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otometrics Madsen AccuScreen PRO User Manual

Otoacoustic emissions and automated abr screener
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AccuScreen PRO
Otoacoustic Emissions and Automated
ABR Screener
User Manual
Doc no. 7-26-6810/08
Part no. 7-26-68100
0 1 2 4 1 2 7 5

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  • Page 1 AccuScreen PRO Otoacoustic Emissions and Automated ABR Screener User Manual Doc no. 7-26-6810/08 Part no. 7-26-68100 0 1 2 4 1 2 7 5...
  • Page 2 Printed in Denmark by GN Otometrics A/S, Denmark All information, illustrations, and specifications in this manual are based on the latest product information available at the time of publication. GN Otometrics A/S reserves the right to make changes at any time with- out notice.

  • Page 3: Table Of Contents

    The different versions of the AccuScreen PRO ................19 The AccuScreen PRO Front view ........................... 21 Top view ............................. 22 Bottom view ..........................22 Reverse side view........................23 Display & control panel ....................... 24 Ear probe ............................ 25 Before You Start Safety............................27 GN Otometrics A/S...
  • Page 4 6.2.2 DPOAE tests ........................51 6.2.3 DPOAE Diagnostic tests....................52 6.2.4 ABR tests........................53 After the test ..........................53 6.3.1 Adding comments to a test ..................... 53 Interpretation of the results ......................54 6.4.1 TEOAE ........................... 54 GN Otometrics A/S...
  • Page 5 11.1.5 Keyboard test ......................... 73 11.2 Settings 1............................ 74 11.2.1 Language........................74 11.2.2 Date/Time ........................75 11.2.3 Date/Time format......................75 11.2.4 Background Lighting (Display)..................75 11.2.5 Sounds ........................... 75 11.2.6 Default test ........................76 11.3 Settings 2............................ 76 GN Otometrics A/S...
  • Page 6 13.3 Repair, after-sales service and regular checks................88 13.3.1 Declaration ........................88 13.3.2 Service and repair ......................88 14 Status and error Messages 15 Technical Specifications 15.1 Device............................91 15.2 Battery and charger ........................91 15.3 Probe ............................92 GN Otometrics A/S...
  • Page 7 AccuScreen PRO User Manual 15.4 Measurement techniques ......................92 15.5 Device class..........................93 15.6 Applied standards ........................93 15.7 Manufacturer..........................94 15.8 Distributor ........................... 94 16 Index GN Otometrics A/S...
  • Page 8 User Manual AccuScreen PRO GN Otometrics A/S...

  • Page 9: Introduction

    The simple, yet reliable technology ensures that hearing loss can be detected, and intervention can be implemented, at an early age. With early intervention, hearing-impaired children are given the possibility of developing normal speech and language skills. GN Otometrics A/S...

  • Page 10: Intended Use

    ABR and DP tests are directed at all age groups. Important: GN Otometrics A/S does not guarantee the accuracy of the test re- sults or the tests themselves, if other accessories than those supplied by GN Otometrics A/S are used for this device (i.e. eartips, elec- trodes, Ear Couplers, etc.).

  • Page 11: New Features

    A warning indicates that there is a risk of danger to persons and de- vice. Caution: A caution indicates that there is risk of damage to the device. Note: A note indicates that you should take special notice. GN Otometrics A/S...
  • Page 12 Introduction AccuScreen PRO User Manual GN Otometrics A/S...

  • Page 13: Test Methods

    (for TEOAE) or two receivers (for DPOAE) to deliver the stimu- li. The microphone records the sound present in the external ear ca- nal in response to the acoustic stimulus. The type of signal analysis used depends on the type of emissions to be recorded. GN Otometrics A/S...

  • Page 14: Types Of Oaes

    The most frequently measured distortion product is at the frequency 2f1-f2, although the cochlea also produces distortion products at other frequencies. The 2f1-f2-distortion product is the largest distor- tion product, and is the only one utilised for clinical purposes at present. GN Otometrics A/S...

  • Page 15: Applications Of Oaes

    Each recorded sweep is assigned to one of eight quality buffers, ac- cording to its amplitude. The statistical analysis is carried out simul- taneously in each quality buffer, and the test result will be a PASS if GN Otometrics A/S...

  • Page 16: How The Accuscreen Pro D-Module Determines A Pass

    Signal-to-Noise Ration (SNR). Such methods show a false PASS rate that is considerably higher than the AccuScreen method. In fact, the false PASS rate can be up to 10% for the commonly used criteria of 6 dB SNR. GN Otometrics A/S...

  • Page 17: About Auditory Brainstem Response (Abr)

    The potentials picked up by the electrodes are called Auditory Evoked Potentials (AEP) or auditory responses. There are different AEP-producing regions between the cochlea and the primary auditory cortex. However, the responses of the brain- GN Otometrics A/S...

  • Page 18: How The Accuscreen Pro A-Module Determines A Pass

    Although this does not preclude testing older children and adults with the Accu- Screen PRO, the sub-optimal fit may result in longer test times for these patients. GN Otometrics A/S...

  • Page 19: Advantages Of Combined Oae/Abr-Screening

    You can choose between the following test methods: AccuScreen PRO T> TEOAE AccuScreen PRO D> DPOAE AccuScreen PRO A> AccuScreen PRO TD> TEOAE and DPOAE AccuScreen PRO TA> TEOAE and ABR AccuScreen PRO DA> DPOAE and ABR AccuScreen PRO TDA> TEOAE, DPOAE and ABR GN Otometrics A/S...
  • Page 20 Test Methods AccuScreen PRO User Manual GN Otometrics A/S...

  • Page 21: The Accuscreen Pro

    AccuScreen PRO User Manual The AccuScreen PRO The AccuScreen PRO Front view Graphic LCD display LED indicator OK button Softkeys Navigation arrows Alphanumeric keypad GN Otometrics A/S...

  • Page 22: Top View

    The AccuScreen PRO AccuScreen PRO User Manual Top view ABR socket Infrared window Probe socket & Y-cable socket Bottom view Connector to PC and label printer GN Otometrics A/S...

  • Page 23: Reverse Side View

    AccuScreen PRO User Manual The AccuScreen PRO Reverse side view Label with serial number Rechargeable NiMH battery pack GN Otometrics A/S...

  • Page 24: Display & Control Panel

    Press OK to activate menu items highlighted by the black bar and to confirm selections. The current function of the softkeys is displayed in the bottom line of the display. GN Otometrics A/S...

  • Page 25: Ear Probe

    Use the alphanumeric keypad to enter digits and letters, for in- stance, if you add a new patient. To move backwards and forwards use the arrow keys on the alphanumeric keypad. Ear probe Acoustic filter disc Probe tip Probe body Test cavity GN Otometrics A/S...
  • Page 26 The AccuScreen PRO AccuScreen PRO User Manual GN Otometrics A/S...

  • Page 27: Before You Start

    Make sure that you have received all neces- sary parts and accessories. If your package is incomplete, contact your service department. If damage has occurred, the device should not be put into operation. In such a case, please contact your service department for assistance. GN Otometrics A/S...

  • Page 28: Operating Temperature

    If the battery symbol appears in the top right corner of the dis- play, you can no longer activate any functions other than going through the menu. Change the NiMH battery pack and recharge it as soon as possible. GN Otometrics A/S...

  • Page 29: Removing And Recharging The Battery

    Use the index finger of your other hand to press the button of the battery pack until it „clicks". Slide the battery downwards to remove it. The charger socket is located in the upper right corner on the inside of the battery pack. GN Otometrics A/S...

  • Page 30: The Charger

    The charger is for indoor use only and should be protected against moisture. Caution: Do not use the charger with non-rechargeable batteries. 4.5.4 Battery safety information WARNING: Keep the battery pack away from open fire, and do not throw it into fire, as it can explode. GN Otometrics A/S...

  • Page 31: Increasing Service Life

    For reasons of safety, testing cannot be carried out as long as the la- bel printer with external power supply is connected to the Accu- Screen PRO. During this time the test function is automatically cut off. For more details please see Chapter 8, “Printing” on page GN Otometrics A/S...
  • Page 32 Before You Start AccuScreen PRO User Manual GN Otometrics A/S...

  • Page 33: Preparing For Testing

    Connecting the Y-cable for ABR testing For ABR-measurements you can use either the ear probe or the Y-ca- ble with Ear Couplers. A major advantage in using the Y-cable is that once the test starts, both ears will be tested consecutively. GN Otometrics A/S...

  • Page 34: Preparing The Test Environment

    Neonatal screening with OAE and ABR is best performed when the baby is sleeping. The ideal time is one hour after the baby has been fed and changed. It is recommended that newborn babies be swaddled tightly for ABR testing - swaddling has a very calming effect. GN Otometrics A/S...

  • Page 35: Placing Electrodes For Abr Testing

    Place the electrodes on the patient as follows: White: High on the forehead Black: Cheekbone (reference electrode) Red: On the nape of the neck Make sure that the electrodes fit tightly on the skin. GN Otometrics A/S...

  • Page 36: Fitting The Eartip On The Probe

    81) and that the probe is connected. See also Section 11.1.1, ‘Probe test” on page 5.5.3 Fitting the Ear Couplers Red Ear Coupler adapter for right ear Blue Ear Coupler adapter for left Cable connector GN Otometrics A/S...
  • Page 37 Place the Ear Coupler with the red adapter over the right ear of the baby, and the Ear Coupler with the blue adapter over the left ear of the baby. Note: Make sure that the adapters face upwards. GN Otometrics A/S...

  • Page 38: Preparing The Accuscreen Pro

    OK or press ADD to add a new patient. If you have selected a patient, the screen CHECK PATIENT DATA appears. Check the data to make sure that you have selected the correct patient. Press OK to continue. GN Otometrics A/S...
  • Page 39 Make sure that the correct patient is selected and press OK to confirm. Scroll to select the appropriate type of test from the SELECT TEST menu. Note: The tests available depend on the configuration of your Accu- Screen PRO. GN Otometrics A/S...
  • Page 40 If you have selected an ABR test, you must also fit the elec- trodes correctly. See Section 5.5.1, ‘Placing electrodes for ABR testing” on page Section 6.1, ‘Test methods” on page 41 on how to proceedwith the specific tests. GN Otometrics A/S...

  • Page 41: Tests

    The TEOAE test The test as it progresses is shown on the display. See also Section 6.2.1, ‘TEOAE tests” on page 50 for monitoring the test. Test duration for babies Less than 10 seconds on babies with normal hearing. GN Otometrics A/S...

  • Page 42: Test Process Dpoae

    See also Section 12.1, ‘Probe cleaning and maintenance” on page 6.1.2 Test process DPOAE Applies to AccuScreen PRO D, DA, TD, TDA. Do as described in Chapter 5, “Preparing for testing” on page GN Otometrics A/S...
  • Page 43 The test frequencies are shown at the top of the display. The se- quence of the test frequencies is as follows: 4000Hz 3200Hz 2500Hz 2000Hz If required, press SKIP to skip testing of certain frequencies. The test continues with the next frequency. GN Otometrics A/S...
  • Page 44 • Before you continue testing the other ear, check to make sure that the probe is clean. See also Section 12.1, ‘Probe cleaning and maintenance” on page GN Otometrics A/S...

  • Page 45: Test Process Dpoae Diagnostic

    The DPOAE Diagnostic test The test as it progresses is shown on the display. See also Section 6.2.3, ‘DPOAE Diagnostic tests” on page 52 for monitoring the test. Test duration Approximately 20 seconds on patients with normal hearing. GN Otometrics A/S...
  • Page 46 The results are ordered and shown in increasing frequencies: 1500 Hz 2000 Hz 3000 Hz 4000 Hz Only L2 is shown. The L1/L2 pair is 65/55 dB SPL and 55/45 dB SPL. GN Otometrics A/S...

  • Page 47: Test Process Abr

    Select Right then left ear to test both ears. Press OK to con- firm your selection. The impedance test is carried out before the actual testing starts. See also the description of Impedance testing below. The right ear is tested first, followed by the left ear. GN Otometrics A/S...
  • Page 48 This value should also be fairly low (> 4000Ω): 0 to 1999 Ω: Good 2000 to 3999 Ω: Fair More than 4000 Ω: Poor (testing is not possible, OK is not available, only STOP can be pressed). GN Otometrics A/S...
  • Page 49 These impedance values are updated and shown every 20 seconds. The actual test is like a race between the test time and ABR: If Time wins, the result is a REFER. GN Otometrics A/S...

  • Page 50: Monitoring The Test

    View results screens and they cannot be printed out. If the message Unstable appears please check if the probe fits correct- If you press OPT, the artifact and stimulus values are shown on the display: GN Otometrics A/S...

  • Page 51: Dpoae Tests

    Tests with a Stopped result are not saved. Accordingly, they cannot be retrieved in the View results screens and they cannot be printed out. If the message CalFail appears, refit the probe and make sure that it fits correctly. Restart the test. GN Otometrics A/S...

  • Page 52: Dpoae Diagnostic Tests

    Tests with a Stopped result are not saved. Accordingly, they cannot be retrieved in the View results screens and they cannot be printed out. If the message CalFail appears, refit the probe and make sure that it fits correctly. Restart the test. GN Otometrics A/S...

  • Page 53: Abr Tests

    21 characters. Press OK to store the comment. Viewing comments You can view the stored comment and the test results relating to the selected patient. To do so, select View results. See also Chapter 9, “View Results” on page GN Otometrics A/S...

  • Page 54: Interpretation Of The Results

    AccuLink. 6.4.1 TEOAE Applies to AccuScreen PRO T, TA, TD, TDA Test result PASS A PASS is a PASS, regardless of the A and S levels (see ‘‘A and S val- ues” on page 55). GN Otometrics A/S...
  • Page 55 If the S value (stimulus stability) is less than 80%, the probe may have shifted or may not be in a position to record the response. Try to reposition the probe and repeat the test. Note: Retro-cochlear hearing loss cannot be detected by TEOAE testing. GN Otometrics A/S...

  • Page 56: Dpoae

    99.5% confidence. Test result REFER A REFER may indicate a significant hearing loss. A REFER may also be the result when too much electrical noise drowns out the response. GN Otometrics A/S...
  • Page 57 In rare cases it may be worth while to relocate to another room for testing. • Is there much acoustic noise in the environment? High noise might mask the stimulus. GN Otometrics A/S...
  • Page 58 Tests AccuScreen PRO User Manual GN Otometrics A/S...

  • Page 59: Quick Test

    Select the type of test you wish to perform. See Chapter 6, “Tests” on page 41 for a the description of the individual tests. Press OK to start the test. If required, see section Section 6.4, ‘Interpretation of the results” on page GN Otometrics A/S...
  • Page 60 Quick Test AccuScreen PRO User Manual GN Otometrics A/S...

  • Page 61: Printing

    If the printer is not connected or if it is switched off, a message ap- pears on the screen: "Error message - No printer connected!" Press any key to return to the previous menu. The "Print results" menu Select Print results from the Main Menu. GN Otometrics A/S...

  • Page 62: Types Of Printout

    Press PRINT to start the selected printout. When the printout is completed, the message "Printing suc- cessful" appears. Press any key to return to the Print Results menu. 8.1.1 Types of printout The following printouts are available: GN Otometrics A/S...
  • Page 63 Scroll to select and press PRINT. For interpretation of the PRINT RESULTS screen, see also Sec- tion 6.4, ‘Interpretation of the results” on page TEOAE results The most recent results are printed. GN Otometrics A/S...
  • Page 64 The most recent results for the four tested frequencies are printed. DD results The most recent results for the four frequencies specified for the two levels of dB are printed. ABR results The most recent results for the ABR test are printed. GN Otometrics A/S...

  • Page 65: View Results

    Select the patient whose data you wish to view. Check that you have selected the correct patient and press OK. The VIEW RESULTS screen appears. GN Otometrics A/S...
  • Page 66 Press VIEW to view the result in detail. Scroll to see more results. Examples TEOAE PASS as a result of a TEOAE test. REFER as a result of a TEOAE test. GN Otometrics A/S...

  • Page 67: The Transfer/Delete Data Menu

    Connect the interface cable to the PC. Activate the AccuLink program on the PC and run the transfer operation from AccuLink. When you have transferred data to AccuLink, delete the data from the AccuScreen PRO (see Section 10.2, ‘Delete data” on page 68). GN Otometrics A/S...

  • Page 68: Transfer Via Infrared

    AccuScreen PRO to prepare for new tests. When you select the Delete data function, you are asked whether you really want to delete all data. The cursor defaults on No. To delete all test data, scroll to Yes and press OK. GN Otometrics A/S...
  • Page 69 All data cleared! After 5 seconds the program returns to the TRANSFER/DELETE DATA menu. When all data has been deleted, the message "No test data in mem- ory" appears in the modes Select patient, Print results and View results. GN Otometrics A/S...
  • Page 70 The Transfer/Delete Data Menu AccuScreen PRO User Manual GN Otometrics A/S...

  • Page 71: Options

    • Language: English • Time format: International • Background light: On • Sounds: Off 11.1 Self Test Select Self test from the Options menu. The Self test menu gives access to a number of functions described below. GN Otometrics A/S...

  • Page 72: Probe Test

    If the probe functions correctly, the message "Probe OK!" appears. If the message "Probe failed" appears, press any key to see a list of possible errors. Press any key to return to the SELF TEST menu. GN Otometrics A/S...

  • Page 73: Discharge Battery

    Select LCD display test to test the functionality of the dis- play. When you receive the message "LCD test passed", press any key to return to the Self test menu. 11.1.5 Keyboard test Select Keyboard test to test the functionality of the key- board. GN Otometrics A/S...

  • Page 74: Settings 1

    Only the languages available are shown on the screen, which therefore may not appear as the one shown. MENU will return you to the Main Menu without storing the new setting. BACK will return you to the SETTINGS 1 menu without storing the new setting. GN Otometrics A/S...

  • Page 75: Date/Time

    Select Sounds to switch on or off the key click and/or the jin- gles (indicating termination of test). Use the Pass/Refer jingles to save time from checking the display. • Sounds off All sounds/jingles are switched off. • Key click Pressing a button will produce a sound (a click). GN Otometrics A/S...

  • Page 76: Default Test

    BACK will return you to the SETTINGS 1 menu without storing the new setting. 11.3 Settings 2 Select Settings 2 from the Options menu. The SETTINGS 2 menu gives you access to basic settings, which you can select and change. GN Otometrics A/S...

  • Page 77: User Login

    MENU will return you to the Main Menu without storing the new setting. BACK will return you to the SETTINGS 2 menu without storing the new setting. 11.3.2 Patient list mode Select Patient list mode to switch between the two modes of listing patients. GN Otometrics A/S...

  • Page 78: Abr Configuration

    Notch filter setting Select Notch filter setting from the ABR Configuration menu. In this screen you can set the mains voltage frequency. Note: Check the regional mains frequency before you change the set- ting in this screen. GN Otometrics A/S...

  • Page 79: Abr Stimulus Level Setting

    ABR configuration menu without storing the new setting. 11.5 Memory Used Select Memory used from the OPTIONS menu to view infor- mation about the memory capacity used for • the patient list, and • the test results GN Otometrics A/S...

  • Page 80: Version Information

    The software version • The software release date • The serial number of the device • The date of the last calibration • The recommended date of the next calibration Press OK to return to the OPTIONS menu. GN Otometrics A/S...

  • Page 81: Maintenance

    • Cleaning with water and/or disinfectant and sterilization Cleaning with water and/or disinfectant and sterilization must always be performed after use in an infected ear canal. GN Otometrics A/S...
  • Page 82 The probe body contains sensitive components. Never clean the sound apertures in the probe body mechanically or with liquids. Doing so may cause damage to the probe. For periodical cleaning of the probe body please contact your au- thorized service department. GN Otometrics A/S...

  • Page 83: Changing The Acoustic Filter Disc

    45 minutes at a maximum temperature of 150°C. Eartips up to 45 minutes at a maximum temperature of 130°C. It is recommended that you do not exceed 50 sterilization cycles for each item. GN Otometrics A/S...

  • Page 84: Cleaning And Disinfecting The Test Cavity

    • Do not open, alter or dismantle the battery pack. • Do not place the battery pack into contact with metal objects. • The terminals may under no circumstances be short-circuited. GN Otometrics A/S...

  • Page 85: Increasing Service Life

    Note: Use only wiping disinfectant. Note: Always make sure that no moisture enters the probe or the sockets (data interface connector and probe plugs). Note: Never immerse the AccuScreen PRO into water or other cleaning so- lutions. GN Otometrics A/S...
  • Page 86 Maintenance AccuScreen PRO User Manual GN Otometrics A/S...

  • Page 87: Safety Information

    The warranty does not apply to the battery, to wearing parts and dis- posable items. This warranty only applies to those instruments purchased from au- thorized distributors or representatives. The purchaser must return GN Otometrics A/S...

  • Page 88: Repair, After-Sales Service And Regular Checks

    Following repair, a qualified elec- tronics engineer should verify the safety of all equipment. Calibration should be performed annually by suitably qualified per- sonnel using the appropriate equipment. GN Otometrics A/S...

  • Page 89: Status And Error Messages

    • Printer is turned off. No probe • Probe not connected to device • Connect probe to device Out of labels • No labels in printer. • Refill labels. Paper jam • Labels not correctly adjusted. • Adjust labels. GN Otometrics A/S...
  • Page 90 • Reposition probe when baby is TEOAE test only) when baby moves its head. calm. • Probe not in ear. • Reposition probe in ear. Wrong probe • A TEOAE probe is connected for • Connect DPOAE probe instead. DPOAE testing. GN Otometrics A/S...

  • Page 91: Technical Specifications

    Supported batteries: 5 NiCd/NiMH 1-2 Ah Operating temperature range: 0° - 40°C (32 - 104°F) Storage temperature range: -20° - 35°C (-4 - 95°F) Charge current: Rapid charge (HL): 800 mA ±6% Trickle charge (EL): 21 mA ±15% GN Otometrics A/S...

  • Page 92: Probe

    Primary tone pair, f2/f1 = 1.24 Frame length: 512 samples Test frequencies (screening): f2 = 2, 2.5, 3.2, 4 kHz Test frequencies (diagnostic/mul- f2 = 1.5, 2, 3, 4 kHz tilevel): Test level (screening): l1/l2 = 59/50 dB SPL GN Otometrics A/S...

  • Page 93: Device Class

    Statistical graph, test progress, EEG-level, ABR detection prob- ability Electrodes: Disposable hydrogel-electrodes (FDA approved) 15.5 Device class II a (according to Council Directive 93/42/EEC Appendix IX) 15.6 Applied standards EN 60601-1 + A1 + A2 EN 60601-1-2 GN Otometrics A/S...

  • Page 94: Manufacturer

    0 1 2 4 Germany Natus Europe GmbH Bärmannstrasse 38 D-81245 München 1 2 7 5 Germany 15.8 Distributor GN Otometrics A/S 9 Hoerskaetten DK-2630 Taastrup, Denmark. +45 45 75 55 55 Phone: +45 45 75 55 59 Fax: www.otometrics.com GN Otometrics A/S...

  • Page 95: Index

    81, 83 Eartips test cavity 84 disposal 83 Y-cable 84 fitting on probe 36 Codec test 73 Electrode cable Comments connecting to AccuScreen 33 adding 53 Electrodes viewing 53 placing on patient 35 Control panel 24 GN Otometrics A/S...
  • Page 96 Recharging battery 29 Removing battery 29 Repair 88 Navigation 24 Results interpreting 54 viewing 65 applications 15 recording, a description 13 Safety 87 types 14 Self test 71 Operating temperature 28 Settings Options 71 ABR configuration 78 date/time 75 GN Otometrics A/S...
  • Page 97 DPOAE process 42 DPOAE test monitoring 51 interpreting results 54 quick test 59 TEOAE process 41 TEOAE test monitoring 50 viewing results 65 Transfer data via cable 67 via infrared 68 Unpacking 27 User login setting 77 GN Otometrics A/S...
  • Page 98 User Manual AccuScreen PRO GN Otometrics A/S...

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