Verification Activities:
- Requirement 1: Run an analysis on the finalized CAD drawings to calculate the internal volume of the socket in it’s fully expanded and fully contracted state.
- Requirement 2: Confirm on material specification sheets that the yield strength exceeds 333 psi. Perform pressure distribution tests in specified regions in Ansys ensuring socket does not deform.
- Requirement 3: Time process of applying the device onto a dummy residual limb. Repeat these steps while taking it off.
- Requirement 4: Confirm that the chosen socket adapter will fit within the 50% market share by comparing manufacturer specification sheets.
- Requirement 5: Apply contaminants to the interior of the socket and use a set of unspecialized cleaning products to clean. Record cleaning effectiveness by visual inspection for residue.
- Requirement 6: Apply pressure to device sensor to ensure device can detect the pressure range.
- Requirement 7: Apply pressure exceeding the threshold to each sensor for the defined duration and ensure notification method activates.
- Requirement 8: Set up the prototype and ensure it will stay powered for the designated amount of time.
- Requirement 9: Perform leakage current testing while in use to ensure the levels are within permissible limits.
Validation Activities:
- Requirement 1: Ensure the socket fits on mock residual limbs that represent the maximum and minimum volumes.
- Requirement 2: Allow the user to apply device to their residual limb and complete activities, like ambulating, donning, doffing, and ensure device does not deform or fail.
- Requirement 3: Perform a survey with a collective group applying and removing the device from a mock residual limb and inquire about the ease of donning and doffing.
- Requirement 4: N/A
- Requirement 5: Have participants clean the socket with set of unspecialized cleaning products and survey them for how easy it was to clean.
- Requirement 6: N/A
- Requirement 7: Have user wear socket during daily activities and ensure pressure induced injuries do not occur prior to notification. Survey user on effectiveness of notification method.
- Requirement 8: N/A
- Requirement 9: N/A
For more information on the requirements check out the “Design Inputs” page!