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App. 3

Technical Specifications

App. 3.1

Accessories

Standard accessories and optional accessories may vary from country to country - please consult your local distributor.

Standard accessories

Carrying case
Docking station, including power adapter and USB cable
Starter kit (includes ear tips, probe tips, and probe tip cleaning tool)
Probe (except ABR w/ear coupler cable) (Cable Approx. length: 150 cm/59 inches)
ABR electrode cable (ABR version only) (Approx. length: 140 cm/55 inches)
ABR ear coupler cable (ABR w/ear coupler cable version only) (Approx. length: 145 cm/57 inches)
ABR tester (ABR version only)
Otometrics Ear Couplers (with cable)
Electrodes, snap, disposable (with cable)
User Manual
Battery
Cleaning cloth

Optional accessories

Ear tips
Probe tips
Probe tip cleaning tool
Label printer with printer cable
Probe (Approx. length: 150 cm/59 inches)
ABR ear coupler cable (Approx. length: 145 cm/57 inches)
External battery charger
EarHugs
Ear coupler cable for EarHugs (Approx. length: 145 cm/57 inches)
Standard accessories and optional accessories may vary from country to country - please consult your local distributor.

App. 3.2

Measurement 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 (randomised)

Input filter:

1 to 4 kHz

Test display:

Averaged waveform, no. of TEOAE peaks, probe fit assistant, noise level, arti-
fact level, stability level and test progress

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Otometrics - MADSEN AccuScreen

App. 3 Technical Specifications

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Summary of Contents for ABR Screener

Page 1: ...MADSEN AccuScreen OAE ABR Screener User Manual Doc No 7 50 0920 GB 11 Part No 7 50 09200 GB ...

Page 2: ... Otometrics the Otometrics Icon AURICAL MADSEN ICS and HORTMANN are registered trademarks of Natus Medical Denmark A S in the U S A and or other countries Version release date 2018 07 03 191357 Technical support Please contact your supplier Otometrics MADSEN AccuScreen 2 ...

Page 3: ...16 2 5 1 The battery 16 2 5 2 Inserting the battery in AccuScreen 17 2 5 3 Battery status 17 2 5 4 Powering the docking station 18 2 5 5 Charging the battery from the docking station 18 2 5 6 Charging the battery with the external charger 19 3 Getting Started with AccuScreen 20 3 1 Switch on AccuScreen 20 3 1 1 Power saving mode and automatic power off 20 3 1 2 The AccuScreen screens 20 3 1 3 Sele...

Page 4: ... test 41 5 3 3 The DPOAE test 42 5 3 4 DPOAE test results 44 5 4 The TEOAE test 45 5 4 1 TEOAE test protocol 45 5 4 2 Starting the test 45 5 4 3 The TEOAE test 46 5 4 4 TEOAE test results 47 5 5 The ABR test 49 5 5 1 Starting the test 49 5 5 2 Impedance testing and calibration 50 5 5 3 The ABR test 51 5 5 4 ABR test results 53 5 6 Options in the test result screens 55 5 7 Adding comments to a test...

Page 5: ...sinfecting the probe tip 82 11 1 2 Cleaning the probe body 83 11 1 3 Probe calibration 84 11 2 Eartips 84 11 3 The ear coupler cable 84 11 3 1 Cleaning the ear coupler cable 84 11 3 2 Ear coupler cable calibration 84 11 4 Cleaning AccuScreen 85 11 4 1 Cleaning and disinfecting the built in test cavity 85 11 5 Battery safety and maintenance 86 11 5 1 Safety information 86 11 5 2 Increasing service ...

Page 6: ...App 3 2 Measurement techniques 94 App 3 3 Device 95 App 3 4 Power supply and battery 98 App 3 5 1077 docking station 98 App 3 6 OAE probe 99 App 3 7 ABR electrode cable 100 App 3 8 ABR ear coupler cable optional 100 App 3 9 Device class 100 App 3 10 Notes on EMC Electromagnetic Compatibility 101 Index 104 6 Otometrics MADSEN AccuScreen ...

Page 7: ...g station which provides for easy recharging of the battery transferring data between AccuScreen and PC printing from a label printer 1 3 The AccuLink software program AccuLink is a software program providing data management handling with result review and configuration capabilities in a single PC application From AccuLink you can create edit view and print data relating to patients and tests user...

Page 8: ... use by audiologists ENT s and other healthcare professionals Important Natus Medical Denmark A S does not guarantee the accuracy of the test results or the tests themselves if accessor ies other than those supplied by Natus Medical Denmark A S are used for this device i e eartips electrodes ear couplers etc 1 6 Physical operating principle AccuScreen uses TEOAE Transiently Evoked Otoacoustic Emis...

Page 9: ...rning notes in Standards and Safety 88 Training It is recommended that you read this manual before you start operating AccuScreen so that you become familiar with the device before testing on a client To obtain a free printed copy of the user documentation contact Natus Medical Denmark A S www otometrics com Maintenance and cleaning For instructions on how and when to clean AccuScreen and accessor...

Page 10: ...1 8 1 Navigating this manual Menus icons and functions to select are shown in bold type as for instance in Press the OK button 10 Otometrics MADSEN AccuScreen 1 Introduction ...

Page 11: ...age 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 AccuScreen 2 2 1 Front and rear of AccuScreen A On Off switch B Touch screen display C Power and charging status light in...

Page 12: ...ocking station Front indicators POWER Lit when power is supplied to the docking station Lit when data is being transferred as follows during transfer of data between AccuScreen and AccuLink during printing from label printer USB Lit when docking station is connected to the PC via a USB cable 12 Otometrics MADSEN AccuScreen 2 Unpacking and Installation ...

Page 13: ...Rear sockets PC USB Socket for USB connection to the PC Printer Modem Socket for printer modem connection Socket for power adapter Otometrics MADSEN AccuScreen 13 2 Unpacking and Installation ...

Page 14: ...ouch the buttons to activate a function Caution Never use any type of sharp instrument on the display If you do reliable operation of AccuScreen can no longer be guaranteed 2 2 5 Ear probe Probe cable plug A Probe tip B Probe body C Probe cable 14 Otometrics MADSEN AccuScreen 2 Unpacking and Installation ...

Page 15: ...connector B Ear coupler cable C Blue ear coupler adapter for left ear D Red ear coupler adapter for right ear 2 3 Storage Store AccuScreen and accessories in the soft case provided to protect the equipment from damage See also Operating environment in Technical Specifications Otometrics MADSEN AccuScreen 15 2 Unpacking and Installation ...

Page 16: ...tery The battery used in AccuScreen is a Lithium Ion rechargeable battery 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 Use only the battery type docking station and charger stated i...

Page 17: ...attery in the compartment Hold the battery so that the arrow with the text Insert this direction points downwards towards the bottom of the compartment 4 Close the compartment 2 5 3 Battery status The battery symbol is shown in the top right corner of the display enabling you to view the status of the battery at all times Otometrics MADSEN AccuScreen 17 2 Unpacking and Installation ...

Page 18: ...ing sta tion must always be done outside the patient area min 1 5 meters 5 ft from the patient You will find an adapter plug kit when you unpack AccuScreen The adapter plug kit contains a range of adapter plugs you can choose from to fit your mains outlet Connecting to the mains supply 1 Select the adapter plug appropriate to your mains outlet and fit it on the adapter 2 Connect the adapter to the...

Page 19: ...Defective battery Charging a fully discharged battery from the docking station takes approximately 80 charged 4 hours Fully charged 6 hours 2 5 6 Charging the battery with the external charger Caution Use only the charger supplied by Natus Medical Denmark A S The battery for AccuScreen can be charged by an external charger optional accessory See the charger manufacturer s documentation for specifi...

Page 20: ... off If you do not use AccuScreen for a certain period of time AccuScreen will first switch to power saving mode and finally switch off automatically These periods are configurable see the AccuLink User Manual When AccuScreen is in power saving mode the display goes black and the power indicator lights up green Simply touch the screen to reactivate AccuScreen 3 1 2 The AccuScreen screens Important...

Page 21: ... screens patient buttons keypad 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 Selecting the user 1 Select a user from the User List The User List is configurable see the AccuLink User Manual Otometrics MADSEN AccuScreen 21 3 Ge...

Page 22: ... the user with the 3 incorrect attempts is locked out An AccuLink user with the Reset users permission can unlock AccuScreen by connecting to the device from AccuLink either to update the device configuration or to send or receive data See the AccuLink User Manual for details 3 1 6 Optional screens The following screens are optional and not part of the default AccuScreen configuration The Location...

Page 23: ...ngs 72 3 2 Patient handling in AccuScreen Note If you wish to perform a Quick Test adding or finding a patient is not necessary You can download patient data in advance from AccuLink see the AccuLink User Manual for instructions 3 2 1 Adding a new patient 1 To add a new patient press the New Patient button on the Home menu Otometrics MADSEN AccuScreen 23 3 Getting Started with AccuScreen ...

Page 24: ...ered data in the required fields and press the OK button the data is saved and the Test Menu screen is shown Regular data entry screens In most of the screens simply use the keypad to enter data For more information see Using the keypad 76 The ID screen The Forename screen The Surname screen Special data entry screens Screens with special data entry features are described in the following The Date...

Page 25: ...en obtained Full consent Screening and data will be identifiable in the national database Screen only Screening and data will be saved in the national database but will appear as anonymous to all viewers except for the local screening programme responsible for the baby The Consent Status screen is configurable see the AccuLink User Manual The Risk Factors screen In the Risk Factors screen you can ...

Page 26: ...ng in an extended patient list 1 To search in an extended list of patients press the Find Patient button in the Find Patient screen 2 The default search criteria is the patient s surname If you wish to change the search criteria press the Search Criteria button If needed press repeatedly until you see the name of the data field you wish to use for searching 3 Enter the patient s data for example s...

Page 27: ...g patient data 1 Find a patient as described in Finding a patient 26 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 AccuScreen 27 3 Getting Started with AccuScreen ...

Page 28: ...Tests 65 Caution Insert only disinfected probe tips in the test cavity See Cleaning and disinfecting the built in test cavity 85 4 2 1 Preparing the probe for testing Inspect the probe for deterioration colour 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 AccuScreen face down The probe plug...

Page 29: ...creen 3 Gently insert the electrode cable plug into the electrode cable socket The plug does not require force to be inserted properly Disconnecting the electrode cable Caution Do not pull the plug by the cable when you disconnect the electrode cable Instead pull the sleeve of the grey connector When disconnecting the plug do not twist it Instead hold the sleeve of the plug and release it by pulli...

Page 30: ... out of the socket The cable will not be released if you pull anywhere else than on the sleeve of the plug 4 3 Preparing the test environment Physical environment Make sure that the test environment is as quiet as possible The quieter the room is the more accurate and quick your testing will be Check that testing is not being done under an air conditioner or in front of a fan or ventilator Check t...

Page 31: ...nd gently pull back and slightly away from the patient s head 3 Look into the ear canal If you can see apparent narrowing of the ear canal it probably is not straight Because newborn ear canals are very soft they are easily pressed out of shape If this is the case wait until the ear canal returns to its original shape Release the pinna and try again Gently massaging the area may help opening the e...

Page 32: ...probe slightly as you insert it Verify visually the correct fitting The probe can be inserted with the probe cable pointing either upwards or down wards depending on which direction fits best Make sure that the probe fits well Any leakage may increase the test duration because of sound leakage excessive noise or both Attach the clip to the patient s clothing or bedding to secure the probe cable No...

Page 33: ... the electrodes Note The black electrode common or ground electrode could alternatively be placed on the baby s chest or shoulder The red and white electrodes must however be placed as stated i e on the nape of the neck and on the upper part of the forehead respectively Other electrode placements have not been validated 4 4 5 Fitting the ear couplers Warning Never place the red and blue ear couple...

Page 34: ...r ABR testing 32 2 Insert an ear coupler adapter into the tube at the top of each ear coupler 3 Peel off the protective film of the ear coupler 4 Place the ear coupler with the red adapter over the right ear of the baby and the ear coupler with the blue adapter over the left ear of the baby The ear couplers can be placed with the cables pointing either upwards or downwards depending on which direc...

Page 35: ...Caution To remove the ear coupler cables do not pull them by the cable Instead hold them by the ear coupler adapter Otometrics MADSEN AccuScreen 35 4 Preparing for testing ...

Page 36: ...testing Quick testing 1 Select Quick Test from the Home screen The test selection depends on the device type the configuration of the device and which cables are connected 2 See the test descriptions in The TEOAE test 45 The DPOAE test 41 The ABR test 49 Note These test results are not stored Regular testing 1 Find a patient see Finding a patient 26 or add a new patient see Adding a new patient 23...

Page 37: ...nual 4 See the test descriptions in The TEOAE test 45 The DPOAE test 41 The ABR test 49 5 2 The TEOAE test 5 2 1 Starting the test 1 To start the test press the Start button that is next to TEOAE 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 Otometrics MADSEN AccuScre...

Page 38: ...peak is valid and counted by the peak counter Peak counter The test must register a total of at least 8 valid peaks in alternating directions counted both above and below the median line in order to lead to a Pass Clear Response Probe Fit If the Probe Fit Assistant is enabled this bar shows the quality of the probe fit The longer the bar the better the probe fit The indicator bar is green when the...

Page 39: ...ends on environmental noise conditions If test conditions are optimal but there is no response measured then the frequency will time out before the progress bar reaches the end Test duration for babies Less than 10 seconds on babies with normal hearing under quiet conditions but highly dependent on test conditions in general 5 2 3 TEOAE test results When the test is completed the test data is save...

Page 40: ...hen 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 important causes of emissions not being detected To eliminate this possibility always make sure that the probe tip and the ear canal are not blocked by cerumen or vernix Clean the probe change the eart...

Page 41: ...vel of that tone is called L1 The other tone is called F2 and its level is L2 5 3 1 DPOAE test protocol The test is conducted by measuring the frequencies in decreasing order the results are displayed with the frequencies increasing from left to right The frequencies tested depend on the setup the standard frequencies are 5 kHz 4 kHz 3 kHz 2 kHz The L1 L2 pair is 59 50 dB SPL Only F2 is shown 5 3 ...

Page 42: ...ally when calibration is completed Incomplete message If the message Incomplete appears Refit the probe and make sure that it fits correctly Press the Start button to restart the test 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 See the Test details table below for a description of th...

Page 43: ...ies are 5 kHz 4 kHz 3 kHz 2 kHz where 5 kHz is tested first The default Pass Clear Response and Refer No Clear Response criterion is 3 4 The test stops automatically if 3 fre quencies reach a Pass Clear Response result or 2 frequencies receive a Refer No Clear Response result DPOAE Response at current test frequency Noise Current noise level Make sure the noise level is as low as pos sible Progres...

Page 44: ... the time of test ing The complete test is terminated successfully with a Pass Clear Response if DPOAEs could be registered for at least 3 out of 4 frequencies Note Retro cochlear hearing loss cannot be detected by DPOAE testing Refer No Clear Response A Refer No Clear Response result indicates that in at least 2 frequency bands out of 4 no significant DPOAE response could be detected The DPOAE re...

Page 45: ... for the test signal is approximately 1 kHz to 4 kHz A Pass Clear Response result requires detection of 8 peaks in the range 6 ms to 12 ms of the response 5 4 2 Starting the test 1 To start the test press the Start button that is next to TEOAE 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 cal...

Page 46: ...peak is valid and counted by the peak counter Peak counter The test must register a total of at least 8 valid peaks in alternating directions counted both above and below the median line in order to lead to a Pass Clear Response Probe Fit If the Probe Fit Assistant is enabled this bar shows the quality of the probe fit The longer the bar the better the probe fit The indicator bar is green when the...

Page 47: ...ends on environmental noise conditions If test conditions are optimal but there is no response measured then the frequency will time out before the progress bar reaches the end Test duration for babies Less than 10 seconds on babies with normal hearing under quiet conditions but highly dependent on test conditions in general 5 4 4 TEOAE test results When the test is completed the test data is save...

Page 48: ...hen 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 important causes of emissions not being detected To eliminate this possibility always make sure that the probe tip and the ear canal are not blocked by cerumen or vernix Clean the probe change the eart...

Page 49: ... that you carry out testing away from such sources of noise 5 5 1 Starting the test 1 Place the electrodes on the patient to ensure that they have time to connect well to the skin for instance while you explain the test process to relatives See Placing the electrodes for ABR testing 32 2 Connect the electrode cable 3 Fit the probe or the ear couplers with the ear coupler cable The ABR display chan...

Page 50: ...l Stimulus and Impedance values are okay Impedance test indicators Stimulus The acoustical stimulus is being calibrated If the Impedance and Balance values are OK green press the Start button to start the test Depending on how your device is configured the test may start automatically if the indicators are green or yellow Red nape The Red reading indicates the sum of the Red and the Black common o...

Page 51: ...e that the electrodes are positioned correctly 3 Make sure that the skin locations are clean Use water and a soft cloth to clean skin locations for all three electrodes well before testing 4 If needed attach new electrodes to see whether they will reduce the impedance values 1 Press the Start button to start the test Depending on how your device is con figured the test may start automatically if t...

Page 52: ...test 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 Single ear testing Binaural testing ABR Shows the ABR response EEG Is an indication of the amplitude of the total registered potential The lower this value is the easier the test will be If the electrode signals are significantly high dis turbances muscula...

Page 53: ...inaural testing Approximately 3 minutes on babies with normal hearing under quiet conditions but highly dependent on test conditions in general 5 5 4 ABR test results When the test is completed the test data is saved and the result is shown on the screen 1 See Options in the test result screens 55 for a description of the buttons available 2 Press the OK button to return to the Test Menu Test resu...

Page 54: ...e test Does the probe fit well in the ear canal Are the electrodes placed correctly and fit properly Even 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 elec trode cable depends strongly on the impedance values Is the patient well at rest and is there no muscle tension Note that el...

Page 55: ...ed for a specific ear the Start button changes to show the result The buttons show the best most recent test Press the specific button to view the result Pass Clear Response Refer No Clear Response Incomplete 2 The Binaural test button for ABR testing if shown does not change Pressing it will start a new binaural test 5 7 Adding comments to a test You can either select from a list of standard comm...

Page 56: ...eral comments by using the data entry functions described below See also Using the keypad 76 3 When you have entered a comment in the field press the OK button to save 5 7 3 Viewing comments You can view comments from the individual test result screens and from the patient s Test Menu 1 To view a comment press the View Comments button This will take you to the Comment screen If comments have alrea...

Page 57: ... results 1 and TEOAE test results 47 See also DPOAE test results 44 TEOAE test results 47 and ABR test results 53 See also TEOAE test results 47 5 10 Test View You can view a patient s tests from the Home screen from the Patient Details screen from the patient s Test Menu From the Home screen 1 On the Home screen press the Test View button This will take you to a patient list for selecting a patie...

Page 58: ... 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 2 To view or print the individual test results press the result icon This will take you to a test result screen displaying the test you wish to view or print For a description of the individual test result types see TEOAE test results 47 DPOAE test results 44 ABR ...

Page 59: ...aring for testing 28 but without adding a new patient or assigning the test to a specific patient 2 Press the Quick Test button on the Home screen From the Quick Test screen you can access the test types available in AccuScreen 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 se...

Page 60: ...printer Note Do not switch off AccuScreen 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 Note Use only the label printer recommended AccuScreen automatically recognises the label printer Note Do not print from AccuScreen when the label printer status light indicates ...

Page 61: ...the button showing the name of the patient you wish to select If needed see Finding a patient 26 This will take you to the Test View screen Printing 1 To print the entire list from the Test View screen press the Print button on this screen Patient specific comments will be printed automatically Otometrics MADSEN AccuScreen 61 7 Printing ...

Page 62: ...ecific comments will be printed automatically 7 2 Printouts from label printer The printouts show The patient s forename and surname Patient ID Date of testing Examiner s name 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 62 Otometrics MADSEN AccuScreen 7 Printing ...

Page 63: ...combined in one printout TEOAE results DPOAE results ABR results If there are no results for a specific type of test the test type is not listed Single results The most recent result is printed Pass Clear Response Refer No Clear Response Otometrics MADSEN AccuScreen 63 7 Printing ...

Page 64: ...Legend Legend L R C Left ear Right ear There are comments relating to a specific test To view these comments a print of the single result is needed 64 Otometrics MADSEN AccuScreen 7 Printing ...

Page 65: ...ectrode cable test 67 Ear coupler cable Ear coupler cable test 68 Combined Electrode cable Ear coupler cable Combined Electrode Cable Ear Coupler Cable 70 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 Cl...

Page 66: ...t 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 66 Otometrics MADSEN AccuScreen 8 Quality Tests ...

Page 67: ...g the probe test 66 8 3 Electrode cable test Every day before you start testing on patients you should test the electrode cable to make sure that it functions correctly 1 Clip the electrode clips onto the metal bars of the ABR Tester 2 Press the Electrode cable button on the Quality Tests screen If the electrode cables function correctly the message Electrode cable OK appears Otometrics MADSEN Acc...

Page 68: ...r rectly The ear coupler cable test consists of two parts 1 An automatic test to check whether there is a cable breakage 2 A manual listening test to make sure the ear coupler adapters are not clogged Automatic test 1 Insert the ear coupler adapters into the sockets at each end of the ABR Tester 2 Press the Ear coupler cable button on the Quality Tests screen If the message Ear Coupler OK appears ...

Page 69: ...t the ear coupler adapter into the ear canal Note Your AccuScreen may indicate that the test has failed This is normal since the test is performed in free air and not in the ABR Tester 4 Press the OK button to confirm 5 While listening to the left blue ear coupler adapter press the Ear coupler cable button on the Quality Tests screen 6 Make sure you can hear the ABR stimulus 7 Press the OK button ...

Page 70: ...ake sure the ear coupler adapters are not clogged Automatic test 1 Clip the electrode clips onto the metal bars of the ABR Tester 2 Insert the ear coupler adapters into the sockets at each end of the ABR Tester 3 Press the Combined button on the Quality Tests screen If the message All tests OK appears the electrode cables and ear coupler cables function correctly If the message Test FAILED appears...

Page 71: ...5 While listening to the left blue ear coupler adapter press the Ear coupler cable button on the Quality Tests screen 6 Make sure you can hear the ABR stimulus 7 Press the OK button to confirm If you can hear the ABR stimulus sound from both ear coupler adapters they are functioning correctly If you are unable to hear the sound from one or both ear coupler adapters the ear coupler adapters may be ...

Page 72: ...of the display view system information AccuLink Settings which can be configured from AccuLink are described in the AccuLink User Manual 9 1 The Settings menu From the Settings menu you can change the basic settings of AccuScreen and see information about AccuScreen and the AccuLinkinstalled 1 Press the Settings button on the Home screen From the Settings menu you can access the settings available...

Page 73: ...by pressing the OK button the set ting of seconds is set to zero 2 Press the arrows to select the day DD month MM year YYYY hours HH and minutes MIN 3 Press the Tool button to change the date and time formats Date format Select from the list how the date setting is to be shown on the screen Time format Select from the list how the time setting is to be shown on the screen Otometrics MADSEN AccuScr...

Page 74: ... shown 9 4 Sound setting 1 Press the Sound button on the Settings screen You can switch sounds on off for button strokes and test results by pressing the rel evant button Sound on Key click Pressing a button will produce a sound a click Result sound A Pass Clear Response or Refer No Clear Response sound is heard at the end of the test Sound off Shows that the sound is disabled 74 Otometrics MADSEN...

Page 75: ...tion of AccuScreen Darkens the display Brightens the display Press the Default button to use the default setting for the display brightness 9 6 System Info 1 Press the System Info button on the Settings screen to view information regard ing Firmware release HW version and Serial number Next AccuScreen service date Connected probe Next service date for the connected probe Memory usage Otometrics MA...

Page 76: ...acter 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 special digits and sym...

Page 77: ...orm 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 p...

Page 78: ...h 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 10 4 Deleting data If needed the system administrator can set up AccuScreen to automatically delete data after data transfer to AccuLink See the AccuLink User Manual 10 4 1 Deleting one patient 1 To delete one single patient press the D...

Page 79: ...h for a patient as described in Finding a patient 26 You will be prompted to confirm that you wish to delete this patient All test results relating to this patient will be deleted 4 Press the Home button to go to the Home screen 10 4 2 Deleting by date 1 To delete a group of patients by date press the Delete button on the Home screen This takes you to the Delete menu 2 Press the By Date button Oto...

Page 80: ...All test results relating to the selected group of patients will be deleted 5 Press the Home button to go to the Home screen 10 4 3 Deleting all patients 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 a...

Page 81: ...ll you will get a warning message on the screen informing that the 10 oldest patients will be deleted from AccuScreen 1 Click Yes to delete the 10 oldest patient records or Cancel to keep the data e g if you wish to delete patients manu ally or send data to AccuLink before deleting New measurements will not be possible until you have deleted some patient data from AccuScreen Otometrics MADSEN Accu...

Page 82: ...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 11 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...

Page 83: ... 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 11 1 2 Cleaning the probe body Important For periodical cleaning of the probe body contact your authorised service department Caution The probe body ...

Page 84: ...oupler adapters from coming into contact with the patient The ear couplers are disposable items 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 1 Disconnect the ear coupler cable from AccuScreen Caution Never immerse the ear coupler cable in liquid 2 Clean ear coupler cable and cable plug between eac...

Page 85: ...s data interface connector and probe plugs or the test cavity Caution Never immerse AccuScreen into water or other cleaning solutions Caution Use of cleaning agents other than those recommended in the user manual can cause damage to the device for example stress cracks in molded plastic 11 4 1 Cleaning and disinfecting the built in test cavity If needed use a tissue moistened with any of the recom...

Page 86: ...Increasing service life Use only the battery type docking station and charger stated in Power supply and battery 98 and 1077 docking station 98 Charge the battery at room temperature whenever possible Do not drop the battery or expose it to sharp impact Store in a cool dry place Keep the battery s terminals clean Clean with a soft cloth if necessary Battery renewal The battery capacity will gradua...

Page 87: ...nvironmental protection When the Li Ion rechargeable battery loses its capacity to be charged make sure that it is disposed of according to local environmental regulations or return it to your dealer Otometrics MADSEN AccuScreen 87 11 Maintenance and Cleaning ...

Page 88: ...th 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 unsor...

Page 89: ...ient and or the user Do not connect any external device e g printer to AccuScreen during testing If AccuScreen 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 or ear coupler to AccuScreen No other device may be con nected to this socket AccuScreen must not be used during the application of HF sur...

Page 90: ...y electronic equipment but negative effect or loss of functionality of other local devices may occur if they are placed in close vicinity of AccuScreen Make sure that the PC and the docking station are not within patient reach When assembling an electro medical system the person carrying out the assembly must take into account that other connected equipment which does not comply with the same safe...

Page 91: ...verify the safety of all equipment Calibration should be performed annually by suitably qualified personnel using the appropriate equipment App 1 7 1 Declaration All devices of the type AccuScreen should be checked and calibrated annually through a service centre authorised by the manufacturer App 1 8 Manufacturer Natus Medical Denmark A S Hoerskaetten 9 2630 Taastrup Denmark 45 45 75 55 55 7 45 4...

Page 92: ...ntact your supplier FLASH runtime error Self test error Invalid patient or test data has been found in flash memory Try to upload data to AccuLink delete all patient data and restart If the mes sage re appears contact your supplier Codec malfunction Self test error Restart the device If the message re appears contact your supplier App 2 2 Usage and test related messages Error message Cause Solutio...

Page 93: ... the test Too much noise Baby or testing environment is too noisy Reduce noise parents talk mobile phones baby crying etc Stimulus high The probe has a poor fit in the ear canal The probe is not in the ear canal Try to refit the probe Stimulus low The probe has a poor fit in the ear canal The probe tip is blocked Try to refit the probe If the prob lem persists clean the probe tip or replace it wit...

Page 94: ...nal accessories Ear tips Probe tips Probe tip cleaning tool Label printer with printer cable Probe Approx length 150 cm 59 inches ABR ear coupler cable Approx length 145 cm 57 inches External battery charger EarHugs Ear coupler cable for EarHugs Approx length 145 cm 57 inches Standard accessories and optional accessories may vary from country to country please consult your local distributor App 3 ...

Page 95: ...evel noise level test progress Result display Overall Pass Clear Response or Refer No Clear Response DP Gram with DPOAE and noise level ABR Evaluation method Noise weighted averaging and template matching Stimulus 30 35 40 or 45 dB nHL chirp Chirp rate 78 82 chirps per second randomised Impedance test range 1 to 99 kΩ Impedance accepted for test 12 kΩ Impedance control Before test periodically dur...

Page 96: ...y Patient memory capacity Max 250 patients Min 500 tests Test memory capacity Max 500 tests Connectors OAE probe connector 14 pin ODU Medisnap For OAE Probe or ABR ear coupler cable ABR ABR version only 4 pin ODU Medisnap For ABR electrode cable Real time clock Integrated real time clock for time stamping of measurements The clock is automatically synchronised with PC clock when docked Accuracy Ma...

Page 97: ...ed Warm up time 20 seconds Note Should be extended if MADSEN AccuScreen has been stored in a cold environment Disposal MADSEN AccuScreen can be disposed of as normal electronic waste according to WEEE and local regulations Essential performance MADSEN AccuScreen has no essential performance and accordingly the applicable requirements are as stated in the fol lowing Otoacoustic emissions as defined...

Page 98: ...time Battery level indicator 5 step battery level indicator Charge time in AccuScreen docking sta tion 80 charged 4 hours Battery Caution Use only rechargeable battery supplied by Natus Medical Denmark A S Part no 8 73 02400 Use of any other battery may present a risk of fire or explosion Battery type Rechargeable Li ion 3 7 V 1800 mAh 6 7 Wh fully charged App 3 5 1077 docking station PC interface...

Page 99: ...rope and Australia App 3 6 OAE probe TEOAE Type EP TE from PATH Medical GmbH 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 Standard cylindrical 4 sizes 3 7 5 mm Si...

Page 100: ...length 140 cm 55 inches App 3 8 ABR ear coupler cable optional Type BAST 01 from PATH Medical Gmbh Flexible shielded cable Approx length 145 cm 57 inches App 3 9 Device class II a according to Council Directive 93 42 EEC Appendix IX 100 Otometrics MADSEN AccuScreen App 3 Technical Specifications ...

Page 101: ...ions CISPR 11 Class B MADSEN AccuScreen is suitable for use in all environments including domestic environments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance and manufacturer sdeclaration electromagnetic immunity for all equipment and systems MADSEN AccuScreen is intended for use in the electromagnetic enviro...

Page 102: ...romagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equip ment marked with this symbol Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequencyrange applies Note 2 These guidelines maynot applyin all situations Electromagnetic propagation is affected byabsorption and reflection from structures ob...

Page 103: ...rding to frequency of transmitter m 150 kHz to 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 ...

Page 104: ...8 storage 16 type 16 Brightness display 75 Buttons function bar buttons 77 general 78 C Calibration Ear coupler cable 84 Changing battery 17 Cleaning 82 device 85 Ear coupler cable 84 probe tip 82 test cavity 85 Comments adding 55 viewing 56 Connecting probe to AccuScreen 28 D Data deleting patient data 78 Data entry with the keypad 76 Delete all patients 80 Deleting a patient 78 Deleting by date ...

Page 105: ...ation 28 Error message 92 device related 92 usage and test related 92 F Finding a patient 26 Function buttons 77 G General buttons 78 H Handling patients 23 I Incorrect password 22 Inserting probe in ear 32 K Keypad using 76 L Labelprinter 62 Language settings 74 M Maintenance 82 battery 86 calibration of ear coupler cable 84 cleaning device 85 cleaning ear coupler cable 84 cleaning test cavity 85...

Page 106: ... tip 14 view 14 Probe body maintenance 82 Probe calibration maintenance 84 Probe tip cleaning 82 maintenance 82 Q Quality test 65 ear couplers 68 electrode cable test 67 electrode cables and ear coupler 70 menu 67 performing 65 probe test 65 Quick Test 59 R Recharging battery 19 Remove battery 17 patient 78 79 Repair 91 Results test view 57 S Safety information 86 88 Safety symbols 88 Screens Home...

Page 107: ...quick test 59 ready to 36 TEOAE procedure 37 45 TEOAE results 39 47 test view 57 Test cavity cleaning 85 Test environment 30 Test result ABR 53 DPOAE 44 TEOAE 39 47 Test View 57 screen 58 Testing preparing for 28 Time and date settings 73 U Unpacking 11 Using AccuScreen incorrect password 22 selecting the user 21 V Views device top 12 display 14 ear probe 14 front 11 rear 11 W Warning notes 89 War...

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