AmpliVox Otowave 102 Operating Manual
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AmpliVox Otowave 102 Operating Manual

Hand-held, portable tympanometer
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Summary of Contents for AmpliVox Otowave 102

  • Page 1 Otowave 102 Operating Manual...

  • Page 2: About This Manual

    ABOUT THIS MANUAL READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT. This manual is valid for the Otowave 102 (applies from firmware version 1.0.0.072100 onwards – see System Information screen). This product is manufactured by: Amplivox Ltd. Amplivox Ltd.
  • Page 3 For supply in US only Caution: Federal Law restricts this device to sale by or on the order of a licenced medical professional.

  • Page 4: Table Of Contents

    Data transfer to NOAH or ampliSuite ......................... 19 Data Management .............................. 20 10.1. List records ................................. 20 10.2. Delete records ................................21 10.3. Print records ................................21 10.4. Send records to a computer ............................21 D-0115690-C (OM001) – Otowave 102 Operating Manual...
  • Page 5 Performance ................................27 15.2. Equipment classification ............................. 28 15.3. Symbols..................................29 Ordering Consumables and Accessories ......................30 Disposal Information ............................31 EMC Guidance & Manufacturer’s Declaration ..................... 32 Use with Non-medical Electrical Equipment ......................36 D-0115690-C (OM001) – Otowave 102 Operating Manual...

  • Page 6: Introduction

    INTRODUCTION 1. INTRODUCTION 1.1. THANK YOU Thank you for purchasing an Amplivox Otowave 102, a hand-held, portable tympanometer that will give many years of reliable service if treated with care. This operating manual covers product variants 102-1 & 102-4. 1.2. INTENDED APPLICATIONS The Otowave 102 is designed for use by audiologists, general practitioners, hearing aid dispensers and child health professionals.

  • Page 7: Standard Contents And Optional Accessories

    Refer to the printer instructions for further details. 1.6. WARRANTY CARD (UK CUSTOMERS ONLY) Please complete the enclosed warranty registration card and return it to Amplivox. This will enable us to register your purchase, help with your enquiries and provide technical support.

  • Page 8: Important Safety Instructions

    As with all instruments of this nature the measurements taken will be influenced by significant changes in altitude & pressure. The Otowave 102 tympanometer must be re-calibrated at the intended operating elevation if it is to be used at elevations greater than 1000m above mean sea level.

  • Page 9: Principles Of Operation

    3.1. COMPLIANCE MEASUREMENT The Otowave 102 measures the compliance of the tympanic membrane and middle ear by playing a continuous 226Hz tone into the ear canal at a level calibrated to give 85dB SPL into a 2ml cavity. The sound level this produces in the ear canal is measured using a microphone and the compliance calculated from the result.

  • Page 10: Using The Otowave

    The function of the left and right keys is usually shown on the bottom line of the display. When not performing a test the Otowave 102 will switch off automatically after 90 or 180 seconds if no key is pressed (see Section 0to make this selection).

  • Page 11: The Probe

    Connection on probe body for attaching nose cone Seal rubber Gasket used to ensure air flow Probe tip Transparent probe tip housing the seal rubber Nose cone Top part of probe to securely fasten probe tip and seal rubber D-0115690-C (OM001) – Otowave 102 Operating Manual...

  • Page 12: Start-Up And Menu Displays

    Video available on how to clean the probe tip. 4.5. START-UP AND MENU DISPLAYS When the Otowave 102 is turned on the start-up screen is shown while internal tests are performed and the pump is initialised. When the start-up sequence is complete the MAIN MENU is displayed:...

  • Page 13: Taking Measurements

    Having selected the required test settings a typical tympanogram measurement and reflex tests are carried out as follows. From the MAIN MENU select NEW TEST: MAIN MENU NEW TEST CONFIGURATION VIEW THE LAST TEST Select D-0115690-C (OM001) – Otowave 102 Operating Manual...
  • Page 14 Once an adequate seal is detected the tympanogram measurement is made. This takes about 3 seconds. It is important not to move the probe and to ask the patient to remain very still during the test. D-0115690-C (OM001) – Otowave 102 Operating Manual...
  • Page 15 ▲ and ▼ keys. The figures displayed will change to reflect the peak selected, and will be saved with the tympanogram. To repeat the test, press ◄. When satisfied with the tympanogram press ►. D-0115690-C (OM001) – Otowave 102 Operating Manual...
  • Page 16 If the Otowave 102 was set to test for a reflex at all levels of the stimulus press ► to view an additional display following the reflex graphs. This shows a summary of the levels and frequencies at which a reflex was detected.

  • Page 17: Ear Seal Check

    High : Cancel The number of bars shown indicates the robustness of the seal. The probe should be adjusted in the ear until two or more bars are shown for Low & High. D-0115690-C (OM001) – Otowave 102 Operating Manual...

  • Page 18: Error Messages

    The ear canal volume is below 0.1ml. Check that the WITHDRAW PROBE probe is not blocked and correctly inserted into the ear. INSERT PROBE Yellow Flashing The seal was lost. Reinsert the probe to repeat the test. D-0115690-C (OM001) – Otowave 102 Operating Manual...

  • Page 19: Configuration

    110dBHL. MULTILEVEL: Use the S keys to choose the maximum level of reflex stimulus to apply and the step size between the levels of the preceding stimuli. The maximum level of ipsilateral D-0115690-C (OM001) – Otowave 102 Operating Manual...
  • Page 20 By default the reflex test at each frequency will stop at the lowest level of stimulus that produces a response. By setting REFLEX AUTO-STOP to NO the Otowave 102 will test for a reflex at all selected levels. (Note that 100dBHL at 4000Hz is not available).

  • Page 21: System Settings

    MPT-II MPT-II or Able AP1300). Please note: In order to use the Sanibel printer, select MARTEL printer in the settings. After confirming the MARTEL printer, the Otowave 102 will connect to the Sanibel printer, too. Primary Battery Type Select what kind of batteries are used with the unit (primary or rechargeable).

  • Page 22: Saving Results In The Internal Database

    SAVING RESULTS IN THE INTERNAL DATABASE 7. SAVING RESULTS IN THE INTERNAL DATABASE Up to 30 tests can be saved in the Otowave 102 internal database. To save the results of a test select SAVE RESULTS from the PROCESS RESULTS menu that is displayed on completion of a test.

  • Page 23: Irda Communications

    If the computer does not have an infra-red port a suitable infra-red adapter will be required. The Actysis ACT- IR2000U USB adapter is specified for and has been tested for use with the Otowave 102. This adapter may be purchased from Amplivox and only this device should be used for this purpose.

  • Page 24: Transferring The Results

    To transfer test results stored within the tympanometer to a NOAH database the Amplivox NOAH Impedance module must be installed on to a computer. Alternatively, Amplivox ampliSuite allows data to be transferred to a computer and subsequently viewed, annotated & printed. This software is supplied on a CD which includes this operating manual.

  • Page 25: Data Management

    DATA MANAGEMENT 10. DATA MANAGEMENT Records stored in the database of the Otowave 102 can be listed, viewed, deleted, printed or sent to a computer using the DATA MANAGEMENT option of the main menu: DATA MANAGEMENT LIST RECORDS DELETE RECORDS PRINT RECORDS ...

  • Page 26: Delete Records

    SEND RECORDS TO PC allows a group of records to be sent to a computer. It is possible to send all stored records or just those records that have not already been sent. D-0115690-C (OM001) – Otowave 102 Operating Manual...

  • Page 27: Performing Daily Checks

    PERFORMING DAILY CHECKS 11. PERFORMING DAILY CHECKS The operation of the Otowave 102 should be checked daily using the 4 in 1 test cavity assembly supplied with the instrument. Select the DAILY CHECK option in the main menu: DAILY CHECK...

  • Page 28: System Information

    Instrument version (Dual Tone = High Frequency option enabled) Battery: Voltage Information Last Cal: Last calibration date Next Cal: Next calibration date Serial No: Serial number of Otowave Ver.: Firmware version Date and Time: User defined date and time D-0115690-C (OM001) – Otowave 102 Operating Manual...

  • Page 29: Routine Maintenance

    13.3. CALIBRATION AND REPAIR OF THE INSTRUMENT Amplivox recommends that the Otowave is calibrated annually. Please contact Amplivox for details. If the instrument is to be used at elevations above that specified re-calibration must be undertaken at the intended operating elevation.

  • Page 30: Error Messages & Fault Conditions

     Volume outside range Ear canal volume is > 5ml.  WITHDRAW PROBE Probe is not properly inserted Reposition the probe into the ear. Indicator LED b and c flash fast. D-0115690-C (OM001) – Otowave 102 Operating Manual...
  • Page 31  and base unit cannot be Ensure connection established. between printer and base unit is established. If difficulties resolving fault conditions occur the equipment distributor (or Amplivox if purchased directly) should be consulted. D-0115690-C (OM001) – Otowave 102 Operating Manual...

  • Page 32: Technical Specification

    Real Time Clock Time stamps Time and date stamp applied to all recordings, and to the last calibration date Backup power supply > 30 days without main batteries fitted D-0115690-C (OM001) – Otowave 102 Operating Manual...

  • Page 33: Equipment Classification

    Degree of protection against ingress of water Not protected Mode of operation Continuous operation Equipment mobility Portable The Otowave 102 Tympanometer is classified as a Class IIa device under Annex IX of the EU Medical Devices Directive. D-0115690-C (OM001) – Otowave 102 Operating Manual...

  • Page 34: Symbols

    Definition: Type BF applied part – an applied part providing a higher degree of protection against electric shock than that provided by a Type B applied part, particularly regarding allowable patient leakage current and patient auxiliary current. The applied part is the ear tip. D-0115690-C (OM001) – Otowave 102 Operating Manual...

  • Page 35: Ordering Consumables And Accessories

    ORDERING CONSUMABLES AND ACCESSORIES 16. ORDERING CONSUMABLES AND ACCESSORIES To order consumables, additional accessories and to replace detachable parts that have been damaged, please contact Amplivox for current prices and delivery charges. The items available are listed below: DESCRIPTION STOCK NO.

  • Page 36: Disposal Information

    DISPOSAL INFORMATION 17. DISPOSAL INFORMATION Amplivox Limited is fully compliant with the WEEE (Waste Electrical and Electronic Equipment) Regulations. Our PRN (Producer Registration Number) is WEE/GA0116XU and we are registered with the approved WEEE Compliance Scheme, B2B Compliance, approval number WEE/MP3338PT/SCH.

  • Page 37: Emc Guidance & Manufacturer's Declaration

    Guidance and manufacturer’s declaration – electromagnetic emissions The Otowave 102 Tympanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otowave 102 Tympanometer should assure that it is used in such an environment.
  • Page 38 Hz) magnetic field fields should be at levels characteristic typical location typical IEC 61000-4-8 commercial hospital environment. NOTE U is the a.c. mains voltage prior to the application of the test level D-0115690-C (OM001) – Otowave 102 Operating Manual...
  • Page 39 Guidance and manufacturer’s declaration – electromagnetic immunity (2) The Otowave 102 Tympanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otowave 102 Tympanometer should assure that it is used in such an environment.
  • Page 40 The Otowave 102 Tympanometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Otowave 102 Tympanometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Otowave 102 Tympanometer as recommended below, according to the maximum output power of the communications equipment.

  • Page 41: Use With Non-Medical Electrical Equipment

    Refer to Diagrams 1 & 2 below for typical configurations of connected peripheral equipment. Refer to Amplivox Limited at the address given on the front of this user manual if advice is required regarding the use of peripheral equipment.
  • Page 42 USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT Diagram 1: Otowave 102 used with the supplied printer Mains Outlet Printer via IrDA Link Printer Power Supply Otowave 102 Tympanometer D-0115690-C (OM001) – Otowave 102 Operating Manual...
  • Page 43 USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT Diagram 2: Otowave 102 used with a computer & IrDA Link Mains Outlet Computer via IrDA Link Computer Power Supply Otowave 102 Tympanometer D-0115690-C (OM001) – Otowave 102 Operating Manual...
  • Page 44 Copyright © 2018 Amplivox Ltd. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of Amplivox Ltd. D-0115690-C (OM001) – Otowave 102 Operating Manual...

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