Development of a Functional Testing System for Test Automation and Statistical Analysis of the behavior of health care device used to treat Deep Vein Thrombosis

Deep Vein Thrombosis (DVT) is a health condition caused by a blood clot formed in a vein lying deep below the skin. It is treated by increasing the venous blood flow in the affected limb. The DVT health care device achieves this by mimicking the body's natural muscle contractions using a pressure controlled air bag placed on the affected limb. Functional testing of such portable devices is important to detect any deviations from the intended behavior and to collect data for statistical analysis. In this study, a functional testing system is developed to extensively test a DVT health care device and collect data for statistical analysis to predict its behaviour. The testing requires simulating a certain sequence of the end user's actions, which is automated by the testing system. The test is initiated using a mobile app which communicates with the testing system using Bluetooth Low Energy (BLE). The testing system then starts the DVT device, feeds in different pressure values through BLE communication and observes its behavior by collecting pressure sensor readings at various time intervals. Based on the medically acceptable range for peak and stabilized pressure values, the test is declared as successful. The test results for all the DVT devices are communicated to the mobile app. This test automation considerably reduces the time and effort to test all the manufactured DVT devices. Data analysis tools are used to perform descriptive statistical analysis that provides a summary of the collected data and its visualization. Inferential statistical analysis is performed to estimate the behavior of the manufactured DVT devices during long operational hours. The inferences are validated by performing parametric statistical tests on the collected data. Statistical data analysis is done using Python.