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1

Introduction

1.1

Brief description

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.

1.2

The docking station

Alpha OAE+ is supplied with a docking station, which provides for:

•

easy recharging of the battery

•

printing from a document printer

•

creating a PDF with test results

•

printing from a label printer

1.3

Printing

For printing instructions see

Alpha OAE+

You can place Alpha OAE+ in the docking station and send reports to a PC. You can then print the reports from the PC. If
you have an optional label printer, it can be connected to the docking station and then you can print test results from the
label printer.

1.4

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.

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

6

Otometrics - MADSEN Alpha OAE+

1 Introduction

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Содержание Otometrics Madsen Alpha OAE+

Страница 1: ...MADSEN Alpha OAE Screener User Manual Doc No 7 50 1360 US 06 Part No 7 50 13600 US ...

Страница 2: ...tometrics the Otometrics Icon AURICAL MADSEN Otoscan ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U S A and or other countries Version release date 12 06 2018 204006 Technical support Please contact your supplier Otometrics MADSEN Alpha OAE 2 ...

Страница 3: ...tation 15 2 5 5 Charging the battery from the docking station 15 2 5 6 Charging the battery with the external charger 16 2 6 Installing the MADSEN Alpha OAE Printing Tool 16 3 Getting Started with Alpha OAE 17 3 1 Switch on Alpha OAE 17 3 1 1 Power saving mode and automatic power off 17 3 1 2 The Alpha OAE screens 17 3 1 3 The Home menu 18 3 2 Patient handling in Alpha OAE 19 3 2 1 Adding a new pa...

Страница 4: ...41 5 10 Test View 41 5 11 The Test View screen 42 6 Quick Start tests 43 6 1 Performing a Quick Start test 43 6 2 Handling Quick Start test results 43 7 Printing 46 7 1 Printing from Alpha OAE 46 7 2 Printouts from label printer 48 8 Alpha OAE settings 50 8 1 The Settings menu 50 8 2 Probe Test 50 8 2 1 Performing the probe test 51 8 2 2 From the Settings menu 52 8 3 Test Settings 52 8 4 Time and ...

Страница 5: ...App 1 3 Docking station symbols 68 App 1 4 Warning notes Alpha OAE 68 App 1 5 Warning notes docking station 69 App 1 6 Warranty 69 App 1 7 Repair after sales service and regular checks 69 App 1 7 1 Declaration 70 App 1 8 Manufacturer 70 App 1 8 1 Responsibility of the manufacturer 70 App 2 Status and Error Messages 71 App 2 1 Device related messages 71 App 2 2 Usage and test related messages 71 Ap...

Страница 6: ...with test results printing from a label printer 1 3 Printing For printing instructions see Printing 46 Alpha OAE You can place Alpha OAE in the docking station and send reports to a PC You can then print the reports from the PC If you have an optional label printer it can be connected to the docking station and then you can print test results from the label printer 1 4 Intended Use The Type 1077 d...

Страница 7: ...vice i e eartips 1 5 Physical operating principle Alpha OAE uses DPOAE Distortion Product Otoacoustic Emissions and TEOAE Transiently Evoked Otoacoustic Emis sions technologies 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 6 About this manual Important Please not...

Страница 8: ...ons The use of Warning Caution and Note To draw your attention to information regarding safe and appropriate use of the device or software the manual uses pre cautionary statements as follows Warning Indicates that there is a 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 In...

Страница 9: ...amage has occurred do not put the device into operation Contact your local distributor for assistance 3 Check with the packing list to make sure that you have received all necessary parts and accessories If your package is incomplete contact your local distributor 2 2 Overview of Alpha OAE 2 2 1 Front and rear of Alpha OAE A On Off switch B Touch screen display C Power and charging status light in...

Страница 10: ...n Front indicators POWER Lit when power is supplied to the docking station Lit when data is being transferred as follows during transfer of a report to the PC during printing from label printer USB Lit when docking station is connected to the PC via a USB cable 10 Otometrics MADSEN Alpha OAE 2 Unpacking and Installation ...

Страница 11: ...Rear sockets PC USB Socket for USB connection to the PC Printer Modem Socket for printer modem connection Socket for power adapter Otometrics MADSEN Alpha OAE 11 2 Unpacking and Installation ...

Страница 12: ...d 2 2 5 Ear probe Probe cable plug A Probe tip B Probe body C Probe cable 2 3 Storage Store Alpha OAE and accessories in the soft case provided to protect the equipment from damage See also Operating environment in Technical Specifications 2 4 Assembly When you receive Alpha OAE do the following before you connect the probe 1 Insert the battery in the battery compartment See Inserting the battery ...

Страница 13: ...attery has a high capacity is lightweight has a low rate of self discharge can be charged continuously guarantees approximately 8 hours of operating time On delivery the battery is charged approximately 50 We recommend to charge the battery fully before starting to test See Battery safety and maintenance 65 Battery Storage If the battery is to be stored for a long time it is recommended that it is...

Страница 14: ...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 When the battery level drops below 10 test results can be viewed but testing is no longer possible Symbol Remaining battery capacity 100 75 The battery is fully charged 75 50 50 25 25 10 The battery should be char...

Страница 15: ...it on the adapter 2 Connect the adapter to the docking station and the mains supply The POWER indicator will light up green Caution Electrical equipment must be positioned so that there is easy access to disconnect the power supply from the mains Disconnecting from the mains supply To disconnect Alpha OAE docking station from the mains supply simply remove the adapter plug from the mains outlet 2 ...

Страница 16: ... a report from Alpha OAE There are the following options Save PDF file If you select this option the file dialog will be shown each time you create a report from MADSEN Alpha OAE You can then select a folder and enter a filename for the report Save PDF file to pre defined folder When you select this option you must enter a folder where all reports will be saved A filename will generated automatica...

Страница 17: ...erforms a self test A On Off switch 3 1 1 Power saving mode and automatic power off If you 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 1 2 The Alpha OAE scr...

Страница 18: ...d for entering data etc C The function bar with available function buttons D The footer with available buttons for main functions such 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 functions in Alpha OAE See Quick Start tests 43 See Finding a patient 20 See Adding a new patient 19 18 Otom...

Страница 19: ...ome menu The New Patient screen shows a list of buttons you can press to select screens for entering patient data 2 Press a field to enter patient data When you have entered data in a field press the OK button and then press the next button in the list 3 To view more fields in the New Patient screen press the arrow buttons 4 When you have entered data in the required fields and press the OK button...

Страница 20: ...t button on the Home screen This will take you to the Find Patient screen 2 You can change the sort order Press the Change sort order button until the list is sorted according to the category that you wish to use 3 If needed press the arrow buttons to scroll in the list of patients 4 Select the patient from the list Searching in an extended patient list 1 To search in an extended list of patients ...

Страница 21: ...f you wish to view the tests performed on the patient press the Test View button 3 2 3 Editing patient data 1 Find a patient as described in Finding a patient 20 2 In the Patient Details screen press the field you wish to edit 3 Edit the field 4 When you have edited data in a field press the OK button to save 5 If needed select the next field you wish to edit Otometrics MADSEN Alpha OAE 21 3 Getti...

Страница 22: ... 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 ridge on the probe plug with the notch in the grey bordered socket on the top end of Alpha OAE 3 Gently insert the probe plug into the p...

Страница 23: ...e working 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 pletely dry Note A sterile alcohol wipe typically contains isopropyl alcohol 70 It is important to have the disinfectant in contact with the surface for the time period speci...

Страница 24: ...unsuitably sized eartip or applying excessive 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 62 and that the probe is connected See also Probe Test 50 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 pull the pinna back and slightly down ...

Страница 25: ...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 Otometrics MADSEN Alpha OAE 25 4 Preparing for testing ...

Страница 26: ...screen dur ing 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 5 2 Ready to test You can choose between two methods of starting a test Start a test without selecting a patient first Select or create a patient and then start a test 26 Otome...

Страница 27: ...pend on your settings in the Test Settings screen To see the details for a protocol press the button with the protocol name A Help screen will open Press OK to close the Help screen Alternatively you can see the test descriptions in The TEOAE test 34 or The DPOAE test 27 5 3 The DPOAE test DPOAEs are responses generated by the inner ear to a two tone stimulation For each frequency that is tested a...

Страница 28: ...Pass Clear Response result Protocol 3 stops automatically if 3 frequencies reach a Pass Clear Response result or 2 frequencies receive a Refer No Clear Response result Protocol 4 tests all frequencies Protocol 5 and 6 6 kHz 5 kHz 4 kHz 3 kHz 2 kHz 1 5 kHz Minimum DP amplitude equals 5 dB Protocol 5 a Pass Clear Response result requires that 4 of the 6 frequencies receive a Pass Clear Response resu...

Страница 29: ...equencies reach a Pass Clear Response result or 2 frequencies receive a Refer No Clear Response result 5 3 2 Starting the test 1 Press the Start button corresponding to the test protocol and ear you wish to test Calibration and speaker test are performed before the actual test starts Calibration If the probe does not fit correctly adjust the position of the probe Otometrics MADSEN Alpha OAE 29 5 T...

Страница 30: ...e arrow appears on the result screen Press the double arrow to start the meas urement with maximum calibrated output levels 5 3 3 The DPOAE test The test as it progresses is shown on the display The test ear and the frequency cur rently being tested is shown at the top of the screen If Child Mode is activated an animated car is displayed on the screen during testing See Selecting Child Mode 26 The...

Страница 31: ...r ation for the frequency Registered DPOAE response Frequency passed DPOAE frequency being tested or referred The height of the bars represents the noise response amplitude The test frequencies are shown below the bar chart DPOAE Response at current test frequency Noise Current noise level Make sure the noise level is as low as pos sible The noise bar turns red when the noise level is over 41 dB S...

Страница 32: ...result indicates that in at least 3 frequency bands out of 6 no significant DPOAE response could be detected In Protocols 3 4 and 7 a Refer No Clear Response result indicates that in at least 2 frequency bands out of 4 no significant DPOAE response could be detected Protocol 6 does not generate an overall Pass Clear Response or Refer No Clear Response result The DPOAE result specifies each frequen...

Страница 33: ...rate response In this case the result is Inconclusive and a message indicates that there was a large ear canal volume or a poor probe fit If noise exceeds acceptable levels for more than half of the test time the result is Inconclusive and a message indicates that the noise was too high Incomplete test If the test was stopped an error message is shown The result screen appears differently from the...

Страница 34: ...otocol 8 and that cor responds to the ear in which you placed the probe Calibration is performed before the actual test starts The test starts automatically when calibration is completed If the calibration fails due to large ear canal volume for example due to a PE tube in the patient s ear and if the Manual start option is enabled in Test Settings then a double arrow appears on the result screen ...

Страница 35: ...de is not enabled test data is shown on the display as the test progresses If needed press the Stop button to stop the test The test will be saved as an incomplete test Test details Shows which ear is being tested A Valid peaks B Higher frequency emissions C Lower frequency emissions The graphic display shows the peaks reaching the test criteria The graph is a statistical graph Valid peak Shows th...

Страница 36: ... probe stability level in percent The stimulus stability eman ating from probe stability should be above 80 if possible Progress Shows the time elapsed for the current test frequency If a Pass Clear Response for the current frequency is not achieved the test frequency will time out Max time depends on environmental noise conditions If test conditions are optimal but there is no response measured t...

Страница 37: ...ear Response result It may be possible to improve the quality of the test and so on repeating the test a Pass Clear Response may be obtained It is always recom mended that you repeat the test when a Refer No Clear Response result is obtained Consider for instance the following when you interpret a Refer No Clear Response result Malfunctions in the transmission of sound are by far the most importan...

Страница 38: ...this case the result is Inconclusive and a message indicates that there was a large ear canal volume or a poor probe fit If noise exceeds acceptable levels for more than half of the test time the result is Inconclusive and a message indicates that the noise was too high Incomplete test If the test was stopped an error message and detailed results are shown The result screen appears differently if ...

Страница 39: ...t Pass Clear Response Refer No Clear Response Incomplete Inconclusive Test completed 5 6 Adding comments to a test You can select from a list of standard comments 5 6 1 Adding a standard comment 1 To add a standard comment press the Add Comments button in the Test Result screen or on the patient s Test Menu 2 In the Comments screen you can select a predefined comment that may apply to this patient...

Страница 40: ...reposition the patient so that you can test the other ear and insert the probe in the new test ear 3 Press the Test Other Ear button in the test results screen The test starts automatically 5 8 Handling test results When you have completed all the tests that you want to perform press the OK button on the Test Menu screen You can now choose to save print or delete the results Save Results Press the...

Страница 41: ... No Clear Response it is recommended that you retest the patient If the patient is given yet another Refer No Clear Response this patient should be referred for further testing If the result is Inconclusive it is recommended that you retest the patient in a quieter environment If the result is still Inconclusive then the patient could be considered for further testing See also DPOAE test results 3...

Страница 42: ...ch ear the test was made The date and time on which the test was made The test results Pass Clear Response Refer No Clear Response Incomplete Inconclusive Test completed 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 For a description of the individual test result types see TEOAE test results 36 DPOAE test...

Страница 43: ...ngs screen To see the details for a protocol press the button with the protocol name A Help screen will open Press OK to close the Help screen 3 Press the Start button that is next to the test you wish to perform and that cor responds to the ear you have selected to test For descriptions of the individual tests see The TEOAE test 34 The DPOAE test 27 On the Test Result screen press the OK button t...

Страница 44: ... a new patient 19 2 When you have filled in the fields that you require press the OK button After saving you can print the results or press the OK button to return to the Home page Print Results To print results 1 Press the Print button You can choose to print the best result for each test or to print selected tests You can also choose whether to create a PDF file or print the report on a label pr...

Страница 45: ... Results If you do not want to save the results of a Quick Start test to a patient you must delete the results Press the Delete button to delete the results Otometrics MADSEN Alpha OAE 45 6 Quick Start tests ...

Страница 46: ...d or if it is switched off an error message appears on the screen Note Use only the label printer recommended Alpha OAE automatically recognizes the label printer Note Do not print from Alpha OAE when the label printer status light indicates Cooling down or Buffer over flow Note The Alpha OAE docking station should not be connected simultaneously to both a PC and the label printer Preparing to pri...

Страница 47: ...DSEN Alpha OAE printing tool installed or with a label printer If you press the PDF button or the Print button under Print best result the best result for each ear and each test protocol will be printed For example if there is a Refer No Clear Response result and a Pass Clear Response result for the same test protocol on the right ear the Pass Clear Response result will be included in the report a...

Страница 48: ...l be included in the report You can choose to save the pdf or print the pdf on a printer connected to the PC 7 2 Printouts from label printer The printouts show The patient s first and last name Patient ID Date of testing Test type Left and or right ear result date and time General comments relating to the patient are listed at the bottom of the printout Best results The most recent and best resul...

Страница 49: ...Pass Clear Response Refer No Clear Response Legend Legend L R P R N Left ear Right ear Pass Refer Inconclusive due to Noise Otometrics MADSEN Alpha OAE 49 7 Printing ...

Страница 50: ... the AccuLinkinstalled 1 Press the Settings button on the Home screen From the Settings menu you can access the settings available in Alpha OAE 8 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 the test cavity See Cleaning and ...

Страница 51: ...automatically e g when a patient is being created If the probe functions correctly the message Probe OK appears If the 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 If needed repeat the test Otometrics MADSEN Alpha OAE 51 8 Alpha OAE settings ...

Страница 52: ... 8 3 Test Settings On the Test Settings screen you can select which test protocols to include in the Test Menu You can also determine what should happen if the device memory becomes full 1 To see the details for a protocol press the button with the protocol name A Help screen will open Press OK to close the Help screen 2 Select or deselect each protocol by pressing the selection button 52 Otometri...

Страница 53: ...ual start option is enabled and cal ibration fails due to large ear canal volume for example due to PE tubes in the child s ears then a double arrow appears on the result screen You can then press the double arrow to start the measurement with maximum calibrated output levels 8 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...

Страница 54: ...me setting is to be shown on the screen 8 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 54 Otometrics MADSEN Alpha OAE 8 Alpha OAE settings ...

Страница 55: ... heard at the end of the test Sound off Shows that the sound is disabled 8 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 of the green bar Note A high level of brightness will influence the power consumption of Alpha OAE Darkens the display Brightens the display Press the Default button to u...

Страница 56: ...n the Settings screen to view information regard ing Firmware release HW version and Serial number Next Alpha OAE service date Connected probe Next service date for the connected probe Memory usage 56 Otometrics MADSEN Alpha OAE 8 Alpha OAE settings ...

Страница 57: ...turn to lower case character Special characters button Select to enter special characters when the keypad is displaying standard characters Select to enter standard characters when the keypad is displaying special characters Digits and symbols button Select to enter digits or symbols when the keypad is displaying standard characters Select to enter standard characters when the keypad is displaying...

Страница 58: ...form these functions simply press the relevant function button Function buttons Patient search Press the button Enter the patient s name Press the OK button to start the search Change sort order Press the button If needed do so repeatedly until the list is sorted according to the category that you wish to use Scroll to see more next page next patients in list Test view Press the button to see the ...

Страница 59: ...Home screen OK Confirm Save Go to next field Go to next screen Toggle search criteria Press the button If needed do so repeatedly until you see the category you wish to use The category is shown as greyed out text at the top of the screen 9 4 Deleting data 9 4 1 Deleting one patient 1 To delete one single patient press the Delete button on the Home screen Otometrics MADSEN Alpha OAE 59 9 Handling ...

Страница 60: ... patient All test results relating to this patient will be deleted 9 4 2 Deleting one test 1 To delete one single test press the Delete button on the Home screen This takes you to the Delete menu 2 Press the Single test button 3 In the Delete screen select the patient whose test you want to delete This takes you to the Test View screen to select one or more tests to delete 4 Press the Delete butto...

Страница 61: ...1 To delete all patients press the Delete button on the Home screen This will take you directly to the Delete menu 2 Press the All Patients button You will be prompted to confirm that you wish to delete all patients All test results relating to all patients will be deleted Otometrics MADSEN Alpha OAE 61 9 Handling Data in Alpha OAE ...

Страница 62: ...ry time you have used the probe Even small amounts of ceru 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 10 1 1 Cleaning and disinfecting the probe tip Please remove the ear probe from the patient s ear and separate the probe tip from the dispo...

Страница 63: ...n control 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 10 1 2 Cleaning the probe body Important For periodical cleaning of the probe body contact your authorized service department Caution The probe body...

Страница 64: ...cleaned Note Eartips should be disposed of according to local regulations 10 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 tissue moistened with cleaning fluid to clean the surface of the device To maximize the housing lifetime avoid the following chemicals Isopropyl 70 Ethanol 40 concentration Formaldeh...

Страница 65: ...cking a piece of tape across the entry hole and contact your authorized service department for cleaning and or replacement of the test cavity 10 4 Battery safety and maintenance 10 4 1 Safety information Explosion hazard Warning Keep the battery away from heat or open fire and do not throw it into fire as this may cause the battery to explode Warning The battery used in this device may present a r...

Страница 66: ...cles and by ageing We recommend that you replace the battery approximately every 12 to 18 months The need for renewing the battery depends on the usage pattern and the battery capacity needed 10 4 3 Disposal of old batteries Note Li Ion batteries can be recycled Caution Dispose of used battery promptly Caution Keep away from children Caution Do not disassemble and do not dispose of in fire Environ...

Страница 67: ...es with Medical Devices Directive 93 42 EEC and RoHS Directive 2011 65 EC 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 products as ...

Страница 68: ...ot touch conductive items including ground The probe socket is intended to connect the ear probe or ear coupler to Alpha OAE No other device may be con nected to this socket Avoid accidental contact between connected but unused applied parts and other conductive parts including those con nected to protective earth Do not store or operate Alpha OAE at temperatures and humidity exceeding those state...

Страница 69: ... 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 authorized distributor or representativ...

Страница 70: ... 2630 Taastrup Denmark 45 45 75 55 55 www otometrics com App 1 8 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 elec...

Страница 71: ...Solution The maximum number of patients is reached Cannot gen erate new patient There is no memory space available for adding more patients or tests Delete patients and tests Probe FAILED The probe did not pass the test There may be several causes the probe tip is blocked the test cavity is blocked the probe is damaged Make sure that the probe tip is clean and that the channels are not blocked Mak...

Страница 72: ...poor fit in the ear canal The probe tip is blocked Try to refit the probe If the problem persists clean the probe tip or replace it with a spare 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 blocking of paper feed 72 Otometrics MADSEN Alpha OAE App 2 Status and Error Messages ...

Страница 73: ...urement techniques TEOAE Evaluation method Noise weighted averaging counting of significant signal peaks Stimulus Non linear click sequence Stimulus level 75 dB A 5 dB in 2 cc coupler self calibration depending on ear canal volume Click rate 67 76 clicks per second randomized Input filter 1 to 4 kHz Test display Averaged waveform no of TEOAE peaks noise level artifact level stability level and tes...

Страница 74: ...80 g 9 9 oz including battery Display Type Color TFT touch screen with adjustable LED backlight Dimensions 89 4 mm 3 5 inches Resolution 240 x 320 pixels Keypad Resistive touch screen can be used with gloves Sound Built in speaker for key click and Pass Clear Response and Refer No Clear Response sounds Language settings Up to 7 user selectable languages available in selected language package Memor...

Страница 75: ...emperature range 20 60 C 4 140 F Humidity range 10 90 rel non condensing Air pressure 500 hPa to 1040 hPa Operating environment Mode of operation Continuous Temperature range 10 40 C 50 104 F Humidity range 30 90 rel non condensing Air pressure 500 hPa to 1060 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 ...

Страница 76: ...while measuring Estimated battery life 8 hours of continuous use based on a typical use scenario Actual use can influ ence the battery life time Battery level indicator 5 step battery level indicator Charge time in Alpha OAE docking sta tion 80 charged 4 hours Battery Caution Use only rechargeable battery supplied by Natus Medical Denmark ApS Part no 8 73 02400 Use of any other battery may present...

Страница 77: ...oltage 5 0 V DC Output current Minimum 1 0 A Mains plug types US UK Europe and Australia App 3 6 OAE probe DPOAE Type EP DP from PATH Medical GmbH Probe cable Flexible shielded cable Approx length 150 cm 59 inches Dimensions Probe body 20 mm Ø x 23 x 11 mm 0 8 inch Ø x 0 9 inch x 0 43 inch Probe tip 3 3 mm Ø x 10 mm 0 13 inch Ø x 0 4 inch Weight Probe incl probe tip Approx 4 5 g Eartips Silicone t...

Страница 78: ...m tip Small 11 mm Orange Medium 12 mm Orange Large 14 mm Orange App 3 7 Device class II a according to Council Directive 93 42 EEC Appendix IX 78 Otometrics MADSEN Alpha OAE App 3 Technical Specifications ...

Страница 79: ...ildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Guidance and manufacturer sdeclaration electromagnetic immunity for all equipment and systems MADSEN Alpha OAE is intended for use in the electromagnetic environment specified below The user of MADSEN Alpha OAE should ensure that it is used in such ...

Страница 80: ...and systemswithin Professional Healthcare use environment MADSEN Alpha OAE is intended for use in the electromagnetic environment specified below The user of MADSEN Alpha OAE should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 3 V rms 150 kHzto 80 MHz 6 V rms IISM Bands 3 V rms 150 ...

Страница 81: ... contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humid ity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical com mercial or hospital environment Su...

Страница 82: ...the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with this symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 80 MHz to 2 5 GHz Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption a...

Страница 83: ...rding to frequency of transmitter m 150 kHzto 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHzto 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 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equa tion applicable to the frequency of the transmitter where P is t...

Страница 84: ...onnecting probe to Alpha OAE 22 D Data deleting patient data 59 Data entry with the keypad 57 Delete a test 60 Delete all patients 61 Deleting a patient 59 Device bottom view 10 cleaning 64 front view 9 preparing for testing 22 rear view 9 technical specifications 73 top view 10 Display 12 error messages 71 Display brightness 55 Disposal device 67 eartips 64 old battery 66 Docking station 6 10 cha...

Страница 85: ...p 62 Manufacturer 70 Messages on display 71 P Patient preparing 23 Patient data deleting 59 editing 21 Patient handling 19 adding new patient 19 editing patient data 21 finding a patient 20 Pinna 23 Power power off automatic 17 saving mode 17 Powering Alpha OAE 13 Preparing device for testing 22 fitting eartip on probe 24 for testing 22 patient 23 Preparing equipment 22 Printing 46 from Alpha OAE ...

Страница 86: ...17 Status messages 71 Storing Alpha OAE 12 Switching on Alpha OAE 17 System info 56 T Technical specifications 73 TEOAE test procedure 34 test results 36 Test adding comments 39 DPOAE procedure 27 29 options in screens 38 prepare probe for 22 ready to 26 TEOAE procedure 34 TEOAE results 36 test view 41 without patient selected 43 Test cavity cleaning 65 Test environment 23 Test result DPOAE 31 TEO...

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