Validation of the Hanvon KSY3600 Korotkoff-sound electronic blood pressure monitor in the general population according to the ISO 81060-2:2018

This study aims to evaluate the accuracy of the Hanvon KSY3600 Korotkoff-sound electronic blood pressure (BP) monitor in the adult population, in accordance with the ISO 81060-2:2018. A total of 90 participants were recruited for this clinical study. After excluding 3 individuals due to excessive BP variability, the remaining 87 participants were enrolled for the evaluation. All enrolled participants met the inclusion criteria, which specified ranges for arm circumference, SBP, and DBP. According to ISO 81060-2:2018 + Amd 1:2020, the mean ± SD of the differences between the test device and the reference BP measurements were -0.3 ± 2.35/-0.3 ± 1.72 mmHg (SBP/DBP), thus meeting the requirements of Criterion 1 (≤5 mmHg mean difference and ≤8 mmHg SD). The mean difference in SBP was -0.3 ± 1.11 mmHg, while that in DBP was -0.3 ± 0.90 mmHg; this also fulfilled the requirements of Standard 2, with standard deviations within the limits of ≤6.95 mmHg for both SBP and DBP. Both ISO criteria were therefore satisfied, showing that the Hanvon KSY3600 Korotkoff-sound electronic BP monitor conforms to the ISO 81060-2:2018 + Amd 1:2020. It can thus be recommended for BP measurements in adults, both in clinical settings and for home use.