User Manual - Pro Edition -
Table of Contents Introduction 3 Patient Home Screen 4 Managing Patients 5 Creating Patients 5 Editing Patient Details 5 Deleting Patients 5 Starting Activities 6 Viewing Results 6 Automatic Pure Tone Test 7 Setup Screen 7 Transducer 7 Test Type 7 Establish Comfortable Listening Level 8 Analyzing Background Noise 9 Tutorial 9 Playing the Game 10 Retesting 11 Configuration 11 Manual Hearing Test 12 Setup 12 Analyzing Background Noise 12 Performing the Test 13 Presenting Tones 13 Indicating Thresholds 14 Masking 15 Bone Conduction Testing 16 Bone Conduction Testing with Masking 17 Notes 18 Configuration 18 Speech Discrimination Test 19 Setup 19 Analyzing Background Noise 19 Performing Test 20 Presenting Words 20 Pausing the Test 20 Progressing the Test 21 Configuration 21 Questionnaires 22 Completing a Questionnaire 22 Configuration 22 Available Questionnaires 22 Settings 23 Test Types 23 Manual Hearing Test 23 Speech Test 23 General 24 Troubleshooting 25 Symbols Legend 26 Specifications 27 User Manual 1
Clearwater Clinical Ltd. Suite 501, 1306 Wellington Street West Ottawa, ON, Canada K1Y 3B2 www.clearwaterclinical.com 1-877-349-9934 SHOEBOX is a Class II medical device listed with FDA (Registration No: 3007307502) and Health Canada (License No: 93571). Intended use: for diagnosis of human hearing loss. Summary: SHOEBOX Audiometry is an ipad-based Type 3 Diagnostic Audiometer (as defined in ANSI S3.6-2010) intended for diagnosis of human hearing loss. 0086 Only applicable to SHOEBOX Audiometry Software Notified Body: BSI UK Ltd Applicable to headphones MDSS GmbH Schiffgraben 41 30175 Hannover, Germany SB-QMS-717 Rev: N / 2018-02 Legend: Catalog Number Manufacturer Authorized Representative Consult IFU A paper copy of this document is available upon request. User Manual 2
Introduction Thank you for choosing SHOEBOX Audiometry, Pro Edition. This ipad-based audiometer offers innovations for hearing testing not found in traditional tools. Users can test themselves via the self-test game interface, or can be tested by an audiologist using the manual testing interface. The test is fun, accurate and cost-effective. SHOEBOX Pro works with nearly any age (4+) and is largely language independent. User Manual 3
Patient Home Screen The Patient Home Screen acts as the main screen in SHOEBOX Audiometry from which all tests and patient management start. This screen is split into three main sections: 1 On the left you will find a list of all the patients included in the currently selected project. 2 To the top right, you ll find activity action buttons. 3 On the bottom right you ll find all the test results for the selected patient. When a patient is selected, the activity buttons will initiate new tests for the given patient while the results section will display the patient s previously completed assessment results. Tap the project selection dropdown to switch projects. View past results for the selected patient and tap an item to view more details. Use the action buttons to start new tests or questionnaires for the selected patient. User Manual 4
Managing Patients Creating Patients New patients can be created by tapping the Add Patient icon at the bottom of the patient list. Doing so will bring up an empty Patient Details Form. Fields marked with a * are required. Tap the Save button when you are done to create the patient entry. Tap the Info icon to view and/ or edit patient details. Tap the Add Patient icon to create a new patient entry. Editing Patient Details If the patient details change, or you notice an input error, you can always edit the information by tapping on the Info icon. This will bring up the same Patient Details Form you used to create the patient. Simply update the desired fields and tap the Save button to update the patient. Deleting Patients If you find yourself in need of deleting a patient you can do so from the main Patient Home Screen. Simply swipe left on the patient you wish to remove and tap the Delete button when it appears. User Manual 5
Starting Activities When you re ready to start a test or questionnaire, simply select a patient and tap the activity button for the type of assessment you wish to start. More information on each activity can be found in the corresponding section in this User Guide: Viewing Results Once an activity has been completed, it will appear in the Patient Home Screen results section. Results are grouped and displayed by day, with most recently completed activities at the top. To view an activity result in more detail, simply tap on the entry in the results list. Automated Pure Tone Test Questionnaire Speech Discrimination Test Manual Hearing Test Did You Know? Most activity result screens will provide the ability to easily print or email the results. Simply select the menu from the top right corner and select the desired action. Result Icons correspond to the icons of the activity that produced them. User Manual 6
Automatic Pure Tone Test Setup Screen From the Setup Screen, you can select your transducer and test type, and set the patient s comfortable listening level. Transducer Start by plugging in a calibrated transducer. If you have a Switchbox, plug the transducer into the appropriate section of the Switchbox, and plug the Switchbox into your ipad. See p. 16 for more information on Switchbox. If you only have one transducer enabled, SHOEBOX Audiometry will automatically select the only available transducer. If you have more than one transducer enabled, no transducer will be selected until you tap the Change button in the Transducer section and select a transducer from the list. Be sure to select the transducer you plugged in. Test Type In this section you can select and change your test type. By default, your test type will be set to the most recently selected test type. Did You Know? Transducers can be enabled or disabled in the Transducers section of the Settings. If you have multiple transducers, tap here to set or change your transducer Tap here to change your test type User Manual 7
Establish Comfortable Listening Level Place the headphones on the patient prior to testing the comfortable listening level. Ensure when placing the headphones that the center of the headphone speaker is lined up with the center of the ear canal. The Establish Comfortable Listening Level section sets the intensity level to start the test. The tone should be loud and clear to the patient. 55dB is selected by default, but the level can be adjusted for different hearing levels. Tips For Headphone Placement Have the patient remove any jewelry or accessories that might affect the placement of the headphones. Ensure that the headphones are over/ in the patient s ears. The speaker should be centered over the external auditory canal. The adjustment band should feel snug. To present a level, select it and tap the Play Tone button. If the patient reports that this is loud and clear, keep this level. If they feel it could be a bit louder, select the next level up. Tap here to change the comfortable listening level Tap Play Tone to present the tone to the patient The speaker appears for the duration of tone presentation to the patient User Manual 8
Analyzing Background Noise When starting an automated test, SHOEBOX Audiometry will optionally analyze the room and confirm whether or not you are in a sufficiently quiet place before the test starts. This is best done in the same room the test will be completed in. We recommend an enclosed room with little to no background noises; such as voices, fans, or announcements. The patient should tap the Play button to start the tutorial Tutorial You can enable or disable the tutorial for a particular test type by navigating to Automated Test Type in Settings. If enabled, a pop up will appear when the test begins. Hand the ipad to the patient and instruct them to tap the play button when ready to watch the tutorial. The tutorial will do a quick animated run through of both the sound and no sound scenarios the patient will encounter. If the Comfortable Listening Level is set properly, the patient should hear a tone presented in the sound scenario of the tutorial. After the tutorial is complete, the patient can tap the replay button to replay the tutorial, or the done button to start the test. User Manual 9
Playing the Game When the test begins, an object will appear on the screen. When the patient touches the object, they will either hear or not hear a sound. All they will need to do is drag the object over the appropriate icon to indicate whether they heard the sound or not. If the Comfortable Listening Level is properly set, the patient should hear the first test tone. Tone Not Heard Tone Heard The patient will be required to repeat this action many times, and will often drag to the Tone Not Heard icon. SHOEBOX Audiometry automatically adjusts the presented volume and displays new objects as it works to pin-point the patient s threshold for the current frequency. Once a threshold is determined, or SHOEBOX Audiometry detects some irregularity in the patient s responses, it will record its findings and move on to the next frequency. When it does this, the background image and object icons may change if specific games are being utilized. * Remember, ANY sound heard should count as a positive response. 1 Touch down on the icon/object to make it present a tone. 2 Drag the object to an icon indicating whether or not a sound was heard. User Manual 10
Once all selected frequencies are tested, the game will conclude and the audiogram results will be displayed according to the default test view setting. For any test performed using Extended High Frequencies (EHF), results will only display in the tabular results view. You can toggle between the tabular and audiogram view for all tests performed using regular frequencies, regardless of your default setting. If you have a SHOEBOX passcode enabled, you will be required to enter it at this point. This is a security feature that blocks the patient from accessing other patients data. After all retesting is complete, a proposed interpretation is made for each ear. Either the results are within normal limits and no further action is required, or it is recommended that the patient be referred for further testing. The proposed result can be edited directly on the screen, allowing the tester to make the final recommendations. Valid Result Unreliable Result Too Noisy Interpreting Results When reviewing the audiogram, each tested frequency will display an icon at the point of the determined threshold. These icons will indicate one of three outcomes: Valid Result - The test at this frequency was successful, no further action is required. Unreliable Result - The test at this frequency was unreliable based on the user s interactions. A retest at this frequency is recommended. Too Noisy - The ambient noise during this portion of the test was too high. A retest at this frequency is recommended. Needs Masking - The test has identified that distraction in the opposite ear is required to test the affected ear appropriately. It is recommended that you retest at this frequency with masking enabled. Bone Conduction Recommended - If your system had a calibrated bone transducer installed and hearing loss was detected, the test may suggest that you test for a bone conduction threshold. Needs Masking Bone Conduction Recommended Retesting If you agree with the recommendations of SHOEBOX as it relates to selected retest frequencies, you simply click on Continue and these frequencies will be retested one more time. If you prefer to accept the results as they are, simply touch all of the affected symbols to disable them, or the function buttons at the bottom of the screen. You ll notice the Continue button changes to a Done button, indicating you re finished with the test. Configuration To configure the Automated Pure Tone Test for your practice visit the Test Types section in the SHOEBOX Audiometry Settings. User Manual 11
Manual Hearing Test Setup Start by plugging in a calibrated transducer and selecting it in the transducer selection menu. Be sure you select the same transducer that you plugged in. If you have a Switchbox, plug the transducer into the appropriate section of the Switchbox, and plug the Switchbox into your ipad. See p. 16 for more information on Switchbox. SHOEBOX Audiometry will automatically detect whether you ve selected a bone or air transducer and will plot the appropriate audiometric symbols as needed. Tips For Headphone Placement Have the patient remove any jewelry or accessories that might affect the placement of the headphones. Ensure that the headphones are over/ in the patient s ears. The speaker should be centered over the external auditory canal. The adjustment band should feel snug. Tap to select which transducer you would like to use. Analyzing Background Noise The Manual pure tone test platform does not automatically analyze the room background noise before starting the test but this action can be initiated at any point from the Menu button in the top right corner of the screen. User Manual 12
Performing the Test Presenting Tones Start by tapping the audiogram chart for the ear you wish to start testing. Next, select a frequency with the left/right arrows in the bottom left corner of the screen or by tapping the chart directly. Set the presentation volume by tapping the up/down buttons. When you re ready, present a tone at the chosen frequency and volume by touching and holding the Tone button for the desired duration. By default, a standard pure tone will be presented. This can be changed by tapping the tone selection dropdown box located above the Tone button. Other available tone options include a warble tone and a pulsed tone. Tap a point on the chart to quickly select both the frequency and volume at once. Tap the left or right audiogram chart to set the current ear being tested. User Manual 13
Indicating Thresholds Once the tone has been presented, a marker may appear on the chart to indicate the point as being previously tested. Continue to adjust volume and present tones until you believe a threshold has been established, then accept the point by tapping the Select button. If you wish to clear a previously accepted threshold, simply select the threshold on the chart and tap the Clear button. If a threshold could not be established, tap the Unreliable button to mark it as such and continue testing. Tap to plot the threshold at the currently selected point. Tap to indicate that a threshold could not be found. Tap to indicate that no response was detected at maximum volume. Tap to clear the threshold at the currently selected point. User Manual 14
Masking If you determine that masking is required to more accurately determine a threshold, tap Masking to enable the masking controls tab. When the masking controls tab is enabled, the ear that s being masked will display Masking below its audiogram chart, and the ear that s hearing the tones will display Tone below its audiogram chart. To start masking, simply tap the Start Masking button, and then tap the Tone button to present a tone for the unmasked ear. The masking volume can be adjusted at any time and will not affect the tone volume. For safety, masking will reset to 0dB and off after changing frequencies. To test the other ear, tap the corresponding audiogram chart. Masking will display below the masked ear s audiogram chart. Tap this button to start masking. Tap this button to present a tone for the unmasked ear. User Manual 15
Bone Conduction Testing Note: The recommended bone conduction configuration includes the use of the Switchbox. If you have a Switchbox, ensure that the transducers are firmly connected to the Switchbox as shown below, and the Switchbox cable is firmly connected to the ipad. The direction of the dial on the Switchbox should be as follows: Center : when performing air conduction testing Left : for bone conduction on the right side Right : for bone conduction on the left side Connection to air transducer Connection to bone transducer Connection to ipad Switch here for air conduction testing Switch here for bone conduction on the right side Switch here for bone conduction on the left side If you do not currently have a Switchbox, we recommend contacting us to learn more.! Avoid patient discomfort (possible loud output) by carefully ensuring the transducers are connected correctly. Select a bone conduction transducer from the transducer selection section to switch to bone testing mode. Have the patient remove glasses prior to using a bone conduction transducer. When you switch to bone testing, a pop-up dialog will appear with instructions on how to properly connect your bone transducer (splitter cables) or select the appropriate dial direction of the Switchbox (Switchbox) based on which ear is currently selected for testing. User Manual 16
Bone Conduction Testing with Masking (Manual Mode) Tap Masking in Manual Mode to enable the masking controls tab. A pop-up dialog will appear with instructions on how to properly set up your bone and air transducers (splitter cables), or select the appropriate dial direction of the Switchbox (Switchbox) for the selected ear. When masked bone is enabled, the single transducer selection will change to a double transducer selection, one for the air transducer and one for the bone transducer. Each transducer drop-down selector will display under the audiogram chart for its corresponding ear, along with an indicator for Masking or Tone. To start masking, tap the Start Masking button, and then tap the Tone button to present a tone for the unmasked ear. The masking volume can be adjusted at any time and will not affect the tone Did You Know? You can check your setup prior to placing the transducers on your patient by tapping the Check buttons and listening through the transducer at each step. When you are certain your setup is correct, tap the Proceed button. volume. Note that masking will reset to off when you change testing frequency. To test the other ear, tap the corresponding audiogram chart. When you switch ears, a popup dialog will appear with instructions on how to properly set up your bone and air transducers (splitter cables), or select the appropriate dial direction of the Switchbox (Switchbox) for testing the other ear. Check your setup at each step by tapping the Check button When you are certain your setup is correct, tap the Proceed button User Manual 17
Notes Notes can be added per ear to a manual test by tapping the Notes button located beside the chart ear label. Configuration Some additional configuration for the Manual Pure Tone Test activity is available in the Manual Hearing Test section of the SHOEBOX Audiometry Settings. User Manual 18
Speech Discrimination Test Setup Start by plugging in a calibrated transducer and select it from the Transducer selection menu. Be sure you select the same transducer that you plugged in. Next select the Word List and ear you d like to start testing with. Downloading Word Lists While connected to the internet, word lists can be enabled and downloaded from the Speech Test section in Settings. Once downloaded, they will become available in the Speech Discrimination Test. If a previous PTA is available for the patient, the volume will be automatically set for the selected ear. If you d like to change the presentation volume before starting the test, you can do so by tapping the left/right arrows. You can also test this new volume with the patient by tapping the Play Test Word button. When you re happy with the test settings tap the Start Test button to get started. Analyzing Background Noise The Speech Discrimination Test does not automatically analyze the room background noise before starting the test but this action can be initiated at any point by tapping Check Room Noise in the top right corner of the screen. Tips For Headphone Placement Have the patient remove any jewelry or accessories that might affect the placement of the headphones. Ensure that the headphones are over/ in the patient s ears. The speaker should be centered over the external auditory canal. The adjustment band should feel snug. User Manual 19
Performing Test Presenting Words Once the test is started, it will automatically begin presenting the first word to the patient and then pause. To mark a word as being correctly repeated tap the Correct button in the bottom right corner of the screen. Tap the Missed button in the bottom left corner to mark the word as incorrectly repeated. Once a word is marked either correctly or incorrectly repeated, the test will resume and the next word will be presented. At any point after the result for a word is set, you can tap the X or checkmark button to change the result. While the test is underway, a summary including the total number of words missed and correctly repeated will be displayed in the Ear Progress panel on the left of the screen. Pausing the Test By default, after 10 words have been presented, the test will pause to let the test administrator end the test if desired. This behavior can be changed at any time during the test by tapping the Use All Words button or by long pressing the blue stop marker and dragging it to the desired stop point. Long touch and drag the stop marker to set your desired stop point. Tap the result icon to change it after it s been set. User Manual 20
Tap the Switch Ear or Finish Test button to complete testing for the current ear. Tap the Restart Ear to clear results for the current ear and restart with new test settings. Progressing the Test To accept the results for the current ear and start testing the second ear tap the Switch Ear button. Alternatively, if testing for the current ear is not going well and you need to readjust the test settings tap Restart Ear to return to the settings area. Configuration Word lists can be downloaded, enabled and disabled from the Speech Test section in the SHOEBOX Audiometry Settings section. Once both ears have been tested, tap the Finish Test button to accept the results for both ears and view the final results. At this point you can add notes to the results summary by tapping on the Notes area for a given ear. User Manual 21
Questionnaires Completing a Questionnaire A questionnaire can be used to gather a variety of information such as how a person s hearing is affecting their quality of life and what treatment options they would be best suited for, as well as gathering information about noise exposure in the workplace. When completing a questionnaire, simply tap the answer box beside a question and select an option from the pop-up menu. Configuration The type of questionnaire used when a questionnaire activity is started can be set in the General section in the SHOEBOX Audiometry Settings. Available Questionnaires Currently, SHOEBOX Audiometry includes the following questionnaires/inventories: 1. Hearing Handicap Inventory for Adults - Screening version (HHIA-S) 2. Hearing Handicap Inventory for the Elderly - Screening version (HHIE-S) 3. Hearing Conservation 1 Questionnaire In addition, custom questionnaires are available. Please contact us for more information. Tap the answer box beside a question then select an option from the pop-up menu. User Manual 22
Settings Once you ve successfully installed the SHOEBOX Audiometry Pro program, and have completed the Setup Wizard, you ll be able to customize SHOEBOX Audiometry to meet your own preferences. To do so, tap the Settings icon at the top left of the Patient Home Screen. Choose which audiogram symbols are used in the audiogram (simple or professional). Set the default view type (audiogram or tabular) of the regular frequency tests. All tests performed with EHF can only be displayed using the tabular results view. Manual Hearing Test This section will let you configure the parameters for the Manual Hearing Test mode. In this section you can: Test Types Use this section to customize the Automated Pure Tone Test. In this section you can: Choose Screening, Adult, Child, or OSHA game mode to edit or create as many custom configurations as needed by selecting the + symbol on the upper right of the screen. Choose which frequencies are used and what order they are presented by tapping the Frequencies section and then touching and dragging the symbol to reorder each frequency. If you have an EHF license and calibrated transducers, you can add EHF frequencies to any new or existing test type. Choose which types of games are used and what order they are presented. Set the upper and lower volume limits. Choose to display test data on the screen. This is helpful when testing children in coaching them through the test, or for training purposes. Choose which frequencies should be enabled by tapping the Frequencies section and then touching and dragging the symbol to sort each frequency. Choose which tone type should be used as default (pure tone, pulsed tone, or warble tone). Set the increase and decrease volume step amounts. Set the default presentation volume Set the upper and lower volume limits. Indicate whether or not you want SHOEBOX Audiometer to place markers when you present a tone. Show or hide masking controls. Speech Test Before starting a speech test you ll first need to download your preferred word lists. SHOEBOX Audiometry will automatically prompt you to do this the first time you try to start a speech test. You can always return to the speech test settings to enable, disable or download additional lists. Current available validated word lists include NU-6 and PBK-50. User Manual 23
Transducers SHOEBOX Audiometry automatically downloads calibration information for each transducer selected during initial set up. Once downloaded, you ll find them listed in the Transducers section of the Settings. Here you can choose to perform daily verification checks, and enable or disable select transducers. When only one transducer is enabled SHOEBOX Audiometry can speed up test setup times by skipping the transducer selection step for each test. General In the General Settings section you ll find a variety of additional configuration options should you require them. These include: Audiogram email - enter a default email address which will be the address from which results are emailed. Enable/disable a SHOEBOX Audiometry passcode. Enable/disable SHOEBOX Audiometry lock screen. Specify frequencies used for calculating Pure Tone Average (PTA). Specify which patient questionnaire should be used when a questionnaire activity is started. Enable/disable Pre-Test Room Scan. Enable/disable Web Cloud Portal sync. Set Test Subject Language. This will set the language used for display text on test subject-facing screens in the automated test. User Manual 24
Troubleshooting Q What is the best way to test younger children? A There are three approaches to using SHOEBOX Audiometry for testing children, based on their age and attention span. 1 Children older than 6 can usually test themselves. Demonstrate the game once at the first frequency and then let them play on their own. 2 For younger children it may be better to hold the ipad for the child, with the game facing the child, and have them direct you on where to place the objects based on what they hear. 3 If the child is distracted by the images, hold the ipad like a traditional audiometer and ask them to indicate when they hear the sounds by raising their hand or nodding their head. Q What thresholds are being used to identify that a patient requires further testing? A The lower intensity limit is -10 db HL. Normal hearing is usually considered to be anything 25dB or less. Anything greater than 25 db will trigger the unit to suggest further investigation and possible referral. Q Is the patient data on the device secure? A We recommend that you include a passcode on your SHOEBOX Audiometry ipad to ensure the data is protected. We also encrypt the information any time you email results. It is your responsibility to ensure these functions meet your organization s privacy requirements. Q What are the recommended ambient noise levels used? A There are two sets of Maximum Permissible Ambient Noise Levels (MPANLs) that can be selected to monitor during testing ANSI 53.1-1999 or OSHA. Q I m being warned it is too loud to test, can I continue anyway? A You may continue the test by accepting this warning. It is important to note that mild hearing loss may not be detected if ambient noise is high. The game will identify which results may be invalid per frequency due to high ambient noise and suggest you retest them, perhaps in a different location. User Manual 25
Symbols Legend Audiogram Threshold Symbols: Symbol Meaning Symbol Meaning Symbol Meaning Left air conduction Right air conduction Air No response to upper limits air conduction, left Left masked air conduction No response to upper limits masked air conduction, left Unmasked bone, left side No response to upper limits unmasked bone, left side Masked bone conduction left side No response to upper limits air conduction, right Right masked air conduction No response to upper limits masked air conduction, right Unmasked bone, right side No response to upper limits unmasked bone, right side Masked bone conduction right side Masked air Bone Too Noisy Unreliable Needs Masking Threshold should be re-tested No response masked bone left side No response masked bone right side No Response Tabular View Abbreviations: Symbol Meaning Symbol Meaning Symbol Meaning NR No response M Threshold was obtained using masking TN Result too noisy +B Bone testing suggested +M Masking suggested? Unreliable Other Software Symbols: Symbol Meaning Symbol Meaning Symbol Meaning Heard a sound Did not hear a sound New Patient Patient Information Upload to Web Portal Notes Add Item / Create New Reorder Item! Warning User Manual 26
SHOEBOX Audiometry Specifications Audiometer Type Type 3 Permissable environmental conditions See ipad technical specifications available on www.apple.com. Permissible power supply variations SHOEBOX Audiometry will only function when ipad is on battery power. Measures to minimise unwanted sound radiation Touch screen interface, no sound is emitted. Identification of the transducers and their reference equivalent threshold levels See transducer calibration certificate for information on transducer calibration. Ear simulator used for calibration As per ANSI s3.6-2010. Static force provided As per ANSI s3.6-2010. Placement of bone vibrator Mastoid Actual bandwidth of narrow-band masking noise Narrow-band masking noise bandwidth is 1/2 octave. Warm up time No warm up time required. See ipad technical specifications on www. apple.com. Sensitivities and nominal impedances of all input facilities. No input facilities. Available voltage and nominal impedance of all output facilities Pin assignment of all external plug connections Mode of operation Rate of change of sound pressure level for automatic-recording audiometers Output is CTIA/AHJ 3.5mm audio output of Apple ipad. See ipad technical specifications on www.apple.com. Output is CTIA/AHJ 3.5mm audio output of Apple ipad. See ipad technical specifications on www.apple.com. Pure tone forced choice modality utilizing a Modified Hughson Westlake algorithm n/a Rate of change of frequency n/a, not a Bekesy algorithm Frequency of modulating signal Warble tone frequency = 5Hz Modulation waveform Sine Modulation range 6% User Manual 27
Sound attenuation characteristics of the earphones as measured in accordance with ISO 4869-1; Maximum hearing level settings provided at each test frequency including limitations in use due to harmonic distortion Effects of airborne sound radiation of the bone vibrator and means to obtain the correct test results. Information about the time window for subject s respose for automated test procedures Type of battery, means of checking the battery and method of replacement, expected battery life time. Maintenance and calibration procedures and schedules. For transducer sound attenuation characteristics, refer to transducer manufacturer documentation. SHOEBOX Audiometry Pro = 120dB HL SHOEBOX Audiometry Standard = 90dB HL No limitations due to harmonic distortion Refer to bone vibrator manufacturer s documentation, reference to compliance with IEC 60645-1. Pure tone forced choice modality does not involve subject response timing. See ipad technical specifications available on www.apple.com. Headphones must be calibrated annually per ANSI S3.6-2010. Calibration procedure verifies correct operation and identifies required maintenance. EMC warning See ipad technical specifications available on www.apple.com. Type of auditory signal Type of transducers and their headband force Pure tones, warble tones, pulsed tones, masking tones, speech recordings Various ANSI S3.6-2010 compliant transducers are available, refer to transducer manufacturer s documentation Sound field system None, not supported. Type of ear simulator or mechanical coupler used for calibration and the method of coupling the transducer Type of calibration Acoustic or Vibratory Signal Level for a given setting of the outputlevel control Polarity of resulting acoustic or vibratory signal See calibration certificate for each transducer. Calibrated in dbhl for known RETSPLs for each transducer according to ANSI s3.6-2010. Control interface displays dbhl based on RETSPL of the currently selected transducer. This is mapped to output voltage level appropriately. Left and right channel outputs produce in-phase sounds and their polarity is set during calibration. Repetition rate Modified Hughson Westlake algorithm is used. Duration of the initial sound pressure or vibratory force wave of a click and/or duration and rise/fall times of acoustic or vibratory tone-bursts. Subjective relationship between test signals and reference signals. Environmental conditions at time of calibration Frequency responses and tolerances in the frequency range from 250 Hz to 4kHz for bone vibrator output Storage As specified in ANSI s3.6-2010 section 7.5.4. RETSPLs from the manufacturers are used to enable normalized hearing level outputs. As specified in ANSI s3.6-2010 and as recorded in annual calibration equipment certification. Refer to bone vibrator manufacturer s documentation. Store ipad and headphone accessories according to accessory manufacturer recommendations. User Manual 28