Development of a high-precision evaluation system for radial pulse wave applanation tonometry devices

The demand for wearable devices for daily health management and tonometry-based pulse wave measurement has grown rapidly. However, the absence of standardized and physiologically realistic evaluation systems remains a major barrier to developing reliable and clinically applicable devices. Although ISO 18615:2020 defines general performance requirements for electronic radial pulse tonometric devices, no evaluation platform has been available to assess these standards with higher precision. We developed a novel high-precision evaluation system that integrates a 3D cam-based pulse wave generation unit, wrist simulation unit, system control unit, and applied pressure unit. This platform enables controlled and reproducible simulation of physiological pulse waves, including variations in base pressure, pulse pressure, applied pressure, and radial skin and arterial properties, which have been difficult to replicate in previous systems. The system was designed not only to meet but also to exceed ISO 18,615 requirements, thereby enabling precise performance assessment. Validation experiments evaluated pulse wave precision and range, as well as artificial radial artery characteristics. The system demonstrated high reproducibility and accuracy. The mean coefficients of variation (CVs) were 0.29% for applied pressure, 0.11% for pulse waves, and 0.05% for pulse rate. The CVs of pulse wave shape parameters H and T were 1.06% and 1.60%, respectively. The systole/diastole ratio (SDR) ranged from 24.45% to 57.69% with a 1.04% error ratio, the pulse rate from 19.93 bpm to 204.90 bpm with a 0.34% error ratio, and the base pressure from − 3.17 mmHg to 116.51 mmHg with a 3.60% error ratio. This study presents the first comprehensive evaluation platform capable of reproducing physiologically realistic radial arterial pulse waves with high precision and reproducibility. By referencing and surpassing ISO 18,615 performance requirements, the system provides rigorous and reliable assessment of device performance. This platform reduces variability, enables precise calibration, and offers a benchmark for evaluating tonometry-based and wearable pulse wave measurement devices. It is expected to accelerate the development of high-quality cardiovascular monitoring technologies and support the clinical translation of wearable health monitoring devices.