User Manual - Shoebox Audiometry

Transcript

User Manual - Pro Edition - Table of Contents Introduction 3 Patient Home Screen 4 Automatic Pure Tone Test 7 Manual Pure Tone Test 10 Speech Discrimination Test 13 Managing Patients Creating Patients Editing Patient Details Deleting Patients Starting Activities Viewing Results 5 5 5 5 6 6 Setup 7 Analyzing Background Noise 7 Playing the Game 8 Retesting 9 Configuration 9 Setup 10 Analyzing Background Noise 10 Performing the Test 11 Presenting Tones 11 Indicating Thresholds 12 Masking 12 Notes 12 Configuration 12 Setup 13 Analyzing Background Noise 13 Performing Test 14 Presenting Words 14 Pausing the Test 14 Progressing the Test 15 Configuration 15 Questionnaire 16 Completing a Questionnaire Configuration 16 16 Settings 17 Test Types 17 Speech Test 17 Transducers 17 General 17 Troubleshooting 18 User Manual 1 SHOEBOX is manufactured by 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). Rev: D 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 from which all tests and patient management starts. This screen is broken into 3 main sections: 1 2 3 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. On the left you will find a list of all the patients included in the currently selected project. To the top right, you’ll find activity action buttons. On the bottom right you’ll find all the test results for the selected patient. View past results for the selected patient and tap an item to view more details. User Manual Tap the project selection dropdown to switch projects. Use the action buttons to start new tests or questionnaires for the selected patient. 4 Managing Patients Creating Patients New patients can be created by tapping the create patient button 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” button 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 Warning! Deleting a patient will cause it to be deleted both on the iPad and in the Cloud Web Portal. All test data associated with that patient will also be deleted. 5 Starting Activities Viewing Results 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: 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 Pure Tone 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 Start by plugging in a calibrated transducer and selecting it from one of the options displayed. Be sure you select the same transducer that you plugged in. If you only have one transducer enabled SHOEBOX will skip this step and automatically select the only available transducer. Did You Know? Transducers can be enabled or disabled in the “Transducers” section of the Settings. 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. Once the transducer is selected, you’ll be prompted to place the headphones on the patient. Analyzing Background Noise When starting an automated test, SHOEBOX 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. User Manual 7 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. Tone Not Heard Tone Heard * Remember, ANY sound heard should count as a positive response. 2 User Manual The patient will be required to repeat this action many times, and will often drag to the Tone Not Hear icon. SHOEBOX 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 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 utalized. 1 Touch down on the object to make it present a tone. Drag the object to an icon indicating whether or not a sound was heard. 8 Once all selected frequencies are tested, the game will conclude and the audiogram results will be displayed. If you have your 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 fine 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. Needs Masking Retesting Configuration 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 circles 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. To configure the Automated Pure Tone Test for your practice visit the “Test Types” section in the SHOEBOX Settings. User Manual 9 Manual Pure Tone 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. SHOEBOX will automatically detect whether you’ve selected a bone or air transducrer and will plot the apropriate 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 currently have connected. Analyzing Background Noise The Manual Pure Tone Test does not automatically analyze the room background noise before starting the test but this action can be initiated at any point from the Menu in the top right corner of the screen. User Manual 10 Performing the Test When you’re ready, present a tone at the chosen frequency and volume by touching and holding the “Tone” button for the desired duration. 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 just above. By default, a standard pure tone will be presented. This can be changed by tapping the tone selection box located under the transducer selection box. Other availible options include a warble tone, and a pulse tone. Tap a point on the chart to quickly select the frequency and volume together. Tap the left or right audiogram chart to set the current ear being tested. User Manual 11 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 clear the threshold at the currently selected point. Masking If you determine that masking should be used to more accurately determine a threshold it can be enabled by turning on the “Masking” toggle. The masking volume can be adjusted at any time. Configuration Some additional configuration for the Manual Pure Tone Test activity is available in the “Manual Hearing Test” section of the SHOEBOX Settings. Notes Notes can be added per ear to a manual test by tapping the “Notes” button located beside the chart ear lable. User Manual 12 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. 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. 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 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. 13 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 icon 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 administer 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 14 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 Settings. 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 15 Questionnaire Completing a Questionnaire A questionnaire can be used to gather more information about how a patient’s hearing is affecting their quality of life and what treatment options they would be best suited for. 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 Settings. Tap the answer box beside a question then select an option from the pop-up menu. User Manual 16 Settings Once you’ve successfully installed the SHOEBOX Pro program and have completed the setup wizard, you’ll be able to customize the iPad Audiometer to meet your own preferences. To do so, tap the Settings icon at the top left of the Patient Home Screen. Test Types Use this section to customize the Automatic 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 tested in by tapping the ‘Frequencies’ section and then touching and dragging the ≡ symbol to reorder each frequency. • Choose which types of games are used and what order they are tested in. • 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. • Choose which audiogram symbols are used in the audiogram. User Manual Manual Hearing Test This section will let you configure the Manual Hearing Test. In this section you can: • 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. • 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 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 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. 17 Transducers SHOEBOX automatically downloads all the calibration information for the transducer(s) you’ve purchased with your system. Once downloaded you’ll find them listed in the ‘Transducers’ section of the settings. Here you can tap to perform daily performance tests and enable or disable your transducers. When only one transducer is enabled SHOEBOX can speed up test setup times by skipping the transducer selection step. General In the General Settings section you’ll find a variety of additional configuration options should you require them. These settings include: • Audiogram email - enter a default email address which will be the address to which results are emailed fram. • Enable/disable SHOEBOX passcode • Enable/disable SHOEBOX lock screen • Frequencies used for calculating PTA • Which patient questionnaire should be used when a Questionnaire activity is started • Enable/disable Web Cloud Portal sync User Manual 18 Troubleshooting Q What is the best way to test younger children? Q What thresholds are being used to identify that a patient requires further testing? A There are three approaches to using SHOEBOX A The test will go down to 10 dB. Normal hearing for testing children, based on their age and attention span. 1 Children older than 6 can test themselves. Explain the game once at the first frequency and then let them play on their own. 2 For younger children 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. is usually considered to be anything 25dB or less. Anything greater than 30 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 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 organizations privacy requirements. Q What are the recommended ambient noise levels used? A Q A The American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms (MPANL ANSI S3.11999) should be referenced for the specific type of headphones you are using. I’m being warned it is too loud to test, can I continue anyway? 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 due to high ambient noise and suggest you retest them. User Manual 19