This Study Aims to Assess the Performances of Optical Blood Pressure Monitoring Device, tBPC Product With Reference to ISO 81060-3:2022

The investigation medical device under evaluation is oCareTM BP 100, a non-invasive continuous blood pressure monitoring system developed by Taiwan Biophotonic Co. (tBPC). The main function is to use a fingerclip sensor to receive PPG signals and collect continuous blood pressure values and uninterruptedly within the initialization time. In this study, according to the latest released ISO 81060-3:2022 standard requirements, non-invasive blood pressure measurement by cuff at the start and the end time points will be used as oCareTM BP 100 start-to-end blood pressure calibration. The A-line invasive arterial catheter blood pressure measurement will be used as a reference invasive BPM equipment. The purpose of the study is to confirm the stability of the investigational medical device under evaluation and its performance of blood pressure change tracking.