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Otoport Screener

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1. Users Select Users to add a New User or to review and edit the current User List Defaults Select Defaults to enter custom Facility or Risk Factor options Date and time Select Date amp Time to adjust the date and time settings Other options Select Other Options to alter patient ID format and login activation preferences and to add a site and device identification which are then saved to Test Records Select Back to return to the main Menu screens 62 CHAPTER EIGHT Management 8 2 8 2 a 8 2 b 8 2 c 8 2 d 8 2 e Users menu USERS iew Users EACE SELECT Add new user Select Add New User to enter details of a new user and save to the User List View users Select View Users to review edit or delete users from the current User List Select Back to return to the Management Menu screen 8 2 1 8 2 1 4 OTOPORT SCREENER Add new user To add a New User complete the field entries shown on the New User screen The following table describes the field choices available 63 User Manual Field Description Max No Characters Name User s name that appears 8 at Login User ID The user s unique identification 3 This is attached toa test record capitalised when saved to the database only Password An alphanumeric password 8 required for secure login capitalised only Admin Select Yes to give the newuser n a administrator access rights Select No to res
2. Test memory Program config memory Analogue performance Output channels Input channels Sample rate Frequency response 420 MIPS 8MB non volatile database for patient details and test results 1 3MB 2 x 16bit resolution 1 x 16bit resolution Variable Electrical 160Hz to 12KHz 158 CHAPTER TWENTY ONE Technical specifications Environmental Transport and storage Operating Temperature range 0 to 40 Celsius Pressure 23KPa to 101KPa Humidity 10 to 90 non condensing Indoor use Temperature range 5 to 40 Celsius Humidity Max 80 up to 31C decreasing linearly to 5 RH at 40C Classifications and standards Device Class 2a BS EN ISO 13485 2001 ISO 14971 BS EN 60601 1 BS EN 60601 1 1 BS EN 60601 1 2 BS EN 60601 1 4 UL 60601 1 CSA C22 601 Directive 93 42 EEC REF EN46001superseded 01 03 2004 Application of risk management Medical Electrical Equipment Part 1 General Requirements for Safety Medical Electrical Equipment Part 1 General Requirements for Safety Collateral Standard Safety Requirements for Medical Electrical Systems Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compatibility Medical electrical equipment Part 1 General requirements for safety Section 4 Collateral standard programmable electrical medical systems Medical Electrical Equipment Part 1 General
3. todynam ics 18 Mas 01 3 2 a Following switch on an Otodynamics logo animation is displayed whilst the device performs a series of hardware system checks A battery graphic will appear to the right of the logo to provide an indication of the Battery Power remaining Please refer to chapter 16 Otoport Power for battery information The date and time are also shown at the bottom of the screen and can be reset by an Administrator in the device Management module See chapter s 4 Date amp Time s Main menu Test COUE eU CKE SELECT 3 3 a You are then presented with the Test main menu screen Other main menu screens can be accessed using the Left Right Arrow buttons Choose Select to enter each menu 4 1 OTOPORT SCREENER 23 User Manual Test preparation General checks before testing Ensure the Otoport is charged see chapter is Otoport power for information Ensure the Otoport weekly checks are being regularly conducted see chapter 12 Probe for information Do not run an OAE test if there is any discharge from the ear to be tested Choose a quiet room without background noises Ensure the patient is comfortable and settled Ensure you can clearly see the ear to be tested 24 CHAPTER FOUR Test preparation 4 2 4 2 a Connecting the probe Prior to the testing session connect the probe to the Otoport The probe plug contains a key that must be aligned with the keyway in
4. print jobs sent to the printer will be stored spooled and printed when the detected condition is rectified The printer s green light will flash when a print job is being stored woe Note The printer memory is not large enough to print a complete Detailed print Summary prints can be completed If a print job is not completed by the printer re initiate the print on the Otoport 0 7 0 7 a 0 7 b 0 7 c 0 7 d 0 7 e OZS 10 8 10 8 a 10 8 b OTOPORT SCREENER 93 User Manual Printer light summary The light at the front of the printer has a number of colour combinations which indicate various conditions Constant green Normal operation running on battery power Flashing green The printer is storing print information spooling that cannot be printed at the time e g no paper or printer lid open Flashing green orange Battery is being charged Red Low battery or other problem No light Unit is in sleep mode has a flat battery or the battery is not connected Paper When the printer is switched on the button provides a paper feed function A double press of the button will initiate a test print The printer is supplied with spare paper rolls To change the printer roll pull the lid release catch 1 forwards with your thumb and the paper roll lid will spring open 94 CHAPTER TEN Printing 10 8 c Unwind a small amount of paper from the roll Insert the new roll 2 ensu
5. 1 With the arrow at the from 2 Press the BS button to turn 3 Date lime and battery connect the probe and on the Otoport Confirm status are displayed whie screw the knurled eleeve within 2 seconds by system checks are until finger tight pressing the button portormad B Fitting the earpiece 1 Select an appropriate tip 2 Fit the tip to the earpiece 3 Fit the earpiece in the ear canal C Performing a TEOAE test ee ee ee Test lt a au gt annro F Pie Sa Satta ena smeer emee eraat ce t T oo l 1 To run a QUICK test press 2 A vertical stimulus meedie and 3 An OAE histogram ie the 0 button low noise with two blue LEDs continuously updated during indicate a good probe fit the test The symbol indicates Press to START the test that a band meets pass criteria OTOPORT SCREENER 15 User Manual is Otodynamics Ltd www otodynamics com Sales 44 0 1707 267667 Support 44 0 1707 267540 Fax 44 0 1707 262327 Otodynamix the amp button for SAVE options 1 Press the buttonto enter 2 Using the buttons or Right ear using ns Press to details for a new patient and keypad to erter patient detale Press if to SAVE gt Initial charge 2 5 a Before using your Otoport Screener fully charge the unit See chapter 16 Otoport Power for details 16 CHAPTER TWO Getting started 2 6 2 6 1 2 6 1 a 2 6 2 2 6 2 a Using the buttons
6. 9 c 2 6 10 2 6 10 a is shown following switch on allows the user to adjust the screen contrast Use the Left Right Arrow buttons to adjust the contrast and select Save to store changes or select Cancel to restore orginal settings The Otoport will need to complete its start up sequence before the next screen is displayed The default setting should be adequate in most circumstances but adjustment may be helpful in unusual environments such as cold operating conditions Hard reset In the unlikely event that the Otoport fails to respond to user control hold the On Off button down for 10 seconds in order to reset the device You may then switch on the device as normal 3 1 3 1 a 3 1 b OTOPORT SCREENER 21 User Manual Switching on Switch on screen Switch Unit On No VES To switch on the Otoport press the green On Off power button found at the bottom left of the keypad The display screen will show Switch Unit On Press Yes to confirm Otoport switch on or press No to turn the unit off again If Yes or No are not selected within two seconds of pressing the On Off power button the device will automatically turn off The unit will turn off if any button other than Yes is pressed This is to prevent accidental switch on during transit Note Following the Otoport being switched off it is not possible to turn it on again for 3 seconds 22 CHAPTER THREE Switching on Logo screen Ie
7. CANCEL SELECT 74 CHAPTER NINE Test set up 9 2 c 9 3 9 3 a 9 3 b 9 3 c Select the desired mode using the navigation buttons Select Save to store the selection made which is confirmed with a pop up screen or Cancel to exit discarding changes You will be returned to the Test Setup screen Edit modes EDIT MODES RREN i TE Screenins P EACK SELECT Select Edit modes to modify Test Modes On the Edit Modes screen use the Left Right Arrows to scroll the test mode choice bar and press Select to choose the mode to edit Back will return to the Test Setup menu The user defined name for the test mode selected is displayed at the top of the screen The Factory test mode is used when performing system tests A padlock symbol adjacent to the mode indicates the mode settings can be viewed but not edited 9 4 9 4 a 9 4 1 9 4 1 a OTOPORT SCREENER 75 User Manual Edit mode menu TE Screenina Bese Lonria o Poss Criteria d3 Aukomoakion 4 Okher Sekt ings BACK SELECT The settable parameters for each test mode are split into 4 sections Test Config Pass Criteria Automation and Other Settings Choose the section to edit then Select Test config p TEST CONF Tl ee Scceeri Skim Level BY abre Skim Ronse 4 02 Noise Reject 52 dBSPL CANCEL SAVE Various test parameters can be configured in this area Up and down arrows on the screen indicate other fields are available but
8. CHAPTER EIGHTEEN Using Otolink 18 2 d 18 2 e 18 2 f 18 3 18 3 a If the Otoport is off when connected a battery charge graphic will be displayed on the Otoport screen that indicates the current battery level See battery charging section for more information If the Otoport is on when connected to the PC the Otoport screen will remain on the screen displayed at the time of connection It is not possible to control the Otoport until disconnected from the PC Once connected Otolink will automatically detect the Otoport After a few seconds a window will appear on your PC screen stating Talking to Otoport Talking to OtoPort Download options The download options screen will appear Otoport Data Download Otolink Otoport Charge e ee 61 Number of patients stored 2 Number of tests stored PC Date and Time 6 09 2007 14 44 29 Ooa DEGE ae ant 20 09 2007 14 44 30 Se ES Otoport download options Delete Test Data from Otoport Yes No Open EZ Screen after Download Yes No 8 3 b 8 3 c 8 3 d 8 3 e 18 3 8 3 8 3 1 8 3 1 8 3 1 8 3 1 8 3 1 OTOPORT SCREENER 143 User Manual The Otolink download screen provides download options and Otoport information An Otoport charge indicator provides information on the Otoport battery level and the charge percentage is given adjacent to the graphic The number of pat
9. Details User name James Name Otodynamies Ltd Forename Address e238 Beaconsfield i JC Han 3 char unique ID C Address Hatfield OAE instrument Address Jario 8BB Type n hard YP Saa email support otodynam Serial num Description Instrument GSN oTo x Cancell _ Help Unique 3 char facility ID OTO Open EZ Screen from the shortcut provided You will be required to enter a license key when running the software for the first time The license key can be found on the CD sleeve and can be entered in upper or lower case letters Following a brief software introduction to read you will be presented with Initial Setup options When used with an Otoport EZ Screen 2 will be used purely for the review of data and not for OAE recording so the software should be configured accordingly 130 CHAPTER SEVENTEEN Installing PC software FAR 7 2 1 7 2 1 Tali 7 2 1 7 2 11 7 2 1 1 7 2 1 7 2 1 7 2 1 7 2 1 Enter the mandatory fields displayed on screen in bold as listed below User details User name Enter a user name 3 character unique ID Enter an abbreviation for your user name OAE instrument Type Select No hardware from the drop down list Instrument GSN As provided on the CD sleeve Facility details Name and Address Enter your facility name and address if desired Unique 3 character facility ID Enter an abbrevia
10. Off Save On Mic Filter If noisy Normal If noisy Normal OTOPORT SCREENER 85 User Manual 10 10 1 10 1 a 10 2 10 2 a 10 2 b 10 2 c Printing Printer accessory An Otoport mini printer is available as an optional accessory The printer is used to create a paper record of the OAE test results recorded on the Otoport The Otoport either communicates with the printer using Bluetooth wireless technology optional or with a custom printer cable When you can print The Otoport provides flexible options to print from various areas of the user interface including printing at the end of the test from the patient database and via a dedicated print menu Printing at the end of a test When the OAE recording is finished and the result has been saved you are presented with the following screen that provides the option to print 86 CHAPTER TEN Printing 10 2 d 10 2 1 10 2 1 a 10 2 1 b 10 2 1 c 10 2 1 d ae 4 UH AS amp a0 0 a Tis ea E PRINT FINISH If you wish to print the test select Print When a print is initiated at the end of a test the Otoport will print the patient details and test results Printing from records Results can be printed from the Records area of the user interface which enables the print of any patient tests stored within the Otoport database Select the patient for which you would like to print results see the Records section for details of ho
11. Probe care 14 2 a 14 2 1 14 2 1 a 14 2 2 14 2 2 a Changing probe coupler tubes The probe has sound tubes combined into a single coupler assembly that can easily be replaced at regular intervals or when contaminated Disassembling the probe First unplug the probe from the instrument Remove the tip and then the lid fig 1 Remove the coupler tubes by pushing the end of the tubes down onto a hard surface fig 2 Pull out the tubes by gripping them fig 3 Never remove them by pulling on the cable Finally pull the coupler tubes away from the probe fig 4 9 Tu Ei a Reassembling the probe Fit the new coupler tubes to the probe assembly fig 1 Fit the outer shell figs 2 and 3 followed by the lid fig 4 Click the lid into place using firm finger pressure only Finally fit a new tip fig 4 SR yy 14 2 3 4 3 4 3 a 4 3 b 4 3 c OTOPORT SCREENER 115 User Manual Notes As with all probes it is important to Fit a new tip for each test Check that the coupler tubes are not contaminated before fitting the tip If the coupler tubes are contaminated replace them We recommend fitting new coupler tubes at regular intervals approx every 20 40 tests as a preventive measure Perform weekly probe QA tests see chapter 10 3 QA Tests Probes safety note Probes are designed for use with an Otodynamics disposable tip Use of a tip is essential Use without a t
12. antiseptic fluid The plastic pockets are disposable so should be replaced weekly or after approximately every 50 tests 118 CHAPTER SIXTEEN Otoport power 16 16 1 16 1 a 16 2 16 2 a Otoport power Battery life The Otoport is powered using an internal rechargeable battery The battery will provide enough power for over 100 tests from a single charge With built in power save functions and by switching the device off for the periods between tests the battery will provide enough power for many days intense use Initial charge The Otoport is fully charged before it leaves the Otodynamics factory However the battery will discharge slowly even if the device is switched off It is therefore recommended that an initial charge is provided to fully charge the battery before using your Otoport for the first time 16 3 6 3 a 6 3 b 6 3 6 3 d 16 3 e OTOPORT SCREENER 119 User Manual Standby To save power the Otoport will go into standby mode after 3 minutes of inactivity The standby screen will be displayed The Otoport will not go into standby if a test is being performed To resume from standby press any button on the keypad The Otoport will wake up and return to the previous screen displayed If the Otoport is left for 20 minutes in standby it will turn off An audible beep will be emitted from the device for a period of 10 seconds to alert the user prior to the automatic shut
13. as it is entered in the Password field To review characters that have been entered simply scroll back through the using the Left Right Arrow buttons Once both User and Password have been added select Login to access the device If the Password has been entered incorrectly then a warning message will appear as below Incorceck Losin Posswoard x 8 6 8 6 a 8 6 1 8 6 1 4 8 6 1 b 8 6 1 c OTOPORT SCREENER 71 User Manual Site ID The Site ID is a three letter site identifier and will be saved to each test record The ID cannot be changed until all data has been downloaded from the database and the database has been cleared Device ID The Device ID is a six letter device identifier This could be used to give simple identification of a unit if multiple units are used in one site for example using colours to code such as yellow blue etc The Device ID will be saved to each test record so it cannot be changed until all data has been downloaded from the database and the database has been cleared Select Save to save changes and return to the Management Menu screen Select Cancel to discard changes and return to the Management Menu screen 72 CHAPTER NINE Test set up 9 Test set up ee SOO Test Secure d SELECT test setup menu 9 1 a The Otoport TEOAE screener provides comprehensive test configuration settings to enable you to tailor the device to specific testing requirements
14. chapter 10 Probe for details If the all three QA tests are OK the device is functioning correctly and can be used for OAE testing again If you receive the Instrument fault message again contact your dealer or Otodynamics for support OTOPORT SCREENER 155 User Manual 20 Obtaining service 20 0 a Otodynamics or its authorised distributor will replace or service free of charge this Otoport for a period of 12 months from the date of purchase where the fault is not associated with misuse Servicing after that period will be provided at reasonable cost 20 0 b Probes failing because of faulty construction will be replaced subject to inspection Probes must be treated with care Do not allow cleaning fluid to enter the sound tubes 20 0 c If you have a problem with your Otoport or probe contact your distributor or Otodynamics for advice before returning the item for repair You will be asked for your unit serial number which can be found on the back on the Otoport Otodynamics Ltd 30 38 Beaconsfield Road Hatfield Hertfordshire AL10 8BB UK Tel 44 1707 267540 Fax 44 1707 262327 E mail support otodynamics com www otodynamics com 156 CHAPTER SEVENTEEN Installing PC software 21 Technical specifications Physical Handheld device Charger Interfaces Indicators Data Display Backlight Probe fit Power Charge Audible Keyboard 195mm x 70mm max x 30mm Weight 250g 90mm x 38
15. connecting to the printer using the wired method the message Printer not connected will be shown briefly and then the screen from which the print was initiated will be displayed Check the printer is connected correctly and switched on then re try If there is a problem connecting to the printer using the wireless method the following screen will be displayed providing options to cancel search for an alternative ALTER or retry Printer nok Found Rekra or search For on ALkernat iwe Prinkerc CANCEL ALTER RETRY To Retry the print ensure the printer is switched on and is within range 5m Then select the RETRY button If printing wirelessly and you have an alternative printer available select ALTER and the Otoport will connect to this printer 92 CHAPTER TEN Printing 10 5 i To cancel the printout select the CANCEL button 10 5 Once your print has completed pull the paper sharply towards you across the serrated tear bar to remove the printout and store it with your patient records os Printer fault detection 10 6 a The printer can detect if the paper roll has run out or if the lid is open 10 6 b For wired printing the Otoport will report the printer is out of paper and the following message will be displayed OUT OF PAPER CANCEL CONT MIE 10 6 c Select Continue to restart the printout once you have rectified the problem or Cancel to cancel the print job 10 6 d For wireless printing
16. down Notes Following an OAE recording always save test data as data that has not been saved prior to auto switch off will be lost Over time batteries will wear and lose their capacity resulting in quicker discharge The batteries may therefore need replacing around every 4 years of use 120 CHAPTER SIXTEEN Otoport power Battery charge Ie todynam ics 1B Has 01 09 2g 16 4 a When the Otoport is switched on the opening screen shows a battery indicator which displays the remaining level of battery charge 16 4 b The indicator has 5 segments which convey the total Battery Charge remaining The battery segments are shaded according to the following criteria Segments Displayed Battery Power 5 2 95 4 2 70 3 50 2 30 1 2 gt 10 0 lt 10 16 4 1 16 4 1 a 16 4 2 16 4 2 a OTOPORT SCREENER 121 User Manual Low battery LOW BATTER PLease Charse nit When the battery power reaches less than 10 remaining a Low Battery warning message will be displayed This equates to approximately 30 minutes of testing time Select OK to accept the message and return to the previous screen This screen will continue to appear every minute as a reminder to charge the battery Critical battery CRITICAL BATTERY f 4 Chorse Okororck before skart ins a New Test ez When the battery power reaches 5 remaining a Critical Battery warning message wi
17. for descriptions of stop results 12 334 On selecting Save each test is automatically saved with a unique date time stamp and can be reviewed individually in the QA Real Ear Test History area OTOPORT SCREENER 111 User Manual 13 Probe tips and accessories 31 Probe and service accessories UGS TEOAE probe red with screw locking connector s E TPC Coupler Tubes for UGS probe BGS Body amp Lid for UGS probe 32 Disposable tips T3E Twin holed elliptical tip fits 3mm ve ear canal Suitable for small and premature newborns 13 2 b T4 5C Twin holed conical tip fits 4 5mm ear canal Suitable for small newborns 13 2 T5 5B Twin holed blob shaped tip fits 5 5mm ear canal Suitable for most newborns 13 2 T6 5B Twin holed blob shaped tip fits 6 5mm ear canal Suitable for large newborns and first year infants 112 CHAPTER THIRTEEN Probe tips and accessories 3 2 f 3 2 h 13 3 13 3 a 13 3 b 13 3 13 3 d T8M Twin holed mushroom fits 8mm ear canal Suitable for infants and small adult ears TOM Twin holed mushroom fits 9mm ear canal Suitable for most adults T11M Twin holed mushroom fits 11mm ear canal Suitable for large adult ears T13 Twin holed mushroom fits 13mm ear canal Suitable for very large adult ears Use of tips All Otodynamics probe tips are disposable and MUST be discarded after each test The probe coupler tubes should be visually examined for s
18. present within the database It is necessary to delete all Patient Records from the device prior to deletion of users Note Patient Results should be downloaded to PC first Select Cancel at any time to discard changes and return to the User List 66 CHAPTER EIGHT Management 8 3 8 3 a 8 3 b 8 3 c 8 3 d 8 3 1 8 3 1 a Defaults menu DEFAULTS is gcor S BACK SELECT Facility Select Facility to edit the name of the hospital or clinic where the device is commonly used Risk factors Select Risk Factors to view or customise the list of 10 patient risk factors choices available Facility FACILITY ERER Hsr i Pol ociLlity Clinic Focility 3 Hore Facility 4 OQbkedysnanic CANCEL SAVE The Facility screen allows a user with administrator access to modify the choice of four Facility names The name should be no longer than 10 characters and identify the hospital clinic or other locality where the device is to be regularly used These options are then presented in the 8 3 1 b 8 3 1 8 3 2 8 3 2 a 8 3 2 b 8 3 2 c OTOPORT SCREENER 67 User Manual Facility choice bar when entering new Patient Details and during the creation of a New User account Please see relevant chapter entries for further information Select Save to save changes to the Facility list and return to the Defaults Menu screen Select Cancel to return to the Defaults Menu screen and discard alterations ma
19. the option to restart the test at Checkfit Select left or right ear SELECT_EAR 4 4 Ane EACE SAVE Use the Left and Right Arrow buttons to select the ear tested The graphic represents a patient facing you and the L and R represent the left and right ears Press the Left Arrow to highlight and select the right ear or press the Right Arrow to highlight and select the left ear Once the correct test ear has been selected select Save to save the test record to the database 42 CHAPTER FIVE Test 5 5 d If the patient s previous test was saved to the same ear the 5 5 e 5 5 f 559 5 5 h pop up message Last Test Saved to Left Right Ear Save Test to Left Right Ear Again will appear Press Yes to accept the current ear choice or press No to return to the Select Left Right Ear screen Select the correct ear and save again A pop up message confirms the ear saved Test review screens 20 10 D 0 1 I4 2 28 4 ac PRINT FINISH When the test record has been saved to the database the Test Screens are displayed again to allow for further review of the data collected The Left Right Arrow buttons can be used to toggle between the three screen choices Select Finish at any time to close the Test Review Screens and return to the Patient Menu 5 6 5 6 a 5 6 b 5 6 c 5 6 1 5 6 1 a 5 6 1 b OTOPORT SCREENER 43 User Manual Quick test Tesk Ci RICE SELECT By selecting Q
20. the test at the point when the test is saved This eliminates the need to initiate the print manually To change the setting using the Up Down Arrow buttons to ensure that Print is highlighted and then use the Left Right Arrow buttons to change the choice bar setting from Manual to Automatic OTOPORT SCREENER 89 User Manual 10 4 1 Print manual is the default setting 142 Print type 10 4 2 a There are two printing formats provided on the Otoport Summary and Detailed The Summary format below left prints core patient details and the test summary screen The Detailed format below right prints all the test screens and a fuller set of patient details Qredynamics Orodynamics OTOPORT OTOPORT ka Machine CET 23 09 05 0846 PATIENT UE TAT S Hachine Ce er Screener iO 1D DOORETLSY321 Fanilu Finch First Matth PATIENT DETAIL DOB jeu Anan A ID DOOSeMHSHaz Notes Tern Lisament Family ind O OB 12 01 1980 EGRE eda HERE 2 4 Ais Noise E18 uu tdau 23 09 te 06 50 TCR e3 09 05 08 50 TCA ALIO ORE Linge Io QO0981bS432 1 Family Finch 0 0 6 12 07 1980 210 ESEL ZILE ESEL 5D E TEOHE 25 El ke Noise 3 3 1422 84 23 09 05 DEE 53 TCE ALID ORE Location Ouk Pokient File MAYHECS1 DTA 35 0 JSP 50 4ESPL Location Ouk Pokient File MAYHECS1 OTA 90 CHAPTER TEN Pr
21. to the chosen Contrast level Select Save to accept the adjusted Contrast level Select Back to ignore changes and return to the Controls Menu 58 CHAPTER SEVEN System 723 Backlight BACEL GHT 410 sec F BACK SAVE 723a Use the Left Right Arrow buttons to toggle between the Backlight control choices The backlight can be configured to be either always on or off or on for a limited period of time 5 10 20 or 30sec after a button press Reduction in the backlight time will help to preserve battery charge during operation 7 23 Select Save to accept the Backlight setting 723 Select Back to ignore changes and return to the Controls Menu 7 3 7 3 a 7 3 b TS OTOPORT SCREENER 59 User Manual Battery BATTERY Charse oc x lt Tire 4 win woLlkoase 3 8 WV BACK CONDITION The Battery screen provides information on the current battery status The total Battery Power remaining is displayed as a percentage and as an approximate operation time The calculated time is only an approximate indication as the power requirements will vary depending on the mode of operation The remaining operation time may fluctuate during review of the Battery screen if the Backlight is set to time out after a limited period of time When the screen Backlight turns off the operation time will increase as a consequence of a change in power requirement This difference in calculated time will show the benefit to bat
22. will be displayed briefly at the top of the screen then the date of birth will revert to today s date Re edit and confirm the D O B if necessary 2 6 6 2 6 6 a 2 6 7 2 6 7 a 2 6 7 b 2 6 8 2 6 8 a OTOPORT SCREENER 19 User Manual Choice bars ENTER DETAILS Family First dd Ammo 4 Hale CANCEL START Left and Right Arrow buttons are used to move through choice bar options For example when entering patient details in the Gender field pressing the Right Arrow button will rotate the selected option between Not Given Male Female and Unknown Choice bars options are enclosed by arrow graphics Deleting characters The bottom right hand Contrast Delete button is used as a delete key If the cursor is at the end of a row of characters press the Delete button to delete the last character Left and Right Arrow buttons can be used to scroll back through the text The selected blinking character can be replaced using the keypad data entry buttons or deleted with theDelete button Continue to press the Delete button to erase characters to the right of the cursor Back light The screen is backlit to assist in testing in dimly lit environments The back light stays on for 5 seconds default following any key press and remains on during testing 20 CHAPTER TWO Getting started 209 Contrast CONTRAST CAMCEL SAVE 269 2 Pressing the Contrast Delete key while the logo screen 2 6 9 b 2 6
23. 03 107 On Off power button 12 Open 147 Open EZ Screen after download 144 Other Options 61 69 Other settings 82 Otolink 127 139 140 Otoport data viewer 151 Otoport Drivers 131 Otoport lock up 153 Otoport power 118 Override 81 162 CHAPTER TWENTY TWO Index P Paper 93 Pass criteria 78 Password 63 70 Patient capacity 149 Patient Details 29 Patient Details Description 30 patient ID input 17 Patient List 47 Patient menu 28 PC cable 11 Poor Probe Fit 40 106 108 Power 157 printer battery 96 Printer fault detection 92 Printer light summary 93 Printing 85 Print options 88 PROBE 38 Probe 101 111 probe 11 Probe care 113 Probe socket 12 Probes safety 115 Probe Test 102 Q QA Test History 101 QA Test Menu 103 QA Tests 101 Quick 43 Quickstart 14 Real Ear Test 110 Records 29 44 45 REPRO 38 Review 41 Review Patient Details 50 RFID scanning 98 Ringing 33 Risk Factors 66 67 Risks 30 S Same As Last 28 44 Save 41 Save Options 43 Select Left Right Ear 41 serial number 13 Signal 37 Site ID 71 151 SNR 37 software 127 Speaker 12 STAB 38 Standby 119 statistics 38 STIM 38 Stim out of Range 34 Stimulus Level Indicator 32 Stimulus Waveform Window 32 Stop Logic 39 Summary 45 Switch on screen 21 System 55 System Details 55 System details 153 T Test 31 43 Test cavity 11 Test Condition Information 33 36 Test config 75 Test main menu 22 Test Result 40 Test Review
24. 2 a OTOPORT SCREENER 99 User Manual When to use the scanners Entering patient details ENTER DETAILS Fomils Fics 0 0 6 OO Hmm ss CANCEL cAH TEST Select Scan when on the Enter details screen to populate the patient details Make further edits manually with the keypad Then continue to either test or save the result as normal At login In order for a user to login using the scanning method it is necessary to set up their login account in the Management area see chapter s Management for more details On the New user screen select Scan The RFID method can set all user parameters For barcode scanning the user name ID and password are automatically set but the other user parameters need to be set manually ae HEW USER User ID Possword Admin 4 Ho k T CANCEL CAH SAVE 100 CHAPTER ELEVEN Scanning 11 3 2 To login using a scanner select Scan on the login screen ee LOG IH FET 4 SCREENER Possvord FERRE CAH NEXT 11 3 20 The Otoport will automatically login the user with their appropriate access rights and present the Test main menu OTOPORT SCREENER 101 User Manual 12 Probe Probe menu PROBE ests J3 QA Tesk Hisktors BACK SELECT 2 4 a The probe menu provides system functional checks which should be conducted weekly or if a fault is suspected 21b Probe test 2 4 c Select Probe Test to check the calibration performance of a probe 214 QAtes
25. 49 Test Review Screens 42 Test Screens 35 Test setup defaults 84 Test Stop Reasons 39 Test Summary 48 TIME 38 tips 111 Title Bar 36 Too Few Bands 40 TPC 111 Tray icon control 146 Troubleshooting 153 U UGS 111 Up down left right navigation buttons 12 User 70 User details 130 User ID 63 User List 64 Username 130 Users 61 OTOPORT SCREENER 163 User Manual vV View Users 62 View Work List 51 Volume 55 56 57 W WorkList 45 51 52 53
26. 5 4 5 a 4 5 b OTOPORT SCREENER 27 User Manual Then refit the probe and try again Problems of debris and middle ear fluid occur mostly in babies younger than 6 hours and are often cleared by feeding or turning the baby If there is no success during the first OAE testing attempts a second OAE testing session usually brings success when the ear has had time to clear Babies are best tested when then are sleeping or sleepy and successful OAE recordings are most often made one hour after a feed The baby may settle down more easily if swaddled Babies older than one month may be too active to test When testing a child it can help to entertain them during the test so they don t become too restless Try to keep the probe cable out of their reach using the probe cable clip may help Instruct adults to be still and remain quiet Noises from the patient may not prevent successful recording but will increase the test time Constant environmental background noise for example from air conditioning or machinery may prevent a successful test Testing should only be conducted in rooms where the noise level recording on the Otoport is mainly below the noise reject level when the probe is not fitted in the ear Some intermittent noise can be tolerated but constant high noise will inhibit successful recordings OAEs and screening OAE testing is commonly used as the primary hearing screen in newborns with no known hearing loss risk
27. 5 4 5 4 a 5 4 b 5 4 c 5 4 d 5 4 e 5 4 f OTOPORT SCREENER 35 User Manual Test Test screens Following Checkfit the OAE recording begins and data is collected and displayed on a choice of three test screens an OAE histogram and two data tables The screens are continually updated to give a real time representation of the OAE response The histogram is the default screen shown at the beginning of a test and the Left Right Arrow buttons can be used to toggle between the screen choices when a test is in progress Histogram oono ceee n O 4 I TE TEST il Test data is displayed graphically on the histogram screen in octave bands 1k 1 5k 2k 3k and 4 kHz The clear section of each hand represents the OAE signal level within each band and the shaded section represents the noise level at that frequency A dot will appear above a band if the band has met its pass criteria Please refer to the Test Setup chapter for further information on the band pass criteria If either the OAE signal or noise level in a 2 octave band is greater than 20dB SPL an up arrow will appear above the band to the right of the dot to show the level is off the graphical scale 36 CHAPTER FIVE Test 5 4 9 Common to all three screens is a noise level indicator to the 5 4 h 5 4 i 54 jj 5 4 k 5 4 1 5 4 m 5 4 n 5 4 0 right of the display the title bar at the top of the screen and the Cancel and End
28. 8 Data Viewer 146 151 Date 22 Date amp Time 61 68 Defaults 61 66 Delete data 149 Delete test data from the Otoport 143 Deleting Characters 19 Device ID 71 151 Dismantling the probe 114 Display 12 Download all data from the Otoport 149 download cable 132 download of Otoport data to PC 127 Download Options 143 Download options 142 Drivers 131 Edit mode menu 75 Edit modes 74 Edit User 65 End 37 Enter Details 43 Entering Characters 17 Entering Dates 18 Environmental 158 Erase All 54 Exit 151 EZ Screen 2 software 128 F Facility 30 63 66 Facility details 130 Family 30 46 Find 45 Find Patient 46 First 30 Foreign Character Table 18 G Gender 30 Good Stimulus 12 GSN 151 Hard reset 20 Hardware Options 157 Hardware processing and storage 157 Highlighted Messages 33 Histogram 35 History Of Last 29 ID 30 ID Input 69 Incomplete 106 108 Initial charge 118 Instrument fault message 154 Interfaces 156 K Keyboard 156 keypad 16 L Location 30 63 Login 70 Logo 22 Low Battery 121 Management 61 Mandatory Patient Details 31 manufacturer details 13 Memory usage 149 Menu selection buttons 12 Mic Filter 82 Model 13 Mother 30 47 OTOPORT SCREENER 161 User Manual Name 63 New 28 NHi 38 NICU 30 63 NLO 38 No Clear Response 40 NOISE 38 Noise 37 Noise Level Indicator 32 36 Notes 30 O OAE 38 OAE instrument 130 Occlusion OK 108 Occlusion Test 1
29. 9 60 60 61 61 62 66 68 72 72 73 74 75 OTOPORT SCREENER 7 User Manual 10 Printing 85 0 1 Printer accessory 85 0 2 When you can print 85 03 Print menu 88 04 Print options 88 05 The printing process 90 o6 Printer fault detection 92 07 Printer light summary 93 os Paper 93 0 9 Charging the printer 95 0 10 Changing the battery 96 11 Scanning 97 11 4 Scanning facility 97 11 2 Scanner types 97 11 3 When to use the scanners 99 12 Probe 101 12 1 Probe menu 101 12 2 Probe test 102 123 QA test menu 103 13 Probe tips and accessories 111 13 1 Probe and service accessories 111 13 2 Disposable tips 111 13 3 Use of tips 112 14 Probe care 113 14 1 Cleaning 113 14 2 Changing probe coupler tubes 114 14 3 Probes safety note 115 15 Care of the Otoport 116 15 1 Use of the Otoport and cleaning 116 8 16 17 18 19 20 21 22 Otoport power 16 1 16 2 16 3 16 4 16 5 16 6 Battery life Initial charge Standby Battery charge Charging the Otoport Conditioning the Otoport battery Installing PC software 17 1 17 2 17 3 17 4 17 5 Introduction Installing EZ Screen 2 software Installing Otoport drivers Otolink CD menu Installing Otolink software Using Otolink 18 1 18 2 18 3 18 4 Opening Otolink Connecting the Otoport Download options Backing up data Troubleshooting 19 1 19 2 19 3 19 4 Otoport lock up Switch on System details Instrument fault message Obta
30. APTER TWELVE Probe 12 3 1 g 12 3 1 h 12 3 1 i 12 3 1 Test Result Description Artefact The data collected has met the set OAE pass criteria according to the locked Factory protocol Artefact If one band has gt 6dB SNR and an absolute signal level gt 5 dB SPL in acceptable conditions OR if two or more bands have greater than 3dB SNR with an absolute signal level gt 5 dB SPL in acceptable conditions Noisy If Noise is greater than 5 dB SPL in any band Poor Probe _ If the final test stimulus level is outside Fit the stimulus ok range or if the final stimulus stability value is lt 85 Cavity OK The data collected is acceptable and in good environmental conditions Incomplete If a user ends the test manually If the result Noisy Poor Probe Fit or Incomplete is achieved save the test and retest checking that the probe ear piece is firmly inserted into the test cavity and that the noise conditions within the room are acceptable for a test to be conducted Continue to retest until the result Cavity OK is given If Artefact is shown at the end of the test save and retest making sure the ear piece has been firmly pressed into the test cavity If the result occurs a second time contact your dealer or Otodynamics for advice If the result Cavity OK is displayed when the test stops the test has passed Save the test and perform the other QA tests if required or exit the QA Tests Men
31. C Otoport Screener 4 Otoport Screener User Manual Issue 2 November 2007 0120 Copyright Notice No part of this publication may be copied by any means translated or distributed to third parties without the express written permission of Otodynamics Ltd Copyright 2007 Otodynamics Ltd All Rights Reserved OTOPORT SCREENER 5 User Manual 1 Introduction 9 1 4 General use precautions 9 2 Getting started 11 214 Otoport and accessories 11 2 2 Controls indicators and connections 12 23 Scanner and labelling 13 24 Quickstart 14 25 Initial charge 15 26 Using the buttons and keypad 16 3 Switching on 21 3 1 Switch on screen 21 3 2 Logo screen 22 33 Main menu 22 4 Test preparation 23 414 General checks before testing 23 4 2 Connecting the probe 24 43 Selecting an appropriate tip and fitting the probe ear piece 25 4 4 Helpful hints 26 45 OAEs and screening 27 6 Test 51 Patient menu 52 Patient details 5 3 Checkfit 54 Test 55 Save and review 56 Quick test Records 6 1 Records menu 6 2 Find patient 6 3 Worklist menu 64 Database summary 65 Erase all System 71 System menu 7 2 Controls menu 73 Battery 74 System details 75 About Management 81 Management menu 8 2 Users menu 8 3 Defaults menu 84 Date and time Test set up 91 Test setup menu 9 2 Current modes 9 3 Edit modes 94 Edit mode menu 28 28 29 31 35 41 43 45 45 46 51 54 54 55 55 56 5
32. Flexible programmable pass criteria control the device s OAE detection logic where the device will automatically end the recording when the criteria have been met There are 4 separate test modes 3 of which may be set by the user 9 1 b Once you have navigated to the Test setup area choose Select You will be presented with the Test setup menu ee TEST SETUP i odes EACK SELECT 9 2 9 2 a 9 2 b OTOPORT SCREENER 73 User Manual Current modes MODE SELECT ESM TE Screen ingk ode 4 OFF b CANCEL SAVE Select Current Modes to view the Mode Select screen which enables the selection of the test mode to be used during OAE measurement The Otoport TEOAE screener has a choice of 4 test modes By default the device will conduct OAE tests in accordance with test Mode 1 named TE Screening by default see the test mode table for details It is possible to configure the device to provide a choice of two test modes at the point of test To enable this function turn on Mode 2 by selecting a test mode When Mode 2 is Off as per default the device will run the OAE test in accordance with the Mode 1 test set If a test mode is selected for both modes you are presented with the Test Choice screen prior to starting a test shown below Mode 1 is on the left and Mode 2 on the right Set Mode 1 to your most frequently used mode for ease of use at the time of test TEST CHOICE i TE Screening ORE1
33. OTOPORT SCREENER 123 User Manual Then connect the slotted charger plug to the Otoport Ensure the arrows are facing upwards i 4 Note If forced it is possible to insert the charger connector into the Otoport the wrong way up In this position the Otoport will not charge Press in the release buttons on the connector and re insert with the arrows facing upwards When the Otoport is connected the display will show the current battery level This screen is updated every minute to show how the charge is progressing A full charge will take up to 4 hours When the device is fully charged a large tick will appear on the screen YE 124 CHAPTER SIXTEEN Otoport power 16 5 2 16 5 2 a 16 5 2 b 16 5 2 c 16 5 2 d 16 5 2 e 16 5 2 f Additional charge indicators There are additional charge indicators on the side of the Otoport e Power light The green light below the plug symbol shows that the device is powered e Charging light The orange light below the battery symbol will illuminate when the device is being charged Note If the device appears fully charged with a tick displayed on screen but the charging light is still on if convenient allow the device to continue to charge until the charge light goes out It is possible to leave the charger connected to the Otoport for extended periods even if the device is fully charged This may be convenient if you wish to leave the d
34. Requirements for Safety Medical Electrical Equipment 22 index Symbols 3 character unique ID 130 2 octave bands 35 A About 55 60 accessories 11 Add New User 62 63 Add Patient 51 Admin 63 Administration area 148 alphanumeric input 17 Analogue performance 157 Arrow navigation buttons 16 Artefact 106 108 Autoadjust 80 Automation 80 Auto Start 81 Auto start for all users 151 Auto start for current user 151 AutoStop 81 OTOPORT SCREENER 159 User Manual Backing up data 152 Back Light 19 Backlight 55 56 58 Barcode RFID scanner 13 Barcode scanning 97 Battery 22 55 59 120 Beginning a Test 31 BGS 111 Body amp Lid 111 buttons 16 Cc Calendar 157 calibration 101 Cancel End 37 Cavity OK 106 Cavity Test 103 104 CD menu 138 certification 13 Changing probe coupler tubes 114 Charger 11 Charger and PC cable socket 12 Charging status indicators 12 Charging the Otoport 122 Charging the printer 95 Checkfit 31 Checkfit OK 33 34 Check Probe Fit 33 36 Choice Bars 19 CHAPTER TWENTY TWO Index Classifications and standard 158 Cleaning 113 cleaning 116 Clear Response 40 Clock 157 Configuration 150 Consent 30 Contrast 20 55 56 57 Controls 55 56 Coupler assembly 113 Coupler Tubes 111 coupler tubes 114 Critical Battery 121 Current modes 73 D O B 30 47 Database Summary 54 Data entry keypad 12 Data management 148 Data Table 37 38 Data Table 1 37 Data Table 2 3
35. a default of five minutes and may be set by the user to a maximum of 15 minutes 10 CHAPTER ONE Introduction 1 1 1 1 9 1 1 h 1 1j Whilst this limits the sound exposure in a single test the user is responsible for limiting the number of separate tests performed on the same ear The Otoport has built in signal analysis proven to distinguish true Otoacoustic emissions from artefactal signals Checks should be performed weekly and before each test session to confirm the system continues to operate effectively see chapter 12 Probe The probe s coupler tubes which carry sound to and from the ear canal are protected from contamination by the disposable tip The probe should never be inserted into the ear without a disposable tip attached Doing so risks damage to the ear by the probe body and contamination of the probe by the ear If contamination occurs the coupler tubes must be replaced see chapter 14 2 Changing probe coupler tubes Visually inspect the coupler tubes before use A blocked sound delivery tube may prevent the Otoport from achieving its target stimulation level and so prevent testing It may also attenuate certain frequencies and limit the number of pass bands A blocked microphone tube will prevent the Otoport from sensing the stimulus level in the ear and from detecting the OAE As a result the Otoport may apply a louder than normal sound to the ear All surfaces of the Otoport may be cleaned with an
36. accordance with the maximum NLo figure amount of data accepted into the result when the noise present is below the reject level set in Test Config Auto start With Auto Start On the stimulus level will automatically be adjusted to the testing target stimulus and the test will commence automatically The device will check if the probe fit is stable and will not adjust or start the test until a good probe fit is obtained With Auto Start Off it is necessary for the user to select Start to begin recording from the Checkfit stage Override When Auto Start is On the Override setting controls the option for the user to manually start the test overriding the Auto Start function If Override is On the Start option is available on the Checkfit screen to force a test start when the conditions are not optimum and the Otoport has not automatically started the test If Override is Off the Start option override is not provided to start the test manually 82 CHAPTER NINE Test set up 9 4 3 p 9 4 3 q 9 4 3 6 9 4 3 8 9 4 3 t 9 4 3 u Other settings TE OTHER SETTINGS ithe Soe OFF P Mic Filkerd IF Noisy Fk CANCEL SAVE The Mandatory save setting controls whether tests started have to be saved This option may be useful if you would like to save all tests performed This can be useful for statistical purposes if you wish to collect information for example on the number of test attempts conducted per pa
37. achieved Yes No Note It is possible to turn off some settings which means the parameter will not be included in the pass criteria logic 80 CHAPTER NINE Test set up o43 Automation EEE sss TE AUTOMATION We o 4 an a Auto Skart 4 Ore F Override 4 es F CANCEL SAVE 94 3 a The Otoport Screener has programmable automation 9 4 3 b 9 4 3 9 4 3 d 9 4 3 e logic to enable the user to configure the test routine to their preference The test process can be set to be fully automated or manually operated depending on the desired control over the test All settings have an On Off or Yes No option Use the Up Down Arrows to highlight a setting and use the Left Right Arrows to change the choice bar setting Autoadjust If Autoadjust is set to On during the test Checkfit stage the click stimulus will automatically adjust its level to the target stimulus set compensating for different ear canal volumes The stimulus will only adjust when the probe fit is stable If Autoadjust is Off it is necessary for the operator to select ADJUST during the test Checkfit stage This will initiate the stimulus adjustment process AY alt CANCEL TART 9 4 3 f 9 4 3 9 9 4 3 h 9 4 3 1 9 4 3 9 4 3 k 9 4 3 1 9 4 3 m 9 4 3 n 9 4 3 0 OTOPORT SCREENER 81 User Manual Auto stop With Auto Stop On the test will stop when the Pass criteria are met With Auto Stop Off the test will timeout in
38. ad to initiate the download Select Cancel to close the Download options screen During the download process a sequence of Otoport download screens will appear Each screen has a progress bar which indicates progress of each sub task When the progress bar is full the sub task is 100 complete Otoport Data Download Progress Downloading data As standard there are two sub tasks First the software builds a list of patients to download The sub task states Building download list The data is then downloaded and the sub task states Downloading data If EZ Screen is installed the data is then imported into the EZ Screen database and the sub task states Importing data 18 3 2 e 18 3 2 f 18 3 2 g 18 3 3 18 3 3 a 8 3 3 b 8 3 3 8 3 3 d 8 3 3 e OTOPORT SCREENER 145 User Manual When the download is complete the Download data screens will close If you have selected to delete the Otoport data the delete confirmation screen will appear Select Yes to delete the data or No to leave the data stored on the Otoport All the Otoport data has been downloaded and is available for viewing in a Data Viewer which will automatically open If EZ Screen is installed all the data will be transferred to EZ Screen for review See the EZ Screen manual for details The data is also available via the Data Viewer but this will not automatically open EZeScreen data notes The OAE waveform response from
39. add the user to the User List The User List will appear with the newly saved user highlighted on screen The message Cannot Save Please enter Name User ID and Password may appear on press of Save if any of the three fields have been left unfilled Select Cancel to cancel the addition of a New User and return to the Users menu screen View user list 11 Chore lt a al Abcder BACK EDIT The User List displays the Name Password and Status of all users currently saved to the device 8 2 2 b 8 2 2 c 8 2 3 8 2 3 a 8 2 3 b 8 2 3 c 8 2 3 d 8 2 3 e OTOPORT SCREENER 65 User Manual If a user has been assigned Administrator rights then an A will be present in the right hand Status column of the table Select Back to exit the User List and return to the Users Menu Edit user a a O EDIT USER AEE E ichard zer ROG Possword Richard Admin 4 Ho k T CANCEL DELETE SAVE Select Edit to alter the details of a highlighted user Select Save to save changes to the user s details and return to the User List Select Delete to remove the selected user from the User List A confirmation message will appear at the top of the screen Select Yes to confirm the deletion or No to retain the user and return to the Edit User screen Itis not possible to delete the default Admin user The message Cannot Delete User has tests in database will appear if the user has performed tests that are still
40. alcohol based wipe or cloth with antiseptic fluid Dry the device immediately with tissue Do not allow liquid to enter the instrument If additional hygienic protection is required clear plastic pockets designed to contain the Otoport during use are available from Otodynamics OTOPORT SCREENER 11 User Manual 2 Getting started Otoport and accessories 2 1 4 Take a few moments to familiarise yourself with the equipment you have received with your Otoport case Otoport Sa eo8 Probe bag PC cable A qj ee Test cavity e wW eee A o Probe accessories aoe 7 Charger and rf i mains lead Sample probe _ tips ft Accessories not shown to scale 12 CHAPTER TWO Getting started 2 Controls indicators and connections Probe socket Stimulus OK and 60 Noise OK indicators Display screen Menu selection buttons Arrow up down q D left right navigation VY buttons Data entry keypad 9 _ a eo On Off power button B Charging status indicators Speaker Charger and PC cable socket OTOPORT SCREENER 13 User Manual Scanner and labelling Model serial gt number certification manufacturer details IO 340d0 39 Barcode RFID scanner options WILS 14 CHAPTER TWO Getting started a Quickstart 24 a The Quickstart guide is included in your document pack le Quickstart
41. and keypad Control buttons SUS The buttons directly below the screen marked with a square a diamond or a circle enable you to execute the functions offered on the screens Their functions vary from screen to screen but generally the right circle button provides affirmative options and the left square button provides negative options Arrow navigation buttons GSD The arrow navigation buttons provide Left Right Up and Down control and allow the user to move to options available on the screen The selected option becomes highlighted The left and right arrow buttons scroll through the main menu options 2 6 3 2 6 3 a 2 6 3 b 2 6 3 c 2 6 3 d 2 6 3 e 2 6 3 f 2 6 3 g OTOPORT SCREENER 17 User Manual Entering characters Character entry is similar to a mobile phone where numbered buttons can be pressed sequentially to select the required character For alphanumeric input the numbered button sequence will be lower case alpha numeric then capitalised alpha for example jkI5JKL For alphanumeric character input at the beginning of a field the numbered button sequence will be capitalised alpha lower case alpha then numeric for example JKLjkI5 For patient ID input the numbered button sequence will be numeric then capitalised alpha only for example 5JKL The character sequence for the 1 button is 1 which starts at 1 for patient ID entry The character sequence for the 0 butt
42. ation page also enables control over the automatic start of Otolink following PC boot Click on the box to enable the setting A tick will appear in the box when the function is selected Auto start for current user With this setting on Otolink will automatically start for the user currently logged into Windows Auto start for all users With this setting on Otolink will automatically start for all the users set up on the PC Note Only a user with Windows administrator privileges will be able to change the auto start setting for all users 3 Data viewer Select Data Viewer to open a data table which shows downloaded Otoport data See chapter 18 3 4 Data Viewer 4 Exit Select Exit to close Otolink software To re start the software either double click on the Otolink shortcut on your desktop or re start your PC 152 CHAPTER NINETEEN Troubleshooting Backing up data 18 4 a It is advisable to back up all the downloaded Otoport data Using Windows Explorer back up folder C Program files Otodynamics Otolink 18 4 b See the EZ Screen Manual for back up of data in EZ Screen OTOPORT SCREENER 153 User Manual 19 Troubleshooting 1 Otoport lock up 19 1 a In the unlikely event of an Otoport lock up and it is not possible to control the device turn the unit off and switch it on again If this is not possible hold down the On off power button for 10 seconds this will force the unit to switch off Turn
43. clock for right ear Turn the probe ear piece to 12 o clock Hold the probe for several seconds Then release the pinna and let go of the probe Yr 26 CHAPTER FOUR Test preparation 4 3 2 4 3 2 a 4 3 2 b 4 3 2 c 4 3 2 d 4 4 4 4 a 4 4 b Fitting for children and adults Line up the probe to 7 o clock for left ear or 5 o clock for right ear Push the probe firmly into the ear canal at this angle Hold the probe for several seconds Then release the probe No discomfort should be felt by the patient The weight of the probe cable should be supported to minimise the risk of the probe being pulled out during testing Use the probe cable clip supplied ensuring there is sufficient slack in the cable to allow for movement of the patient s head If the correct tip is used the probe should stay in place without aid However it is acceptable to hold the probe gently in the ear if the patient is restless Helpful hints The most frequent cause of unsuccessful OAE recordings is failure to fit the probe correctly so that it is deep enough in the ear canal The presence of fluid and debris in the ear canal or middle ear will also inhibit recordings If a pass result is not obtained remove the probe and inspect the probe tip Discard the tip if it has collected debris or moisture Also check that the probe coupler tubes are clear and replace these if a blockage is noticed 44 c 4 4 d 4
44. cord or edit the Work List entry View work list 5 WORK LIST 5 ja FAMILY BACK Bet ILZ The Work List displays the ID and Family name of each patient to be tested The format of the Work List is identical to the Patient List Use the Up Down Arrows to scroll between patients and the Left Right Arrows to jump 5 patients at a time Select Details to review the complete Patient Details of the highlighted patient Once a patient on the Work List has been tested and saved to the database it is automatically removed from the list Select Back at any time to return to the Work List Menu 6 3 3 6 3 3 a 6 3 3 b 6 3 3 6 3 3 d 6 3 3 e 6 3 3 f OTOPORT SCREENER 53 User Manual Review patient details work list PATIENT DETAILS p Be g04943 ami Ls Finch Ficsk Moke he 0 0 6 l2 JuL 1980 CANCEL OFT IONS TEST Selecting Details on the Work List screen displays the selected Patient Details in a non editable format Select Test to enter test details specific to the test Please refer to chapter 3 3 Checkfit for an explanation on how to setup and perform a test Select Options to view a pop up menu giving a choice to Edit Patient Details or Delete the patient from the Work List Choose Select when Edit is highlighted to show an editable version of the Patient Details Please refer to chapter 3 2 Patient Details for guidance on field entry and format Select Save when changes to the Patien
45. ct Condition and following the confirmation screen the device will automatically be set to full power to drain the battery a SSO CONDITIONING BATTERY VoLEose 2 0 Y CANCEL This process can take up to 6 hours Select Cancel to stop the conditioning process The Otoport will automatically switch off when the battery has been fully discharged Now fully charge the Otoport to complete the battery condition cycle Wait for the tick on the screen and for the charge light to extinguish to confirm a full charge OTOPORT SCREENER 127 User Manual 17 Installing PC software v introduction 17 1 a Otolink software is provided with the Otoport OAE system to enable download of Otoport data to PC and provide PC based system configuration The intelligent software detects an Otoport when connected and automatically opens a user friendly options screen The Otoport patient and test data is then seamlessly transferred to PC for review in a Data Viewer If you have purchased the EZ Screen software option the downloaded information will be merged with EZ Screen Here the full Otoport test data including OAE waveforms can be viewed in high resolution on your PC screen 17 1 b There are several stages to Otolink installation and they should be conducted in the order detailed below Prior to the installation close all programs running on your PC vic Note For Windows XP and Windows 2000 you will require Windows Administrator privileg
46. ctave band passes and total OAE signal level The following diagram details all features of a Test Summary screen Patient s Family Name Current test of total Test Result number of tests Ear Tested R Right or L Left Band Pass Total OAE signal level dB SPL Indicators showing which octave bands achieved their pass criteria FRINT SELECT Total Noise level ID of user who dB SPL performed test Date of Test aude Time of Test 6 2 2 b 6 2 2 c 6 2 2 d 6 2 2 e 6 2 3 6 2 3 a 6 2 3 b 6 2 3 OTOPORT SCREENER 49 User Manual The number of tests currently saved to the patient is displayed in the top right of the screen Press the Up Down Arrow buttons to scroll between tests The test number will increment accordingly The up and down arrow indicators to the left of the screen show that other Test Results are available Choose Select on a Test Summary screen to analyse the test result in detail Select Cancel at any time to exit the Test Summary screens and return to the Patient List to review tests of another patient Detailed test review k amp 20 10 D 10 1 I5 Z 4 4 ac BACK FR INT WAWE Test Results can be reviewed in detail by choosing Select on the Test Summary screen The OAE test data is shown on three Test Screens and test details are also available Please refer to chapter 3 4 Test for a full description of the screen displays Use the Left Right Arrow but
47. de to Facility names o aee OO RISK FACTORS Py Emm Congenital i Cranio Focia Risk 3 Fomilyu Hisko Riek 4 NICU HB hour CANCEL SAVE Risk factors The Risk Factors screen allows a user with Administrator access to modify the list of 10 risk factors available The name chosen to identify each risk factor should be no longer than 12 characters and organised from 1 to 10 Select Save to save changes to the Risk Factors list and return to the Defaults Menu screen Select Cancel to return to the Defaults Menu screen and discard changes made to Risk Factor entries 68 CHAPTER EIGHT Management 8 4 8 4 a 8 4 b 8 4 c 8 4 d 8 4 e Date and time DATE amp TIME Tine Marae Doke O04 Aus 200b Formak 4 dd Hmm 39994 CANCEL SAVE The date and time set on the device can be altered in the Date amp Time screen The Otoport displays the time in a 24 hour format When the Date field is highlighted press the Right Arrow button to access the calendar pop up table The day will be highlighted first and can be altered using the Up Down Arrow buttons Continue to use the Left Right Arrow buttons to jump between the Day Month Year and the Up Down Arrow buttons to select the required date The date format can be changed from dd Mmm yyyy to dd mm yyyy or mm dd yyyy for use in the USA Select Save to set the current date and time settings and return to the Management Menu screen Select Cancel to disca
48. e bar is full the capacity is reached The number of patients stored is also displayed to the right of the graphic The maximum number of patients that can be stored is 1024 Memory usage The database memory on the Otoport can be filled with either patient or test data with a varying number of tests per patient There is no limit to the number of tests that can be conducted on one patient other than the memory capacity of the device The device can potentially hold 1024 patients and each of these could have up to 3 tests However if one patient record has say 100 tests this will reduce the memory capacity for other patients and tests A bar graphic shows the total percentage of memory used Download all data from the Otoport This function enables download of data from the Otoport Delete data Once the download has been completed successfully the Delete data button will become active The button remains inactive and greyed out until successful download has occurred Select the Delete data button to erase the Otoport memory A confirmation message will appear Select Yes to delete or No if you wish the data to remain on the Otoport Open EZ Screen This button will open EZ Screen software to allow review of the data downloaded See the EZ Screen manual for full details 150 CHAPTER EIGHTEEN Using Otolink 18 3 5 q 18 3 5 r 18 3 5 s 18 3 5 t Configuration 4 0 1 13 The Configuration page enables the
49. e device measures OAEs correctly Select Back at any time to return to the main menu screens Cavity test ce Probe inko Pla Okodsnamics Test Cowiks Press OK Eo besin kest CANCEL DK Cavity tests should be run weekly to ensure that the Otoport is working correctly On selection of Cavity Test from the QA Tests Menu the message Place Probe into Otodynamics Test Cavity Press OK to begin test will appear on screen Ensure the probe ear piece has been firmly inserted into an Otodynamics test cavity without a tip attached and the cavity has been positioned on a flat surface Select OK to enter the standard Checkfit screen and begin the Cavity Test or Cancel to return to the QA Tests Menu screen 12 3 1 c 12 3 1 d 12 3 1 e OTOPORT SCREENER 105 User Manual Patient Details are automatically entered depending on the QA test type selected For a Cavity Test Patient Details Field Cavity Test Default ID QA1 Name QA First Cavity Follow the Checkfit and Test screen sequences until the test stops In a cavity the testing stimulus level should adjust to 84dB Please refer to chapter 3 3 Checkfit and 3 4 Test for a detailed description of how to perform a standard TEOAE test Data collected during the Cavity Test is analysed against set pass criteria The following table lists all possible test results and gives an explanation of the circumstances under which each result would be shown 106 CH
50. ear piece and cable with an alcohol based sterile wipe or cloth and antiseptic fluid Dry the assembly with tissue immediately afterwards and do not let liquid pass down the coupler sound tubes The probe ear piece is serviceable and its body lid and coupler tubes can be replaced The coupler tubes should be replaced weekly or after 20 40 tests or if they have been contaminated The body and lid should be replaced if contaminated Visually check the ear piece for signs of dirt before each test Before fitting each tip ensure the sound tubes are carefully examined for any sign of debris that may have entered them Replace any part of the probe ear piece as necessary See chapter 14 Probe care for details Ensure your hands are cleaned thoroughly between each patient tested Clean the Otoport each day before a testing session or according to local requirements Ensure the Otoport is cleaned if it becomes contaminated Clean surfaces of the Otoport with an alcohol based sterile wipe or cloth and antiseptic fluid Dry the Otoport with tissue immediately afterwards Do not allow liquid to enter the instrument and do not immerse in fluid Do not allow liquid to come into contact with the connection sockets Do no poke any materials into either the probe or charger pc cable sockets If additional hygienic protection is required use the Otoport in an Otodynamics clear plastic pocket This can also be cleaned with a sterile wipe or cloth with
51. ed stimulus level is correct and the noise is consistently below the reject level Noisy appears if high noise conditions cause the shaded noise bar to be consistently above the reject level for a period of time Check Probe Fit is shown if the adjusted stimulus level falls outside the accepted stimulus range The needle on the Stimulus Level Indicator will be outside the shaded area of the arc Ringing is displayed when there is obvious oscillation within the Stimulus Waveform after the initial positive and negative peaks instead of a flat line response The table below describes the highlighted message which will appear if more than one condition is met Consistent Stimulus Out Stimulus Highlighted High Noise of Range Ringing Message No No No Checkfit OK No No Yes Ringing No Yes No Check Probe Fit No Yes Yes Check Probe Fit Yes No No Noisy Yes No Yes Ringing Yes Yes No Check Probe Fit Yes Yes Yes Check Probe Fit 34 CHAPTER FIVE Test 5 3 p When Checkfit OK is present on screen indicating conditions are suitable for testing select Start to begin a test or Cancel at any point in Checkfit to return to Patient Details 5 3 q Stim out of Range will appear if Start is selected when the stimulus is outside the accepted range It is advisable to select Back to return to Checkfit and readjust Select Continue to test with the current stimulus level a 4 Ee H ETH ka T EACK CONT NUE
52. ence as a standard TEOAE ear test 108 CHAPTER TWELVE Probe 12 3 2 d 12 3 2 e Data collected during the Occlusion Test is analysed against set pass criteria The table on the next page lists all possible test results and gives an explanation of the circumstances under which each result would be shown Patient Details are automatically entered when the test is saved Patient Details Field Occlusion Test Default ID QA2 Name QA First Occlusion Test Result Description Artefact The data collected has met the set OAE pass criteria according to the locked Factory protocol Artefact If one band has gt 6dB SNR and an absolute signal level gt 5 dB SPL in acceptable conditions OR if two or more bands have greater than 3dB SNR with an absolute signal level gt 5 dB SPL in acceptable conditions Noisy If there is three times more noisy data recorded than good quality low noise data OR if Noise is greater than 5 dB SPL in any band Poor Probe If the final test stimulus level is gt 40dB Fit Occlusion OK The data collected is acceptable and in good environmental conditions Incomplete If a user ends the test manually 12 3 2 f 12 3 2 g 12 3 2 h 12 3 2 i OTOPORT SCREENER 109 User Manual If the result Noisy Poor Probe Fit or Incomplete is achieved save the test and retest checking that the coupler tubes are fully occluded by a finger and that the noise co
53. ere is no Otoport connected the software will display the message No Otoport connected Please check connection from PC to Otoport and retry Ensure the Otoport is connected correctly and re try The Otolink tray icon provides four options Right click with the mouse on the tray icon to display the options 1 Open This option will open the Download options screen Note A left mouse click on the Otolink tray icon will also initiate the Open function 148 CHAPTER EIGHTEEN Using Otolink 1335 2 Administration area The Otolink Administration area provides additional functions to control the configuration of the Otoport 18359 Note APC operator with Windows user permissions cannot access the Administrator area 18 3 5 On each of the various tabs a green battery charge indicator shows the current Otoport battery level as a percentage When the indicator is filled completely the battery charge on the Otoport is 100 13 3 5 Data management Otolink 18 3 5 The data management tab provides duplicated data download functions but allows the user more manual control over the process 18 3 5 k 18 3 5 1 18 3 5 m 18 3 5 n 18 3 5 0 18 3 5 p OTOPORT SCREENER 149 User Manual Various database information is provided Patient capacity Shows the number of patients stored on the Otoport A bar graphic shows the amount of patients stored as a percentage of the patient storage limit When the blu
54. es to complete this installation Please contact your IT administrator if you do not have this level of PC access 128 CHAPTER SEVENTEEN Installing PC software 17 2 17 2 a 17 2 b 17 2 c 17 2 d 17 2 e 17 2 f Installing EZ Screen 2 software Available if the EZ Screen option has been purchased Install ILO Software Install Acrobat Reader View Manuals Browse CD Visit Otodynamics com The first stage of the installation is to install EZ Screen 2 software Insert your EZ Screen CD into your CD ROM drive and a CD menu will automatically appear shortly Select Install ILO Software from the CD menu Follow the on screen instructions to proceed with the installation Note EZ Screen must be installed as a standard Desktop or Network server version for use with the Otoport You will be asked to enter a password this will be found on the CD sleeve Accept a PC re start if requested 17 2 9 17 2 1 17 2 1 a 17 2 1 b OTOPORT SCREENER 129 User Manual Following installation an EZ Screen 2 icon will be placed on your PC desktop E Screen 2 EZeScreen initial setup 1 Initial setup options Choose database location Path to database Locally on this PC Type path to data file use browse if C Ona LAN server local or type local path on server OtodynamicsiLO4windatabase Gy Confirm connection to server rr Filename 0AEdata 1B Server name User Details Facility
55. evice charging overnight When powered by either a charger or PC the Otoport is powered from the attached device and not its internal batteries 16 5 2 g 16 5 2 h 16 5 3 16 5 3 a 16 5 3 b OTOPORT SCREENER 125 User Manual When connected to a charger it is possible to switch on and control the Otoport but it is not possible to run a test When connected to a PC it is not possible to control the Otoport If the Otoport is on when it is connected to a PC the current screen displayed will remain until the device is unplugged again Disconnecting the Otoport To disconnect the Otoport from the charging lead squeeze the release buttons together and pull out the cable The power light will extinguish on the Otoport and if the Otoport was off prior to the charging session the screen will return to blank If on during the charging session the current screen will remain displayed 126 CHAPTER SIXTEEN Otoport power 16 6 16 6 a 16 6 b 16 6 c Conditioning the Otoport battery In order maintain the Otoport batteries and keep them at optimal performance you should condition the battery once per year or if the unit batteries appear to run down more quickly than expected This process involves completely discharging the battery using a function provided in the Otoport System area and then fully charging the device To initiate the battery condition enter the System main menu and select Battery Sele
56. f patients who match the search criteria entered This number updates as search criteria change Select Search to display the Patient List meeting the search criteria Select Cancel at any time to return to the Records Menu Patient list oo aaee SO B9COMEbA BACK DETAILS RESULTS The Patient List will display Patient Records that meet the search criteria or will list all the patients in the database if no search criteria were specified The Patient List displays patients alphabetically from the Family name field and also shows the patient ID The up and down arrow indicators to the left of the Patient List show that there are other Patient Records not currently visible on screen 48 CHAPTER SIX Records 6 21 c Use the Up Down Arrow buttons to scroll through the list one Patient Record at a time A selected patient will be shown as highlighted in the list 621d Use the Left Right Arrow buttons to skip through the Patient List 5 records at a time 621 e Select Details to review the complete Patient Details of the highlighted patient 6 2 14 Select Results when a patient is highlighted to inspect the patient s saved Test Records A summary of each test will be shown 621g Select Cancel at any time to exit the Patient List screen and return to Find Patient to begin a new search 622 Test summary 6 22 a When reviewing Results a summary of each of the patient s tests is given on screen This includes 2 o
57. factors Failure to show a strong OAE indicates that further testing or observation is necessary OAE testing is frequently used as the initial screen within the at risk population Passing the OAE test indicates that normal middle ear and cochlear function is present The specific risks must be evaluated to determine whether ABR auditory brainstem response testing is necessary even after a pass at OAE Certain conditions indicate the possibility of retro cochlear neurological disorders which the OAE test cannot detect 28 CHAPTER FIVE Test 5 Test 5 1 5 1 a 5 1 b 5 1 c 5 1 d 5 1 e Patient menu FAT ENT ome Hs Las J History OF Last 4 Records EACK SELECT New Select New to enter details of a new patient to test The device will check that the previous patient has test data for both the left and right ears If only one test has been saved then a pop up message will appear stating Only RIGHT LEFT Ear Test Saved to Last Patient Proceed with New Select Yes to continue with a new patient or No to return to the Patient Menu screen Same as last Select Same As Last to begin a test using the details of the last saved patient Patient details will be displayed in a non editable format to allow confirmation of the patient before starting the test Select Test and enter appropriate test details Select Test again to begin the test This option will not function if there is no patient information st
58. gin card which the Otoport will scan and verify in order to provide access to the machine 2 Scanner types 11 2 a The Otoport has two scanning methods available 21 Barcode scanning 11 24 a This method will scan barcodes which as standard hold numerical data In screening programs which use barcode identification for patient ID the Otoport can be used to scan this number quickly into the device 11 24 To scan with the barcode scanner position the Otoport parallel with the barcode at a distance of around 10cm and select Scan Line up the red light across the barcode 98 CHAPTER ELEVEN Scanning 11 2 1 11 2 1 d 11 2 2 11 2 2 a 11 2 2 b 11 2 2 c The Otoport will show a Scanning screen ee CANNING CANCEL When the barcode is read successfully a beep will sound and the barcode number will populate the required field Select Cancel to abort the scan RFID scanning This method scans radio frequency identification RFID chips which can hold enough alphanumeric data for a complete patient data record on the Otoport To scan with the RFID scanner hold the card up to the Otoport scanning window Select Scan and swipe the Otoport across the card slowly The Otoport will show a Scanning screen as above When the RFID card is read successfully a beep will sound and data will populate the required fields Select Cancel to abort the scan 11 3 11 3 1 3 1 a 3 1 b 3 2 3
59. he test at the Checkfit stage Data table 1 4 TE TEST in F Data Table 1 numerically displays the octave OAE Signal Noise and Signal to Noise SNR levels It can be accessed during the test by pressing the Right Arrow button or pressing the Left Arrow button twice 38 CHAPTER FIVE Test 5 4 u 5 4 v Data table 2 al TE TEST We H FROEE MCE ESOBD l2 ee SSHHOOE1 OTA Data Table 2 lists other statistics required for test analysis The following table describes each field in detail Table Field Description Units OAE The total OAE Signal level dB SPL NOISE The total Noise level dB SPL NLo The amount of data accepted n a due to noise being below the noise reject level NHi The amount of data rejected n a due to noise being above the noise reject level STAB Stimulus stability shows the change in probe fit during a test REPRO The correlation of the two OAE waveforms TIME Test time sec STIM The Stimulus level at the start dB pe of the test PROBE The probe identification number n a FILE The unique test file name populated on Save OTOPORT SCREENER 39 User Manual 5 4 w During the test Data Table 2 is accessed by pressing the Left Arrow button or pressing the Right Arrow button twice s4x Test stop reasons 5 4 y The test will either stop automatically or can be manually terminated by the user A beep will sound at the end of the test When the test sto
60. he main Menu screens Erase all Select Erase all to delete all tests in the database 46 CHAPTER SIX Records 6 2 6 2 a 6 2 b 6 2 c 6 2 d 6 2 e 6 2 f 6 2 9 6 2 h 6 2 1 6 2j 6 2 k Find patient FIND PATIENT 102 102 Fomily User 4 Screener F Skart OO Mmm s994 T CANCEL SEARCH The Otoport provides powerful database search facilities The Find Patient screen gives the option to search and filter the Patient Records by specific criteria ID The ID field provides a partial field search function As each character is entered the database returns the number of patients meeting the criteria Family The family name field also provides a partial field search function User The Otoport can filter for patients results saved by a specific user Choose the user with the Left Right Arrows Start end The start and end dates provide the option to search for patient tests within the specified date range First Enter characters to filter for patients with the specified first name 6 2 1 6 2 m 6 2 n 6 2 0 6 2 p 6 2 q 6 2 7 6 2 1 6 2 1 4 6 2 1 b OTOPORT SCREENER 47 User Manual D O B Enter a date to filter by date of birth Mother Enter characters to filter for patients with the specified mother s name The number on the right at the top of the screen shows the number of patients in the database the number on the left specifies the number o
61. ients and number of tests stored on the Otoport are displayed for information The PC and Otoport dates and times are displayed Select Sync with PC to synchronise the Otoport date and time with the PC s Note Ensure the PC date and time are correct before you synchronise the date and time Otoport download options Download options are provided in the bottom half of the screen Each option is presented as a question and with Yes or No choices Delete test data from Otoport This option enables the deletion of Otoport data following successful download If Yes is selected a confirmation message will appear after the download is complete Select Yes to delete the data or No to leave the data stored on the Otoport 144 CHAPTER EIGHTEEN Using Otolink 18 3 1 F 18 3 1 g 18 3 1 h 18 3 2 18 3 2 a 18 3 2 b 18 3 2 c 18 3 2 d Open EZ Screen after download This function provides the option to automatically open EZ Screen software following download of data if EZ Screen is installed This is useful if you wish to review the Otoport data at the time of download Alternatively EZ Screen can be opened using the shortcut provided on your PC desktop Select Yes to open EZ Screen or select No if you do not wish to open EZ Screen If you choose to open EZ Screen see the EZ Screen manual for more information Initiating the download Once you have chosen your desired download options click Downlo
62. igation buttons to scroll up and down the settings and highlight a parameter to edit The parameter variable will flash Use the Left Right arrows to change each setting It is possible to turn off some settings which means the parameter will not be included in the pass criteria logic When Setup Bands is selected a pop up table enables the edit of each octave band criteria Use the Up Down Arrows to select the parameter to edit and to move between the SNR and RQRD required columns and Left Right Arrows to edit the settings Move down at the bottom of the SNR column to edit the RQRD column OTOPORT SCREENER 79 User Manual 9 4 2 c See the table below for details of the settable pass criteria Field Description Range Min NLo The minimum number of low noise data samples when the noise present is below the reject level that has to be been collected 10 to 222 Min OAE sig The minimum total OAE signal level 10 to 20 required or Off Min SNR The minimum required total signal to noise ratio the difference in the total 0 to 20 noise and total signal required or Off Min band sig The minimum level of OAE signal 10 to 20 required in each band or Off Pass The minimum number of band passes bands required in order to meet the overall pass criteria 1to5 Setup bands Min SNR The minimum signal to noise ratio 1 to 14 required for a band pass or Off RQRD Controls which bands are mandatory for a pass to be
63. igns of contamination and the outer parts cleaned with an antiseptic wipe Take care not to squeeze any cleaning fluid into the tubes The TEOAE tip design leaves a 0 5mm gap between the end of the coupler tubes and the end of the tip Therefore the tubes should never come into contact with the patient OAEs should NOT be conducted if there is evidence of fluid of any kind in the ear canal Not only does this pose a contamination risk but OAEs cannot be recorded through fluid In the event of an accident with body fluids the tip coupler tubes and probe body must be changed OTOPORT SCREENER 113 User Manual 14 Probe care ui Cleaning 14 1 4 The following is the suggested method of cleaning an Otodynamics probe It should be noted that the probe is a precision assembly and as such care should be taken throughout in its handling and cleaning 14 1 b Cable The cable may be cleaned with antiseptic fluid or wipes 14 1 c Probe casing The probe casing may be cleaned using antiseptic wipes and dried with a tissue immediately afterwards Do not allow liquids to enter the sound tubes 14 1 d Coupler assembly Each coupler assembly has two sound tubes These are protected from ingress of foreign materials by wax guards in the tubes and by the disposable probe tip There is a loudspeaker at the end of one tube and a microphone at the end of the other Cleaning solution must not penetrate the tubes 114 CHAPTER FOURTEEN
64. ining service Technical specifications Index 118 118 118 119 120 126 127 127 131 138 139 140 140 141 142 152 153 153 153 154 155 156 159 OTOPORT SCREENER 9 User Manual Introduction The Otoport Screener provides high quality OAE measurement features in a compact handheld format The Otoport Screener is simple to use and with powerful measurement features performs an automatic analysis of cochlear status within seconds Customisable pass criteria control the test s automatic stop mechanism and a clear Pass Refer indication is provided The Otoport Screener s impressive list of features includes TEOAE Quickscreen testing e Ultra fast interactive graphic display e ILO Gold Standard data format e Frequency band or waveform analysis e Mobile phone type keypad e 1000 patient secure database e Long battery life e Data transfer allowing viewing and analysis on PC Options include e Integral barcode or RFID card reader e Wireless printer General use precautions Measuring OAEs requires that the ear is exposed to sound Whilst the level of this exposure is harmless under normal test conditions it is not recommended that tests be allowed to continue indefinitely even if there is no result The Otoport includes stop criteria which will automatically terminate the test when an OAE pass has been achieved or after a pre determined time set by the user which has
65. inting 10 5 10 5 a 10 5 b 10 5 c The printing process If you are using the wired printing method ensure the printer is connected to the Otoport using the printing cable provided Connect the flat connector to the Otoport with the arrows facing upwards and the square connector to the back of the printer Printer cable socket The wireless printing method has a range of up to 10m in direct line of sight It is recommended that the printing distance is reduced to 5m to help ensure robust communication Remain within this range for the duration of the printout Printouts will not complete if wireless communication is lost The printer is powered from batteries or can be connected to mains power when printing Prior to printing switch on the printer using the power button on the top When the printer is powered a green light will be displayed To save power the printer will automatically switch off after 4 minutes or inactivity 10 5 d 10 5 e 10 5 f 10 5 9 10 5 h OTOPORT SCREENER 91 User Manual When a print is initiated the Otoport will establish communication with the printer The screen Connecting to Printer will be displayed Connecking Eo Prinker tv CANCEL The printout will then commence Each screen to be printed will briefly be displayed on the Otoport Once the printout is completed the screen from which the print was initiated will be displayed If there is a problem
66. ip will expose the ear canal to the hard plastic sound tubes and this might cause injury Use without a tip or with an incorrect or non Otodynamics tip may also cause serious errors in measurement This could invalidate the OAE recording 116 CHAPTER FIFTEEN Care of the Otoport 15 15 0 a 15 0 b 15 1 15 1 a 15 1 b Care of the Otoport The Otoport is robustly constructed but is a precision instrument so should be handled with care Be careful when connecting the probe charger PC cable or printer cable e Do not drop the Otoport Do not leave in strong sunlight Do not expose to high temperatures e Do not touch the connector socket pins by hand Do not force the connection of the probe or charger PC cable printer cable Use of the Otoport and cleaning The following is a suggested cleaning method for the Otoport and probe The Otoport and accessories are precision assemblies so care should be taken throughout handling and cleaning Other than the probe ear piece and cable the Otoport hardware should not come into contact with the patient being tested Otodynamics probe tips are disposable and for single use only A new tip should be used for each ear tested The tip protrudes 0 5mm beyond the end of the probe coupler to prevent contact of the sound tubes with the patient 15 1 15 1 d 15 1 e 15 1 15 1 9 OTOPORT SCREENER 117 User Manual Between patients wipe the probe
67. ll appear on screen This equates to approximately 10 minutes of use Select OK to accept the message and return to the previous screen It will not be possible to start a new test when the Otoport has reached this level of charge The Otoport should be charged as soon as convenient 122 CHAPTER SIXTEEN Otoport power 16 4 3 16 4 3 a 16 5 16 5 a 16 5 b 16 5 c 16 5 1 16 5 1 a 16 5 1 b Auto switch off The Otoport will automatically switch off when the battery level reaches 2 It will be necessary to charge the Otoport before it will switch on again Charging the Otoport Observe the on screen battery indicators to determine when to charge your Otoport In general it is advisable to charge the Otoport batteries when the indicator is empty showing less than 10 charge However the batteries should be at least 30 charged if a full day s testing is planned It is recommended to charge the Otoport using the charger supplied but it is also possible to charge the device using the PC cable connected to a PC Note Do not charge more than one Otoport on the same PC at any one time Connecting the Otoport for charging Switch off the Otoport prior to charging Connect the mains lead to the charger and plug the mains lead into a power socket and switch on the power The green light on the charger will illuminate indicating it is powered 16 5 1 c 16 5 1 d 16 5 1 e 16 5 1 f 16 5 1 g
68. minated by noise This filter will help measurements to be taken even in noisy conditions but the signal and noise will be attenuated by around 6dB at 1 kHz and 3cB at 1 5 khz Data at 4kHz is also attenuated by a few dB The attenuation at these frequencies does not affect the signal to noise ratio obtained during recording which is a primary pass criteria for good data quality 84 CHAPTER NINE Test set up o43x Test setup defaults 94 3y The table below shows the test setup default parameters for the Otoport OAE 2 pass criteria is configured according to the UK NHS screening program Test Setup Parameter Default Mode 1 TE Test Config Locked Mode Name Screening OAE 1 OAE 2 Factory Stim Level 84dB pe 84dB pe 84dBpe 84dBpe Stim Range 1dB 1dB 1dB 1dB Noise Reject 52dB SPL 52dB SPL 52dB SPL 52dB SPL Ring Reject 20dB 20dB 20dB 20dB Max NLo 260 260 260 260 Test Time 300sec 300sec 300sec 300sec TE Pass Criteria Min NLo 30 30 40 40 Min OAE Sig 0dB SPL OdB SPL OdBSPL OdBSPL Min SNR Off Off Off Off Min Band Sig 5dB 5dB 5dB 5dB Pass Bands 2 3 2 3 1K SNR 6 6 Off 6 1 5K SNR 6 6 6 6 2K SNR 6 6 6 6 3K SNR 6 6 6 6 4K SNR 6 6 6 6 1K RQRD No No No No 1 5K RQRD No No No No 2K RQRD No No No No 3K RQRD No No No No 4K RQRD No No No No TE Automation AutoAdjust On Off On On AutoStop On Off On Off AutoStart Off Off On Off Override Off Off Yes Off TE Other Settings Mandatory Save Off Save Off Save
69. mm x 28mm Weight 120g Data USB 1 1 2 0 Probe connector compatible with Otodynamics UGx probes 8 pin Charging Data connector connects to Otodynamics PSU charging or PC USB port Serial to 115200 Baud via Data connector Bluetooth wireless print transfer option RFID reader writer option Resolution 128 x 64 pixels Technology Graphic LCD Dimensions 48mm x 30mm White intelligent control Noise OK Blue LED Stimulus OK Blue LED Power OK Green LED Fast charge Amber LED Wide range speaker provides audio feedback of status 19 key alphanumeric with cursor control and soft keys Clock Calendar OTOPORT SCREENER User Manual 157 Internal Real Time Clock Calendar operates to 2099 Power Intelligent multi level power control for charging testing idle sleep shutdown After 3 minutes unit will enter sleep mode After 30 minutes in sleep mode unit will shut down Sleep time Running time Max consumption when testing Max consumption when charging Source Charge time Hardware Options 20 hours with fully charged battery 8 hours minimum continuous testing 720mMW 2 5W 860mAh NiMh internal rechargeable cells 3 hours to 80 capacity Approximately 4 5 hours to 100 Bluetooth wireless printing data transfer Barcode scanner RFID reader writer Hardware processing and storage Multiple distributed processors plus dedicated hardware DSP engine Total processor performance
70. nditions within the room are low Continue to retest until the Occlusion OK result is given If Artefact is shown at the end of the test save and retest making sure again that a finger is pressed firmly over the end of the coupler tubes and the testing stimulus level is below 40dB at the start of the test If the result occurs a second time contact your dealer or Otodynamics for advice On selecting Save each test is automatically saved with a unique date time stamp and can be reviewed individually in the QA Occlusion Test History area Note If an artefact is reported in the occlusion test ensure that five successful occlusion tests are performed on the Otoport before returning it to use 110 CHAPTER TWELVE Probe 233 Real ear test Ploce Probe into on dgFFCorFigoke Ear Press OK bo besin kest CAHCEL OK 233a Testing with a known good ear checks that the Otoport correctly detects OAE responses 233b On selection of Real Ear Test from the QA Tests Menu the message Place Probe into an appropriate Ear Press OK to begin test will appear on screen 23 3 c The Real Ear Test utilises the identical test sequence as a standard TEOAE ear test 233d Patient Details are automatically entered For a Real Ear Test Patient Details Field Real Ear Test Default ID QA3 Name QA First Ear 12 3 3 e The result logic for a Real Ear Test is set to the locked factory mode Please refer to chapter 5 4 Test
71. not currently visible Use the Up Down navigation buttons to scroll up and down the settings and highlight a parameter to edit The parameter variable will flash Use the Left Right Arrow buttons to change each setting See the following table for details of the settable test parameters 76 CHAPTER NINE Test set up Field Description Range TE mode name User settable mode name 8 characters max Stim level Peak target stimulus level 70 90 dB pe for testing Stim range Stimulus OK range the permitted change in stimulus level during TEOAE testing before probe movement warnings are provided If the stimulus is out of range the Stimulus OK indicator will extinguish and the screen will display Check probe fit 1 2 or 3dB Noise reject The threshold of noise permitted during a test above which causes data to be rejected from the final result Reducing the noise reject level could result in better quality data collected but less data will be accepted if there is noise which could result in a longer test time Increasing the noise reject level will allow more data to be collected in noisy conditions but this could have a negative affect on data quality as it could contain more noise and there is an increased risk of noise artefacts 40 74 dB SPL Ring alert Controls the sensitivity of a warning provided if the stimulus becomes oscillatory and rings Stimulus ring only occurs in large ear canals so i
72. o Changing the battery 10 10 The printer battery will provide up to 500 charge and discharge cycles If the battery performance deteriorates the batteries will need to be changed A spare battery cradle which takes 4 AAA batteries is provided with the printer Alternatively a new battery pack can be obtained from your dealer or Otodynamics 10 10 b To change the battery pack 10 10 c Remove the screw 1 from the battery compartment cover 1010 0 Push down and slide back the battery compartment cover 2 10 10 Remove the old battery pack and disconnect the battery pack connector noting its orientation 2 of Fit the battery pack connector 3 taking care to insert it correctly 010g Fit the battery pack ensuring wires 4 are not trapped oh Slide back the battery compartment cover and replace the screw 2 10104 Important Note Only charge the printer if it contains an approved battery pack supplied by your dealer or Otodynamics Ltd OTOPORT SCREENER 97 User Manual 11 Scanning uo Scanning facility 11 1 a As well as the standard data entry method using the keypad the Otoport provides two optional methods for data entry using scanners The scanning methods are designed to reduce testing session times by making the patient data entry method efficient 11 1 b The scanners can also be used as part of the device security system during login Each operator can be assigned a lo
73. on is Space 0 which switches to 0 Space for patient ID entry Characters will scroll left off the screen if entering text which is greater than the visible area A left arrow will appear at the beginning of the line to indicate that text is off screen When the field choice changes the beginning of the text is shown with a right arrow at the end of the line to indicate that the text entered is greater than the visible area 18 CHAPTER TWO Getting started 2 6 4 2 6 4 a 2 6 5 2 6 5 a 2 6 5 b 2 6 5 c 2 6 5 d 2 6 5 6 Foreign character table A foreign character pop up table can be accessed by holding down the 1 button for 1 5 sec Use the Arrow buttons to navigate around the table Select Insert to enter the required character or select Cancel to close the table window Entering dates A right arrow symbol is shown at the end of a date field When the field is highlighted press the Right Arrow button to access the calendar pop up table The day will be highlighted first and can be altered using the Up down Arrow buttons Continue to use the Left and Right Arrow buttons to jump between the Day Month Year and the Up and Down Arrow buttons to select the required date Select Insert to accept the date displayed or press Cancel to ignore the changes If the date has not been edited it will remain as dd Mmm yyy For Date of Birth entry D O B the Otoport will not permit entry of a future date Invalid D O B
74. on the Otoport again 2 Switch on 19 2 a During switch on the Otoport conducts a series of system checks If the Otoport will not switch on and complete its start up sequence check that it is charged and try again If it still does not turn on hold down the On off power button for 10 seconds and then try to switch on the device Ifthe Otoport still fails to complete its start up sequence then contact your dealer or Otodyamics for support o System details 19 3 a The System main menu area includes System details This screen provides information for Otodynamics engineers relating to the Otoport hardware If your device is not functioning correctly or you suspect a fault go to the System details menu and check for any error number reported at the top of the screen If zeros are reported at 154 CHAPTER NINETEEN Troubleshooting 9 4 9 4 a 9 4 b 9 4 c 19 4 d the top of the screen no errors have been detected on the device For support regarding a fault report error numbers to your dealer or Otodynamics Instrument fault message In the event of an instrument fault the following message will be displayed at the start a test Instrument fault turn off Otoport then run system checks No stimulus will be delivered from the Otoport probe and you will not be able to start a test Turn off the device and then switch it on again Run all three QA Tests from the Probe main menu in order to check the system see
75. options Noise level indicator The noise level indicator allows continuous monitoring of the noise level during a test The noise reject level is now displayed numerically below the indicator Use the Up Down Arrow buttons to adjust the noise reject level Title bar When conditions are good for data collection TE TEST will be shown at the top of the screen and progress indicators will move either side of the title to show that a test is currently running Test condition information Noisy appears if the noise level is above the noise reject level for a period of time Check Probe Fit is shown if the adjusted stimulus level falls outside the accepted range The following table describes the test condition information which appear if more than one condition is met Consistent Stimulus Highlighted High Noise Out of Range Message No No TE TEST No Yes Check Probe Fit Yes No Noisy Yes Yes Check Probe Fit 5 4 p 5 4q 5 4 1 5 4 8 5 4 t OTOPORT SCREENER 37 User Manual Cancel end 4 I TE TEST Im L E 20 10 i 10 I l5 Zz 4 4 se CANCEL END Select End at any time during a test to stop the test Select Cancel at any time during a test to pause the test This may be useful if the ambient noise increases Cancel Test is displayed at the top of the screen and three options are provided Yes will terminate the test No will continue the OAE recording and Checkfit will restart t
76. ored on the Otoport 5 1 f 5 1 9 5 1 h 5 1 i 1 j 52 5 2 a 5 2 b 5 2 0 OTOPORT SCREENER 29 User Manual History of last Select History Of Last to review test results of the last saved patient This option will not function if there is no patient information stored on the Otoport Records Select Records to test or review results of a previously saved patient Select Back to return to the Patient menu Patient details ENTER DETAILS Firsk 0 B DO Hmm sees T CANCEL TEST The Patient Details screen allows patient data to be entered and saved with the test record Patient details fields Patient Details Fields can be selected by pressing the Up Down Arrow buttons The field name becomes highlighted and a cursor flashes at the beginning of the line ready for data entry Up and down arrows are present on the screen to indicate that other fields are available but not currently visible 30 CHAPTER FIVE Test s24 Patient details description 5 2 e An explanation of the Patient Details fields is shown in the following table Field Description Max no Characters ID The patient s ID number or local hospital number 12 Family The patient s family name 20 First The patient s first name 20 D O B The patients date of birth n a Gender The patient s gender n a Mother The mother s maiden name 20 Notes Any additional comments relating to the patien
77. ps a result is displayed as a message on the full screen shown below Select OK to accept the test stop reason The result is then displayed at the top of the test screen TEQAE Pass 5 4 z Pressing End at any time will stop the test 40 CHAPTER FIVE Test 5 4 aa 5 4 bb Test results The following table lists all possible test results and gives an explanation of the circumstances under which each result would be shown Test Result Description TEOAE Pass The data collected has met the set pass criteria Note The following results will only occur if a TEOAE Pass is not obtained providing test information feedback to the user Noisy If the noisy data collected is three times greater than the low noise data collected Poor Probe Fit If the final test stimulus level is outside the stimulus ok range or if the final stimulus stability value is lt 85 No Valid OAE The data collected has not met the set pass criteria and the test conditions were acceptable Too Few Bands If insufficient bands meet their pass criteria Stopped Too If a user ends the test manually before Soon the required minimum amount of data has been collected 5 5 5 5 a 5 5 b 5 5 c OTOPORT SCREENER 41 User Manual Save and review Once a test is completed it is possible to save the result by selecting Save Select Cancel to discard the result a confirmation screen is provided which also gives
78. rd changes made to date and time settings and return to the Management Menu screen 8 5 8 5 a 8 5 b 8 5 c OTOPORT SCREENER 69 User Manual Other options OTHER OPTIONS 4 HHS a oain On Site ID HAH Device ID Yellow CANCEL SAVE Other Options are available to customise the use of the device within a specified screening environment ID Input The ID Input choice bar can be used to alter the input format of the Patient s ID field When adding new Patient Details characters will be restricted for Patient ID input according to the chosen format Below is a table listing the options available ID Format Description 123 Numeric only 123 amp ABC Alphanumeric ABC Alpha only 70 CHAPTER EIGHT Management esa Login ee LOGIN User 4 Admin F EE LOGIN 8 5 e The Otoport provides the option of User Login When Login 8 5 f 8 5 g 8 5 h 8 5 i is switched on the Login screen will appear automatically following device switch on Check that the correct User name is displayed The Otoport will remember the last user of the device and automatically default to that user at the next login Use the Navigation Arrow buttons to select a User from the choice bar if necessary Once a User is selected use the Navigation arrows to return to the password entry row and the data entry keypad to enter a corresponding Password To improve security during Login a symbol will replace each character
79. ring the paper will pass through the paper feed 3 and close the cover with a click 10 8 d After loading check that the paper advances properly using the paper feed function and tear off any excess by pulling the paper sharply towards you across the serrated tear bar In the event of a jam or other paper loading problem release the lid and straighten the paper before closing again 10 8 e Self adhesive paper rolls are also available and may be used in the same way as standard paper but can be stuck to your patient records 10 9 10 9 a 10 9 b 10 9 c 10 9 d OTOPORT SCREENER 95 User Manual Charging the printer To charge the printer plug the charger into a mains outlet socket and insert the charger jack plug into the rear of the printer The light on the printer will flash green orange to show the printer is on charge The red charger light will also illuminate A full charge will take approximately 15 hours Ti ivyre Charger jack plug socket The printer can be used as normal whilst charging Once fully charged the printer has enough power for around 10 hours standby use The batteries should provide enough power to print several rolls of paper The printer light will flash green red when the batteries are low Note The printer charger is not medically approved The Otoport must not be in patient contact if connected to the printer whilst the printer is charging 96 CHAPTER TEN Printing o
80. s chip which requires driver installation on both its Aand B communications channels The driver installation process must therefore be conducted twice once for each channel When the Otoport is connected it will be detected by your PC and a message will pop up to acknowledge the detection of new hardware r J Found New Hardware X OtoPort OAE Screener E J Found New Hardware X Otodynamics OtoPort Chan The found new hardware wizard will automatically start Found New Hardware Wizard Welcome to the Found New Hardware Wizard Windows will search for current and updated software by looking on your computer on the hardware installation CD or on the Windows Update Web site with your permission Read our privacy policy Can Windows connect to Windows Update to search for software O Yes this time only Click Next to continue Select No not this time and click Next 134 CHAPTER SEVENTEEN Installing PC software Found New Hardware Wizard This wizard helps you install software for Otodynamics OtoPort Chan4 If your hardware came with an installation CD S amp P or floppy disk insert it now What do you want the wizard to do O Install from a list or specific location Advanced Click Next to continue 17 3 1 4 Accept the option to Install the software automatically This should find the Otodynamics Otoport drivers on the CD already in your CD ROM drive Found New Hard
81. s not an issue when making OAE measurements on newborns A ringing stimulus can increase the risk of a stimulus artefact The Otoport displays Ringing during checkfit to warn the users if the stimulus is ringing see fig 1 In most ears the stimulus click becomes flat following the click stim see fig 2 but in longer large ear canals the stimulus can oscillate for longer The Ring alert displays the ratio in dB of the peak stimulus over the stimulus level recorded at 3 milliseconds 10 to 30dB Max NLo This is a test timeout function which stops the test when the specified number of low noise data samples when the noise present is below the reject level has been collected 10 990 Test time The maximum time the test before automatic stop 10 900 secs OTOPORT SCREENER 77 User Manual 1 LC CAHCEL START Fig 1 CANCEL TART Fig 2 osip Note If the maximum test time specified is not long enough for the device to complete the max NLo requirement then the test time is automatically reset to longer than the Max NLo 78 CHAPTER NINE Test set up 9 4 2 9 4 2 a 9 4 2 b Pass criteria ooo oaeee OO TE FASS CRITERIA poma ic in i3 D__a65FL Hin SHA OFF ae Hin Bond Sia 5 465SFPL T CANCEL SAVE The test pass logic is controlled in this section Up and down arrows on the screen indicate other fields are available but not currently visible Use the Up Down nav
82. se For good testing conditions the shaded bar should be consistently below the Noise Reject Threshold Level which is represented by the horizontal line across the Noise Level Indicator The threshold level is displayed numerically above the indicator Use the Up Down Arrow buttons to change the Noise Reject Level Stimulus level indicator A Stimulus Level Indicator is shown on the left of the Checkfit screen With the probe in an ear the device will attempt to adjust the stimulus to the set testing level The indicator s needle and the numeric display to the left of the arc show the change in stimulus level during adjustment The stimulus is at the set testing level when the needle is vertical Stimulus waveform window 4 Sb B44E Sz H CANCEL START Pressing Left Right Arrow buttons during Checkfit switches the screen display between the Stimulus Level Indicator and the Stimulus Waveform Window which shows a real time view of the stimulus waveform With a good probe fit the waveform should have an initial large positive then negative peak followed by a flat line response After stimulus adjustment the large positive peak should be just inside the Stimulus Waveform Window and the numerical display above the window should read 84dB default 3 j 5 3 k 5 3 1 5 3 m 5 3 n 5 3 0 OTOPORT SCREENER 33 User Manual Test condition information Checkfit OK will appear at the top of the screen if the adjust
83. se the Up Down arrows on your PC keyboard or your mouse to select an individual test for a patient Their half octave OAE data will be displayed in an OAE response histogram The blue represents the signal and the red represents the noise 18 3 4 e To search for a specific test various filters are provided It is possible to search for data downloaded between specific dates tests conducted in a specific data range or patients with a specific date of birth Tick the relevent boxes to filter by any of these options 18 344 The Data Viewer will also filter by Screener ID Machine ID or Probe ID Use the drop down lists to select the variable 18 3 4 g 18 3 5 18 3 5 a 18 3 5 b 18 3 5 18 3 5 d 18 3 5 e OTOPORT SCREENER 147 User Manual The family name and ID fields are provided to enable a partial field search Select deselect the required filters and click Apply Refresh filters to update the data displayed Tray icon control As standard Otolink software automatically starts when the PC is started The software runs in low PC memory usage mode until the software is opened or detects an Otoport A tray icon is present in the system tray Otolink software will automatically open when an Otoport is detected but it is also possible to open the software manually using the tray icon Note The download options and administration areas of the Otolink software will only open when an Otoport is connected If th
84. t 15 Risks 10 national and local risk factors configure choices in Management with options of Yes No or Unknown UKN n a Location Either inpatient outpatient or at home n a Facility The name of the hospital clinic etc where the test is being performed configure choices in Management n a NICU Is the patient in the Neonatal Intensive Care Unit Yes or No n a Consent This option allows the consent to the test to be stored with the test details Two levels of consent are provided Full and Screen Only n a 5 2 f 5 2 9 5 2 h 5 2 5 3 5 3 a 5 3 b 5 3 c OTOPORT SCREENER 31 User Manual Beginning a test Select Test to begin the OAE test once the correct patient details have been entered or Cancel to return to the Patient Menu screen Mandatory patient details ID and Family name entry are mandatory and must be entered before a test result can be saved Checkfit Checkfit display a amao IONO 4 a ETH FRH CANCEL START It is important to perform a test in the appropriate conditions The Checkfit screen allows a user to assess the testing environment before starting the test Excessive noise or a poor probe fit may mean that it is not possible to record OAEs 32 CHAPTER FIVE Test 5 3 d 5 3 6 5 3 f 5 3 g 5 3 h 5 3 i Noise level indicator A Noise Level Indicator is shown on the right of the Checkfit screen The shaded bar moves in response to changes in noi
85. t Details have been made A pop up message may appear if edits to mandatory fields e g ID and Family name prevent the Patient Details from meeting the requirements for saving a patient The screen will return to Edit Patient to modify the changes made Choose Select when Delete is highlighted to remove the patient from the Work List The message Delete Patient will appear at the top of the screen Select Yes to delete the Patient Details or No to cancel the deletion and return to the Edit Patient screen Select Back to return to the Work List 54 CHAPTER SIX Records Database summary SUMMARY Fat i ents 000 Tests 3000 BACK 6 4 A Database Summary can be accessed from the Records Menu screen It details the present number of Patients and Tests saved to the database 6 4 b Select Back to return to the Records Menu a Erase all YES NO 6 5 a The Erase all function will delete all tests stored in the database Itis then necessary to confirm the erase request to help eliminate accidental deletion 6 5 b Select Yes to Erase all tests or No to leave the records stored on the Otoport 7 1 a OTOPORT SCREENER 55 User Manual System System menu STSTEM SETUP aktEers 3 Susten Deksils 4 Abouk EACK SELECT Controls Select Controls to adjust Volume Contrast and timing of the Backlight Battery Select Battery to view current battery status System details System De
86. tails displays information for Otodynamics engineers About Select About for Otoport firmware revision number and issue date and device identification numbers Select Back to return to the main menu screens 56 CHAPTER SEVEN System La 7 2 a 7 2 b F206 7 2 d 7 2 6 7 2 7 2 9 Controls menu CONTROLS i aa d3 BockLishk BACK SELECT Volume Select Volume to increase or decrease the unit s volume level or to turn sound off Contrast Select Contrast to adjust the contrast of the screen for varying light conditions Backlight Select Backlight to configure the status of the blue screen backlight Select Back at any time to return to the System Menu 7 2 1 7 2 1 a 7 2 1 b 7 2 1 7 2 2 7 2 2 a 7 2 2 b 7 2 2 OTOPORT SCREENER 57 User Manual Volume a O VOLUME SILT LITT T E BACK SAVE The current Volume level is represented on the display by a number of shaded blocks Use the Left Right Arrow buttons to decrease or increase the Volume level To turn the sound off press the Left Arrow button repeatedly until Sound Off appears in the centre of the display Select Save to accept the new Volume level Select Back to ignore changes and return to the Controls Menu Contrast CONTRAST T DE EACK SAVE The screen Contrast can be altered by press of the Left Right Arrow buttons The shaded section of the graphic will vary according
87. tery life of a reduced Backlight time The Battery graphic on the right of the screen conveys the total remaining Battery Power The battery segments are shaded according to the following criteria Segments Displayed Battery Power 5 295 4 270 3 2 50 2 2 30 1 2 10 0 lt 10 60 CHAPTER SEVEN System 7 3 d 7 3 e 7 3 6 7 4 7 4 a 7 5 7 5 a The Battery Voltage is provided as a diagnostic tool at the bottom of the screen The battery graphic is also displayed on the Logo screen to inform the user of the Battery Power every time the device is switched on Select condition to condition the Otoport battery See chapter 15 Otoport power for more information System details System Details displays information for Otodynamics engineers The device performs electrical self checks and any errors during these tests are displayed About ABOLIT Revision 0 0 5 sued 2d Feb 2007 Hardware 3286499 GSN CEF Probe 10 WUG5 BS 12084 CANCEL The About screen details information relating to the Otoport s identification and mode of operation The firmware revision number and creation date is stated together with the unit s unique hardware ID If a probe is connected the Probe ID will also be displayed for reference 8 1 OTOPORT SCREENER 61 User Manual Management Management menu MANAGEMENT err 3 Dote amp Time 4 Obher Orkions EACK SELECT
88. the Otoport is reprocessed in EZ Screen and all of the OAE data is recalculated from this waveform You may notice up to 0 2dB difference in signal and noise values The total noise is 3dB different The test outcome and band passes will not be affected as these are imported directly from the Otoport The stimulus level is recalculated from the stimulus waveform and a variation of a few dB may be observed The stimulus stability figure for all imported Otoport data will be 1 irrespective of the value on the Otoport The level of noise reject will be reported at the level set in the Otoport in dB SPL If there is no Gender set on the Otoport the patient will default to Male in EZ Screen 146 CHAPTER EIGHTEEN Using Otolink 18 3 4 Data viewer o x goo ee a a eana E creen 456PTW 26 09 2007 NotGiven Left TEQ 26 09 2007 15 14 19 Ef creen 456PTW 26 09 2007 NotGiven Right _TEQ 26 09 2007 15 14 42 TF Enable data filtering CG Apply Retresh filters Family name filter ys ID filter SceenerID any Machineio fany E Proben fany E V Download date range IV Test date range 1834 2 The Data Viewer provides the facility to view all the downloaded Otoport data including patient and test details with OAE data 18 3 4 b All data is downloaded to the Data Viewer which shows a test per row On subsequent downloads new data appends to the bottom of the table 18 340 Selecting a patient to view 18 3 4 4 U
89. the probe socket on the Otoport The arrow at the front of the probe plug indicates the position of the key and should be aligned with the front of the Otoport It is possible to feel when the probe key is aligned as the probe will mate with the socket easily Push the probe into the socket until it hits the end stop DO NOT force in the probe Screw up the knurled sleeve clockwise until finger tight 4 3 4 3 a 4 3 4 3 1 4 3 1 4 3 1 4 3 1 OTOPORT SCREENER 25 User Manual Selecting an appropriate tip and fitting the probe ear piece Tip selection and probe fit are essential to ensure successful OAE recordings A good probe fit will help to block out external noise and enhance the OAE signal The Otoport is supplied with a full range of tips to fit all ear canal sizes see chapter 13 2 Disposable tips When selecting a tip first inspect the ear to be tested to assess its size and to check that it is clear and free from debris If debris subsequently enters the probe sound tubes do not attempt to clean them the coupler tubes should be changed The correct size tip will look slightly larger than the ear canal and should fit snugly forming a complete seal with the ear canal wall Fitting for newborns Gently lift the pinna upwards away from the baby s head and then towards the back of the head This will open the ear canal Insert the probe at approximately 10 o clock for left ear or 2 o
90. tient Set Mandatory Save On to save all tests During the test it will be possible to Pause the recording but not Cancel and it will not be possible to conduct another test without saving the data With Mandatory Save Off it is possible to Cancel the test or abort the data saving process Mic filter It is possible to select various Mic Input Filters on the Otoport which can be helpful when testing in various environmental noise conditions The filters significantly attenuate signals outside the filter frequency range This helps to stop noise at these frequencies having a negative affect on the result Only data collected within the filter frequency range will be added to the OAE recording process 9 4 3 v 9 4 3 w OTOPORT SCREENER 83 User Manual There are three filter settings provided The following table shows the name of the filter and the frequency cut off points Frequencies outside the filter range will be attenuated Filter name Frequency range Hz Wide band 400 6400 Normal 841 4757 If noisy 1189 4757 The Wide band filter will collect data at the widest frequency range The Normal filter allows data collection between a tighter range eliminating more low and high frequency noise This filter will attenuate OAE signal and noise collected at 1 and 4Khz by a few dB The If noisy filter is a tight filter that attenuates a significant range of low frequency signals which are in practice often conta
91. time to exit Patient Details and return to the Test Summary 6 3 6 3 a 6 3 b 6 3 c 6 3 d 6 3 e 6 3 f 6 3 1 6 3 1 a OTOPORT SCREENER 51 User Manual Worklist menu WORE LIST iew Wor iS EACE SELECT The Work List facility allows for Patient Details to be entered and saved prior to the test to reduce data entry time during the testing session Add patient Select Add Patient to add a new patient to the work list View work list Select View Work List to review edit or test a patient on the current Work List Select Back to return the Records Menu Add patient ADO PATIENT T First MIE dd Hmm s994 CANCEL SAVE Anew patient can be added to the current Work List by entering their Patient Details in the Add Patient screen 52 CHAPTER SIX Records 6 3 1 b 6 3 1 6 3 2 6 3 2 a 6 3 2 b 6 3 2 c 6 3 2 d The screen format and data entry is identical to entering patient information when performing a test Please refer to chapter 3 2 Patient Details for guidance on entering data in fields and mandatory requirements for save Once the correct patient details have been entered select Save to add the patient to the Work List or select Cancel to return to the Work List Menu screen to discard entered data A warning will appear if the patient added to the Work List is already present in the Otoport database It is possible to append the entry to that patient re
92. tion to represent your facility Click OK to open EZ Screen software Please see the EZ Screen manual provided for further information on reviewing data in EZ Screen OTOPORT SCREENER 131 User Manual s Installing Otoport drivers 7 3 a In order for your PC to communicate correctly with the Otoport it is necessary to load driver software The software is available on the Otolink software CD provided 7 3 b This example installation guide is for Windows XP Installation for other operating systems may vary 7 3 c Insert the Otolink CD into your CD ROM drive A menu will appear shortly with various options Install Otolink Otoport User Manual Install Acrobat Reader Browse CD Visit Otodynamics com 17 3 d The menu is not required at this stage but leave the menu open as it will be needed later 132 CHAPTER SEVENTEEN Installing PC software 17314 Connecting the Otoport 17 3 1 a Plug the Otoport into the PC using the PC download cable provided Do not connect more than one Otoport to the same PC at any one time 17 3 1 The end with USB symbol fig 1 should be connected to a USB socket on the PC fig 2 Fig 1 Fig 2 17 3 1 c The Otoport connector fig 3 should be plugged into the bottom of the Otoport fig 4 with the arrows facing upwards Fig 4 17 3 1 d 17 3 1 e 17 3 1 f 17 3 1 g OTOPORT SCREENER 133 User Manual The Otoport contains an advanced USB PC communication
93. tolink PC software W Found New Hardware x Your new hardware is installed and ready to use Disconnecting the Otoport To disconnect the Otoport gently squeeze the release buttons together as indicated by the arrows and pull out the connector DO NOT ATTEMPT TO PULL OUT THE CABLE WITHOUT SQUEEZING THE RELEASE BUTTONS 138 CHAPTER SEVENTEEN Installing PC software 17 4 17 4 a 7 4 b 7 4 c 7 4 d 7 4 e 7 4 f 7 4 9 7 4 h 7 4 i 7 4j Otolink CD menu Following Otoport driver installation return to the CD menu screen which should be open on your PC desktop If this has been closed simply open and then close your CD ROM drive and the menu will shortly appear Install Otolink Otoport User Manual Install Acrobat Reader Browse CD Visit Otodynamics com Select the various options using a left mouse click Install Otolink This will begin the Otolink software installation Otoport user manual This opens the Otoport user manual Install Acrobat Reader This will install Adobe Acrobat Reader the program used to view the product manual provided Browse CD This allows the contents of the CD to be viewed 17 4 k 17 4 7 5 7 5 a 7 5 b 7 5 7 5 d 17 5 e OTOPORT SCREENER 139 User Manual Visit Otodynamics com This will open the Otodynamics website on your web browser your PC will need to be connected to the internet Installing Otolink soft
94. tons to scroll between the screen choices Select Wave to show the OAE waveform Two interleaved OAE waveforms are collected during a test named A and B The current waveform displayed is labelled on the OAE waveform graph Select Show A or Show B to toggle between the two waveforms Waveforms that correlate well represent good quality recordings where the noise level is low If the waveforms are significantly different 50 CHAPTER SIX Records 6 2 3 d 6 2 4 6 2 4 a 6 2 4 b 6 2 4 c this indicates noise was present during the measurement Examine the waveforms to help identify artefactual signals which typically do not have an even distribution of energy across the complete response window If you are concerned about the performance of your Otoport run the system QA test see chapter 12 Probe Select Back at any time to exit and return to the Test Summary Review patient details database PATIENT DETAILS ME B 604434 Fomily Finch Ficsk Hotkhew Be E l2 JuL 1480 BACK FRINT TEST A non editable version of highlighted Patient Details can be reviewed by selecting Details in the Patient List Please refer to chapter 3 2 Patient Details for a full description of the screen format Select Test to enter specific test details for the current test Select Test again to start the test process Please refer to chapter 3 3 Checkfit for an explanation on how to setup and perform a test Select Back at any
95. trict the user to screener rights described on the next page Location Where the default test will be n a performed either Inpatient Outpatient or at Home Facility The default name of the hospital n a clinic etc where the test will be performed configure choices NICU Are patients tested by this user predominantly in the n a neonatal intensive care unit Yes or No 64 CHAPTER EIGHT Management 8 2 1 b 8 2 1 c 8 2 1 d 8 2 1 e 8 2 1 f 8 2 2 8 2 2 a The User ID is added to a saved test record to identify the user who performed the test The User ID must therefore be unique and the message Cannot Save User ID already exists will appear on Save if the chosen User ID is already associated with a current user The device will return to the New User screen where the User ID field will be selected for editing A new user is given a choice of two levels of access rights If Yes is selected in the administrator field then the user will have full access to all modules of the device Select No to restrict the user s rights to only Test Records Probe Print and System modules Default Location Facility and NICU options can be set for each user On future login by the user the Patient Details for each new patient will switch to these default options If a test is not being performed in the normal testing location the default options can be easily changed when entering Patient Details Selecting Save will
96. ts 2 1 Select QA Tests to conduct system checks to ensure the device is functioning correctly 2i QA test history 21g Select QA Test History to review previously performed system checks 2 1 h Select Back at any time to return to the main menu screens 102 CHAPTER TWELVE Probe 12 2 12 2 a 12 2 b 12 2 c 12 2 d 12 2 e Probe test PROBE UGDOSOAD 2 STORED WEH 1EHZ 18 5 19 0 GGSS SH2 11 5 74 8 FAIL 13 2 13 3 Ta BACK SAVE RETEST A Probe Test should be performed weekly to monitor the calibration of the probe s output stimulus level and microphone response On selecting Probe Test the message Place Probe into Otodynamics Test Cavity Press OK to begin test will appear on screen Ensure the probe ear piece without a tip attached has been firmly inserted into an Otodynamics test cavity and the cavity has been positioned on a flat surface Select OK to begin the Probe Test or Cancel to return to the Probe Menu screen The probe outputs sound at 1 2 and 4kHz and the system compares the response at these frequencies against values already Stored on the probe A Pass result is given for each frequency if the New and Stored data are within 3dB If the values differ by more than 3dB then a Fail result is given If all frequencies Pass then select Back to exit the probe test and return to the Probe Menu screen If a Fail is shown on screen inspect the probe coupler t
97. u screen On selecting Save each test is automatically saved with a unique date time stamp and can be reviewed individually in the QA Cavity Test History area 12 3 1 k 12 3 2 12 3 2 a 12 3 2 b 12 3 2 c OTOPORT SCREENER 107 User Manual Note If an artefact is reported in the test cavity ensure that five successful cavity tests are performed on the Otoport before returning it to use Refit the probe in the cavity between each test Occlusion test Block Coupler Tube ends with Finger Press OK Eo besin kest CANCEL OKE If the probe coupler is not fitted correctly sound may leak between the probe loudspeaker and microphone The Occlusion Test helps to check that the probe is assembled and is performing correctly On selection of Occlusion Test from the QA Tests Menu the message Block Coupler Tube ends with Finger Press OK to begin test will appear on screen To occlude the probe place a finger firmly over the end of the coupler tubes which will stop sound from being omitted from the ear piece and prevent ambient noise from being detected by the microphone Select OK to enter the standard Checkfit screen The stimulus needle should be to the bottom left of the scale and no noise should be detected On selection of Start the Stim Out of Range message will appear which is expected as the stimulus is being occluded Select Continue to start the test The Occlusion Test utilises the identical test sequ
98. ubes for debris replace the coupler if necessary and repeat the Probe Test by selecting Retest ensuring the ear piece is firmly inserted in the test cavity If the test continues to fail there may be a fault with the probe or system Contact your dealer or Otodynamics for advice 12 2 12 2 9 12 2 h 12 3 12 3 a 12 3 b 12 3 c 12 3 d OTOPORT SCREENER 103 User Manual The 1 2 and 4kHz values may not be Stored in the probe if a new probe is being used with the system To save new data run a Probe Test record the values for each frequency and repeat by selecting Retest Check that the values from two sequential tests are within 0 5dB before selecting Save On selecting Save the screen title Overwrite Stored will be shown highlighted Select Yes to save the new data or No to keep the current stored values which may be blank for a newly registered probe Before entering Probe Test the user will be prompted to register the probe with the Otoport Select Back to exit the Probe Test screen and return to the Probe Menu screen QA test menu GA Tesks i TARTE ion J3 ReaL Ear Test EACK SELECT Cavity test Select Cavity Test to run a test in the test cavity Occlusion test Select Occlusion Test to check for sound leakage within the probe ear piece 104 CHAPTER TWELVE Probe 2 3 e 2 3 f 2 3 g 2 3 1 12 3 1 a 12 3 1 b Real ear test Select Real Ear Test to ensure th
99. uick on the Test menu screen an OAE test can be started directly bypassing Patient Details entry This option gives the user flexibility when testing conditions are variable On selecting Quick the device will enter the Checkfit screen Once a test has stopped select Save to access the Save Options menu screen Save options menu SAVE OPTIONS ame Hs Las J Records EACK SELECT Enter details Select Enter Details to add new Patient Details before saving the test 44 CHAPTER FIVE Test 5 6 1 5 6 1 d 5 6 1 e 5 6 1 5 6 1 9 Same as last Select Same As Last to save the test to the last saved patient A non editable view of the patient s details will be shown on screen to confirm the patient before the test is saved Enter the test details and Save the results Records To append the result to a patient record in the database select Records Please refer to chapter 4 Records for guidance Select Back to return to the Save Options 6 1 OTOPORT SCREENER 45 User Manual Records Records menu RECORDS 2 Work Lisk Summarcs 4 Erase all BACK SELECT Find Select Find to search for saved Patient Records within the database Work list Select Work List to edit or add a new patient to the Worklist The Worklist can be reviewed and a patient selected to test Summary Select Summary for information on the current records in the database Press Back to return to t
100. update of the Otoport firmware The existing product version is displayed at the top of the screen and it is possible to select the location of the firmware to upload Either type the filepath or select the Browse button using your mouse Select Update all Firmware Now to update the Otoport firmware A confirmation message will appear upon successful completion of the firmware update Important Note Only select Update all firmware now if it is necessary to re install or upgrade the Otoport firmware Your dealer or Otodynamics will provide you with the necessary files in order to do this DO NOT disconnect the Otoport during this process A confirmation message appears at the end stating the process has completed 18 3 5 u 18 3 5 v 18 3 5 w 18 3 5 x 18 3 5 y 18 3 5 z 18 3 5 aa 18 3 5 bb 18 3 5 cc 18 3 5 dd OTOPORT SCREENER 151 User Manual The Configuration area also allows various device identifiers to be read from the Otoport Select Read configuration from Otoport to download various device identifiers Device ID This field is provided so that a user defined description of the device can be read if desired Site ID This field is provided so that the site of use for the Otoport can be read if desired GSN The GSN is the unique machine ID which is programmed at the Otodynamics factory All data file names generated on the device start with the unique 3 character machine GSN The Configur
101. w to retrieve specific records from the database Once you have located the patient to print you have two options 1 Printing the patient details and all OAE results Initiate the print from the Patient Details screen o o aaee O FATIEHT DETAILS Ti Grab Famil Finc Firsk Dan O 12 ass 2007 BACK FRI WNT TEST OTOPORT SCREENER 87 User Manual io2ie 2 Printing patient details and individual QAE results 10 214 Initiate the print from the test summary screen or any of the test details screens To select a specific test to print scroll through the different tests for the patient using the Up and Down arrow keys on the test summary screen TEDE Pass TEORE 2d d Noise 5 0 24 09 05 06 50 TCR PRINT SELECT Test summary screen Test details screen 88 CHAPTER TEN Printing o Print menu Printe d SELECT 0 3 a From the Otoport Print menu it is possible to initiate prints for the last test or last patient as well as configuring print options 0 3 b Choose Select to enter the Print menu 0 3 c Last test 0 3 d This prints the last test recorded including the associated patient details ose Last patient 0 3 This option prints all the test results for the last patient including their patient details w4 Print options w41 Manual or automatic printing 10 4 1 a2 If you always wish to print OAE results it is possible to set the device to automatically print
102. ware The final stage of the installation is to install Otolink software Select Install Otolink from the CD menu Follow the on screen instructions to proceed with the installation Following the installation Otolink will automatically run A shortcut will also be placed on your PC desktop in case it is necessary to start Otolink manually Note If it is necessary to uninstall Otolink re start your PC following this process prior to reinstallation of the software 140 CHAPTER EIGHTEEN Using Otolink 18 Using Otolink 1 Opening Otolink 18 1 4 Otolink will automatically start each time your PC is started The software will run in low PC memory usage mode until an Otoport is detected 18 1 b An Otolink tray icon will be placed in your system tray on JA the bottom right of your PC screen o 0O 11 49 18 1 c Prior to connection switch off the Otoport 18 1 d Note It is possible to connect the Otoport to the PC when the Otoport is ON but it will not be possible to control the Otoport once the PC is connected OTOPORT SCREENER 141 User Manual 2 Connecting the Otoport 18 2 a Plug the Otoport into the PC using the PC cable provided 18 2 b The end with USB symbol fig 1 should be connected to a USB socket on the PC fig 2 Fig 1 Fig 2 18 2 c The Otoport connector fig 3 should be plugged into the bottom of the Otoport fig 4 with the arrows facing upwards Fig 4 142
103. ware Wizard This wizard helps you install software for Otodynamics OtoPort Chan4 E If your hardware came with an installation CD e SP o floppy disk insert it now What do you want the wizard to do O Install the software automatically Recommended Click Next to continue 17 3 4 If the driver is not found during the automatic search click Back and select Install from a specific location then Next OTOPORT SCREENER 135 User Manual Found New Hardware Wizard Please choose your search and installation options Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed Search removable media floppy CD ROM O Include this location in the search Es Don t search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware 173 1 Select Search removable media and click Next 173 14 Windows will search for the correct drivers Hardware Installation The software you are installing for this hardware e Otodynamics OtoPort Chand has not passed Windows Logo testing to verify its compatibility with Windows XP Tell me why this testing is important Continuing your installation of this software may impair or destabilize the correct operation of your s
104. ystem either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the hardware vendor for software that has passed Windows Logo testing Continue Anyway STOP Installation 17 3 1 When the drivers have been found Windows will prompt that the drivers have not passed Windows logo testing The drivers have been certified for use by Otodynamics engineers Select Continue Anyway 136 CHAPTER SEVENTEEN Installing PC software Found New Hardware Wizard Please wait while the wizard installs the software Otodynamics OtoPort Chan4 me im Setting a system restore point and backing up old files in case your system needs to be restored in the future 17 3 1 m Windows will then install the drivers Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for ad Otodynamics OtoPort Chan4 Click Finish to close the wizard 17 3 1 Once complete click Finish The driver installation for Otoport channel A is now complete and the same process is necessary for channel B 17 3 1 0 17 3 1 p 17 3 2 17 3 2 a 17 3 2 b OTOPORT SCREENER 137 User Manual Repeat the process for the channel B installation as described from paragraph 14 2 1 e onwards Once complete again click Finish The driver installation for the Otoport is now complete and the hardware is ready to communicate with the O

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