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200 Series Formative Planning - Coggle Diagram
200 Series Formative Planning
Simulated Use Environment
Portable Clinics
A&E
Ward Side
GP Practice
Endoscopy Suite
Ambulance
Labelling and IFU
Testing
Cleaning and Disposal
Small Task groups
Interviews/Questionnaires
Can be remote
Focus Groups
Need a draft IFU
Test Cleaning Protocol
Test Disposal method
Performance
Porcine Study
Worst case testing
Fluids are testable
Might be unable to reach D2
Test mechanical properties
More endoscope focused
Prototype disposed of after use
Stomach mucus/hay needs to be removed before study
Live porcine preferred over deceased porcine
Dissected Anatomy
Quick small studies
Able to perform by engineers
Representative for visualisation and illumination
Early stage sigmoidoscope testing
More representative than manikin
Potentially inhouse
Need to find a supplier
Cadaver Study
Test mechanical properties
Test PU sleeve
Cannot test fluids (anatomy will be 'clean')
Representative of patient
More endoscope focused
Prototype disposed of after use
Will not have representative muscle contractions
Will need to run a lubricated endoscope through cadaver ahead of study
Manikin Studies
Ergonomic focused studies
Feedback on touch and feel of device
Easy to compare device against competitors
1 set-up location and have multiple users
Test whole system, storage, set-up, performance and disposal
Testing User Profiles
Clinicians
Trainees
Nurses
Care assistants - Set-up/cleaning
Storage/porter staff
Disposal routes
Accessory Compatibility
G200 to Q200
Easy to plug in
Plug in and Go
3rd Party Image Capture
Ease and set up
Water bottles
Vacuum pump
Irrigation Pump
CO2 Bottles/hospital supply
Monitors
HDMI/SDI
Verification and Validation
Verification Usability for Q200
All non-hazard related URS points
IEC 62366-1