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)

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.