CDRHAdvisoryCommitteeMeetingOrthopedicand详解.pptVIP

CDRH Advisory Committee Meeting:Orthopedic and RehabilitationDevices Panel November 20, 2002 INDEPENDENCE? iBOT? 3000 Mobility System Independence Technology CDRH Review Team Robert J. DeLuca, MS (Engineering) CAPT Marie A. Schroeder (Clinical) Phyllis M. Silverman, MS (Statistics) Laurel Mendelson, MS (Patient Labeling and Human Factors) Donald Witters, MS (EMC) Joseph Jorgens III (Software) William Defibaugh, BS (Manufacturing) Presentation Overview Non-Clinical (Robert J. DeLuca) Introduction Device Description Qualification Testing Electromagnetic Compatibility Clinical (Marie A. Schroeder) Indications for Use Pivotal Study Summary Assessments and Training Safety Effectiveness Analyses Human Factors Device Description Main Components User Seating/Support System User Control Panel Power Base Battery and Battery Charger Unique Features Dynamic Stabilization (I-Balance Technology) Multiple Operating Functions Five Operating Functions Standard Function 4-Wheel Function Balance Function Stair Function Remote Function Standard Function Similar to conventional powered wheelchair Casters contact ground: provides good turning performance and mobility on firm, level surfaces (e.g., indoors, sidewalks, pavement) Dynamic stabilization not used Inclines up to 5 degrees Obstacles up to 1/2 inch Maximum Speed: 1.8 – 5.7 mph Range: 9.3 miles 4-Wheel Function Four drive wheels contact ground (casters are elevated): provides good performance and mobility on soft or loose terrain (e.g., outdoors on dirt, grass, gravel), and for traversing small curbs and obstacles. Dynamic stabilization is used Inclines up to 8 degrees Obstacles up to 4 inch (e.g., small curbs) Maximum Speed: 2.0 – 3.4 mph (depending on template) Range: 7.4 miles Balance Function Only one pair of drive wheels makes contact with the ground Provides mobility at an elevated height Enables eye-level conversations Can be turned on or off by clinician Can turn in conf