Clinical evaluation of Bionet sphygmomanometer module BN1 based on ISO 81062-2:2018 protocol

According to INTERNATIONAL STANDARD (hereafter ISO) blood pressure monitor clinical evaluation protocol (ISO 81060-2:2018, Non-invasive sphygmomanometers- Part2: Clinical investigation of intermittent automated measurement type) for BN1 (BNiBP), an electronic sphygmomanometer module newly developed by Bionet Co., Ltd., the clinical group and evaluation criteria presented in , the effectiveness of blood pressure measurement performance was evaluated. The auscultation method used as a reference (gold standard) of a non-invasive blood pressure (NIBP) measurement method was used. The first blood pressure measurement was performed once each (R0, T0) with auscultation and the test medical device (BM5 equipped with BN1 (BNiBP)). The blood pressure was measured three times (T1 to T3) by the test medical device alternately. A minimum interval of 1 min was allowed between each blood pressure measurement. A total of 86 study subjects were enrolled. Three data pairs (mean value of R1, R2 & T1 / R2, mean value of R3 & T2 / R3, mean value of R4 & T3) were obtained from one study subject, and a total of 258 data pairs were obtained. Among them, some data of three study subjects did not satisfy the conditions required by ISO 81060-2:2018, so one dropout data pair (total of three dropout data pairs) occurred. Therefore, 255 valid data pairs were obtained from 86 study subjects, and the distribution conditions required by ISO 81060-2:2018 were satisfied. Criterion 1 is that for 255 valid data pairs, the average value of the difference between the test medical device and the auscultation method blood pressure should be 5 mmHg or less and the standard deviation should be 8 mmHg or less. In this study, SBP was -1.55±6.25 mmHg and DBP was -0.02±6.61 mmHg, confirming that Criterion 1 was satisfied. Criterion 2 is that, for 86 study subjects, the standard deviation of the average value of the difference between the data pairs of each study subject must satisfy the standard deviation criterion according to the average value of the blood pressure difference provided by ISO 81060-2:2018. The mean value of the difference in blood pressure in this study was SBP -1.6 mmHg and DBP -0.0 mmHg, and the standard deviation should be less than SBP 6.76 mmHg and DBP 6.95 mmHg, respectively. In this study, it was confirmed that the standard deviation satisfies Criterion 2 with SBP 4.97 mmHg and DBP 5.82 mmHg.