Validation of the Hanvon KSY8600 Blood Pressure Monitor in the General Population Based on AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020 Protocol

This study evaluated the accuracy of the Hanvon KSY8600 blood pressure monitor in adult populations in accordance with the AAMI/ESH/ISO (ISO 81060-2:2018) and AMD 1:2020 standards. 90 people were recruited as research participants, among which 88 eligible participants were chosen and analyzed according to the research plan. The average age of these participants was 51.3 ± 17.35 years old, with an average arm circumference of 28.1 ± 3.41 cm, and with females accounting for 60.2%. The test results showed that the mean differences (standard deviations) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) displayed on the blood pressure monitor were − 0.4 mmHg (2.09 mmHg) and − 0.3 mmHg (1.86 mmHg) respectively, meeting the requirements of Criterion 1 ( ≤ ± 5mmHg (8mmHg)). Additionally, the average standard deviations of the participants' SBP and DBP were 0.91 mmHg and 0.90 mmHg respectively. According to Table 1 of Criterion 2, the mean values of SBP and DBP were − 0.4mmHg and − 0.3mmHg respectively, with maximum allowable standard deviations of SBP and DBP of ≤ 6.93 and ≤ 6.95 mmHg respectively, meeting the requirements of Criterion 2. It was thus proved that the blood pressure monitor complies with AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020, and is recommended for clinical and home blood pressure measurement for adults.