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AmpliVox Otowave 202 Operating Manual

Portable high frequency tympanometer
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  • Page 1 Otowave 202 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 202 (applies to firmware version 1.0.0.072200). This product is manufactured by: Amplivox Ltd. Amplivox Ltd. 6 Oasis Park, Eynsham 10393 West 70th Street...
  • Page 3 Reflex tests are used to measure stapedial reflexes. The Otowave 202 measures ipsilateral reflexes and, when selected, reflex measurement is automatically carried out after a tympanogram is taken.

  • Page 4: Table Of Contents

    Ear seal check ..............................21 6.2. REFLEX OPTIONS ................................22 6.3. SYSTEM SETTINGS ............................... 23 SAVING RESULTS IN THE INTERNAL DATABASE ......................25 7.1. DATA ENTRY ................................25 7.2. DATABASE FULL ................................25 D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 5 EMC GUIDANCE & MANUFACTURER’S DECLARATION ....................43 USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT....................47 1000HZ TYMPANOMETRY AND MEATUS COMPENSATION ..................51 20.1. TYMPANOMETRIC PROPERTIES ........................... 51 20.2. TYMPANOMETRIC MEASUREMENTS ........................... 51 20.3. ADDITIONAL POINTS TO CONSIDER..........................52 D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 6: Introduction

    This operating manual applies to the Otowave 202 which is available as a standard option (with 226Hz probe tone) and as an H-option (with 226Hz and 1000Hz probe tones). Text that applies to 1000Hz operation only is marked 1.2.

  • Page 7: Standard Contents And Optional Accessories

    CAUTION equipment. 1.7. 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. 1.8. GUARANTEE All Amplivox instruments are guaranteed against faulty materials and manufacture. The instrument will be repaired free of charge for a period of two years from the date of dispatch if returned, carriage paid, to the Amplivox service department.
  • Page 8 The pressure pump and transducers may go out of calibration due to rough CAUTION handling or impact (dropping).  The lifetime of probe, probe seals and eartips is dependent upon conditions of use. These parts are only guaranteed against faulty materials or manufacture. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 9: Important Safety Instructions

    As with all instruments of this nature the measurements taken will be influenced by significant changes in altitude & pressure. The Otowave 202 tympanometer must be re-calibrated if it is to be used at elevations greater than 800m above mean sea level.

  • Page 10: Power Supply Options

    For connected parts marked * only connect the accessories supplied with the instrument or supplied by Amplivox or an Amplivox distributor. These parts have been tested for use with the Otowave 202 tympanometer for compliance with the standards IEC 60601-1 and IEC 60601-1-2. The use of accessories other than those specified may compromise compliance with these standards.

  • Page 11: Data Transfer To A Printer

    The tympanometer is supplied with software to allow connection to a computer for the transfer of test results (see Section 8). You must use the designated USB cable which is available from Amplivox (see Section 15). D-0115692-C (OM031) –...

  • Page 12: Principles Of Operation

    +200 daPa to -400 daPa by means of a small pump. The admittance peaks when the air pressure is the same on both sides of the tympanic membrane. The change of admittance with pressure is displayed graphically. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 13: Acoustic Reflex Measurement

    The reflex stimulus may be produced in the ear being measured (ipsilateral mode), the opposite ear (contralateral mode) or in both ears (ipsilateral mode followed by contralateral mode). For contralateral stimulation the reflex tone is produced in a separate transducer supplied with the instrument. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 14: Using The Otowave

    Refer to Section 6. 4.1. INSTALLING & REPLACING BATTERIES The Otowave 202 may be powered from Alkaline ‘AA’ batteries or rechargeable Nickel-Metal Hydride (NiMH) batteries (see Section 14). Four batteries are required. Do not mix battery types or old and new batteries.

  • Page 15: Controls And Indicators (Base Unit)

    4.3. CONTROLS AND INDICATORS (BASE UNIT) Press the On/Off key momentarily to turn the Otowave 202 on (refer to the diagram below). No warm-up time is required, although a short diagnostic routine will run for a few seconds. During this time the internal pump will operate.

  • Page 16: The Probe

    Do not use any tools to tighten the nose cone. After replacing the tip a Daily Check should be carried out (refer to chapter Error! Reference source not ound.). Video available on how to clean the probe tip. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 17: Contralateral Transducer

    Do not use any tools to tighten the contralateral probe tip. 4.7. START-UP AND MENU DISPLAYS When the Otowave 202 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 18: Taking Measurements

    Please note: Never suitable ear tip fitted. The ear tip size is chosen based on the diameter of the external ear canal and should suit the patient’s ear but also provide a comfortable pressure seal. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 19: Performing A Test

    TESTING LEFT EAR INSERT PROBE Cancel Present the ear tip to the ear and obtain a seal. If a good seal has been detected the following sequence of messages will be seen D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 20 The display changes to show the frequency and level being used, starting with the lowest frequency and level selected. This will be followed by a contralateral reflex test if this has been selected, with the display showing the frequency and level being used: D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 21 1000Hz probe tone (see Section 5.5). To repeat the test, press ◄. When satisfied with the tympanogram press ►. If reflex test(s) were carried out these results will now be displayed: D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 22 If the Otowave 202 was set to test for a reflex at all levels of the stimulus (see Reflex autostop in Section 5.7) 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 23 Results of the last test will be erased as soon as a new test is started. Test results should be saved to the Otowave’s database, printed or sent to a computer to ensure that data is not lost. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 24: Configurations

    -400daPa may be selected if required (as shown in the diagram on the right and indicated by 4S on the display). See Section 5.5.3 for details of how to switch between the available display modes. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 25: Scalar And Vector Mode - 1000 Hz

    It is thus theoretically possible for the trace to appear to rise (i.e. take higher positive values) at the end opposite to the selected offset. The user is advised to view traces with each of the +200daPa and - 400daPa offsets selected before deciding which result to save. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 26: Selecting Alternative Display Modes

    The type of ear seal check employed at the start of a test can be set in the CONFIGURATION menu (Section 6). The default QUICK option is adequate for most tests, although it may not always be possible to generate the extremes of pressure with this setting. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 27: Reflex Options

    1kHz ipsi the ipsilateral and contralateral stimuli (500Hz, 1000Hz, 2000Hz & ▲ 4000Hz), and then the key to select () or deselect (-) the D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 28: System Settings

    Select PRINT CAL. DATES to show the serial number for the base PRINT CAL. unit and the transducers on the print-out provided by the Sanibel Dates Thermal printer. Date Mode: Set the format of how the date is displayed: DD/MM/YY or DD/MM/YY MM/DD/YY D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 29 Reset the instrument and all profiles to the original settings. Language: Change the operation language to English, German, French, English Spanish, Portuguese, Italian or Chinese. Defaults: Reset the sweep settings of the selected profile(s) to its original settings. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 30: Saving Results In The Internal Database

    OVERWRITE OLDEST will overwrite the oldest record in memory with the results being stored. Back will return to the previous menu. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 31: Sending The Results To A Printer

    The Otowave sends data to the printer through a small window on the right of the base unit. The data is received through a window in the front of the printer. The environment in which the Otowave 202 and printer are used can affect the printing process.
  • Page 32 Trying to connect.. Do Not break IR link! Cancel The Otowave 202 will then attempt to connect to the printer. When this has been done the data will be transferred. During this time the following message is displayed. PLEASE WAIT...

  • Page 33: Data Transfer To Noah Or Amplisuite

    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 34: Data Management

    DATA MANAGEMENT 10. DATA MANAGEMENT Records stored in the database of the Otowave 202 can be listed, viewed, printed, deleted or sent to a computer using the DATA MANAGEMENT option of the main menu: DATA MANAGEMENT LIST RECORDS DELETE RECORDS PRINT RECORDS ...

  • Page 35: Delete Records

    Print option described in Section 9.1. If printing the entire database it is recommended that a full roll of paper is loaded into the printer. 10.4. CONNECT VIA USB May be used as an alternative to the automatic connection (see Section 8). D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 36: Performing Daily Checks

    PERFORMING DAILY CHECKS 11. PERFORMING DAILY CHECKS The operation of the Otowave 202 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 37: 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-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 38: Routine Maintenance

    13.3. CALIBRATION AND RETURN OF THE INSTRUMENT Amplivox recommends that the Otowave is calibrated annually. A warning message will be displayed at power up if the instrument was calibrated more than twelve months ago. The date of the last calibration is displayed on the SYSTEM INFORMATION screen.
  • Page 39 When packing the instrument for shipping, please use the original shipping carton and packing materials. Place the instrument parts in plastic bags before packing to prevent dirt and dust getting into the probe. Do not return the batteries with the instrument. D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 40: Error Messages & Fault Conditions

     Volume outside range Ear canal volume is > 5ml.  WITHDRAW PROBE Probe properly Reposition the probe Indicator LED b and c flash inserted into the ear. fast. D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 41 No connection can be established not charged Restart the printer with the printer   Connection between Charge printer  printer and base unit Ensure the connection cannot be established. between printer and base unit is established. D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 42 Connection to a computer is made automatically when the USB cable is connected as long as the appropriate software (NOAH Interface or ampliSuite) has been installed and the Otowave 202 has the main menu displayed. The message ‘Awaiting PC … OK to disconnect’ is displayed if the connection is successful. Further commands are then executed from the computer.

  • Page 43: Technical Specification

    100dBHL max, with 5dB or 10dB steps 95/90/85dBHL max, with 5dB steps Contralateral - three lower levels: 110/105/100dBHL max, with 5dB or 10dB steps 95/90/85dBHL max, with 5dB steps D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 44 190mm long x 85mm wide x 40mm high excluding connections 260mm long including connections Weight (base - no batteries) 330 g Weight (base - with batteries) 430 g Dimensions - probe 130mm long x 25mm (max) diameter Weight (probe, incl connection) 110g D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 45: Equipment Classification

    Mode of operation Continuous operation Equipment mobility Portable The Otowave 202 Tympanometer is classified as a Class IIa device under Annex IX (Section 1) of the EU Medical Devices Directive. 15.3. SYMBOLS The following symbols appear on the tympanometer or mains adapter: Definition: Refer to instruction manual (mandatory) Definition: Type B applied part –...

  • Page 46: 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 47: 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 48: Emc Guidance & Manufacturer's Declaration

    Guidance and manufacturer’s declaration – electromagnetic emissions The Otowave 202 Tympanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otowave 202 Tympanometer should assure that it is used in such an environment.
  • Page 49 0.5 cycle 0.5 cycle hospital environment. If the supply input lines user of the Otowave 202 40% U 40% U Tympanometer requires (60% dip in U ) for 5 (60% dip in U...
  • Page 50 Guidance and manufacturer’s declaration – electromagnetic immunity (2) The Otowave 202 Tympanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otowave 202 Tympanometer should assure that it is used in such an environment.
  • Page 51 The Otowave 202 Tympanometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Otowave 202 Tympanometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Otowave 202 Tympanometer as recommended below, according to the maximum output power of the communications equipment.

  • Page 52: Use With Non-Medical Electrical Equipment

    Refer to Diagrams 1 to 3 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 53 USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT Diagram 1: Otowave 202 used with the medically-approved mains adapter Mains Outlet Medical Mains Adapter Otowave 202 Tympanometer D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 54 USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT Diagram 2: Otowave 202 used with the supplied printer Mains Outlet Printer via IrDA Link Printer Power Supply Otowave 202 Tympanometer D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 55 Diagram 3: Otowave 202 used with the medically-approved mains adapter and a computer Mains Outlet Medical Mains Adapter Otowave 202 Tympanometer Mains Outlet Computer Power Supply Computer via USB socket D-0115692-C (OM031) – Otowave 202 Operating Manual...

  • Page 56: 1000Hz Tympanometry And Meatus Compensation

    The baseline value (Y ) is the measured admittance of the ear when at maximum pressure (normally +200daPa for the Otowave 202). This approximates Y because the applied pressure reduces Y towards zero (but not all the way to zero, otherwise it would not be possible to hear the probe tone at all; nonetheless the approximation is sufficient for clinical purposes).

  • Page 57: Additional Points To Consider

    An additional feature of the Otowave 202 not found on other screening tympanometers is that the user can decide whether to use +200daPa or 400daPa as the reference point for the baseline value.
  • Page 58 Y (which here would be close to 0), due to the conductance values and the possibility of mass dominated ̅ ̅̅̅̅̅ − Y_ec measurements. Vector subtraction ( ) is necessary. D-0115692-C (OM031) – Otowave 202 Operating Manual...
  • Page 59 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-0115692-C (OM031) – Otowave 202 Operating Manual...

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