Accuracy of the Combei BP880W Wrist Device for Self-Blood Pressure Measurements in General Population According to the International Organization for Standardization Universal Standard (ISO 81060-2:2018/AMD 1:2020) Protocol.

BACKGROUND

Scientific societies universally recommend evaluating the accuracy of electronic devices designed for blood pressure (BP) measurement using established validation protocols.

OBJECTIVE

This study aimed to assess the accuracy of the Combei BP880W wrist device for BP measurement in the general population, according to the ISO 81060-2:2018/AMD 1:2020 Universal Standard.

METHODS

The Combei BP880W is an oscillometric device designed to measure BP at the wrist. This study adhered to the ISO 81060-2:2018/AMD 1:2020 protocol and employed the same-arm sequential BP measurement method. A total of 85 participants, meeting protocol-specified age, gender, BP, and cuff distribution criteria, were included. The accuracy analysis utilized Criterion 1 (differences and standard deviations between reference and test device measurements) and Criterion 2 (intra-individual standard deviation of BP differences).

RESULTS

Eighty-five participants were included. Mean BP differences between the simultaneous observer measurements were -0.2 ± 1.9 mmHg for systolic BP (SBP) and 0.1 ± 1.9 mmHg for diastolic BP (DBP). For Criterion 1, the mean difference ± standard deviation (SD) between the reference and test device measurements were -2.7 ± 5.9 mmHg (SBP) and -2.0 ± 3.9 mmHg (DBP), meeting the required threshold (≤ 5 ± 8 mmHg). For Criterion 2, intra-individual SDs were 4.6 mmHg (SBP) and 3.4 mmHg (DBP), both below the respective limits (≤ 6.39 mmHg for SBP and ≤ 6.65 mmHg for DBP).

CONCLUSION

The Combei BP880W wrist device meets the accuracy requirements of the ISO 81060-2:2018/AMD 1:2020 protocol, supporting its use for home BP monitoring in the general population.