otometrics MADSEN Alpha OAE User Manual
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otometrics MADSEN Alpha OAE User Manual

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MADSEN Alpha OAE Screener
User Manual
Doc no. 7-50-1370-US/01
Part no. 7-50-13700-US
0 4 5 9

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  • Page 1 MADSEN Alpha OAE Screener User Manual Doc no. 7-50-1370-US/01 Part no. 7-50-13700-US 0 4 5 9...
  • Page 2 Copyrightnotice No part of this documentation orprogram may be reproduced, stored in a retrieval system, ortransmitted, in any form orby any means, electronic, mechanical, photocopying, recording,or otherwise,without the prior written consent of GN Otometrics A/S. Copyright© 2013, GN Otometrics A/S Published in Denmark byGN Otometrics A/S, Denmark All information, illustrations, and specifications in this manual are based on the latest productinformation available at the time of publication.

  • Page 3: Table Of Contents

    The DPOAE test 5.3.1 Starting the test 5.3.2 The DPOAE test 5.3.3 DPOAE test results Options in the test result screens Continuing testing on the other ear Viewing a patients test record 5.6.1 Test View Otometrics - MADSEN Alpha OAE...
  • Page 4 App. 1.6 Repair, after-sales service and regular checks App. 1.6.1 Declaration App. 1.7 Manufacturer App. 1.7.1 Responsibility of the manufacturer App. 2 Status and Error Messages App. 2.1 Device related messages App. 2.2 Usage and test related messages Otometrics - MADSEN Alpha OAE...
  • Page 5 App. 3.5.2 DC power input App. 3.5.3 Power adapter App. 3.6 OAE probe App. 3.6.1 Probe cable App. 3.6.2 Dimensions App. 3.6.3 Weight App. 3.6.4 Eartips App. 3.7 Device class App. 3.8 Notes on EMC (Electromagnetic Compatibility) Index Otometrics - MADSEN Alpha OAE...
  • Page 6 Otometrics - MADSEN Alpha OAE...

  • Page 7: Introduction

    TEOAE module can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. Otometrics - MADSEN Alpha OAE...

  • Page 8: About This Manual

    The 1077 device comes in various configurations. The Alpha OAE device, which is a 1077 device, is only available in an OAE configuration. Important GN Otometrics A/S does not guarantee the accuracy of the test results or the tests themselves, if • accessories other than those supplied by GN Otometrics A/S are used for this device (i.e. eartips).

  • Page 9: Typographical Conventions

    Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device. • Note Indicates that you should take special notice. • 1.4.1 Navigating this manual Menus, icons and functions to select are shown in bold type, as for instance in: • Press the button. Otometrics - MADSEN Alpha OAE...
  • Page 10 1 Introduction Otometrics - MADSEN Alpha OAE...

  • Page 11: Unpacking And Installation

    Views of Alpha OAE 2.2.1 Front and rear view On/Off switch Test cavity Touch screen display Button for opening battery compartment Power and charging status light indicator Cover on battery compartment with serial number label Otometrics - MADSEN Alpha OAE...

  • Page 12: Top And Bottom View

    Never use any type of sharp instrument on the display. If you do, reliable operation of Alpha OAE can • no longer be guaranteed. 2.2.4 Ear probe Probe cable plug Probe tip Probe body Probe cable Otometrics - MADSEN Alpha OAE...

  • Page 13: Storage

    Storing the battery in a refrigerator can be recommended. If the battery is stored with full battery capacity and at room temperature or warmer, the battery will permanently degrade with about 10-20% after one year. Otometrics - MADSEN Alpha OAE...

  • Page 14: Inserting The Battery In Alpha Oae

    The battery symbol is shown in the top right corner of the display, enabling you to view the status of the battery at all times. • When less than 25% of the battery capacity remains, we recommend that you change the battery and recharge it as soon as possible. Otometrics - MADSEN Alpha OAE...

  • Page 15: Charging The Battery With The External Charger

    2.5.4 Charging the battery with the external charger Caution Use only the charger supplied by GN Otometrics A/S. • The battery for Alpha OAE is charged by an external charger. See the charger manufacturer’s documentation for specifications and instructions for use.
  • Page 16 2 Unpacking and Installation Otometrics - MADSEN Alpha OAE...

  • Page 17: Getting Started With Alpha Oae

    When Alpha OAE is in power-saving mode, the display goes black and the power indicator lights up green. • Simply touch the screen to reactivate Alpha OAE. 3.1.2 The Alpha OAE screens • Buttons are described in – Function buttons ► 41 – General buttons ► 41 Otometrics - MADSEN Alpha OAE...

  • Page 18: The Home Menu

    3.1.3 The Home menu The Home menu Home From the menu, you can select all main functions in Alpha OAE. • The DPOAE test ► 26 • Viewing a patients test record ► 30 Otometrics - MADSEN Alpha OAE...
  • Page 19 3 Getting Started with Alpha OAE Printing ► 33 • Deleting data ► 42 • Alpha OAE settings ► 35 • Selecting child mode ► 25 • Otometrics - MADSEN Alpha OAE...
  • Page 20 3 Getting Started with Alpha OAE Otometrics - MADSEN Alpha OAE...

  • Page 21: Preparing For Testing

    3. Gently insert the probe plug into the probe socket on top of Alpha OAE. The plug does not require force to be inser- ted properly. Disconnecting the probe Caution Do not pull the plug by the cable when you disconnect the probe. • Otometrics - MADSEN Alpha OAE...

  • Page 22: Preparing The Test Environment

    2. Grasp the pinna and gently pull back and slightly away from the patient's head. 3. Look into the ear canal. 4. Inspect the ear canal to make sure it is clear of cerumen or debris as this may affect the res- ult of the test. Otometrics - MADSEN Alpha OAE...

  • Page 23: Fitting The Eartip On The Probe

    The probe can be inserted with the probe cable pointing either upwards or down- wards, depending on which direction fits best. Make sure that the probe fits well. Any leakage may increase the test duration because of sound leakage, excessive noise or both. Otometrics - MADSEN Alpha OAE...
  • Page 24 4 Preparing for testing Note Make sure that the cable is not in contact with any vibrating surfaces during testing. • Warning In case of ear or ear canal trauma, don’t start any measurements. • Otometrics - MADSEN Alpha OAE...

  • Page 25: Testing With Alpha Oae

    • Press the Child Mode button to activate or deactivate the function. When Child Mode is activated, an animated car is displayed on the screen during testing instead of the data that is normally displayed. Otometrics - MADSEN Alpha OAE...

  • Page 26: Ready To Test

    Probe fit If the probe does not fit correctly, adjust the position of the probe. Speaker test The probe fit is followed by a speaker test to make sure that the two speakers function correctly. Otometrics - MADSEN Alpha OAE...

  • Page 27: The Dpoae Test

    3 kHz • 2 kHz where 5 kHz is tested first. PASS The default PASS/REFER criterion is 3/4. The test stops automatically if 3 frequencies reach a result or 2 fre- REFER quencies receive a result. Otometrics - MADSEN Alpha OAE...

  • Page 28: Dpoae Test Results

    The results for Alpha OAE are measured and shown in decreasing frequencies. The frequencies tested are: 5000 Hz 4000 Hz 3000 Hz 2000 Hz The L1/L2 pair is 65/55 dB SPL. Only is shown. Otometrics - MADSEN Alpha OAE...
  • Page 29 Incomplete test If the test was stopped, an error message is shown. The result screen appears differently from the one shown, if the test failed or was abor- ted during calibration. Otometrics - MADSEN Alpha OAE...

  • Page 30: Options In The Test Result Screens

    , this patient should be referred for further testing. 5.6.1 Test View Home You can view tests from the screen. Home Test View 1. On the screen, press the button. This will take you to a list of tests. Otometrics - MADSEN Alpha OAE...

  • Page 31: The Test History Screen

    Print 3. To print the individual test results, press the icon next to the test you wish to print. For a description of the individual test result types, see DPOAE test results ► 28 Otometrics - MADSEN Alpha OAE...
  • Page 32 5 Testing with Alpha OAE Otometrics - MADSEN Alpha OAE...

  • Page 33: Printing

    The printouts show: • Test type • Left and/or right ear result, date and time • At the top of the print-out you will find additional fields for entering: – Last Name – First Name Otometrics - MADSEN Alpha OAE...
  • Page 34 6 Printing – – Date of Birth – Examiner PASS REFER Legend Legend • Left ear • Right ear Otometrics - MADSEN Alpha OAE...

  • Page 35: Alpha Oae Settings

    Cleaning and disinfecting the test cavity ► You can start the probe test in two ways: Performing the probe test ► 36 • Simply by inserting the probe in the test cavity of Alpha OAE (see Otometrics - MADSEN Alpha OAE...

  • Page 36: Performing The Probe Test

    1. Insert the probe tip without eartip in the test cavity on the device, or in an external test cavity. Probe Test Settings 2. Press the button on the screen. Performing the probe test ► 36 3. For more information, see Otometrics - MADSEN Alpha OAE...

  • Page 37: Test Settings

    2. Press the arrows to select the day (DD), month (MM), year (YYYY), hours (HH) and minutes (MIN). Tool 3. Press the button to change the date and time formats. Otometrics - MADSEN Alpha OAE...

  • Page 38: Language Setting

    2. To change the language on Alpha OAE, press the button with the preferred lan- guage. Note Your screen showing the available languages may not appear as the • one shown. Otometrics - MADSEN Alpha OAE...

  • Page 39: Sound Setting

    A high level of brightness will influence the power consumption of • the device. – Darkens the display – Brightens the display – Press the Default button to use the default setting for the display brightness. Otometrics - MADSEN Alpha OAE...

  • Page 40: System Info

    – Firmware release – HW version and Serial number – Next MADSEN Alpha OAE service date – Connected probe – Next service date for the connected probe – Memory usage Otometrics - MADSEN Alpha OAE...

  • Page 41: Handling Data In Alpha Oae

    To perform these functions, simply press the relevant function button. Function buttons • Scroll to see more/next page General buttons Available main functions are shown in the footer bar of the Alpha OAE screens. • To perform these functions, simply press the relevant button. Otometrics - MADSEN Alpha OAE...

  • Page 42: Deleting Data

    4. When you have deleted all the tests you wish to delete, press the button Home to go to the screen. 8.3.2 Deleting all tests 1. To delete all tests, press the Delete button on the Home screen. Otometrics - MADSEN Alpha OAE...
  • Page 43 8 Handling Data in Alpha OAE Delete This will take you directly to the menu. All tests 2. Press the button. You will be prompted to confirm that you wish to delete all tests. All tests will be deleted. Otometrics - MADSEN Alpha OAE...
  • Page 44 8 Handling Data in Alpha OAE Otometrics - MADSEN Alpha OAE...

  • Page 45: Maintenance And Cleaning

    Please remove the ear probe from the patient’s ear and separate the probe tip from the disposable ear tip before clean- ing. Caution You should always comply with local hygienic standards. • Hygienic precautions ► The probe tip – Remove the probe tip from the probe. Otometrics - MADSEN Alpha OAE...

  • Page 46: Cleaning The Probe Body

    – Use a moist tissue with alcohol for regular surface cleaning. Caution No part of the ear probe should be subjected to ultrasonic cleaning solutions or machines. • Otometrics - MADSEN Alpha OAE...

  • Page 47: Probe Calibration

    9.3.1 Cleaning and disinfecting the test cavity If needed, use a moist tissue with alcohol to clean the entry surface of the test cavity. Caution Make sure that no liquid enters the test cavity. • Otometrics - MADSEN Alpha OAE...

  • Page 48: Battery Safety And Maintenance

    The need for renewing the battery depends on the usage pattern and the battery capacity needed. 9.4.3 Disposal of old batteries Note Li-Ion batteries can be recycled! • Caution Dispose of used battery promptly. • Otometrics - MADSEN Alpha OAE...
  • Page 49 Do not disassemble and do not dispose of in fire. • Environmental protection • When the Li-Ion battery loses its capacity to be charged, make sure that it is disposed of according to local envir- onmental regulations, or return it to your dealer. Otometrics - MADSEN Alpha OAE...
  • Page 50 9 Maintenance and Cleaning Otometrics - MADSEN Alpha OAE...

  • Page 51: App. 1 Standards And Safety

    This requirement applies in the European Union. Do not dispose of these products as unsorted municipal waste. You can return your device and accessories to Otometrics, or to any Otometrics supplier. You can also con- tact your local authorities for advice on disposal.

  • Page 52: App. 1.3 Docking Station Symbols

    This requirement applies in the European Union. Do not dispose of these products as unsorted municipal waste. You can return your device and accessories to Otometrics, or to any Otometrics supplier. You can also con- tact your local authorities for advice on disposal.

  • Page 53: App. 1.5 Warranty

    Alpha OAE is within the war- ranty period. Service and repair of electro-medical equipment should only be carried out by the equipment manufacturer or by author- ized representatives. Otometrics - MADSEN Alpha OAE...

  • Page 54: App. 1.6.1 Declaration

    The equipment is used in accordance with the instructions for use. The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties. Otometrics - MADSEN Alpha OAE...

  • Page 55: App. 2 Status And Error Messages

    Replace the probe with a spare one and – the probe is damaged carry out the probe test to establish if the probe is damaged. Too much noise • Testing environment is too • Reduce noise (talking, mobile phones, noisy. etc.). Otometrics - MADSEN Alpha OAE...
  • Page 56 The probe tip is blocked. Paper feed error • The labels are not adjusted cor- • Re-adjust the labels and remove possible rectly in the label printer or blocking of paper feed. there is a paper jam. Otometrics - MADSEN Alpha OAE...

  • Page 57: App. 3 Technical Specifications

    DP-Gram, DPOAE level, noise level, test progress Result display: DP-Gram with DPOAE and noise level, and overall PASS/REFER SNR: 6 - 8 dB Minimum Amplitude: - 5 dB App. 3.3 Device MADSEN Alpha OAE is type 1077 from GN Otometrics A/S. Otometrics - MADSEN Alpha OAE...

  • Page 58: App. 3.3.1 Dimensions

    Language settings Up to 6 user selectable languages available in selected language package App. 3.3.7 Memory Test memory capacity: Max. 50 tests App. 3.3.8 Connectors OAE probe connector: 14 pin ODU Medisnap - For OAE Probe Otometrics - MADSEN Alpha OAE...

  • Page 59: App. 3.3.9 Real Time Clock

    Should be extended if MADSEN Alpha OAE has been stored in a cold environment. • App. 3.3.14 Disposal MADSEN Alpha OAE can be disposed of as normal electronic waste, according to WEEE and local regulations. Otometrics - MADSEN Alpha OAE...

  • Page 60: App. 3.3.15 Standards

    Battery level indicator: 5-step battery level indicator Battery Caution Use only rechargeable battery supplied by GN Otometrics A/S, Part no. 8-73-02400. Use of any other • battery may present a risk of fire or explosion. Battery type: Rechargeable Li-ion 3.7 V/1800 mAh (6.7 Wh), fully charged App.

  • Page 61: App. 3.5.2 Dc Power Input

    8 - 11 mm Transparent (1 size) 12 - 16 mm Blue (1 size) Foam tip: 9 - 13 mm Yellow (1 size) App. 3.7 Device class II a (according to Council Directive 93/42/EEC Appendix IX) Otometrics - MADSEN Alpha OAE...

  • Page 62: App. 3.8 Notes On Emc (Electromagnetic Compatibility)

    Power frequency magnetic fields should be at levels characteristic of a typical loc- (50/60 Hz) magnetic ation in a typical commercial or hospital environment. field IEC 61000-4-8 • Note is the AC mains voltage prior to application of the test level. Otometrics - MADSEN Alpha OAE...
  • Page 63 RFcompliance level above, the Alpha OAE should be observed to verify normal operation. If abnormal performance is observed, addi- tional measures might be necessary, such as reorienting or relocatingAlpha OAE. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Otometrics - MADSEN Alpha OAE...
  • Page 64 :At 80 MHzand 800 MHz the separation distancefor the higher frequency range applies. Note 2 :These guidelinesmay not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Otometrics - MADSEN Alpha OAE...

  • Page 65: Index

    47 Connecting probe to Alpha OAE 21 Inserting probe in ear 23 Data deleting data 42 Labelprinter 33 Delete a test 42 Language settings 38 Delete all tests 42 Device bottom view 12 Otometrics - MADSEN Alpha OAE...
  • Page 66 Storing Alpha OAE 13 fitting eartip 23 Switching on Alpha OAE 17 maintenance 45 System info 40 prepare for testing 21 tip 12 view 12 Technical specifications 57 Probe body Test maintenance 45 DPOAE procedure 26 Otometrics - MADSEN Alpha OAE...
  • Page 67 Test View 30 screen 31 Testing preparing for 21 Time and date settings 37 Unpacking 11 Views device top 12 display 12 ear probe 12 front 11 rear 11 Warning notes 52 Warranty repair 53 Otometrics - MADSEN Alpha OAE...

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