Verification and Validation
Anna DiRienzo, Katelyn Lesk, Amber Loree, and Jude Menie
Verification
Stability
The stability of the device was evaluated using a vibration test. Pressurewas applied totwo areas of the device that would experience unintended forces (the gooseneck and the IV pole), and then the duration of the vibrations was timed using a stopwatch. The testwas performed using each group member(four different people) to ensure that the pressure applied was an average.
Sterilization
The effects that sterilization would have on our device were measured, not in how well the methods would work, but rather, how, or if, the current sterilization regimes affected the material and stability of the system. This was accomplished by treating novel surfaces of the apparatus with ethyl alcohol (EtOH)oncea day for a week straight while visually inspecting the areas for apparent material deterioration.
Strength
The strength of the device was quantified using a maximum weight test in which loads were added to the end of the gooseneck where the iSCAN will eventually be attached. Weight wasincrementally added until the device became unstable prior to five minutes. This was tested with the gooseneck in two positions: normal and maximum.The gooseneck’s“normal”positionwas deemed as the position the gooseneck will be when the iSCAN is in use (bent downward). The second position, named the “maximum” position (horizontal gooseneck), applies the greatest amount of force of the gooseneck attachment to the L-plate.
Positioning
The range of motion wasevaluated by immobilizing the base and measuring the distance in each direction that the iSCAN can be positioned.The positions chosen to evaluate are its range of motion laterally and vertically, furthermore, the distances of the gooseneck in its normal and maximum positions to the IV pole were measured.
Validation
Ease of use
The ease of use of the device will be tested using time trials for the complete process of set-up, positioning, a simulation of ICP reading, and removal of the apparatus from the bedside. These trials will be done by each group member a series of times to get an average for the amount of time that would be needed to use this device in an emergency room setting.
Physician Survey
A survey will be generated including questions about ease of attachment and detachment of parts, ease of movement and positioning, and overall effectiveness of the support device. These surveys will be given to physicians who will be asked to answer the questions based on their personal interaction with the device.
Client Expectations
The device will be shown to our group’s mentors who will evaluate the effectiveness of the support device as well as its interface capability with the iSCAN. Necessary changes will be made upon evaluation.