Preliminary Clinical and Technical

Specifications

Any User - Anywhere

1Part-financed by the European Regional Development Fund

Part-financed by the European Regional Development Fund

Contents

• Clinical Considerations• Technical Considerations• SYSIASS Implementation• Project Risk Management • Clinical Risk Management

2

Part-financed by the European Regional Development Fund

Clinical Considerations

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

Part-financed by the European Regional Development Fund

Clinical Considerations• User Environment

– Home– Care Home– School or College– Hospital

Part-financed by the European Regional Development Fund

Technical Considerations

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

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

Part-financed by the European Regional Development Fund

Technical Considerations

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?

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

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

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

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

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

Part-financed by the European Regional Development Fund

Medical Devices Directive• Requirements for Clinical Evaluation• Technical File development• Ethics Approval

Clinical Risk Management

Part-financed by the European Regional Development Fund

SYSIASSAny User - Anywhere

Thankyou