Validation of B.Well PRO-33 oscillometric blood pressure monitor for professional office use in the general population in accordance with Amendment 2 of the Standard 81060-2:2018 by the International Organization for Standardization (ISO 81060-2:2018/AMD 2:2024)

Blood Pressure Monitoring. 2025. No. 11.

Posnenkova O., Simonyan M., Akimova N.

We aimed to evaluate the accuracy of B.Well PRO-33 (B.Well, Widnau, Switzerland) oscillometric device for professional office measurement of blood pressure (BP) on the upper arm in the general population in accordance with the Amendment 2.2024-01 of the Standard 81060-2:2018 by the International Organization for Standardization (ISO 81060-2:2018/AMD 2:2024). Study participants were recruited according to the age, gender, BP, and cuff distribution requirements of the ISO 81060- 2:2018/AMD 2:2024 in the general population using the sequential BP measurement method on the same arm. The test device was used with one universal cuff for arm circumferences of 22–42 cm. We chose aneroid sphygmomanometers Riester Big Ben Square Desk (Rudolf Riester, Jungingen, Germany) with small, medium and large cuffs and Welch Allyn 767 Desk (Welch Allyn, Skaneateles Falls, NY, USA) with a large adult cuff for arm circumferences of 22–37 and 38–42 cm, respectively, as control devices. We enrolled 112 study subjects, of whom 85 were analyzed. For validation criterion 1, the mean ± SD of the differences between the readings of the tested device and reference BP (systolic/diastolic; threshold ≤5 ± 8 mmHg; N = 255) was 1.7 ± 5.4/1.8 ± 5.7 mmHg. For validation criterion 2, the SD of the mean BP difference between the tested device and reference BP readings per subject (systolic/diastolic; threshold ≤ 6.73/6.71 mmHg; N = 85) was 4.7/4.7 mmHg. B.Well PRO-33 professional office BP monitor met the requirements of the ISO 81060-2:2018/AMD 2:2024 for the general population, and therefore can be recommended for clinical use

Keywords: accuracy, automated blood pressure measurement

Publication based on the results of: Математическое и радиофизическое моделирование сложной динамики живых систем для развития методов анализа экспериментальных данных (2025)