The BTL-001-2 ABPM blood pressure monitoring device will be evaluated in a total of 100 subjects that will approximate the distribution of blood pressures as outlined in ISO 81060-2:2013 / ISO 81060-2:2018 + A1: 2020. The maximum number of subjects enrolled will not exceed 100 subjects. Two trained observers who are medical professionals will observe (listen to) the Korotkoff sounds at the brachial artery of the arm. The reference blood pressure measurements by the medical professionals will be performed sequentially with the device under test. The medical professionals will complete 1 or 2 initial baseline auscultatory reference blood pressure measurements and device under test (BTL-001-2 ABPM) measurements. This is followed by minimum 3 and a maximum of 8 valid paired blood pressure readings of auscultatory reference blood pressure measurements alternated with device under test measurements.

Once the BTL-001-2 ABPM (Automated Non-Invasive Blood Pressure Sphygmomanometer) passes the clinical investigation as per the requirements ISO81060-2:2013/ISO 81060 – 2: 2018 + A1:2020 (given in sections 5.1 and 5.2), then it shall undergo clinical investigation according to 5.2 in at least an additional 45 pregnant (special) population.

It is expected that the data collection will take up to approximately 1 hour per subject. There is no additional follow-up required for the study.

For accuracy claims, the test device measurements will be compared to those made by the reference device. The data for the final analysis will contain no fewer than 85 subjects with a minimum of 255 valid paired observations. At least 90% of the subjects will contribute 3 valid paired observations. In this case, additional subjects shall be used to complete the minimum number of valid paired observations.