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GN Otometrics A/S

AccuScreen PRO User Manual

Technical Specifications

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

Test levels (diagnostic/multilevel): l1/l2 = 55/45 dB SPL

l1/l2 = 65/55 dB SPL

Measurements per test:

Screening: 4 frequencies

Diagnostic/multilevel: 4 frequencies x 2 levels

Display:

Phase statistics diagram, test progress, noise

Result display:

PASS/REFER for all tested levels and frequencies

ABR:

Sampling rate:

10.2 kHz

Evaluation method:

Binomial statistics on template-convoluted signal

Stimulus:

35, 40 or 45 dB nHL click

Click rate:

Approx. 55 Hz

Frame length:

170 samples/17 ms

Amplifier gain:

2000

Amplifier CMRR:

> 100 dB

Input impedance:

|| 50 pF

Input bias current:

< 10 nA

Amplifier noise:

10 nV/

Hz at 1 kHz

Input bandwidth:

70 Hz to 4 kHz

Notch filter:

Digital, -40 dB at 50Hz or 60 Hz (user configurable)

Impedance sense current:

5µApp

Impedance sense signal:

1 kHz square wave

Impedance test range:

1 to 99 k

Impedance accepted for test:

< 12 k

Impedance control:

Before test, periodically during test, stimulus continues during

impedance control

Display:

Statistical graph, test progress, EEG-level, ABR detection prob-

ability

Electrodes:

Disposable hydrogel-electrodes (FDA approved)

Summary of Contents for Madsen AccuScreen PRO

Page 1: ...AccuScreen PRO Otoacoustic Emissions and Automated ABR Screener User Manual Doc no 7 26 6810 08 Part no 7 26 68100 0124 1275 ...

Page 2: ...th out notice Warranty Disclaimer The warranty of GN Otometrics A S and the manufacturer Fischer Zoth Diagnosesysteme GmbH Natus Eu rope GmbH with regard to operation quality or functionality of the AccuScreen does not apply if The equipment is not installed and used in accordance with the instructions in the manual Installation assembly extensions readjustments modifications service and repair ar...

Page 3: ...AEs 15 2 1 4 How the AccuScreen PRO T module determines a PASS 15 2 1 5 How the AccuScreen PRO D module determines a PASS 16 2 2 About Auditory Brainstem Response ABR 17 2 2 1 How the AccuScreen PRO A module determines a PASS 18 2 2 2 Advantages of combined OAE ABR Screening 19 2 3 The different versions of the AccuScreen PRO 19 3 The AccuScreen PRO 3 1 Front view 21 3 2 Top view 22 3 3 Bottom vie...

Page 4: ...le for ABR testing 33 5 3 Connecting the Y cable for ABR testing 33 5 4 Preparing the test environment 34 5 5 Preparing the patient 34 5 5 1 Placing electrodes for ABR testing 35 5 5 2 Fitting the eartip on the probe 36 5 5 3 Fitting the Ear Couplers 36 5 6 Preparing the AccuScreen PRO 38 6 Tests 6 1 Test methods 41 6 1 1 Test process TEOAE 41 6 1 2 Test process DPOAE 42 6 1 3 Test process DPOAE D...

Page 5: ...ete Data Menu 10 1 Data transfer 67 10 1 1 Transfer via cable 67 10 1 2 Transfer via infrared 68 10 2 Delete data 68 11 Options 11 1 Self Test 71 11 1 1 Probe test 72 11 1 2 Discharge battery 73 11 1 3 Codec test 73 11 1 4 LCD display test 73 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 Sou...

Page 6: ...rtips 83 12 1 4 Cleaning and disinfecting procedures 83 12 1 5 Cleaning and disinfecting the test cavity 84 12 2 Cleaning the Y cable 84 12 3 Battery maintenance 84 12 3 1 Safety information 84 12 3 2 Increasing service life 85 12 3 3 Environmental protection 85 12 4 Cleaning the AccuScreen PRO 85 13 Safety Information 13 1 Safety 87 13 1 1 Safety Symbols 87 13 2 Warranty 87 13 3 Repair after sale...

Page 7: ...AccuScreen PRO User Manual GN Otometrics A S 7 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 ...

Page 8: ...User Manual AccuScreen PRO 8 GN Otometrics A S ...

Page 9: ...vioural observation The AccuScreen PRO uses TEOAE Transiently Evoked Otoacoustic Emissions and DPOAE Distortion Product Otoacoustic Emissions technologies which are highly effective for neonatal hearing screen ing Otoacoustic Emissions measure cochlear mechanics and indi cate whether the cochlea is functioning correctly or not Children s emissions are typically strong which makes them easy and fas...

Page 10: ...oftware please see AccuHelp in the AccuLink software 1 2 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 a description of the main functions of the Ac cuScreen PRO GN Otometrics A S recommends that you make yourself familiar with the following issues Installation Section 4 2 Unpa...

Page 11: ...5 dB nHL The stimulus level can be preset ei ther from the Options menu or by the user being prompted to select the level before every ABR test see how to select the stimulus level in Section 11 4 1 Notch filter setting on page 78 1 4 Typographical conventions The use of WARNING CAUTION and NOTE For safety reasons and appropriate use of the AccuScreen PRO the manual contains WARNINGS Cautions and ...

Page 12: ...12 GN Otometrics A S Introduction AccuScreen PRO User Manual ...

Page 13: ...which are transmitted through the middle ear chain Consequently they can be detected only when the middle ear is op erating normally OAEs are generated only when the Organ of Corti is in normal or near normal condition They can emerge spontane ously but more commonly follow acoustic stimulation Note that otoacoustic emissions do not contribute to hearing but are by products of an active process in...

Page 14: ...n for low level inputs and lends support to the notion that OAEs arise from outer hair cell activity TEOAEs do not correlate with behavioural audiometric thresholds Consequently it is not possible to predict hearing thresholds based on TEOAE thresholds However since the presence of TEOAEs cor relates strongly with normal hearing the most common clinical ap plication involves click stimulation at m...

Page 15: ...lear function This makes them helpful in pinpointing sites of lesion as well as in making management deci sions 2 1 4 How the AccuScreen PRO T module determines a PASS Applies to AccuScreen PRO T TA TD TDA AccuScreen PRO uses a binomial statistical test to give either a PASS or a REFER result Most TEOAE instruments use the signal averag ing technique with two buffers In contrast the AccuScreen PRO...

Page 16: ...cates that the probe has moved during testing 2 1 5 How the AccuScreen PRO D module determines a PASS Applies to AccuScreen PRO D DA TD TDA Distortion Products are the result of cochlear activity which origi nates from processing a two tone signal The two tones are called primaries and their frequencies are designated as f1 and f2 and the levels are termed L1 and L2 The challenge of DPOAE evaluati...

Page 17: ...imed on a 99 7 confidence level This criterion is set up for each of four frequencies applied 2 kHz 2 5 kHz 3 2 kHz and 4 kHz An overall PASS result requires 3 passes out of 4 frequencies The Diagnostic DP facility performs DP testing at two stimulation levels which results in 8 measurements 4 frequencies at 2 levels 1 5 kHz 2 kHz 3 kHz and 4 kHz The statistical analysis described above is also us...

Page 18: ... Brainstem Response ABR is a low amplitude signal usually buried in the electric brain and muscle activity EEG and EMG It can only be extracted by applying special filtering tech niques Averaging is the procedure most commonly used to make it visible the stimulus is presented repeatedly up to several thou sand times and the signal from the electrodes which follow the stimulus is summed continuousl...

Page 19: ...the ABR dis criminates more precisely between mild and moderate hearing loss es Consequently its specificity for detecting moderate losses is higher However the test requires more time for preparation and testing than an OAE test Automated ABR tests are therefore ideal as a second step following an OAE screening test with a REFER result as well as screening children who are at greater risk for ret...

Page 20: ...20 GN Otometrics A S Test Methods AccuScreen PRO User Manual ...

Page 21: ...AccuScreen PRO User Manual The AccuScreen PRO GN Otometrics A S 21 3 The AccuScreen PRO 3 1 Front view LED indicator Navigation arrows Graphic LCD display Softkeys Alphanumeric keypad OK button ...

Page 22: ...22 GN Otometrics A S The AccuScreen PRO AccuScreen PRO User Manual 3 2 Top view 3 3 Bottom view Infrared window Probe socket Y cable socket ABR socket Connector to PC and label printer ...

Page 23: ...GN Otometrics A S 23 AccuScreen PRO User Manual The AccuScreen PRO 3 4 Reverse side view Label with serial number Rechargeable NiMH battery pack ...

Page 24: ...Activates the selected item Starts measuring func tions Softkey left MENU OPT Option SKIP PAUSE Reverts to the Main Menu Shows artefacts and stimu lus stability TEOAE Skips test functions DPOAE Interrupts measurement ABR Softkey right OFF BACK SELECT STOP Switches off the device Reverts to the previous menu Cursor for selecting date time Discontinues testing Navigation arrow up Cursor for navigati...

Page 25: ...pad If you do reliable operation of AccuScreen PRO can no longer be guaran teed Entering data 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 3 6 Ear probe Test cavity Probe body Acoustic filter disc Probe tip ...

Page 26: ...26 GN Otometrics A S The AccuScreen PRO AccuScreen PRO User Manual ...

Page 27: ...atient and or the user If the AccuScreen PRO is used during surgery the probe and connectors must not touch conductive items including ground During application of HF surgical devices the AccuScreen PRO must not be used During application of defibrillators the AccuScreen PRO must not be used The probe socket is intended to connect the ear probe to the AccuScreen PRO device No other device may be c...

Page 28: ... Charge up the battery completely before using the equipment for the first time Please use only the recommended charger The NiMH battery pack guarantees approximately 10 hours of oper ating time 4 5 1 Battery test Press OK to switch on the AccuScreen PRO The device auto matically performs a battery test If the necessary minimum voltage should drop the message Change battery appears in the display ...

Page 29: ...e you use the rechargeable NiMH battery pack please read the following instructions carefully 1 Hold the AccuScreen PRO with the reverse side facing you 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 ...

Page 30: ... the charger indicates when the battery is charging and when it is fully charged The LED also indicates faults in the system 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 LED o...

Page 31: ...an Clean with a soft cloth if necessary 4 5 6 Environmental Protection When the NiMH battery looses its capacity to be charged make sure that it is disposed of according to local environmental regulations or return it to your dealer Note NiMH batteries can be recycled Note Damage resulting from failure to observe the operating instructions will invalidate all warranty claims The manufacturers take...

Page 32: ...32 GN Otometrics A S Before You Start AccuScreen PRO User Manual ...

Page 33: ...ng it backwards Caution Do not pull the plug by the cable when you disconnect the probe The probe will not be released if you pull anywhere else than on the sleeve of the plug 5 2 Connecting the electrode cable for ABR testing Applies to AccuScreen PRO A TA DA TDA Insert the ABR cable plug in the provided socket Make sure that the red dots are aligned Disconnecting the electrode cable Caution Do n...

Page 34: ...vironment Make sure that the test environment is as quiet as possible The quieter the room is the more accurate your testing will be Check that testing is not being done under an air conditioner or in front of a fan or ventilator Check that there is no running water people talking etc Hygienic precautions Be sure to follow any established infection control procedures for the setting in which you a...

Page 35: ...ure it is clear of vernix or debris as this may affect the result of the test Clean the ear canal if required 5 5 1 Placing electrodes for ABR testing Applies to AccuScreen PRO A TA DA TDA Skin preparation Note Do not use alcoholic skin cleaning material or surgical spirits to pre pare the skin as they may cause the skin to dry out leading to a high er skin impedance 1 If you are using separate el...

Page 36: ...emove the eartip if you turn it gently When you do so make sure that you hold the probe by the plug and not by the cable Note Accurate testing is only guaranteed if you use the eartips pro vided Note The probe can be used for both ears If you suspect infection in one ear exchange the eartip and clean the probe tip or replace it with a spare before you continue testing on the other ear WARNING Usin...

Page 37: ...r Fitting Ear Couplers WARNING Never place the red and blue Ear Coupler adapters directly in the ear canal Use them only with the Ear Couplers fitted Note Use the Ear Couplers only with the Y cable not with the OAE probe 1 Peel off the protective film of the Ear Coupler 2 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 le...

Page 38: ...e that the probe is functioning correctly See Section 11 1 1 Probe test on page 72 Caution Insert only disinfected probe tips in the test cavity If required see Section 12 1 5 Cleaning and disinfecting the test cavity on page 84 3 If you are going to do an ABR test make sure the stimulus level setting is correct See Section 11 4 2 ABR stimulus level setting on page 79 4 Select Test from the Main M...

Page 39: ...ame First name Date of birth Press CLEAR to cancel incorrect input and or use the keypad arrow buttons to move backwards and forwards in the text Note You cannot edit patient data once you have pressed OK to save the data 2 Press OK to confirm 3 To save all data press OK The screen CHECK PATIENT DATA appears Make sure that the correct patient is selected and press OK to confirm 4 Scroll to select ...

Page 40: ... may increase the test duration because of distortion and excessive noise Note Make sure that the cable is not in contact with any vibrating surfaces during testing You can easily compensate for spontaneous movements of the head by reducing the pull on the probe cable To do so form a big loop which you hold loosely with one hand close to the head of the patient 2 If you have selected an ABR test y...

Page 41: ...cribed in Chapter 5 Preparing for testing on page 33 2 Select TEOAE from the SELECT TEST menu and select the ear on which you wish to start the test 3 Press OK to start the test Calibration Calibration is performed before the actual test starts The test starts automatically when calibration is completed The TEOAE test The test as it progresses is shown on the display See also Section 6 2 1 TEOAE t...

Page 42: ...the result is a REFER the detailed results are shown immediately after the test Add comments and view results as required See Section 6 3 After the test on page 53 and Section 6 4 Interpretation of the results on page 54 You can now scroll to select the baby s other ear on the screen and if required reposition the baby so that you can test the other ear Before you continue testing the other ear ch...

Page 43: ...le Balance test The probe fit is followed by a balance test to make sure that the two microphones function correctly The test starts automatically when calibration is completed The DPOAE test The test as it progresses is shown on the display See also Section 6 2 2 DPOAE tests on page 51 for monitoring the test Test duration Approximately 10 seconds on patients with normal hearing The test frequenc...

Page 44: ...creasing frequencies 2000 Hz 2500 Hz 3200 Hz 4000 Hz Only L2 is shown The L1 L2 pair is 59 50 dB SPL The complete test is terminated successfully with a PASS if DPOAEs could be registered in at least three frequency ranges areas Add comments and view results as required See Section 6 3 After the test on page 53 and Section 6 4 Interpretation of the results on page 54 You can now scroll to select t...

Page 45: ...rts Probe fit If the probe does not fit correctly the screen displays the word LEAK Adjust the position of the probe so that the graphical line be tween 1K and 2K is as horizontal as possible Balance test The probe fit is followed by a balance test to make sure that the two microphones function correctly The test starts automatically when calibration is completed The DPOAE Diagnostic test The test...

Page 46: ...es with the next frequency The keynote on the display indicates which frequency is cur rently being tested The results are indicated by following symbols 9 PASS R REFER S Skipped stopped If the result is a PASS a PASS message appears briefly before the de tailed results are shown At the end of each test a result display appears automatically show ing the individual results of the tested frequencie...

Page 47: ...reen PRO A TA DA TDA 1 Do as described in Chapter 5 Preparing for testing on page 33 2 Fit probe or Y cable and electrodes to ensure that the elec trodes have time to connect well to the patient for instance while you explain the test process to relatives 3 Select ABR from the SELECT TEST menu and select the ear on which you wish to start the test 4 Make sure that the Notch Filter setting is corre...

Page 48: ...s the skin impedance of the white electrode high on the forehead Red indicates the skin impedance of the red electrode the nape of the neck Less than 6000 Ω Good 6000 to 12000 Ω Fair More than 12000 Ω Poor testing is not possible OK is not available only STOP can be pressed Balance indicates the difference in the skin impedance of the white and the red electrode This value should also be fairly lo...

Page 49: ... the balance are OK press OK to start the test LED flashes green The acoustical stimulus is now calibrat ed Level shows the stimulus level Canal shows the volume of the outer ear canal If the values are OK the system automatically proceeds with the ABR test The ABR test Time shows the test duration ABR shows the probability of detecting an ABR signal EEG is an indication of the amplitude of the to...

Page 50: ...so Section 12 1 Probe cleaning and maintenance on page 81 6 2 Monitoring the test 6 2 1 TEOAE tests The LED flashes green during the test If the LED is red this indicates an error during testing The probe is unstable or Artifacts are present indicating high environmental noise or a noisy baby In these cases check the test conditions and make sure that the probe fits If required press STOP to stop ...

Page 51: ...probability circle during testing A response is always in constant phase compared to the stimuli When a response is registered it is mapped from the center towards the outer edge of the probability circle forming a more or less straight line A PASS is determined with a confidence of 99 7 for each frequency Noise no response is randomly distributed in the circle and will reach the outer edge only w...

Page 52: ...sponse is always in phase When a response is registered it is mapped from the center towards the outer edge of the probability circle forming a more or less straight line A PASS is determined with a confidence of 99 7 for all frequencies Noise no response is randomly distributed in the circle and will never reach the outer edge If mapping is randomly distributed the test is heading towards a REFER...

Page 53: ... a test If you select Add comments the COMMENTS screen appears You can either select from a list of 25 standard comments or add a comment of your choice You can edit the 25 standard comments from AccuLink and then download them to the AccuScreen PRO Selecting from the list of comments Scroll to select the appropriate comment and press OK to store the selected comment Adding a new comment Press ADD...

Page 54: ... tient If the patient is given yet another REFER this patient should be referred for further testing The results screen is explained in the following PS PASS Testing successful OAE or ABR present RE REFER OAE or ABR criterion not reached Date Time format depends on the setting in Section 11 2 3 Date Time format on page 75 The year of the test is stored as well and can be seen if the test is transf...

Page 55: ...lity of the test and so on repeating the test a PASS may be obtained It is always recommended that you repeat the test when a REFER result is ob tained Consider for instance the following when you interpret a REFER re sult Malfunctions in the transmission of sound are by far the most important causes of emissions not being detected To eliminate this possibility always make sure that the probe and ...

Page 56: ...uency at least indicates near to normal hearing in the speci fied band The major reason for non detection is a too noisy situation or a bad probe fitting in the ear canal In DPOAEs this is especially true for the lowest frequencies Therefore low frequency REFER with high frequency PASS is a strong indicator that test conditions were not optimal If this is the case it is recommended that you improv...

Page 57: ... if the device accepts the impedance values it is often worth while to attempt to reduce impedance values and particularly the impedance differences The noise in the electrode cables depends strongly on the impedance values Is the patient well at rest and is there no muscle tension Note that electric muscle artifacts may arise from non moving but tensed muscles isometric contraction Please check e...

Page 58: ...58 GN Otometrics A S Tests AccuScreen PRO User Manual ...

Page 59: ...aved in this mode As a consequence no data is available in the modes View results and Print results 1 Select Quick test on the Main Menu 2 Do as described in Chapter 5 Preparing for testing on page 33 but without assigning the test to a specific patient 3 Select the type of test you wish to perform See Chapter 6 Tests on page 41 for a the description of the individual tests 4 Press OK to start the...

Page 60: ...60 GN Otometrics A S Quick Test AccuScreen PRO User Manual ...

Page 61: ... Accu Screen PRO Printing from a label printer 1 Switch on the AccuScreen PRO with the Main Menu on view 2 Connect the label printer cable to the AccuScreen PRO 3 Switch on the printer 4 Select from the printer menu as described below Note Do not switch off the AccuScreen PRO while printing is in progress Doing so may result in distorted test data Note If the printer is not connected or if it is s...

Page 62: ...e PRINT RESULTS menu If you select Single Results a list of results appears The most recent is highlighted by a black bar Scroll to select the required result For all other types of printout printing starts when you press PRINT 5 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...

Page 63: ...ected patient appears with the most recent test highlighted by the black bar 1 Scroll to select and press PRINT 2 For interpretation of the PRINT RESULTS screen see also Sec tion 6 4 Interpretation of the results on page 54 TEOAE results The most recent results are printed AccuScreen PRO TDA 0003592 Jones Arthur 07 02 2005 Examiner HHE TEOAE Resultats 08 12 10 41 R PASS 08 12 10 42 L PASS ABR Resu...

Page 64: ...al DPOAE results 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 ...

Page 65: ...g or from the View re sults item on the specific test screen 1 Select View results from the Main Menu The patient list appears 2 If the AccuScreen PRO has not been switched off since the last test the name of the last tested patient is highlighted automat ically Select the patient whose data you wish to view 3 Check that you have selected the correct patient and press OK The VIEW RESULTS screen ap...

Page 66: ...r Manual 4 The VIEW RESULTS screen shows a list of results The most recent is highlighted by a black bar 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 ...

Page 67: ...ransfer Delete data from the Main Menu 10 1 1 Transfer via cable If you select Transfer via cable a message is displayed 1 Connect the interface cable to the PC 2 Activate the AccuLink program on the PC and run the transfer operation from AccuLink 3 When you have transferred data to AccuLink delete the data from the AccuScreen PRO see Section 10 2 Delete data on page 68 ...

Page 68: ... tact between the AccuScreen PRO and the infrared adapter 4 Activate the AccuLink program on the PC and run the transfer operation from AccuLink 5 When you have transferred data to AccuLink delete the data from the AccuScreen PRO see section 10 2 Delete data 10 2 Delete data This function deletes all test data in the AccuScreen PRO The AccuScreen PRO memory can store approx 250 test results For me...

Page 69: ... data is deleted the message All data cleared appears on the display 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 All data cleared ...

Page 70: ...70 GN Otometrics A S The Transfer Delete Data Menu AccuScreen PRO User Manual ...

Page 71: ... tests see information about memory used and see information about the hardware and the software installed See the description of the individual menu items below Default settings The default settings of the AccuScreen PRO are on delivery set as follows 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 ...

Page 72: ...the probe type the serial number of the probe the date of the last calibration 2 Insert the probe tip without eartip in the test cavity and press any key to start the 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 3 Press any key to return to the SELF TEST menu ...

Page 73: ...letely 11 1 3 Codec test Select Codec test to test the functionality of the Codec When you receive the message Codec test OK press any key to return to the Self test menu 11 1 4 LCD display test 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 1 Select Keyboard test to t...

Page 74: ...cess to basic settings which you can select and change 11 2 1 Language 1 Select Language to see the implemented languages Select the language of your choice 2 Press OK to confirm and return to the SETTINGS 1 menu Note 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 r...

Page 75: ... 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 11 2 4 Background Lighting Display Select Backlight to switch the background lighting on or off Select and press OK The background lighting will light up shortly and switch off automatically after 20 seconds if the keys are not touched MENU will return you t...

Page 76: ...oring the new setting BACK will return you to the SETTINGS 1 menu without storing the new setting 11 2 6 Default test 1 Select Default test to set the test of your choice to appear as default when you select Test from the Main Menu 2 Press OK to confirm and return to the SETTINGS 1 menu MENU will return you to the Main Menu without storing the new setting BACK will return you to the SETTINGS 1 men...

Page 77: ... 21 letters and a grammalog max 5 letters are required to access the AccuScreen PRO Login and gramm alog must be set up in advance in AccuLink and transferred to the AccuScreen PRO Up to 100 examiners can be listed The user switching on the AccuScreen PRO will be asked to enter the login The grammalog appears in the test result printouts 2 Scroll to select and press OK to confirm and return to the...

Page 78: ...SETTINGS 2 menu 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 4 ABR configuration Select ABR Configuration from the Options menu The ABR configuration menu gives you access to basic settings which you can select and change 11 4 1 Notch filter setting 1 Select Notch filter setting from the ABR Con...

Page 79: ...te stimulus level in accordance with your local screening protocol 1 Select Stimulus level from the ABR Configuration Menu Press OK to confirm 2 You can choose between three different stimulus levels 35 40 and 45 dB nHL 3 You can select the appropriate stimulus level or select Ask before ABR test which allows you to select the stimulus level before each test Select the required function Press OK t...

Page 80: ...is completely full Every 5 tests after the first reminder the percentage of memory used will be displayed again Download data to AccuLink as soon as possible When you have downloaded data to AccuLink you must delete the data in the AccuScreen PRO To do so see Section 10 2 Delete data on page 68 11 6 Version information 1 Select SW HW information from the OPTIONS menu The SW HW INFORMATION screen s...

Page 81: ... the channels in the probe tip every time you have used the probe Even small amounts of cerumen or vernix can block the probe channels Clean the channels if required see below 12 1 1 Cleaning and disinfecting the probe tip Cleaning and disinfecting the probe tip is a two step procedure which consists of the following Regular cleaning Regular cleaning without water or disinfectant must be per forme...

Page 82: ...g with water and or disinfectant as well as sterilization see Section 12 1 4 Cleaning and disinfect ing procedures on page 83 4 Make sure that the sound channels are completely dry before you fit the tip back onto the probe body or use a spare probe tip Caution Even the slightest amount of moisture may dissolve any resid ual cerumen and thus contaminate the sensitive parts in the body of the probe...

Page 83: ...rding to local regulations 12 1 4 Cleaning and disinfecting procedures You should always comply with local hygienic standards for disin fection and sterilization Sterilization of the probe tip is required after use in infected ear ca nals Regular cleaning Use a wet tissue for regular surface cleaning Immerse the probe tip for 5 10 minutes in a lukewarm mild soap water solution Disinfecting Immerse...

Page 84: ...ms and should be used only on one patient If there is a risk of cross infection clean the adapters Otherwise clean the adapters at the end of the day Disconnect the Y cable from the AccuScreen PRO Use a wet tissue with alcohol to clean the Y cable and the Ear Coupler adapter Wipe only with disinfectants and make sure that liquid does not enter the Ear Coupler adapter Never immerse the Y cable in l...

Page 85: ...observe the operating instructions will invalidate all warranty The manufacturers take no responsibility for damage resulting from negligence 12 4 Cleaning the AccuScreen PRO Prerequisites Before cleaning switch off the AccuScreen PRO and unplug it from any external power source Unplug the probe and the data transfer plug from the Accu Screen PRO Cleaning Clean the AccuScreen PRO with a moist clot...

Page 86: ...86 GN Otometrics A S Maintenance AccuScreen PRO User Manual ...

Page 87: ... to indicate compli ance with Type BF requirements of EN 60601 1 This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care professional The instrument is marked with this symbol to indicate that it is elec tronic equipment covered by the Directive 2002 96 EC on waste elec trical and electronic equipment WEEE 13 2 Warranty The AccuScreen PRO is ...

Page 88: ...ler will repair replace or re calibrate the instrument at no cost to the purchaser while the AccuScreen PRO is within the warranty pe riod Service and repair of electro medical equipment should only be car ried out by the equipment manufacturer or by authorized represent atives The manufacturer reserves the right to disclaim all responsibility for the operation safety reliability and performance o...

Page 89: ...e Note Following the mes sage Codec failure the device is switched off automatically Codec is defect Contact your service depart ment Interference during ABR test only Ambient interference Try to eliminate interference sources See Section 5 5 1 Plac ing electrodes for ABR testing on page 35 LCD test failed LCD is defective Contact your service depart ment LED flashes digit code is shown Run time e...

Page 90: ...tion Contact your service depart ment Testing not possible Impedance of electrodes or bal ance is too high EEG values are constantly high Check electrodes and replace them if necessary Repeat test if the patient is quiet Testing not possible Please disconnect the label printer Testing cannot be done while the printer is connected to the device Disconnect the label printer from the device The calib...

Page 91: ... converter 2 channels AD 2 channels DA Resolution 16 bit Sampling rate Variable Data memory 128 kByte built in flash memory etc Real time clock Own battery runs minimum 2 years Interfaces RS232 up to 115 kbps infrared Data transmission Via cable Via infrared Serial cable SUB D 9 pole m w 9600 bps Operating conditions Storage temperature range 0 40 C 32 104 F Operating temperature range 5 35 C 40 9...

Page 92: ...1V microbar 0 1 N m2 Output impedance 2800 to 6800 Ω 4400 Ω nominal Operating voltage 0 9 to 20 V DC Dimensions Probe body Probe tip 10 mm Ø x 35 mm 0 4 Ø x 1 4 3 5 mm Ø x 10 mm 0 14 Ø x 0 4 Probe adapter 4 0 mm to 12 mm Ø 0 16 to 0 47 silicone Weight Probe incl probe adapter 4 grams Probe tip TEOAE Exchangeable green Probe tip DPOAE Exchangeable blue Eartips Standard cylindric Mushroom Tree tip 8...

Page 93: ...Binomial statistics on template convoluted signal Stimulus 35 40 or 45 dB nHL click Click rate Approx 55 Hz Frame length 170 samples 17 ms Amplifier gain 2000 Amplifier CMRR 100 dB Input impedance 1010 Ω 50 pF Input bias current 10 nA Amplifier noise 10 nV Hz at 1 kHz Input bandwidth 70 Hz to 4 kHz Notch filter Digital 40 dB at 50Hz or 60 Hz user configurable Impedance sense current 5µApp Impedanc...

Page 94: ...r Fischer Zoth Diagnosesysteme GmbH Walter Kolbenhoff Str 34 D 82110 Germering Germany Natus Europe GmbH Bärmannstrasse 38 D 81245 München Germany 15 8 Distributor GN Otometrics A S 9 Hoerskaetten DK 2630 Taastrup Denmark Phone 45 45 75 55 55 Fax 45 45 75 55 59 www otometrics com 0124 1275 ...

Page 95: ...88 Cleaning device 85 probe tip 81 83 test cavity 84 Y cable 84 Codec test 73 Comments adding 53 viewing 53 Control panel 24 D Data deleting data 68 entering data 25 transfer via cable 67 transfer via infrared 68 Date time format setting 75 Date time setting 75 Deleting data 68 Device cleaning 85 memory 79 preparing 38 technical specifications 91 version 80 Discharge battery 73 Display 24 messages...

Page 96: ...8 Options 71 P PASS description A module 18 description D module 16 description T module 15 Patient adding to patient list 39 fitting electrodes 35 preparing 34 selecting from patient list 38 Patient list adding patient 39 selecting patient 38 setting 77 Preparing device 38 ear coupler 36 fitting eartip on probe 36 for testing 33 patient 34 Printer 61 Printing 61 types of printout 62 Probe cleanin...

Page 97: ...environment 34 Test methods 13 device types 19 Testing preparing for t 33 Tests ABR process 47 ABR test monitoring 53 default test setting 76 DPOAE Diagnostic process 45 DPOAE Diagnostic test monitoring 52 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 U Unpackin...

Page 98: ...98 GN Otometrics A S User Manual AccuScreen PRO ...

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