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Preliminary Clinical and Technical Specifications

Part-financed by the European Regional Development Fund. Preliminary Clinical and Technical Specifications. Any User - Anywhere. Contents. Clinical Considerations Technical Considerations SYSIASS Implementation Project Risk Management Clinical Risk Management.

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Preliminary Clinical and Technical Specifications

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  1. Part-financed by the European Regional Development Fund Preliminary Clinical and Technical Specifications Any User - Anywhere

  2. Contents Clinical Considerations Technical Considerations SYSIASS Implementation Project Risk Management Clinical Risk Management

  3. Clinical Considerations

  4. Users – The Patient Learning Difficulty [LD] Cerebral Palsy [CP] Cerebral Vascular Accident [CVA or Stroke] Traumatic Brain Injury [TBI] GuillainBarre Syndrome Duchenes Muscular Dystrophy Motor Neurone Disease [MND or ALS] Users – The Carers Users – Wheelchair Services and Clinical Engineers Clinical Considerations

  5. Clinical Considerations User Environment Home Care Home School or College Hospital

  6. Technical Considerations

  7. Clinical Goal Any patient Any input device/controller Any environment Carer friendly Any Powered Chair Therapist and Engineer Friendly Technical Considerations

  8. Commercial Powered Chair Control Systems Modular Programmable Multifunction Wide range of controllers/user inputs e.g. Joystick Switches Sip and puff Technical Considerations

  9. Technical Considerations

  10. Technical Considerations Access to the Powered Chair Control System Input by Secondary Remote Switch Input Analogue input Design and Build aMaster Remote Possible Advantages and Disadvantages?

  11. Technical Considerations Advantages and Disadvantages Input through Secondary Remote Switch Input – Forward, Reverse, Left, Right + ….. Manufacturers programmable functions available Focus on control, collision avoidance and navigation Any powered chair system Loss of proportional control Loss of option of using other controls e.g. sip and puff Low risk Analogue Input Proportional Control All the above Higher Risk – not yet available from manufacturer

  12. Technical Considerations Advantages and Disadvantages Design and Build a Master Remote Proportional control possible Any of manufacturers controls can be used Sip and puff Specialised joysticks Attendant control etc Dependent on knowledge of BUS protocols Dependent on manufacturers cooperation Subject to changes in bus protocols Implementation of Master Remote set ups Specific to one manufacturer Focus and resources removed from Specialised controls Collision avoidance Autonomous navigation Medical Devices Directive Compliance more complex Greater Benefits Higher Risk

  13. SYSIASS Implementation • Control System Input • Secondary or Master Remote? • Project Risk vs Benefit • Collision Avoidance and Assisted Navigation. • Control of Other Technology • Environmental Controls • Computer Access • Feedback - Voice and Display • Feedback to user • Chair taking over control • Control commands e.g. selected direction • Route Selection

  14. SYSIASS Implementation Display - multifunction? – e.g. communication aid Recording User Input Learning? Health? Progression of Condition? Response to rehabilitation? Training of user over simulated routes Transmission of Chair Location System settings User performance

  15. SYSIASS Risk Management Maximise Benefit & Minimise Risk What are the Novel Aspects of this project? What is already available commercially? What are the priorities? What is the Project Plan? Coordination of the three Activities and Clinical Evaluation Necessary for application for Ethical Approval

  16. Clinical Risk Management Medical Devices Directive Requirements for Clinical Evaluation Technical File development Ethics Approval

  17. SYSIASSAny User - Anywhere Thankyou

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