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

2. Part-financed by the European Regional Development Fund Contents Clinical Considerations Technical Considerations SYSIASS Implementation Project Risk Management Clinical Risk Management 2

3. Part-financed by the European Regional Development Fund Clinical Considerations

4. Part-financed by the European Regional Development Fund Users – The Patient – Learning Difficulty [LD] – Cerebral Palsy [CP] – Cerebral Vascular Accident [CVA or Stroke] – Traumatic Brain Injury [TBI] – Guillain Barre Syndrome – Duchenes Muscular Dystrophy – Motor Neurone Disease [MND or ALS] Users – The Carers Users – Wheelchair Services and Clinical Engineers Clinical Considerations

5. Part-financed by the European Regional Development Fund Clinical Considerations User Environment – Home – Care Home – School or College – Hospital

6. Part-financed by the European Regional Development Fund Technical Considerations

7. Part-financed by the European Regional Development Fund Technical Considerations Clinical Goal – Any patient – Any input device/controller – Any environment – Carer friendly – Any Powered Chair – Therapist and Engineer Friendly

8. Part-financed by the European Regional Development Fund Technical Considerations Commercial Powered Chair Control Systems – Modular – Programmable – Multifunction – Wide range of controllers/user inputs e.g. Joystick Switches Sip and puff

9. Part-financed by the European Regional Development Fund Technical Considerations

10. Part-financed by the European Regional Development Fund Technical Considerations Access to the Powered Chair Control System – Input by Secondary Remote Switch Input Analogue input – Design and Build a Master Remote Possible Advantages and Disadvantages?

11. Part-financed by the European Regional Development Fund 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. Part-financed by the European Regional Development Fund 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. Part-financed by the European Regional Development Fund 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 SYSIASS Implementation

14. Part-financed by the European Regional Development Fund 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. Part-financed by the European Regional Development Fund 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. Part-financed by the European Regional Development Fund Medical Devices Directive Requirements for Clinical Evaluation Technical File development Ethics Approval Clinical Risk Management

17. Part-financed by the European Regional Development Fund SYSIASS Any User - Anywhere Thankyou