Clinical evaluation of the BP2 upper arm blood pressure monitor according to the ISO 81060-2:2018+Amd 1:2020

OBJECTIVE: To evaluate the clinical measurement accuracy of the BP2 oscillometric upper arm blood pressure monitor in the general population according to the ISO 81060-2:2018+Amd 1:2020 standard. METHODS: Participants were recruited and the same arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+Amd 1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results. RESULTS: A total of 85 participants were included in the final analysis. For the validation criterion 1, the mean ± SD of the differences between the test device and reference readings was -2.93 ± 7.65 and -2.40 ± 6.82 mmHg for systolic and diastolic blood pressure, respectively. For criterion 2, the ±SD of the averaged differences between the test device and reference readings per participant was ±6.16 and ±5.74 mmHg for systolic and diastolic blood pressure, respectively. CONCLUSION: The BP2 upper arm blood pressure monitor passed all the requirements of the ISO 81060-2:2018+Amd 1:2020 standard and can be recommended for clinical use and self-measurement in the general population.