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.

Abstract

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.