D-EYE App Guide. App Version. Description

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D-EYE App Guide - SDE1312W10004 last review 5 October 2017 11:54 AM D-EYE App Guide App Version iphone 2.0_15 2.0 Description D-EYE Srl Via Niccolò Tommaseo 77 35131 Padova, (PD), Italy Tel.

1 D-EYE App Guide - SDE1312W10004 last review 5 October :54 AM D-EYE App Guide App Version iphone 2.0_ Description D-EYE Srl Via Niccolò Tommaseo Padova, (PD), Italy Tel info@d-eyecare.com ISO 9001:2008 i EN ISO 13485:2012 Consult D-EYE User Guide for use: link The portable D-EYE retinal and eye examiner attaches to a smartphone to record high-resolution images and video of the interior of the eye for ophthalmic and clinical assessment. The innovative fundus lens system allows regular screenings of the eye providing specific information about noticeable eye diseases, and it also can be used as a pre-screening recording device for further evaluation of specific medical conditions. The low-cost D-EYE system will enable sharing the images and related data via smartphone or other app, facilitating wide-spread screening anywhere, even in developing countries, bringing critical eye screening services to people in the most remote locations. CAUTIONS For safety reasons the D-EYE App does not work on jailbreak Apple smartphone. Install and later versions for Apple devices with ios 10. The supported smartphones are iphone 5/5S, SE, 6/6S, 6+/6S+ and 7. INSTALLATION NOTES FOR IPHONE Make sure that your date, time, and time zone are correct. Tap Settings > General > Date & Time Make sure that you can install 17+ years restricted app. Tap Settings > General > Restriction. Then disable restriction or select 17+ in Allowed Content: > App. The final design, including color, may differ from printed images. Copyright D-EYE Srl. All Rights Reserved. D-EYE, D-EYE Vet and the D-EYE Smartphone Based Retinal Screening System are trademarks of D-EYE Srl.

2 2 / 21 D-EYE App Guide - Index INDEX D-EYE Description Index Installation Sign up Sign in, Touch ID and Password recovery Homepage Description Manage User Profile LAN Share How to use the LAN share Patient definition Find a patient Create a patient Transform the incomplete patient profiles into the complite Review definition Find a local review Result Parameters Check the exam and share it Delete the images into the review Image and Video editing Report in pdf Start a review Camera advanced controls and diabetes info Review option - Multishot Review option - Video Configure the Focus Help Notification D-EYE Version Technical Description Contact Information

D-EYE App Guide - Installation and Sign in INSTALLATION D-EYE is easy to learn and simple to use.

Firstname, lastname, username, password and SN are mandatory fields. You insert the Serial Number manually or by scanning the bar code on the box or on the D-EYE lens.

SIGN IN, TOUCH ID AND PASSWORD RECOVERY Username 3 4 5 READ THE DISCLAIMER CARE- FULLY.

3 D-EYE App Guide - Installation and Sign in INSTALLATION D-EYE is easy to learn and simple to use. Download the smartphone app (by searching for D-EYE on the App Store), affix the mounting bumper and fundus lens, set up patient/ exam file, focus the phone s camera and begin recording. It s that easy, that simple. Once downloaded, launch the D-EYE app and sign up. SIGN UP Scan the SN code on the box Username (*) Serial number on the box 1 2 Fill out all fields to register. Firstname, lastname, username, password and SN are mandatory fields. You insert the Serial Number manually or by scanning the bar code on the box or on the D-EYE lens. After sign up you will receive an e- mail with the verification link. You shall click on this link before using the app. SIGN IN, TOUCH ID AND PASSWORD RECOVERY Username READ THE DISCLAIMER CARE- FULLY. You must accept and confirm the rules and the restrictions of the disclaimer to access the D-EYE login page. Log into the D-EYE app. If you don t remember your password, click on Forgot and recover the password. If you have not registered, click on Signup. 3 / 21 Selecting the Touch ID you can connect with the fingerprint. (This works when the switch is enabled and when you already are logged at least once with the password entered manually). Touch ID is not supported on iphone 5.

4 4 / 21 D-EYE App Guide - User Profile SIGN IN AND PASSWORD RECOVERY On first access after registering the application asks to set some preferences. For security purposes, the password may expire. Simply insert a new one as directed. 6 Setup your preferences: Advanced camera controls: enable greater controls on the camera; Diabete field on exams: more fields for the info on diabetes; 7 If your password has expired, the app describes how best to set up a password. MULTIUSER The D-EYE App can be used by multiple users. The datas and informations of each user are not shared among users who use the same device. The app configurations and Camera advanced controls (n.6 in this page) are shared among all app users on the same device. HOMEPAGE In help, there are some tips and setting to improve the app use. In help, there are some tips and setting to improve the app use. Area for doctor name and doctor . Doctor picture Logout doctor@ .com Profile Doctor profile to check the D-EYE licenses and other profile info. Button to performe a new review Button to search the patients Button to search the local reviews Button to read about the pathalogies Button disappears after the first click. It serves to provide a quick reference on use of D-EYE application

5 D-EYE App Guide - User Profile MANAGE USER PROFILE After the registration, the doctor can edit your profile any time. doctor@ .com Profile General practitioners 8 Clicking on the doctor image, adds your picture. Clicking on edit, adds your info: name, birthyear, specialization, nationality, SN... 9 Save your profile that can be edited at any time. LAN SHARE The doctors share the examinations with own computer. The App creates a Local Area Network with the doctor s computer in order to share the examinations without the DIV service. Name 10 Click on Wizard Configuration to configure the sharing the examinations with your computer by the local area network. 11 Fill out all fields to connect to your computer by the local area network. Click on the Wizard configuration to find your computer. Insert the username and password that you normally use to access your PC. In the Folders insert the path to the folder on your desktop with whom to share the exams. (for example: users\ username \desktop\ folder name ). 5 / 21

6 D-EYE App Guide - User Profile HOW TO USE THE LAN SHARE After the LAN connection with the computer, it s possible to share the local reviews. Local Reviews doctor@ .com Alberto Scarpa Profile 12 Clicking on local reviews. 13 Select the review that you want to share. Open it. 14 Clicking on the share icon to copy the examination on the computer. Click Lan to share 15 After the LAN sharing, find your examinations on your computer. 6 / 21

7 D-EYE App Guide - Patient Management PATIENT DEFINITION Patients, saved by the application, are divided into patients with complete profiles and incomplete profiles. The complete profile is a profile with the fields NAME, SURNAME, BIRTHDATE, PATIENT ID completed. The incomplete profile is a profile with at least one NAME, SURNAME, BIRTHDATE, PATIENT ID of the fields not completed. The doctor decides to speed up the examinations when he has many patients and complete the profile later. Through the application, both profiles are accessible. It is preferable to have complete profiles and avoid incomplete profiles. When you save a patient, the application checks whether a patient with similar parameters already exists in your patients list in local. In such a case, the application prompts the user to merge the contacts in a single profile so as to avoid duplication: John Doe xxxxxxx John Doe xxxxxx John V. Doe 7 / 21

8 / 21 D-EYE App Guide - Patient Management FIND A PATIENT The Patient page is split in two sections: Search and Incomplete. On the first line you have a selector to move between the sections.

Use the search boxes, for compound words as name, surname, birthdate and patient ID to find a patient. John Doe john.doe@email.

8 8 / 21 D-EYE App Guide - Patient Management FIND A PATIENT The Patient page is split in two sections: Search and Incomplete. On the first line you have a selector to move between the sections. In the Search one you have the search fields to search a patient. In the Incomplete there is the list of patients with an incomplete profile. Use the search boxes, for compound words as name, surname, birthdate and patient ID to find a patient. John Doe john.doe@ .com Profile (0) John Doe (Male) John Doe xxxxxx Jane Doe xxxxxx Joe Bloggs xxxxxx John V. Doe Select Patients on the home screen. Once the search, a list of names of patients appears below the search form. Clicking on the patient to see his medical reviews. In the medical reviews of each patient you view the list of the selected patient exams. CREATE A PATIENT Create a patient by filling all fields John Doe john.doe@ .com Profile ID Patient ID Patient 27 Select Patients on the home 28 Select Add to save a new patient. 29 screen. Click on Save to save the profile. If the fields are completed, the profile is complete. If at least one field is not completed, the profile will be saved as incomplete.

9 D-EYE App Guide - Patient Management TRANSFORM THE INCOMPLETE PATIENT PROFILES INTO COMPLETE The incomplete profile becomes the complete profile when each field is filled in with information. Edit (1) 30 Click on patient s name to fill in the 31 Edit the incomplete profile. missing information. Next to the patient s name there is 32 the icon showing that this is an incomplete profile. Editing the patient s profile, you merge the incomplete patient with an existing profile. In such a case, the application prompts the user to merge the contacts in a single profile so as to avoid duplication. (24a) If there is no duplicate patient name, the profile will be recorded as a new patient. (24b) Alberto Bianchi 12 Jan 1964 Alberto Bianchi xxxxxx Alberto Boe 33a The D-EYE App identifies a possible profile s duplication (patient profiles with similar name/information) and asks to verify the profile match with a list of patients suggested. If you have matches you choose one of the patients in the list. 9 / 21 33b If there are no duplicates, the profile will be saved as a new patient.

10 10 / 21 D-EYE App Guide - Review Management REVIEW DEFINITION The Review contains these parameters: PATIENT NAME, RECOMMENDATION, presence of DIABETES, ASSESSMENT, NOTE AND VISU- AL ACUITY. If Healthcare Professionals save the exam without fulfilling all the parameters, the review is incomplete and can not save it. A filter is available in the reviews page to view only the incomplete review. The exam will be synchronized with your computer. FIND A LOCAL REVIEW The Review page is split in two sections: Search and Incomplete. On the first line the doctor has a selector to move between the sections. In the Search section there is the search field to search a review. Search the exam by name, diagnosis, note and recommendation. In the Incomplete section there is the list of exams with an incomplete review (as previously mentioned the doctor can not save an incomplete examination, but this section ensures the recovery of the exams if there was an error during image acquisition). The icon, next to the patient s name, indicates that the review is shared via LAN. Local Reviews John Doe john.doe@ .com Profile Assessments 34 Click on reviews icon. 35 Search the exam by name, diagnosis, note and recommendation.

11 / 21 D-EYE App Guide - Review Management RESULT PARAMETERS The review information includes: PATIENT NAME, RIGHT

Patient s name Diabetes and Insulin Type: Those two pieces of information are diabetes type and insulin dependent.

patient s exam. New acquisition is the way to start a new examination. Acquisition is the gallery of all examinations.

Visual Acuity: Assessments: The identification of the pathology.

11 11 / 21 D-EYE App Guide - Review Management RESULT PARAMETERS The review information includes: PATIENT NAME, RIGHT EYE OR LEFT EYE OR BOTH, RECOMMENDATION, DIABETES INFO, DIAGNO- SIS, NOTE AND VISUAL ACUITY. Patient s name Diabetes and Insulin Type: Those two pieces of information are diabetes type and insulin dependent. New acquisition and acquisitions: Assessments Recommendation: The doctor can suggest the best action to apply to the patient s exam. New acquisition is the way to start a new examination. Acquisition is the gallery of all examinations. The number in parentheses indicates the number of media acquired. Visual Acuity: Assessments: The identification of the pathology. Associating a pathology with the exam helps to locate the exam results in the archive, and to classify the exam for discussion with other physicians. The list of diseases is the international classification ICD (International Classification of Diseases) managed by the WHO: Classification_of_Diseases_and_Related_Health_Problems Note: The doctor can insert other note about the examination

12 / 21 D-EYE App Guide - Review Management CHECK THE EXAM AND SHARE IT Check the examination and share it via email or by other application. Share with apps without PHI.

29 Look at the images clicking on the thumbnail.

12 12 / 21 D-EYE App Guide - Review Management CHECK THE EXAM AND SHARE IT Check the examination and share it via or by other application. Share with apps without PHI. Action on the result: Carlo Bianchi - Double tap to zoom in and zoom out - Pinch and Spread to zoom in and zoom out - Swipe right and left to show the image 28 Look at the result of the exam. 29 Look at the images clicking on the thumbnail. DELETE THE IMAGES INTO THE REVIEW ACQUISITION - If images are left in the D-EYE app they can be shared using mail or text and can also be moved to the camera roll. In both cases, patient information will be removed by the D-EYE app for privacy reasons. Through post-exam editing using a third party application, you cut the video A review can be edited only during the review acquisition. The images and videos can only be deleted while performing an examination. Any changes have to have to be made before pressing the save button. 30 Click on delete when the image is opened.

D-EYE App Guide - Review Management EDIT IMAGES AND VIDEOS INTO THE REVIEW ACQUISITION CAPTURE FRAME FROM VIDEO DURING THE EXAMINATION MODE Capture frame from video only during the

31 Click on Edit button 32 Click on left and right or swipe left-right to identify your perfet frame and click on plus button to add the frame into the patient s album 34a If you

13 D-EYE App Guide - Review Management EDIT IMAGES AND VIDEOS INTO THE REVIEW ACQUISITION CAPTURE FRAME FROM VIDEO DURING THE EXAMINATION MODE Capture frame from video only during the review acquisition. The videos can only be edited while performing an examination. Any changes have to have to be made before pressing the save button. 31 Click on Edit button 32 Click on left and right or swipe left-right to identify your perfet frame and click on plus button to add the frame into the patient s album 34a If you decide to not delete the source video, it remains in the medias. 33 Click done when you ve captured all the frames you need 34b If you decide to delete the source video, it doesn t remain in the medias. 13 / 21

Any changes have to have to be made before pressing the save button.

apply to the image IMAGE EDITING REPORT IN PDF 36 Many filters and

14 D-EYE App Guide - Review Management EDIT IMAGES AND VIDEOS INTO THE REVIEW ACQUISITION EDIT IMAGES DURING THE EXAMINATION MODE Edit image only during the review acquisition. The images can only be edited while performing an examination. Any changes have to have to be made before pressing the save button. 35 Edit the review images 36 Choose which type of adjustment you want to apply to the image IMAGE EDITING REPORT IN PDF 36 Many filters and functions to edit acquired images and improve their quality. 36 Create the report in pdf with the patient and examination info. 14 / 21

15 / 21 D-EYE App Guide - Perform a Review START A REVIEW Verify that the

Select the patient from the list or add one and click Activate.

CAMERA ADVANCED CONTROLS AND DIABETES INFO The D-EYE smartphone app allows

15 15 / 21 D-EYE App Guide - Perform a Review START A REVIEW Verify that the mounting bumper and D-EYE lens are firmly attached to the phone and start the examination. To begin, click on New Review and set up the parameters for the examination. John Doe john.doe@ .com Profile 37 Select New Review. 38 Choose Right OD or Left OS or both of them. Select the patient from the list or add one and click Activate. 39 Start the examination clicking on new acquitision. CAMERA ADVANCED CONTROLS AND DIABETES INFO The D-EYE smartphone app allows you to access advanced controls for the camera. Click on settings and turn on the advanced camera controls. The diabetes field can also be turned on or off. The doctor choose whether to display the information on diabetes.

16 16 / 21 D-EYE App Guide - Perform a Review REVIEW OPTION - MULTISHOT The application allows you to record the examination either as a series of still images (Multishot mode) or a full motion video. In Multishot mode, the camera will take a sequence of still shot images. You check the number of images taken and the time between shots in the Settings section of the app. 40 Select Multishot mode. 41 Before performing the examination configure the settings of LED clicking on 42 icon. Click on the slider and the button near the icon to adjust the intensity of the LED or to turn it off. Click on the slider near the icon to adjust the exposure for the contrast. Click on the to adjust the brightness. Click on the gray circle to start recording and wait for the acquisition of a sequence of images. Adjustments of light and exposure are stored for the next examination. Press the icon to reset all the adjustments. If you are examining patients with dark brown eyes, increase the brightness slider. If eyes are lighter, decrease the brightness slider. If you choose the dilated eye or the manual configuration of the focus, the icon appears that allows you to set the focus manually. 43 When the Multishot photo sequence is complete, you will see the Examination page and the multiple images that were taken during the exam. To view an enlarged image of a photo, press on the image until the larger version appears on the screen. Add the patient s name if you have not done so before starting the examination. Add more information like diabetes type, recommendation, assessments... From Help on the home page it s possible to active the more advanced controls of the camera. Clicking on the Settings to switch the control.

17 17 / 21 D-EYE App Guide - Perform a Review REVIEW OPTION - VIDEO In addition to Multishot mode, the D-EYE app allows to record the retina examination in full motion video. The video mode is helpful for obtaining a complete panoramic view of the posterior of the eye, as the doctor is able to move the phone up and down, and side-to-side to capture a full view. Through post-exam editing, select the very best frames for archiving (and reducing the video file size). 00:00 45 Enter the patient, configure the examination for either left or right eye viewing, and select Video mode Before performing the examination configure the settings of LED clicking on icon. Click on the slider and the button near the icon to adjust the intensity of the LED or to turn it off. Click on the slider near the icon to adjust the exposure for the contrast. Click on the to adjust the brightness. Click on the red circle to start recording. The red circle will turn to a red square when the recording begins. To stop the recording, just press the red square. Adjustments of light and exposure are stored for the next examination. Press the icon to reset all the adjustments. If you are examining patients with dark brown eyes, increase the brightness slider. If eyes are lighter, decrease the brightness slider. If you choose the dilated eye or the manual configuration of the focus, the icon appears that allows you to set the focus manually. 48 When the Video is complete, you will see the Examination page and the videos that were taken during the exam. Add the patient s name if you have not done before starting the examination. Add more information like diabetes type, recommendation, diagnosis... 00:00 From Help on the home page it s possible to active the more advanced controls of the camera. Clicking on the Settings to switch the control.

$The app asks some questions about dilation and refractive error, and then indicates on how to set the focus. If the user is an advanced user, use the manual configuration of the focus.$ $49a Select and configure the degree of the refractive error. Just follow the on-screen instructions.$

18 18 / 21 D-EYE App Guide - Perform a Review CONFIGURE THE FOCUS To set the camera focus step-by-step before starting the examination, by following the guide on the screen of the smartphone. The app asks some questions about dilation and refractive error, and then indicates on how to set the focus. If the user is an advanced user, use the manual configuration of the focus. Locking the auto-focus mechanism of smartphone camera is a key step before conducting your D-EYE retinal exam. Just follow the on-screen instructions. 49a Select and configure the degree of the refractive error. Just follow the on-screen instructions. 49 Configure the examination for either left or right eye viewing, select multishot or video mode and press Start Examination to begin the automatic setup of the focus. 49b If you want skip the focus setup step by step, you can click on manual and you can set the led with own preferences. A Without error selected: The application sets the focus automatically to proceed with the examination. A B C B With hyperopic error selected (pupils less than 3mm): 1. Select the diopters; 2. The application sets the focus automatically to proceed with the examination. C With myopic error selected (pupils less than 3mm): 1. Select the diopters; 2. The application sets the focus automatically to proceed with the examination.

19 / 21 D-EYE App Guide - Support HELP Learn about D-EYE products, view online manuals, get

Get service, support, and professional advice from the D-EYE team. John Doe john.doe@email.

email to us at customerservice@d-eyecare.

Issues and troubleshooting requests; or download the User manual.

can re-view it by clicking on Help/First steps help.

It s possible to reactivate the assistance mode from the Help menù.

19 19 / 21 D-EYE App Guide - Support HELP Learn about D-EYE products, view online manuals, get the latest downloads, and more. Get service, support, and professional advice from the D-EYE team. John Doe john.doe@ .com Profile Clicking Help will open a menu of options By selecting Support you open an to us at customerservice@d-eyecare.com to send us: Feedback on reactions to the product (device + app); Support, Technical Issues and troubleshooting requests; or download the User manual The first steps help appears when you first log in, by clicking on the button: You can re-view it by clicking on Help/First steps help. At the first launch of the D-EYE App, the assistance mode is active. It s possible to reactivate the assistance mode from the Help menù. When you turn on the Assistance mode, you can use the D-EYE Assistant to teach how to use the app as best as possible and to explain various steps through tooltips. Select Assistance mode on the support screen. Just after installing the application appears the tutorial that tells you what is the d-eye and how to use it.

20 / 21 D-EYE App Guide - Support NOTIFICATIONS The app is always in touch with you. If there are updates to our App you will be notified and can read the updates by pressing the bell icon.

20 20 / 21 D-EYE App Guide - Support NOTIFICATIONS The app is always in touch with you. If there are updates to our App you will be notified and can read the updates by pressing the bell icon. The notification area is divided into two parts. One for the warnings and one for the notifications. In the warnings, the D-EYE App will alert you if: you have an incomplete patient; you have some possible matches with other patients (some name, surname, ID,...); you don t have internet connection; In notifications, the D-EYE App will send you some info from the D-EYE Team. John Doe john.doe@ .com Profile You can access the notifications available for you. Read the warnings or the notifications. D-EYE APP VERSION To control the D-EYE application version installed: Tap on Settings / General / Storage & icloud Usage / Manage Storage (Storage section) / D-EYE App

21 D-EYE App Guide - Some D-EYE Info TECHNICAL DESCRIPTION Supported Electronic Camera Devices: iphone 5/5S/SE, 6/6S, 6+/6S+, 7 Patient Pupil Size: 3mm diameter or greater Field of View: 5-8 with undilated eye, with dilated eye Illumination: White light LED (provided by electronic camera device) Working Distance: mm Diopter Correction: -10D to +8D autofocus accommodation Image Size: 864x1536 Pixels (100 Kbyte/img) with iphone 6S Image Format: JPEG Video Size: 1280x720 Pixel (660k/sec) Video Format: MP4 Software: Downloaded from App Store and Google Play D-EYE Lens sizes: (50,51 x 20,99 x 9,7)mm D-EYE Packaging Weight: 227 g Lens with bumper Weight: 27 g Power Source: Internal smartphone camera battery CONTACT INFORMATION D-EYE Srl Headquarter Via Niccolò Tommaseo Padova, (PD), Italy Tel Fax US Sales and Marketing T: Keep in touch info@d-eyecare.com website: Need help support@d-eyecare.com 21 / 21

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