AmpliVox Otowave 102 Operating Manual
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AmpliVox Otowave 102 Operating Manual

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Otowave 102
Operating Manual

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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 1.71.C onwards – please refer to SYSTEM INFORMATION screen). This product is manufactured by: 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 5 Ear seal check ................. 17 5.5. Reflex options .................. 18 5.6. Error messages ................18 Saving Results in the Internal Database ........19 6.1. Data entry ..................19 6.2. Database full..................20 IrDA Communications ..............20 Otowave 102 Operating Manual Page 1 OM001-16...
  • Page 6 Performance ..................32 14.2. Equipment classification ..............35 14.3. Symbols ................... 35 Ordering Consumables and Accessories ........36 Disposal Information ..............37 EMC Guidance & Manufacturer’s Declaration ......38 Use with Non-medical Electrical Equipment....... 44 Page 2 Otowave 102 Operating Manual OM001-16...

  • Page 7: Introduction

    1. Introduction 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. 1.1. Intended applications The Otowave 102 is designed for use by audiologists, general practitioners, hearing aid dispensers and child health professionals.

  • Page 8: Standard Contents

    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 102 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

    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 11: Stapedial Reflex Measurement

    Refer to Section 12.2. 4.1. Installing & replacing batteries The Otowave 102 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 12: Operating Language

    Press the up ▲ and down ▼ navigation keys to scroll through the menus or set values Press the right navigation key ► to accept a menu choice or go to the next step. Page 8 Otowave 102 Operating Manual OM001-16...
  • Page 13 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 12.2 to make this selection).

  • Page 14: The Probe

    After replacing the tip a Daily Check should be carried out (see Section 10). 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...

  • Page 15: Initial Settings

    Tympanometric and reflex testing should always be performed in a quiet room or in an acoustic booth. Otowave 102 Operating Manual OM001-16 Page 11...

  • Page 16: Ear Tip(S)

    From the MAIN MENU select NEW TEST: MAIN MENU NEW TEST VIEW THE LAST TEST DAILY CHECK Select Select the ear(s) required for test: SELECT EAR BOTH LEFT RIGHT  Back Select Page 12 Otowave 102 Operating Manual OM001-16...
  • Page 17 Equalising Pressure Cancel TESTING LEFT EAR Pressure Settling Cancel Press ◄ at any time to cancel the test and return to the ear selection menu. TESTING LEFT EAR  Seal Obtained Taking Tympanogram Cancel Otowave 102 Operating Manual OM001-16 Page 13...
  • Page 18 The display confirms that the test has been completed along with the instruction WITHDRAW PROBE. Remove the ear tip from the patient and after a short period the tympanogram will be displayed. Page 14 Otowave 102 Operating Manual OM001-16...
  • Page 19 ▼ keys to view the results for the other frequencies. If the Otowave 102 was set to test for a reflex at all levels of the stimulus (see Reflex autostop in Section 5.5) press ► to view an additional display following the reflex graphs.
  • Page 20 When the selected ears have been tested and the results saved the PROCESS RESULTS menu will be displayed. This accesses the following functions:  Print the results  Send the results to a computer  Save the results in the internal database Page 16 Otowave 102 Operating Manual OM001-16...

  • Page 21: 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. Otowave 102 Operating Manual OM001-16 Page 17...

  • Page 22: 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 102 will test for a reflex at all selected levels. (Note that 100dBHL at 4000Hz is not available).

  • Page 23: Saving Results In The Internal Database

    6. 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. This option can also be accessed by selecting VIEW THE LAST TEST from the main menu and scrolling through the results using the ►...

  • Page 24: Database Full

    DELETE OLDEST will overwrite the oldest record in memory with the results being stored. Cancel will return to the previous menu. 7. IrDA Communications Please refer to Section 18 for important information regarding the connection of non-medical electrical equipment to medical electrical equipment Page 20 Otowave 102 Operating Manual OM001-16...

  • Page 25: Transferring The Results

    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 (see Section 15) and only this device should be used for this purpose.

  • Page 26: Data Transfer To Noah Or Tympview

    Option2 setting (for IrDA communications) is set to 2 (9600 baud) If the Martel MCP8830 printer is also to be used with an Amplivox audiometer it may be necessary to ensure that the Option 4 setting (for RS232 Baud Rate) is set to 4 (2400 baud).

  • Page 27: Data Management

    If the problem persists contact an Amplivox service centre. 9. 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:...

  • Page 28: List Records

    When a record is selected the PROCESS RECORD menu will be displayed. This accesses the following functions:  View the selected record  Print the selected record  Send the selected record to a computer  Delete the selected record Page 24 Otowave 102 Operating Manual OM001-16...

  • Page 29: Delete Records

    Refer to Section 8.2 for more general information. 10. 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:...

  • Page 30: Routine Maintenance

    The seal should be replaced when the probe tip is replaced, if it shows signs of wear, or if a pressure leak is suspected. Refer to Section 4.4 for illustrations of these components. Page 26 Otowave 102 Operating Manual OM001-16...

  • Page 31: Calibration And Repair Of The Instrument

    11.3. 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 in Section 2.1 re-calibration must be undertaken at the intended operating elevation.

  • Page 32: Sub-Menu Selections

    ALL RECORDS – Delete all records PRINT Print stored records. Select: RECORDS UNPRINTED RECORDS – Print all records not previously printed. ALL RECORDS – Print all records Page 28 Otowave 102 Operating Manual OM001-16...
  • Page 33 Select 90 or 180 seconds Change the display contrast. 0 – 15. LCD CONTRAST Default 7. EAR SEAL Select QUICK or THOROUGH CHECK See Section 5.4. Otowave 102 Operating Manual OM001-16 Page 29...

  • Page 34: Error Messages & Fault Conditions

    If the end of travel is reached in such conditions the instrument may lock up and become un-usable. If difficulties resolving fault conditions occur the equipment distributor (or Amplivox if purchased directly) should be consulted. Page 30 Otowave 102 Operating Manual...
  • Page 35 Amplivox service centre. “WARNING! DEVICE UNCALIBRATED. This message should never One or more default values require normally be seen. If it persists recalibration before further tests are contact your Amplivox service Otowave 102 Operating Manual OM001-16 Page 31...

  • Page 36: Technical Specification

    Ear Canal Volume (ECV) @ 200 daPa Probe tone levels and accuracy 226Hz +/- 2%; 85dB SPL +/-2dB over range 0.2ml to 5ml Pressure levels and accuracy +200daPa to -400daPa +/-10daPa or +/-10% (whichever is larger) over range Page 32 Otowave 102 Operating Manual OM001-16...
  • Page 37 Right Ear, Time and Date of recording, which ears were tested, whether or not the record has been printed and/or sent to a computer, parameters used for analysis, 128 bit Globally Unique Identifier (GUID) Otowave 102 Operating Manual OM001-16 Page 33...
  • Page 38 Auto power-off delay 90 or 180 seconds Idle current 70mA Current while testing 230mA Physical Display 128 x 64 pixels / 8 lines of 21 characters Dimensions 190mm long x 80mm wide x 40mm high Page 34 Otowave 102 Operating Manual OM001-16...

  • Page 39: Equipment Classification

    Not protected Mode of operation Continuous operation Equipment mobility Portable The Otowave 102 Tympanometer is classified as a Class IIa device under Annex IX (Section 1) of the EU Medical Devices Directive. 14.3. Symbols Definition: Refer to instruction manual (mandatory) Definition: Type BF applied part –...

  • Page 40: Ordering Consumables And Accessories

    The applied part is the ear tip. 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.

  • Page 41: 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 42: 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. Emissions test Compliance Electromagnetic environment –...
  • Page 43 Guidance and manufacturer’s declaration – electromagnetic immunity 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 44 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 40 Otowave 102 Operating Manual OM001-16...
  • Page 45 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 46 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Otowave 102 Tympanometer is used exceeds the applicable RF compliance level above, the Otowave 102 Tympanometer should be observed to verify normal operation.
  • Page 47 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...

  • Page 48: 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 44...
  • Page 49 Diagram 1: Otowave 102 used with the supplied printer Mains Outlet Printer via IrDA Link Printer Power Supply Otowave 102 Tympanometer Otowave 102 Operating Manual OM001-16 Page 45...
  • Page 50 Diagram 2: Otowave 102 used with a computer & IrDA Link Mains Outlet Computer via IrDA Link Computer Power Supply Otowave 102 Tympanometer Page 46 Otowave 102 Operating Manual OM001-16...

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