An Open Source Validation System for Continuous Arterial Blood Pressure Measuring Sensors

Highlights What are the main findings? An electromechanical, cam-based continuous arterial blood pressure simulator consisting of cost-effective 3D printable parts was developed. This simulator is capable of accurately repeating waveform samples consisting of multiple cardiac cycles. An open-source Python software package is provided to generate new cams from custom waveforms and validate sensors against them. What is the implication of the main finding? Hardware components of the proposed simulator are easy to fabricate even within academic or clinical institutions due to the widespread availability of low-cost 3D printing technology. Thus, early-stage development of continuous non-invasive blood pressure sensors benefits from an accessible and easily customizable tool. The validation software provides an extensible framework to store, organize, and evaluate sensor data and to generate statistical reports from them. Abstract The advancement of sensor technologies enables the measurement of high-quality continuous blood pressure signals, which has become an important area in healthcare. The development of such application-specific sensors can be time-consuming, expensive, and difficult to test or validate with known and consistent waveforms. In this manuscript, an open-source blood pressure waveform simulator with a Python validation package is described. The core part, a 3D-printed cam, can be generated based on real blood pressure waveforms. The validation software framework compares in detail the waveform used to design the cam with the time series from the sensor being validated. The simulator was validated using a 3D force sensor. The RMSE of accuracy was 1.94 (44)–2.74 (63)%, and the Pearson correlation with the nominal signal was 99.84 (13)–99.39 (18)%. As for precision, the RMSE of the repeatability of cam rotations was 1.53 (71)–2.13 (116)% and the Pearson correlation was 99.85 (16)–99.59 (57)%. The presented simulator proved to be robust and accurate in short- and long-term use, as it produced the signal waveform reliably and with high fidelity. It reduces development costs for early-stage sensor development and research, offering a solution that is easy to manufacture yet capable of continuously outputting human arterial blood pressure waveforms spanning multiple consecutive cardiac cycles.