Basics of the design:

• Design is an add-on to the ECMO circuit (Figure 1).
• The gate connects about every six hours to allow blood into the testing loop.
• Both tests have gates that collect the optimal amount of blood before closing off.
• After both tests are run, the computer runs through an algorithm (Figure 2) to decide the next steps and alert a medical provider if necessary.

Figure 1: Schematic of Design

Logic of the Machine (Figure 2):

• If both tests agree, the computer will alert a provider if the coagulation levels are too high or too low.
• If there is a disagreement or inconclusiveness, the computer will alert a provider to perform an ultrasound first on the leg or other high-risk areas to confirm whether there is clotting. Then, the provider can take the necessary steps to adjust the coagulation levels.

Figure 2: Logic diagram of determining what a patient needs

Iterative Design Process (Figure 3):

• We have a current design but have yet to truly test the accuracy and efficacy
• The iterative design process allows us to test and make adjustments until the product is what we want
• Once the design/prototype satisfies accuracy and efficiency (and other criteria), we can begin manufacturing and distribution

Figure 3: Iterative Design Process