Below is the proposed design solution.
Requirement 2: The device must collect a clinically acceptable urine sample.
Design Solution:
The final design solution for the urine collection cup can be seen below.
Requirement 3: The device must be able to detect the
presence of bioburden associated with UTIs.
Design Solution:
Colorimetric analysis will be conducted using colorimetric sensors to show the intensity of the color reaction when leukocytes and nitrites are present in urine. The images below showcase the color ranges of both Leukocyte Esterase and Nitrites once the urinalysis occurs, along with the reagent reactions.
Requirement 4: The device must communicate the levels of
bioburden detected in the urine sample.
Design Solution:
The front panel of the control box will have a screen that displays the results and allows for user input. Once the colorimetric analysis is complete, the microcontroller will process the results as either negative, caution, or positive, based on predefined ranges.
Requirement 5: The device must be able to provide results
in a clinically relevant amount of time.
Design Solution:
A sensor will be placed in the sample collection area to trigger the peristaltic pump to turn on, and allow for quick sample transport and testing. The optimal sensor for this functionality is shown below.
Requirement 6: The device must meet electrical safety standards IEC 60601.
Design Solution:
The control box will include both a separate compartment for high-voltage components to ensure that the voltage supplied to various electrical components, as well as the power from the wall, is operating at a safe level. The device will be powered by a wall outlet to ensure that all components have ample power.
Requirement 7: The device must be sanitizable.
Design Solution:
The device will be programmed to have the option to run a cleaning sequence, in which a cleaning agent as well as water are run through the device to a waste cartridge, similarly to how urine flows through the device, in order to disinfect it. When selecting device materials, one of the parameters considered was whether or not the material can be cleaned with an EPA grade disinfectant.
Below is an algorithm of the device from a user functionality standpoint.
