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otometrics MADSEN OTOflex 100, Reference Manual

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otometrics MADSEN OTOflex 100 Reference Manual Download Page 171

18

Standards and safety

This manual contains information and warnings, which must be followed to ensure the safe performance of the devices and
software covered by this manual. Local government rules and regulations, if applicable, should also be followed at all times.

See

Symbols used

►

171

and

Warning notes

►

173

.

18.1

Symbols used

MADSEN OTOflex 100 complies with the standards listed below.

18.1.1

MADSEN OTOflex 100 symbols

MADSEN OTOflex 100

Complies with Type BF requirements of EN60601-1.

See Technical Specifications, Standards in the OTOflex 100 Guide.

Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).

Complies with the Radio Equipment and Telecommunications Terminal Equipment Directive 1999/5/EC.

Electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment
(WEEE).

All electrical and electronic products, batteries, and accumulators must be taken to separate collection at
the end of their working life. This requirement applies in the European Union. Do not dispose of these
products as unsorted municipal waste.

You can return your device and accessories to Otometrics, or to any Otometrics supplier. You can also con-
tact your local authorities for advice on disposal.

Classified with respect to electrical shock, fire, mechanical and other specified hazards only in accordance
with UL 2601-1 and CAN/CSA-C22.2 NO 601.1-90.

In France, it is only permitted to use the device indoors.

This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions:

•

This device must not cause harmful interference.

•

This device must accept any interference received, including interference that may cause undesired
operation.

Refer to Notes 5 through 7 in the section Warning notes - 215 for more details.

The term”IC” before the certification/registration number signifies that the Industry Canada technical spe-
cifications were met.

Otometrics - MADSEN OTOflex 100

171

18 Standards and safety

Summary of Contents for MADSEN OTOflex 100

Page 1: ...MADSEN OTOflex 100 OTOsuite Immittance Module Reference Manual Doc No 7 50 0880 EN 22 Part No 7 50 08800 EN ...

Page 2: ...d Otometrics the Otometrics Icon AURICAL MADSEN ICS and HORTMANN are registered trademarks of GN Otometrics A S in the U S A and or other countries Version release date 2016 10 10 144154 Technical support Please contact your supplier Otometrics MADSEN OTOflex 100 2 ...

Page 3: ...installation 18 3 4 Powering 18 3 4 1 Powering MADSEN OTOflex 100 18 3 4 2 Powering the charger 19 3 4 3 Batteries 19 3 4 3 1 Inserting batteries 20 3 4 3 2 Battery type setting 21 3 4 3 3 First time charging 21 3 4 3 4 Charging status 22 3 4 3 5 Powering status 22 3 4 4 Switching MADSEN OTOflex 100 on and off 23 4 MADSEN OTOflex 100 main description 24 4 1 Switching MADSEN OTOflex 100 on and off ...

Page 4: ... 7 3 Preparing MADSEN OTOflex 100 47 7 3 1 Preparing the probe 47 7 3 2 Connecting probe and insert phone 48 7 3 3 Using the cap 48 7 3 3 1 Mounting the cap 48 7 3 3 2 Removing the cap 50 7 3 4 Daily probe check 51 7 3 5 Users 51 7 3 6 Selecting patient folder and test type in MADSEN OTOflex 100 52 7 3 7 Test flow setup 53 7 3 8 Selecting the test ear 53 7 4 Preparing the patient 54 7 4 1 Inspecti...

Page 5: ...TF P procedure 84 8 10 3 Viewing ETF P results 85 9 Managing Test Results in MADSEN OTOflex 100 86 9 1 When testing is done 86 9 2 Swap ear results 86 9 3 Deleting measurements 86 9 4 Deleting test results 86 9 5 Communicating and synchronizing with OTOsuite 87 9 5 1 Synchronizing data 87 10 Printing 89 10 1 Printing from MADSEN OTOflex 100 89 11 Testing with the OTOsuite Immittance module 90 11 1...

Page 6: ...st settings in MADSEN OTOflex 100 120 13 1 Test setups 120 13 1 1 Changing individual settings 120 13 1 2 Uploading test settings to the Immittance module 122 13 1 3 Creating a setup 122 13 1 4 Editing a test setup 123 13 1 5 Using a test setup 123 13 2 General actions 124 13 2 1 Test result management settings 124 13 2 2 Procedure options 126 13 2 3 Advanced 128 13 2 4 Device settings 129 13 3 Ty...

Page 7: ...nt failure 161 15 2 Service and repair 161 15 3 Maintenance 162 15 3 1 Calibration 162 15 3 2 Probe cleaning and maintenance 162 15 4 Cleaning and disinfecting the probe tip 163 15 4 1 Cleaning and disinfecting the probe tip 164 15 4 2 Changing the wax filter 165 15 5 Cleaning MADSEN OTOflex 100 166 15 5 1 Eartips 166 15 5 2 Disposable articles 167 15 5 3 Batteries and charger 167 15 5 4 Battery s...

Page 8: ...4 App 1 2 5 Toynbee s Maneuver 184 App 1 3 Acoustic Reflex testing 185 App 1 3 1 Acoustic Reflex Screening 185 App 1 3 2 Acoustic Reflex Threshold 186 App 1 3 3 Acoustic Reflex Decay 186 App 1 3 4 Admittance monitoring 186 App 1 4 ETF P Eustachian Tube Function Perforated 186 App 1 5 Susceptance and Conductance B G 187 App 1 5 1 Susceptance B 187 App 1 5 2 Conductance G 188 App 1 5 3 B G viewing o...

Page 9: ...ts patients launching hearing test applications and fitting soft ware and storing audiological test results MADSEN OTOflex 100 test results can be stored in the NOAH database via OTO suite 1 2 The OTOsuite Immittance module The OTOsuite Immittance module offers real time presentation of test results and full test control of MADSEN OTOflex 100 directly from a PC Test devices with integrated user in...

Page 10: ...coustic reflex measurements measure the mechanical response of the middle ear and form a basis for evaluating whether the related physiological structures are functioning correctly or not The MADSEN OTOflex 100 probe is extremely lightweight only 4 5 grams and comes with comfortable easy to insert ear tips This makes it ideal for use with children and adults MADSEN OTOflex 100 can be configured fo...

Page 11: ... Configuring the Immittance module 168 Basic OTOsuite functions The basic OTOsuite functions are described in the OTOsuite User Guide 1 5 Typographical conventions The use of Warning Caution and Note To draw your attention to information regarding safe and appropriate use of the device or software the manual uses pre cautionary statements as follows Warning Indicates that there is a risk of death ...

Page 12: ... service the original packing material will protect against damage dur ing transport etc 2 Visually inspect the equipment for possible damage If damage has occurred do not put the device into operation Contact your local distributor for assistance 3 Check with the packing list to make sure that you have received all necessary parts and accessories If your package is incomplete contact your local d...

Page 13: ...s of MADSEN OTOflex 100 and its charger from various angles as well as instructions on how to assemble the charger Front view 13 Top view 14 Bottom view 14 Reverse side view 14 The charger 15 Desktop installation 17 You will find a description of the keypad and how to navigate and enter data in MADSEN OTOflex 100 in Controls and menu selections 28 3 1 1 Front view A Probe B Probe plug C Screen D K...

Page 14: ...l socket B Pneumatic connection C Probe socket 3 1 3 Bottom view A Battery casing with cover B Charger cavity 3 1 4 Reverse side view A Track for probe cable B Labels 14 Otometrics MADSEN OTOflex 100 3 Installing MADSEN OTOflex 100 ...

Page 15: ... 1 5 The charger Front view A Charger tab for charging the device B Charging indicator C Probe test cavity D Base Rear view A Power socket Otometrics MADSEN OTOflex 100 15 3 Installing MADSEN OTOflex 100 ...

Page 16: ...ary To ensure safe performance you must make sure that MADSEN OTOflex 100 is correctly installed and that the require ments listed in Standards and safety 171 are complied with MADSEN OTOflex 100 can be used as a hand held device with no specific requirements to location However keep MADSEN OTOflex 100 away from all liquids and sources of heat for detailed specifications see Technical specificatio...

Page 17: ...ey to screw the hexagonal screws into place 2 Tighten the screws well so that the charger is stable when you place MADSEN OTOflex 100 in the char ger A Charger body B Charger base C Hexagonal screws D Hexagonal key A Base B Hexagonal key Otometrics MADSEN OTOflex 100 17 3 Installing MADSEN OTOflex 100 ...

Page 18: ...ckplates of the wall mount A 2 screws B 2 washers C 2 rawl plugs D washer E wall mount backplate F plastic shelf 3 4 Powering 3 4 1 Powering MADSEN OTOflex 100 MADSEN OTOflex 100 MADSEN OTOflex 100 is powered by batteries Caution Use only the battery types listed in Technical specifications 176 18 Otometrics MADSEN OTOflex 100 3 Installing MADSEN OTOflex 100 ...

Page 19: ... power outlet The device is delivered preset for rechargeable NiMH batteries 3 When you are not using the device leave it in the charger so that it is always ready for testing Warning If you use the device with Alkaline batteries always switch off the mains power supply to the charger Failure to do so may cause the Alkaline batteries to leak and cause damage to the device A Power socket 3 4 3 Batt...

Page 20: ... charger Failure to do so may cause the Alkaline batteries to leak and cause damage to the device When you are using Alkaline batteries the battery icon in the top right corner of the screen will show the status of the Alkaline batteries even if you place the device in the charger 3 4 3 1 Inserting batteries Caution Use only the battery types listed in Technical specifications 176 Inserting batter...

Page 21: ...to do so may cause the Alkaline batteries to leak and cause damage to the device 1 If you are in doubt of the setting or if you are using Alkaline batteries check the battery type and the setting in the device When MADSEN OTOflex 100 is ready for use switch it on Press and hold the On Off key on the keypad 2 Press Select to access the Menu followed by Advanced Device Settings and scroll to Battery...

Page 22: ... ger or the device is turned on Amber steady The device is charging Charging is discontinued automatically based on a timer to ensure that batteries are not over charged Amber flashing The charger is faulty Contact your supplier Device status Powered by charger When the device is charging a small power plug icon is shown in the top right corner of the screen Powered by batteries only When the devi...

Page 23: ...ng capacity of the batteries in the top right corner of the screen 3 4 4 Switching MADSEN OTOflex 100 on and off Switching on Press and hold the On Off key on the keypad until the start up screen appears approximately 2 3 seconds Switching off Press and hold the On Off key on the keypad until the message Power Off appears Otometrics MADSEN OTOflex 100 23 3 Installing MADSEN OTOflex 100 ...

Page 24: ...e Power Off appears When you have installed MADSEN OTOflex 100 there are a number of settings you can customize for your use See Device settings 129 Check the specific device settings If needed adjust the altitude setting Set up the user s who will be using MADSEN OTOflex 100 See Users 51 Check the default test settings to acquaint yourself with the various settings See Test setups 120 If needed c...

Page 25: ...ur choice and press Select 9 Press the softkey Return to test screen to go to the Tympanometry test screen 4 3 Keypad main functions You can access most of the functions in MADSEN OTOflex 100 from the menu or by pressing one or more keys and softkeys A Left softkey B On Off Press hold Press hold to switch on off Press to toggle between test modes C Select key Select highlighted item Toggle value s...

Page 26: ... bottom of the screen just above each softkey During testing Pressure release Press for immediate release of air pressure and stop pause of measurement Between measurements Ear selection Press to toggle the ear selection associated with the current measurement On Off Press and hold 3 5 seconds to turn the device on or off Toggle test type Press to toggle between test types Left softkey Right softk...

Page 27: ... L Left R Right B Patient C Menu and settings D Tympanometric curve selector E Selected test setting F Selected test G Connection indicator H Power indicator I Selected test sequence J Start measurement test sequence Icons R L Ear selection the ear selection icon shows the ear selected for testing Connection indicator Bluetooth communication disabled in menu Connection indicator Bluetooth communic...

Page 28: ...fic test sections 4 5 1 The MADSEN OTOflex 100 Menu 1 Scroll to the Menu icon From the menu you can access most functions available in MADSEN OTOflex 100 2 Press Select to access the menu From the menu you can access most functions available in MADSEN OTOflex 100 When you navigate the menu the following functions are available A Left softkey Return to previous menu B Scroll bar Use the scroll whee...

Page 29: ...s Del ete Sub test Del ete Current Test Del ete Patient Del ete All Printed Patients Del ete all Patients General settings Procedure options Sequence Sequence testing 60 Auto start on seal Auto resume on seal Auto free memory First ear to test 226 Hz tymp unit 226 Hz deflection unit Reflex adjustment Intensity safety see Procedure options 126 Done prompt see Preparing for testing 47 Print when don...

Page 30: ...asiest way to change from one test to another is to briefly press the On Off button In Test Selector mode you can scroll through each of the displays for the individual tests types For tympanometry this includes a Tymp Data screen with additional results In Test Selector mode no screen items can be selected and no deflection curves are displayed 1 Press and hold the Select key to see the double ar...

Page 31: ...ing to the icon shown Tymp curve select or enter menu Press and hold to display patient and user info Right Press to carry out the function according to the icon shown typically starts stops pauses or continues a test Print is always available in this mode Icons Menu and settings icon Press Select to access when highlighted Test selector or Text editor Use scroll wheel to change test in test selec...

Page 32: ...ntil you have entered the data 5 Press OK to confirm 6 Turn the Scroll Wheel to go to the next field and press Select to access the field 7 If you need to move the cursor to insert or delete letters digits in the data field see below for editing entered data Editing data You can edit data in the Patient User screen You can edit data in the Patient User screen Keypad Function Left softkey DEL Delet...

Page 33: ...gle the value in the settings field Settings with several value options Press Select to access the settings field and use the Scroll Wheel to scroll to the desired setting 4 5 4 The Tympanometric Curve Selector With the Curve Selector you can switch between the different tympanometric curve views The data shown in the test screen or in the Tymp Data screen relates to the curve in focus Press the s...

Page 34: ...ive ETF P Pressure build up negative ETF P Return to previous menu Return to test screen Start semi automatic testing Start automatic testing Stimulus Stop testing 4 6 2 Powering Battery status Empty Good Normal Powered by charger 34 Otometrics MADSEN OTOflex 100 4 MADSEN OTOflex 100 main description ...

Page 35: ... MADSEN OTOflex 100 connected to OTOsuite MADSEN OTOflex 100 disconnected from OTOsuite Printer 4 6 4 Messages error message info message warning_message 4 6 5 Leakage Probe leak status Blocked Leak Not inserted OK Otometrics MADSEN OTOflex 100 35 4 MADSEN OTOflex 100 main description ...

Page 36: ...enus and toolbar icons General icons See the OTOsuite User Guide Immittance module toolbar The icons available in the toolbar depend on the test function that you have selected General Immittance icons Get Test Results from Device Ctrl G Opens the dialog box for uploading patient folders from the test device Select device Opens the dialog box for selecting a specific test device See Connecting a t...

Page 37: ...st See Deleting data 114 Measurement menu Menu item Icon Shortcut Description Get Test Results from Device Ctrl G Get Test Results Opens the dialog box for uploading patient folders from the test device See Uploading test results to OTOsuite 119 Tools menu Menu item Icon Shortcut Description Select and Manage Test Devices F9 See description in Uploading test results to OTOsuite 119 5 2 The control...

Page 38: ...efault test settings select from the drop down menus and click to enable disable radio buttons or check boxes See also General settings 145 5 2 1 Sequence selection You can perform the immittance tests in sequences In the Sequence field in the Control Panel click the drop down list to select Test sequences are described in detail in Sequence testing 90 5 2 2 Test control buttons Test control butto...

Page 39: ...ram Auto Scale Click to select deselect autoscaling of a tympanogram in order to display the entire curve When you change the ear or the patient the scale will revert to the default scale When no data is available the scale selected will be used Note Autoscaling adjusts viewing dynamically according to the highest of all currently displayed curves so that you can visually compare ear results Viewi...

Page 40: ...m panometry screen Any stimulus types that are not tested during a Reflex Thresholds test will remain in the Reflex Screening results table Note If you try to do a Reflex Screening for fields where threshold values are available you will be prompted to decide whether to proceed Check the Reflex Threshold screen to decide whether to overwrite existing results Reflex screening results The deflection...

Page 41: ...ighlighted in the table As you click the individual fields in the table the values listed in the title field will be updated to reflect the field cur rently selected If subsequently a Reflex Threshold test is made the table becomes a Reflex Threshold results table now titled Thresholds db HL scr hidden The screening values will be removed from the Reflex Threshold table and can only be found in th...

Page 42: ...lts table If the deflection decreases to 50 or more of the initial deflection during presentation of the stimulus the point in time when this occurs is shown If no decay is registered the field shows a dash The Ipsi results are shown in the top row The stimulus ear referenced contra lateral results appear in the bottom row Tympanogram In the top right corner of the screen the most recent tympanogr...

Page 43: ...phs manually if needed 1 Click the line closest to the pressure value to be adjusted 2 Click and hold the left mouse button on the line to move it to the desired position The corresponding values in the ETF P table at the bottom of the screen change accordingly Note You can only adjust the line within the range determined by the adjacent lines This is because the lines are linked to their individu...

Page 44: ...MADSEN OTOflex 100 must be turned on and not connected to another PC 2 Click the Select Device icon or select Tools Select and Manage Test Devices 3 Click the Search button if the device you want to connect to is not listed Searching for devices may take a couple of minutes All test devices visible within the Bluetooth range will be added to the list 4 Highlight the test device and click Select to...

Page 45: ...at MADSEN OTOflex 100 and OTOsuite perform correctly Upgrading of the firmware will leave your device settings unchanged The new firmware may take up slightly more MADSEN OTOflex 100 memory than the previous version If the memory is full of patient results the upgrade process will automatically erase some of the oldest patient results from the MADSEN OTOflex 100 memory if needed results that have ...

Page 46: ...ck Upgrade to upgrade the MADSEN OTOflex 100 firmware 8 Wait Do not interrupt the upgrade in any way 9 Turn MADSEN OTOflex 100 off and back on 10 When you have restarted MADSEN OTOflex 100 click OK 11 Check that there is No newer kernel for upgrade Click OK to finish the MADSEN OTOflex 100 firmware upgrade 46 Otometrics MADSEN OTOflex 100 6 Communication between OTOsuite and MADSEN OTOflex 100 ...

Page 47: ...is minimal ensuring that hygienic precautions are taken to protect the patient from cross infection and setting up equipment such as speakers test device and computers Immittance tests require no specific test environment with regard to noise but the test environment should in some cases be adapted to suit the specific test types 7 2 Hygienic precautions Be sure to follow any established infection...

Page 48: ...plug are equipped with a locking mechanism Therefore when you disconnect the probe do not pull the plug by the cable Grip the probe by the sleeve of the plug and free it by gently pulling it away from the device The probe will not be released if you pull anywhere else than by the sleeve of the plug Note The probe forks on the charger base plate or on the wall mounting provide a practical place to ...

Page 49: ... the cap on MADSEN OTOflex 100 Place the two small projections located on the rear side of the cap in the groove on the top front edge of MADSEN OTOflex 100 A Recesses 3 Snap the wings into place by pressing them downwards into the two recesses in the top rear edge Otometrics MADSEN OTOflex 100 49 7 Preparing for testing ...

Page 50: ...the probe with the short cable you can place the cable in the cable track on the back of MADSEN OTOflex 100 to avoid cables getting tangled 7 3 3 2 Removing the cap 1 Remove the probe from the cap 2 Remove the cap from MADSEN OTOflex 100 To do so press the wings of the cap gently towards each other and ease the cap out of its groove 50 Otometrics MADSEN OTOflex 100 7 Preparing for testing ...

Page 51: ...s a probe error In case of a probe error check the following Make sure that the threaded ring holding the probe tip in place is firmly tightened Make sure that the sound channels in the probe tip are clear and that the probe is connected Make sure that the probe tip goes into the cavity at a 90 angle If the probe is faulty contact an authorized service department for repair 7 3 5 Users If several ...

Page 52: ... patient if needed MADSEN OTOflex 100 with NOAH If you are using MADSEN OTOflex 100 with the Immittance module and NOAH and you have created a new Patient the patient s name is downloaded from NOAH to MADSEN OTOflex 100 To learn more about the communication between MADSEN OTOflex 100 OTOsuite and NOAH see Data man agement in MADSEN OTOflex 100 118 MADSEN OTOflex 100 as stand alone test device If y...

Page 53: ...data and continuing with the next patient Select Menu Procedure options Set the following settings to On if needed Setting What happens if On is enabled Done prompt The Done prompt will appear when you have performed the same number of tests on both ears of the patient Print when done The results will be printed if you press Yes in response to the prompt When printing is done the Done prompt reapp...

Page 54: ...ous types of eartips depending on the type of test you wish to do Screening eartips Regular eartips Infant eartips Warning Choking hazard Do not leave eartips unsupervised within the reach of children Note Accurate testing is only guaranteed if you use the eartips approved specifically for MADSEN OTOflex 100 by Otometrics Note Check the sound channels in the probe tip every time you have used the ...

Page 55: ...inna and try again Gently mas saging the area may help opening the ear canal 1 Fit the eartip on the probe 2 To stabilize the probe and to avoid blocking the probe against the ear canal of the patient grasp the pinna and gently pull the pinna back and slightly away from the patient s head For adults pull the pinna upwards and back For infants and children pull the pinna downwards and back 3 Insert...

Page 56: ...n MADSEN OTOflex 100 Probe problems can be caused by an occluded probe a blocked wax filter Probe status icons MADSEN OTOflex 100 OTOsuite Description The probe is OK The probe is blocked There is a probe leak The probe is not fully inserted 7 5 Preparing for the next patient When you have finished testing a patient and wish to test a new patient 1 For the sake of patient privacy when you receive ...

Page 57: ...to start testing 1 When you switch on MADSEN OTOflex 100 you are first presented with the Patient User screen 2 Use the Text Editor to enter patient information The Text Editor 31 3 When you have entered patient information press or OK to go to the Load Settings screen if enabled in Menu Procedure options Settings prompt or the test screen with MADSEN OTOflex 100 in test mode 4 If needed press the...

Page 58: ...the MADSEN OTOflex 100 probe 5 Press the right softkey for 1 second to start the sequence automatic or manual 6 Press the Ear Selector key to switch ear 7 Insert first the contralateral insert phone and then the MADSEN OTOflex 100 probe 8 Press the right softkey for 1 second to start the sequence automatic or manual 9 Press the right softkey under Yes to confirm that testing is done if the device ...

Page 59: ...when you view data Pressure release during testing If the patient is troubled during testing press this key to stop the test Select a menu item Selects an item from the menu Activates the scroll function Toggles between test screens and menu screens see Test Selector mode 30 Enter the menu Activates the menu from the Tymp or ETF screens Scroll to move between choices and then press this key to sel...

Page 60: ...croll to increase or decrease a selected value 8 3 Sequence testing A test sequence is a predefined set of automatic tests which can be performed automatically MADSEN OTOflex 100 will always perform the most recently selected sequence regardless of whether it has been selec ted in the OTOsuite Immittance module or in MADSEN OTOflex 100 If the sequence selection is set to Off in the device and a se...

Page 61: ... for instance by pressing the Pressure Release key on MADSEN OTOflex 100 Resuming a sequence If Menu Procedure options Auto resume on seal is On and a leak is detected or the probe is removed from the patient s ear the sequence pauses automatically The sequence will automatically resume from the pause state when seal has been reestablished The sequence continues from where it was paused An interru...

Page 62: ...ympanometry testing and continues automatically to reflex screening if Reflex Screening is selected Prepare MADSEN OTOflex 100 to start measuring as soon as seal is achieved 1 Do as described in Preparing for testing 47 2 Load a test setting configured for screening patients in the relevant age group See recommended settings below 3 If needed toggle the Ear Selector to select the ear on which you ...

Page 63: ...al Menu Procedure options On Auto resume on seal Menu Procedure options This function is ideal for speeding up the test procedure On Stop when results are available Menu More settings The measurement stops automatically when satisfactory values have been registered On 8 4 2 Reflex screening A Press to start the test if Auto start on seal is set to Off If you use screening eartips it is recommended...

Page 64: ...reening only Without applying the eartip to the patient s ear press to start the test 4 Apply the probe to the patient s ear with a steady grip This will prevent probe movements from resulting in leakage or changes in admittance The test starts automatically as soon as a good probe fit with an airtight seal is achieved Warning If the patient is troubled by the test stop the test The test is interr...

Page 65: ...t is recommended that you set the max intensity to 95 dB HL 95 dB HL No of intensities Menu More settings 1 intensity Check marks or dashes indicate whether a reflex has been detected or not 2 or 3 intensities Numerical values or crossed out numerical values indicate whether a reflex has been detected or not Intensity increment Menu More settings Step in dB between each stimulus intensity presente...

Page 66: ...s The deflection curves of the tested intensities are displayed in the graphs for the highlighted stimulus Individual results for stimulus intensity and admittance change are listed below each graph Check marks or dashes indicate whether a reflex has been detected or not This applies when the measurement setting Menu More settings No of intensities is set to 1 Numerical values or crossed out numer...

Page 67: ...suit your purposes Preparing for testing 1 Do as described in Preparing for testing 47 2 If contralateral stimulation is used in the test make sure that both the ipsilateral probe and the contralateral phone are in place before you start the measurement 3 Ask the patient to sit very still and quiet during the test without moving head or jaw 4 If needed toggle the Ear Selector to select the ear on ...

Page 68: ...t Flashing Press to continue The test resumes at the intensity it came to or was interrupted in Stopping the test Press to stop test 2 To make a new sweep press Start You can save up to 3 separate measurements for each ear 3 When you have finished testing one ear switch ears if needed 4 To continue testing press Start and test the other ear 5 To view tympanometry results see The diagnostic tympano...

Page 69: ...tor 33 to select a specific curve for viewing The results for the highlighted curve are displayed To return to the standard Tymp view press again The Tymp Data screen 1 If needed press On Off briefly to select the Tymp Data screen The results shown in the Tymp Data screen reflect the curve cur rently selected in the Tymp test screen The following features are described in detail in Tympanometric f...

Page 70: ...ust the settings to suit your purposes Setting Menu More settings Auto next curve The tympanometry graph shows a maximum of 3 curves per ear per patient Default On On The curve number is advanced automatically before the tympanogram is recorded except if the current curve memory is empty If you continue measuring the curve number is cyclically increased and older tympanograms are overwritten Off Y...

Page 71: ...re the tympanogram is recorded except if the current curve memory is empty If you continue measuring the curve number is cyclically increased and older tympanograms are overwritten Off You must manually toggle the Curve selector to the next curve number to preserve a previously recorded tympanogram Menu Layered curves When viewing ETF I results this view setting is useful when set to On 8 7 Acoust...

Page 72: ... testing is paused You are then prompted to decide whether to continue or to move on to the next stimulus type Warning The sound pressure level in the ear canal increases when you test patients with small ear canals Always comply with local practice and recommendations for presenting loud stimuli Measurements saved MADSEN OTOflex 100 automatically keeps the last 3 deflection curves measured When s...

Page 73: ... auto test see below Press and hold to start sequence Scroll wheel Select stimulus type and side moves between preset settings only Allows the user to skip the rest of the intensities for current stimulus type in pause mode Select If stimulus types I psi or C ontra are in focus press to activate manual mode If the Menu icon is in focus press to access the menu Automatic and semi automatic softkey ...

Page 74: ...ect the Reflex Threshold test screen The initial reflex threshold test screen is shown with ipsilateral 1 kHz stim ulus highlighted The dashed horizontal line in each reflex graph indicates the predefined reflex criterion It is offset from the base line marker on the vertical axis The degree of offset is influenced by the setting in Menu More settings Reflex criterion Warning If the patient is tro...

Page 75: ...ciate the threhold Adjust the intensitiy and press the right hand softkey to present the stimulus Continue until you register the reflex threshold or until the max intensity is reached The measurement stops automatically at the end of each stimulus presentation To test another level use the scroll wheel to scroll to the next stimulus level and press the right hand softkey to present the stimulus U...

Page 76: ...ls are used in the audiogram Pure tone air unmasked masked Pure tone bone unmasked masked Ipsi Thr found not found Contra Thr found not found Stim x 8 8 3 Viewing Reflex Threshold results This Reflex Threshold test result example shows the three deflection curves for the highlighted 1 kHz ipsilateral stimulus Manually changed thresholds are marked with an asterisk The dashed horizontal line in eac...

Page 77: ...and semi automatic testing The following settings are useful Menu selection Setting Menu Procedure options Auto resume on seal Off If there is a probe leak the test is interrupted You must resume testing manually if testing is paused due to a leak On Testing resumes automatically when a proper seal is obtained if testing was paused due to a leak Menu Custom TPP offset On The pressure is offset fro...

Page 78: ...ped If no reflex threshold is available the stimulus level is Off This is useful for admittance monitoring For a maximum amount of monitoring time set the Menu More settings Stim time setting to 26 seconds The res ulting curve can be saved as an ordinary decay graph Note There may be a warning that the stimulus level is in the extended intensity range Reflex decay may not be possible due to highly...

Page 79: ... icon is in focus press to access the menu Automatic mode functions Softkeys Functions Left Stop stimulus and return to idle mode Press and hold to display patient and user info Right Steady Press to pause test Flashing Press to continue Manual mode functions Softkeys Functions Left Press and hold to display patient and user info Right Start stimulus If the safety intensity level is greater than t...

Page 80: ...s relieved immediately Already meas ured results are kept Automatic RT testing Press the right hand softkey to start a fully automatic reflex decay measurement for all pre set stimuli Manual RD testing Press the right hand softkey If needed repeat testing of more stimulus levels Scroll to the needed stimulus type and press Select to activate manual test mode Scroll to select the stimulus level for...

Page 81: ...en you have finished testing one ear switch ears if needed 5 To continue testing click press Start and test the other ear The test progresses as follows Deflection graph The deflection graph is limited by blue markers indicating stimulus on and off A third marker appears as indication of the half life time where the curve decreases to 50 of its initial deflection Half life time seconds Results tab...

Page 82: ...lts When the measurement is completed the result fields show the detected half life time for each stimulus Changing view settings You can change the following view settings to customize your view None of these settings influence the test data as such Menu More settings Deflection scale Menu More settings Show 500 Hz Show 1000 Hz 8 9 4 Settings Reflex Decay Setting Value Toolbar icon Auto resume on...

Page 83: ...ied in the Acoustic Reflex Decay test setting to ensure consistent reflex testing but not vice versa Verification Tools Options Reflex Threshold Depending on your settings you can select the type of verification to be used after the deflection criterion has been met by the auto matic threshold search The lowest stimulus intensity where the reflex criterion was met may be retested for reproduceabil...

Page 84: ...ached Left Stop and go to idle mode Press and hold to display patient and user info Scroll wheel Optional method Turn the scroll wheel clockwise positive or counter clockwise negative to manually control the pump instead of using the pressure control softkeys The manual pressure control works in accordance with the current softkey symbol 8 10 2 ETF P procedure A Scroll wheel Manual pressure build ...

Page 85: ...ally expands by 10 second steps to a maximum of 60 seconds 8 10 3 Viewing ETF P results The ETF P test screen in MADSEN OTOflex 100 provides a simple view for quickly assessing the Eustachian tube function For more extensive analysis use the ETF P screen post analysis tool OTOsuite Immittance module to retrieve the numer ical pressure values This ETF P test result example shows how the pressure ch...

Page 86: ... or graph numbers in this icon group if you want to view a specific curve or graph The curve will be highlighted 2 To delete a curve select Menu Manage Test Results Del ete Sub test Reflex Threshold In Reflex Threshold you cannot delete a single curve only a complete test including all the stimulus intensities for the selected stimulus type 9 4 Deleting test results Deleting current test To delete...

Page 87: ... transferred to OTOsuite during synchronization Other Patient Folders made while MADSEN OTOflex 100 was off line must be transferred manu ally Synchronization takes just a few seconds and is usually initiated automatically when MADSEN OTOflex 100 connects to OTOsuite Select from the dialog box shown Each test is identified by a time stamp patient name gender date of birth the type of test done on ...

Page 88: ... recent change regardless of whether it was made in MADSEN OTOflex 100 or in the Immittance module will be applied or synchronized 88 Otometrics MADSEN OTOflex 100 9 Managing Test Results in MADSEN OTOflex 100 ...

Page 89: ...in MADSEN OTOflex 100 To print from MADSEN OTOflex 100 you must first select a Bluetooth printer 1 Select Menu Printers 2 Press Select to search your Bluetooth Neighborhood 3 Scroll to the desired printer in the list and press Add 4 If needed use the Text Editor The Text Editor 31 to enter a name of your choice Printing from MADSEN OTOflex 100 Printing from MADSEN OTOflex 100 can be done in two wa...

Page 90: ... Reflex Screening T RT Tympanometry Reflex Threshold T RT RD Tympanometry Reflex Threshold Reflex Decay Off MADSEN OTOflex 100 The press and hold function is disabled and only the currently selected measurement type will be performed 11 1 2 Running a test sequence Starting a sequence 1 Connect to MADSEN OTOflex 100 2 Select the desired sequence from the drop down list below the Immittance module C...

Page 91: ...if you need to repeat the tympanometric measurement If Tools Options General Auto resume on seal is Off The probe must remain in place throughout the sequence If the probe is removed the test will restart with Tym panometry testing when testing is resumed 11 2 Screening You can perform Tympanometry Reflex Screening T RS as a sequence from the Tympanometry test screen Note The safety intensity leve...

Page 92: ...ADSEN OTOflex 100 to start measuring as soon as seal is achieved do the following 2 Load a test setting configured for screening patients in the relevant age group See recommended settings below 3 If needed toggle the Ear Selector to select the ear on which you wish to start the test Screening tympanometry Without applying the eartip to the patient s ear click Start in the Tympanometry section of ...

Page 93: ...st starts automatically as soon as a good probe fit with an airtight seal is achieved Regardless of the setting in Tools Options Tymp and Reflex Scr Auto next curve the test automatically changes to the next tymp curve for each tymp sweep This is to prevent overwriting already recorded tymps if a tymp measurement is triggered by accident Sequence Auto resume on seal Tools Options General This func...

Page 94: ...screening 1 In order to prepare MADSEN OTOflex 100 to start measuring as soon as seal is achieved do the following 2 Prepare the patient for testing See Preparing for testing 47 3 Load a test setting configured for screening patients in the relevant age group See recommended settings below Note The safety intensity level cannot be exceeded in screening mode 4 If needed toggle the Ear Selector to s...

Page 95: ...at the intensity it came to or was interrupted in Stopping the test Press to stop test Recommended settings Reflex screening Setting Value Toolbar icon Pump speed Control Panel AFAP As Fast As Possible Auto start on seal Tools Options General If set to Sequence The test starts automatically as soon as a good probe fit with an airtight seal is achieved Sequence Auto resume on seal Menu Procedure op...

Page 96: ...he results from this test will replace the screening values shown in this view The deflection curves of the tested intensities are displayed in the graphs for the highlighted stimulus Individual results for stimulus intensity and admittance change are listed below each graph Check marks or dashes indicate whether a reflex has been detected or not This applies when the measurement setting No of int...

Page 97: ... and quiet during the test without moving head or jaw 4 If needed toggle the Ear Selector to select the ear on which you wish to start the test Procedure 1 Select the Tympanometry test screen If you are using OTOsuite In the Tympanometry screen click Start on the Control Panel Warning If the patient is troubled by the test stop the test The test is interrupted and the pump pressure is relieved imm...

Page 98: ...tympanometry result 68 6 When you have finished testing see When testing is done 86 Recommended settings Diagnostic tympanometry Setting Value Toolbar icon Auto next curve Tools Options Tymp and Reflex Scr The test starts automatically as soon as a good probe fit with an airtight seal is achieved Regardless of the setting in Tools Options Tymp and Reflex Scr Auto next curve the test automatically ...

Page 99: ...weep from a positive value to a negative value or vice versa Default Negative 11 3 3 The diagnostic tympanometry result Auto Scale tympanogram Click to select deselect autoscaling of a tympanogram in order to display the entire curve When you change the ear or the patient the scale will revert to the default scale Curve selector Show Previous Curves Show Next Curves Toggles between specific curves...

Page 100: ... and maneuvers in a sequence of test ing to fully evaluate the functioning of the Eustachian tube 11 4 1 Settings ETF I Recommended settings ETF I Setting Menu More settings Auto next curve The tympanometry graph shows a maximum of 3 curves per ear per patient On The curve number is advanced automatically before the tympanogram is recorded except if the current curve memory is empty If you continu...

Page 101: ...tic settings are set according to your needs These settings are found in the Automatic section in the Tools Options Reflex Threshold Reflex Decay Stimulus types dialogs High intensity levels Note To avoid automatic testing being interrupted because of high stimulus intensity levels when reaching the warning limits it is recommended that you set the max intensity to 95 dB HL When testing the stimul...

Page 102: ...est make sure that both the ipsilateral probe and the contralateral phone are in place before you start the measurement 4 If needed toggle the Ear Selector to select the ear on which you wish to start the test During testing Warning If the patient is troubled by the test stop the test The test is interrupted and the pump pressure is relieved immediately Already measured results are kept or 11 6 1 ...

Page 103: ... Warning If the patient is troubled by the test stop the test The test is interrupted and the pump pressure is relieved immediately Already measured results are kept or Reflex Threshold automatically follows the tympanometry sweep if you start the T RT sequence see Sequence test ing 90 Automatic RT testing 1 Click Start in the Auto section of the Control Panel to start a fully automatic reflex thr...

Page 104: ...on of the Control Panel to present a single stimulus intensity 3 To manually determine a threshold click on the drop down box of the specific field in the Thresholds table and select the stimulus intensity to be reported as the threshold value Note The audiogram symbol for Not found will remain until a threshold is determ ined manually If a measurement consists of more than 3 intensities toggle th...

Page 105: ...shold is found immediately The test will automatically decrease the stimulus intensities until a threshold is no longer registered Deflection curves The deflection curves result in a complete reflex deflection graph The curves shown are sorted according to increased stimulus intensity Thresholds table Shows the determined threshold If no threshold is detected the field in the Thresholds table will...

Page 106: ... can always highlight a graph which will then be overwritten when you make a new meas urement The three curves showing reflex responses with the highest intensity where the threshold value has been detected are stored automatically by the system If you repeat a measurement at a specific intensity the previous measurement for that intensity will be over written You cannot see several curves with th...

Page 107: ...ng manually if testing is paused due to a leak On Testing resumes automatically when a proper seal is obtained if test ing was paused due to a leak Custom TPP offset Control Panel Checked The pressure is offset from the TPP by the TPP offset defined in Tools Options Reflex Threshold General Custom TPP offset If the offset is is set to a value with the post fix more it shifts the pressure in the sa...

Page 108: ...at is chosen for reflex decay testing The decay test stimulus level will then automatically be set to the threshold level 10 dB If the reflex has not been determined the decay measurement will be skipped If no reflex threshold is available the Control Panel Intensity setting is Off This is useful for admittance monitoring For a maximum amount of monitoring time set the Tools Options Reflex Decay S...

Page 109: ...ved immediately Already measured results are kept or 11 7 1 Reflex Decay procedure Procedure 1 Press PageDown to go to the Reflex Decay test screen or select the test from View Immittance Warning If the patient is troubled by the test stop the test The test is interrupted and the pump pressure is relieved immediately Already measured results are kept or Automatic RD testing 1 Click Start in the Au...

Page 110: ...s Options View If needed adjust this view setting 2 In the Reflex Decay screen click Start on the Control Panel 3 If needed repeat testing of more stimulus levels Pausing the test 1 To interrupt the test click press Pause 2 To resume the test click press Pause again After the pause the test resumes at the intensity it came to or was interrupted in Continuing the test 1 When you have finished testi...

Page 111: ...d testing one ear switch ears if needed 2 To continue testing click press Start and test the other ear 11 7 2 Viewing Reflex Decay results Measurements saved Since a reflex decay measurement typically is made using either ipsilateral or contralateral stimulus side not both only two measurements are saved i e different stimuli and or ipsi contra To view the graphs click the desired field in the Hal...

Page 112: ...eflex Decay test setting to ensure consistent reflex testing but not vice versa Verification Tools Options Reflex Threshold Depending on your settings you can select the type of verification to be used after the deflection criterion has been met by the auto matic threshold search The lowest stimulus intensity where the reflex criterion was met may be retested for reproduceability or the next one o...

Page 113: ...a lower initial time value which will then be shown on the horizontal axis If the initial time scale value is exceeded during the measurement the axis automatically expands by 10 second steps to a maximum of 60 seconds Select Tools Options ETF P Time axis Scale sec The ETF P result The time pressure graph The ETF P test result shows how the pressure changes throughout the measurement as the Eustac...

Page 114: ...sults When you select Edit Delete Selected Sub Test you delete Any single tympanometric curve identified by curve number Any full set of curves relating to a specific reflex stimulus type for one of the reflex tests e g all reflex decay curves for Ipsi 2000 Hz stimuli The ETF P curve 1 To delete a sub test click on one of the curve or graph icons in this icon group to view a specific curve or grap...

Page 115: ...eeded 1 Toggle the Ear Selection icon on the OTOsuite toolbar before testing the other ear The icon shows the currently active probe ear 2 Switch the probe and if needed insert phone to the opposite ear s 3 Continue testing 11 12 Saving measurements The Immittance module keeps 3 curves for each ear When you have made the number of measurements you need you can save the curves 1 To save the patient...

Page 116: ...lex Screening measurements IS If an action contains only Ipsilateral Screening measurements CS If an action contains only Contralateral Screening measurements Reflex Threshold RT If an action contains both ipsilateral and contralateral Reflex Threshold measurements IT If an action contains only Ipsilateral Threshold measurements CT If an action contains only Contralateral Threshold measurements Re...

Page 117: ... information about previous patient 2 Select or create a new patient If you have not already saved the test results you will be prompted to do so Click Save or Cancel as needed 3 Prepare for the next patient as described in Preparing for testing 47 Otometrics MADSEN OTOflex 100 117 11 Testing with the OTOsuite Immittance module ...

Page 118: ... never deleted without confirmation from the user Synchronization takes just a few seconds and is in many cases automatically initiated on connection If you synchronize the patient folder shown in MADSEN OTOflex 100 will be overwritten If you cancel synchronization you can save print out the patient folder shown in MADSEN OTOflex 100 and then syn chronize Note Only the patient folder currently sho...

Page 119: ...ploading test results to OTOsuite 119 1 Click on the set of data you wish to upload and click OK If data is already available in OTOsuite you will be prompted to either overwrite the data or cancel OTOsuite automatically disconnects from MADSEN OTOflex 100 when data has been transferred 12 3 Data clean up Patient folders that have been saved in OTOsuite or printed will be deleted by MADSEN OTOflex...

Page 120: ... measurement settings in MADSEN OTOflex 100 are automatically transferred to the Immittance module If you make changes in the test setup of both MADSEN OTOflex 100 and OTOsuite MADSEN OTOflex 100 will use the most recent settings When MADSEN OTOflex 100 is connected to OTOsuite you can make changes in the test setup in the Immittance module and or in MADSEN OTOflex 100 as you like The setup is syn...

Page 121: ...ed settings When you press Menu the most frequently used test specific settings you can view change are shown Scroll to view other menu items Otometrics MADSEN OTOflex 100 121 13 Test settings in MADSEN OTOflex 100 ...

Page 122: ... press Select again If the setting is not available directly in the menu select More settings and if needed Procedure options Then scroll to the setting you wish to change The settings may appear in abbreviated form but when you scroll to the setting the actual wording is shown 2 Settings can be changed in two ways If there is a list of values to choose from press Select to access the values scrol...

Page 123: ... test setup If you want to make additional changes to a test setup do the following 1 Select Menu My Settings Load Settings 2 Select the test setup of your choice and press Select 3 Change the settings as needed 4 Select Menu My Settings Save settings 5 The test setup is saved with the new changes 13 1 5 Using a test setup If you want to use another test setup than the one currently selected do on...

Page 124: ...rom the keypad press and hold Select If you activate this item 5 times instead of using the shortcut you will see the hint Press and hold select key to select tests New patient folder Use this function for instance before you start testing a new patient MADSEN OTOflex 100 automatically creates a new patient folder when switched on of if Menu Procedure options Patient prompt is set to On Patient Us...

Page 125: ...to press the Ear Selector to define the ear currently being tested Del Sub test Select this function to delete individual measurements Del Current Test Select this function to delete all measurements in the current test Del Patient Select this function to delete an entire patient folder Del all printed patients Select this function to delete all patients that have been printed Del all patients Sel...

Page 126: ...OTOflex 100 memory is full 13 2 2 Procedure options These settings apply regardless of the test type or sequence selected To access these settings 1 Press Select to access the Menu 2 Scroll to Procedure options and press Select 126 Otometrics MADSEN OTOflex 100 13 Test settings in MADSEN OTOflex 100 ...

Page 127: ...seal If a measurement is paused by a leak the test or sequence is automatically resumed when the probe is properly refitted in the ear canal Default On Auto free memory Setting for defining automatic deletion of patient folders from the MADSEN OTOflex 100 memory when memory is close to running full and a new patient folder is to be created Old patient folders are deleted according to the following...

Page 128: ...c testing is paused You are then prompted to decide whether to continue or to move on to the next stimulus type In Manual testing whenever a stimulus level exceeds the Intensity Safetp buy level 115 dB SPL re 2cc the stimulus intensity value will start flashing Warning When you test on small ears the sound pressure level will increase in the ear canal It is therefore not recommended to exceed the ...

Page 129: ...deleted and press Select Device Settings Accesses a menu where the items relate to the settings of the test device in general See Device settings 129 Service This menu item is for service purposes only Password protected 13 2 4 Device settings These settings apply regardless of the test type or sequence selected To access these settings Select Menu Advanced Device Settings Otometrics MADSEN OTOfle...

Page 130: ...ir density The setting is listed in increments of 100 meters 100 meters approx 330 ft 100 to 4000 metres Bat tery power save This setting applies when MADSEN OTOflex 100 is running on battery power After this time period in active mode without any user actions on MADSEN OTOflex 100 or via OTOsuite MADSEN OTOflex 100 will enter power save mode where the display changes to a power save screen and th...

Page 131: ...After this time period in power save mode MADSEN OTOflex 100 will power off Power off allows the batteries to charge and prolongs device life time Recommended setting 60 minutes or as short as possible No power off before This setting applies when MADSEN OTOflex 100 is placed in a powered charger and uses rechargeable batteries Prevents automatic power off until a certain hour of the day Adjust th...

Page 132: ... is meas ured Off The total ear admittance including the ear canal is measured Default On Tymp scale Menu This setting follows unit probe tone and baseline comp settings Default 1 5 mmho 226 Hz Default 3 0 mmho 1000 Hz Layered curves Menu When Layered curves is On this affects a number of areas If Auto Scale is checked the graph will be scaled to allow for showing the highest curve Auto scaling is...

Page 133: ...is selected You can extend the pressure range of 400 to 200 daPa to as much as 600 to 400 daPa or decrease it to 50 to 50 daPa Default Normal Custom min press ure Menu More settings Custom minimum pressure ranges from 50 to 600 daPa in steps of 50 daPa Default 600 daPa Custom max press ure Menu More settings Custom maximum pressure ranges from 50 to 400 daPa in steps of 50 daPa Press Select and sc...

Page 134: ...ically according to the highest of all currently displayed curves so that you can visually compare ear results Default Off Norm type Menu More settings None or Jerger For controlling whether auto classification is performed and according to which norm Default Jerger Show Norm Area Menu More settings Switch for displaying the normative area in the graph Important This setting is not saved as part o...

Page 135: ...cedure options Auto resume on seal Off The screening eartip must remain in place against the patient s ear If the probe is removed the test is interrupted On If the screening eartip is removed from the patient s ear the test continues from the intensity it came to or was interrupted in when there is seal Probe Tone Menu Scroll to select the appropriate frequency for this measurement setup Adult de...

Page 136: ...s Ipsi Contra Ipsi then Contra Contra then Ipsi diagnostic version only Default Ipsi Max intensity Menu More settings Select the desired maximum level of the stimulus intensity up to 100 dB Default 95 dB HL The test is interrupted at Max level and must be continued manually Warning Be careful when you enter the Max setting so as not to expose the patient to too high intensity levels Note To avoid ...

Page 137: ...t follows unit and probe tone set tings The applicable unit mmho cc ml cm 3 or µl is selected automatically when Unit is set If µl is used for 226 Hz probe tone then all values are multiplied by 1000 Default criterion 0 02 mmho 13 5 Acoustic Reflex Threshold setup The following settings are useful Probe Tone Menu Scroll to select the appropriate frequency for this measurement setup Adult default 2...

Page 138: ...n Menu More settings Enter the appropriate setting for the reflex criterion The dashed horizontal line in each reflex graph indicates the predefined reflex cri terion It is offset from the base line marker on the vertical axis The degree of offset is influenced by this setting The applicable unit mmho cc ml cm 3 or µl follows unit and probe tone settings Default criterion 0 02 mmho Deflection scal...

Page 139: ... be included in manual threshold testing On Off Default Off Show HBN Menu More settings Select or deselect High Band Noise to be included in manual threshold testing On Off Default Off Pre stim ulus time Menu More settings Defines the recording time before each stimulus is presented Default value 0 2 seconds Stim ulus time Menu More settings Defines the duration of the stimulus Displays the text M...

Page 140: ...ult 500 Hz Stimulus5 Menu More settings Auto Settings 500 Hz 1000 Hz 2000 Hz 3000 Hz 4000 Hz BBN LBN HBN Off Default Off Stimulus6 Menu More settings Auto Settings 500 Hz 1000 Hz 2000 Hz 3000 Hz 4000 Hz BBN LBN HBN Off Default Off Stimulus7 Menu More settings Auto Settings 500 Hz 1000 Hz 2000 Hz 3000 Hz 4000 Hz BBN LBN HBN Off Default Off Stimulus8 Menu More settings Auto Settings 500 Hz 1000 Hz 2...

Page 141: ...enever a stimulus level exceeds the Intensity Safety level 115 dB SPL re 2cc the stimulus intensity value will start flashing Start intensity Menu More settings Auto Settings Select the desired start level of the stimulus intensity from 40 to 105 dB Default 70 dB HL Intensity increment Menu More settings Auto Settings Select the step size to increment the stimulus intensity in increments of 1 2 5 ...

Page 142: ...n as TPP sign 50 x 50 daPa offset according to TPP sign Default value 20 daPa Pump during stim Menu More settings On Off If On the pump will actively keep the TPP pressure even during stimulus presentation If Off the pump will adjust the pressure between presentations Default value Off Deflection scale Menu More settings Enter the appropriate setting for the reflex decay deflection scale The appli...

Page 143: ...I psi Pause time Menu More settings Auto Settings Defines the inter stimuli interval Default value 0 5 seconds Note The Intensity increment setting used in Reflex Decay is set in the Acoustic Reflex Threshold setup This is because the Reflex Decay stimulus level defaults to the reflex threshold 10 dB Warning When testing manually be careful when you select the setting for Stimulus Intensity so as ...

Page 144: ...v ity 100 to 600 daPa presented in 50 daPa increments Default 400 daPa Pump speed Menu Changes the speed of the pressure sweep Indicated in daPa per second See ETF P Eustachian Tube Function Perforated 186 Note It is highly recommended that the lowest setting 50 daPa s is always used for ETF P Default 50 daPa Initial time scale Menu 30 60 seconds If the test exceeds the time axis the axis will exp...

Page 145: ...hanges to the next tymp curve for each tymp sweep This is to prevent overwriting already recorded tymps if a tymp measurement is triggered by accident This setting is part of the measurement setting Depending on the selected test setting define this setting to suit the specific test set ting purposes First ear to test First ear to test Defines the first ear to be tested on a new patient General Se...

Page 146: ...nd Reflex Scr view settings Admittance axis Unit Changes the admittance compliance unit on the vertical axis for 226 Hz probe tone use See the description of admit tance compliance in the MADSEN OTOflex 100 Guide The admittance axis can be configured to exclude the ear canal component This is called Baseline compensation Baseline compensation must be selected to get the static admittance which is ...

Page 147: ...use the tympanometric type classification is defined by the TPP relation to the range of the norm data Admittance axis Select Baseline compensation or Not compensated mode This will enable you to set the scaling of the view setting for Scale Baseline compensated and Scale Not compensated individually Baseline compensated Enabling Baseline compensated displays a tympanogram view showing the compens...

Page 148: ... curves Enables a typical ETF I setting with layered tympanograms When Layered curves is enabled this affects a number of areas If the Autoscale tympanogram icon is selected the graph will be scaled to allow for showing the highest curve Auto scaling is still ear dependent If a 1000 Hz tympanogram is included among the layered curves the applicable units and tymp results labels for 1000 Hz probe t...

Page 149: ...or 226 Hz probe tone the units available are mmho cc ml cm 3 and µl For 1000 Hz probe tone the unit mmho is always used Threshold table Always show Lists the stimulus types that are always shown In addition any meas ured stimulus types are also shown Select and deselect stimulus types One stimulus type must always be selected as a minimum 14 2 3 Reflex Decay view settings Admittance axis Unit Chan...

Page 150: ...y for this measurement setup 226 Hz Adult default If 226 Hz is selected you can set admittance to be shown in the admittance unit mmho or in the compliance volume units ml cc or cm 3 as described in Tymp and Reflex Scr view settings 146 1000 Hz Infant default Recommended for testing on infants younger than 4 6 months See also the MADSEN OTOflex 100 Guide For frequencies higher than 226 Hz admittan...

Page 151: ...direction The air pressure determines the direction of the pressure sweep from a positive value to a negative value or vice versa Positive from a negative towards a positive value Negative from a positive towards a negative value Default Negative 14 3 1 2 Tympanometry Test settings Click icon or select Tools Options Tymp and Reflex Scr Measurement Tympanometry Auto next curve Enable or disable to ...

Page 152: ... Pump speed In the dropdown list on the Control Panel select AFAP As Fast As Possible Auto resume on seal Select Tools Options General Measurement and enable this function This function is ideal for speeding up the test procedure Auto start on seal SelectTools Options General Measurement and select Sequence below the Control Panel Note If you want to generate a very fast tympanogram set Auto start...

Page 153: ... the frequency for this measurement setup 226 Hz Adult default If 226 Hz is selected you can set admittance to be shown in the admittance unit mmho or in the compliance volume units ml cc or cm 3 as described in Tymp and Reflex Scr view settings 146 For frequencies higher than 226 Hz admittance is shown only in mmho The value in Y scale automatically changes to mmho 1000 Hz Infant default Recommen...

Page 154: ...ements of 10 15 or 20 dB Default 10 dB Number of intens ities Depending on the increment selected you can select or deselect the intensity You can select up to three stimulus intensities The com plete range of intensities available will appear when you deselect all Stimulus side Stimulus side Ipsi Stimulus is presented in the probe ear where the measurements are made Contra Stimulus is presented t...

Page 155: ... Panel Custom TPP offset is checked select Tools Options Reflex Threshold Meas urement General Custom TPP offset Disabled TPP is automatically set to 25 daPa more Enabled TPP TPP offset according to TPP setting in Tools Options Reflex Threshold Measurement Custom TPP off set are used Default value Enabled Manual Stimulus Select the stimulus types to be included Available types 500 Hz 1000 Hz 2000 ...

Page 156: ...rom ears showing steeply sloped tympanograms The TPP offset can be adjusted in increments of xx daPa more less 50 daPa more to 50 daPa less offset according to TPP sign Default value 35 daPa Reflex criterion mmho Enter the appropriate setting for the reflex criterion It follows unit and probe tone settings Default 0 02 mmho Stimulus Intensities You can select the start and maximum stimulus intensi...

Page 157: ...recording time after each stimulus is terminated Default value 0 5 seconds Pause time Defines the inter stimulus interval Default value 0 5 seconds Stimulus types Auto matic Stimulus types Click to select the stimulus types to be included excluded At least one stimulus type must always be selected Available types 500 Hz 1000 Hz 2000 Hz 4000 Hz BBN LBN and HBN Verification Verification Select the t...

Page 158: ...lt Not currently available Intensity Select the stimulus intensity from the drop down list If no reflex threshold is available the Control Panel Intensity set ting is Off This is useful for admittance monitoring Default Threshold 10 dB or Off Stimulus levels at or above the warning level 108 dB SPL re 2cc are marked by an orange bar in the Intens ity drop down list Stimulus levels at or above the ...

Page 159: ... Stimulus is presented through an ear phone or insert phone in the ear opposite to the probe ear Ipsi then Contra Contra then Ipsi Stimulus Timing sec Pre stim ulus time Defines the recording time before each stimulus is presented Default value 0 2 seconds Stimulus time Defines the duration of the stimulus Displays the text Manual when set to 0 Default value 1 3 seconds Post stim ulus time Defines...

Page 160: ...00 daPa presented in 50 daPa increments Default 400 daPa 14 3 6 2 ETF P Test settings Click icon or select Tools Options ETF P Measurement Pump speed daPa s Pump speed daPa s Changes the speed of the pressure sweep Indicated in daPa per second Note It is highly recommended that the lowest setting 50 daPa s is always used for ETF P While the pump is operating a scale at the top of the screen indic ...

Page 161: ...rger as there is a risk of electric shock For the sake of safety and in order not to void the warranty service and repair of electro medical equipment should be car ried out only by the equipment manufacturer or by service personnel at authorized workshops In case of any defects make a detailed description of the defect s and contact your supplier Do not use a defective device The manufacturer is ...

Page 162: ...nd probes must be calibrated once a year by your authorized service department 15 3 2 Probe cleaning and maintenance Note Never immerse the MADSEN OTOflex 100 probe into water or other cleaning solutions The probe body Caution For periodical cleaning of the probe body contact your authorized service department The probe tip Note Never place the probe tip in the ear canal without using a clean eart...

Page 163: ...n Thorough cleaning of the probe tip is required after use in infected ear canals Cleaning the threaded ring may also be necessary Note Always comply with local hygienic standards for disinfection 1 To remove the probe tip hold the probe by the probe body and unscrew the threaded ring Take out the probe tip A Probe body B Threaded ring C Probe tip 2 Check to see if the sound chan nels of the probe...

Page 164: ...y before fitting the tip back into the probe body or use a spare probe tip 5 Fit the probe tip and screw the threaded ring firmly back onto the probe body Tighten well to prevent leakage 15 4 1 Cleaning and disinfecting the probe tip Ear canal debris blocking the probe tubes can lead to abnormally large ear canal volume readings leak messages and other odd results Check the channels of the probe t...

Page 165: ...up to 45 minutes at a maximum temperature of 150 C The probe tip is designed to withstand up to 3 000 autoclaving cycles in which tem peratures typically reach 134 C Make sure that the probe tip has not been deformed by the autoclaving process The test cavity Caution The test cavity is located in the charger which contains electrical components and electrical power con nection Therefore do not use...

Page 166: ...wipes to clean the unit according to local infection control regulations Keep the unit away from liquids Do not allow moisture inside the unit Moisture inside the unit can damage the instru ment and it may result in a risk of electrical shock to the user or patient Clean the device screen periodically Use an anti static non solvent solution on a lint free cloth The probe tip See Cleaning and disin...

Page 167: ...e small red plus signs indicating which way the batteries fit 3 To put the battery cover back in place insert the cover with the curved edge facing upwards in the opening Press the cover inwards and downwards until it clicks into place 15 5 4 Battery safety information Explosion hazard Do not throw the batteries into the fire and keep them away from fire as they may explode Incorrect handling appl...

Page 168: ...device is turned on and ready to be found and click Search Select the device and click Next or Close If you are using a Bluetooth device other than OTOair and you are having prob lems connecting to a device that is included in the list click Repair If you continue to have connection problems click Test to see the con nectivity status This may help you or the Otometrics support team to dia gnose co...

Page 169: ... supply There are no batteries in the MADSEN OTOflex 100 unit or the batteries are inserted incorrectly Wrong battery type Connect the charger to the electrical power supply Place batteries in the battery compartment and make sure they are inserted correctly 17 2 Testing Problem Possible cause Solution I forgot to switch to the correct ear in MADSEN OTOflex 100 before testing See Swap ear results ...

Page 170: ... cable connection prob lems Check the connections See Preparing MADSEN OTOflex 100 47 17 4 Probe fit related problems Leakage Problem Possible cause Solution Leakage Leakage can be caused by a num ber of factors such as Pneumatic probe plug not inserted prop erly Inappropriate ear tip size either too small or too large Ear canal debris blocks for good ear tip seal 170 Otometrics MADSEN OTOflex 100...

Page 171: ...s and accumulators must be taken to separate collection at the end of their working life This requirement applies in the European Union Do not dispose of these products as unsorted municipal waste You can return your device and accessories to Otometrics or to any Otometrics supplier You can also con tact your local authorities for advice on disposal Classified with respect to electrical shock fire...

Page 172: ...ce Local regulations and precautions for other equip ment in the environment should always be followed to avoid interference The separation distance from this device to other devices complying with standard immunity require ments in EN 60601 1 2 is minimum 0 35 m 1ft For use in restricted areas the OTOflex 100 features the ability to turn off the built in Bluetooth module i e disabling the Bluetoo...

Page 173: ...efect s and contact your supplier Do not use a defective device 2 Accidental damage and incorrect handling can have a negative effect on the functionality of the device Contact your supplier for advice 3 Keep the unit away from liquids Do not allow moisture inside the unit Moisture inside the unit can damage the instrument and it may result in a risk of electrical shock to the user or patient 4 Do...

Page 174: ...n the applications defined in the Intended Use section of this manual 14 The device and charger unit can be disposed of as normal electronic waste according to local regulations Please investigate local regulations concerning the disposal of rechargeable and alkaline batteries Local government rules and regulations if applicable should be followed at all times 15 If the device is not to be used fo...

Page 175: ...s re adjustments modifications or repairs are carried out by the equipment man ufacturer or personnel authorized by the manufacturer The electrical installation to which the equipment is connected complies with EN IEC requirements The equipment is used in accordance with the instructions for use The manufacturer reserves the right to disclaim all responsibility for the operating safety reliability...

Page 176: ...0 Hz High Pass 1600 to 4000 Hz Roll off 12 dB Octave Range at BBN LPN at 50 to 100 dB HL 3 dB HPN at 50 to 95 dB HL 3 dB Step size dB 1 2 5 10 dB E A RTONE 3A Range at 500 Hz at 50 to 105 dB HL 3 dB 1000 Hz at 50 to 120 dB HL 3 dB 2000 Hz at 50 to 115 dB HL 3 dB 3000 Hz at 50 to 105 dB HL 3 dB 4000 Hz at 50 to 110 dB HL 3 dB THD 3 in 2 cc measured 5 dB below max output Immittance probe Range at 50...

Page 177: ...mal 200 to 400 daPa s Extended 400 to 600 daPa s Pressure sweep rate 50 100 200 400 daPa s A F A P A F A P will start at 500 daPa s and slow down to 400 daPa when at peak is detec ted Pressure accuracy 10 or 10 daPa whichever is greatest Pump measure direction Positive to negative or negative to positive Safety Separate safety 530 daPa and 730 daPa 70 daPa Software safety 450 daPa and 650 daPa 70 ...

Page 178: ...plied by GN Otometrics A S Battery supply voltage Nom 5 V max 6 4 V min 4 0 V instrument power off voltage Operating environment Temperature 15 C to 35 C 59 F to 95 F Rel humidity 30 to 90 non condensing Warm up time 2 min Air pressure 600 hPa to 1060 hPa Operation at temperatures below 20 C or above 60 C may cause permanent damage Storing and handling Temperature 20 C to 60 C 4 F to 140 F Rel hum...

Page 179: ...027 Type 1 ANSI S3 39 Type 1 2 Basic safety as defined by IEC 60601 1 All information required by IEC 60601 1 2 2007 5 2 2 1 5 2 2 10 is available in the MADSEN OTOflex 100 User Guide Standards Safety ANSI AAMI ES 60601 1 2005 CAN CSA C22 2 NO 60601 1 2008 MADSEN OTOflex 100 IEC 60601 1 Class II Internal Powered Type BF IPX0 Charger unit EN 60601 1 Class II IPX0 EMC EN 60601 1 2 EN 300 328 2 EN 30...

Page 180: ...19 Technical specifications 180 Otometrics MADSEN OTOflex 100 ...

Page 181: ...ir pressure or muscle activity applied The maximum acoustic energy admittance the point at which the most acoustic energy enters the middle ear is obtained when the middle ear mobility is maximized This occurs when the ear canal air pressure is equal on both sides of the eardrum membrane and the middle ear muscles are in a neutral state When using a 226 Hz probe tone the acoustic admittance of air...

Page 182: ...of the external ear middle ear cavity and mastoid a change in the orientation of the tympanic membrane fusion of the tympanic ring a decrease in the overall mass of the middle ear due to changes in bone density loss of mesenchyme connective tissue of the embryo tightening of the ossicular joints closer coupling of the stapes to the annular ligament the formation of the bony ear canal wall The infa...

Page 183: ...valent Ear Canal Volume ECV is measured as the com pliance at 200 daPa ear canal pressure Accordingly the ECV is only shown when a 226 Hz probe tone is used When using a higher frequency probe tone the Equivalent Baseline Volume EBV is shown instead of ECV Fig 2 Measurement plane tympanogram Baseline compensation OFF A SA ECV Total Admittance Tympanometry type Type Tympanometry type Type is a clas...

Page 184: ...zation of negative pressure will displace the tympanometric peak in a positive direction in the tym panogram It is less common with standing positive pressure in the middle ear due to the anatomical properties of the Eus tachian tube The tube is likely to be forced open by the pressurized air itself Equalization of positive pressure will displace the tympanometric peak in a negative direction in t...

Page 185: ...pecific In case of baseline instability due to a hyper flaccid eardrum a pressure offset of 20 30 daPa in the same direction as TPP displacement may be used A pressure offset of this magnitude will stabilize the flaccid eardrum without obscuring the reflex induced admit tance change Due to the physiology of the neural pathways involved acoustic reflexes can be elicited either with stimulation of t...

Page 186: ...hlear pathology The two different time criteria have been used by different researchers The acoustic reflex is more prone to adaptation with higher stimulus frequencies Accordingly adaptation to the 500 Hz stimulus is considered a stronger indicator of abnor mality than adaptation to the 1000 Hz stimulus App 1 3 4 Admittance monitoring The default stimulus level is automatically set to Off when no...

Page 187: ...c tor length derived from the Cartesian graph as shown App 1 5 1 Susceptance B Susceptance is determined by the ease with which energy flows through the Compliant elements of the ear and the ease of energy flow through the Mass elements of the ear Compliant elements are the tympanic and round window membranes the ossicular ligaments the middle ear muscles and the air in the ear canal and middle ea...

Page 188: ...nal Susceptance This Susceptance is mainly Compliance Susceptance since the Mass element in this enclosed air is negligible The value of the notch in the Susceptance tympanogram can then be determ ined from the corresponding value on the vertical axis and the relation of the probe tone frequency to the ear resonance frequency can be estimated according to the above description App 1 5 2 Conductanc...

Page 189: ...including the extreme point where the ear canal admittance is determined Using higher frequency probe tones The covariation between Susceptance and Conductance is no longer true when the probe tone frequency is increased approaching a Mass controlled frequency region As the influence on the Susceptance curve of Mass ele ments increases when approaching the peak pressure the relationship between th...

Page 190: ...s due to a change in Mass or Compliance contribution it is still an absolute change rel ative to the ear canal admittance reference point 190 Otometrics MADSEN OTOflex 100 App 1 MADSEN OTOflex 100 Immittance methodology and features ...

Page 191: ...tus volume The volume of audible seal status feedback Can be turned off 0 volume Audible test status volume The volume of audible test status feedback Can be turned off 0 volume Auto delete test Automatically delete test results when they have been successfully reported or uploaded to the PC Auto new Patient Folder Start of the first measurement after reporting will cause the test device to store ...

Page 192: ... mounted Provides a better grip for the probe Can be mounted on the test device Allows a screening handle to be inserted Charger cradle Charger cradle designed for test device charging and desktop or wall mount operation Closing pressure The pressure at which the Eustachian tube closes Compliance C Synonymous for admittance The term compliance is used when admittance is used in volume units not mm...

Page 193: ... test with perforated tym panic membrane ETF P The pressure applied to the ear canal passes the perforated tympanic membrane and can pass directly through the Eustachian tube The pressure is recorded as a function of time F Factory defaults Factory installed default settings First ear to test First ear Applies when testing starts on a new patient G Get test results from device Fetch results from t...

Page 194: ...ally Max stimulus intensity The highest applied stimulus intensity during reflex screening or automatic reflex threshold Maximum positive pres sure The maximum positive pressure that may be applied during the ETF P test The pressure will often not be reached as a spontaneous opening of the Eustachian tube may occur at a lower pressure Maximum pressure The maximum applied pressure positive pressure...

Page 195: ...ces static compliance static admittance deflection results from a sub traction of 2 admittance values Admittance has both an amplitude and phase The phase compensation takes phase differences into account during subtraction to produce more accurate results Post meridiem pm After noon Post stimulus time The delay from the end of the applied stimulus to the end of recording of the deflection curve d...

Page 196: ...ndication of whether a reflex was detected or not at a single stimulus intensity b An indication of the lowest intensity at which a reflex was detected up to 3 intensities used Reflex threshold The lowest stimulus intensity that can elicit a reflex Reflex threshold test RT A search for the reflex threshold made by applying stimuli at increasing intensities until a reflex is detected Reflex thresho...

Page 197: ...test to provoke a reflex response 1 2 or 3 Stimulus output side The side where a stimulus is applied relative to the side where the response is measured Same side Ipsilateral Opposite side Contralateral Stimulus time The duration of the stimulus during a reflex measurement Stimulus type Type A pure tone at a given frequency or a given filtered noise Stop on results A stop criterion for the automat...

Page 198: ...rve at the height where TPP 50 daPa intersects with the tympanogram The gradient is the ratio between the peak height from this hor isontal line and the total peak height measured from the positive tail Tympanogram width The width of the tympanogram measured at half the tympanogram height halfway between the positive tail and peak Y values Width is given in daPa Tympanometric peak pres sure TPP Th...

Page 199: ...be function test with perforated tympanic membrane HL Hearing level HBN High band noise hr hour Ipsi Ipsilateral LBN Low band noise MEP Middle ear pressure NiMH Battery type rechargeable pm Post meridiam RD Reflex decay test RS Reflex screening test RT Reflex threshold test SA Static admittance SC Static compliance SPL Sound pressure level T Tympanometry tympanogram TPP Tympanometric peak pressure...

Page 200: ...App 2 Glossary 200 Otometrics MADSEN OTOflex 100 ...

Page 201: ...on tympanometry setting 132 Batteries Alkaline 20 NiMH 20 power off mode 130 power save mode 130 rechargeable 20 set type in device 21 Battery type settings 130 BBN setting acoustic reflex threshold 139 Bluetooth enabling 44 enabling communication 130 Brightness device setting 130 C Calibration 162 Cap attaching 48 detaching 50 cc setting tympanometry 127 Charger charging status 22 desktop install...

Page 202: ...26 59 setting 127 Eartips disposal 166 Editing data 32 Entering data 31 ETF I 100 description 184 layered curves 135 settings 135 Toynbee s maneuver 184 Valsalva s maneuver 184 ETF P 112 description 186 Eustachian tube function see ETF I or ETF P 184 186 F Firmware update test devices Imm 45 G General actions my settings 124 new patient folder 124 patient user 124 start sequence 124 test selector ...

Page 203: ...ff 23 26 59 scroll wheel 25 60 select in display 59 select key 26 31 softkeys 26 60 Test Selector softkeys 31 L Language selection 131 Layered curves setting ETF I 135 setting tympanometry 132 LBN setting acoustic reflex threshold 139 Leakage 56 Localization 131 M Maintenance cleaning device 166 Manufacturer 175 responsibility 175 Max intensity setting acoustic reflex screen ing 136 setting acoust...

Page 204: ...5 acoustic reflex threshold setting 137 tympanometry setting 132 Procedure option settings 126 Pump active during stimulation acous tic reflex decay 142 active during stimulation acous tic reflex threshold 138 active during stimulation RD 159 active during stimulation RT 156 speed ETF P 144 speed screening tympanometry 134 speed tympanometry 133 R Rechargeable batteries 20 Reflex Decay automatic 8...

Page 205: ...creening 135 for acoustic reflex threshold 137 for ETF I 135 for screening tympanometry 134 for tympanometry 131 initial pressure 144 initial time scale 144 intensity increment acoustic reflex screening 137 intensity increment AR screen ing 154 157 intensity safety 128 intensity step size acoustic reflex threshold 141 language selection 131 layered curves ETF I 135 layered curves tympanometry 132 ...

Page 206: ...ecay 142 show xxx Hz acoustic reflex threshold 138 start intensity acoustic reflex threshold 141 stim output acoustic reflex threshold 140 stim time acoustic reflex decay 143 stim time acoustic reflex threshold 139 stim time RD 159 stim time RT 157 stim x acoustic reflex decay 143 stim x acoustic reflex threshold 139 stimulus side acoustic reflex decay 143 stimulus side acoustic reflex screening 1...

Page 207: ...reshold 139 side acoustic reflex screening setting 136 start intensity acoustic reflex threshold setting 141 stim time setting acoustic reflex decay 143 stim time setting acoustic reflex threshold 139 stim time setting RD 159 stim time setting RT 157 Swap ear results 86 Sweep direction setting 134 setting ETF I 135 Switching on device 23 Synchronization of data 87 118 T Test devices Immittance fir...

Page 208: ...tric width description 183 Tympanometry classification system 183 data screen 69 description 182 diagnostic 70 97 ETF I 100 features 182 layered curves 132 screening 62 92 settings 131 testing infants 182 type description 183 Tympanometry screening settings 134 U User interface 36 Users 51 V Valsalva s maneuver 184 View settings tympanometry 70 Views 13 W Wax filter 165 208 Otometrics MADSEN OTOfl...

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