Low-Cost Fundus Camera Detailed Design Review

Project Background A fundus camera is used to photograph the retina to provide information about a patient's eye. Diabetic retinopathy is a complication associated with diabetes, eventually leading to blindness. Most people will only see a specialist after damage to the retina has occurred Used exclusively in an Opthamologist's office With proper care, patients with retinopathy can reduce their risk of blindness by 95%. Typically very expensive and heavy [Ask audience about having any corrective lenses] We are project 16590, the Low Cost Fundus Camera and I am Casey Petzel, the EDGE lead. A fundus camera is typically a medical imaging device to used diagnose diabetic retinopathy, a disease that can cause blindness if not caught early enough. This poses a problem because symptoms are typically noticed after the retina is damaged then where a patient would see an Ophthalmologist. These devices are normally stationary, heavy and mydriadic, a chemical dilation of the eye; something that many people like to stray away from. After looking at current commercial products and taking aim at the goals of our customer, we have developed what we would like to correct for our fundus camera.

Problem Statement Due to the need for pupil dilation, specialized camera equipment, staff, and facilities, diabetic patients often do not receive regular screenings. By creating a low-cost, portable, and easy to use fundus camera, screening for retinopathy in diabetic patients can be performed by a general practitioner. Our goal is to create a light, portable and affordable Fundus camera to be used by a General Practitioner, or trained individual. It is important that this does not use chemicals to dilate the retina. This camera would screen the patient for retinopathy, and should anything look peculiar, the screener would recommend going to an ophthalmologist for an official diagnosis.

Software Linux distribution - Ubuntu Embedded program written in Python and Java Python for opening communication ports, and control Java for implementing active video filters and noise reduction. 60Hz flicker filter can be implemented in both GUI written in Java

Hardware ODROID XU-4 ODROID-VU7 (7 inch screen) See3CAM Solid State Drive 8Gb eMMC

Hardware - ODROID-VU7

Hardware - ODROID-VU7

Mechanical Base Preconstructed Base FDA - approved provided by Prof. Sisson FDA - approved Allows for large and fine movements Commercially available

Controls The X and Z axis are controlled using a joystick for fine movements and a loose base for large movements. The Y axis is controlled by a dial connected to a screw allowing for fine movements. The X axis can be locked by tightening a thumb screws.

Additional Mechanical Design (Central housing) The central stand will hold a detachable component which will hold: ODROID-C processor (Green) ODROID-VU7 7in Screen (Black) See3CAM (Yellow) Solid State Drive (Blue) Lens housing (Yellow)

Additional Mechanical Design (Lens housing) By modifying a film based fundus camera we achieve: Has a proven lens structure. Has a dated but optically sound lighting system. This will require: Integrate sensor at correct distance. Replace dated electrical lighting components with LED system.

Mechanical Design Risk analysis Stand is unsecured and is unstable while in transport causing difficulties in portability. Will make Central housing separable allowing them to be transported separately. Team does not own design for stand Central housing attachment to stand will be made adaptable. Lens housing was recovered from an old device. Will make CAD diagrams of the housing to insure ability to duplicate final design.

Illumination and Flash Kowa RC-2 Xenon bulb Infrared lighting required to align camera with pupil while avoiding dilation

Kowa RC-2 Illumination Diagram of Kowa RC-R retinal camera produced to image a rat’s eye. Shows use of a hole mirror (HM), xenon light source (Xe LS), liquid light guide (LLG), source ring (SR), and green filter (GF). Xe light source requires 10W Replace with LEDs? https://www.osapublishing.org/boe/fulltext.cfm?uri=boe-2-11-3094

FDA Requirements Must conform to: ISO 10940: 2009 Ophthalmic instruments - Fundus cameras IEC 60601-1:2005 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Capability – Requirements and Tests; ISO 15004-1:2006 Ophthalmic instruments – Fundamental requirements and test methods – Part 1: General requirements applicable to all ophthalmic instruments ISO 15004-2:2007 Ophthalmic Instruments – Fundamental requirements and test methods – Part 2: Light hazard protection

Form FDA 3654 Form used to ensure compliance standards have been met. Checks that standards match regulations

Form FDA 3654

Current BOM

BOM of Previous Team’s Materials

Additional Items

Budget Overview P16590- MSD I P15590 Prototype Approximate Part Cost Purchased % Budget Spent $2000 $445.63 22.3% Purchased $2087.99 Item Cost $973.19

End of Semester Overview Task Assigned To Due Date Go over design review notes, create new action items if necessary Team 12/10/2015 Put out any extra purchase requests Gate review 12/11/2015 Go over gate review notes Design central mechanical housing Matt TBD Load kernel Cecelia