Trial Outcomes & Findings for Clinical Evaluation of the Performance of Bionet Sphygmomanometer Modules Based on Protocol Presented by the International Organization for Standardization (NCT NCT06609486)

Recruitment is made through the recruitment notice for patients and their guardians who visit Hanyang University Hospital. Subjects who meet the criteria presented in ISO 81060-2:2018 Protocol 5.1 Subject requirements are recruited.

\[Selection Criteria\] - Subjects who have consented to participate in the clinical trial and voluntarily consented in writing - Subjects who meet the criteria presented in ISO 81060-2:2018 Protocol 5.1 Subject requirements \[Items excluded from clinical trials\] - Complete blood pressure range recruitment (Range complete) - Arrhythmia - Device failure - Cuff size unavailable - Poor quality of Korotkoff sounds - Observers disagreement - Other factors

Unit of analysis: Data pair

Race and Ethnicity were not collected from any participant.

The blood pressure used for evaluation was measured four times by auscultation (first reference BP to fourth reference BP, R1 to R4) and three times by the test medical device (first test BP to third test BP, T1 to T3) alternately. A minimum interval of 1 min was allowed between each BP measurement. 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. Criterion 1 is that for valid data pairs, the mean value of the difference between the test medical device and the auscultation method BP (test device BP - auscultation BP) should be 5 mmHg or less and the standard deviation (SD) should be 8 mmHg or less. Criterion 2 is that, for study subjects, the ISO 81060-2:2018 for presenting different SD thresholds depending on the mean value of the difference should be satisfied. When mean value of the difference is ±1.6, ±0.0 mmHg, the SD should be less than 6.76 and 6.95 mmHg, respectively.