AmpliVox Otowave 202 Operating Manual
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AmpliVox Otowave 202 Operating Manual

Portable tympanometer
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Summary of Contents for AmpliVox Otowave 202

  • 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. This product is manufactured by: Amplivox Ltd. Amplivox Ltd. 6 Oasis Park, Eynsham 10393 West 70th Street Oxfordshire, OX29 4TP...
  • Page 3 Caution: Federal Law restricts this device to sale by or on the order of a licenced medical professional. Indications for Use The Otowave 202 Portable Tympanometer is designed for use by trained operators (audiologists, general practitioners, hearing aid dispensers, and child health professionals) in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders in the general population associated with the functioning of the middle ear.

  • Page 5: Table Of Contents

    Saving Results in the Internal Database ........30 6.1. Data entry ..................30 6.2. Database full..................31 Sending the Results to a Printer ..........31 Data Transfer to NOAH or TympView .......... 34 Otowave 202 Operating Manual Page 1 D-0115696-B...
  • Page 6 EMC Guidance & Manufacturer’s Declaration ......56 Use with Non-medical Electrical Equipment....... 62 1000Hz Tympanometry and Meatus Compensation....67 19.1. Tympanometric Properties .............. 67 19.2. Tympanometric Measurements ............67 19.3. Additional Points to Consider ............69 Page 2 D-0115696-B Otowave 202 Operating Manual...

  • Page 7: 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).

  • Page 8: Unpacking

    Additional rolls of thermal paper 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. 1.7. Guarantee All Amplivox instruments are guaranteed against faulty materials and manufacture.

  • Page 9: Important Safety Instructions

    2. Important Safety Instructions The Otowave 202 instrument must be used only by practitioners qualified to perform tympanometric tests. It is intended for transient use as a screening and diagnostic tool; however no surgical or medical procedure should be undertaken solely on the basis of results obtained from the instrument.

  • Page 10: Electromagnetic Compatibility (Emc) Considerations

    Section 14. 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 11: Power Supply Options

    The mains adapter is the mains disconnect device and therefore the tympanometer should be positioned such that easy access to the mains adapter is possible. If a replacement mains adapter is required, please contact Amplivox or your Amplivox distributor. D-0115696-B Otowave 202 Operating Manual...

  • Page 12: Tympanometer Connections

    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 13: Data Transfer To A Computer

    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). 3. Principles of Operation Please note: This operating manual is not intended as a training manual for tympanometry.

  • Page 14: Stapedial Reflex Measurement

    The Otowave 202 can measure a stapedial reflex at 500Hz, 1000Hz, 2000Hz and 4000Hz; any combination of these frequencies may be selected for ipsilateral and contralateral mode. The maximum level for the reflex stimulus may be preset, along with the step size in dB between the three preceding lower levels of stimulus (see Section 5.7).

  • Page 15: Operating Language

    Portuguese or Italian) use the options within the CONFIGURATION menu (see Section 12.2). 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.

  • Page 16: Controls And Indicators (Probe)

    The function of the left and right keys is usually shown on the bottom line of the display. When powered by batteries and not performing a test the Otowave 202 will switch off automatically after 90 or 180 seconds if no key is pressed (see Section 12.2 to make this selection).

  • Page 17: Probe Components

    A small seal will be found in the base of the probe tip. This should be examined and replaced if it is blocked or damaged. Do not remove the nut securing the boss to the probe body. D-0115696-B Otowave 202 Operating Manual Page...

  • Page 18: Contralateral Transducer

    4.8. 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 19: Initial Settings

    CONFIGURATION options in Section 12.2 To view the test settings ensure that the MAIN MENU is displayed and then press and hold the function button on the probe to display the TEST SETTINGS screen as shown below. D-0115696-B Otowave 202 Operating Manual Page...

  • Page 20: Prior To Testing And Ambient Conditions

    (seated or standing) so as to be able to initiate a test by using the tympanometer controls and then apply the ipsilateral probe to the patient’s ear Page 16 D-0115696-B Otowave 202 Operating Manual...

  • Page 21: Ear Tip(S)

    If a contralateral reflex stimulus is to be applied, fit a new ear tip to the contralateral transducer before presenting it to the patient’s opposite ear canal. Refer to Sections 2.1 and 11.2 regarding these single- use parts. D-0115696-B Otowave 202 Operating Manual Page...

  • Page 22: 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 Page 18 D-0115696-B Otowave 202 Operating Manual...
  • Page 23 Before starting the reflex test the ear canal pressure will be set to the value that gave the peak admittance during the tympanogram test. The instrument will then step through the tone frequencies and levels set in the D-0115696-B Otowave 202 Operating Manual Page...
  • Page 24 226Hz probe with the default offset of +200daPa. See Section 5.5 for a description of the displays for other baseline modes. Page 20 D-0115696-B Otowave 202 Operating Manual...
  • Page 25 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-0115696-B Otowave 202 Operating Manual Page...
  • Page 26 ▼ keys to view the results for the other frequencies. 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.
  • Page 27 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-0115696-B Otowave 202 Operating Manual Page...

  • Page 28: Sweep Settings

    226Hz or 1000Hz. 5.5.3 Baseline Mode The Otowave 202 can display tympanograms in a variety of graphical formats allowing the operator to choose the most appropriate for the patient under examination. The initial baseline display mode may be changed from the default using the CONFIGURATION menu (see Section 12.2).
  • Page 29 1000Hz modes may be selected if required (see Section 5.5.3). The units displayed on the vertical axis are mmho (mƱ) which is normal practice for 1000Hz operation. The ear canal volume (ECV) is shown in ml. D-0115696-B Otowave 202 Operating Manual Page...
  • Page 30 (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. Page 26 D-0115696-B Otowave 202 Operating Manual...
  • Page 31 226Hz and the differences in the mathematical analysis needed to treat the two cases. 5.5.3.3 Selecting alternative display modes Switching between baseline display modes is carried out using the function button on the probe (see Section 4.4). D-0115696-B Otowave 202 Operating Manual Page...
  • Page 32 Low & High. The method used for the thorough ear seal check places a maximum limit on the ear canal volume of ~4.5ml. Page 28 D-0115696-B Otowave 202 Operating Manual...

  • Page 33: Reflex Options

    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 202 will test for a reflex at all selected levels. (Refer to table 14.1 in the specification for limits on the ipsilateral & contralateral reflex stimulus levels.)

  • Page 34: Error Messages

    Use the ▲ ▼ ◄ and ► keys to select a character Press and hold the ► key to enter the selected character Press and hold the ◄ key to delete the last character Page 30 D-0115696-B Otowave 202 Operating Manual...

  • Page 35: Database Full

    7. Sending the Results to a Printer Two thermal printers (the Able AP1300 or Sanibel MPT-II) are available as options for use with the Otowave 202 both of which communicate via an infra-red link (IrDA). Either (or both) printer model(s) may be specified when ordering and only these printers should be used.
  • Page 36 The following are recommendations but may need to be modified depending on the environment.  The Otowave 202 should be placed on the desk 10-20cm in front of the printer  The two communication windows should be in line and pointing directly at each other ...
  • Page 37 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 38: Data Transfer To Noah Or Tympview

    8. Data Transfer to NOAH or TympView 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 TympView 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 39: Data Management

    9. 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:...

  • Page 40: Delete Records

    DELETE RECORDS allows a group of records to be deleted. It is possible to delete all records, all records that have been printed or all records that have been sent to a computer. Confirmation of the deletion is required. Page 36 D-0115696-B Otowave 202 Operating Manual...

  • Page 41: Print Records

    May be used as an alternative to the automatic connection (see Section 8). 10. 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:...

  • Page 42: Routine Maintenance

    Use a soft lint-free cloth lightly dampened with cleaning solution to clean: all exposed surfaces other parts that contact the patient  Single use components such as ear-tips do not require cleaning Precautions: Page 38 D-0115696-B Otowave 202 Operating Manual...

  • Page 43: Eartips And Probe

    11.3. 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 44: Menu Summary

    Select 100daPa/s 200daPa/s or CONFIGURATION SWEEP SPEED 300daPa/s See Section 5.5. PROBE Select 226Hz or 1000Hz for the FREQUENCY frequency of the probe signal. REFLEX Select ipsilateral, contralateral or SEQUENCE both for the reflex stimulus. Page 40 D-0115696-B Otowave 202 Operating Manual...
  • Page 45 +200daPa or -400daPa offset (in Scalar mode); +200daPa or -400daPa offset (in Vector mode); or Component mode (Y/B/G). See Section 5.5 for details of these display modes. Select “QUICK” or “THOROUGH”. EAR SEAL CHECK See Section 5.6. D-0115696-B Otowave 202 Operating Manual Page...
  • Page 46 Select 90 or 180 seconds. Change the display contrast. 0 – 15. LCD CONTRAST Default is 7. Select “PRINT CAL. DATES” or REPORT CAL. “HIDE CAL.DATES” for the printout. DATES Select “DD/MM/YY” or “MM/DD/YY” SET DATE FORMAT Page 42 D-0115696-B Otowave 202 Operating Manual...
  • Page 47 Shows the volume in ml measured by the probe. DATA LIST RECORDS Lists the test results stored in the MANAGEMENT internal database. Allows individual records to be viewed, printed, sent to a computer or deleted. D-0115696-B Otowave 202 Operating Manual Page...

  • Page 48: Error Messages & Fault Conditions

    If the end of travel is reached in such conditions the instrument may lock up and become un-usable. Page 44 D-0115696-B Otowave 202 Operating Manual...
  • Page 49 If difficulties resolving fault conditions occur the equipment distributor (or Amplivox if purchased directly) should be consulted. 13.1 General error messages Message Displayed Indicator Likely Cause(s) Status PROBE NOT CLEAR Yellow Check that the probe is not Please ensure the...
  • Page 50 Green & The ear seal has been broken while Pressure lost Yellow testing for seal. WITHDRAW PROBE (Fast alternate) Green & An error condition has been INSERT PROBE Yellow recovered and the test may Page 46 D-0115696-B Otowave 202 Operating Manual...
  • Page 51 Connection to a computer is made automatically when the USB cable is connected as long as the appropriate software (NOAH Interface or TympView) 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.

  • Page 52: Technical Specification

    Impedance Module or TympView software for details of the data transfer operation and errors that may occur. If data transfer is not required simply unplug the USB cable and the Otowave 202 will return to normal operation. 14. Technical Specification 14.1.
  • Page 53 0daPa Reflex stimulus control Stimulus presented at all levels, or Stimulus ceases when a reflex is found Reflex detection threshold and 0.01ml to 0.5ml +/-0.01ml (configurable accuracy in 0.01ml steps) D-0115696-B Otowave 202 Operating Manual Page...
  • Page 54 & clinician’s details to be entered. Serial Interface to Computer Interface USB Version 1.1 Information sent Patient header, full left & right ear data. Power Supply Battery types 4 AA cells; either Alkaline (1.5V Page 50 D-0115696-B Otowave 202 Operating Manual...
  • Page 55 900 hPa to 1100 hPa atmospheric pressure range Standards conformance Safety IEC 60601-1 (plus UL, CSA & EN deviations) IEC 60601-1-2 Performance IEC 60645-5, Type 2 Tympanometer CE mark To the EU Medical Device Directive D-0115696-B Otowave 202 Operating Manual Page...

  • Page 56: 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. 14.3. Symbols The following symbols appear on the tympanometer or mains...
  • Page 57 Definition: Industry-standard Type-B USB connection to a computer D-0115696-B Otowave 202 Operating Manual Page...

  • Page 58: Ordering Consumables And Accessories

    15. 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: Stock No. Description T527 Probe tip...

  • Page 59: Disposal Information

    Therefore for any waste electrical units purchased from Amplivox that either:  bear the crossed out wheeled bin symbol with black bar underneath, or ...

  • Page 60: 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. Emissions test Compliance Electromagnetic environment –...
  • Page 61 Guidance and manufacturer’s declaration – electromagnetic immunity 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 62 IEC 61000-4-8 typical location in a typical commercial or hospital environment. NOTE U is the a.c. mains voltage prior to the application of the test level Page 58 D-0115696-B Otowave 202 Operating Manual...
  • Page 63 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 64 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Otowave 202 Tympanometer is used exceeds the applicable RF compliance level above, the Otowave 202 Tympanometer should be observed to verify normal operation.
  • Page 65 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...

  • Page 66: Use With Non-Medical Electrical Equipment

    The Otowave 202 tympanometer uses an industry-standard infra-red means of communication (an IrDA port - as described in Section 7). In addition, the following signal inputs and outputs on the Otowave 202 tympanometer are electrically isolated to the requirements of IEC 60601-1:...
  • Page 67 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. Diagram 1: Otowave 202 used with the medically-approved mains adapter Mains Outlet Medical Mains Adapter...
  • Page 68 Diagram 2: Otowave 202 used with the supplied printer Mains Outlet Printer via IrDA Link Printer Power Supply Otowave 202 Tympanometer Page 64 D-0115696-B Otowave 202 Operating Manual...
  • Page 69 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-0115696-B Otowave 202 Operating Manual Page...
  • Page 70 Page 66 D-0115696-B Otowave 202 Operating Manual...

  • Page 71: 00Hz Tympanometry And Meatus Compensation

    (Y ) from the total measured admittance (Y ), to yield the admittance in the plane of the tympanic meas membrane (Y ). This separation is variously called baseline removal or D-0115696-B Otowave 202 Operating Manual Page...
  • Page 72 (as shown in Fig. 1), and this approach is taken by most if not all commercial tympanometers. But for 1000Hz measurements, the Otowave 202 optionally can take the more advanced approach, employing vector based subtraction. It is a mathematically more thorough and...

  • Page 73: Additional Points To Consider

    Although vector subtraction is the only correct solution at 1000Hz, it may be unfamiliar to users and therefore the Otowave 202 offers the option of selecting either scalar or vector baseline compensation for 1000Hz tympanograms.
  • Page 74 4. The Otowave 202 allows the baseline compensation mode to be changed after a test has been performed, for comparative purposes. The test can then be stored with the new mode applied. It can also be reloaded and the baseline compensation mode changed again for further review and printing.
  • Page 75 ) is adequate. Contrast this with Figure 2 where the phase angles are very different and a scalar subtraction would erroneously give a value close to zero, instead of the length of the vector in orange D-0115696-B Otowave 202 Operating Manual Page...
  • Page 76 Y and Y (which here would be close to 0), due to the conductance values and the possibility of mass dominated measurements. Vector subtraction ( ) is necessary. Page 72 D-0115696-B Otowave 202 Operating Manual...

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