Product Design Specification BME 301 Portable Patient Training Device for Lung Cancer Treatment Team Members Thomas Chia Leader Jason Ethington BWIG Brent Geiger BSAC Kawai Chan Communicator Advisor Willis Tompkins Ph D Revision date April 30th 2004 Problem Statement 4 D tomotherapy treatment outcomes for lung cancer depend on the stability and repeatability of a patient s breathing pattern A portable patient training system is desired to allow more practice for the patients The portable device will measure a patients breathing pattern then display the guiding cycles and provide feedback on the patient s current breathing curve on the display of a Pocket PC Client Requirements Device should be portable and be able to be used at the patient s home Display should show patient s breathing pattern superimposed on the guiding cycles Device should be easy to use and comfortable for the patient The client envisions three major components to the device 1 Breathing measurement device 2 Signal processor 3 Personal Digital Assistant PDA software Design Requirements Physical and Operational Characteristics a Performance requirements Must be portable and intuitive to use by the patient Able to be attached operated solely by the patient Simple to operate and as unobtrusive as possible b Safety Must not harm patient in any way Device will not have any sharp areas exposed wires or abrasive material All wires electrical components should be consolidated into one location and should not come in contact with the patient All currents and voltages used should not pose any risks to the patient Minimal effort needed to transport and operate device c Accuracy and Reliability Must be able to accurately calibrate the patient s natural breathing cycle Afterwards must accurately measure that patient s breathing in real time and display its position in reference to the guiding cycle d Life in Service e f g h i j k Must be in service for as long as patient is able to utilize the device PDA batteries should be replaced when necessary Proper operation should be checked for each week Major calibration checked for every patient Shelf Life The shelf life will be five years stored at room temperature in a dry location Operating Environment This device will be used in a home environment It will be subjected to constant use by multiple patients The device may be subjected to fluids and or dust caused by everyday use Ergonomics Device should be comfortable and not affect the patient s natural breathing pattern PDA display should be easily readable Device should not require significant strength to assemble Size The device must fit for a range of bodily sizes Needs to be easily portable for the patient and contained in a box for easy transport Weight The entire device should not weigh more then 2 kg Materials There are no restrictions on materials Aesthetics Appearance and Finish Device should not appear dangerous or fragile to the patient Production Characteristics a Quantity One prototype b Target Production Cost 600 Miscellaneous a b Standards and Specifications Human subjects testing approval may be required Competition No devices are known that accomplish this goal
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