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1

Introduction

Thank you for purchasing the Alpha OAE handheld Otoacoustic Emissions Screener.

Note

•

This manual is your guide to the use and maintenance of Alpha OAE. We

strongly recommend that you read it carefully before using Alpha OAE for the first time.

We also recommend that you take particular note of the cleaning and maintenance instructions.
Failure to use and maintain Alpha OAE correctly may void your warranty.

Alpha OAE is a fast, reliable, easy to use, and lightweight hearing screener.

Alpha OAE provides for easy navigation using its touch screen function.

Alpha OAE uses DPOAE (Distortion Product Otoacoustic Emissions) technology. Otoacoustic Emissions measure cochlear
mechanics and indicate whether the cochlea is functioning correctly or not. Emission strength usually decreases with age
or hearing impairment.

1.1

Printing

For printing instructions see

Printing

►

33

.

Alpha OAE

With Alpha OAE you can print test results from a label printer connected to Alpha OAE.

You can connect a label printer via a special printer cable supplied with the label printer.

For reasons of safety, testing cannot be carried out as long as the label printer with external power supply is connected to
Alpha OAE. During this time the test function is automatically disabled.

An optional docking station is also available with Alpha OAE. You can place Alpha OAE in the docking station and print to a
label printer connected to the docking station.

1.2

Intended Use

The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening
auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related dis-
orders. The device is especially indicated for use in the screening of infants to determine hearing loss.

Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions:

The Type 1077 DPOAE module

and 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

7

1 Introduction

Содержание MADSEN Alpha OAE

Страница 1: ...MADSEN Alpha OAE Screener User Manual Doc no 7 50 1370 US 01 Part no 7 50 13700 US 0 4 5 9 ...

Страница 2: ...ent ofGN Otometrics A S Copyright 2013 GN Otometrics A S Publishedin Denmark byGN Otometrics A S Denmark Allinformation illustrations and specifications inthis manual are based on the latest productinformation available atthe time of publication GN Otometrics A Sreserves the right tomake changes atany time without notice Versionrelease date 2013 12 04 Technicalsupport Please contact yoursupplier 2...

Страница 3: ... 1 Power saving mode and automatic power off 17 3 1 2 The Alpha OAE screens 17 3 1 3 The Home menu 18 4 Preparing for testing 21 4 1 Preparing Alpha OAE 21 4 2 Preparing the equipment 21 4 2 1 Preparing the probe for testing 21 4 2 2 Connecting the probe 21 4 3 Preparing the test environment 22 4 4 Preparing the patient 22 4 4 1 Fitting the eartip on the probe 23 4 4 2 Inserting the probe with ear...

Страница 4: ... 9 1 1 Cleaning and disinfecting the probe tip 45 9 1 2 Cleaning the probe body 46 9 1 3 Probe calibration 47 9 2 Eartips 47 9 3 Cleaning Alpha OAE 47 9 3 1 Cleaning and disinfecting the test cavity 47 9 4 Batterysafety and maintenance 48 9 4 1 Safety information 48 9 4 2 Increasing service life 48 9 4 3 Disposal of old batteries 48 App 1 Standards and Safety 51 App 1 1 Alpha OAE symbols 51 App 1 ...

Страница 5: ... time clock 59 App 3 3 10 Data interfaces 59 App 3 3 11 Transport and storage environment 59 App 3 3 12 Operating environment 59 App 3 3 13 Warm up time 59 App 3 3 14 Disposal 59 App 3 3 15 Standards 60 App 3 4 Power supply and battery 60 App 3 5 1077 docking station 60 App 3 5 1 Printer modem interface 60 App 3 5 2 DC power input 61 App 3 5 3 Power adapter 61 App 3 6 OAE probe 61 App 3 6 1 Probe ...

Страница 6: ...6 Otometrics MADSEN Alpha OAE ...

Страница 7: ...plied with the label printer For reasons of safety testing cannot be carried out as long as the label printer with external power supply is connected to Alpha OAE During this time the test function is automatically disabled An optional docking station is also available with Alpha OAE You can place Alpha OAE in the docking station and print to a label printer connected to the docking station 1 2 In...

Страница 8: ...s 1 3 About this manual Important Please note that menu selections and screen shots in this manual may not reflect the configuration of your test device This manual contains adescription ofthe main functions of Alpha OAE We recommend that you make yourself familiar with the following issues Installation Unpacking and Installation 11 and Preparing for testing 21 contain a full description of unpack...

Страница 9: ...arning Indicates that there is risk of death or serious injury to the user or patient Caution 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 OK button Otometrics MADSEN Alpha ...

Страница 10: ...1 Introduction 10 Otometrics MADSEN Alpha OAE ...

Страница 11: ... Ifdamage has occurred do not put the device into operation Contact your local distributor for assistance 3 Check with the packinglist to make sure that you have received all necessary parts and accessories If your package is incomplete contact your local distributor 2 2 Views of Alpha OAE 2 2 1 Front and rear view A On Off switch B Touch screen display C Power and charging status light indicator ...

Страница 12: ... icons and fields shown serve as buttons Touch the buttons to activate afunction Caution 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 A Probe tip B Probe body C Probe cable 12 Otometrics MADSEN Alpha OAE 2 Unpacking and Installation ...

Страница 13: ...y with the external charger 15 2 5 1 The battery The battery used in Alpha OAE is a rechargeable Li Ion battery Part no 8 73 02400 has a high capacity is low weight has a low rate ofself discharge can be charged continuously guarantees approximately 8 hours of operating time On delivery the battery is charged approximately 50 Before you start testing we recommend that you charge the battery fully ...

Страница 14: ...th the text Insert this direction points downwardstowards the bottom ofthe compartment 4 Close the compartment 2 5 3 Battery status The battery symbol is shown in the top right corner ofthe 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 14 Otometrics M...

Страница 15: ...sible Ifthe necessary minimum voltage should drop Alpha OAE switches off automatically Recharge or change the battery as soon as possible 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 O...

Страница 16: ...2 Unpacking and Installation 16 Otometrics MADSEN Alpha OAE ...

Страница 17: ...shown while Alpha OAE performsa self test A On Off switch 3 1 1 Power saving mode and automatic power off Ifyou do not use Alpha OAE for a certain period of time Alpha OAE will first switch to power saving mode and finally switch off automatically 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 ...

Страница 18: ...est screens C The function bar with available function buttons D The footer with available buttons for main functionssuch as returning to the previous screen accessing help returning to the Home screen 3 1 3 The Home menu The Home menu From the Home menu you can select all main functionsin Alpha OAE See The DPOAE test 26 See Viewing a patients test record 30 18 Otometrics MADSEN Alpha OAE 3 Gettin...

Страница 19: ... See Printing 33 See Deleting data 42 See Alpha OAE settings 35 See Selecting child mode 25 Otometrics MADSEN Alpha OAE 19 3 GettingStarted with Alpha OAE ...

Страница 20: ...3 Getting Started with Alpha OAE 20 Otometrics MADSEN Alpha OAE ...

Страница 21: ...y 47 4 2 1 Preparing the probe for testing Inspect the probe for deterioration color changes surface changes of the reusable probe parts before every usage If deterioration occurs contact your distributor 4 2 2 Connecting the probe 1 Place Alpha OAE face down 2 Align the double arrow on the probe plug with the arrow in the grey bordering around the socket ofAlpha OAE 3 Gently insert the probe plug...

Страница 22: ...orking Clean probe body probe cable and probe plug before each patient or if surface is visibly contaminated Use a sterile alcohol wipe to clean the surfaces and wait until the probe body probe cable and probe plug are com pletelydry Note A sterile alcohol wipe typicallycontains isopropyl alcohol 70 It is important to have the disinfectant in contact with the surface for the time period specified ...

Страница 23: ...ther ear Warning Using a probe with an unsuitably sized eartip or applyingexcessive force may irritate the ear canal Note In case of a probe error make sure that the probe tip channels are clear see Maintenance and Cleaning 45 and that the probe is connected See also Probe Test 35 4 4 2 Inserting the probe with eartip in the patient s ear canal 1 When you have fitted an eartip on the probe gently ...

Страница 24: ...e 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 24 Otometrics MADSEN Alpha OAE 4 Preparing for testing ...

Страница 25: ...child mode On the Home screen you can select Child mode to display a child friendly screen during testing 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 25 5 Testing with Alpha OAE ...

Страница 26: ...of one of the tones presented is called F1 and the level of that tone is called L1 The other tone is called F2 and its level is L2 5 3 1 Starting the test Calibration and speaker test are performed before the actual test starts Probe fit Ifthe probe does not fit correctly adjust the position of the probe Speaker test The probe fit is followed by aspeaker test to make sure that the two speakers fun...

Страница 27: ...nder the animated picture is green if the test conditions are good and it is gray ifthere is too much noise The bar gets longer as each test frequency in the sequence is completed IfChild Mode is not activated a bar chart is displayed See the Test details table below for a description of the bar chart and other data displayed Ifneeded press the Stop button to stop the test The test will be saved a...

Страница 28: ...endent on test con ditionsin general 5 3 3 DPOAE test results In Child Mode when a test is completed the Reward screen is displayed This screen shows an animated bunch of balloons floatingup to the sky The outcome ofthe test is then displayed on the Test result screen If Child Mode is not activated the Test result screen is displayed immediately after the test is completed See Options in the test ...

Страница 29: ...e could be detected The DPOAE result specifies each frequency tested This facilitates decisionsconcerning further procedures A PASS Test passed at asingle frequency indicates near to nor mal outer hair cell function in the corresponding frequency region ofthe cochlea The common reasons for non detection are noisy test conditions or apoor probe fit In DPOAEs this is especially true for the lowest f...

Страница 30: ... the new test ear 3 Press the Test Other Ear button in the test results screen The test starts automatically 5 6 Viewing a patients test record A patient screened by Alpha OAE is either given a PASS Test passed or a REFER Test referred Ifthe result is a PASS Test passed no further action is required Ifthe result is a REFER Test referred it is recommended that you retest the patient Ifthe patient i...

Страница 31: ...ut on which ear the test was made the date and time on which the test was made The test results PASS Testingsuccessful OAE present REFER OAE criterion not reached Incomplete 2 To view the individual test results press the result icon This will take you to a test result screen displaying the test you wish to view 3 To print the individual test results press the Print icon next to the test you wish ...

Страница 32: ...5 Testing with Alpha OAE 32 Otometrics MADSEN Alpha OAE ...

Страница 33: ...s not possible when Alpha OAE is placed in the docking station or connected to the printer Note Do not switch off Alpha OAE while printing is in progress Doing so may result in distorted test data Note If the label printer is not connected or if it is switched off an error message appears on the screen 1 Connect the label printer cable to Alpha OAE Note Use only the label printer recommended Alpha...

Страница 34: ... ID Date ofBirth Examiner PASS REFER Legend Legend L R Left ear Right ear 34 Otometrics MADSEN Alpha OAE 6 Printing ...

Страница 35: ...formation about the hardware and the software installed 1 Press the Settings button on the Home screen From the Settings menu you can access the settings available in Alpha OAE 7 2 Probe Test Every day before you start testing on patients you should test the probe to make sure that it functions correctly Caution Make sure that the probe tip has been cleaned and disinfected before you insert it in ...

Страница 36: ...nctionscorrectly the message Probe OK appears Ifthe probe does not function correctly the message Probe failed appears You will also see a list of possible errors 2 Press the OK button to confirm the test result Ifneeded repeat the test 7 2 2 From the Settings menu 1 Insert the probe tip without eartip in the test cavity on the device or in an external test cavity 2 Press the Probe Test button on ...

Страница 37: ... check box then you will get an error when the memory is full and you will be required to manually delete old tests See Deleting data 42 7 4 Time and Date setting 1 Press the Time and Date button on the Settings screen You can set the date in the upper part of the screen and the time in the lower part Note If you leave the Time and Date screen bypressing the OK button the settingof seconds is set ...

Страница 38: ...me setting is to be shown on the screen 7 5 Language setting 1 Press the Language button on the Settings screen 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 38 Otometrics MADSEN Alpha OAE 7 Alpha OAE settings ...

Страница 39: ... of the test Sound off Shows that the sound is disabled 7 7 Display Brightness 1 Press the Display Brightness button on the Settings screen To change the brightness of the display press the buttons on either side ofthe green bar Note A high level of brightness will influence the power consumption of the device Darkens the display Brightensthe display Press the Default button to use the default set...

Страница 40: ...he Settings screen to view information regard ing Firmware release HW version and Serial number Next MADSEN Alpha OAE service date Connected probe Next service date for the connected probe Memory usage 40 Otometrics MADSEN Alpha OAE 7 Alpha OAE settings ...

Страница 41: ...m screen to screen To perform these functions simply press the relevant function button Functionbuttons Scroll to see more next page 8 2 General buttons Available main functionsare shown in the footer bar of the Alpha OAE screens To perform these functions simply press the relevant button Otometrics MADSEN Alpha OAE 41 8 Handling Data in Alpha OAE ...

Страница 42: ...test button This takes you to the Test History Delete screen to select one or more tests to delete 3 Press the Delete button to the right ofthe test you wish to delete You will be prompted to confirm that you wish to delete this test 4 When you have deleted all the tests you wish to delete press the Home button to go to the Home screen 8 3 2 Deleting all tests 1 To delete all tests press the Delet...

Страница 43: ...e you directly to the Delete menu 2 Press the All tests button You will be prompted to confirm that you wish to delete all tests All tests will be deleted Otometrics MADSEN Alpha OAE 43 8 Handling Data in Alpha OAE ...

Страница 44: ...8 Handling Data in Alpha OAE 44 Otometrics MADSEN Alpha OAE ...

Страница 45: ...ry time you have used the probe Even small amounts ofceru men or vernix can block the probe channels or be deposited on the probe tip Warning If needed replace the probe tip with a spare one Note Probe tips should be disposed of according to local regulations 9 1 1 Cleaning and disinfecting the probe tip Please remove the ear probe from the patient sear and separate the probe tip from the disposab...

Страница 46: ...ontrol procedure dictates autoclaving make sure that the probe tip has not been deformed by the autoclaving process Make sure that the sound channels are completely dry before you fit the tip back onto the probe body If needed use a spare probe tip 9 1 2 Cleaning the probe body Important For periodical cleaning of the probe body contact your authorized service department Caution The probe body con...

Страница 47: ...eaned Note Eartips should be disposed of according to local regulations 9 3 Cleaning Alpha OAE Before cleaning switch off Alpha OAE and unplug it from any external power source Unplug the probe from Alpha OAE Use a moist tissue with alcohol to clean the surface of the device Caution Always make sure that no moisture enters the probe the sockets data interface connector and probe plugs or the test ...

Страница 48: ...ery Do not open alter or dismantle the battery Do not place the battery in contact with metal objects The terminals must under no circumstances be short circuited 9 4 2 Increasing service life Use only the battery type and charger stated in Power supply and battery 60 Charge the battery at room temperature whenever possible Do not drop the battery or expose it to sharp impact Store in a cool dry p...

Страница 49: ...not dispose of in fire Environmental protection When the Li Ion battery loses its capacity to be charged make sure that it is disposed ofaccording to local envir onmental regulations or return it to your dealer Otometrics MADSEN Alpha OAE 49 9 Maintenance and Cleaning ...

Страница 50: ...9 Maintenance and Cleaning 50 Otometrics MADSEN Alpha OAE ...

Страница 51: ...o 601 1 M90 X X X X Complieswith Medical Devices Directive 93 42 EEC Electronic equipment covered by the Directive 2002 96 EC on waste electrical and electronic equipment WEEE All electrical and electronic products batteries and accumulators must be taken to separate collection at the end of their working life This requirement applies in the European Union Do not dispose of these productsas unsort...

Страница 52: ...ossible injury or danger to the patient and or the user Do not connect any external device e g printer to Alpha OAE during testing IfAlpha OAE is used during surgery the probe and connectors must not touch conductive items including ground The probe socket is intended to connect the ear probe to Alpha OAE No other device may be connected to this socket Alpha OAE must not be used during the applica...

Страница 53: ...l defects in material and workmanship It is also guaranteed to perform in accord ance with the manufacturer s specifications for a full 2 years from the date of purchase The warranty does not apply to the battery to wear parts and disposable items This warranty only applies to those instruments purchased from authorized distributors or representatives The purchaser must return the instrument to an...

Страница 54: ...trup Denmark 45 45 75 55 55 45 45 75 55 59 www otometrics com App 1 7 1 Responsibility of the manufacturer The manufacturer is to be considered responsible for effects on safety reliability and performance of the equipment only if All assembly operations extensions re adjustments modifications or repairs are carried out by the equipment man ufacturer or personnel authorized by the manufacturer The...

Страница 55: ...test data and restart the device If the message re appears contact your supplier Codec malfunction Self test error Restart the device Ifthe message re appears contact your supplier App 2 2 Usage and test related messages Error message Cause Solution Measurement memory full Measurement cannot be car ried out Alpha OAE s measurement memory is full Delete tests Probe FAILED The probe did not pass the...

Страница 56: ...oor fit in the ear canal The probe tip is blocked Try to refit the probe If the problem per sists clean the probe tip or replace it with aspare Paper feed error The labels are not adjusted cor rectly in the label printer or there is a paper jam Re adjust the labels and remove possible blockingof paper feed 56 Otometrics MADSEN Alpha OAE App 2 Status and Error Messages ...

Страница 57: ...g power adapter App 3 2 Measurement techniques App 3 2 1 DPOAE Evaluation method Noise weighted phase statistics Stimulus Primarytone pair F2 F1 1 24 Available test frequencies F2 2 3 4 and 5 kHz Default test frequencies F2 2 3 4 and 5 kHz PASS at 3 out of 4 Default test level L1 L2 65 55 dB SPL Test display DP Gram DPOAE level noise level test progress Result display DP Gram with DPOAE and noise ...

Страница 58: ...els Backlight type LED adjustable App 3 3 4 Keypad Resistive touch screen can be used with gloves App 3 3 5 Sound Built in speaker for key click and PASS REFER sounds App 3 3 6 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 58 Oto...

Страница 59: ...ressure 500 hPa to 1040 hPa App 3 3 12 Operating environment Mode ofoperation Continuous Temperature range 10 40 C 50 104 F Humidity range 30 90 rel non condensing Air pressure 600 hPa to 1040 hPa At locations where the normal air pressure is below 800 hPa at altitudes of more than 2000 meters it is recommended to recalibrate the OAE probe App 3 3 13 Warm up time 20 seconds Note Should be extended...

Страница 60: ...rs of continuous use based on atypical use scenario Actual use can influ ence the battery life time Batterylevel 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 batterymay present a risk of fire or explosion Batterytype Rechargeable Li ion 3 7 V 1800 mAh 6 7 Wh fully charged App 3 5 1077 dockin...

Страница 61: ...E probe App 3 6 1 Probe cable Flexible shielded cable approx length 150 cm approx 59 inches App 3 6 2 Dimensions Probe body 20 mm Ø x 23 x 11 mm 0 8 Ø x 0 9 x 0 43 Probe tip 3 3 mm Ø x 10 mm 0 13 Ø x 0 4 App 3 6 3 Weight Probe incl probe tip Approx 4 5 grams App 3 6 4 Eartips Standard cylindric 5 mm Blue Tree tip 6 9 mm Blue 1 size 8 11 mm Transparent 1 size 12 16 mm Blue 1 size Foam tip 9 13 mm Y...

Страница 62: ...missions CISPR 11 ClassB Alpha OAEis suitable foruse in all environments includingdomestic environmentsand thosedirectly connected to public low voltage power supply networksthat supply buildingsused fordomestic pur poses Guidanceand manufacturer sdeclaration electromagnetic immunity forall equipmentand systems Alpha OAEis intended foruse in the electromagneticenvironment specified below Theuser o...

Страница 63: ...ctromagnetic sitesurvey a should beless than thecompliance level in each frequencyrange b Interferencemay occur in the vicinityof equip ment marked with this symbol Note 1 At 80 MHz and 800 MHz the separation distancefor the higherfrequency range applies Note 2 These guidelines may notapplyin allsituations Electromagnetic propagationis affectedby absorption andreflection from structures objectsand...

Страница 64: ...quency oftransmitter m 150kHz to 80 MHz d 1 2 80 MHzto 800MHz d 1 2 800MHz to 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 Fortransmittersrated at a maximum output power not listed above therecommended separation distance d in metres m can be estimated using theequa tion applicableto thefrequency of thetransmitter where Pis themaximum output power ...

Страница 65: ... Data deleting data 42 Delete a test 42 Delete all tests 42 Device bottom view 12 cleaning 47 front view 11 preparing for testing 21 rear view 11 technical specifications 57 top view 12 Display 12 error messages 55 Displaybrightness 39 Disposal device 51 eartips 47 old battery 48 DPOAE test 27 test procedure 26 test results 28 E Ear probe view 12 Eartips disposal 47 fitting on probe 23 maintenance...

Страница 66: ...fitting eartip 23 maintenance 45 prepare for testing 21 tip 12 view 12 Probe body maintenance 45 Probe calibration maintenance 47 Probe tip cleaning 45 maintenance 45 R Recharging battery 15 Remove battery 14 test 42 Repair 53 Results test view 30 S Safety information 48 51 Safety symbols 51 Screens Home menu 18 Service life increasing 48 Settings 35 brightness 39 from the Settings menu 36 languag...

Страница 67: ...Test cavity cleaning 47 Test environment 22 Test View 30 screen 31 Testing preparing for 21 Time and date settings 37 U Unpacking 11 V Views device top 12 display 12 ear probe 12 front 11 rear 11 W Warning notes 52 Warrantyrepair 53 Otometrics MADSEN Alpha OAE 67 Index ...

Страница 68: ......

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