 5000 User Manual

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Summary of Contents for KUDUwave 5000

  • Page 1 thinking out the booth User Manual eMoyo...
  • Page 2 Doc Number: EM-KW-IFU | Revision 07 Tel: +27 11 782 1154 | Fax: +27 11 86 542 0142 | Email: info@emoyo.net Address: 179 Beyers Naude Drive, Northcliff, Johannesburg, 2195, South Africa eMoyoDotNet (Pty) Ltd | Reg No: 2005/032169/07 | www.emoyo.net...

  • Page 3: Table Of Contents

    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)
  • Page 4 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...
  • Page 5 16. Electromagnetic Compatibility (EMC) 17. End User License Agreement (EULA) 18. Warranty and Disclaimer Limited Warranty Disclaimer...

  • Page 6: Introduction

    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.

  • Page 7: Patient Populations

    (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.

  • Page 8: Frequently Used Functions

    Frequently Used Functions 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.

  • Page 9: Description Of Symbols And Markings

    Description of Symbols 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.

  • Page 10: Operator Training Requirements

    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.

  • Page 11: Unpacking The Kuduwave™ Hardware

    (NRR) of 34 dB (disposable) The bone vibrator is mounted on an independent headband and is connected 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™...

  • Page 12: Kuduwave™ Configurations

    • Three meter long twisted KUDUwave™ dual USB cable • 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™...

  • Page 13: Serial Number

    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.

  • Page 14: Software Launch

    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.

  • Page 15: Preparing And Positioning The Patient

    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.

  • Page 16: Kuduwave™ Headset

    Warning: Please wind the USB cable up in large loops to prevent 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.

  • Page 17: Positioning The Kuduwave™ Headset

    Alternatively it may also be attached directly to the personal 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™...

  • Page 18: Step 3: Kuduwave™ - Final Position

    Warning: Improper insertion of eartips may affect test results. 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.

  • Page 19: Step 5: Bone Vibrator Positioning (Optional)

    For a quick reference, please see the emoyo 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.

  • Page 20: Remote Testing

    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.

  • Page 21: When Cleaning The Kuduwave

    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.

  • Page 22: Calibration

    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.

  • Page 23: Ad Hoc Calibrations

    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.

  • Page 24: 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.

  • Page 25: Support Service

    (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.

  • Page 26: Troubleshooting

    USB port. Try the second set of two new USB cables eMoyo software does not recognise in case the original pair have become that the KUDUwave™ is connected. damaged. Ensure the Patient Response Handset has been connected to a USB port.

  • Page 27: In Need Of Assistance

    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...

  • Page 28: Instrument Specifications

    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 Operational temperature 15 - 35 °C...

  • Page 29: Audiometry Specifications

    Pure tone testing, speech testing, general, air conduction frequency specification, 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...
  • Page 30 (RETSPL) are different to those of ISO 389-5 for insert earphones. Refer to table X for the RETSPL values used. 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...

  • Page 31: Air Conduction Frequency Specifications

    Operational background sound < 70 dB SPL at 125 Hz pressure levels to test down to < 69 dB SPL at 250 Hz 0dBHL < 58 dB SPL at 500 Hz < 53 dB SPL at 1000 Hz EN 26819 <...

  • Page 32: Bone Conduction Frequency Specifications

    Bone Conduction Frequency Specifications Maximum Maximum Maximum Mastoid Freq RETFLs Mastoid Forehead Hearing Levels (Hz) (dB) Hearing Levels Hearing Levels (Occluded ear) (dBHL) (dBHL) (dBHL) 67.0 58.0 48.5 1000 42.5 1500 36.5 2000 31.0 3000 30.0 4000 35.5 Occluded ear (bilateral eartips in sito) Narrowband Masking Specifications Freq Max Output...

  • Page 33: Replacement Item Specification

    • 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.
  • Page 34 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions 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...
  • Page 35 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.
  • Page 36 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...
  • Page 37 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™.
  • Page 38 Recommended separation distance between portable and mobile RF 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™...

  • Page 39: End User License Agreement (Eula)

    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.

  • Page 40: Warranty And Disclaimer

    • 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™.

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