Key result
The BP2 upper arm blood pressure monitor met ISO validation criteria with mean differences of -2.93 ± 7.65 mmHg for systolic and -2.40 ± 6.82 mmHg for diastolic blood pressure versus reference.
Why the study?
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.
Does the BP2 oscillometric upper arm blood pressure monitor provide accurate clinical measurements compared to reference readings in the general population?
Cross-Sectional (n=85)
Does the BP2 oscillometric upper arm blood pressure monitor provide accurate clinical measurements compared to reference readings in the general population?
Mean Difference: -2.93
The BP2 upper arm blood pressure monitor meets ISO standards for accuracy and is recommended for clinical and self-measurement use.
BP2 meets ISO accuracy criteria in general adults; leaves open independent outcome data before broad clinical adoption.
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.
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Wan et al. (2025) conducted a cross-sectional in general population (n=85). BP2 oscillometric upper arm blood pressure monitor vs. reference readings was evaluated on mean difference between test device and reference readings (validation criterion 1) (MD -2.93). The BP2 upper arm blood pressure monitor met ISO validation criteria with mean differences of -2.93 ± 7.65 mmHg for systolic and -2.40 ± 6.82 mmHg for diastolic blood pressure versus reference.
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