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Support Device for the iSCAN Anna DiRienzo Katelyn Lesk Amber Loree Jude Menie Daniel McChesney, MD April 13, 2007. Outline. Background Methods/Materials Conceptual designs Testing Methods Results Discussion Future Directions. Background on ICP measurement. ICP (intracranial pressure)
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Support Device for the iSCANAnna DiRienzoKatelyn LeskAmber LoreeJude MenieDaniel McChesney, MDApril 13, 2007
Outline • Background • Methods/Materials • Conceptual designs • Testing Methods • Results • Discussion • Future Directions
Background on ICP measurement • ICP (intracranial pressure) • Key indicator for various neurological diseases and trauma • Traditional measurements • Noninvasive measurements
Background of the iSCAN • Function • Applies pressure to the exterior of the eye • Images the central retinal vein (CRV) • Relates changes in the CRV to intraocular pressure • Necessity • Other uses • Regulation: Class II device; de novo – 510(k)
Background cont. • Parts: Lens, means to monitor applied pressure, visualization screen, control pad • Advantages: Noninvasive, single handheld unit • Disadvantages: Sterilization, difficult positioning, hard to stabilize, high risk of patient injury
Necessity of Support System • Increases stability of iSCAN and ease of use in an emergency room setting • Prevents excessive applied pressure • Reduces risk of iSCAN dropping onto patient
Client Requirements • Support a weight analog of the iSCAN (approx. 4 pounds) • Mobile • Sterilizable • Compact and easy to store • Stable within its expected range of motion • Large and small adjustment
iSCAN Initial Designs • Design 1: Pivoting support system
iSCAN Initial Designs cont. • Design 2: Over the hospital bed iSCAN support
Initial Designs cont. • Design 3: Hospital cart as base of the support system
Current Prototype • Conceptual design • IV pole • Universal clamp with IV handle attachment • 90 degree L-plate • Flexible gooseneck
Methods of Testing • Stabilization • Sterilization • Strength • Positioning
Stabilization • Pressure was applied to places that will most commonly come into contact with unintended forces • Gooseneck and IV pole • Times were recorded until the area of the attachment to the end of the gooseneck stopped vibrating • Four trials for four different people
Results: Stabilization • Average vibration time with 5 lb load: • Striking gooseneck: 2.1 seconds • Striking IV pole: 2.1 seconds • Average vibration time without 5 lb load: • Striking gooseneck: 3.6 seconds • Striking IV pole: 3.3 seconds
Sterilization • EtOH was applied to each novel surface of the support system once a day for one week
Results: Sterilization • Visually inspected everyday for one week with EtOH • No deterioration observed
Strength • Added weights in 2.5 lbs increments until unstable • Each weight increment was held stable for 5 minutes • Failure in this test was defined as instability at a time less than 5 minutes
Strength cont. • Two positions were tested: Maximum Normal
Results: Strength • Normal position • A weight of 7.5 lbs was held for 5 minutes • No additional weight was tested • Maximum position • A weight of 2.5 lbs was held for 5 minutes • A weight of 5 lbs was tested but was taken off after instability was observed (1.5 inch drop in gooseneck position)
Positioning • Range of motion was determined in the following directions: • Lateral • Vertical • Distance from IV Pole • Normal vs. Maximum gooseneck
Results: Positioning • Lateral • 16.5 inch range if base is immobilized • Vertical • Maximum height of 55 inches • Distance from IV Pole • Normal gooseneck - 19.5 inches • Maximum gooseneck - 22 inches
Milestones Sept Oct Nov Dec Jan Feb Mar Apr Project Ideas Conceptual Designs #2 #1 #3 Parts Ordered Prototype Building Prototype Redesign Parts Ordered Testing All parts of this project were contributed to equally by all members of this group
Discussion • Supported more than twice the weight analog of the redesigned iSCAN • Mobile, accomplished by six swivel wheels on IV pole base • Sterilizable - using EtOH • Compact and easy to store • Mechanically stable within its expected range of motion • Large adjustment
Future Direction • Vertical Tracking System • Locking Wheels • Animal Testing
Acknowledgments • Neurolife - Noninvasive Neurosurgical Solutions • Daniel McChesney, MD • Optomation • Nobuhiko “Poohsan” Tamura, Ph.D • Financial Support • Drs. Hal Wrigley and Linda Baker • Department of Bioengineering