Validation of the Hanvon FY730 upper-arm blood pressure monitor according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018)

This study evaluates the measurement accuracy of the Hanvon FY730 upper-arm blood pressure (BP) monitor, which uses the Korotkoff sound method, in compliance with the AAMI/ESH/ISO universal standard (ISO 81060-2:2018). A clinical trial involving 86 eligible adults was conducted, and data were analyzed based on standardized protocols. The mean differences between the device and reference measurements for systolic blood pressure (SBP) and diastolic blood pressure (DBP) were −0.37 mmHg (SD: 2.25 mmHg) and −0.17 mmHg (SD: 2.02 mmHg), respectively. Standard deviations for SBP (≤6.93 mmHg) and DBP (≤6.95 mmHg) met the required thresholds. A total of 258 effective paired measurements demonstrated that the Hanvon FY730 provides highly consistent results compared with reference methods, with all deviations falling within acceptable limits. The study also confirmed the device’s reliability across a wide range of arm circumferences (22–36 cm) and BP levels (SBP: 90–188 mmHg, DBP: 53–107 mmHg). These findings confirm that the Hanvon FY730 complies with ISO 81060-2:2018 standards, demonstrating its suitability for accurate BP monitoring in clinical, personal, and home settings.